-------
cr/067
* to Inspect books and records required to
be maintained under section 8 and
copies of records which are available
¦under section 8 of Uie
Act, It Is unlawful for any person to re-
fuse to keep or to permit Inspection of
books and records, or to refuse to permit
inspection of an establishment Pursuant
to section 12* a) (1) of the
Act or Initiate criminal proceedings pur-
suant to section li'b> of the Act. If,
upon Inspection or tests, a device is be-
lieved to be in violation of the Act, or if
It Is believed that a device is intended to
be distributed or sold in violation of the
Act, a Stop Sale. Die or Removal Order
may be Issued pursuant to section 13.
Additionally/section 13 authorizes in
rem seizure proceedings in a federal dis-
trict court against any device which Is
mlsbranded or which, when used In ac-
cordance with the requirements Imposed
under the Act causes unreasonable ad-
verse efiects upon the environment.
Finally, the Administrator may seek in-
junctive relief pursuant to section 16(c)
to prevent and restrain violations of the
Act
VZZ. Public Cotttusn
The Administrative Procedure Act <5
U.S.C. 533(b)) provides that the solici-
tation of comments is not required of
Federal agencies for "interpretative
rules, general statements of policy, or
rules of agency organization, procedure,
or practice." EPA has determined that
this Notice falls within this exemption
from the requirement to solocic public
comment. Nonetheless, interested pern
sons may submit written comments re-
garding the policy set forth in this
Notice to the Pesticides and Toxic Sub-
stances Enforcement Division (EN-342),
Office of Enforcement. 0.3, Environ-
mental Protection Agency. 401 M St,
SW„ Washington. DC. 20460. Three
copies of these comments should be sub-
mitted to facilitate the work of the EPA
and others interested In inspecting such
documents.
Dated: November 8, 1976.
Stanley \v. Lkcro.
Assistant Administrator
for Enforcement.
I PR Doc.70-.34U9 Filed U-1B-7«:S:4S *m|
ffDESAl tEClSTft, VOL 41, NO. J7J—feiOAr. NOViMSEf 1». |976
-------
K&TJCES ^Z6"/3
irai mhj
PEST COfJTROL DEVICES PROCEDURES
Consolidation and Clarification of
Requirements
Correction
In FK Doc. 76-34113 appearing on page
510C3 Ln the Issue for Friday, November
10. 1076, on page 51066. middle column,
third /uU paragraph, in the 12Ui line.
"January 18. 19"6" should have read
"January 18, 1877",
vol. «1. NO. «._TU«SOAr. NOVEMSI* 30. ,9..
-------
Publicity and Outreach
Environmental News Release
Letter to Manufacturers ani Professional Associations
-------
EPA invironmental
IHlsws
draft
Sibbison (202) 755-0344
EPA WILL The Environmental Protection Agency said today it
INVESTIGATE'
WATER is initiating a program to test the ability of non-
PURIFIERS
chemical water purifi ation devices to purify water.
EPA said it will take enforcement action against the
manufacturer of any product which fails in the tests to
remove microorganisms that could cause disease.
A non-chemical water purification device is a product
which uses a physical means to eliminate microorganisms,
such as bacteria and viruses, from previously untreated
water. These physical means include ultraviolet
radiation, filtration, reverse osmosis, distillation,
and ozone or chlorine generation.
Water purification devices are most often used in areas
where municipally treated water is not available and
the individual is dependent on water from a well, lake,
or stream. Often the quality of this water is of
questionable safety because it may be contaminated, with
disease causing microorganisms.
If a water purification device fails to eliminate
these microorganisms, there is a'risk of causina such
diseases as hepatitis,^dysentery, and infection of
the stomach and intestines.
EPA will have about 50 water purification devices
tested by the State of New York Department of Health,
Division of Laboratories and Research, Environmental
Health Center, in Albany.
A.E. Conroy II, of EPA's Office of Enforcement, said
thie Agency has received aomplaints from consumers
indicating that some of the devices do not work
properly. In addition, he said, a 1979 study published
by the Canadian Environmental Health Directorate .
concerning three tv::=s of purifiers using ultraviolet
light showed that two of them effectively removed
bacteria but a third device did not.
(more)
-------
-2-
"We have reason to believe that users of some of these
purifiers sold in the United States may be exposed to
dangerous levels of microorganisms," Conroy said.
Under Section 7 of the Federal Insectiicde, Fungicide, and
Rodenticide Act, all manufacturers of water purification
devices are required to register with the Environmental
Protection Agency and submit annual production reports on
their devices. This information is crucial, Conroy said,
to the Agency's ability to successfully carry out this
monitoring program and protect the public health.
Once a manufacturer has been registered, he or she will
receive an EPA establishment registration number which
must appear on the device's label. If a consumer should
find a water purification device that does not bear an
EPA establishment registration number on its label, he or she
should write to A.E. Conroy II, U.S. EPA, EN-342, 401 M Street,
S.W., Washington, D.C. 20460, Attention: Water Purification Devices.
# # #
-------
Letter to Manufacturers and Professional Associations
DRAFT
To Whom It May Concern:
The Environmental -Protection Agency (EPA) has recently become aware
of the fact that many manufacturers of water purification devices do not
realize they are required to register their establishments with the Agency.
v:e have learned that,your firm may be a.manufacturer of water purifi-
cation devices and therefore subject, along with the device, to the Federal
Insecticide, Fungicide, and Rodenticide Act as Amended (FIF3A). A device
is defined in FIFRA as "any finstrunent or contrivance...which is intended
for trapping, destroy ing^repelling, or mitigating any pest...." Bacteria,
viruses and other microorganisms are considered pests under FIFRA section
2(t) and 40 CFR 162.14 (B)(4) and (5).
Any product which claims to purify water must make previously untreated
water, suitable.foe human consusption-{.i.e.,-eliminate, all pathogenic micro-
organi's.TS). This definition of a water purifier comes from a 1964 ruling
in Federal Trade Commission v. Sibco and has recently been reiterated in a
1973 E?A decision In re-Contact Industries Inc.
There are basically two broad categories of water purifiers, those
which use a chemical means to destroy the microorganisms and those.which
use a physical means. Purifiers which use a chemical means are considered
pesticides and subject to registration requirements in section 3 and section
7 of the Act-(product and establishment registration). Those which use
a physical means are considered devices and subject only to those registration
requirements,rin section 7 (establishment registration). Examples of such
devices include but are not limited to: Ultraviolet light systems, subcnicron
filters; reverse osmosis units, distillers, chlorine generators, and ozone
generators.
All manufacturers of water purification devices are required to register
their establishments with the Agency and submit annual production and distri-
bution data on their devices. Enclosed you will find a copy of FIFRA, two
Federal Register Notices, and 40 CFR 162.15 clarifying the Agency's authority
and requirements of the Act.
Also enclosed is EPA form 3540-8, Application for Registration of
Pesticide Producing Establishment, if you manufacture water purification
devices, please complete EPA form 3540-6 if you have not already done so.
-------
Once an Z?A estaihlishment ruaber has been assigned, EPA form 3540-16,
Pesticides Report for Pesticide-Producing Establishments, will be sent
to you for completion. Include either the words "point-of-use" or "small
S73tez" in parentheses after the product name, depending on the intended
use of the product. Point-of-use purifiers are those intended for use in
a single family household, camper, boat, etc. Small systems would be used
for industrial or ccnmercial purposes or to supply water for twenty-five
people or core.
If you do not manufacture water purification devices, we would greatly
appreciate it if you would inform us at the address given below so that we
may recove your name from our li3t.
If you have ary questions concerning your product and whether it is subject
to FIT?.A, please contact Joseo'nine Huang, Toxicologist, U.S. EPA, EI-342, 401
H Street S.W., Vashir^ton, D.C. 20460, (202) 472-3701.
Sincerely yours,
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
Siclosures
-------
:rrcrt Documents
Protocol for Product Testing
raft available from headquarters)
Criteria for Review Teaa Analysis
(under developnent)
List of Products
(under development)
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. DC. 20460
OCT 17 B80
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: Routine Use of SEC "KMC" Statements in TSCA and FIFRA
Civil Penalty Actions
TO: Regional Enforcement Division Directors
Introduction
The Office of Enforcement is interested in the financial
status of companies charged with TSCA or FIFRA violations
for two reasons:. (1) to establish appropriate civil
penalties and (2) to challenge corporate claims that
severe economic consequences will result from civil
penalty assessments.
At present, the Regions utilize Dun and Bradstreet
publications to determine the general financial condition
of a business enterprise. However, the general level of
detail provided by the Dun and Bradstreet publications,
if used.as the only source of information, may provide
an incomplete and potentially misleading picture of a
company's financial condition.
In exploring various alternative' sources of financial
information, PTSED has discovered a potentially excellent
tool for determining financial status: the "10-K" state-
ments filed by companies with the Securities and Exchange
Commission (SEC). The purpose of this memo is to explain what
10-K statements are and how they can be used in the TSCA./
FIFRA enforcement program to improve our ability to determine
financial status.
The '10-K Statement
Purpose of,10-K Statement
A basic purpose of the federal securities laws is to
provide disclosure of.financial and other information on
companies seeking to raise capital through , the public ~
offering of their "securities and companies whose securities
are already publicly held. The goal is to enable investors
to evaluate the securities of these companies on an informed
and realistic basi3.
-------
-2-
The Securities Exchange Act of 1934 deals in large
part with securities already outstanding and requires the
registration of securities listed on a national securities
exchange as well as over the counter securities in which
there is a substantial public interest. Companies which
issue registered securities must file annual and other
periodic reports designed to provide a public file of
current material information. Currently over 11,000 com-
panies file disclosure statements with the SEC (July 1980
estimate).
Contents of 10-K Statement
The 10-K statement is the official annual business
and financial report which must be filed by most companies.
The financial section (Part I) must be filed within 90
days of a company's fiscal year end. Supporting data
(Part II) of the 10-K contains the information normally
required in a proxy statement. Schedules to financial
statements may be filed by amendment within the 120-day
limit. No other source of corporate information provides
more comprehensive or current information about a company
than this report with its schedules, exhibits and amendments.
The following is a description of the items contained in parts I
and II of the 10-K statement that pertain to a company's
financial status.
Form 10-K
Business. Identifies principal products and services
of the company, principal markets and methods of distribution
and, if "material", competitive factors; backlog and
expectation of fulfillment; availability of raw materials;
importance of patents, licenses, and franchises; estimated
cost of research; number of employees; and effects of com-
pliance with ecological laws.
Summary of Operations. Summary of operations for each
ofv the last five fiscal years and any additional years
required to keep the summary from being misleading (Per-share
earnings and dividends are included). Includes explanatory
material describing reasons for changes in revenues, earnings,
etc.
Properties. Location and character of principal plants,
mines, and other important properties and if held in fee or
leased.
Parents and Subsidiaries. List or diagram of all
parents and subsidiaries and for each named, the percentage
of voting securities owned or other basis of control.
-------
-3-
Legal Proceedings. Brief description of material legal
proceedings pending. When civil rights or ecological status
are involved, proceedings must be disclosed.
Executive Officers of the Registrant. List of all
executive officers, nature of positions and offices held.
Enforcement Use of 10-K Statements
Civil Penalty Assessment
A 10-K statement will greatly assist the Regions in
applying the adjustment factors as required by the TSCA
civil penalty process. Section 16 of TSCA provides for
civil penalty amounts which range up to $25,000'per violation.
A number of factors must be considered in assessing a civil
penalty:
"In determining the amount of a civil penalty, the
Administrator shall take into account the nature, circum-
stances, extent, and gravity of the violation or violations
and, with respect to the violator, ability to pay, effect
on ability to continue to do business, any history of prior
such violations, the degree of culpability, and other such
matters as justice may require" (Section 16, TSCA).
The gravity based penalty in the Civil Penalty System
(Federal Register, September 10, 1980) developed to implement
this Section reflects the seriousness of the violation's
threat to health and environment. The 10-K statement is not
applicable to this part of the Agency penalty assessment.
However TSCA also requires the Agency to consider certain
adjustment factors related to the violator. The following
is a discussion of the ways EPA can use 10-K statements
during its deliberations concerning the applicability of the
adjustment factors to a particular company.
1. Violation History
The TSCA Gravity Based Penalty is designed to apply
to "first offenders."^ Where a violator has demonstrated
a similar history of violations, the Act requires the
penalty to be-adjusted upward. Generally, companies with
multiple establishments are considered as one when deter-
mining violation history. Thus, if one establishment of
a company commits a TSCA violation, it counts as history
when another establishment of the same company, anywhere in
the country, commits another TSCA violation. The same policy
applies where a parent corporation in the substantially
similar line of business as that of its subsidiary, commits
a violation. Because many large companies are comprised of
smaller corporate entities with'different names than their
-------
-4^-
parent company, it is sometimes difficult to identify past
violations.
The 10-K statement ahould be requested whenever'there
is any question about the corporate holdings of a violator
during civil penalty assessment. This is particularly true
where a large corporation is involved since there is an
increased likelihood of subsidiary companies. This information
can then be used to determine if any part of the company
has committed TSCA violations in the past.
2. Ability to Pay and Ability to Continue in Business
Section 16 of TSCA lists "ability to pay" and "ability
to continue in business" as two adjustment factors. The
TSCA penalty policy states that "the distinctions between
the two are so narrow and artificial that they are treated
as one." Consequently "ability to pay" will henceforth
be used to include "ability to continue in business."
Measuring a firm's ability to pay a cash penalty without
ceasing to be operable can be extremely complex.
The current formula in the TSCA penalty policy determines
ability to pay by reference to the company's yearly net
income as determined by a fixed percentage of total sales.
This formula may not yield a complete and accurate picture
of the company's ability to pay.
Since the 10-K statement provides a more comprehensive
summary of financial status, it ^is suggested that the Regions
take the following steps in reviewing 10-K statements to
determine ability to pay.
1. Look at the assets of the company for the most current
two year period. The factors in this category include
cash on hand, marketable securities, receivables, inven-
tories, current assets, property, plant and equipment,
and depreciation. All of these factors should be summed
and to obtain the total assets of the firm.
2. Look at the liabilities of the company for the most
current two year period. The factors in this category
include accounts payable, notes payable, taxes due, total
current liabilities, long term debt, and shareholders
equity.
3. Look at the income statement of the company for the
most current two year period. The factors in this
category include net revenue, cost of goods, gross
profit, general and administrative expenses, income
before tax, extraordinary items, and net income.
-------
The income section of the 10-K statement is the most
useful for assessing a company's ability to pay a civil penalty
(item 3 above). In particular, the gross profit of a company
provides a good picture of the stability of a company. Gross
profit is the income that, the company derives after the deduction
of the cost of goods. It does not reflect the general and adminis-
trative expenses associated with running the business.
The gross income should be compared with the net Income of
the company. Net income reflects the "bottom line" on a company's
profitability. A negative net income may Indicate that the company
cannot afford to stay insbusiness if a civil penalty is assessed.
However this may not be true in view of the company's gross income.
For instance non-recurring "extraordinary" items may have caused a
temporary loss. If so, the company can probably afford to pay a
civil penalty. Additionally, the Region should remember that a
company can liquidate assets to meet penalty amounts and still
remain in business.
In complex cases, the Region may need to rely on a management
division economist or an accountant to analyze the firm's ability
to pay and, on a case by case basis, to evaluate the proposed
penalty. The usual case can be satisfactorily evaluated by
an analysis of the gross and net income figures on the 10-K.
statement.
Obtaining 10-K Statements
The Regions should obtain 10-K statements before assessing
civil penalties in enforcement actions. A 10-K statement may
be obtained in various ways.. EPA regional offices in San
Francisco, Chicago, and New York may contact the local SEC
office to obtain 10-K statements for companies with headquarters
located in the Region. In addition, the SEC Headquarters in
Washington will mail out 10-K statements, upon request.
Inquiries should be mailed to the SEC, 500 N. Capital Street,
Washington, D.C. 20549. Regio.ns must specify the name of
tfi*e company and the years for which the 10-K is requested.
A.nominal fee is charged for this service; twenty-four hour
response is possible upon request.
I hope that the Regions will begin using this important
tool immediately. Please, contact Russell B. Selman of my
staff if any questions arise at 755-9404.
JJ-Z
Conroy II, D^-retHior
Pesticides and Toxics^ Substances
Enforcement Division
-------
Sample Extracted Filings
COMPANY PRORLE
0392799 PROFILE USt FILED; 79/07/31 00 NOi C321300000
CUES 00 INC
cenesoo pass
NASHVILLE TH 37202
naWW&JffCD tMt' TM
GtauiKC: ITTS TICKER SYMBOL: CCO
RC rru NO: t-3083 IRS HDt 62-0211360 CDSIPi 3713323
SIC CODES J 2311 2331 31*3 314A 3661
description or BUS IKES S: XANurAcmts and bet ails cicrrainc. ofehaiioks arc
OIVIDEDINTO FOOT SECKENTSt FOOTWEAR. MEN'S APPASEL, SPECIALTY RETAILING AMD
VARIETY RETAILING. OPERATES 61 MANUFACTURING PLANTS AND WAREHOUSES AND
APPROXIMATELY 1,400 RETAIL STORES AND LEASE DEPARTMENTS THROUGHOUT THE U.S. AMD
CANADA.
FISCAL YEAR'END: 07/31
»-* 79/07/31
ARS' 79/07/31
10-Q 79/04/30
«¦: i9mm.
MSJCT 19/02/13
BECST S08 78/03/01
,0-K EXTRACT
0392791" 10-R BRttl 79/07/31, 03 HO:. 0321300000.
cms CO IKC
.shares or ooretOH srpci;: 12,620,9:0
RT90ER OP SHAREHOLDERS: 32,403
KCHBER OP EMPLOYEES: 26,300
PARENTS:
N/A
SUBSIDIARIES:
BBC, DC.i "
college grove truce company;
.PIACS BROS. OP PUERTO RJCQ, INC.;
•CEBEiUB;!RETAIL, CORPORAIIOK;
CENESOO APPAREL AND FOOTWEAR- (PAR EAST)' LIMITED;
CEHLEATHER INCORPORATED:
S. R. CRESS OP LOUISIANA, INC.;
CENESCO ITALIA S.P.A.;
TEHNESSB RAVENWOOD PROPERTIES, TKC.|
CCO PB3PERTIES, QIC.;
' CENESOO CROOP INC.;
UNIVERSAL SHOE AND APPAREL EXPORT, SIC.;
RZITRI 9EHDEL, IHC.;
I. MtLlER & SONS, INC.;'
3. R. KRESS AMD COMPANY;
V. J. ELMORE AND COMPANY;
CENESCO MERCER COMPANY, INC.;
~^C0 SVC PS INCORPORATED;
®l RESTAURANT "CORPORATION;
.rfESCO APPAREL LIMITED; .
ACHW-SURPASS- SHOE. STORES, LIMITED;
7
-------
10-K Extract cont.
ACCOUNTS PAYABLE
(OTIS PAY AS LI
TAXES CUE
TOTAL CURRENT LIAS.
tOKC TERM DEBT
SHAREHOLDERS EQUITY
iirr REVENUE
COST or GOODS
cwss profit
SELL, CEN.4 AW IK. EXP.
INCOKE BEFORE TAX
EXTRAORDINARY ITEM
ntt income
COMMENTS:
EXTRAORDINARY ITEM IS OPERATINC LOSS CARRYFORWARD
FOOTNOTES:
ACCOUNTING PRINCIPLES: ACCOUNTING CHANCE.FOR COMPVTINC THE U.S. TAX
PROVISION
MERCER AND/OR ACQUISITION: PURCHASE, TENNESSEE RAVENUOOD PROPERTIES. INC.,
PA WE NT IN CASH
PRINCIPLES OF CONSOLIDATION: GENESCO FINANCIAL CORP. CARRIED ON EQUITY
i!RHOt>v
DEPRECIATION: SUM OF WCITS: DOUBLE 'DECUNfBC BALANCE: PRINCIPAL METHOD IS
STRAICHT LINE
INVENTORIES: FIFO: RETAIL METHOD USED FOR RETAIL COMPANIES
SHORT TERM DEBT: LINE OF CREDIT: COMPENSATING BALANCE". RESTRICTING
LONG TERM DE3T: COLLATERALIZED: CONVERTIBLE: RESTRICTING: AMENDED:
"^OUINATED NOTE, SENIOR SINXINC FUND NOTE, SUBORDINATED DEBENTURES, FIRST
¦CACE NOTES
aJCES j NET OPERATINC LOSS CARRYFORWARD, $66,433,000, EXPIRES IN 1985 -
STOCK" OPTION: ONQUALIFIED: KEY EMPLOYEES STOCK OPTION. PLAH, DIPL0YEE
INCENTIVE PLANS A & B
FOREIGN OPERATIONS: TRANSLATION CAINS' OR LOSSES
LEASES:. .CAPITALIZED: EXPENSED: FAS! 13: SUBLEASES.
TENStON PLANS.:1 FVNDED:- COST ACCRUED:' VESTED BENEFITS EXCEEDED"ASSETS
COWITMEWTS/CONTINCENCIESi .LEASES: LITICATIONS
SUBSEQUENT EVENTS: N/A
OTHER FOOTNOTES: REPLACEMENT COSTS: QUAJfEftlY FINANCIAL DATA: SECMENT
INFORMATION: COMMON STOCK: SUPPLEMENTARY INCOME STATEMENT INFORMATION: CAPITAL
STOCK, PREFERRED STOCK: RECEIVABLES: CURRENT ASSETS OF OPERATIONS BEINC
DIVESTED: INVESTMENTS AND LONC TERM RECEC VA3LES: FIXED ASSETS OF OPERATIONS
BEING DIVESTED: SUBORDINATED COKMTTMEVT TO FOREIGN FINANCE SUBSIDIARY:
PROVISION FOR OPERATIONS BE INC DIVESTED ANT RETAIL STORE CLOSINGS
LIABILITIES
75,367.000 87 , 035,000
"27,365.000 18,361,000
It/A It/A
U7.17(i,000 187,078,000
129,928,000 126.662', 000
90,698,000 84,104„ 000
INCOME STATEMENT
992,925,000 1,068,351,000
672,812,000 705,7^0,000
320,113,000 .342,611,000.
292,157 iOOO 302,960,000
(1,065,000) 19,366,000
N/A N/A
6,332.000 14,936,000
The cost for retrieval and display of the above information (all
3 reportsJ is in the approximate range of S6.00 to S 12.00 de-
pending on search complexity and system vendor used.
-------
10-K Extract cont.
DISCD SHOES LIMITED;
cehesco or Canada co. ltd. :
com kintal shoe sales corporation lid. i
SHOE VILU LIMITED;
J. A. JOHHSTOH COMPANY OP CAHADA LIMITED;
tEWARD SHOE STORES 07 CAKA0A LMITCD;
DEXTER SHOES,'LIMITED;
CENESOO WORLD APPAREL, LTD.J
PWEBROOK REALTY CORP.;
CENESCO INTERNATIONAL CORP. t
fOLTOH ¦ PROCESS 6 CHEMICAL CORPORATION
LEGAL PROCEEDINGSl
VIOLATION 07 SECURITIES, IMPROPER SUSPENSION OP EXCHANGE RIGHTS OP HOLDERS OP
SERIES C STOCK AND SERIES > STOCK, CLASS ACTTOH, OENCO AND KtCHAEL W. CRAMER
V. CE8ESC0, INC., DISPOSITION ADVERSE, APPEAL PENDING;
VIOLATIOT OP SECURITIES, IMPROPER SUSPENSION OP THE RIGHT TO EXCHANGE SERIES B
STOCK, TALSE AND MISLEADING STATEMENTS, ERW1N CAMP, ET AL. V. CENESCO. INC.,
DISPOSITION ADVERSE SUttlARY JUDCEMEMT, OTHER ISSUES PENDING:
VIOLATION OP SECURITIES, WRONCFUL'-REFUSAL TO MAKE' DEPOSITS TO SINKING FUND,
CEORCE THOMAS, ET AL. Vl CENESCO, INC., DISPOSITION PENDING:
VIOLATION OF ANTITRUST, RETAIL PRICE rtXINC, VARIOUS CLASSES OP CHARGE ACCOUNT
CUSTOMERS V. CENESCO, INC. AND CERTAIN RETAILERS, DETTHDWTS W SEVERAL
.ACTIOHS, Dl$?OSt«Otl.fQSDWCy
•vitoUTioft 'or' sEGrtfriss', -msz- AND mtsleading- -statements ? murine or comon
SIOCK PRICES, CLASS ACTION, LILA EIPKIN V. CENESCO, INC., DISPOSITION PENDING:
VIOLATION OP SECURITIES, CUSS ACTION, CENESCO, INC., CENESCO FINANCIAL CORP.
LEEDS SHOES, INC. ET AL. DEFENDANTS, DISPOSITION PENDING:
VIOLATION OP SECURITIES. FALSE AND MISLEADING STATEMENTS, INFLATING COVWON
STOCK PRICES, PORKER OWNERS OF AH ACQUIRED CORPORATION V. CENESCO, INC.,
OISPOSrTIOH PENDISC
DIRECTORS AND OFFICERS:
JAM CAN, JOHN L.: CHAIRMAN, ..PRESIDENT AND' CHIEF' EXECUTIVE OFFICER
MWLES> RALPH H.; EXECUTIVE VICE PRESIDENT,- CENERAL MANAGER OF RETAILING
UNGSTAFF, CEORCE Q.s EXECUTIVE VICE PRESIDENT, CENERAL MANAGER OF FOOTVEAR
SHEIXON, URKf' EXECUTIVE VICE PRESIDENT, CENERAL MANAGER OF MEN'S APPAREL
WIRE, WILLIAM S. PI} ¦ VICE PRESIDprr. - FINANCE AND,TREASURE*, 'CHIEF .FINANCIAL
OFFICER'
CURK, THOMAS 'B.f VICE PRESIDENT, .GENERAL COUNSEL
O'CONNOR, WILLIAM C.: SECRETARY, ASSISTANT GENERAL COUNSEL
WHITE, Jim IE D.: VICE PRESIDENT, CHIEF ACCOUNTING OFFICER
EXHIBITSl COMPUTATION EARNINGS PER SHARE: REVOLVING CREDIT AGREEMENT,
3/13/79, CROUP OF 16 BANKS AND CENESCO FINANCIAL CORPORATION; EMPLOYMENT
AGREEMENT, AMENDED, 9/26/79, CENESCO AND JOHN L. HANIGAN: STOCKHOLDERS'
PROPOSAL, FUTURE STOCK OPTION PUNS, ANNUAL MEETING 12/4/78; CENESCO
RETIREMENT SAVINGS PUN, 1/1/79; HICHLICHTS OP THE CENESCO RETIREMENT SAVINGS
PUN; CENESCO. RET IRE5OT. PLAN, 1/1/79, SUMMARY PUN DESCRIPTION
¦AUDITOR:: PRICE WAttRkaBSE: 6 COi
AUDITOR'S-REPORT: UNQUALIFIED
FISCAL YEAR OF REPORT 1979 1978
9. ASSETS S
CASH li,3711000 10,576,000
MARKETABLE SECURITIES N/A N/A
RECEIVABLES 24,337,000 27,374,000
INVENTORIES 197,687,000 313,471,000
CURRENT ASSETS 242,226,000 294,419,000
PROP, PUNT AND EQUIP. 98,330,000 102,431,000
DEPRECIATION N/A N/A
TOTAL ASSETS 360,127,000 426,933,000
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
• z.j 17 iscv'
OFFICE OF ENFORCCMCNT
MEMORANDUM
SUBJECT: Regulation of Public Healch Related Disinfectant Products
TO: Enforcement Division Directors
Pesticide Branch Chiefs
In a memorandum dated July 31. 1980, we requested a temporary stop
to the collection of sample requests intended for testing at the Chemical
and Biological Investigations Branch, Beltsville, MD. This action vas
requested to facilitate an on-going review of the Agency's Disinfectant
Monitoring Program.
We have at this time completed our evaluation of the disinfectant
program. Based on this review we have developed a new program plan for
monitoring claims of selected disinfectant products. The major program
changes are as follows:
o Testing of medical related disinfectant products
only
o A new testing procedure for determining efficacy
failures
o Beltsville will perform both chemical analysis and
biological efficacy testing
o Failure of a product to destroy Ps. aeruginosa trill
be considered equal to failure oT""a product to destroy
S. choleraeuis or S. aureus
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We are in Che process of selecting disinfectant products to be
tested under this program and will be forwarding sample requests to
Regions beginning February 1, 1961. Appropriate measures should
taken to facilitate the collection of these requests. We have
attached for jour review several documents which explain the details
of this program.
We look forward to your help and cooperation on this program. Please
address aoy questions or comments by January 12, 1981, Co Josephine Uuaog,
Toxiologist, U.S. CPA, EN-342, 401 M Street S.W., Washington D.C. 20460.
A. E. Conroyjil, Director
Pesticides and uoxi^ Substances
Enforcement hivif'sion
Attachments
cc: W. Bontoyan
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Table of Attachments
Attachment A : Program Development Strategy
(To be placed in the Case Proceedings Manual
and Inspectors Manual)
Attachment B
Summary of Data Collection and Data Flow
(To be placed in the Case Proceedings Manual
and Inspectors Manual)
Attachment C
Laboratory Procedures/Enforcement Actions
(To be placed in the Case Proceedings Manual)
Attachment D : Test Level I
(To be placed in the Case Proceedings Manual)
Attachment C : Test Level II
(To be placed in the Case Proceedings Manual)
Attachment P : Request to Stop Collection of Sample Requests
for Testing at Beltsville.
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1.11 rruceeo
and Inspectors Manual
PROCRAM DEVELOPMENT STRATEGY
A. Criteria of Selection:
o Sample requests will include only those disinfectant
products'with public health related claims, such as
those used on clinic or hospital premises.
o Selection of products to be tested vill focus on:
- disinfectant products for which there
is reason to believe that a violation
has occured;, this vill be determined
by consumer or competitor complaints
and scientific judgment based on the
study of product formulation
- disinfectant products widely used on
hospital or clinic premises
- disinfectant products produced and
distributed in large volumes
B. Data Collection" and Data Flow:
o Samples to be tested will be aelected by:
- Headquarters/Pesticides and Toxic
Substances Enforcement Division -
Compliance Monitoring Branch (PTSED-
CMB)
o PTSED-ChB will send the sample requests to the Regions
for collection en a quarterly basis (approximately 40
sample requests on a national level every three months).
o The Regions will set-up an I.D. jacket for each sample
requested.
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o When the requested sample has been collected, the PRD
Acknowledgment copy will be forwarded to the Compliance
Monitoring Branch with the "Sample Identification"
Section of the request form completed. This will inform
Headquarters that an inspector has been assigned and the
sample collected.
o The regional (or state) inspector will obtain and/or com-
plete all information necessary for sample collection
(see the Pesticide Inspector's Manual for instructions).
- All information obtained by the inspector
will be placed in the I.D. jacket and for-
warded to Beltsville along with the requested
sample.
- This information will include a copy of the
product label ijn addition to the label
attached to the sample container. This
copy is intended for the sample's E.O.
jacket.
o Beltsville will perform the chemical analysis and bio-
logical efficacy teGts for sample requests originating
from headquarter3.
- These samples will be retained at the Belt6ville
laboratory for a two year period.
o Once testing has been completed:
- All test results will be placed in the
sample's I.D. jacket and sent t-o the
Regions.
o The Beltsville laboratory will forward a copy of the test
results to;
- Headquarters/Compliance Monitoring Branch
(PTSED)
- Headquarters/Disinfectant Branch (OPTS)
-2-
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COMPLIANCE MONITORING
BRANCH (PTSED)
o request samples
o review test results
request &
I.D. Jacket
*
V/
REGION
o set-up I.D. Jacket
o inspector assigned
o sample collected
o PRD Acknowledgment
to Headquarters
o reports compiled 6
placed in I.D. Jacket
sample 6
I.D. Jacket
PRD Acknowledgment
copy of special
request form
I.D. Jacket &
test results
BELTSVILLC
o chemical analysis
o biological
efficacy testing.
teat results
test
results
V
DISINFECTANTS BRANCH
(OPTS)
o record test results
in the establishment's
enforcement record
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o All Z.D. jackets will be retained on file at the appropriate
Region.
- In some instances the Regions may be re-
quested to forvard a copy of information
retained in the I.D. jacket to Headquarters
for review.
C. Monitoring Failures for Enforcement Action:
o Teat failures are of two types:
* Formulation violations/chemical defecta -
product does not comply with accepted
labeling
- Biological efficacy - product does not
effectively eliminate certain organisms
as claimed by the manufacturer
o The Regions will initiate all enforcement actions.
3-
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LABORATORY PROCEDURES/ENFORCEMENT ACTIONS
flace in case
Proceedings Manual
Testing Scheme (Beltsvilie);
o All samples requested under Cbis prograa will
undergo chemical analysis.prior Co efficacy
testing.
o The A.O.A.C. "Use Dilution Method" (modified
for soil load 1-step cleaner disinfectants)
will be used to test the efficacy of disinfect-
ants products with, claims against the following
organisms:
-Salmonella choleraesuis
-Staphylococcus aureus
-Pseudomonas aeruginosa
o 60 carriers will be tested for each of the above
organisms.
Definition of Failuree/Eoforcement Procedures;
A. Test Level I:
o 3 6ample8 representing different batches will be
tested at .this level.
o Each sample vill be tested against each of the above
mentioned organisms.
o The definition of failure at Level I will be based
on the performance standards required by OPTS for
registration of disinfectant products (a sample which
fails in 2 or more of the 60 carriers in any test is
determined to have failed efficacy testing).
o A product will be determined to have failed efficacy
testing., at Level I if the product fails to destroy any
organism in 2 or more of the 3 samples.
-For each batch which fails efficacy
testing at; Level I, the manufacturer
vill be issued a stop sale, use or
removal order against the batches
from which the samples were collected.
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o If the product fails at Level I:
- The otDufacturer will be in-
formed of the product's failure
aod that S additional samples
(each representing a different
batch) will be collected for
testing at Level II.
- A civil complaint will be issued
for violations at Level I according
to the Penalty Matrix.
o If only 1 sample out of the three batches tested
fails to effectively eliminate the test organism,
then the product will be determined to have success-
fully passed efficacy testing.
Test Leve1 II:
o If a produce is determined to have failed Level I
testing, 5 additional samples representing different
batches will be collected for testing ac Level II.
o Each sample will be tested against the orgaoismCs)
the product fails to destroy in Level I.
o 60 carriers will be tested for each organism.
o At Level II, 2 or more failures out of the 60
carriers tested for each organism in each sample
constitutes failure of the batch to meet efficacy
requi rements.
o The definition of product failure at Level II will
be based on the upper bound of the 95Z Confidence
Interval for 2 failures out of 60 carriers. The 952
Confidence Level • 5 failures out of 60 carries.
o A product will be determined to have failed efficacy
testing at Level II if the product fails to destroy
any organism in 3 or more of the five samples.
o OPTS will initiate action to cancel product registra-
tion for efficacy failure at Level II based on the
95Z Confidence Interval.
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o Representative* froa PTSED agreed that failure to
effectively eliminate the test organism (based on
the mininua of 2 failures out of 60 carriers) in
any of the soaplea tested will result in:
- a stop sale, use or removal order
issued against the batch froa which
the samples failing efficacy testing
were collected
- a civil coaplaint issued according
to the Penalty Matrix
-3-
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Place in Case
Proceedings Manual
TEST LEVEL I
Definition of Failure/Enforcement Action:
Definition of Failure:
1) Sample Failure
¦ failure to destroy the test organists in 2 or more out of
the 60 carriers
2) Product Failure
Enforcement fiction: a stop sale, use or removal order
will be issued on the batch from
which the sample was collected
a civil penalty will be issued
for failure of the batch to meet
efficacy requirements
» failure to destroy any test organism in 2 or more out of
the 3 samples
Enforcement Action: initiate Level H testing
EXAMPLE
Product X with claims against Ps. aeruginosa; S. choleraesuis; S. aureus
Failure out of 60 carriers
Sample 3
Ps. aeruginosa S. cholaraesuis S. aureus
>4/60
*7/60
~3/60
1/60
0/60
1/60
0/60
1/60
0/60
Enforcement Action
~stop sale, use cr
removal, order and
civil penalty
~stop sale, use or
removal order and
civil penalty
~stop sale, use or
removal order and
civil penalty
Hie product falls to-destroy Ps. aeruginosa in Sa.-nples tl, »2.and #3
thus Level II. testing: is to be initiated.
At Level II only tnose ocganisms the product failed to destroy at Level
• are to be tested.
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ItiJ'v, Xi
Proceedings Manual
Definition of Failure/Enforcement A< tlon:
Definition of Failure;
1) Sample Failure = failure to destroy the teat organism in 2 or more of.
the 60 carriers
Enforcement Action: a stop sale, use or ronoval onier
will be issued on the batch iron
vhlch the sample was collected
a civil penally will be issued
for failure of the batch to
meet efficacy requirements
2) Product Failure = failure to destroy any test organism in 3 or core of
the five samples based on the 95^ Confidence Interval
for 2 failures out of 60 carriers; Confidence Inteval
s 5 or more failures out of the 60 carriers (see ec-
emple below, Possibility B)
Enforcement Action: procedures will be initiated to
cancel product registration
3) A ircduct is determined to have failed efficacy testing if 3 or more
of the five samples fail testing. For those products which fail in enly
1 or 2 samples enforcement actions vill be taken a^inst the batches fr'
vhich the samples failing efficacy tests were collected.
Enforcement Action:
EXAMPLE
a stop sale, use or removal order vill be issued
on the batch firaa which the sample was collected
a civil penalty will be issued for failure of the
batch to meet efficacy requirements
Product X with claims against Ps. aeruginosa; S. choleraesuis; S. aureus.
At Level I Product X successfully destroyed S. cholaraesuis and S. aureus
but failed to destrcy Ps. aeruginosa
£oasiMlit2_ A
Failure out of 60 carriers Enforcement Action
Sample ft Pa, aeruginosa * a stop sale, use or
removal order will be
1 *4/60 issued a^inst the pro-
duct batch Aran which
2 *4/60 the sample failing effi-
cacy test was collected;
3 *5/60 a civil penalty vill
also be issued agains*
4 '*6/60 these batches
5 *3/60
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pBsibUltj, B
Sample 9
failure out of 60 carriers
Pa* aeruginosa
1
•7/60
2
*10/60
3
•4/50
4
•6/60
5
*7/50
Enforcement Action
* a stop sale, use or
reaoval order will be
Issued a&inst the pro-
duct batch ft* an vhich
the easpLe falling effi-
cacy test was collected;
a civil penally vlll
also be lssied egairat
these batches
Since "product I falls to destroy the test organise In 3 or more of the samples
tested based on the 955 Confidence Interval for 2 failures out of 60 carriers*
(product failed, in saaoles ff\. ffj,: 4A, & Jf5), procedures will be Initiated to
cancel product registration.
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JUL 3 I I960
MC;iDRM3U!i
SUBJECT* Request to Stop Collection of Sasple
Requests Cor Testing at 3eltsville
roi
Enforcement Division directors
Pesticide 3r3nch Chiefs
;ic arc in trie process of evaluating the Agency's Disinfectant
lonitocin^ ^ro^caia. Tne objective of our review is to establish an
effective aonitoriny system for the purpose of israsovinj test pro-
cedures and data flow between Jvadquarters# tne Hejions, ani
3tltsvillc.
jntil further notice, appropriate measures should fee taken
-.a stnj collection of all outstanding sanpl»: requests int«:n-.iej
ir testing at the Chemical" anJ 3iolo.?irai Investijations Jranch#
j«-l t3Vlllc, J,
four cooperation in this satter is appreciatei.
2. Conroy zi« Director
Pesticides and rosie Substances
enforcement Division
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Tuesday
March 3, 1S31
F-2 2.
Part III
Environmental
Protection Agency
Pesticide Registration, Reregistration, and
Classification Procedures; Clarification of
Policies on Special Packaging
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13:0-5
Fecrr::! Register I 1^. .no. -il i t'u
i a.'ij .-\?2uiaucr.s
environmental protection
agency
•40 C\;R Part 1S2
r "nL 1 7-14-1; OPP isconsi
(
f .:tie Registration, Serecistrstion,
and Classification Procedure;
Clarification of Poiicy Issues on
Special Packaging
agency: Environmental Protection
Acer.cy (EPA).
action: Rule rsiated notice.
Summary: This interpretation of the
child-resistant packaging reg-Jation (-iO
CJ?. 152.16) provides clarification on
several aspects of tha regulation. This
interpretation became necessary
because the pesticide industry had
raised a number of questions which the
agency feels can best be resolved by
this publication. It is intended that
through these clarifications the affected
pesticide registrants will be in a better
position to comply with the regulation
by March 9,19S1, when it becor.es
effective.
for furthss information contact:
P.osalir.d L Gross. Registration Division
(TS-rerC). Office of Pesticide Programs,
Environmental Protection Agency. Rra.
2C7. CM=2. 1921 Jefferson Davis
Highway. Arlington, VA 22222. (7C3-
3.;" tI).
S' **EKTARY INFORMATION: On
Mi,..; 9.1979, the Environmental
Protection Agency (EPA) issued final
regulations which require certain toxic
pesticides to be in special, i.e., child-
resistor.'., packaging after March 9.1981.
The regulations are now contained Ln -50
CFR ".62.IE. Because so many registrants
have had questions about the
implementation of these regulations,
EPA has decided to publish this Notice,
to answer those questions and to clarify
the regulations in areas where they
might be unclear. These clarifications
car. be used immediately in order to
amend registrations with respect to
child-resistant packaging. Where EPA
proposes to amend the regulations,
those amendments will of course
become effective after full notice and
comment rulemaking.
A. Eye and Skin Lrriation Criteria
Many questions were received
concerning the conduct and
interpretation of eye and skin irritation
studies. As indicated in the preamble to
the final regulations (44 FR 13021),
testing for a pesticide's eye and skin
irr-.taiicn effects should be done in
ac r.ce with the National Academy
of Science/National Research Council
Publication 1138 protocols.
B. "Inherently Child-Resistant" Products
A number of registrants have
questioned whether their products need
to be tested for child-resistant
effectiveness, contending that they are
"inherently" child-resistanL These
products fail into two main categories:
(1) those where it is claimed that the
package is intrinsically unoper.able by
children, and therefore "inherently"
child-resistant, and (2) those where it is
admitted that the product is toxic and
accessible to children, but where it is
contended tha: it would not be possible
for a child to consume or be exposed to
a sufficiently large amount of the toxic
pesticide to cause him harm.
It is the agency's position that neither
of these classes of products is
"inherently child-resistant." In the first
case, where product design is the basis
for the "inherently child-resistant "
claim, it will be necessary for that
package to be tested, like all other
pesticide packages, in accordance with
the Consumer Product Safety
Commission protocols, as discussed in
the relations and clarified below. Fn
the second case, it is open to the
registrant to attempt to show that its
product falls within the exemption
category of -50 CFR 162.16(c)(3), on the
ground that despite the pesticide's
meeting of one or more of the toxicity
criteria, it is not hazardous to man. The
registrant must show that a child could
not be exposed to a toxic or harmful
amount of the pesticide. The fact that a
pesticide has not been implicated in a
large number of accidents involving
children is not in itself sufficient
grounds for exemption. Product specific
test data and an appropriate scientific
rationale must be submitted in support
of an exemption request.
C. Distinction Between "Exempt From
Special Packaging" and "Not Being
Subject to Special Packaging"
Many registrants are requesting
exemptions for products, when in
actuality they are asking if their product
is subject to the regulation. An exempt
is only appropriate for a product which
is subject to the regulation.
A product whose label does not allow
for residential use. is classified for
restricted use. or does not meet the
toxicity criteria, is generally not subject
to the special packaging regulations. A
product "allows for residential use" if its
label either directly recommends
residential use or reasonably can be
interpreted to permit residential use.
Determining the potential for
residential use from the label directions
may be difficult. Many ornamental
plants and garden vegetables, for
example, are grown by the individual
homeowner and. therefore, a label
which lists them can be ir.terpre'.ed as
permitting residential use. Residential
use thus may not be automatically
excluded for a relatively large number of
products. In fact, the same formulation
may be used, for example, by the
commercial vegetable grower as we!! a3
the home gardener raisins the same
crop. The registrant of a product is best
aware of the actual use area/user group
of the pesticide. The registrant is
therefore in a position !o either choose
proper labeling (see I below) for those
products not intended to be used by the
homeowner or to choose child-resistant
packaging for those products used and
stored in residential areas. For those
products which will no; enter the
residential area even by use of a
serviceperson (see 1 below) the agency
will continue to follow its customary
distinction between pesticides products
entering the home market and those
which are intended fcr commercial
production of food crops and
ornamental plants. This distinction has
over the years been accomplished by a
number of means, for example", use
directions and size limitations. On a
case-by-case basis, and in case of
uncertainties, the agency has also '
allowed or requested label language
such as "for agricultural use only" or
"not for use in or around the home."
The regulations provide for
exemptions under two circumstances:
(1) technical Lnfeasibilitv or (2) where a
product's meeting of the toxicity criteria
is not indicative of a genuine hazard to
man.
Technically feasible means that the
technology exists to produce special
packaging for a particular pesticide. The
agency is not required to find either that
the packing is readily available or that it
will lend itself conveniently to the
existing packages or packaging
equipment of the registrant. EPA
considers practicability and
appropriateness to be components of
technical feasibility. In EPA's view,
packaging is practicable if it is
susceptible to modern mass production
and assembly line techniques and
appropriate if it is chemically
compatible with the pesticide contained
in the package.'
Thi? definition is consistent with that of the
Consumer Product Safety Connijsicn ICrSC).
pubi.sr.cd in the Federal Register ot Feoru«rvlB,_
19."; (37 FR H"|.
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Federal Register / Vol. 46. No..41 /'Tuesday;'.March 3. 1981 / Rules and Regulations 1510:
•D. "Dormant" Pesticide Registrations
A pesticide whose resistmtion is
"dormant" is one which is v:iiic!y
registered with EPA but is act currently
in production. Obviously, the registrant
of a "dormant" product subject to the
c.hild-resistar.t packaging regulations
must cc.r.piy with these regulations
when it either begins cr renews
production after March 9.1581.
E. Voluntary Child-Resistant Packaging
A number of registrants whose
products are not required to be in child-
resistant packaging have asked whether
they may nonetheless use it The anwer
'is yes. However, once a registrant
chooses to use child-resistant packaging,
the registrant must coir.ply in all
respects with the child-resistant
packaging regulations. It would be
misleading to the public to have two
types of child-resistant packaging—
voluntary and compulsory—which were
not of equal safety or effectiveness.
F. Product Toxicity and Child-Resistant
Packaging
A pesticide product's toxicity places it
in one of three categories in regard to
child-resistant packaging. These are:
1. Those products which dearly meet
or exceed the toxicity criteria in 40 CFR
162.16(c)(2). These products must be in
child-resistant packaging unless the
registrant can demonstrate grounds for
an exemption under 40 CFR 16116(c)(3).
2. Those products for which the
existing toxicity data are not precise
enough to indicate whether the product
.meets or exceeds the toxicity criteria of
40 CFR 16116(c)(2). The registrants of
these products may either do further
testing to determine the precise toxicity
of their products, cr they may concede
that their products are sufficiently toxic
to be. in child-resistant packaging, and
comply with the child-resistant
packaging.reguldtions. This second
situation does not constitute voluntary
child-resistant packaging. There are
three notable situations where this may
occur
(i) For purposes of precautionary
labeling the agency may have
considered oral toxicity data sufficient
to show that the product was in toxicity
category HI (LD«» of from 500 through
5.GGO mg/kg), but not specific enough to
determine whether the product has an
LDm of 1-5 g/kg or less. ^
(ii) Eye irritation studies may have
been submitted which showed correal
effects past day 7. and the study may
have been terminated without
determining whether the effects were
reversible in 21 days. Such a study was
sufficient for purposes of precautionary
labeling (category I) but is no lonssr
adequate to determine whether or not
child-resistar.t packaging (Cr.P) is
needed.
(iii) The third situation applies to skin
irritation studies using an exposure
period of 24 hours. These studies would
not necessarily allow a conclusion.as to
whether the criteria for CRP have been
exceeded.
3. Those products which clearly do
not meet the toxicity criteria in 40 CFR
162.16(c)(2). These products are not
required to be in child-resistant
packaging, although a registrant may
choose to use child-resistant packaging
voluntarily, in accordance with E above.
G. Released for Shipment
The phrase "released for shipment" is
defined as follows: "A product is
released for shipment by a producing
establishment when it is the intent of the
producer to introduce the product into
commerce." Products at the distributor
and retail levels are considered to have
been previously released for shipment
by the producing establishment
H. Testing Procedure for Child-Resistant
Packaging Which Requires a Tool for
Opening
As the regulations indicate, the
protocol testing procedures of the
Consumer Product Safety Commission
(CPSC) 16 CFR 1700.20) are to be
followed in testing the child-resistant
packaging of pesticides. The CPSC
policy for testing child-resistant
packaging which requires a tool to open
the packaging, published in the Federal
Register of October 13.1972 (37 FR
21632). will also be followed. The test
policy is that:
1. children need not be given the tool
during the test unless the tool and
product are marketed together, and
1 adults will be given the tool for
testing.
L Limited Exception for Products Sold
to, and Used by, Servicepersons
EPA has determined, based on
comments submitted by various industry
groups, that pesticides which are used in
residential areas by janitors,
professional pest control applicators,
exterminators, swimming.pool
operators, lawncare and landscaping
personnel, and other similar people need
not be in child-resistant packaging. This
is because the storage and usage
patterns generally employed by these
people are such that a significant hazard
to young children is not apparent.
Therefore. EPA plans to propose to
amend the present child-resistant
packaging regulations to provide that
pesticides applied and used by
servicepersons. as defined below, •.viii
not be within the scope of the
regulations. EPA's proposed
amendments to the regulations w:-l be
published shortly, ana wiil be sublet to
public comment In the meantime. EPA
will exercise its prosecutional discretier
not to enforce the child-resistar.t
packaging regulations against thcsS
manufacturers who comply with these
restrictive measures enumerated selc.v.
EPA now plans to propose
amendments which are substantially as
foilows:
1. Serviceperson. As used in the child-
resistant packaging regulations, a
serviceperson is defined as one who
provides a service of .controlling pests
without delivering any unapplied
pesticide to any person so, served. The
term "serviceperson" includes, but is no
limited to, a janitor, pest control
operator, maintenance person, lawncare
and landscaping personnel.
"Serviceperson" does not induce a
household servant, such as maid,
housekeeper, or private gardener.
2. A pesticide which meets the criteria
for child-resistant packaging and is
distributed only to servicepersons may
be marketed without child-resistant
packaging if the registrant labels its
product (either by conventional or
sticker label). "Only for Sale to. Use.
and Storage by Servicepersons.'- This
statement must be in type at least as
large as the child hazard warning
statement Sale or other distribution of a
pesticide labeled in this way to a person
other than a serviceperson will violate
FTFRA section 12(a)(2)(F), once the
restriction is imposed by regulation. Use
of a pesticide labeled in this way by
anyone other than a serviceperson will
be a violation of F1FRA section
12(a)(2)(C).
J. Testing Each Size of a Design
The regulations provide that
"Standards for special packaging shall
be evaluated for each size of a design
used'pursuant to the Consumer Product
Safety Commission protocols specified
in 16 CFR 1700.20 40 CFR
162.16(d)(3). In explaining the necessity
for testing each size of a design, the
Preamble to the final regulations stated
that:
Tests do not have to be run on each
pesticide product only on each special
packaging design ' * *. However, in
3 102.16(d)(3) a requirement has been added
to test each size of a closure dssisn used. in
discussions with the Consumer Product
Safety Commission. EPA was advised that
changing the size of a design often reduces
the child-resistant effectiveness. RcqtiiVir^-'
each ciosure size to be tested iviii rrh—:e '
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13: Co
iwt'. ji At ,.ja;
possibility o'. an ine::"ec:iv; pacKaj? bc.r.z
I~A recrzr.izss that '.his preamble
\ir.:u=:e is somewhat ambisuous.
brcsuse it refers both to the testing of
- lire special packaging cisign ar.d
J testing of the closure sirs alone.
i it '.vas the intent cf She drafters of
t.-.e :ei'jia:;cr.s to require that ;he entire
irec:ai p2cxi;e be tested for its child-
resistant effectiveness,1 the preamble
lanr-iaie apparently prompted some
rests:.* ar.ts to test only the ciosure size
which they intended to use cn their
pesticide product.
Ir. v-.ew of the closeness cf the March
9.153;. deadline for compliance with the
special packaging relations. EPA is
r.cw prepared to resoive this possible
ambiguity by permitting pesticide
registrants to certify that their pesticides
packages are in compliance with the
regulations based solely on the testing
of each ciosure size. EPA will then
propcse amended regulations, to be
open for public comment, which will
make it clear that the phrase "each size
of a design" means the entire package.
The entire package will be defined to
consist of the following elements:
belonging to a specific AS7M (American
Society for Testing and Materials)
classification of packages: being made
by a particular packaging manufacturer,
having a specific trade name: being a
specific nodel/stvle number: having a
pa* ' -tlar shape: having a particular size
\j r capacity) container/package:
h'. a particular size closure (if
applicable): having a specific liner (if
'applicable): and having the container/
closure or package being constructed of
a particular material.
EPA recognizes that the time and
expense necessary to test each specific
package cf each product requiring
registriticn would be considerable.
Accordingly, to lessen the impact which
would occur if such testing were
required. EPA will offer manufacturers
an alternative method by which the
packaging of products can be certified.1
It is believed that this scheme provides
a reasonable degree of assurance that a
package r.ot tested will still meet the
effectiveness specifications for special
packaging.
: As eariv as the 1977 proposed regulations. IPA
rated ir.au "SL'Jr.cer this recusation ii is intended
Lhat the entire paci-a^e he tesied. Containers which.
Ict exa.r.rie. use saiety cioiures whtch art not
cc.T.pa::bie w;th the container body are not
ac:esi35;o" [AZ T2. i;2J5).
'Ho ev?:, shouid a pesticide package be tested
arc fg-^r.d r.ot jo ccrr.piy with the chiid-resis;ant
e.':ect:ver.8ss standards of 16 CFR 17CO.CC. it vmII not
I* a cefer.s* thai th? similar product cn which the
fts:s«dr.t C.d meet :hj*? standards.
L'.e^ch spec;ai package must be evaloated
os * raer.u.
EPA's proposal is set forth below, in
the hepe that some manufacturers '.vill
voluntarily compiy with it before it
becomes effective.
Proposed Testing Scheme
If a registrant uses a package other
than the exact package system for which
the protocol test data are available. EPA
will accept certification if the package
used meets the following criteria:
(1) Package shape: The package for
which protocol data are available must
be a conventional shape, e.g.,
cylindrical, rectangular, square, sr.d the
package for which certification is
sought, even if different from the shape
of the package tested, must also be
conventional in shape. If an "F" style
metai can or a conical metal can are
involved, the shape used must be the
same as the shape tested. All
npr.conveniicnal package shapes, e.g..
hourglass configuration, triangular
packages, must be tested individually.
(2) Container/package material: The
material of the package/container for
which certification is sought'must be
generically equivalent and have the
same physical/chemical properties (e.g.,
bursting strength, tear strength, etc.) as
the material of the package for which
protocol data are available. Different
materials include polypropylene, low
density polyethylene (LDFE), high
density polyethylene (HDPE). glass, tin
plate (steel), aluminum, etc. If data are
available for a glass package and an
LDP£ package is used, it must be tested.
(3) Volume of the package: For
certification on the basis of data
involving a package other than the exact
one used by the registrant, the protocol
test data must demonstrate that the
package tested has a child-resistant
effectiveness of SS percent of more after
demonstration. The size of the package
used must fall within the limits set forth'
below. The 88 percent figure was
chosen, based on statistical analysis, to
ensure that a package similar but not
identical to the one tested would meet
the 30 percent and 85 percent
effectiveness testing requirements of the
CPSC protocols. See 16 CFR 1700.20. If a
registrant wants to certify that its
package is child-resistant on the basis of
testing the package actually used, a
minimum of 80 percent child-resistant
effectiveness after a demonstration is
proper.
1. To use test data from a package
which contains 0 to 8 fL oz.,4 the
* Volumes r-.»asurtd in c-jbi: inches can be
ccnvtried to flj:d o-jrcei usir! [he rule that 1 fl.
oz. = l.9cu. in. Numberi s.-.ould be rounded to ihe
cent higher, whole number.
registrant's package must be the exrtct
size of the package Vested.
2. To use test acta from a package
which contains 3-54 fl. oz..4 the
registrant's package can be equal to or
as much as twice the size of the package
test. For example, if an 3 fl. oz. package
has been tested, its cata (assuming that
ail ether factors were equal) could be
used for a package from 3 to 16 ft. oz.
3. To use data from a package which
is larger than 64 fl. oz..* the regisrant's
package can be equal to or as much as
1.5 times the volume of the package
tested.
4. Closure/package: The closure/
package used must be the same ASTM
classification, the same model/style, the
same model/style number,
manufacturer, and trade name as the
package tested.
5. Closure size: For certification on the
basis of data involving a closure other
than the exact one used by the
registrant, the protocol test data must
demonstrate that the closure tested has
a child-resist3nt effectiveness of 68
percent or more after demonstration
(see (3) above). jThe size of the closure
used must fall within the limits set forth
below:
a. To use data from a closure with a
diameter less than 20 mm or greater
than 45 mm, the registrant's closure
must be the exact size of the closure
tested.
b. If the registrant wishes to rely on
data from one other closure, which is
between 20 and 45 mm in diameter,
inclusive, he may do so, provided that
the diameter of the registrant's closure is
in the size range between 20 and 45 mm
inclusive and is between 1 and 1.15
times that of the closure tested.
(Numbers should be.rounded to the next
highest whole number). For example, a
registrant with a 28 mm closure could
rely on test data for a 24 mm closure.
c. If the registrant wishes to rely on
test data for two closures, which are
between 20 and 45 mm in diameter,
inclusive, and within 10 mm cf each
other, he may rely on that data for any
closure which fails between the two
tested. For example, if a 24 mm and a 33 .
mm closure of the same design were
tested, the registrant could certify to the
child-resistant effectiveness of its
similar closures which were 26, 28. and
30 mm in diameter. . -
6. Closure material: The material cf
the closure used must be generically
equivalent and have the same physical/
chemical properties, i.e.. bursting
strength, tear strength, etc.. as the
closure material for which protocol data
are available.
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Federal Register / Vol. 46. No.'-4i / Tuesday;; March 3. 1981 / Rules and Regulations 151C7
7. Liners: The materials cf '.he
registrant's iiner and the iir.er on whose
test cata the registrar.: wishes to rely
must be identical. This is because, ir. rha
experience of the Consumer Product
Safety Ccmrr.issicn. the closure Iir.er is
an integral part of the child-resistant
package. ar.d changing the liner —av
impair or eliminate the child-resistant
. effectiveness of a closure or packaging
design.' In the situation '.vhere test data
exist for a closure-liner system that
oiifers from the clcsure-'.iner system
used or.ly in terms of closure diameter
(>20 nr. ar.d <45 mm) certification is
permissible if:
a. closure diameter used is greater
than the diameter,tested but is within
the permissible range (size used is equal
to or greater then the size tested and
equal to or less than 1.15 times the size *
tested), then the closure to be used heed
not be tested if scientific data exist to
demonstrate that the mechanical
properties of the closure-liner system
used are comparable to that tested. An
, example Is if a 24 xm closure with a
PVC liner is tested, then its data'inay be
used for certification of a 28 mm version
of the same closure with a PVC liner,
provided there is Scientific evidence that
the 28 mm closure-liner system'has
mechanical properties similar to the 24
nun closure-User system or
b. test data exist for two closure sizes
with a difference equal to or less than 10
mm. the Iir.er used in the two closure
sizes for which data exist must be the
same as the liner in the size used, then
the closure to be used need not be
tested. An exainple would be the test
data for a 24 mm ar.d 33 mm closure,
both with a vinyl pulp backed liner.
These data can be used for the,
certification cf a 23 mm closure with a
vinyl pulp backed liner.
The agency acknowledges that only a
limited amount of data are available on
large size packages. Consequently,
exceptions will be considered in those
cases where a registrant has submitted
appropriate scientific ar.d technical
data.
K. Label Language
The particular wording of the label
giving directions for child-resistant
packaging opening and closing
instructions is at the discretion of the
registrant, so long as it clearly explains
to the adult user how to use the
package.
•This is why even an apparently minor
modification in the liner, such as arlJinc in insert
for pi-motional rurpejes. .nay require reteni.-.q to
thai the ehild-reiijtant et'fectiveneM of she
elciu.-c or pacxaft has not been irrp.iirecL
L Certification of Child-Resistant
Effectiveness
Accsrii.-.g '.o 40 CTR :S2.iS{e). the
amcsw/r.-srsts fsr child-resistant,
packaging shall include a certification
by the registrant that-the package meets
the standards of §162.16(c).
The registrant is furthermore required
to maintain records concerning the .
package (§ 162.16(5;) which include a.
ccmpicte copy of the data resulting from
the tests conducted in accordance with
J 152.16(d). As indicated under J. above,
the agency realizes that it was r.ct made
entirely clear whether certification as to
the child-resistant effectiveness.of a
particular package should be based on
protocol tests carried out on the entire
package or merely the closure.
Therefore, by March 9,1981. the agency-
is allowing two types of certifications,
both of which ivill equally serve to
comply with the regulation. After the
agency has formally proposed and
published a final regulation concerning
the testing of package designs (see ), '
above) certain packages may have to be
retested and recertified;
(a) Certification of effectiveness
based on testing.scheme listed under]
above. If the protocol test data in the
registrant's files show that either the
exact package or a package meeting the
criteria enumerated under J, above, has
been tested, the registrant shall certify
that the package meets the effectiveness
criteria for child-resistance. The
certification statement must include the
registration number of the product, the
registered product name, the registrant's
name and address, date; the name, title,
and signature of the company official.
The certification, which should be
submitted in triplicate, should include at°
a minimum the following statement*
1 hereby certify that the special packaging
for this product and all applicable
supplementally registered distributor
products have been tested and found to meet
the requirements of 40 CFR 162.16(d),
Standards' of Special Packaging.
I understand that I am required to retain
the records described in 40 CFR 152.16(^,(1), ¦
(2). and (3) for as long as the registration is
valid These records shall be available upon
request, for inspection or copying purposes or
for submission to EPA. Furthermore! I certify
that should the speriaj packaging far this
product be changed. 1 will update this
certification statement'
Additionally, if the product is sotd in
several sizes of packages all the sizes
which this certification applies must be-
listed.
(b) Certification of effectiveness
based on testing the^package closure
cnly. If the protocol test data in the
registrant's files show that the closure
used has been tested for effectiveness
but it was actually tested or a ccr.:a'.-:.r
(package) other than the one used or
outside the limitations of the
listed under J, above, he snsii certify'the
effectiveness on the basis of the exact
size closure. The certification statement,
which should be submitted in ;::piica:s.
shall include the information listed
under (a) above and shall inci'.-ce afs
minimum the following 3ta:e-;r.::
I hereby certify :hat the exact cicsurs uscu
on the package of this product arc dli
applicable supplementally registered
distributofprccucts have beer. tested ar.d
found to tneet the requirements ct -id CFR
162.1C(d), Standards far Specisi'Piixss:"?.
' I understand that I am required :o retain
the records described in 40 CFR
(2). and (3] for as long as the reg:s:ra:icn is
valid.Thesarecords shall be available upen
request, for/inspection and copying purposes
or for submission to EPA Furthermore. 1
certify that should the special packaging for
this product be changed. I will update 'Jiis
certificationstatement
If a product is sold in a line of several
size packages, some of these packages
may be certifiable under method [a] and
some under (b). In this case two
certification statements are required,
one for those packages meeting the
specifications of (a) and one for those
which meet the specifications of (b).
(c) Information concerning the
package/closure used. The child-
resistant packaging regulation does not
require the registrant to submit
'information concerning the type and
make of child-resistant packaging used,
although this information is part cf those
records which must be kept, ar.d which
must be available for inspection and
submission upon request by EPA. TJte
agency at this time, however/requests
the cooperation of registrants to supply
this information voluntarily as.an
addendum to the certification statement
This request is made for purposes of
gathering informaon the variety of
packages and/or closures which have
undergone extensive.testing to allow
certification by (a) above, for example.
The agency feels that this information
will be exjreately helpful in providing
data which may permit it to propose a
more liberal testing scheme than the one
listed under). The information
requested is as follows: Fro duct sizes;
name of special packaging
manufacturer, name of special.
packaging and model/style: (ASTM
classification): closure sizes, and liners
used.
M. Amended Product Registrations for
Child-Resistant Packaging (CRP)
There are basically three types of .
amended registration applications that ~
may be submitted in conjunction with
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151CJ
Federal Kcgisier Vci. 4fi. No. 41 / Tuescny. March 3, 19£1 /' Rules arid Reauia:
ipTT,.-. ?jc.\.-soguiuticns. An
amendmerT. may be filed :o indicate the
•jse c: ;reciai packaging anc ;o submit
tre 2s?"C.h:sc certification statement:
ar am'sndmem —ay be filed to revise
I 'mc :o remove a package from :he
' :f :he special packaging
r. _ jurns: sr ar. amendment may be
filed :o change Lr.e prcd.ct formulation
c: s-b.-it new toxicity data to remove a
pesticide frcm the sccpe cf the special
packaging rervisticr.s. The regis^3n:
must indicate the use of special
packaging :n Form 8570-11 and must
designate CR Package in Eox 5 under
"type cf amendment."
1. Amendments for child-resistant
packaging certification: The registrant
must submit the required certification
statement (original ar.d rwo copies)
alone with the amended application. If
chile-resistant packaging instructions
for opening and resecuring such
packaging appear on the product label
or or. an accompanying circular, then
the label or circular must be submitted.
If the instructions are on Lhe container
or closure, only a copy of the
instructions should be submitted.
2. Labeling amendments: Registrants
must file an amended application to
rev::f> ;heir labeling to indicate specific
nonresidential use areas, or restricted
use. i.e.. the elected restriction of
purchase, storage, and use only by a
ser. icepersor.; see section I. Registrants
v- ish to amend their registrations to
!
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Federal Register / Vol. 46. No. 41 / Tuesday. March 3. 1931 / Rules and Reauictions 13ir
. submit adequate evidence :o support the
allegation.
d. If the allegation of incompatibility
is based upon the fact that the shelf-life
of the product limits package choice, the
-exemption shall outline the particular
limitation ana shail'ir.ciuce a time
schedule tor the registrant to reestablish
shelf-life data.
Grant;.-.; exemptions: Where the
agency detemir.es that reasonable
grounds for an exemption are presented,
(he agency snail publish that decision in
the Federal Register, ar.d it shall be
applicable to any product with identical
or substantially similar composition and
intended uses.
"Reasonable grounds" for granting an
exemption are information and data
sufficient to support the;condusion that:
(a) The hazard indicated by the
toxicity criteria in 40 CFR 162.16(c)(2)
are not indicative of the risk to man.
(b) Special packaging is not
techrJcally feasible, which includes
compatible, practicable, or appropriate
for the product
Denying exemptions: Where the
agency determines that reasonable
grounds for an exemption are not
presented, the exemption shall be
denied, and the registrant notified in
writing of the denial, including a brief
statement of the reasons therefor.
Effect of filing an exemption: The
- filing of an exemption shall not have the
effect of staying the regulation from
which the exemption is sought.
Therefore, products subject to special
packaging shall be considered to be in
violation of the law unless packaged in
special packaging during the agency's
consideration of the exemption request
after March 9.1S81.P.
Data Compensation
In accordance with the data
compensation regulations contained in
.40 CFR 162.9-1. and particularly
paragraph {b)(irj thereof, all
amendments to registration which are
made solely to achieve compliance with
the special packaging regulations and
Which do hot require EPA to review
scientific data before deciding whether
to permit the amended registration, will
not be subject to the data compensation
provisions of FIFRA sections 3(c)(1)(D)
and 3(c)(2)(B).
(Sec. 25(e)(3) as amended (Pub. L 92-S16. 86
Slat. 963: Pub. L 94-1-JO. 89 Slat 733; Pub. L
95-396. 92 Stat 819: 7 L'.S.C 138 et jeq.))
Dated: Jjnuary 28.1981.
Edwin L Johnson.
Deputy Assistant Adnir.istra'.or for Pesticide
Pro" rami.
jFS Due. r:i«] jm|
BIUJNO COOl
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STRATEGY FOR THE ENFORCEMENT
OF THE CHILD RESISTANT PACKAGING
REGULATION UNDER FIFRA
OVERVIEW
REQUIREMENTS OF THE RULE
Applicability
Exceptions
Exemptions
Specific Requirements
REGULATED INDUSTRY
ENFORCEMENT
Objectives
Voluntary Compliance
Vi olations
Inspection Scheme
Violation Detection Priorities
ADMINISTRATIVE CONSIDERATIONS
Program Management and Allocation of Responsibilities
Program Integration
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Strategy for_ths Enforcement of the Chi 1 d _R_esistant
£ai_kXCtn"s_fle.9 An_I,rri^J f. yJsM."
0vervi ew
On March 9, 1979, the Environmental Protection Agency
published a final rule at 44 _Fe d e r a J RejjJ s t e£ 13019 (40
CFR 152.15) which requires ch'i Id TVs i s'ta n't packaging (CRP)
of certain pesticides labeled for residentia 1 use. The
intent of the rule is to reduce the number of accidental
exposures by children to pesticides.
The regulation requires child resistant packaging for
any pesticide product released for shipment after March 9, 1981 ,
if (1) its labeling allows for residential use, (2) it has not
been classified for restricted use, and (3) 1t meets certain
toxicity criteria. Exemptions may be granted for products
for which special packaging 1s not technically feasible or
where the toxicity criteria are not Indicative of hazard to
humans.
The rule also requires affected registrants to,submit
applications for amended registration and maintain records on
child resistant test data.
Poissibie violations Include misbranding, failure to keep
records, failure to file reports, and falsification of data.
It is anticipated that states operating under grants will
have major responsibility for conducting inspections concerning
the CRP requirements. The Regions will handle the casework since
these types of violations would not be in violation of many
State statutes. Concurrence from PTSED is required for enforce-
ment actions resulting from violations of the CRP regulation.
Headquarters support will be available for data review and to
answer questions on whether or not a product meets the criteria
that trigger the requirement for child res i-stant ..packaging.
In addition, PTSED will provide Inspection targeting Information.
Requirements of the Rule
App1i cabi1i ty
As indicated in the overview, child resistant packaging 1s
required for any pesticide product released for shipment after
March 9, 1981, if (1) its labeling allows for'resident 1 a 1 use,
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-2-
{ 2) it has not been classified for restricted use, and (3) it
meets certain toxicity criteria. In addition, registrants with
products subject to the rule must amend their registrations to
reflect changes in packaging and certify that the packaging
complies with the C 3P regulation.
For your information certain terms used in the Strategy have
been defined below:
5 "Released for shipment" is defined as that point in time
when it is the intent of the producer to introduce the
product into commerce. Intent exists in any of the
following situations:
(1) a producer asserts that what is being sampled is
representative of what is actually sold;
(2) a product is stored in an area where finished
products are held for shipment in the ordinary
course of business (warehouses, loading docks,
etc.);
(3) the custom of the pesticide chemical industry
indicates that similarly situated products are
intended for release; or
(4) the custom of the particular producer indicates that
similarly situated products have been intended for
release in the past.
"Residential use" - A pesticide meets this criterion if
it is applied (other than by a commercial applicator)
directly to humans or pets or is applied in, on or
around all structures, vehicles, or areas associated with
the household or homelife or noncommercial areas where
children spend time, including, but not limited to gardens,
houses, yards, patios, mobile homes, campers and
recreational vehicles, noncommercial campsites, home
swimming pools, educational, lounging, and recreational
areas of preschools, nurseries, and day camps, etc.
Furthermore, residential use is determined by whether
a product has a use on the label which is within the
meaning of residential use. A registrant may have a
product that is not really intended for residential
use, but the labeling is either vague concerning use
areas, or use areas are actually omitted. Such a
product is subject to the child resistant requirements
unless its registration and label are amended to indicate
a strictly non-residential or agricultural application.
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s "Toxicity criteria" are defined in 44 Federal Reaister
13 019 (March 9 , 1 979) and at 40 CFR 16 2.15(C) ("?7~
Exceptions to CRP
5 "Dormant" Product Registration
A dormant product registration is defined as a product
which is not currently 1n production but retains valid
EPA registration.' For a product not 1n production and
which is not scheduled to be released for shipment on
or after March 9, 1981, an amended registration,
special packaging certification and other related
forms need not be submitted at this time. However, at
any time after March 9, 1981, if the product is put back
into production, an amended registration, child resistant
certification, etc., must be submitted before the
product is released for shipment if it meets the
criteria for special packaging.
0 Toxicity Data
If the toxicity of a product 1s not known to the level of
specificity necessary to determine whether or not the
toxicity criteria are met (e.g., the Information on file
with EPA is extrapolated data), the registrant may perform
additional testing. If testing Indicates that the toxicity
criteria are not met, the product is not required to
have child resistant packaging. However, 1f the regis-
trant does not conduct further testing when the toxicity
is not known to the necessary level of specificity,
child resistant packaging is required.
° Products for Residential Use by a Serviceperson
The Agency has decided to remove from the scope of CRP
requirements certain products which meet the criteria
for special packaging but are not normally stored in
areas where children could 1ikely have access to them.
Examples include, products used by janitors in nurseries
or daycare centers and products used by exterminators or
lawncare serv1cepersons. To accomplish this, EPA will
allow products such as those listed above to be sold and
distributed without child resistant packaging if such
products bear a statement restricting the sale, use, and
storage to servicepersons.
-------
This provision has been communicated to producers
through a Federal Register Notice issued March 3, 1931;
it will also appear in proposed revisions to Section 3
Registration regulations. Until it appears in final
regulations, EPA will use prosecutorial discretion and
not take enforcement action if a subject product is
' not specially packaged but is labeled or sticker-labeled
with a statement restricting the product's sale, use,
and storage to servicepersons, e.g., "Only for Sale
to, Use, and Storage by Servicepersons." The statement
must appear in type size at least as large as the
child hazard warning statement. Labels need not be
submitted to the Agency for approval but must be submitted
for the official label file used to determine compliance
with FIF R A .
° A registrant may amend his/her registration so that
the new label does not allow for residential uses.
In such a case the product bearing the new approved
label would no longer be subject to the special packag-
ing requirement.
ExernDtions to CRP
Exemptions may be granted by the Director of the Regis-
tration Division for products for which special packaging is
not technically feasible or where the toxicity criteria are
not indicative of hazard to humans.
Note that only the- Agency may grant an exemption. It is
not up to the registrant to decide if he or she is exempt
or— not, based on the two factors listed in the above paragraph.
Specific Requirements for Registrants of
Products Subject to the Special Packaging Requirement
0 Develop and test special packaging
"Special packaging" refers to packaging that is designed
and constructed to be significantly difficult for
children under five years old to open or obtain a
toxic or harmful amount of the substance contained
therein within a reasonable time. In addition, it
should not be difficult for normal adults to use pro-
perly. Effectiveness testing procedures which must
be used are those specified by the Consumer Product
Safety Commission (CPSC) at 16 CFR 1700.20(a), (b),
and (c). Effectiveness specifications and standards
for special packaging are delineated in 40 CFR 162.16.
° Amend registration - Certification
Prior to changing a product's packaging, the registrant
must submit an application for an amended registration
and have it approved by EPA. Instead of submitting
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-5-
detailed information demonstrating that the packaging
meets the requirements, the registrant shall include
with his application a certification that the package
^eets the standards of 6162.16(d). An applicant for
a new registration shall also submit a certification
statement that the package meets the standards.
3 Utilize special packaging
Products subject to the requirement must be in child
resistant packaging if released for shipment after
March 9, 1981 .
0 Recordkeeping
Certain records must be retained by the applicant or
registrant for as long as the registration is valid.
These records shall be available, upon request, for
inspection and copying purposes or for submission
to EPA. The records which must be kept are:
(1) A full description of the package Including:
(i) A full description of the container including:
(A) Its dimensions, and
(B) Its composition; and
(ii) A full description of the closure or special
package, if appropriate, Including:
(A) The name of its manufacturer,
(B) The manufacturer's designation (title)
for the special packaging closure or
the physical working of the special
packaging mechanism, and
(C) The explicit' directions for proper use
of the closure or special packaging
and the placement of these directions
on the package;
(2) A complete copy of the data resulting from the
tests conducted 1n accordance with §162.16(d);
and
(3) Data demonstrating the compatibility of the
pesticide formulation with1the entire package to
determine that the chemica11 and physical charac-
teristics of the substance will not interfere
with the s'afety and efficacy of the pesticide
and functioning of the special package.
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-6-
Note: The registrant may not have actual data on file if the
company did not perform the testing but, instead, relied
cn verification from others such as the company which
produces the packaging. The registrant should have a
letter or literature verifying that the packaging has
been tested and met the CRP standards.
Regulated Industry
The regulated community consists of registrants of those
products subject to these regulations. Estimates suggest that
approximately 9000 products may be involved.
The Registration Division of EPA has prepared a pre-
liminary list of types of products which are expected to be
covered by the CRP regulations if used and stored in and around
residential areas. (See attachment.) A second, more complete
list will be developed and forwarded as soon as it is available.
A company may remove its product from these requirements by
amending the label to remove residential uses, stickering or
amending the label so that sale, use and storage is restricted,
to a serviceperson , or by receiving an exemption.
Enforcement
Objectives
The objective is to assure compliance with this regulation
so as to minimize or eliminate accidental exposures to highly
poisonous pesticides used in and around residential areas.
Outreach
Registrants should be aware of the regulation through its
publication in the Federal Register. In addition, the Glass
Packaging Institute prepared and distributed, with EPA's
concurrence, a pamphlet entitled, "Pesticides and Protective
Packaging." Personnel in the Registration Division are generally
available to answer any questions and clarify the requirements
for registrants.
Violations
0 Misbranding - §12(a)(l)(E) of FIFRA
As defined in §2(q)(1)(B) of FIFRA, a pesticide is
misbranded if "it is contained in a package or other
container or wrapping which does not conform to the
standards established by the Administrator pursuant
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-7-
zo §25{c)(3). Failure to have special packaging
for thos.e products released for shipment after March
3, 19 81, would make the product misbrandedif it is
subject to the special packaging requirement.
There are three variations of this violation:
(1) No special packaging, although required.
(2) Company's new toxicity test data indicate
that such packaging is not required, but
the Agency does not agree that the
toxicity data support their conclusion
(e.g., improperly conducted toxicity
tests or'Incorrect -toxicity tests
utilized).
(3) Company changes packaging, but 1t does
not meet the child resistant requirements
because tests were incorrectly done or the
tests were conducted on the incorrect
container size.
0 Failure to File Reports Required - §12(a)(2)(N) of FIFRA
It is unlawful for a person who 1s a registrant to
fail to file reports required by this Act. Prior to
changing a pesticide's packaging, the registrant
must submit an application for amended registration to
EPA. Failure to do *so prior to distributing the product
in new packaging would be in violation of thiS: section.
In addition, the,registrant 1s required to
submit a certification statement with the.amended
registration application.
0 Failure to Maintain Reports Required - §12(a)(2)(3) of FIFRA
It 1s unlawful for a registrant to fall to maintain
reports required by FIFRA. The regulation requires
the registrant to- submit a certification that the
product is In compliance as opposed to detailed data
supporting this. However, it Is required that the
detailed data be maintained and be subject to Agency
inspection or request for submission. The registrant
is not required to have such-data on file 1f the firm
relied on testing conducted-by others such- as the package
supplier. In lieu.of such data he or she must have
some verification on file that the product 1s in compliance.
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-3-
In some cases, the company may claim that the parent
company/company headquarters has the data. This should
be noted on the inspection report and sent to the
appropriate region. The regional office should forward
this to PTSED so that a request for the data can. be sent to
the company's headquarters by OPP.
s Falsification of Application/Report or of Records
Maintained or of Exemption Request - § 1 2 (a ) ( 2 ) ( M) of
FIFRA or Title 13 of the U.S. Code.
It is unlawful to falsify all or part of any appli-
cation for registration, any records required to be
maintained pursuant to §8, or any report filed under
this Act. Thus, falsification of an application for
amended registration, the certification, or data such as
test protocol and results would be in violation of FIFRA.
Title 18 of the U.S. Code also makes this type of activity
i1 1 egal .
INSPECTION SCHEME
Inspections to determine compliance with these special packaging
requirements should be incorporated into a state/region's existing
inspection program, which should be based on a Neutral Administra-
tive Inspection Scheme. Generally, only producer establishments
will be inspected for compliance with the CRP regulation. Prior
to inspecting a pesticide producing establishment, the appropriate
personnel (inspector or whomever is designated to do this)
should determine if the company produces any of the products
on the attached list prepared by the Registration Division.
If so, the inspector should check for compliance with
the child resistant requirements.
Reports from inspections involving possible violations of
these requirements should be forwarded to the regional office
for case review and appropriate enforcement action.
Violation Detection Priorities
During an inspection, it is helpful to establish priorities
for detecting violations. The following table gives the general
priority ranking for violation detection. The following is
meant only as a guide to decision making and is not a rigid OE
policy.
Priority 1 - Misbranding
Failure to utilize Child Resistant Packaging where required.
This will probably be the most common violation found initially.
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-9-
Priority 2 - Failure to Maintain Records
Such records may be necessary to verify compliance with the
regulations. This includes test data which either (a) show the
package meets the child resistant requirement (CPSC test results)
or (b) show the product's actual toxicity does not meet the
criteria.
Priority 3 - Failure to File Reports
This refers to a company's failure to amend the registration
prior to a packaging change. This should not be a frequent viola-
tion but is easy to determine.
Priority 4 - Falsification of Data
While this 1s one of the most serious violations, 1t should
not be encountered frequently. Child Resistant Tests are
expensive (approximately $8000) and may be conducted under
contract if a company's test results are suspect.
ADMINISTRATIVE CONSIDERATIONS
PROGRAM MANAGEMENT AND ALLOCATION OF RESPONSIBILITIES
State and regional personnel 1f appropriate will be responsi-
ble for conducting Inspections and documenting cases.
With regard to actual casework, issuing penalties, notices of
warning, etc., the regions will have primary responsibility but
must request and receive concurrence from PTSED.
This is necessary for 3 reasons:
1) A violation of the child resistant requirement
1s not a violation of many state laws.
2) Some companies may have received exemptions or
the product may not be subject based on toxicity data
on fi1e wi th EPA.
3) The Registration Division may consider cancellation
action for those products which remain 1n violation.
PTSED's Case Development and Legal Branch will be respon-
sible for resolving questionable cases, I.e., those for
which there is some doubt or question as to the product's
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-10-
status or the validity of the data, and reviewing concurrence
requests .
P ro a_ra_nj_ I nt e g rat i on
The Case Development and Legal Branch, PTSED, will coordinate
with the Regions and the Registration Division to resolve any
questions regarding the child resistant packaging requirement
and the status of products covered.
The Regions will coordinate with the States regarding the
enforcement of the special packaging requirements.
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L'.'IITED STATES ENVIRONMENTAL PROTECTION AGENCY
w
WASHINGTON, D.C. 20460,
emc: S?
ys* I0F.--TDUI 1 PESTICIDES AN5 TOX : c
SUBJECT: Enforcement Strategy Concerning C'.iild-Resistant Packaging of
Pesticide Products.
TO: Jack Neylan
Pesticide Toxic Substances
Enforcer.ent Division (EN-342)
As a follow-up to our recent meeting concerning an enforcement strategy
on co-pliance with CRP regulations we are providing to you s list of
generic products for which an unqualified assumption can be made that
they need to be in CRP if used and stored in the household. This is con-
sidered phase I of the strategy. Phase II will consist of a nore refined
list which will be based on the actual CRP anendr.ents we receive.
1. Disinfectants
Product Concentration Dse
1
1.
Calcium
hypochlorite
65%
swimming pool
2.
Lithium
hyprochlorite
35%
ft M
3.
Sodium dichloro
s- triazine trione
and Trichloro-s
triazine trione
98-100%
ti u
4.
Mono (Trichloro
tetra (ironopotassium
dichloro) penta-s-
triazinetrione 99%
Swircring pool
5.
Hydrochloric acid
8%
Toilet bowl
6.
Phosphroric acid
17%
o n
7.
Chlorophenolics
6%
Disinfectant
3.
Sulfamic Acid
20%
Toilet bowl
9.
Quaternary AruT.oniuir.
Compounds
10 *
General disinfectant
10.
Par af o-,alde hyde
953
M l»
11.
Formaldehyde
37%
n ¦
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I. Insecticide and Rocenticice
Pesticide Cher.icai % At ar.c Above Requiring CR?
1. Carbophenothicr. 1.4
2. Chlcrdane 2S.0
3. Chlorpyrifos (Dursban) 9.0
4. Cryolite 15.0
5. Diazinon 7.0
o. Dir.ethoate (Cygon) 17.0
7. Disulfoton (Disystox) 0.4
8. Dvfonate 1.2
9. Ethion 3.5
lO.Imidan 10.0
11.Lindane 6.5
12. :*etaldenvde 20.0
13. Mexacarbate (Zectran) 2.0
14. Naled 18.0
15. Propoxur (Baygon) 6.2
16. Phosphorus (white) 1.1
Remarks
Sorr.e lawn use
products
Terir.ite control
products
Sprays for outdoor
Ornamentals
Plant dusts
Many plants and garden
sprays; encapsulated
diazinon does not require CRP
Systemic insecticides
for indoor and outdoors
plants
Some combinations with
lawn fertilizer
Borer sprays, dog
dips
Slug and snail
control
Insect, slug and
Snail control
Rodenticide
-------
3. Herbicides and Fungicides
Chenical Formulation / % A.I.
Bis (tributyitir.) oxide Above 0.5%
Paraquat
Pentachlorophenol
Chlorothalonil
Coppe r-8-qu ino1i no1a t e
any %
above 88%
above 40%
above 5%
bo Engler,
Disinfectants Branch
Registration Division (TS-767)
cc: D. Caanpt
R. Gross
J. Jenkins
H. Harrison
J. Akerman
Use
wood Presenv'ative
Homeowner herbicide
V.'ood preservative
Homeowner fungicide
Wood preservative
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*vG e n.ex.a j_~C.ojn pJlTnc e St raTegy f or Pro due ts Sub j.ec tZi^o_t.h e—
(Label Improvement Program/
Overview
On June 5, 1980 EPA published 1n the Federal Register (45 FR
37884) a notice Initiating a program to Improve pesticide labeling.
The Label Improvement Program (LIP) was Initiated to upgrade pro-
duct labeling In an attempt to better protect health and the environ-
ment as well as further defining legal use of a product. This program
was designed to work 1n conjunction with currently existing registra-
tion programs and to respond rapidly to labeling needs Identified by
the Agency. To date, four major label Improvement program notices
have been Issued and are 1n effect. Two additional label improvement
program notices have been recently Issued but are not yet 1n effect.
Regulated Industry
Some label Improvement rules affect all registrants, while
others affect only registrants of certain products.
Requirements of the Rule
Submission of Applications
The Office of Pesticide Programs (OPP), Registration Division
(RD) will notify each registrant of an affected product by certified
letter or a certified mall copy of a PR Notice that his product is
subject to specific requirements under that label Improvement program
revision. For each affected product* the registrant is required to
submit the following to EPA:
1) An, app1ication for amended registration (EPA Form 8570-11).
2) Five copies of draft labeling incorporating required changes.
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- 2 -
3) If necessary, a Statement of Confidential Formula (EPA Form
8570-4 ).
Registrants must normally submit applications within 60
calendar days of receipt of the LIP Notice. The Agency will state
any deviation from this deadline in the LIP Notice.
Products for which the Agency has not received an application
for amended registration within the stated deadline will be subject
to cancellation. The Agency will issue a Notice of Intent to Cancel
for any such product, effective 30 days from its receipt, unless
within that time the registrant or an interested party with the
consent of the registrant, either applies for amended registration
or requests a hearing under section 6 of FIFRA.
Exemption from Compensation Requirements
In many cases an amended registration to meet the requirements
of a Label Improvement Program Notice will not be subject to com-
pensation requirements. If this is the case, the Offer to Pay or
Certification Statement will not be required.to be submitted to RD
and approval of labeling submitted will not convert registrations
to conditional status. Each notice will address the compensation
status of applications submitted in response to the LIP Notice.
Processing of Applications
Generally, the Registration 0 i vision will review labels
for compliance with the requirements of the LIP Notice. A regis-
tration amendment submitted in response to a LIP Notice is not
complete until the amended labeling is submitted and accepted by
RD. If draft labeling is not acceptable, RD will notify the
registrant of the deficiencies by letter and give the registrant
75 calendar days to submit amended labeling. Amended labeling
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- 3 -
must be limited to changes required by the letter 1n order to
maintain the exemption from compensation requirements.
Combined Application In Response to Multiple Label Improvement
Not1ces
Applicants receiving multiple notices requiring LIP labeling
amendments for the same product may combine responses Into one
application for amended registration provided the relevant LIP
Notices are clearly referenced. Applications that are non-compen-
sable under FIFRA section 3(c)(1)(D) may not be combined with
applications that are compensable. The submission deadline for
combined applications for amended registration 1s the later of
the deadlines established In the LIP Notices.
Time Frames for Compliance .
Any product released for shipment 180 calendar days after the
registrant receives RD's acceptance of amended labeling must bear
that accepted label. Registrants are responsible for compliance
by their sub-reglstrants (distributors).
Products that have been released for shipment and are In
retail channels of trade prior to the 180 day deadline may continue
to be distributed 1n commerce, sold and used until supplies are
exhausted.
Enforcement Objectives
The objective of LIP compliance program 1s to ensure that
product labeling Is 1n compliance with the requirements of the
various Label Improvement Program Notices. This will be accom-
plished through producer establishment inspections.
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- 4 -
Types of Vi olat i ons
Producers not complying with the requirements of the notices
issued under the Label Improvement Program are in violation of
of FIFRA section 12(a)(1)(E) in that their products are misbranded
under sections 2(q)(l)(F) and (G). Products being sold in violation
of a cancellation order are 1n violation of FIFRA section 12(a)(2)(L)
and subject to the penalties thereunder.
Administrative Considerations
The Office of Pesticide Programs has issued four major label
improvement notices (See Attachments) which are currently in effect
with two more LIP Notices issued but not yet in effect. The four
existing LIP Notices are listed below in order of inspectional
targetting priority according to their potential hazard.
1 ) Fumi qant s - Issued 12-4-80 - This LIP Notice requires
registrants of products containing certain active ingredients to
add additional precautionary labeling, misuse statements and storage
and disposal statements.
2) Termi ti ci des - Issued 11-7-81 - This LIP Notice requires
registrants of termiticide products containing one of the active
ingredients listed in the LIP Notice to revise use directions of
their product, use the appropriate storage and disposal statements,
add a misuse statement, and reformat their labels.
3) Ant i fouling Paints - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.
-------
- 3 -
4) Salt Water E me s 1 s - Issued 11-30-80 - This LIP Notice
requires all registrants to delete salt water emesls statements
from their labeling. Since the revision was a simple deletion,
registrants were not required to submit amended labeling for review.
Two more LIP Notices have been recently Issued dealing with
worker reentry Intervals and disposal requirements. As they become
effective they will be Included for targettlng 1n the 1nspect1onal
program.
Targettlng Inspections .
The Registration Division, OPP Is responsible for compiling
lists for each LIP Notice consisting of:
1) The name and address of each registrant affected;
2) The name and registration numbier of each .product affected;
3) The registration status of each product affected, I.e.,
. compliance, pending, or subject to cancellation; and
4) The date of acceptance of the amended labeling 1f the
product Is tn compliance.
These lists, which the Compliance Monitoring Staff will forward to
the Regions, will be a basis for the States' or Regions' Inspection
targettlng.
States should target Inspections* based on the priority as-
signed to each LIP Notice 1n this document and on the current
registration status of products regulated under each Notice.
To identify Inspection targets, States should first list under
each LIP Notice the registrants and the number of their products
whose: a) product labels are subject to cancellation for failure
'Only producer establishments should be targetted for inspection
under this guidance. Marketplace inspections are not appropriate
for determining compliance with this'rule. Products in the channels
of trade prior to the date when amended final. printed label1ng
must- appear on a product may continue to be sold. Therefore, it
Would not be an effective use of resources to determine the existence
of violations based on marketplace samples.
-------
to respond to the.LIP Notice; and b) label amendments RD has
approved. Inspection priorities will not include registrants
whose products have label amendments pending with RD. Priority
for inspection should then be as'signed on the following basis:
1) Registrants of products subject to cancellation for failure
to respond to the LIP Notice. These registrants should
be ranked based on the number of their products subject to
the LIP Notices in the following order: Fumigants, Termi-
ticides, Antifouling Paints and Salt Water Emesis.
2) Registrants with the most number of products with accepted
amended labels subject to any LIP Notices in the following
order: Fumigants, Termiticides, Antifouling Paints and
Salt Water Ernesi s.
After determining inspectional priorities for the LIP, the
States should integrate these priorities with the criteria listed
in the FY 84 Cooperative Agreement Guidance for scheduling
producer establishment inspections (past violative history, products
subject to Label Improvement Program, products subject to Child
Resistant Packaging (CRP) regulations, and Restricted Use Pesticides).
The highest priority in scheduling inspections should be given to
those producers which meet the largest number of these criteria.
Inspect i ons
Inspectors will examine products released for shipment at
the producer establishment to determine compliance with the terms
of the LIP Notice. Registrants have 180 calendar days following
acceptance of amended labeling to bring the product into compliance.
Any product released for shipment after this 180 calendar day period
must bear accepted amended labeling.
Registrants with products not in compliance with any LIP
Notice will be issued a Stop Sale Use or Removal Order (SSURO) by
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- 7 -
the State or EPA 1n addition to any enforcement action taken by
the State or EPA. The SSURO will be removed only after the registrant
brings the product into compliance. SSURO's will not be lifted for
cancelled products sold 1n violation of a cancellation order.
Issuance of a SSURO 1s an appropriate response to non-compliance
as the LIP Is designed to mitigate the risks of handling pesticides
through labeling changes and the registrant Is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters Responsibility
a) Provide Regions with a compliance strategy for Label
Improvement Program,
b) Provide Regions with copies of each LIP Notice,
c) Provide list of registrants affected by a Notice,
status of the products affected and date of accep-
tance of final printed labeling for each product
1n compl1ance.
Regional Responsibility -
a) Provide copies of all pertinent materials to the States.
b) Provide guidance and assistance for State enforcement
efforts.
c) Assist In Issuance of SSURO's.
State Responsibility .
a) Schedule and conduct Inspections of affected registrants.
b) Issue SSURO's to non-comply 1ng registrants.
c) Take enforcement actions where appropriate.
-------
* note! this docunent may not be identical to original document
Order number 930528-081520-PLC -001-001
page 1 set 11 with 3 of 6 items
Item 4
ACCESSION NUMBER
DOCUMENT NUMBER
DOCUMENT CATEGORY
DATE
TITLE
ISSUING OFFICE
LAU
REGULATION
STATUS
RELEASABLE
DOCUMENT LENGTH
: 4415
: FIFRA;PC
: Policy
: 05/12/92
: Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Good Laboratory Practice Standards (GLPS) Questions and Answers
: Office of Compliance Monitoring; Office of~Prevention, Pesticides, & Toxic Substances
: FIFRA Sections 5,7,8,9,11,12,14,19-
: 40CFR160.1,160.3,160.10,160.12,160.17,160.33,160.35,160.47,160.105, 160.120,160.185,160.190,160.195,
169.2
: Active
: Yes
: 31 Screens
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT ( FIFRA )
GOOD LABORATORY PRACTICE STANDARDS ( GLPS )
QUESTIONS AND ANSWERS
Prepared by the
Pesticides Enforcement Policy Branch
Policy and Grants Division
Office of Compliance Monitoring
Office of Prevention, Pesticides, and Toxic Substances
U.S. Environmental Protection Agency
Nay 12, 1992
- 1 -
INTRODUCTION
On August 17, 1989, EPA published in the Federal Register revisions
to the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA ) Good
Laboratory Practice standards ( GLPS ) ( 54 FR 34052 ). This revision
included changes that the Food and Drug Administration made to its
GLPS ( September 4. 1987; 52 FR 33768 J and expanded the scope of the
regulations to include data submissions which nad previously not been
under GLPS. The expansion of GLPS to include field studies has brought
many facilities under GLPS for the first tine while also making the
standards applicable to entirely different types of testing environments
than had previously been the case.
Since the publication of the revised rule in 1989, EPA has received
many questions from persons who wish clarification regarding the
\
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Order number 930528-081520-PLC -001-001
page 2 set 11 with 3 of 6 items
applicability of the rule to their activities. These questions have
ranged from simply asking whether the work they are doing is reauired to
comply to technical questions regarding how the standards should be
applied in the context of field as opposed to laboratory studies. Many
written replies have been made to persons who have submitted specific
questions in writing to EPA. Copies of specific correspondence have
been provided upon request.
Notwithstanding, the correspondence file is of limited usefulness
to other persons since the issues addressed are often specific to a
particular situation. There have been requests for a general guidance
document regarding EPA's FIFRA 6LP policy. The following questions and
answers have been prepared by the Policy and Grants Division of the Office
of Compliance Monitoring to serve as official written policy for the
regulated community.
- 2 -
QUESTIONS AND ANSWERS
APPLICABILITY
1. What is the applicability of GLPS to work in progress at the time
that the rule became effective?
The GLPS apply to all study-related work which is performed on or
after the effective date of the rule. Studies in progress must be
in compliance with GLPS from the effective date onward. A statement
of compliance or non-compliance must accompany the final study report
for such a study. This statement must either (1) state that the
study was in compliance with GLPS, (2) describe in detail how it did
not comply with GLPS, or (3) state that the submitter did not sponsor
or conduct the study and does not know Its compliance status. The
statement must account for compliance or deviations with both the
previous GLP rule ( effective 1984 ), and the current rule
( effective 1989 ), as applicable.
2. If a study was in progress on October 16, 1989, must it have a
protocol? What parts of the study would the protocol address?
All portions of the study performed on or after the effective date
must be performed according to a written protocol as provided at 40
CFR 160.120. That protocol need only address those parts of the
study performed on or after the effective date. Please note that if
a study was subject to the 1984 GLPS. a protocol was required for all
?arts of the study conducted after tne effective date of that rule,
he compliance statement submitted with that study's report must
specify in detail those study activities which were not performed in
accordance with GLPS.
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3. Current reregistration procedures involve submission of data that
resulted from studies performed prior to the effective date of 6LPS.
Do GLPS apply to such data, and if so, how?
Any data presently submitted in support of a pesticide research or
marketing permit must be accompanied by a true and correct compliance
statement as described at 40 CFR 160.12 regardless of when the study
was performed. Therefore, data submitted to meet reregistration
requirements are required to be accompanied with a true and correct
compliance statement informing EPA in detail of all differences
between the practices used in the study and those required by GLPS.
It is not unlawful to truthfully admit that studies supporting such
- 3 -
submissions did not comply with GLPS, nor would such an admission
necessarily lead to rejection of the data. The compliance statement
will help the Agency to determine the reliability of the data
based on current data requirements. Note that such an admission may
nevertheless result in an enforcement action if they indicate that an
unlawful act has occurred. For example, other regulations, i.e.,
books and records as stated at 40 CFR 169.2
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7. Uhat applicability do GLPS have when State, Federal, or independent
laboratories are used to provide soil or weather data for 6LP
studies?
6LPS are applicable in such circumstances if such data are gathered
as part of a FIFRA study. Only where such data are gathered
independently of the study, and the study report clearly indicates
that such data were not gathered as part of the study, would GLPS not
apply.
- 4 -
DEFINITIONS
8. Will EPA issue separate 6LP standards for field testing as opposed to
laboratory testing?
The expansion of GLPS to cover field studies was based on the need to
assure identical standards for all data submitted to EPA under FIFRA,
and on the determination that GLPS are technically general enough to
cover virtually any type of research environment. EPA does not
Intend to issue separate standards.
9. Can an experiment be divided into more than one study, based on where
or when the work is performed, or the phase of the experimental work?
Under GLPS, the term "study" refers to an experiment to determine
or predict the effects or characteristics of a test substance. EPA
considers a study to be composed of all of the necessary elements of
research which are performed in order to obtain the reported results.
If the elements of research consist of several phases of work which
must be taken in the context of each other to get meaningful results,
they are all considered to be elements of the same study. An example
of this would be where one laboratory treats a test system with a
test substance and sends the treated test system to another
laboratory for analysis.
If the experiment involves treatment of test systems in several
different locations, the experiment may be considered to be composed
of either one study encompassing all locations or several studies
each involving one or more locations. In the latter case, however,
it would be necessary that each separate study 3tand entirely by
itself, i.e., meet all of the criteria of a study. There would have
to be separate compliance statements for each, separate tracking on
master schedules, separate quality assurance inspections, etc. Each
study would have to have a study director ( and only one study
director ), although it may be possible for the same study director
to oversee several of such studies at the same time. Finally, where
several studies are compiled for submission, the submission must
include true and correct compliance statements for each study
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Order number 930S28-081S20-PLC -001-001
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involved in the submission.
10. What is EPA's formal policy on certifying copies of raw data? Hust
each page be signed and dated?
EPA stated in the preamble to the August 17, 1989 rule ( 54 FR
34066 > that acceptable alternatives to signing and dating each page
may be devised and incorporated into standard operating procedures.
EPA did not further elaborate in order to allow each testing facility
flexibility in implementing SOPs that would
- 5 -
provide adequate assurances within its facilities. Note that EPA
may inspect the original records, which must be maintained by the
registrant as provided at 40 CFR 169.2(k), to assure that they have
been kept and that the copies are correct.
11. Is it permissible to discard original raw data worksheets after exact
copies have been made?
Destruction of original raw data is prohibited. The registrant is
responsible for maintaining all original raw data as specified at 40
CFR 169.2(k). Copies of data may be used to assure compliance with
GLPS at the level of the testing facility, but EPA requires that the
registrant maintain all original data that support a study.
12. Uhat type of sponsor-testing facility communication is considered to
be raw data which must be archived at the end of the study?
All records of sponsor-testing facility communication which occur
as part of the activities of a study are considered to be raw data,
as defined at 40 CFR 160.3. This includes memoranda, letters, and
records of telephone conversations which occur during the course of
the study. Communication conducted prior to the study ( i.e., before
the protocol is signed > or following the completion of the study
( i.e., after the report is signed ) would not normally be considered
to be raw data. Note that certain records not specific to a
particular study which are generated when the study is not in
progress still need to be retained to prove that study's compliance
with GLPS. Examples include records of a sponsor's notifying a
facility of the need to comply with 6LPS as required at 40 CFR
160.10, and records of facility documents 3uch as standard operating
procedures.
STUDY DIRECTOR
13. Many field studies involve more than one technical phase, each
involving different personnel and different methodologies, often by
different contractors. Concern has been raised over the difficulty
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for a single individual to physically oversee all phases and to be
expert in all techniques involved. Within the same study, is it
acceptable to assign a different study director to different phases?
No. Each study must have a single study director who represents the
single source of study control. This is explicitly stated in the
GLPS at 40 CFR 160.33. A single point of control is necessary to the
integrity of the study and to avoid the potential for conflicting
instructions and confusion in study implementation.
- 6 -
14. If there can only be one study director assigned to a study, 1s it
acceptable to assign "field directors" and "analytical directors" to
manage the work which involves different phases and/or locations?
The assignment of responsibility for the study to the study director
need not interfere with ordinary delegation of authority necessary
for the performance of study duties. Any authority accepted by
persons other than the study director does not reduce the study
director's overall responsibility for the study.
QUALITY ASSURANCE UNITS ( QAUs )
15. Is it acceptable to inspect study-related procedures at a time other
than when the study is ongoing?
The GLPS state at 40 CFR 160.35(a) that a testing facility shall have
a Quality Assurance Unit ( QAU ) that shall monitor each study to
assure management that the facilities, equipment, personnel, methods,
practices, records, and controls are in conformance with the GLPS.
The GLPS further state at 40 CFR 160.35(b)(3) that the QAU shall
inspect each study at intervals adequate to ensure the integrity of
the study.
Clearly, the QAU must conduct inspections adequate to provide the
assurances required at 40 CFR 160.35(a) and, in the course of so
doing, must inspect each study at least once. All parameters oust
be verified adequate for each site, but it is acceptable to use
inspections conducted during other studies to provide necessary
assurances. It is also acceptable to use inspections conducted when
no study 1s in progress to assure that methods, personnel, etc. at a
particular site are in conformance with GLPS. However, acceptability
of such inspections is contingent on assuring that the facilities,
personnel, methods, etc., which are inspected are representative of
those used 1n the study. Note that it is necessary to reinspect
facilities periodically to account for changes in personnel,
equipment, etc. Finally, no matter how complete QAU inspectional
coverage is regarding the sites involved in a study, it is still
necessary to conduct at least one inspection of study activities
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while the study is in progress.
- 7 -
16. Uhat would constitute adequate inspection of the ongoing study?
Uould an audit of the protocol or of data records be adequate?
At least one inspection must be conducted while the study is in
progress. Under GLPS, the QAU monitoring of protocols, data records,
or other documentation phases of a study are important just as is
directly observing the experimental phase of the study. However, the
6LPS state at 40 CFR 160.35(b)(3) that Inspections must be done at
Intervals adequate to ensure the integrity of the study, and further,
at 40 CFR 160.35(b)(4), that periodic status reports noting problems
and corrective actions be submitted to management.
An audit of a study protocol would be of very limited utility since
the subsequent reporting would be to management which, in all
likelihood, has already reviewed the protocol. Data record audits
would also be of very limited utility since they may occur after all
experimental work is completed—in snort, too late for any corrective
actions to be taken. This problem also applies to protocol audits
conducted after the experimental phase is completed. Thus, reliance
solely on 3uch types of audits would not meet the GLP requirements as
stated at 40 CFR 160.35.
FACILITIES
17. Is it permissible to store mixed feeds containing the test substance
in the same room with the test system during feeding studies?
As discussed at 40 CFR 160.47(b) test substance mixture storage areas
must be stored in separate areas from the areas where test systems
are kept. However, working quantities of test substance mixtures
need not be stored in separate rooms from test systems. Separate
areas within the same room may be designated for test substance
mixture storage and test systems as long as the separation is
adequate to preserve the integrity of the study and the identity,
strength, purity and stability of the mixture.
- 8 -
TEST, CONTROL, AND REFERENCE SUBSTANCE CHARACTERIZATION
18. Do characterization requirements at 40 CFR 160.105 apply to
analytical standards?
Analytical standards are considered to be reference substances and
are subject to all GLP standards that apply to reference substances,
including characterization.
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19. Can data developed by the supplier of the standard be accepted? If
not, can it be used on an "interim" basis until the standard is
adequately characterized?
Information developed by a supplier can be used to support
characterization requirements, but the compliance statement for the
overall study must state whether such data were developed under GLPS.
Any data not developed under GLPS may be rejected by the Agency.
Analyses oust be performed to characterize the reference substance
before it is used. In the case that a standard is used before it is
analyzed, this is a violation of 40 CFR 160.105(a), which requires
such determinations to be made before the standard is used in the
study.
20. Uhat documentation would apply to standards?
Full characterization information as stated at 40 CFR 160.105 is
required of standards. This section requires that any information
that is appropriate for defining the standard, including identity,
strength, purity, or composition, shall be determined for each batch
before it is used. In tne case of an analytical standard,, for
example, it is necessary to obtain analysis data documenting the
identity, strength, and purity, for each batch. A labeled assay
value, in and of itself, is insufficient.
TEST SUBSTANCE STORAGE CONTAINERS
21. Is it necessary to retain test substance storage containers for the
duration of a field study?
Yes, as provided at 40 CFR 160.105(c), storage containers for test
substances shall be assigned for the duration of a study. This
requirement is necessary to assure that test substances are stored
in proper containers, and that the containers that are used can be
accounted for during the study. At any time during the study, it
must be possible to examine tne containers to assure that this
standard is met. However, requests for waivers involving large
numbers of containers or safety
- 9 -
concerns may be made to the Director, Policy and Grants Division
( see question #23 ).
22. If a large number of containers are involved in a study and/or
unusual safety problems are caused by the storage of such containers,
is there any alternative to storage?
Yes, but only if written permission is obtained from the Director,
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Policy and Grant9 Division ( see question 0 23 ). The written letter
authorizing disposal of containers will impose certain requirements
that will ensure that the intent of the GLP standards are net.
23. How does one obtain such permission?
A request for permission must be submitted 1n writing to the
Director, Policy and Grants Division, Office of Compliance Monitoring
( EN-342 ), U.S. Environmental Protection Agency, 401 H Street, SW,
Washington, DC 20460. The request must identify the study for
which permission is requested, the testing facility, the nature and
quantity of containers involved, and the time and location(s) of the
study. The request should also identify any special storage burdens
or safety hazards which retention of the containers may pose.
24. Uhat types of conditions would be imposed by EPA in granting such
permission?
EPA will request that sufficient documentation be available to assure
that any containers which have been used for test substance storage
during the course of a study are thoroughly accounted for from the
time of receipt to disposal. This documentation would generally
include such items as bills of lading, inventory records, receipts,
use logs, and any other supportive records. In addition, the letter
will stipulate that the Director the of Laboratory Data Integrity
Assurance Division of 0CH be notified of the location of sucn records
in order that they be available for inspection.
25. Can "generic" permission be obtained to cover multiple studies and/or
test substances?
No. Each case will be evaluated individually. However, more than
one study and/or test substance may be included in given request, as
long as each study and test substance is specifically identified.
- 10 -
PROTOCOLS
26. Can a "generic protocol" be used for obtaining sponsor approval?
The GLPS require that the protocol be approved by the sponsor, and
the date of approval must be included with the protocol; however the
GLPS also provide flexibility in how this approval is obtained. A
"generic protocol" approach may be acceptable for obtaining sponsor
approval of certain protocol elenents. In such a case, the testing
facility which is drafting the protocol for a study would only need
to obtain approval of those elements which were not included in the
generic protocol. Please note that since the GLPS require protocols
to include certain information that would not be included in a
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generic protocol, such as the test substance or the proposed start
and termination dates, it would still be necessary to obtain sponsor
approval for such information in addition to the approval of the
generic protocol.
27. What records of seeds or transplants of crops or plants used in field
studies must be maintained?
Uhere crops or plants are the test system or a component of the
test system, all 6LP standards relating to test system records are
applicable. These include protocol provisions given at 40 CFR
160.120(a)(6) and (7), as applicable. Included, for example,
would be the source of the test system supply, species, method of
Identification, etc. Lot numbers of seeds, brand names, and other
information uniquely identifying the test system would be relevant.
REPORTING
28. The GLPS at 40 CFR 160.185(a)(12) require that signed and dated
reports of each scientist or other professional in the study be
included in the final report. Can these reports be combined into
one report, with all of the scientists and professionals dating and
signing that report?
This requirement is intended to ensure that all information related
to the study is included in the final report. Specifically, when
individual scientists findings are part of the study effort, they
are required to be included separately. Combined reports may in
effect be consensus documents, and that would defeat the purpose of
this requirement. Note that this requirement is not intended to
require separate reports of all scientists participating in a study
if such scientists are not,
- 11 -
in fact, providing individual findings or opinions. For example,
pathologist's reports are considered to be separate findings which
must be reported separately.
ARCHIVES
29. The GLPS state that the study director must assure that raw data are
transferred to archives during or at the close of the study. Is
there a "grace" period allowed after the end of the study to allow
this to be done?
Under GLPS, the study director is required to assure that all raw
data, documentation, the protocol, specimens, and final reports are
transferred to the archives during or at the close of the study ( 40
CFR 160.33(f) ). Thus, there is no grace period. The study director
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must comply with this requirement prior to signing the compliance
statement. This ensures that data are fully accounted for at the
completion of the study.
30. How does EPA define "close of study" in regard to archiving?
The term "at the close of the study" is strictly interpreted to mean
that point of time at which the study director signs the final study
report. The act of signing the final report is one of assurance by
the study director that the report is a true representation of the
data that support the report. At or prior to the time that the study
report is signed, the study director oust pass control of the raw
data to the archives where their integrity will be maintained. Any
delay in the transfer of data beyond the close of the study creates a
lapse between the time that the study director assures that the raw
data support the study report and the time that the data are secured
from damage, misuse, or loss.
31. Given that data must be transferred to archives at the close of the
study, is it possible to use temporary archives prior to transfer to
a central archive?
There is flexibility in the location of the archives of raw data and
specimens. At 40 CFR 160.190(b), the GLPS state retention of records
at alternate locations is acceptable, provided that there is specific
reference to those locations in the archives. Such off-location
archives must still meet the full requirements of 40 CFR 160.190.
Whether records are archived at the registrant's facility, at a
contractor's central location, or at separate contractors' locations,
the study director must assure that all raw data and specimens have
been archived before the study report is signed. If the study
director cannot assure that records at a particular location are
archived correctly, he should not sign a compliance statement that
indicates that this standard has been met. Note that, for the
- 12 -
purpose of complying with GLPS, true copies may be archived at the
close of the study. The original records will have to be maintained
as well but need not be archived at the end of the study if this is
impractical, for example where the original data constitutes a
facility record shared by other studies still in progress at the
close of the study.
32. Is it necessary to retain frozen tissue samples in archives, or may
these be discarded after quality assurance verification?
Under FIFRA GLPS, 40 CFR 160.195, frozen tissue samples are required
to be retained in archives, and there are no specific allowances
for their being discarded as there are for "specimens obtained from
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mutagenicity tests, specimens of soil, water, and plants, and wet
specimens of blood, urine, feces, and biological fluids." The GLPS
do not require specially prepared material to be retained beyond the
period that it affords evaluation if such material is relatively
fragile and differs markedly in stability or quality during storage.
EPA doe3 not believe that this is the case for many types of frozen
tissues. The reason that tissues are frozen 1s to retain their
utility for evaluation. Please note that, as provided at 40 CFR
160.195(h), non-documentary material such as samples and specimens
may be discarded after EPA has notified the sponsor or testing
facility in writing that retention is no longer required.
33. Must field notebooks be archived during or at the close of a study?
If a notebook contains raw data, the notebook or the raw data must
be archived at the close of the study. Note that the registrant
is responsible for the original records under 40 CFR 169.2(k) and
section 8 of FIFRA, so it is inadvisable to enter raw data for
studies related to different registrations in the same bound
notebook.
34. Must analytical preparations ( e.g., scintillation vials and
solutions ) be archived?
Such preparations need not be retained beyond the period that they
afford evaluation, as stated at 40 CFR 160.195(c). Generally,
samples prepared for analysis have limited utility beyond the time
of analysis and can be discarded.
35. How long must soil, water and pLant specimens be retained?
These need only be retained until the QAU has verified that their
disposal will not jeopardize the integrity of the study, as provided
at 40 CFR 160.190(a) and 160.195(c). Please note that there may be
study-specific sample retention
- 13 -
requirements in addition to and independent of GLP requirements.
Failure to retain such samples may result in rejection of data by EPA
or enforcement actions independently of whether GLP violation has
occurred.
GLP VIOLATIONS
36. Can EPA assess penalties for GLP violations?
Yes. FIFRA section 14 states the EPA's authority to assess penalties
for violations of the Act.
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37. Uhat are the possible violations under the statute?
Violations of 6LPS may constitute unlawful acts under FIFRA. Under
section 12(a)(2)(H) it is unlawful to knowingly falsify all or part
of any application for registration, application for experimental use
permit, any information submitted to tne Administrator pursuant to
section 7, any records required to be maintained pursuant to this
Act, any report filed under this Act, or any Information marked as
confidential and submitted to the Administrator under any provision
of this Act to be submitted to EPA or of records required to be
maintained. Under section 12(a)(2)(0) of FIFRA it is unlawful to
falsify all or part of any information relating to the testing of
any pesticide ( or any ingredient, metabolite, or degradation
product thereof ), including the nature of any protocol, procedure,
substance, organism, or equipment used, observation made, or
conclusion or opinion formed, submitted to the Administrator, or that
the person knows will be furnished to the Administrator, or will
become a part of any records required to be maintained by this Act.
Under section 12(a)(2)(H) of FIFRA it is unlawful to submit to the
Administrator data known to be false in support of a registration.
Finally, it is unlawful under FIFRA section 12(a)(2)(B)(i) of FIFRA
to refuse to prepare, maintain or submit any records required by or
under sections 5,7,8,11, or 19.
38. Uhat are the maximum penalties that can be imposed?
Section 14(a) of FIFRA provides for maximum civil penalties of not
more than $5000 per offense for violations of the Act by registrants,
commercial applicators, wholesalers, dealers, retailers, or other
distributors, and of not more than $1000 per offense for other
persons. For knowing violations of the Act, FIFRA section 14(b)
provides for maximum criminal penalties of not more than $50,000
and/or 1
- 14 -
year imprisonment for producers, registrants, or applicants for
registration and of not more than $25,000 and/or 1 year imprisonment
for other knowing violators.
39. Uill civil or criminal penalties be imposed for all GLP violations?
No. Section 9(c)(3) of FIFRA allows a written notice of warning to
be issued for a minor violation, if such warning is determined to be
adequate to serve the public Interest. Section 14(a)(4) of the Act
further provides that in determining the size of a penalty EPA may
issue a warning in the case that a violation occurred despite
exercise of due caution or did not cause significant harm to health
or the environment. Finally, section 14(a)(2) of FIFRA provides that
persons other than registrants, commercial applicators, wholesalers,
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dealers, retailers or other distributors who violate an/ provision of
the Act may be assessed a ctvll penalty only subsequent to receiving
a written warning for a prior violation. Thus, persons who only
perform testing and are not engaged in the distribution and sale of
pesticides will not be assessed civil penalties for their first
offense. This does not extend to criminal penalties as described at
section 14(b)(2) of FIFRA.
40. Can EPA reject studies not conducted in accordance with GLPS?
yes. The regulations specifically provide for this at 40 CFR
160.17(a), which states that "EPA.may refuse to consider reliable
... any data from a'study which (is) not conducted in accordance with
( GLPS ).° GLP violations associated with a study submitted to EPA
may also result in enforcement actions whether or not a study is
rejected.
**End of document reached**
4424
: FIFRA;PC;PG553
ACCESS
OQa*0rrhu#
DoWHENT'CAT
DATE
TITLE k
ISSUING OFFICE
: Methyl Brom
: Office of O
Fumigants
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dealers, retailers or other distributors who violate any provision of
the Act may be assessed a civil penalty only subsequent to receiving
a written warning for a prior violation. Thus, persons who only
perform testing and are not engaged in the distribution and sale of
pesticides will not be assessed civil penalties for their first
offense. This does not extend to criminal penalties as described at
section 14(b)(2) of FIFRA.
40. Can EPA reject studies not conducted in accordance with GLPS?
The regulations specifically provide for this at 40 CFR
rffiich states that "EPA may refuse to consider reliable
Yes.
160.17(a), wn
... any data from a study which (is) not conducted in accordance with
( GLPS ).n GLP violations associated with a study submitted to EPA
may also result in enforcement actions whether or not a study is
rejected.
**End of document reached**
Item S
ACCESSION NUMBER
DOCUMENT NUMBER
DOCUMENT CATEGORY
DATE
TITLE
ISSUING OFFICE
ADDRESSEE
LAU
STATUS
RELEASABLE
DOCUMENT LENGTH
4424
FIFRA;PC;PG553
Policy
09/01/92
Methyl Bromide Label Revision in Response to Health Concerns of Structural Fumigants
Office of Compliance Monitoring; Office of Pesticides & Toxic Substances
Addressees
FIFRA Section 12
Active
Yes
38 Screens
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
MEMORANDUM
SUBJECT: Methyl Bromide Label Revision in Response
to Health Concerns of Structural Fumigants
FROM: /s/ John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
In response to EPA's health concerns about Methyl Bromide pesticides
used for commercial and structural fumigation, the registrants for methyl
tl
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bromide structural funigants have revised their labeling, as required by
EPA, to incorporate the language set out in Attachment A. There are five
registrants with thirteen methyl bromide products which are affected by
the labeling revisions. ( See attachment B. )
All five registrants committed to certain conditions for continued
registration of their Methyl Bromide products. The methyl bromide
registrations listed in Attachment B nave been amended to add the
following conditions:
o By June 15, 1992, registrants were to submit revised product labeling
as stated in the Interim Approved Labeling ( Appendix A ). This
deadline has already passed and all of the registrants have adhered to
this.
o By August 15, 1992, all products which are sold or distributed by the
registrant oust bear the June 1992 revisions concerning aeration and
reentry and the fact sheet for commercial and residential structural
fumigation ( see enclosure-Interim Approved Labeling, Appendix A ).
Please note that the Registrant may request that its label(s) contain
aeration procedures different from those specified in Appendix A if
the registrant submits data showing that such procedures will provide
an adequate margin
- 2 -
of safety for persons reoccupying the structure. However, all five
registrants revised their labeling to add the aeration procedure
specified by the Agency. None have submitted data supporting a
different aeration procedure.
o Registrants must notify all of their customers by certified mail
that sale or distribution of Hethyl Bromide pesticide products for
residential or commercial structural fumigation will be prohibited
after September 1, 1992 unless the product labels bear tne revised
use directions. Registrants must then keep copies of both the
notifications and the receipts for two years.
o The Registrant will use the Customer Letter provided by the Agency on
Hay 15, 1992 as the notification letter referenced in the preceding
paragraph. ( See Attachment C. )
o Registrant wilL offer to relabel products for their distributors, and
if distributors agree, the Registrant will relabel such products.
o The Registrant will put a month / year code on all amended labels.
Please note that a policy question arose regarding the use of
California's Hethyl Bromide Fact Sheet in place of EPA's Fact Sheet. Upon
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review of both, the Office of Pesticide Programs ( OPP ) has determined
that in the state of California only, the use of California's Customer
Fact Sheet will be permitted. In light of this decision, we are issuing
Compendium Policy No. 3.10 entitled, "Use of California's Methyl Bromide
Fact Sheet." ( See Attachment. )
Please also note that a question has been raised regarding the
deletion of the greenhouse use site from two product labels which have
voluntarily removed all structural residential and commercial fumigation
uses from the label. This issue has been referred to OPP and we will
notify you when this issue is resolved.
If you have any additional questions regarding this label revision,
please call Phyllis Flaherty or Shruti Desai of my staff at (703) 308
-8383 or (703) 308-8291, respectively.
Attachments
ADDRESSEES
Douglas D. Campt
Daniel Barolo
Anne E. Lindsay
Stephen L. Johnson
Hike Walker
Jim Nelson
Michael Stahl
Connie Husgrove
John J. Neylan III
Hike Uood
David Dull
Phyllis Flaherty
Frances Liem
Bob Zisa
Jerry Stubbs
Maureen Lydon
Jan Bearden
Linda Flick
Jim Jones
( H7501C )
( H7508W )
( H7505C )
( H7506C )
( LE-134P )
( LE-132P )
( EN-342 )
( EN-342U )
( EN-342 )
( TS-788 )
Jake Mackenzie
Western Regional Compliance Director
I Linda H. Murphy, Director Harvin Rosenstein, Chief
Air, Pest. & Toxics Hangt. Div Pesticides & Toxic Substances Br
II Barbara Metzger, Director Ernest Regna, Chief
Environmental Services Division Pesticides & Toxic Substances Br
III Thomas J. Haslany, Director James Burke, Chief
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Air, Tox. ft Radiation Mangt. Div Toxics & Pesticides Branch
IV Winston A. Smith, Director
Air, Pest, ft Toxics Mangt. Div
V Uilliam H. Sanders III, Director
Environmental Sciences Division
VI Stanley Neiberg, Director
Air, Pesticides & Toxic Division
VII William A. Spratlin, Director
Air and Toxics Division
VIII Irwin Dickstein, Director
Air and Toxics Division
IX David P. Howekamp, Director
Air Management Division
X Gary 0'Nealf Director
Air and Toxics Division
CC.
Artv WiIliams
Katny Taylor
OCN Staff
( H7506C >
( H7506C )
William J. Patton, Chief
Pesticides ft Toxic Substances Br
Phyllis Reed, Chief
Pesticides & Toxic Substances Br
Robert Murphy, Chief
Pesticides & Toxic Substances Br
Leo Alderman, Chief
Pesticides ft Toxic Substances Br
C. Alvin Yorke, Chief
Toxic Substances Branch
Davis Bernstein, Chief
Pesticides S Toxics Branch
6eorge A. Abel, Chief
Pesticides & Toxic Substances Br
APPENDIX A
INTERIM APPROVED LABELING
LABELING FOR MANUFACTURING USE PRODUCTS:
This product cannot be formulated into an end-use product for residential
or commercial structural fumigation unless the label of the end-use
product incorporates the following directions:
FUMIGATION FOR RESIDENTIAL OR COMMERCIAL STRUCTURES
Aeration and Reentry:
At the end of the exposure period, after all tarpaulins or seals are
removed from the structure, open all interior and exterior doors, windows,
and vents that are operational. No person shall be allowed to reenter the
structure unless wearing protective clothing and a NIOSH / HSHA approved
self-contained breathing apparatus ( SCBA ) or combination air-supplied
/ SCBA respirator until the following criteria are met:
1. A) If non-mechanical or natural ventilation is U3ed, the structure
must be aerated for a minimum of seven days from the time the tarpaulins
are removed.
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B) After aeration is completed, the level of methyl bromide in the
structure must be measured using a gas detector device with a minimum
detection limit of 3 ppm for methyl bromide. Measurements must be taken
from an interior electrical outlet by inserting the detection device in
the ground receptacle, or from other enclosed space within the wall on an
interior and a perineter wall; and
- 1 -
C) (i) The level of methyl bromide is less than 3 ppm from each
area measured; or
(1i) If the level of methyl bromide is 3 ppm or greater, the
structure shall be aerated for an additional 24 hours. At the end of
the 24 hour period, the level of methyl bromide must be measured from
the areas previously sampled. These procedures must be repeated until
the level of methyl bromide is below 3 ppm.
2. If mechanical aeration is used:
A) For structures without attics, an aeration fan(s) must be inserted
in a window or other exterior opening and sealed so that the air inside
the structure is exhausted out of. the structure. The aeration fan(s)
must be capable of displacing 5,000 cubic feet of air per minute. To
facilitate aeration, exterior openings, such as windows, vents, or an
access door to the subarea, should be utilized. The structure must be
aerated with the fan(s) operating for a minimum of 72 hours;
B) After aeration is completed, the level of methyl bromide in the
structure must be measured using a gas detector with a minimum detection
limit of 3 ppm for methyl bromide. Measurements must be taken from an
interior electrical outlet by inserting the detection device in the ground
receptacle, or from other enclosed space within the wall on an interior
and a perimeter wall; and
C) (i) The level of methyl bromide is less than 3 ppm from each area
measured; or
- 2 -
(ii) If the level of methyl bromide is 3 ppm or greater, the
structure must be aerated for an additional 12 hours. At the end of
the 12 hour period, the level of methyl bromide must be measured from
the areas previously sampled. These procedures must be repeated until
the level of methyl bromide is below 3 ppm.
3. A) For structures with attics, an aeration fan must be inserted
in the attic access door and a window or other exterior opening, and
both sealed so that air Inside the structure is exhausted outside the
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page 19 set 11 with 3 of 6 items
structure. The aeration fan9 oust be capable of displacing a minimum
of 5,000 cubic feet of air per minute. To facilitate aeration, exterior
openings, such as windows, vents, or an access door to the subarea should
be utilized. The structure must be aerated with the fans operating for a
minimum of 72 hours;
B) After aeration is completed, the level of methyl bromide in the
structure must be measured using a gas detector device with a minimum
detection limit of 3 ppm for methyl bromide residues. Measurements must
be taken from within an Interior electrical outlet by Inserting the
detection device in the ground receptacle, or other enclosed space within
an interior and a perimeter wall; and
C) (i) The level of methyl bromide is less than 3 ppm from each area
measured; or
(ii) If the level of methyl bromide is 3 ppm or greater, aeration
oust continue for an additional 12 hours. At the end of
- 3 -
the 12 hour period, the level of methyl bromide must be measured from the
areas previously sampled. These procedures must be repeated until the
level of methyl bromide is below 3 ppm.
4. For structures with basements, in addition to the requirements of
paragraphs 1, 2, 3 above, the windows, vents, and interior doors of the
basement must be open, and
A) After aeration is completed, the level of methyl bromide in the
basement must be measured using a gas detector device with a minimum
detection limit of 3 ppm for methyl bromide residues. A measurement must
be taken from an interior electrical outlet by inserting the detection
device in the ground receptacle, or from other enclosed space within
the wall on an interior wall. In the absence of an interior wall, a
measurement must be taken of the ambient air in the basement; and
B) (i) The level of methyl bromide is less than 3 ppm; or
(ii) If the level of methyl bromide is 3 ppm or greater, the
structure must be aerated for an additional 24 for natural ventilation
or an additional 12 hours for mechanical aeration. At the end of the
additional ventilation period, the level of methyl bromide must be
measured from the area in the basement previously sampled. These
frocedures must be repeated until the level of methyl bromide is below
ppm.
Structural Fumigation Fact Sheet
A. The applicator must obtain a structural fumigation fact sheet which
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page 20 set 11 with 3 of 6 items
has been signed by, and provided to, the following persons:
- 4 -
(1) an adult occupant of a single family dwelling prior to the
parties entering into a fumigation agreement,
(2) (A) The owner, manager, or designated agent of the building for
multiple-famiLy dwellings, provided he or she acknowledges in writing to
the applicator that a copy of the Structural Fumigant Fact Sheet has been
provided to an adult occupant of each unit prior to the parties entering
into a fumigation agreement; or
(B) An adult occupant of each unit in a multiple family dwelling
prior to the parties entering into a fumigation agreement, or
(3) the owner, manager, or designated agent for all structures or
businesses other than family dwellings,
B. The Structural Fumigation Fact Sheet shall state:
The purpose of this handout is to inform the consumer of possible health
hazards associated with the use of the structural fumigant, methyl
bromide. To make sure you have been given an opportunity to read this,
applicators are required to obtain the signature of the owners and
occupants of property to be fumigated with methyl bromide. You will also
be given a copy of tnis fact sheet to keep.
Structural Fumigants: Methyl Bromide
ATTENTION
Read This Fact Sheet Completely Before Signing
- 5 -
Fumigation involves the introduction of poisonous gases into every
part of the structure, including inside the walls. Because overexposure
to these gases can be harmful to people, your building will be ventilated
before you will be allowed to return.
This fact sheet provides basic information about the structural
fumigant, methyl bromide, as well as information about why and how
buildings are fumigated, methyl bromide health risks, how to know if you
are exposed, ways to minimize your exposure, and several phone numbers to
call for more information.
New rules for structural fumigation have substantially increased
the time between fumigant use and the time an occupant is allowed back
into the building. Post-fumigation ventilation has also been improved
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significantly. These changes should be adequately protective, but you
should know some basic facts about structural funigants.
Why Buildings Are Fumigated - Houses and other structures are
fumigated to kill insect pests living in walls or wood. There are
sometimes other ways to deal with these pests, and building owners should
investigate then. However, fumigation is sometimes the only method for
handling extensive infestations of wood-destroying insects. You can
discuss the possibility of alternatives with your pest control company.
Why- BuiIdings Are Fumigated - There are two pesticides used for
structural fumigations: methyl bromide and sulfuryl fluoride ( known by
the trade name, Vikane. ) Each has advantages and disadvantages in terms
of their effectiveness in killing pests
- 6 -
which professional fumigators can discuss with you. Your fumigator should
also provide you with a list of items you need to remove from your home
before the fumigation starts.
Methyl bromide is a gas. Before fumigation starts, the building to be
fumigated is completely sealed and covered with a tarp to keep the gas in
the building so it can penetrate wood to kill the pests. The tarp is left
on for one to two days. Uarning signs are posted around the building
notifying people to keep out because the levels of the pesticide in the
building during fumigation can kill a person.
After the tarp is removed, a professional fumigator will go into the
building wearing a compressed air tank and mask ana open the doors and
windows.. Powerful fans nay also be set up to pull fresh air into the
building.
It is now required that buildings fumigated with methyl bromide be
aired out for a mini muni of 72 hours after the tarp is removed. Then, the
fumigators are required to measure the levels of methyl bromide inside the
walls of buildings to make sure they are below three parts per million
before you are allowed to go back in.
The ventilation procedures make it unlikely that any remaining
fumigant in the living space will be a health hazard after the house is
cleared for reoccupancy. However, you should be aware of the symptoms of
overexposure to methyl bromide, since it is sensible to be cautious when
dealing with a potentially hazardous chemical.
- 7 -
Snail pockets of fumigant can remain in dead air space between walls
and inside cabinets, and in porous material such as furniture, and may
enter into the living space for a few days after fumigation. That's why
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Order number 930528-081520-PLC -001-001
page 22 set 11 with 3 of 6 items
a mandatory aeration period is required after the tarp is removed. Your
building snould not be cleared for reoccupancy until it is safe for you
to reenter.
How Oo You Know Uhether You Are Exposed - Methyl bromide is a
colorless, odorless gas, so a warning agent is added which causes watery
eyes and a scratchy throat. If you experience these symptoms in a
building that has been recently fumigated, you should leave immediately
and call the pest control company to have your building retested. You
should also consult with your physician.
Methyl Bromide Health Risks - Methyl bromide enters your body as a
gas when you breathe it. Exposure which may occur from touching treated
surfaces is insignificant.
Nervous system, eyes, and respiratory irritations:
Overexposure to methyl bromide can cause blurred vision, headache,
and nausea. At higher concentrations, it can cause tremors, sleepiness,
convulsions, pneumonia, and excess fluid in the lungs. These symptoms
may not appear for 12 to 24 hours. If you experience these symptoms in
a recently fumigated building, you should leave immediately and call the
pest control company to have the building retested. You snould also call
your personal physician. Physicians are encouraged to report suspected
pesticide-related illnesses to EPA.
- 8 -
Birth defects: In recent animal studies, methyl bromide caused birth
defects when pregnant animals were exposed under experimental conditions.
There is no evidence that methyl bromide affects human reproduction,
although some chemicals which cause birth defects in animals may also
cause Birth defects in humans. Any person, including pregnant women,
should avoid unnecessary exposure.
Other effects: It is not known whether long-term exposure to methyl
bromide causes cancer. Experiments in animals are underway to study tnis,
although tests so far are negative. However, even if methyl bromide were
shown to cause cancer over a lifetime of exposure in animals, it is
unlikely that your exposure from the one-time fumigation of your building
would be high enough to cause a significant risk of cancer.
Ways to Reduce Your Exposure If You Are Having Your Building
Fumigated -
o Carefully evaluate all your pest control alternatives.
o Talk over your treatment program in advance with the pest control
company, so you can fully understand what will be done, and what
you need to do.
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Order number 930528-081520-PLC -001-001
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o Carefully follow the instructions you are given about items you are
to remove from your building.
o Stay out of the treated building for at least three days after the
tarp is removed. If you have additional concerns, you may choose
to be away for an extra period of time after the building is
cleared for reoccupation.
- 9 -
o If you are interested or concerned, you can ask your pest control
company to show you the records of the air monitoring it did before
your building was cleared for reoccupation.
o You may wish to increase ventilation by opening doors and windows.
0 If you have symptoms of exposure, or vou believe that aeration was
not done properly, you should leave tne building and contact the
pest control company and your physician. You may also wish to call
one of the phone numbers listed below.
For information about pesticides, the U.S. Environmental Protection
Agency has a toll-free information service, the National Pesticide
Telecommunications Network Hotline, which can be reached at 1 (800) 858
-7378.
In a medical emergency, call 911, or contact the nearest Poison
Control Center. See "Crisis Hotlines" listed near the front of the white
pages in your phone book.
If you feel uncomfortable entering the structure, or if you do not
fully understand the potential hazards, you should calL the company that
performed the fumigation:
Name:
Address:
city:
Telephone:
- 10 -
1 acknowledge receiving a copy of this methyl bromide fact sheet.
( You will sign one copy for the company doing the fumigation, and get
a second copy to keep for later reference. )
Signature: Date:
Please print your name here: '
Your address:
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Order number 930528-081520-PLC -001-001
page 24 set 11 with 3 of 6 itens
FOR FUMIGATION OF RESIDENTIAL AND COMMERCIAL STRUCTURES, THESE DIRECTIONS
SUPERSEDE ANY OTHER DIRECTIONS ON THE LABEL CONCERNING AERATION AND
REENTRY
LABELING FOR END-USE PRODUCTS:
The label language for Fumigation of Residential and Commercial
Structures: Aeration and Reentry would be the same as for manufacturing
-use products except the introductory paragraph concerning formulation
into end-use products would be omitted.
- 11 -
Attachment B
Products Affected by
Great Lakes Chemical Company
5785-4 Brom-O-Gas
5785-7 Brom-O-Gas 1X
5785-8 Brom-O-Gas 0.5X
5785-42 Brom-O-Gas 2X
5785-55 Brom-O-Gas 0.253!
Tri-Cal Inc.
the Methyl Bromide Label Revision
11220-17 Methyl Bromide 98Z
Soil Chemicals
*8536-5 Pic-Brom 23
*8536-11 Pic-Brom 25
8536-12 Methyl Bromide 99.5X
8536-17 Methyl Bromide 99.75X
8536-19 Methyl Bromide 98X
Shadow Mountain Products
58266-3 Trical Methyl Bromide 99.5X
Ameribrom Inc.
8622-17 Hetabrom 99
Ethyl Corporation
3377-7 M-B-R-98
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Order number 930528-081520-PLC -001-001
page 25 set 11 with 3 of 6 items
Reddick Fumigants Inc.
37733-5 Bro-Hean C-2R
*/ Structural fumigation use directions have been removed from the label
while soil and greenhouse fumigation uses remain.
Attachment C
Customer Letter
Dear Customer:
Due to recent exposure data generated on methyl bromide structural
fumigation, the United States Environmental Protection Agency ( USEPA ) is
concerned that there may be a potential health risk for people reoccupying
structures too soon following fumigation. Accordingly, the USEPA is
requiring changes regarding methyl bromide fumigation of residential and
commercial structures.
Our records indicate that you have purchased methyl bromide from
( company name ) in the past. This letter is to notify you that effective
immediately the use directions for structural fumigation are changed to
require longer aeration times before reentry is allowed following
structural fumigation. Under the revised directions, the structure cannot
be reoccupied until the methyl bromide level is below 3 ppo. In addition,
the use directions now require applicators to provide owners and/or
occupants of a building to which methyl bromide is applied with a copy of
a Fact Sheet explaining more about the product. A signed copy of the Fact
Sheet must be obtained from the owner / occupant at tne time a contract is
signed. Copies of these signed fact sheets should be kept along with your
application records. A copy of the new U3e directions and Fact Sheet is
enclosed.
We realize that the amended procedure will pose some additional
burden to you. However, the label changes are mandated under the Federal
Insecticide, Fungicide, and Rodenticide Act ( FIFRA ), and distribution or
sale of a methyl bromide pesticide product for commercial or residential
structural fumigation is prohibited after September 1, 1992 unless the
labeling contains the revised use directions an Fact Sheet. Ue ask for
your cooperation, and remind you that distribution or sale of this product
after September 1, 1992 without the revised labeling is a violation of
FIFRA Section 12(a)(1)(E), and that use of this product in a manner
inconsistent with the instructions in its labeling is a violation of FIFRA
Section 12(a)(2)(G).
Enclosure
FIFRA COMPLIANCE PROGRAM POLICY No. 3.10
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Order number 930528-081520-PLC -001-001
page 26 set 11 with 3 of 6 items
Use of California's Methyl Bromide Fact Sheet
FIFRA Section: 3
Issue:
Label directions for all Methyl Bromide products require that
customers sign an EPA Fact Sheet before structural fumigation occurs.
Through regulation the state of California requires a California fact
sheet be signed. Will EPA allow California's Fact Sheet ( revised Hay
1992 ) to be used in lieu of EPA's Fact Sheet for customer signature
before fumigation in California?
Policy:
Upon review of both Fact Sheets,, the Office of Pesticide Programs has
determined that use of the California Fact Sheet ( Revised Nay 1992 )
would be sufficient to meet the Agency's intent in notifying customers
prior to beginning fumigation. At the request of the Office of Pesticide
Programs, the Office of Compliance Monitoring will allow applicators in
California only to use California's Fact Sheet ( Revised Hay 1992 ) for
customer signature in lieu of EPA's Fact Sheet for customer signature
before the applicator starts the fumigation process.
Discussion:
Hethyl Bromide registrants voluntarily agreed to a label revision of
Methyl Bromide products with structural ( commercial and residential )
fumigation use directions on the label due to health concerns of
structural fumigants. Methyl Bromide Registrants with structural
fumigation uses on their product labels nave revised their aeration and
reentry directions according to the Interim Approved Labeling. A Federal
requirement of the new, approved label language is that applicators give
their cuistomers a fact sheet for their review and signature before the
fumigation process begins. In addition to this Federal requirement, the
state of California has passed regulations requiring applicators in
California to give their customers the California Fact Sheet for review
and signature. Without this policy, both fact sheets are required to be
presented to the customer and signed. The Office of Pesticide Programs
nas reviewed both fact sheets and have requested the Office of Compliance
Monitoring to allow applicators in California only to use the California
Fact Sheet ( Revised Hay 1992 ) in lieu of both. The EPA Fact Sheet is
required to be signed in all other states.
References
Letters from:
D. Barolo, Office of Pesticide Programs, to J. Neylan, Director,
Policy and Grants Division, and P. Flaherty, Chief, Pesticides
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er number 930528-081520-PLC -001-001
age 27 set 11 with 3 of 6 items
Enforcement Policy Branch, 8/6/92; J. Neylen, Office of Compliance
Monitoring, to FIFRA Addressee List including Regional and
Headquarters Division Directors, Branch Chiefs, and Section Chiefs,
September 1, 1992.
ey Words:
Methyl Bromide, Structural Fumigants, Fact Sheet
ate: September 1, 1992 John J. Neylan III
/8/ J6HN J. NEYLAN IU, Director
Policy and Grants Division
Office of Compliance Monitoring
Office of Prevention, Pesticides
and Toxic Substances
nd of document reached**
m 6
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
d JAN 12/3
OFFICE OF ENFORCEMENT
SUBJECT: Primary Use Enforcement Responsibility
TO
Pesticide Branch Chiefs
Enforcement Division Directors
The Federal Pesticide Act of 1978 (P. L. 95-396) which amended the
Federal Insecticide, Fungicide, and Rodenticide Act, as amended (FIFRA)
was signed into lav; by President Jimmy Carter on September 30, 1978.
This law contains two new sections, §26 State Primary Enforcement
Responsibility and §27 - Failure by the State to Assure Enforcement of
State Pesticide Use Regulations, which substantially affect the manner
by which EPA will be dealing with the use and misuse of pesticides. I
have included as Appendix A these two nea sections of FIFRA.
In many respects these new sections to EIFRA .contain directives
which approximate current procedures fcund in the guidance for coopera-
tive enforcement grants. For ejarple, one najor aspect of successful
cooperative agreements is the establishment of on-going working rela-
tionships with State enforcement officials. A part of this working
relationship should include a mechanism for the orderly flow of
information concerning pesticide enforcement activities, including
information arid coqplaints about alleged pesticide use violations and
subsequent State action. Such a scheme is also contenplated in these
new FIFRA sections dealing with primary use enforcement. Where such
relationships have not been established, Congress intends, through the
primary use enforcement mechanism, that EPA imnediately establish such
work relationships.
This nEirorandura provides an interim policy under which EPA and
Sta„tes can operate until regulations formalizing this relationship are
in place. EPA and States need a means by which either can recognize
who has primary use enforcement responsibility at any instant iroment.
In addition, until a formal rechanism for referring complaints or infor-
mation about alleged violations of the use provisions of FIFRA is in
place, the procedures outlined in this memorandum will govern.
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-2-
A. Primary Enforcement Responsibility
1. What is it?
When a government entity, be it EPA or State, has primary
enforcement responsibility, it has the first (or primary) option
for investigating and taking appropriate enforcement action
against pesticide'use violations.
2. How does a State get it?
In brief, there are three ways by which a State shall have
primary responsibility for pesticide use enforcement:
a. A State will have the primary responsibility for pesticide
use enforcement if, upon request by the State, EPA has
determined that 1) the State has adequate pesticide use
laws and regulations, 2) the State has adequate procedures
for implementing these laws and regulations, and 3) the
State will keep records and make reports shaving compliance
with 1) and 2) above.
b. Notwithstanding this, any State with a cooperative agreement
with EPA to cooperate in the enforcement of FIFRA, pursuant
to Section 23, shall immediately upon implementation of that
agreement, have primary responsibility for pesticide use .
enforcement within its borders.
c. A State may also receive primary responsibility for use en-
forcenant if EPA determines that the State has an approved
plan under section 4 for certifying applicators and the plan
meets the criteria of a. above.
If at anytinB after September 30, 1978, a State asks for and
receives a determination that^it r.eets the test of adequate laws,
regulations, and procedures under a. above, implements a coopera-
tive enforcement agreement with EPA or, upon final approval of its
section 4 Plan, receives a determination that the plan meets the
criteria of a. above, that State shall have primary enforcement
responsibility for use violations within that State.
If a State with a cooperative enforcement agreement chooses to
withdraw from that agreement, the State will lose their prinnry
enforcement responsibility upon the cate of termination of the co-
operative agreement. Should that same State have an approved State
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-3-
Plan under section EPA will review that plan for enforcement ade-
quacy as soon as practical to determine whether the State can regain
use enforcement prinaey.
3. Who has it?
The following States, as of the date of this memorandum, have
primary enforcement responsibility for pesticide^use violations:
Region I
Region IV
Region VIII
Connecticut
New Hampshire
Vermont
Region II
New Jersey
New York
Puerto Rico
Virgin Islands
Region III
D. C.
Delaware
Maryland
Pennsylvania
Virginia
West Virginia
Kentucky
Mississippi
North Carolina
Tennessee
Region V
Indiana
Michigan
Minnesota
Region VI
Arkansas
Louisiana
New Mexico
Oklahoma
Texas
Region VII
Iowa
Kansas
Montana
North Dakota
South Dakota
Region IX
V
Arizona
California
Guam
Hawaii
Region X
Idaho
Oregon
Washington
1/
Arizona divides responsibility for use' enforcenent between the
structural Pest Control Board and the Arizona Board of Pesticide
Control (Agriculture). EPA has a cooperative enforcement agree-
ment with the former, not the latter. Therefore, Arizona has
primary use enforcenent responsibility for pesticide use viola-
tions that come within the jurisdiction of the Structural Pest
Control Board; EPA has responsibility for all other use enforce-
ment activities. If there are other instances of very distin-
guishable separation of use enforcenEnt authority within a State
and EPA has a cooperative enforcement agreement with only one of
the authorities, the region should bring this to the attention
ofPTSED.
-------
Who does not have it?
The following States, as of the date of this.memorandum, do
not have primary enforcement responsibility for pesticide use
violations; EPA continues to have primary responsibility.
Region I
Maine*
Massachusetts
Rhode Island*
Region VII
Missouri*
Nebraska
Region X
Alaska*
Region IV
Alabama*
Florida*
Georgia
South Carolina*
Region VIII
Colorado*
Utah*
Wyoming*
Region V
Illinois*
Ohio*
Wisconsin*
Region IX
Trust Territories
Saiaoa
* EPA will be conducting a rapid evaluation (to be completed
within 6 months of the date of enactment of this law) of
these State's §4 Plans in order to determine the enforce-
ment adequacy of the State's pesticide use lawiir regulations,
and procedures.
What is EPA's role in pesticide use enforcement?
In States that do not have primary use enforcement .'s.-sponsi-
bility, EPA will have the prinary responsibility. In those States
where EPA has the primary responsibility for pesticide use enforce'
msnt, Congress has affirmatively provided that the Agency cEy
inspect the books and records and work establishments of commer-
cial applicators and "for hire" applicators. Also, samples may
be taken of pesticides or use dilutions of pesticides held by
those applicators. "For hire" applicators are those applicators
that are in the business of applying pesticides. Exanples of
"for hire" applicators, for whom controlling pests is all or part
of their occupation, are structural pest control operators, aerial
applicators, arborists, lawn maintenance workers, and janitorial
service workers. Nothing in this Act precludes the Agency from
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-5-
continuing routine use surveillance, (i.e. use observations where
there is no prior evidence of misuse) whether or not that surveil-
lance takes place in a State that has primary use enforcesnt
responsibility. However, in those States having primary use
enforcement responsibility, the Agency may not include within that
routine surveillance visits to commercial or "for hire" applicator
establishments for purposes of sampling or reviewing bodes and
records. IrT"those States, routine use surveillance shall be con-
fined to application sites where entry has been gained by consent
of the owner. Any information or evidence that points to a signi-
ficant violation of 5FHA (i.e. one which we would deem worthy of
Airther investigation/shall be referred to the State if that State
State has pnrary enforcement responsibility.
6. How will the referral of coaplaints or infornation indicating
use violations of FIFRA wortc?
Section 27(a) of the amended FIFRA requires that EPA refer
any conplaints or other information alleging or indicating a
significant violation of the, pesticide use provisions of FIFRA
to the appropriate State,.officials for. their investigation. Of
course, such referral need only be made when the State has pri-
mary use enforcement responsibility. Further, if the State dees
not corunence appropriate enforcement action within thirty "days,
EPA may act upon the conplaint or information.
If any information or cocplaint, indicating or alleging a
significant violation of FIFRA, is received after September 30,
1978, and the alleged violation tock place in a State with pri-
mary use enforcement responsibility, such information
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-6-
At the conclusion of the thirty day tire period, the regional
office shall request information on the status of the particular
investigation. Obviously, in sere cases States may be unable to
investigate and commence appropriate enforcement action, particular-
ly in complicated cases, within the thirty day tine frame referred
to in the amended FIFRA. Regions shculd use their discretion when «-
determining whether to extend the time period for a State to com-
mence appropriate enforcement action or to request return of the
case file. It is expected that States will forward all evidence
obtained in an investigation to the EPA regional office: 1) where
no enforcement proceedings have been initiated within thirty days
of a determination of a possible violation of State law and FIFRA,
2) where the investigation determines that a possible violation
of only FIFRA occurred, (not State law), or 3) where EPA deter-
mines that the enforcement action taken by the State is not
appropriate to the alleged violation. Until regulations are
in place for rescinding prirary enforcement responsibility
for failure by the State to assure enforcement of State
pesticide use regulations, a region shall request concurrence
from their PTSSD regional coordinator before overriding any
State enforcersent action.
Complete and thorough documentation must be kept of all
referrals to States of complaints or information on alleged
use violations and subsequent follow-up actions by States. A
draft cos?laint referral fora is attached for use by those
regions without any current referral form (Appendix E). Two
copies of this fern, with additional attached information,
where appropriate, shall be completed and forwarded to the
appropriate State official immediately upon receipt of any
complaint or information about a use violation. Within thirty
days (or longer, if extended), the State shculd be instructed
to return one copy of the State form with a brief description
of the disposition of the case, i.e. either a notation of the
kind of enforcement action taken (e.g. 2 month suspension of
applicator's license) or an explanation as to why no enforce-
ment action was taken (e.g. not a violation of State law). If
no report on the disposition of a case is received within a
suitable period of tiro, the region shall follow-up with either
a written or telephonic request for such information. Such
records will be necessary for future determinations as to
whether States are properly discharging their enforcement res-
ponsibilities in the pesticide use area.
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-7-
7. Hew should emergencies arising cut of the use of pesticides be
handled?
When the region bee ores aware of emergency conditions arising
out of the use of pesticides, they should immediately inform the
appropriate State officials. State officials are to be requested
to respond to the emergency; the region should offer whatever
assistance they can. If State officials indicate that they are
unwilling or unable to adequately respond to the emergency, the
region should respond to the fullest extent possible.
Should you have any questions concerning this interim policy, please
contact your PTSED regional coordinator or Jack Nerylan (755-0997).
P(
Enforcement Division
Attachments
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
MAR 1 4 1379
OFFICE OF ENFORCEMENT
HE>3P.fiHDGM
SUBJECT: Review of State Certification Plans Pursuant to
FIFRA "Section 26
TO:
Regional Enforcement Directors
Regional Branch Chiefs
The new section 26 of the amended FIFRA automatically grants
to States who have Cooperative Enforcement Agreements (CEAs) with
EPA the primary enforcement responsiblity for pesticide use viola-
tions. States without CEAs, but who have section 4 (applicator
certification) plans approved by the Administrator, should have
their pesticide laws and regulations reviewed by EPA by March-29,
1979, to determine whether they are adequate for EPA to also grant
then primary use enforcement responsiblity. At present there are
thirteen (13) States which fall into this latter cateaory (see
ATTACHMENT A).
In light of the fact that EPA was given a short deadline for
the completion of this review and in the absence of any delegation
of authority from the Administrator for the implementation of this
nw FIFRA provision, PTSED plans to carry-out this congressionally
mandated review of the thirteen approved State plans at a meeting
to be held on -March 23rd at EPA KekSauartersin Washington, D. C.
(see ATTAC-iKENT B). I have designated Kr. John C. 'Ulfelder, Head
of the Legal Support Section, as Chairperson for this meeting.
PTSED will also be represented by Jack Neylan, David Stangel and
Joseph Virgilio of the Policy and Guidance Branch, as well as
John Martin, William Danson and David Hanneman of the Program
Operations Branch. In addition, CPP has agreed to allow Ralph
Colleli, formerly with the Operations Division, to assist us with
our review of the thirteen State plans.
-------
-2-
Basically the Stats plans will be measured against the standards
=-2t forth in sections 25(a)(1) and (2) of the amended FIFPA. They
require that the State:
(1) has adopted adequate pesticide use laws and
regulations; Provided, that the Administrator may
not require a State to have pesticide use laws
that are more stringent than this Act; {and]
(2) has adopted and is impleuienting adequate pro-
cedures for the enforcement of such State laws and
regulations;...
V.hile there is a presumption that States with approved applicator
certification plans have adopted adequate laws for violations involv-
ing restricted use pesticides, it will still be necessary to rrake
certain that their laws and regulations are also adequate for viola-
tions involving general use pesticides. It is clear, however, that-the
focus of the review will be on the question whether each State has, in
fact, established adequate procedures for enforcing against use viola-
tions and whether they are implementing those procedures adequately.
Some of the procedural aspects that will be examined include: 1. Are
sufficient State resources committed to the investigation and' actual
enforcer,ent of use violations; 2. Are complaints of pesticide misuse
follcved-up prarotly and concluded in a timely manner; 3. Are State
personnel properly trained to handle investigations and enforcement
actions involvirc allegations of pesticide misuse; 4. Da substantive
complaints of misuse actually result in State enforcement action; and
5. Is the State enforcement action appropriate in light of the viola-
tion and the enforcement options open to the State enforcement Agency?
Since EPA regional representatives are the most knowledgable about
the status of pesticide enforcement in the States in their regions, it
will be essential to the success of the revie;-; of each State's plan and
operating procedures to have strong regional participation on March 23rd.
Although the Regions' views can either be presented in writing in
advance of the meeting or in person on March 23rd (or both), if a Region
is of the opinion that a particular State should not be granted primary
use enforcement responsibility, it should plan to send a representative
to the March meeting to discuss that position with the Headquarters
personnel. For States where the regional office thinks there is little
question about the appropriateness of granting State primary use enforce-
ment, it would be sufficient to submit such a recommendation in writing
before March 23rd. Once a decision has been made about the status of
each of the thirteen States, letters will be prepared for Mr. Costle's
-------
-3-
sicnature notifying the various State lead agencies about EPA's deci-
sion. In addition, each State being granted primary use enforcement
responsibility in accordance with the new section 26 will be asked to
meet certain minijral reporting requirements concerning pesticide use
enforcement until final regulations implementing sections 26 and 27
are implemented.
I would appreciate it if each of the seven Regions that have State
plans to be reviewed at the March meeting would notify-Mr. Ulfelder
whether or not they plan to be represented at that meeting. If you have
arc/ questions about the review of the thirteen State plans, please direct
your questions to Mr. Ulfelder at 472-3701.
a. e. conroy n,fDirector
Pesticides and Toxiq Substances
Enforcement Division
Attachments
-------
ATTACHMENT A
List of States With Approved Section 4 Plans, But .Without CEAS
REGION I:
REGION 3V:
RE ION V:
RH3ION VIIs
RESIGN Villi
REGION IX:
RE ION X:
Maine
Alabama
Florida
Georgia
South Carolina
Illinois
Ohio
Wisconsin
Missouri
Utah
Wyoming
Arizona (Agricultural Use Only)
Alaska
-------
ATTACHMENT B
Friday, March 23, 1979
Location: EPA Headquarters
Washington, D.C.
3rd Floor Conf. Rn., East Tower
Room Mo. 344
I. 9:00 a.m. - 12:00 noon
The following States will be reviewed:
Region I: Maine
Region IV: Alabama
Florida
Georgia
South Carolina
Region V: Illinois
Ohio
Wisconsin-
II. 1:30 p.m. - 4:30 p.m.
The following States will be reviewed:
Region VII: Missouri
Region VIII: Utah
Wyoming
Region IX: Arizona
Region X: Alaska
-------
"SEC. :S. STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
"(a) For the purparts of this Act. a State, ihall have primary en-
forcement responsibility for ptsiiciae use violations during any ¦period
for which the Administrator determine.1! that such State—
u (J) tuts adopted adequate pesticide use laves and regulations^
Providedj That the Administrator may not require a State to have
pesticide ttse lavs that are more stringent than this Act;
u(2) has adopted and is implementing adequate procedures for
the enforcement of such. State laics and regulations; and
"(J) xaill keep such records and moke such reports showing
compliance with paragraphs (1) and (2) of this subsection as the
Administrator may require by regulation.
"(6) Notwithstanding the provisions of subsection ia) of this sec•
tion, any State that enters into a cooperative agreement with the Ad-
ministrator under section 23 of this Act for the enforcement of pesti-
cide use restrictions shall have the primary enforcement responsibility
for pesticide use violations. Any State thai has a plan approved by the
Administrator in accordance with the requirements of section 4. of this
Act that the Administrator determines meets the criteria set out in sub-
section (a) of this section shall have the primary enforcement respon-
sibility for pesticide use violations. The Administrator shau make such,
determinations rcith respect to State plans under section U of this Act
in effect on the date of enactment of the Federal Pesticide Act of 197S
not Inter than siv months after that date.
u{c) The Administrator ahaR have primary enforcement responsi-
bility for those States that do not have primary enforcement responsi-
bility under this Act. Notwithstanding the provisions of section 2(e)
(J)'Of this Act. during any period when the Administrator has such
enforcement responsibility, section %(b).of this Act shall apply to the
books and records of commercial applicators and to any apvlicator tcho
holds or appiies pesticides, or use dilution* of pesticides*only to provide
a service of controlling pests without delivering any unapplied pesti-
cide to any person so nerved, and section 0(a) of thin Act shall apply to
the establishment or other place where pesticides or devices are held for
application by such persons icith respect to pesticides or devices field
for such application.
"SEC. 27. FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF
STATE PESTICIDE USE REGULATIONS.
"(a) Upon receipt of any complaint or other information alleging or
indicating a significant violation of the pesticide use provisions of this
Act, the Administrator shall refer the matter to the appropriate State
officials for their investigation of the metier consistent urith the re-
quirements of this Act. If. within thirty days. the State has not com-
menced appropriate enforcement action* the Administrator may net
upon the complaint or information to the extent authorised under this
"(b) Whenever the Administrator determines that a State having
primary enforcement resvonsibilitv for pesticide use notations is not
carrjtintj out (or cannot carry out due to the lack of adequate legal au-
thority) such responsibility, the Administrator shall notify the State.
Such notice shall specify those aspects of the administration of the
State program that are determined to be inadequate. The State shall
have ninety days after receipt of the notice to correct any deficiencies.
If after that time the Administrator determines that the State program
remains inadequate, the Administrator may rescind, in whoia or in
party the State** primary enforcement responsibility far pesticide use
violations.
"(c) Neither section 2S of this Act nor this section shall limit the
authority of the Administrator to enforce this Act. where the Admin-
istrator determines that emergency conditions exist that remiire im-
mediate action on the part of the Aaministrator and the Slate authority
is unwilling or unable adequately to respond to the emergency.
-------
J'
aEFERRAL FGF.M
Date Rec'd
Description of Alleged Corrplaint or Information
i
Disposition
Referred to:
Referred by:
Date referred
!¦ '.m
For further information, contact
Date response
-------
JF2?
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 2C460
•¦•"5 /
OfFICEOF ENFORCEMENT
MS-'ORAXDUM
SU3JECT: Clarification of Prir.ary Use Enforcement Responsibility Guidance
Oh January 4 of last year, the Pesticides and Toxic Substances
Enforcement Division (PTSED) sent out an interim policy statement
describing procedures for E?A/State cooperation in the area of primary
responsibility for enforcing pesticide use violations. This memoranda®
supplements the January 4 guiaance by expanding upon the proper Agency
response to receipt of a State file which indicates a pesticide use
violations.
Since the amended FIFRA, per sections 26 and 27, directs the Agency
to allow the States to have first option for bringing enforcement actions
against violators of pesticide use requirements; EPA should take no
action except in emergencies as described under section 27(c), based on
any State file until thi appropriate Region consults with the State on
the investigatory or enforcement status of the case. After the State
has been allowed tine to conduct its inquiry, the Region should request
a statement indicating the proposed enforcement action chosen by the
State. If the State's action is not "appropriate" (see section 27(a))
in light of the gravity of the alleged violation? the Region should
after obtaining concurrence from the Office of Enforcement's Pesticides
and Toxic Substances Enforcement Division, send a notice to the State
(1) consnunicating its disagreement with the selected action, (2) re-
commending the t>*pe of State action which the Agency would consider to
be "appropriate", and (3) notifying the State that it has 30 days to
cciraence an appropriate action.
TO:
Regional Pesticide Branch Chiefs
Regional Enforcement Division Directors
-------
- 2
As a general operating principle, the Regions should avoid using
already-scarce Federal resources merely to reinforce state enforcement
actions taken in response to minor violations of the pesticide- laws.
Rather the Regional Offices, in accordance with stated Agency goals of
protecting public health and safety and preserving sensitive ecosystems,
should be careful to focus their efforts and resources on those situations
which significantly endanger public health or the environment and which
are not otherwise appropriately addressed by state actions.
Deputy Assistant Administrator
for General Enforcement
-------
ut i i AT ti fcNVirfONMENTAL PROTECTION AGcNCV
® I8QB0
MEMORAMDPM
SUBJECTS Appropriate Documents to be Presented by State
Inspectors Conducting Pesticide Use Inspections in
States Having Primacy
TO i Enforcement Division Directors
Air 6 Hazardous Materials Division Directors
Pesticide Branch Chiefs
At present most State inspectors conducting pesticide
use inspections present credentials headed t "United States
Environmental Protection Agency". The credential later
identifies the inspector as "an employee of the State of
This credential has bean supplied by the Agency
as a convenience to States which have cooperative enforcement
agreements with EPA. (EPA Pom 3540-28 (Rev. 4-78))
These credentials were designed before primacy vhen
States conducted use inspections for violations of FIFRA
under the auspices of a cooperative agreement. Pursuant to
Section 26, most States now exercise primary enforcement
responsibility for all use violations. Use inspections are,
therefore, primarily a State activity. Consequently, UBe
inspections in States with primacy are undertaken under the
authority of State law, (this is true even where the use
inspections are Federally funded)•
Therefore, during use inspections# it is appropriate
for State inspectors to present credentials which indicate
that the inspectors are acting under authority of State law.
The existing Federally supplied credentials are misleading
since they are headed "United States Environmental Protection
Agency." Zn the fi^are^State inspectors conducting pesticide
use inspections shears present credentials that are issued
by their,-State employers. If State credentials do not
already exist, the State is responsible for designing and
providing such credentials to their Inspectors.
-------
1*_ i^ a-UIitionally nocjiisary for Ctatrjn to cease uain^
Ll-.c i'odcrjllj cu^.plicci 'Tocicv..- ui Iii^^cction" fori:., (C?r-.
ror:.. 354u-2 (i
-------
4W Federal Register / Vol. 40, No. 3 / Wednesday, January 5, 1983 / Rules and Regulations
(1) The desirability of developing an
integrated linearsystem of air
transportation whenever such a system
most adequately meets the air
transportation needs of the eligible point
involved;
(2) The experience of the applicant in
providing scheduled air service in the
vicinity of the eligible point involved;
(3) The relative efficiency of the
aircraft that the competing carriers use
or propose to-use:
(4) The relative financial strength of
the competing carriers;
(5) The time necessary for the
applicant to begin providing the service
it proposes;
(6) The performance of the incumber^
carrier in serving the eligible point
involved;
(7) The amount of time that the
incumbent carrier was on the subsidy
rate to question;
(8J The effect of granting the bumping
application on other points in the
incumbent carrier's system:
(9) The availability of slots for the
applicant at the hub or hubs that it
proposes to serve; and
(10) In Alaska, the experience of the
applicant in providing scheduled air
service, or significant patterns of
nonscheduled air service under Part 298
of this chapter, in that State.
(e) In evaluating the standards
described above, the Board will give
great weight to the views of
representatives of the eligible point
involved.
§ 326.8 Transition from the incumbent
carrier to the applicant.
(a) If an applicant is successful in its
bid to replace an incumbent carrier and
receive a subsidy for serving the eligible
point, it shall nflrify the Board and the
incumbent carrier of the date that it is
prepared to begin service at the eligible
point. It shall allow the incumbent 45
days to close down its operation at the
eligible point, unless another date is
agreed on.
(b) The incumbent carrier shall
continue service at the eligible point
until the successful applicant begins
service there.
(c) The Board will continue to pay the
subsidy to the incumbent carrier for at
least 45 days after it grants the bumping
application, unless the two carriers
agree to a different date for the transfer
of service. The Board will continue to
pay the subsidy to the incumbent carrier
thereafter until the successful applicant
begins service at the eligible point.
§ 326.9 Conformity with Subpart A of Part
302.
Except where they are inconsistent,
the provisions of Subpart A of Part 302
of this chapter shall apply to
proceedings under this part.'-
Phyllis T. Kaylor.
Secretary. .
[PR Doc. B3-22" Filed 1-4-83: B:45 ami
BILLING CODE 6320-01-M'
14 CFR Part 385
[Organization Reg. Amdt. No. 130 to Part
385, Reg. OR-205]
Delegations and Review or Action
Under Delegation; Nonhearing Matters
AGENCY: Civil Aeronautics Board,
action: Final rule.
summary: The CAB is revising its filing
fee schedule and is setting procedures
by which persons can apply for refunds.
This rule delegates authority to the
Comptroller to decide whether refunds
are owed and to order payment. This
rule is at the Board's own initiative to
expedite refund procedures.
DATES: Effective: January 10,1983.
Adopted: December 20,1982.
FOR FURTHER INFORMATION CONTACT:
For financial information, Joseph L. Kull,
Office of Comptroller, 202-673-5476; for
legal information; Joseph A. Brooks,
Office of the General Counsel, 202-673-
5442. Civii Aeronautics Board, 1185
Connecticut Avenue, N.W., Washington,
D.C. 20428.
SUPPLEMENTARY INFORMATION: The
reasons for the rule are fully explained
in OR-204, issued contemporaneously.
List of Subjects in 14 CFR Part 385
Administrative practice and
procedure, Authority delegations.
PART 385—[AMENDED]
Accordingly, the Civil Aeronautics
Board amends 14 CFR Part 385,
Delegations and Review of Action
Under Delegation; Nonhearing Matters,
as follows:
1. The authority for Part 385 is:
Authority: Sees. 102, 204. 401, 402, 403. 407,
416, Pub. L. 85—72G, as amended; 72 Stal. 740,
743, 754, 750. 766. 771, 49 U.S.C. 1302. 1324.
1371. 1372.1373,1377,1386: Reorganization
Plan No. 3 of 1961, 26 FR 5989.
2. A new paragraph (g) is added to
§ 385.27 to read:
§ 385.27 Delegation to the Comptroller.
The Board delegates to the
Comptroller the authority to:
(g) Grant or deny applications under
i 389.27(b) of this chapter for refunds of
fees paid, consistent with Board policy,
and to order amounts refunded as
necessary.
By the Civii Aeronau'ics Uoard.
Phyllis T. Kaylor,
Secretary.
[KR Doc. M-226 Tiled l^i-a.1: 8:45 an|
BILLING CODE 6320-Ot-M
DEPARTMENT OF THE INTERIOR
Office of Surface Wining Reclamation
and Enforcement
30 CFR Part 946
Approval of Permanent Program
Amendments From the State of
Virginia Under Surface Mining Control
and Reclamation Act of 1977
Correction
In FR Doc. 82-33680 beginning on page
55675 in the issue of Monday, December
13, 1982 make the following correction:.
On page 55675, third column, second
line from the bottom should rend,
"EFFECTIVE DATE: This approval is
effective December 13,1982."
BILLING CODE 150S-O1-M
(ETWIRONMENTAtr PROTECT! ON
AGENCY — '
40 CFR Part 173
[OP? 00159; PH-FRL 2215^3] \
(Federal insectlcrcferFunglciderand
pFfodenticide Act, State Primary'
/Enforcement'Responsibltities^
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final interpretive rule.
summary: This rule states EPA's
interpretation of several of the key
provisions in sections 26 and 27 of the
Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA], but does not
impose substantive requirements on the
States. Sections 26 and 27 established a
standard and procedure for according
States Ihe primary enforcement
responsibility for pesticide use
violations (primacy]. The rule also
provides operational substance to the
criteria used by EPA for primacy relate'
decisionmaking, and ensures that such
decisionmaking is consistent throughou
the regions.
effective DATE: This rule will not take
effect before the end of 60 calendar daj
of continuous session of Congress after
-------
£f>A c£/£ A*c/73
Federal Register / Vol. 48, No. 3 / Wednesday, January 5, 1983 / Rules and Regulations 405
the date of publication. EPA will publish
a notice of the actual effective: date of
this rule. See SUPPLEMENTARY
information for further details..
FOR FURTHER INFORMATION? CONTACTS
Laura Campbell. Pesticides ana Toxic
Substances Enforcement Division (EN—
342),. Office of Pesticides and Toxic
Substances,. Environmental Protection
Agency, Rm. M-2B24E. 401M St. SW..
Washington-D.C. 2046Q, (2D2-oa2-oa86).
SUPPLEMENTARY INFORMATION:
Background
In 1978, Congresa enacted Pub.L.95-
398 which contained numerous: revisions
to the Federal Insecticide. Fungicide',
and Rodent;cide Act (7 U.S.C. 136 et
seg.). One of the changes added two>
new sections to FIFRA, sections 2S and
27, U.S-CL 136W-1 andl38w-2. which,
together established a. standard ami-
procedure, ferae cording States the
primary enforcement responsibility far
pesticide- use violations (primacy
Section 2ft provides three methods by
whiclr. a State can obtain! primacy.
Section 28fa).reqoires,» State ta be
accorded primacy if the Administrator
finds that the State has (1) adopted:
adequate use laws, (2) adopted
adequate procedures far implementing:
those laws, and (3) agreed to keep such,
records and make suclr reports: as the*
Administrator may require by
regulations Section. 26(b) allows, a State
to obtain primacy if the State: has an
a pproued section 4- certification plan,
that meets the criteria set forth: in.
section 26(a), or if a State enter? into a
cooperative agreement, for the .
enforcement of pesticide use restrictions
under section 23.
Section 27 authorizes, the
Administrator ta override or rescind a
grant of primacy in certain situations.
Section 27(a) requires the Administrator
to refer significant allegations of
pesticide use violations to the States. If
a State does not commence appropriate
enforcement action within 30 days of
such referral, EPA may bring its own
enforcement action.
Section 27(b) authorizes the
Administrator to rescind the primary
enforcement responsibility of a State.if
she finds that the State is not carrying,
out such responsibility. The
Administrator initiates a rescission
proceeding by notifying, the State af
those aspects of the State's pesticide use
enforcement program which, the
Administrator has found to be
inadequate. If the State does not correct
the deficiencies in its program- within 90.
days, the Administrator may rescind the
States's primary enforcement
responsibility in whole or in part. EPA
has promulgated procedures which
govern the conduct of a proceeding to
rescind State primacy . TTiese procedures
were pubiisiied in the Federal Rejpster
of May IT. 1981 (48 FR 26058). (40 CFR
Part 173).
Section 27(c) authorizes the
Administrator to take immediate action
to abate an emergency situation where
the State is unable or unwilling to
respond to the crisis.
As- is- evident from the above
description, several a£ the operative
terms in sections 23. and 27 require
further definition. This rule clarifies the
meaning of such, words as "adequate"
and "appropriate'" which FIFRA sets
forth as the criteria far most of the
decisions which will be maH* uttHct-
these tvaa sections. The rule also sets
guidelines ta be used by EPA in making
primacy-related decisions. and ensures
thaf audi HpHflritTTTTTmlrrnfji [3 consistent
by limiting! althrnigkiiotHinTiraating',.
Agency discretion: in the primacy areaa.
Specifically,, this rule addresses the
following: issues^
1. Procedures EPA will fbllaw when
referring allegations of pesticide use
violations to the State tttA tracking
State responses. ta these referrals (sea
Unit L Subdivision A below)..
2. The meaning, of "appropriate
enforcement action'" (see Unit L
Subdivision B).
3. Clarification of when, a State will be
deemed to have (1). adapted adequate
pesticide use laws and regulations, and.
(2) implemented adequate procedures
for the enforcement of such laws and
regulations (see Unit II)..
4. The criteria the Administrator will
use to determine whether a State is
adequately carrying out its primary
enforcement responsibility for pesticide
use violations (see Unit III}.
5. The factors whiclr constitute art
emergency situation, and the
circumstances winch: require EPA ta
defer to the Stare far a response to the
crisis (see Unit LV).
Comments Received
Four comments were received in
response to the proposal of the
Interpretive Rule, (47 FR 18799-, A aril 2a
1982).
In the proposed rule, a determination
of the gravity of violation was based cn
two factors: (1) risk associated with the
violative action, and (Z) risk associated
with the pesticide. Some of the
comments stated that EPA should
determine the gravity of each violation
based on whether actual harm occurred
as a result of the violation. If the Agency
were to determine the seriousness of a
violation based on the actual harm
which occurred in a particular case.
pesticide users would be encouraged tcr
take the risk of misusing a pesticide,
with the hope that no actual harm would
result from their unlawful act. Congresa
charged EPA with regulating pesticide
use in a manner which, will prevent
unreasonable risk of pesticide exposure
to man or the environment.
Congressional intent would not be
carried cut if EPA encouraged pesticide
user9 to engage in nrrgafo activities by
not charging" violations in cases where
no. actual harm occurred.. For this
reason, the final rule retains, the
language of the proposed rule.
Two comments concerning the
imposition of criminal penalties for
pesticide misuse were received. One
comment stated that Congress intended
criminal sanctions to be appi£ed only in'
cases involving unlawful inamit'artnrp of
pesticides. Nothing in FIEHA. or its
legislative history so limits the use: of
criminal pnnalfrimi The nnly rrjturirm in.
the statute Cor imposition of r-rimitral
penalties is a violation is
"knowing!'. The language referring ttx
criminal penalties in the proposed rule
has been largely retained in the final
rule.
Another comment expressed the
concern that imposing more stringent
sanctions where violations are found to
be "knowing" penalizes persons wha
are> informed about the law. Section 14l
of FIFRA states that "knowing."
violations are subject to criminal
penalties. Knowledge of the violator is a:
valid criterion to use in determining:
gravity because of a "knowing"
violation shows a disregard for the Taw.
One comment stated that no State
with more stringent pesticide use iaws
than the Federal law should be granted
primacy. Although EPA cannot require a
State to enact a pesticide use law that is
more stringent than FIFRA, there is.no
prohibition against granting primacy to a
State whose pesticide use law is more
stringent-
One comment suggested a change in
the requirement that State laboratories
conducting sample analysis participate
in EPA'a check sample program. The
comment stated that the National
Enforcement Investigation Center
(NEIC) check sample program should be
coordinated with the American
Association of Pesr Control Officials
(AAPCO). The NEIC check sample
program is currently coordinated with
the AAPCO check sample program. The
rule has been changed to reflect this
comment.
-------
406 Federal Register / Vol. 48, No. 3 / Wednesday, January 5. 1983 / Rules and Regulations
Further Information on Effective Date of
This Rule
On December 17,1980, the Federal
Insecticide, Fungicide, and Rodenticide
Act extension bill (Pub. L 96-539)
became law. This bill amended several
sections of FIFRA, including section 25
on rulemaking. Section 4 of the
Extension Act adds a new paragraph,
section 25(e), to FIFRA which requires
EPA to submit final regulations to
Congress for review before ihe
regulations become effective. Copies of
this rule have been transmitted to
appropriate offices in both Houses of
Congress.
Under section 4 of the 1980 FIFRA
Extension Act, this rule will not take
effect before the end of 60 calendar days
of continuous session of Congress after
the date of publication of this rule. Since
the actual length of this waiting period
may be affected by Congressional
action, it is not possible, at this time, to
specify a date on which this regulation
will become effective. Therefore, at the
appropriate time EPA will publish a
notice announcing the end of the
legislative review period and notifying
the public of the actual effective date of
this regulation.
Compliance With the Regulatory
Flexibility Act.
I hereby certify that this rule will not
. have a significant economic impact on
small entitles. The rule affects only
State pesticide control agencies, which
are not small entities under the
Regulatory Flexibility Act 5 U.S.C. 601
etseq.
Compliance With Executive Order 12291
Under Executive Order 12291. EPA n
must judge whether a regulation is
"Major" and therefore subject to the
requirement of a Regulatory Impact
Analysis. This regulation is not Major
since it is Interpretive in nature and
does not contain new substantive
requirements. The regulation:
1. Does not have an annual effect on
the economy of $100 million or more.
2. Will not substantially increase
costs to consumers, industry, or
government.
3. Will not have a significant adverse
effect on competition, employment
investment productivity, or innovation.
This regulation was submitted to the
Office of Management and Budget for
review as required by Executive Order
12291^ (Sec. 25(a)(1) (7 U.S.C. 136w)).
[Note: This rule will not appear in the
Code of Federal Regulations.]
I. Appropriate Enforcement Action
A. Procedures Governing Referrals. 1.
General. Section 27(a) requires EPA to
refer to the StateB any information it
receives indicating a significant'
violation of pesticide use laws. If a State
has not commenced appropriate
enforcement action within 30 days, EPA
may act on the information.
Given current resource limitations,
EPA 1b not in a position to monitor State
responsesto every allegation of
pesticide misuse referred by the Agency.
Rather, die Agency will focus its
oversight activities on evaluating the
overall success of State pesticide
enforcement programs, and will track,
on a case-by-case basis, only those ~
allegations involving particularly serious
violations. Such "significant" allegations
will be formally referred to the States
and tracked by EPA. while other less
serious complaints wUl be forwarded to
the States for information purposes only.
2. Criteria for significant cases. To
determine which alleged violations are
sufficiently significant to warrant formal
referral and tracking/the regions will go
through a two step process; First the
regions, in consultation with each State,
will identify priority areas for referral.
These priority areas will consist of those
pesticide activities in the State which
present the greatest potential for harm
to health or the environment (e.g. the
application of a pesticide by a certain
method to a particular crop, such as
ground application of endrin.to apple
trees]. The selection of these priority
areas will depend primarily on the
results of pesticide enforcement program
evaluations conducted by the States and
the regions. The priority areas will be
revised on an annual basis based upon
the effectiveness of the program in
reducing the harm associated with
pesticide use.
Thereafter EPA-will determine on a
case-by-case basis which allegations in
these priority areas involve sufficiently
"significant" violations to be formally
referred to the State and tracked. If a
complaint received by EPA alleges a
minor infraction which clearly presents
little o^no danger to health or the
environment or if the information
contains patently spurious allegations,
such as those from sources which have
repeatedly proved unreliable, the matter
will be forwarded to the State for
information purposes only.
3. The 30-day time period. The Agency
interprets the term "commence
appropriate enforcement action" in
section 27(a) to require States to initiate
a judicial or administrative action in the
nature of an enforcement proceeding, if
one is warranted. Starting an
investigation of the matter would not be
sufficient. If the State does not
commence an appropriate
administrative, civil, or criminal
enforcement response, EPA would then
be permitted, although not required, to
bring its own enforcement action.
Although section 27(a) permits EPA to
act if the State has not commenced an
enforcement action within 30 days, the
Agency recognizes that States may not
be able to complete their Investigation
of many, formal referrals in so short a
time. The time needed to investigate a
possible use violation will vary widely,
depending upon the nature of the
referral. A referrsi which simply
conveys an unsubstantiated allegation
will usually require more investigation
than a referral which partially or fully
documents a pesticide use violation.
Consequently, the Agency Wishes to
develop a flexible approach towards the
tracking of referrals.
To accomplish this objective, EPA is
adopting a system in which the referral
process is broken down into two stages,
investigation and prosecution.
4. The investigation stage. Following
the formal written referral of an
allegation of a significant pesticide use
violation, the appropriate regional.
pesticide official will contact the State
to learn the results of the investigation
and the State's intended enforcement-
response to the violation. If the State
has not conducted an adequate
investigation of the alleged violation, the
region may choose to pursue its own
investigation or enforcement action after
notice to the State. As a-general rule,
however, the regional office will attempt
to correct any deficiencies in the
investigation through informal
communication with the State.
An investigation will be considered
adequate if the State has (1) followed
proper sampling and other evidence-
gathering techniques, (2) responded
expeditiously to the referral, so that
evidence is preserved to the extent
possible, and (3) documented all
inculpatory or exculpatory events or
information.
5. The prosecution stage. After
completion of the investigation, the
State, will have 30 days, the prosecution
stage, to commence the enforcement
action, if one is warranted An
appropriate enforcement response may
consist of required training in proper
pesticide use, issuance of a warning
letter, assessment of an administrative
civil penalty, referral of the case to a
pesticide control board or State's
Attorney for action, or other similar
enforcement remedy available under
State law. The 30-day period may be
extended when necessitated by the
procedural characteristics of a State's
regulatory structure (see Unit V.A.
Hypothetical 1).
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Federal Register / Vol. 48, No. 3 / Wednesday, January 5. 1983 / Rules and Regulations 407
If, after consultation with the State,
EPA determines that the State's
intended enforcement response to the
violation is inappropriate (see
subdivision B), EPA may bring its own
action after notice to the State. Regional
attorneys will not however, initiate an
enforcement proceeding sooner than 30
days after the matter was referred to the
State.
At times, a State may find that the
particular enforcement remedy it views
as the appropriate response to a use
violation is not available under the
State's pesticide control laws. Therefore
the State may, at any time, request EPA
to act upon a violation utilizing remedies
available under FIFRA. In these
instances, of course, EPA will
immediately pursue its own action, if
one is warranted.
To illustrate better the proposed
referral system, two hypothetical
situations are described in Unit V. A.
B. Appropriate Enforcement Action. 1.
General. After the Agency learaB of the
enforcement action, if any, the State
proposes to bring against the violator,
the EPA regional pesticide office will
consider, in consultation with the State,
whether the proposed action is
"appropriate", relative to the remedies
available to the State under its pesticide
control legislation. EPA interprets the
modifier "appropriate" in section 27(a)
of FIFRA to require that the severity of
the proposed enforcement action
correlate to the gravity of the violation.
It is not possible-in this Interpretive
Rule to prescribe the specific
enforcement action which will constitute
an appropriate response to a particular
violation. There are too many variables
which will influence the treatment of a
use violation, including the disparity
between'the types of enforcement
remedies available under the various
State pesticide control statutes. This
document can, however, establish
criteria to be employed in evaluating the
appropriateness of a proposed State
enforcement action. More detailed
guidance on evaluating relative gravity
is contained in EPA's "Guidelines for
the Assessment of Civil Penalties under
Section 14(a) of the Federal Insecticide,
Fungicide, and Rodentidde Act as
amended", published in. the Federal
Register of July 31,1974 (39 FR 27711).
The Guidelines establish dollar amounts
to be applied under the Federal statute
to use violations in civil penalty
proceedings. Regional personnel can use
these figures as a guide in evaluating the
gravity of a particular violation. Hie
Agency will not require that a State
response to a violation have a monetary
impact equivalent, to that of a civil
penalty which EPA would impose under
the Guidelines. Rather, the dollar
amounts contained in the penalty
matrices can be used by regional
personnel to define the relative gravity
of a violation by comparing the figures
applicable to different violations..
2. Gravity of the violation. The
Agency believes that the gravity of a
pesticide use violation is dependent
upon the risk the violation poses to
human health and the environment The
factors which determine the degree of
risk presented by a use violation can be
divided into two categories: factors
related to the particular action which
constituted the violation and factors
related to the pesticide involved in the
incident.
a. Risk associated with the violative
action. The circumstances surrounding
the violative action partially determine
the risk the violation presents to human
health or the environment To assess the
degree of such risk. State, and regional
personnel should ask such questions as:
L Did the violation occur in a highly
populated area, ornear residences,
schools, churches, shopping centers,
public parks or public roads, so that
health was endangered?
ii. Did the violation occur near an
environmentally sensitive area, such as
a lake or stream which provides
drinking water to the surrounding,
community, a wildlife sanctuary, a
commercial fishery, or other natural
areas?
iii. Did a structural application
threaten to contaminate food or food
service equipment?
iv. Did the violation have the potential
to affect a large or a small area?
v. What was the actual harm which
resulted from the violation?
vi. Was the nature of the violation
such that serious consequences were
likely to result?
This last question is designed to take
into account the variation in the'
inherent risk associated with different
categories of use violations. For
example, a drift violation resulting from
Improper aerial application generally
presents a greater risk of harm than a
storage violation, since the latter
infraction does not necessarily involve
the improper exposure of the pesticide
to the environment
b. Risk associated with the pesticide.
The factors which will be crucial in
evaluating the risk associated with the
pesticide itself include:
L The acute toxicity of the pesticide or
pesticides involved in the incident The
toxicity of a pesticide will be indicated
by the "human hazard signal word" on
the labels (see 40 CFR 162.10). "Danger"
or "Poison" are indicators of a highly
toxic pesticide while "Warning" and
"Caution" signify successively less toxic
substances.
ii. The chronic effects associated with
the pesticide, if known.
iii. The amount of the pesticide
involved in the incident relative to the
manner of application (e.g., aerial versus
structural).
iv. Other data concerning the harm a
pesticide may cause to human health or
the environment such as data
concerning persistence or residue
capability.
An analysis of the interrelationship
between these two categories of risk
factors-should yield a notion of the
relative gravity of the violation and the
severity of the action which should be
taken in response.
3. Category of applicator, size of
business, and history of prior violation.
Gravity is not the only factor which EPA
will take into account in evaluating the
propriety of an enforcement action.
Section 14 of FIFRA requires that
distinctions in the severity of an.
enforcement response be made between
the categories of persons who commit
use violations. The intent of Congress,
as expressed in section 14, is that
commercial pesticide applicators who
violate use requirements will be subject
to more stringent penalties that other
persons who violate use restrictions.
Congress also envisioned that the size of
the violator's business will be a factor in
determining the severity of the penalty.
In addition, section 14 distinguishes
between violators who have committed
previous infractions and those who are
first offenders. Thus, the issuance of a
warning letter by a State to a person or
.firm who has been repeatedly warned in
the past about a certain violation would
not generally be considered an
appropriate response to the violation.
4. Knowing violations; criminal
penalties. The state of mind of the
violator is another important
consideration. In extreme circumstances
where the civil penalty remedy is
inappropriate, it is the Agency's policy
to pursue a criminal action against
persons who knowingly violate a
provision of FIFRA. EPA will be
particularly interested in pursuing
criminal prosecution for those violations
which involve a death or serious bodily
Injury or in which the violator has
demonstrated a reckless or wanton
disregard for human safety,
environmental values or the terms of the
statute. To be appropriate, a State's
response to a knowing violation under
the circumstances indicated above must
be similarly severe.
5. Deterrence. It should be noted that
the appropriateness of an enforcement
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Federal Register / VoL 48. No. 3 / Wednesday. January 5, 1983 / Rules and Regulations
action is a dynamic, rather than a static,
concept. Because it is dynamic,
penalties must be periodically
evaluated. If a certain violation to
occurring more frequently,..the leniency
of the remedies which have been
applied to this infraction in the past
should be questioned. Consequently,
what is appropriate in one. year may be
viewed as an inadequate response in the
next.
The factors described above, together
with the aforementioned-Guidelines,,
should help to clarify the Agency's
definition of "appropriate enforcement
action." To understand better how the
criteria described aboye can be used to
evaluate whether a proposed State
enforcement action is appropriate, the
reader is referred to the hypothetical
fact situations in Appendix B.
II. Criteria Governing Grants of Primacy
Section 26 of FIFRA sets.fdrth the
general criteria which apply to EPA's
decision whether to grant primacy to a
State:
"(a) For the purposes of this Act, a State shall have primary enforcement
responsibility for pesticide use violations- during any period for which the-Ad-
ministrator determines thai such. State—
. "(1) has adopted adequate pesticide use laws and regulations; Pro-
vided. That the Administrator may not require a State to-have pesticide
use laws that are more stringent than this Act;
"(2) has adopted and is implementitig adequate procedures for the
enforcement of such State laws and regulations: and
"(3) will keep such records and make such reports showing com-
pliance with paragraphs (H> and (2) of this subsection as the Ad-
ministrator may require by regulation.
"{^.Notwithstanding. the provisions-oi subsection (a> of this section, any
State that enters into a cooperative agreement with the Administrator urnfcw
section 23 of this Act for the enforcement of pesticide userestrictions shall
have the primary enforcement responsibility, for pesticide use. violations. Any
. State that has a plan approved by the Administrator in accordance with the re-
quirements of section 4- of this Act thai the Administrator determines meets
the criteria set out-in subsection (a) of this section shall have tBe 'primary en-
forcement responsibility for pesticide use violations. The Administrator shall
make such determinations with respect to State plans under Section 4-of this
Act in effect on September 30, 1978 not later than March Jl. 1979,
Thus, a State may obtain primacy In
two ways: (1) by demonstrating that the .
elements of its use enforcement
program, or of its approved certification
program, satisfy the two main criteria in
section 26(a), (adequate laws and
adequate procedures implementing
those laws), or (Z] by entering into a
cooperative agreement for the
enforcement of use restrictions,
provided the terms of the agreement do
not specify otherwise. The Agency will
also evaluate the adequacy of a State's
use enforcement program before
conferring primacy by this latter
method.
A.Adequat&Laws and Regulations. -
To be considered adequate, a State's
pesticide control legislation-must
address at least the following areas:
L Use'restrictions. State pesticide
control legislation will be considered
adequate for purposes of assuming full
primacy if State law prohibits those acts
which are proscribed under FIFRA and
which relate to pesticide use. The
activities presently proscribed under
FIFRA include: *
a. Use of a registered pesticide in a
manner inconsistent with its label
(FIFRA section 12(a)(2)(G)}.
b. Use of a pesticide which is under
an experimental use permit contrary to
the provisions of the permit (section
12(a)(2)(H)).
c. Use of a pesticide in-tests on
hnxnana contrary to the provisions of
section 12(a)(2)(P).
d. Violation of the provision in section
3(d)(1)(c) requiring pesticides to be
applied for any restricted ose only by or
under-the direct supervision of a
certified applicator. Violations of
suspension or cancellation orders are
not considered use violations for
purposes of the primacy program.
States may be granted partial primacy
if they regulate less than all categories
of use violations. For example: EPA may
in the future decide to issue "other
regulatory restrictions" on us'e under
section 3(d)(l)(C)(ii). (such as a
requirement to notify area residents
before pesticide spraying). If such a
restriction were issued, (and not
reflected on pesticide product labels),
each State would automatically have
partial primacy extending to all of the
categories listed above which are
proscribed by State law. unless the
State already has authority to enforce
guch restrictions. A State with partial
primacy would obtain full primacy by
enacting a prohibition tracking the
section 3(d)(l)(C)(ii) restriction.
2. Authority to enter. To carry out
effectively their use enforcement
responsibilities. State officials should be
able.to. enter, through consent warrant
or other authority, premises or facilities
where pesticide use violations may
occur. States should also have
concomitant authority to take pesticide
samples as part of the use inspection
process.
3. Flexible remedies. Finally, State
legislation must provide for a
sufficiently diverse and flexible array of
enforcement remedies. The State should
be able to select from among the
available alternatives an enforcement
remedy that is particularly suited to the
gravity of the violation. Without such
flexibility, a State may frequently be
forced to underpenalize violators, and
thereby fail significantly to deter future
use violations. Thus, in order to satisfy
the "adequate laws" criterion: States
should demonstrate that they are able
to:
a. Issue Warning Letters or Notices of
Noncompliance;
b. Pursue administrative or civil
actions -resulting in an adverse economic
impact upon the violator, e.g., license or
certification suspensions or civil penalty
assessments; and
c. Pursue criminal sanctions for
knowing violations.
B. Adequate Procedures for Enforcing
the Laws. En order to obtain primacy,
States must not only demonstrate
adequate regulatory authority, but must
also show that they have adopted
procedures to implement the authority.
These procedures must facilitate the
quick and effective prevention,
discovery, and prosecution of pesticide
use violations.
1. Training. One step towards thia
objective is the training of enforcement
personnel. At a minimum, States, in
cooperation with EPA, should
implement procedures to train
inspection personnel in such areas as
violation discovery, obtaining consent
preservation of evidence, and sampling
procedures. Enforcement personnel
should be adequately versed in case
development procedures and the
maintenance of proper case files.
Instruction in these techniques should
take the form of both on-the-job training
and the use of prepared training
materials. The Agency also considers a
continuing education program to.be a
crucial training procedure, so that
enforcement personnel can be kept
abreaBt of legal developments and
technological advances.
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Federal Register / Vol. 48, No. . 3 / Wednesday, January 5. 1983 / Rules and Regulations
409
2. Sampling techniques and
laboratory capability. Requests for
primacy should also show that the State
is technologically capable of conducting
a use enforcement program. States must
have Feady access to the equipment
necessary to perform sampling and
laboratory analysis, and should
implement a-quality assurance program
to train laboratory personnel and
protect the integrity^! analytical data.
Laboratories conducting sample
analyses must also agree to participate
in EPA (NEIC) Check Sample programs
which are designed to ensure minimum
standards of analytical capability. (Such
a program is already operational for
formulation samples, and a residue
sample program is also under
consideration). The EPA Check Sample
program is coordinated with the
Association of American Pesticide
Control Officials (AAPCO) to reduce,
unnecessary duplication of effort The
EPA will be guided in evaluating the
adequacy of State analytical procedures
by official compilations of approved
analytical methods, such as the Food
and Drug Administration's (FDA)
Pesticide Analytical Manual the CIPAC
(Collaborative International Pesticides
Analytical Council) Handbook, the EPA
Manual of Chemical Methods for
Pesticides, and Official Analytical
Chemists Analytical Procedures. For
additional guidance on adequate
sampling techniques. States should
consult EPA's FIFRA Inspectors Manual
or contact the appropriate regional
office.
3. Processing complaints. Since a
significant portion of pesticide use
violations are identified through reports
from outside EPA or the State lead
agency, the State must implement a
system for quickly processing and
reacting to complaints or other
information indicating a violation. An
adequate Referral system should contain:
a. A method for tunneling complaints
to a central organizational unit for
review.
b. A logging system to record the
receipt of the complaint and to track the
stages of the follow-up investigation.
c. A mechanism for referring the
complaint to the appropriate
investigative personnel.
d. A system for allowing a rapid
determination of the status of the case.
e. A procedure for notifying citizens of
the ultimate disposition of their
complaints.
4. Compliance monitoring and
enforcement Along with the above
described enforcement procedures,
States must provide: assurance that
sufficient manpowerand financial
resources are available to conduct a
compliance monitoring program, i.e.,
either planned or responsive use
inspections. In addition, States must
implement procedures to pursue
enforcement actions .expeditiously
against violators identified through
compliance monitoring activities.
The Agency also believes that
program planning and the establishment
of enforcement priorities is an integral
part of an adequate enforcement
program. Such planning, takings Into
account the national program priorities
as manifested through the grant
negotiation process, as well as the
priorities specific to the individual State,
will help assure that compliance
monitoring and enforcement resources
are properly allocated.
5.- Education. States should implement
a program to inform their constituencies
of applicable pesticide use restrictions
and responsibilities. Examples of
education methods include
disseminating compliance information
through cooperative extension services,
seminars, publications similar to the
Federal Register, newspapers, and
public assistance offices where persons
can call to ask.questions or report
violations. Such an educational program
will promote voluntary compliance arid
is essential to effective enforcement
States should also devejop procedures
for soliciting input from the public
regarding the administration of the
pesticide use enforcement program.
m. Criteria Governing Rescission of
Primacy Under Section 27(b)
Section 27(b) authorizes the
Administrator to rescind primacy from a
State in certain situations:
"(b) Whenever the Administrator-determines that a State having primary
enforcement responsibility for pesticide use violations is not carrying out (or
cannot carry out due to the lack of adequate legal authority) such responsibili-
ty, the Administrator shall notify the State. Such notice shall specify those
aspects of.'the administration of the State program that are determined to be
inadequate. The State shall have ninety days after receipt of the notice to cor-
rect any deficiencies. If after that time the Administrator determines that the .
State program remains inadequate, the Administrator may rescind, in whole
or in part, the State's, primary enforcement responsibility for pesticide use
violations.
In deciding whether a State is not
carrying out, or cannot carry out. its use
enforcement responsibilities, the
Administrator will apply the criteria for
an adequate program set forth in Unit 0
to the performance of the State during
the time the State had primacy.
A. Adequate Laws. The legal authority
can conduct an adequate use
enforcement program is a criterion
which affects both the decision to grant
primacy and the decision to rescind iL
Within the context of rescission, the
Administrator will assess the impact of
any amendments or supplements to the
State's pesticide use laws and
regulations. If legislative changes have
adversely affected the State's ability to
collect information-or bring enforcement
actions, the State may be subject to a
rescission action on grounds of
inadequate laws.
B. Adequate Procedures. In
determining whether a State which has
adequate legal tools is carrying out iU
use enforcement obligations, the Agency
will examine the efficacy of the
procedures adopted by the State to
implement its pesticide laws. The
Agency will be particularly interested in
the remedies the State has actually
applied to the various use violations.
The lack of sufficient correlation
between the gravity of a use violation
and the severity of-the enforcement
response would be evidence that the
State's arsenal of remedies Is not being
applied in a flexiblejnanner.
In addition, EPA will evaluate each,
program element listed in Unit 113., in
light of the performance of the State
during the period the State had primary
use enforcement responsibility.
1. Training. The Administrator will
note whether any difficulties
encountered by the State in enforcing
pesticide use restrictions have resulted
from a lack of adequate training of State
enforcement personnel
2. Sampling techniques and
laboratory capability. The
Administrator will consider whether the
State's sampling techniques and
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Federal Register / VoL 48. No. 3 / Wednesday. January 5. 19B3 / Rules and Regulations-
analytical capabilitiesare enhancing or
hindering, the State's ability ta unearth,
and prosecute successfully persons who
misuse peaticfdes; Another important
consideration wilt be the dejp-ee to
which State tab oratory and anmpfTn&.
procedures have-kept, paca with. ..
development in. analytical technology.
3. Processus rmrtp/mrittr TTlW
Administratorwill examine whether
complaints base hrnm prnrmnrrf quickly
and efficiently. The degree to whlrh
/•iHTPTin allpgingmum ginhtinn seek
redresa from EPA after first directing
their complaint ta the Stale will be.
considered^la addition., the
Administrator voUl take- irUo. account the-
performance of the Statain reloading
to allegationa referred, to the State by
EPA under; section 27(a) of FIFRA.
4. Compliance monitoring and
enforcement. Under thjp elementt&e
AHnilnlahraterwHt COmpaTB tfaeSfcBte?»
level of compliance monitoring acflwitlBS
with that ofothsrcompaxable:SfcatB8~
The EPA will review State case files to
determine whether, the State, has.
aggressively investigated: acase before
deciding on the d&positiosn at th»-
matter. The EPA wiil al!BO>&ivesSgate
whether a Staters Attorney General's
office or other prosecutorial authorities
have demonstrated a willingness ta
pursue cases refecredby the Stata'a
pesticide control lead "agency.-
The Agency will examine whether
State enforcement resources have teen
directed tovanbthsmsRaigiificaBt -
enforcement problem oreas^ and
whethesenforeement- priorities have
been reevalaatedas the'demands a£ anr
adequate program change ever times.
5. Education. The- Administrator v*ill
evaluatewhetbar the State-s education
program i» encouraging, voluntary
compliance with pe 8 ticidte uae .
restrictions. Aa part o£ this, ptpcessi the
Administrator will note those use
violations which are at least partially
attributable to the violator's lack of
familiarity with applicable laws and
regulations. The. Administrator will also
review State procedures for facilitating,
public participation in tire enforcement-
program;
These-criteria-ate-indicea of the
. adequacy of a State's use enforcement
program; but they do not conclusively
determine whether a State ia discharging
its primacy responsibilities. Since the
Agency's goal ia. to protect the public
from the risks associated with
pesticides, one of EPA's central inquiries
will be whether the State's primacy
program assures compliance with
pesticide use restrictions. EPA. in
evaluating State program adequacy, will
consider both the deficiencies of the
program and the success of the program
in achieving compliance.
IV. Emergency Response
Notwithstanding other provisions of
sections 2& and 27* theAdniizaatEator
may, after nbti&c&tiDn.tD:thB'States take
immediate "Hinu to abate emergency
situations! i£ the State is "unwitting or
unable adequately to respond totke-
emergency."
FIFRA does aot define "eauugmcy
conditional" Other EPA-admiaiatered
statutes, however, characterize
emergencies ia fairly, consistent terms.
The conssBana of these statutes is that
aa emergency peesenta a risk o£ harm to
hlimftn hrWltfl Off ***» ¦™ rrmmant is
both serioMfl-aBd Imminent,, and that
requires irasaediata abatement action.
Examples of use-related emergency
situations-mes.
1. P^ntamiiidtimt at i °
highly toxic peBttdtfc-
2. Hospitalizations, deaths, or other
severe health effects- resulting from ubb
of a pesticide.
£. A geographically speoficpafiemof
nseer-mfstisa wftisft presente
tmressona bis risk of adverse effects to
HpaWI of senmthre. nHhirnf areas*. This
situation, may occnr. fat example, if a-
im. rniwrfgtMnHy
misused irr a particular area a* Hart the
neteffect is-the creation of sobstantlai
endangerment to the environment such
as runoff into a water supply;
A. ' 'UnwillingWhen EPA learns, of
as emergency Hihuttbin. Agsncjr
representatives rasas netlfy dnr affected
State- lbeac iiiMi'iiwUiliuea wffl try to
¦ ifc^SgOmil
to (a|twlnt the State fecnpaWiH? erf doing
in response toth*ffltea4Bnak.ara£(h£
wijen. the State intends torespond to the
crisis.
EmergencKft. by natere. reqs&e the
quickestpossible Eeqwnse. In nog*
caseavdoeteproa&ni^; the Stele-wilV
have tte opportunity to-he first es» the-
scese. 8 the State manifests an
unwillingness to respond rapidly to the
situation, or if the Slate cannot give
assurances, that itwiO respond more
quickly than EPA cotrid respond. Agency
emergency response teams wifl be
activated:
B. "Unable". ThaEPA will
immediately take action to abate an
emergency if the State is unabie to do
so. The Agency interprets "tmable" to
mean that either the ^ate does not have,
the authority to adequately respond of
that the State is incapable of solving- the
problem due to the lack of technology or
resources.
1. Authority. The EPA can utilize its
authority in section 16(c) of FIFRA to
seek, in conjunction with the
Department of Justice, a district court
order preventing Or restraining misuse of
a pesticide. States should also be able to
address a use-related emergency in this
manner or by the rapid issuance of an
enforceable stop-use order or other
similarmeans. If the State. lacks- this
authority and the emergency conditions
warrant a legal response in the natare of
specific enforcement or equitabfe relief,
EPA may initiate it* own actios after
notice to the State.
£ Technical capability: Some
emergency situations; may present
problem*which. the States are-
technologically incapable of sotvmg. In
these-instances;, if EPA possesses the
requisite technology or equipntent the
Agency will immediately respond to the
crisis. For example, where a dissolved
organic pestidda has contaminated a
surfac&water system. EPAwoakl
activateita portable advanced waste,
treatment unit,, a resource that- is. not
generally available to the States.
The EPA will also take action il the
State cannot rapidly committhe
necessary manpower to the-emergency
situation. Ia most cases. EPA will not,
however, initiate a response on this
basis, if the State has developed an.-
emergency response plan detailing the
procedures, to be fallowed ini
counteracting a pesticide emergency.
V. Hypothetical Sitnatinns
In reading the hypotfaeticals in Units .
A and B;.assnme tirat the cases
discossed fall under priority referral
areas dracussedin Unit I.A.2.
A. Action by Citizen. Hypothetical I.
EPA refers tor the State a citizen's
allegation that an aerial applicator has
allowed pesticides to drift over his
property. After 25 days, the EPA Region
obtains the results of State's
investigation^ and learns that the State
plans to issue a warning letter to the
applies tot: The. EPA advocates a more
firm response and. after discussion, the
State-agrees to suspend the applicator's
certification. The State certification
board does not meet, however, until two
months later. In this Instance, the Region
may decide to extend the normal 30 day
prosecution stage to accommodate the
schedule of the boards
Hypothetical 2. A citizen calls EPA
with information concerning a fish kill
which occurred in a stream near his
residence. The citizen claims that he
reported his information to the State, but
State officials have not responded to-his
complaint The EPA's Regional official
calls the State, and learns that the State
did indeed know of the problem, but has
not yet had the opportunity to
investigate the allegation. The Regional
-------
Federal Registrar / Vol. . 48, No. 3: / Wednesday, January 5. 1983 / Rules and Regulations 411
official, believing the allegation to be
significant, formally refers the complaint
to the State, and the State agrees that
the matter should be investigated within
20 days. After 20 days, the Region learns
that the State has-not yet begun its
investigation. In this case, the Regon
will begin its own inquiry into the'
matto; and may commence its own
enforcement action, after notice to the
State- provided that30 days have
elapsed from the date of the referral_
B. Action by State. In both, of these:
hypotheticataiassume that the State has
chosen a Warning Letter as the
appropriate enforcement response.
Hypothetical T. Mr. Smith: operates a
one-man crop dusting company. Smith is
hired to s{H&y'Herbidde&over a powet
company's leng&y right-of-way. The
right-ofrway ia bounded on one side- by
a residential development and on the
other by awaodedazefeSmith performs
the aerial application amidst high,
swirlingwinda in contravention of the
instructioaa on the.berUcide'alabeLA
significant portion of the herbicide drifts
onto the wooded area; Herbicide A.-
which contains the hazard ward
"danger'* on Ua labaL is a highfy toxic ¦
and persistent restricted ose pestidriev
Smith has no record of prior ^estieida-
related. mnfitinna witft gnuam—Mi*
pesticide control offices.
The Agency would consider the
issuance of a. warning, letter to he an.
inappropriate response to this-violation-
a. Risk, associated with tie violative
action. Fortunately in this instancy the
herhidde did not result in damage to
humans or sensitive environmental
areas. Bat atthe time the violation was ¦
committed^ tba risk that harm would
result from the misuse was quite
significant, given the High, swirling
winds and the proximity of a residential
neighborhood. Onjy chance prevented
the herbicicfe from, drifting into an
inhabited ares. The risk, of harm was
also increased by the fact that a great
deal of land was subject to drift given
the length of the target area.
b. Risk associated with the pesticide.
Herbicide A is labelled^'danger" and is
therefore an acutely toxic Category I
pesticide trader 40 CFR 18230. Ute harm
that would result front expoame to this
persistent substance is substantia^
regardless of whether chronic effects or
residue properties have been escribed to
it. In addition, a large amount o#
herbicide A was involved in the
violation.
c. Other factors. Sinith is a
commercial applicator under FIFRA and
would-be. subject to the maximum
penalty. As a mitigating factor, however;
Smith could point to the absence of prior
FIFRA violations.
In summary, since Smith's actions
were highly likely to result in serious -
harm to human health, his drift violation
warrants a severe enforcement
response, such as assessing a fine or
suspending his certification. Despite
Smith's clean record, a warning letter
would not be deemed "appropriate
enforcement action."
Hypothetical Z A small food
processing firm which markets frozen
TVdinners utilizes company
maintenance personnel to. accomplish its
pest control needs. Naparticulra
training is provided for such-employees
but they are instructed to read and
follow the label direrttnma.They am
provided all appmprmtff_nppliratimi
equipment and protective dgtfeiag.. A
company employee applied a non-
persistent general-use (Category IV)
pestidderwhich was registered for
structural pes tcontrol to combaFt &
particularly serious, cockroach
infestation. Despite label instructions
requiring the user to avoid
contaminating food food containers, or
crooking utensils; die employee applied
the pestiddedirectly upon and batow
counter tops and related surfaces in the
room where food cookingracks are
stored Hie application took place tats
Friday afternoon;.Thecookingracks
were not utilized again uotiLMondsy
morning. An. inspection took place on
Monday morningt This, was ma third
pestidde use innjpegtlnn wbicktha Stata
hadconducted at tha-fim fas thelast-
£our years. None of the prior inspections
had revealed a pestidde-selated
violation. Residua samples taken
Monday morning; revested ho trace
residue ofthe pestidde on the. treated
surfaces.
Since the violation constitutes a first
offense by an. "other persoa" undei
section 14(aK2} of FIFRA, the maximum
federal enforcement response would ba
a Notice of Warning. Accordingly, the
Warning Letter issued by the State
would constitute an appropriate
enforcement action;
a. Risk associated with the violative
action. The direct application of any
pestidde to a cooking rack in a food
processing establishment poses some
risk of exposure to humans: Although
the pestidde used In this casewas not
applied in great amounts or over large
areas, the inherent risk associated with
the violation is relatively high, since
violation results in the introduction of
the pestidde into non-target surfaces
with the likelihood of human exposure.
b. Risk associated with the pesticide.
In this instance, the risk assodated with
the pestidde itself is relatively small.
This Category IV pestidde is not acutely
toxic or persistent, and is not known to
cause any chronic effects. Sample
analysis revealed no trace of the
product at the time the exposed cooking
racks were to be used.
c. Other factors: Under FIFRA, the
issuance of a Notice of Warning is the
maximum enforcement response to a use
violation committed by a private
applicator with no history of prior
violations. Thus, the Agency would of
course, view the proposed State
enforcement action as appropriate. If the
violation were repeated a more
sMngent enforcement action would' be
warranted.
Dated: December 22.1982.
John W.Hemandes.Jr,
Acting-Administrator.
IBBOoc. 83-6-FUsd l-t-83: &4S am|
BttkOMt CODB 6580-4MI
40CFR Part 18(X
[OPP-300089A; PH-FRt 2277-71
Tolerances and Exemptions Ftom
Tolerances for PestlddaClteinlcate lit
or on Raw Agricultural Commodities;
Methyl Bis (2-Hydroxyettiyl)Alkyt
AmmoniumChloride-
AGENCY: Environmental Protection
Agency (EPA}.
action: Final rule.
summary: This rule exempts methyibfs
(2-hydroxyethyl)alkyS ammonium
chloride from the requirement of a
tolerance, where the carbon chain. (C«-
Cu) is derived from-coconut, cottonseed,
soya, or tallow adds, when-used as a
surfactant in pesticide formulations.
This regulation was requested by the
Armak Company.
EFFECTIVE DATES. January 5,1983.
ADDRESS: Written objections maybe
submitted to the: Hearing Clerk (A-110),,
Environmental Protection Agency, Rm~
3708, 401 M St., SW., Washington, D.C.
20460.
FOR FURTHER INFORMATION CONTACT;
Roland Blood Process Coordination
Branch (TS-767C). Registration Division,
Office of Pestidde Programs,
Environmental Protection Agency, Rm.
716D, CM#Z, 1921 Jefferson Davis
Highway. Arlington, VA 22202 (703-557-
7700).
SUPPLEMENTARY INFORMATION: EPA
issued a notice of proposed rulemaking
published in the Federal Register of
November 3.1982 (47 FR 49874) which
announced that at the request of Armak
Company, 300 South Wacker Drive,
Chicago, IL 60806, the Administrator
proposed to amend 40 CFR 180.1001(d)
-------
\F'2>M>
' J UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. DC. 20460
APR 2 1 1983
orF»c« or
FCSTICIOCt ANO TOKIC SUBSTANCES
EMJRANDUM
S'imJECT: Final FY* 4 Cooperative Agreement Progr.an Guidance
TO: Air and Waste Management Division Directors
£nvi ronnental Service Division Directors
Pesticide branch Chiefs.
Attached is the final guidance for the FY^4 FIFRA cooperative
agre^nent progran. This document coiM tes guidance for both the
pesticides enforcenent and the applicator certification and train-
ing programs. For your convenience, the sections entitled FY 1994
FIF -i A Cooperative Agreenent Program Guidance and FIFRA Cooperative
A^reenent Progran Guidance are included in their entirety. These
sections replace the FY 1^3 Cooperative Aorsenent Progran Guidance
and the FIFRA .Cooperative Agreenent. Programs Guidance sections in
the FY33 guidance. Also, na-ny of the Appendices -in the FY;::-3 cuii-
-nca'hjve either been amended, revised or replaced ana' * i vie new
in^e:ndic«s have been added.
This final guidance has been modified in response to nost
comnents on the earlier Craft. Specifically, the following areas
have been changed:
o Base Allotment
o Product/Facility Related Priority Setting Model
(Appendix I, addendum)
o Nonfunded Priority Program
o §26 and §27 Interpretive Rule Procedures
o LIP and CRP Inspection Strategies
/
For FY84, the enforcement cooperative agreement base funding
level has been increased from $45,000 to $60,000. The weighted
factors used to distribute the funds remaining after each State's
hase allotments were subtracted from the total program allotment
have also been revised to reflect new data on the numbers of private
and commercial applicators reported fir FYS2.
-------
2-
C o 'i 11) r s if a State could condyct, as part of its
' i rst quarter outputs, the product/facility priority setting.
jtjr.es who are 'unable to complete their p rodu ct i f a c i 1 i ty priority
setting prior to the awarding of their FY«4 cooperative agreement
nay include that portion of their priority setting as part of
their first quarter outputs. Part III, Award Conditions of the EPA
Notification of Assistance Award Action for such States must include
* condition requiring States to conduct product/facility priority
setting by no later than the end of the first quarter.
The section on nonfunded priority problems has been clar-
ified. Some States' current pesticide programs nay already
address pesticide problems identified through priority setting.
In such cases, States are requested to provide this information
as a supplement to their cooperative agreement applications so
that EPA will have a complete picture of how a State is addres-
linij all its pesticide problems. This irfonation will aid the
p. q i o s in evaluating the State's cooperative agreement application.
All States n u s t update their previous years use priority
sotting and include it in t^eir FY^4 cooperative agreement
a T- P 1ications.
Tbe final guidance document S'jnnarizes and expands tne
procedures to be followed by the Regions in reviewing State
investigations and enforcement actions ji'( r the Interpretive
0,j!e for FIFRA, §§25 and 2 7. The P. e Q i o n a ; offices and the States
ii a nu a 1 1 y define significant cases to ne tracked by c'jk
. f*. er referral to the State. The ojila.ocr outlines the oroced-jres
w h i •: h the Regions "v.i s t f o 1 1 n w 1 ) in revi ?/' ng the a d e q u a c y of
c. t a t ¦? inves'tigations or enforcement actio'S sn j ?.) before c u 1 H u : : -
i n g a Federal investigation or taking ^ e -1 ^ r a 1 enforcement action.
Finally, inspection strategies for the LIP and^CRP programs
are included in Appendix XI and Appendix XII. The Office of
Pesticide Programs, Registration Division will provide the
required data as outlined in the inspection strategies.
If you have any questions, please contact John Martin,
of my staff, at (202) 382-5572,
Compliance Nonfitoring Staff
Office of Pesticides and Tnxic Substances
A. E. Conro/'| I, Director
Attach men t
-------
TABLE OF CONTENTS
FY 1984 FIFRA COOPERATIVE AGREEMENT PROGRAM GUIUANCT
ENFORCEMENT 1
A11otment of Funds 1
Initial A11otment 1
Adjustments to Initial Allotment 2
Final Allotment 2
Alternative Funding 2
National Priorities 3
APPLICATOR CERTIFICATION AND TRAINING 5
A11otnent of ' Funds 5
Initial Allotment 5
rinalAllotment 6
At* ac finer, ts : Allotment Scnedules
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FY 1984 FIFRA COOPERATIVE AGREEMENT,PROGRAM GUIDANCE
This annual guidance outlines Regional funding allotments and
discusses national priorities to be followed by the Regions 1n
implementing FY84 cooperative agreements for pesticides enforce-
ment and appl1cator cert 1f1 cation and training. The Compliance
Monitoring Staff (CMS) of the Office of Pesticides and Toxic
Substances Compliance Monitoring Staff (OPTS) expects to receive
S6,913,400 to fund State and Indian Tribe cooperative enforcement
programs and has received $2,000,000 for funding cooperative
applicator certification and training programs.
ENFORCEMENT
Allotment of Funds
The President's annual budget submission to the Congress requests
an overall program appropriation for pesticides enforcement
cooperative agreements. Individual State allotments for financial
assistance are initially determined by application of a two step
formula. States are to use these initial allotments to develop,
witn their respective Regional offices, work programs.that meet
both State and Agency needs.[40 CFR Part 35.115(h)] Final allot-
ments-will be based on the States' initial allotments and a
redistribution o * surplus funds.
I n i ti a 1 Allo t m e n t
Secause of a proposed reduction in the amount of pesticides
enforcement cooperative agreement funds available for FY84, EPA
Headquarters' initial financial assistance allotments will con-
si der only those States, Territories and Indian Tribes presently
participating in the pesticides cooperative agreement program.
Any non-participating State (Ohio, Nebraska, Colorado, Wyoming,
and Alaska) or Indian Tribe which wishes to. be Included in the
final allotment, must send EPA a written commitment to submit
an application and participate 1n the program prior June 15, 1983.
For F Y 841 EPA Headquarters will first determine the initial
Regional allotments for pesticides enforcement cooperative
agreements by adding the following: $60,000 for each participating
State, Puerto Rico and the District of Columbia (47); $25,000
for the Virgin Islands; and S10.000 for each participating Ter-
ritory (4) which comprise a base level of funding. The initial
Regional allotment also includes 10" of the available funds (1%
per Region) as pesticides enforcement incentive funds; and
5200,00 0 for cooperative agreenents witri Indian Tribes (7).
-------
Then, Headquarters will distribute the funds remaining after the
base funds, pesticides enforcement incentive funds and Indian
Tribe funds are subtracted from the proposed budget appropriation
according to the following factors and weightings:
1981 July 1, 1981, Provisional Estimates of Popu1 a - 20%
tion, U.S. Bureau of the Census - April 1982.
1982 Number of Pesticide Producing Establishments 2 0%
per State - FIFRA and TSCA Enforcement System
(FATES) printout, December 23, 1982, CMS.
(Numbers do not include Custom Blenders).
1982 Number of Certified Private Applicators per 10%
State, September 30, 1982, CMS.
1982 Number of Certified Commercial Applicators per 20%
State, September 30, 1982, CMS.
(Individual categories were counted separately).
1932 Estimated Number of Farms Per State - Crop 20%
Reporting Board, (SRS) U.S. Department of
Agriculture (USDA) Farm Numoers, August 1982.
1982 Estimated Farm Acreage Per State - Crop 10%
Reporting Board, SRS, USDA Farm Numbers,
August 1982.
Each Region's initial allotment is obtained by adding the appro-
priate base amount for each of its States, Territories or Indian
Tribes, the proportioned amount determined by the above factors
and weightings and the pesticides enforcement incentive funds.
Each State's initial allotment is obtained by adding the appro-
priate base amount and the proportioned amount determined by the
above factors and .weightings. The pesticides enforcement incentive
funds will be used by the Regional Administrator to reward i/movati v
or exceptional pesticides enforcement programs. (Regional and
State allotments are attached.)
Adjustments to Initial Allotment
Regions should not award funds based solely on a State's initial
allotment but rather based on the negotiated need of the State.
rhe Regional Administrator may modify any State allotment as
necessary as long as total funding for all States does not exceed
the Regional allotment. 40 CFR Part 35.115(d) states that the
A dmi n i s t r a t o r or the Regional Admi n i s t r a t o r 'may use funds not
awarded or committed to an applicant to supplement awards to
o t-n e r applicants for pesticides enforcement.
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-3-
A 11otment
The Regional office must furnish the following information in
writing to Headquarters no later than July 1, 1983:
1. The names of States and Indyan Tribes that will be
participating in Fiscal Year 1984.
2. The anticipated financial assistance funding level
for each participating State and Indian Tribe.
The EPA Headquarters will make the fin^l allotment of cooperative
agreement funds and notify the Regional offices in writing by
July 15 , 1983. This final a 11otment w111 include a reallotment
of funds from Regions whose States do not need their entire
initial allotments to Regions whose States demonstrate a need
for additional funding. The final Regional a 11otment consists
3 f trie sum of each part i ci pa ti ng . State 1 s final allotment and
oesticide enforcement incentive funds and will be included in
each Region's FY84 operating budget.
The Regions will base the distribution of cooperative agriee-
nent funds on &oth the allotment schedule and the thoroughness
?f the State's own priority setting process. The States should
iC i fy priority enforcement problem areas by a method similar
at outlined in the Priority'Setting section of the State
.cation Standards and Evaluation Procedures, Appendix I and
its addendum, so that resource allotment decisions will be
)5sed on objective measures. The Region will aase final State
runding allotment decisions for St ate app1ications on the initial
illctment, the demonstrated pesticide enforcement priorities
)f the State and the exceptional nature of a program justifying
iward of a portion of the pesticide enforcement incentive funds.
>:terna11ve Funding
"he Regional Administrator may use current year funds remaining
ifter the initial State awards to 1) supplement existing awards
>r 2) award new partially funded cooperative agreements for
:he next year. A partially funded cooperative agreement is a
iew agreement that would begin immediately after the current
cooperative agreement had ended and is funded, partially, witn
current year funds.
'artially funded cooperative agreements offer States a method
>f -nairitainlng program continuity during EPA's trdnsition
rorn fiscal year to fiscal year. All funds must be obligated
n accordance with the legislative restrictions that 11 in it
:ne anount of funds that can be obligated in the fourth quarter,
"hese funds shall not be used to extend budget or project
i3 "is of existing cooperative agreements.
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-4-
National Priorities
Each year, Headquarters formulates national pesticide enforcement
priorities based on major recurring areas of concern identified
by the States through their priority setting systems and on related
information from other sources.
Based on the available data and priorities established by States
that conducted priority setting in their FY83 cooperative agree-
ment applications, Headquarters has identified the following
general areas of concern as National Priorities for F Y 8 4.
1) Drift from pesticide application;
2) Misuse by pest control operators during structural
applications;
3) Disposal of pesticides and pesticide containers;
and
4) Pesticide use problems associated with major spray
programs, i.e. gypsy moth, forest service (conifer
release), and mosquito control.
5) Worker exposure to pesticides before, during and
after application.
The EPA has designated these areas of concern as national
priorities to guide the States in their priority setting process.
Although these areas may not be of apparent concern in all States,
the States should consider these areas as they develop data for
use in setting their individual priorities. After considering
pertinent data, a State may find that some or all of these areas
are not priority problems in the State. In that case, the State
should, of course, direct its enforcement resources to those
areas which do present major pesticide problems..
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-5-
APPLI CATOR CERTIFICATION AND TRAINING
A 11otment of Funds
The President's annual budget submission to the Congress requests
an overall financial assistance program appropriation for pesticide
applicator certification and training cooperative agreements.
Individual State allotments for financial assistance are Ini-tally
determined by application of a two step formula including certain
factors and weightings described below. States are to use these
initial allotments to develop, with their respective Regional
offices, work programs that meet both State and Agency needs.
[40 CFR Part 35.115(1)]
Initial Allotment
In FY34 financial assistance funds for the pesticides applicator
certification programs with States will be alloted from FY33
funds . *
?or FY34, EPA Headquarters will first determine the initial
Regional allotment for pesticide applicator certification and
trairving_ca.operat.ive agreements by adding $10,000 for each parti-
cipating?'Stat e wnich comprises a base level of funding. Each,
Regional allotment will also include an amount for cooperative
agreements.with Indian Tribes that are approved and operating
tefore the issuance of this guidance document.
Then, Headquarters will distribute the funds remaining after the
oase funds and Indian Tribe funds are subtracted from the proposed
budget appropriation according to the following factors and
weightings:
1982 Estimated Number of Farms Per State - Crop
Reporting Board, SRS, U.S. Department of
•Agricu1ture (USDA) Farm Numbers, August 1982.
1932 Number of Certified Private Applicators per
State, September 30, 1982, CMS.
(Adjusted for recertification period).
1982 Number of Certified Commercial Applicators
by Category per State, September 30, 1982,
CMS. (Adjusted for recertification period).
- In FY33 the 52,000,000 for the Pesticide Applicator Certification
and Training Program will be distributed as follows: S174.000
for t^e Federal pesticide applicator certification and training
programs in Colorado and Nebraska and Indian-Tribes for FY33;
$913,000 to USDA for training of pesticide applicators in
participating States for FY33; $913,000 or the remainder will
•be proportioned between the States through cooperative agreements
f o r F Y 34 .
25%
30%
35%
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-6-
Regional discretionary allotment for 10%
pesticide applicator certification and
training programs.
Each Region's initial -a-Llotment is obtained by adding for
each of its States the-base funding amount, the proportioned
amount determined by the above factors and weightings and the
Regional discretionary allotment for pesticide applicator
certification and training.
Each State's initial allotment is obtained by adding the base
funding amount and the proportioned amount determined by the above
factors and weightings. The Regional discretionary allotment for
pesticide applicator certification and training programs will
be used by the Regional Administrator to reward exceptional
programs. (Regional arm 'S'tate initial allotments attached).
Final Allotment
The initial allotment will become the State's final allot ment.
However, if a State cannot use its entire initial allotment
the unused funos will be redistributed by the Regional Adminis-
trator to other States within the Region requiring addition's!
assistance. Prior to awarding unused funds to another State the
Regions n-.jst inform CMS where these unused funds will be used.
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\ ;
i.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C. 20J60
April 11, 1983
orrtee of
pcsnciocs a mo roMic substances
memorandum
TO :
Addressees
SUBJECT: Revised State and Regional Initial Allotments
for Pesticide Enforcement Cooperative Agreements
Attached is a copy of t n e revised State and Regional Initial
Allotments for Pesticides Enforcement Cooperative Agreements for
FY?£ and the supporting allotment formula data. This allotment
scn^jule incorporates two najor changes:
f
c Utilizes the 'lumbers of private and commercial certified
applicators on September 30, 1942, instead of the 1931
nj-^ers. "he 1?82 numbers were unavailable when the
previous allocation was made on January 11, 1933.
0 Base funding level was increased from $-15,000 to S50,000
per state. Tiiis change was recommended by the Association
of American Pesticide Control Officials and the State-
r-'IFRA Issues Research and Evaluation Group.
This al 1 otment schedj,1 e 1s based on the President's FY84
budget request of 56,918,400 for pesticide enforcement cooperative
agreements. These allotments should be used in planning the FY84
pesticide enforcement program with the States 1n your Region. As
indicated in the Draft FY84 Cooperative Agreement Program Guidance
the Initial Allotment Schedule may be revised to provide funding
for any non-participating State (Ohio, Nebraska, Colorado, Wyoming
and Alaska) making a written commitment, prior to June 15, 1983, to
apply for a grant. The final allotment schedule will be issued by
July 15, 1933.
• tor
Compliance Monitoring Staff
Office of Pesticides and Toxic Substances
:tor
t\f i n g Staff
and Toxic Su
11 achment
-------
State and Regional Initial Allotments for Pesticide
Enforcement Cooperative Agreements for FY84
Reg. I
Formula
Percent
Fundi ng
Amounts
Base
Funding
Total
Funding
CT
— *627
^ 19,708
60,000
79,708
ME
.383 ^
12.038
60,000
72,038
MA
1.155
36,303
60,000
96,303
NH
- .214
6,726
60,000
66,726
RI
.226
7,104
60,000
67,104
VT
.232
7,292
60,000
67,292
Regional
Incenti ve
69,000
69,000
Regional
Totals
2.837
89,171
42$,000
518,171
Reg. II
NJ
2.275
71,507
60,000
131,507
NY
•i.912
154,392
60,000
214,392
PR
1 .243
39,069
60,000
99,069
V!
-
-
25,000
25,000
Regi onal
Incenti ve
69,000
69,000
Regional
Totals
8.430
264,968
274,000
538,963
Reg. Ill
DC
.112
3,520
60,000
63,520
DE
.227
7,135
60,000
67,135
MO
1.010
31,746
60,000
91,746
PA
2.981
93,697
60,000
153,697
VA
1 .7 7?
55,917
60,000
115,917
W VA
.677
21,279
60,000
81,279
Regional
Incenti ve
69,000
69,000
Regional
Totals
6. 7bb
213,29-;
42^,U00
642,2*4
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Formula Funding Base Total
Percent Amount Fundi ng Fundi nq
Reg. IV
AL
1.665
52,333
60,000
112,333
FL
4.376
137,544
60,000
197,544
GA
3.154
99,135
60,000
159,135
KY
3.060
96,180
60,000
156,180
MS
1.369
43,030
60,000
103,030
NC
3.103
97,532
60,000
157,532
SC
1.189
37,372
60,000
97,372
TN
2.910
91 ,466
60,000
151 ,466
Regi ona 1
Incent i ve
69,000
69,000
Regi on a 1
Tcta1s
20.826
654,592
549,000
1,203,552
Rec. V
T •
-.636
147,288
60,000
207,288
4 ' «
2.517
79,113
60,000
139,113
M »
2.533
79,616
60,000
139,616
KN
2.661
83,639
60,000
143,639
OH
-
-
-
-
WI
2.731
85,840
60,000
145,840
Regional
Incenti ve
69,000
69,000
Regi ona 1
Totals
15.128
475,496
369,000
344,496
Reg. VI
AR
1 .487
46,739
60,000
106,739
lA
1 .362
58,525
60,000
118,525
f.M
.221
28,94 8
60,000
88,948
OK
2.107
66,226
60,000
126,226
TX
10.331
321,719
60,000
334,719
Regi ona1
Incenti ve
69,000
69,000
Reg'ona•
Totals
16.70S
;q:! t k 7
-------
-3-
Formula
Percent
Funding
Amount
Base
Funding
Total
Funding
Reg. VII
IA
2.848
89,517
60.000
149,517
KS
2.097
65,912
60,000
125,912
MO
3.172
99,700
60,000
159,700
NB
-
-¦
-
-
Regional
Incentive
69,000
69,000
Regional
Totals
8.117
255,129
249,000
504,129
Reg. VIII
CO
-
-
-
-
MT
1.201
37,749
60,000
97,749
ND
1.422
44,696
60,000
104,696
SD
1.310
41,175
60,000
101,175
/
.615
19,230
60,000
79,330
WY
-
-
-
-
Indian Tribes(6)
-
-
100,000
100.000
Regional
Incenti ve
69,000
69,000
Regional
Totals
4.648
U2,9*0
409,000
551,950
Reg. IX
AZ
1.481
46,550
60,000
106,550
CA
9.322
293,005
60,000
353,005
HI
.369
11,598
60,000
71,598
NV
.427
13.421
60,000
73,421
An Samoa
-
-
10,000
10,000
Guar.
-
10,000
10,000
Mari ana
Is.
-
-
10,000
10,000
vust Terr.
-
-¦
10,000
10,000
indian Tribes(2)
-
-
100,000
100,000
2eci onal
Incenti ve
69,000
69,000
: : •_ ; - •
¦?* ~ ••7.1
-------
-4-
Formula Funding Base Total
Percent Amount Fundi ng Fundi nq
Reg. X
AK ....
ID 1.254 39,415 60,000 99,415
OR 1.656 52,051 60,000 112,051
WA 2.119 66,603 60,000 126,603
Regional Incentive 69,000 69,000
Regional Totals 1 b8,069 249,000 407,06$
Total to Regions 100.008 3,143,400 3,775,000 6-,918,400
-------
FY84 FIFRA ENFORCEMENT GRANT
Allotment Formula Data
March 21, 1983
The attached table shows the statlslcal data used 1n developing
the formula for the allotment of the FY84 Pesticides Enforcement
Grants. Only data from the 45 states participating In the program
plus Puerto R1co and the District of Columbia are Included. The
other territories and the Indian Tribes do not-receive any formula
funds. The statistics used in the formula were amended to include
the 1982 certified applicator numbers and Include the following:
Population
July 1, 1981 Provisional Estimates of the Population -
3ureau of Census, April 1982.
Farn Nunbers and Acreage
1982 Preliminary estimates - Crop Reporting Board, SRS, USDA,
Au yti st 1 982...
Producer Establishments
FATES Data Systen - December 23, 1982 printout. Numbers used
Jo not include Custom Blenders.
Private Applicators
Number of Private Applicators certified on September 30, 1982.
Commercial Applicators
Number of Commercial Applicators certified on September 30,
1982. Individual categories were counted separably.
-------
Reg. I
CT
ME
MA
NH
R I
VI
Reg. Total
Reg. II
NJ
NY
PR
Reg. Total
Reg. 111
DC
OE
MD
PA
VA
W VA
Rt.*g. Total
Pnnu 1 .it Ion
F arms
K.ami Acreage
Pest.. Prinliicers
Private Aiml ic.
Cornin Appl i c.
Forinn] a
Mat.'
'' "i ""
State
i
State
t
\it»>
"1.
State
*
A,
State
I
Fun
Q0l)0)_
(_HJl)0)
3,134
.290
4 ,.300
.038
4'Jl)
. 005
52
.150
2,074
.021
2,005
.123
.627
1,133
.105
7,900
.071
1 ,560
.01/
19
.055
2,975
.031
1,698
.104
.383
5,773
.534
5,300
.047
630
.00/
113
.327
1,879
.019
3,622
.221
1.155
936
. 087
3,200
.029
540
.006
14
.040
803
.008
725
.044
.214
953
. 088
750
.007
fill
.001
23
. 066
338
.004
981
.060
.226
616
.048
7,500
.067
1,70U
.019
5
.014
2,565
.027
928
.057
.232
12,445
1.152
28,950
.259
"5 [7)00
"7055
266
.652
10,634
.110
9,959
.609
2.837
7,41)4
.685
9,500
.085
1.030
.011
271
.783
3,270
.034
11,073
.677
2.275
17,602
1.628
50,000
.446
9,500
.105
280
.809
15,507
.160
28,846
1.764
4.912
3,186
.295
31,837
.284
1,750
.019
53
.153
16,260
.168
5,296
.324
1.243
78,79?
91,337
.875"
12, ?i!o
"7m
" '"6(1.1
1.745
35,037
.362
45,215
2.765
8.430
631
.058
0
0
0
0
6
.017
0
0
601
.037
.112
598
.055
3,400
.030
660
.00/
16
.046
2,260
.023
1,089
.066
.227
4,263
.394
18,000
.161
2,750
.030
78
.225
8,288
.086
1,865
.114
1.010
11,871
1.098
60,000
.536
8,800
.097
233
.673
32,780
.338
3,903
.239
2.981
5,430
.502
60,000
.536
9,800
.108
66
.191
15,687
.162
4,577
.280
1.779
1,952
.181
20,600
.184
4,300
. 04B
22
.064
14,129
.146
.880
.054
.677
24,745
TTZM
WTftOC)
T7W7
7 jO
""*27
17276
|7371 4*
.755
12,915
.790
6.786
-------
?. i 1093
Population
Farms
Farm AcrtMiji*
Post. Producers
Private Applic.
Comin A
jplic.
I 1
Formula !
State
(1000)
%
State
%
State
(1000)
t
Stato
*
State
%
State
X
Funds
IV
AL
3,917
.362
57,000
.522
12,300
.116
129
.373
9,977
.103
2,757
.169
1.665
FL
10.183
.942
41,000
.366
13,000
.144
864
2.497
17,308
.179
4,059
.248
4.376
GA
5,574
.515
58,000
.518
15,200
.168
281
.812
34,865
;360
12,771
.781
3.154
KY
3,662
.339
101,000
.902
14,500
.160
89
- .257
86,257-
.890
8,376
.512
3.060
MS
2.531
.234
53,000
.473
14,500
.160
64
.185
8,632
^089
3,733J
.228
1.369
NC
5,953
.551
88,000
.786
11,100
.123
182
.526
52,292
.540
9,432
.577
3.103
SC
3,167
.293
33,000
.295
6,100
.067
79
.228
12,391
.12?
2,914
.178
1.189
TN
4.612
.427
95,000
.848
13,400
.148
140
.405
79,441
.820
4.2&*
.262
k.
2.910
Reg. Total
V
39.S99
3.663
526,000
4.710
100,100
1.106
1,828
5.283
301,163
3.109
48,334
2.9$$
20.826
V
11
11,462
1.060
104,000
.928
28,700
.317
418
1.208
53,808
.556
10,087
.617
4.686
IN
5,468
.506
89,000
.794
17,000
.188
166
.480
15,000
.155
6,443
.394
2.517
MI
9,204
.851
65,000
.580
11,500
.127
184
.532
6,041
.062
6,226
.381
2.533
MN
4,094
.379
103,000
.919
30,400
.336
152
.439
20,000
.206
6,247
.382
2.661
OH
-
0
-
0
-
0
-
0
-
0
-
0
.000
Ml
4,742
.439
92,000
.821
18,500
.205
152
.439
28,737
.297
8,677
.530
2.731
Reg. Total
377J5
45T,(Jfla
4.042"
TOfT.TOO
1.17 J
1,072
3.098
121758?
1.276
37,680
2.304
15.128
-------
Pomilat ion
Farms
Furu Acr\
Pest. Producers
Private Applic.
Comm A
ipiu.
%
.ul a
St.ite
1L°M
*
Statu
t
Stat.?
SjmiL
'j,
St aLc
%
State
I
State
%
Funds
VI
AR
2,296
.212
57,000
.509
16,400
.18)
52
.150
20,807
.215
3,596
.220
1.487
LA
4,308
.398
37,500
.335
10,200
.113
146
.422
38,316
.396
3,237
.198
1.862
NM
1,328
.123
13,500
.121
47,400
.524
19
.055
3,004
.031
1,104
.067
.921
0 V.
3.1UO
.287
71,000
.634
34,300
.379
58
.168
26,856
.277
5,929
.362
- 2.107
TX
14,766
1.366
185,000
1.651
1 38,4(J0
1.531
508
1.468
118,493
1.223
50,567
3.092
10.331
Kc(j.
Total
f'JtJ
1738b
TfrTjTOti
J. 250
247T, f(Td
783
207,476
ore
64,433
3.939
16.708
/II
IA
2,tm
.268
117,000
1.044
33,800
.374
220
.636
19,609
.202
5,305
.324
2.848
KS
2,383
.220
76,000
.678
48,500
.536
100
.289
16,054
.166
3,397
.208
2.097
MO
4.941
.457
117,000
1.044
31,400
.347
204
.590
52,886
.546
3,079
.188
3.172
NR
T otal
w;m
0
•Jfo~t"TO
0
-
0
-
0
-
0
-
0
.000
Reg.
.945
T.Tfa
TfJ.Tfln
T.T5/
524
1315
88,549
.914
11,781
.720
8.117
Ill
CO
-
0
-
0
-
0
-
0
-
0
-
0
.000
MT
793
.073
24,000
.214
62,100
.687
25
.072
7,828
.081
1,214
.074
1.201
NO
658
.061
38,000
.339
41,700
.461
38
.110
17,527
.181
4.426
.270
1.422
SD
686
.063
37,000
.330
44,500
.492
56
.162
14,930
.154
1,782
.109
1.310
'IT
1,518
.140
12,900
.115
12,300
.136
22
.064
5,562
.057
1,679
.103
.615
WY
-
0
-
0
-
0
-
0
-
0
-
0
.000
Beg.
Total
3,655
.337
111,900
.998
160,600
\.V
141
.408
45,847
.473
9,101
.556
8
-------
ei).
Populal
.ion
Farms
Farm Acrftacje
Pest. Producers
Private
Applic.
Coinm Ap
plic.
Total X 1
State
(1000)
f
State
%
State
(10U0)
State
%
State
t
State
Tormu1 a |
unds |
IX
AZ
2,794
.258
7,200
.064
.431
94
.272
992
.010
7,286
.446
t
1
1
1.481'
CA
24,196
2.238
80,000
.714
33.700
.3/3
886
2.560
40,000
.413
49,466
3.024
1
9.32i".
HI
9B1
.091
4,300
.038
1,960
.022
37
.107
4,640
.048
1,0.32
.063
1
.369!
1
NV
845
.078
2,900
.026
8,900
.098
29
.084
773
.008
2,179
.133
.427j
t
J
Reg. Total
y
28,816
2~.66£
94,400
.842
83,560
.924
1,046
3.023
46,405
.479
59,963
3.666
11.599 i
1
1
1
A
AK
-
0
-
0
-
0
-
0
.
0
-
0
1
1
.ooo;
i
ID
959
.089
24,000
.214
15,100
.167
45
.130
9,572
.099
9,077
.555
1.2541
f
OR
2,651
.245
36,000
.321
18,300
.202
92
.266
11,467
.118
8,245
.504
/ ;
1.6561
HA
4,217
.390
39,000.
.348
16,300
.180
139
.402
15,677
.162
10,426
.637
2.11V
l
Reg. Total
7,827
.724
99,000
.883
49,700
33SS3S r = *
.549
276
rssssso]
.798
sssosssas:
36,716
:sssa:asss:
.379
27,748
S3S3SSSS!
1.696
5.02^
National Totals
(45 States
plus DC & PR)
216,266|20.003J2,240,587J20.0121904,050|9.993J 6,9211 20.0011 968,557| 9.999|372,129|20.000| 100.00:'
-------
FtB 2 4 Y3S3
ft 03 State Certl Meat Ion Breakout - S In Thousands
(Finds to support activities in FY 84)
Region I
Regional
Connecticut
Maine
Massachusetts
Hew Hampshire
Rhode Island
V»rnont
total
3.3
11.5
ll.B
12.4
10.6
in.*
n .1
71.3
Region !V
Regional 8.0
Alabama lfi.9
Florida 22.3
Georgia 23.5
Kentucky 29.2
Mississippi 16.A
North Carol ina 13.9
South Carolina 11.S
Tennessee
TOTAL
2*.0
172.9
Peg*. 3*- I!
R93iona,< 3.i
New Jersey 16.7
flew vq.-k 2<*.0
Puerto Rico 17.1
Virgin Islands 10.2
TOTAl. 76.7
Region 111
Regional 4.6
Delaware 10.3
01 strict of Columbia 10.S
Maryland 16.7
Pennsylvania 22.6
Virginia 19.8
Must Virginia 1* .S
on V
*
-ecional
111 inoi S
!nrl i ana
Michigan
Minnesota
Ohio
W1 sconsln
TOTAL
6,7
26.9
19.1
19.1
22.4
29.5
22.1
145.8
-------
FEB 2 4 !36j
-2-
legion VI
Reg Ional
Arkansas
loul slana
flew Mexico
Okl a horrj
Texa s
TOTAL
Region vil
«eg i cn a 1
Iowa
'.i l s: s
s::t •
c'l.'a ska
(Fed. Program)
•O ^ • '
I J i
4J
13.3
22.1
It.5
19. 5
18.2
ftfl. 7
3.1
22.2
1 3. 2
24. ?
67.7
Region X
Reg 1onal
Alaska
Idaho
Oegon
Wa sMngton
2.4
10.3
11.1
17.3
11.7
Region VHI
Regional 2.8
Colorado
(Fed. Program)
*V>ntana 13.1
ftorth Dakota 17.7
South Hakota lS.n
Utah 12.1
'Wyoming (no fed. S requested)
TOTAL
Reclcn IX
^3g •. oa 1
Ar i :c. 3
Ci' » fz rn i a
Ha wa"i
60.7
3.S
U.3
37.4
11.3
Nevada (No fed. S requested)
Guam
total
If). 4
76.S
total
total t~;m.
52.3
<51 3
-------
TABLE OF CONTENTS
FtFftA COOPERATIVE AGREEMENT PttOfiftAM fidibAhcE
REQUIRED -APPLICATION ELEMENTS'
Ability to Implement the Program 2
State Certifying Statements 2
Authority to Conduct the Proposed Program 2
Authority to Accept Federal Fihu^s 2
Designation of Lead Agency 2
Discussion of Perform'ance 3
Enforcement Management Plan Development 4
Defining State Program Objectives 4
Setting Priorities 4
Enforcement Work Program 7
Action PI an 7
Nonfunded Priority Program 8
Proposed Budget 9
Enforcement Conditions of the Cooperative Agreement 10
Quality Assurance & Procedures 10
Case Preparation and Enforcement- 12
State Records and Reports 14
oolicator Certification and Training Management
Plan Development 15
Defining State Program Objectives 15
Applicator Certification and Training Work Program 15
Action Plan 15
Program Budget 16
Applicator Certification and Training
Conditions of the Cooperative Agreement 16
State Reports 16
-------
EPA Application And awArd procedures
Summary of EPA Role 18
Hea dqua rters respons i bi1 i ty 18
Regional responsibility 18
Application Submission 19
Application Review 19
technical and Program Review 19
Admin istratlve Review 21
PROGRAM MANAGEMENT AND ACCOUNTABILITY
Accountability Under the Cooperative Agreement 22
Training 22
Regional Reporting 22
Program Evaluation 23
Mid-year Evaluation 23
E.nd-o f-year Evaluation 24
Evaluation Report 24
.Modification, Suspension, or Termination 24
Appendices: I through XV
-------
Introduct i on
Section 23 of the Federal Insecticide, Fungicide, and Rodent1c1de
Act authorizes the U.S. Environmental Protection Agency to enter
into cooperative agreements with the States and I ndl an. Tr1 bes
for pesticides enforcement and for applicator certification and
training. Regulations governing financial assistance to parti-
cipants 1n the cooperatlve pesticides enforcement and applicator
certification and training programs are found at 40 CFR Part
35.001 to 35.605. This guidance document, developed by the
Compliance Monitoring Staff (CMS) of the Office of Pesticides
and Toxic Substances (OPTS), supplements those regulations by
setting forth in detail the required elements of cooperative
agreement applications, the process of awarding financial assist-
ance and requirements for program management.
Financial assistance 1n the form of cooperative agreements for the
pesticides enforcement program 1s designed to support (a) Improved
coordination of a cooperative Federa1/State pesticides enforcement
program, (b) more efficient allocation of resources through
1nproved pi ann1ng and management, and (c) program review and
evaluation. The program which a State conducts under the cooper-
ative agreement should provide for pesticides enforcement that
satisfies both State and Federal pesticide laws. Areas of mutual
pesticides enforcement include use/misuse investigations, producer
establishment inspections, experimental use permit Inspections,
marketplace inspections, restricted use pesticide surveillance,
and applicator certification enforcement inspections.
Financial assistance 1n the form of cooperative agreements for
the pesticide applicator certification and training program is
designed to support (a) the pesticide applicator certifi cati on
and training program, (b) more efficient allocation of resources
through improved program planning and management and (c) Improved
program review and evaluation. The program conducted by the
State should provide pesticide applicator certification and
training to all persons who wish to use restricted use pesticides.
State work programs conducted under the cooperative agreement
will include an estimate of the number of applicators to be
certified or recertified by the State, the number of training
sessions to be monitored and the number or frequency of the
certification testing sessions.
In FY84 States are encouraged to consolidate their pesticides
enforcement and applicator certification and training cooperative
agreement applications. The consolidated cooperative agreement
process is voluntary. A State which chooses to follow this process
may develop a single application for separate financial assistance
programs that are administered by the same agency within the
State. Consolidating cooperative agreement applications does
not alter existing statutory requirements governing eli g1bi1i ty,
matching funds or malntainence of effort. Consolidating coopera-
tive agreement applications does eliminate duplicating similar
procedures In each Individual assistance application. The single
consolidated application will reduce excessive paperwork and
administrative costs.
-------
REQUIRED APPLICATION ELEMENTS
The formal application for assistance will consist of an
"Application for Federal Assistance", EPA Form No. 5700-33,
and shall include all elements outlined in this section. This
form contains a section entitled "Part IV Narrative Statement"
which the new 40 CFR Part 35.130 simplifies and replaces.
In addition to meeting the requirements contained In 40 CFR
Part 30, a complete assistance application must contain the
fo11owing element s:
o Ability to Implement the Program Including certifying
statements that the State program 1s consistent with
EPA-approved strategies and there are no Impediments to
the State's ability to carry out the program; designation
of a lead agency; and a discussion of the State's per-
formance to date under the existing award.
o State Program Management PI an detailing a 11st of program
oojectives and priori11es ; and a description of the process
through which the State Identifies priorities.
o Work Program specifylnq the work years and amount and
source of funding estimated to be needed for each program
element including any outputs required; a schedule for
accomplishment of outputs; and an identification of the
agency responsible for each of the elements and outputs.
o Conditions of the Cooperative Agreement containing a
statement that the State agrees to follow the quality
assurance, and case preparation and enforcement or
certification and training requirements.
-------
-2-
Ability to Implement the Program
State Certifying Statements
Each applicant must certify that there are no impediments to the
State's ability to carry out its proposed program or programs.
Applicants with continuing cooperative agreement programs are
not required to annually certify their ability to carry out the
proposed programs unless one or more of the areas described below
has changed. The applicant should address the areas described
below as well as any others which might pose problems.
Authority to Conduct the Proposed Program
A State must have enacted legislation which empowers it to:
o Enter into a cooperative agreement with EPA, and
o Conduct specific activities proposed under the
cooperative agreement or consolidated agreement.
Authority to Accept Federal Funds
A 3t a te which can only implement a program under a cooperative
agreement with prior authorization by its legislature to spend
Federal funds must include a statement indicating the date on
which such authorization will be obtained. Commitment of EPA
funds will be contingent upon such authorization by the State
1egi siature.
Designation of Lead Agency
Although several State agencies may be responsible for regulating
various aspects of pesticide manufacture, handling, and use, EPA
will enter into only one cooperative agreement with a State
for pesticide enforcement and only one cooperative agreement for
pesticide applicator certification and training.
The Governor of the State, through a letter to the Regional
office, should designate a separate lead agency which will be
responsible for each of the cooperative agreement programs or
a single lead Agency responsible for both programs under a
consolidated agreement. The designated lead agency(ies) must
have the authority to enter Into contracts or interagency agree-
ments with other agencies for the performance of all necessary
activities.
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Discussion of Performance
Each State 1s required to provide a discussion of progress under
Its current cooperative agreement. In this discussion the State
shall examine the appropriateness of Its established priorities
as well, as the quality and effectiveness of its compliance.moni-
toring and enforcement-actlvltiesv For,the applicator certifi-
cation and training program, .tha-State shall disucss the number
of training programs in which the State participated; the
number of training sessions monitored; the number of individuals
examined for certification, foau/ecert-i f 1 catl on ; the number of
certification sessions conducted, recertificat ion sessions
conducted; and any changes made to training materials.
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Enforcement Management Plan Development
Defining State Program Objectives
Each State should define objectives which support the achievement
of the national priorities, adjusted for the particular needs of
the State. Identification of specific State pesticide problem
areas is central to the task of developing the State objectives
(see Priority Setting, below).
State objectives may include management oriented objectives such
as improving planning of the enforcement program, achieving
greater compliance through increased compliance monitoring in
certain areas or improving the quality or availability of
compliance information.
Priority Setting
To attain its objectives, the State should establish enforcement
priorities that permit the most efficient use of resources and
personnel. The priority setting process will enable a State to
concentrate its training, compliance monitoring, and enforcement
programs on specific pesticide manufacturing, distribution, and
use activities which pose a risk to health or the environment.
Use or Product Related Priorities
As part of the process of setting general objectives for its
pesticides enforcement program, the State should identify specific
problem areas related to pesticide use, production, distribution
and disposal. To identify priority pesticide problems, the
State should develop a mechanism which analyzes information from
a variety of sources. The result of the State's analysis should
be a list of specific pesticide problems in the State. Following
is a discussion of basic elements which should be Involved in
the priority setting process.
Review of Information Sources
In establishing priorities, the States should consult as many
information sources as are reasonably accessible. The most
accessible Information source is likely to be a State's enforcement
and complaint files. These records should indicate trends in
certain use and non-use violations, and recurrence of violations
involving specific pesticide producing or distribution establish-
ments, pesticides or practices, as well as potential associations
between a pesticide or application practice and health or
environmental incidents.
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Information related to potential areas of priority concern would
ve found In State records on local pesticide production and dis-
ibution establishments, or pesticides and pesticide practices
jmmonly used In the State. The State may wish to consider
information concerning chemicals which pose more serious health
and environmental risks such as restricted use pesticides, emer-
gency or 'experimental use pesticides, and special local use
registrations as well as application methods most likely to
result 1n harm if Improperly carried out.
Finally, the State should identify and consider the concerns of
persons in the State who may be exposed to pesticides or otherwise
affected by the pesticides enforcement program. The EPA considers
a State effort to gain public participation 1n the planning
process to be an important element of the program. Each State
may use a variety of means to identify the concerns of the public
and involve them 1n the State planning process. The States, in
formulating their policy, may wish to use EPA's Public Participa-
tion Policy, January 19, 1981, 46 Fed. Reg. 5736, as a guide.
Establishing Priority Setting Criteria
Since States may have a large body of information to review and
analyze, each State should develop a set of criteria for use in
ranking problem areas. For use-related problems, these criteria
nay reflect such factors as the degree of actual or potential
ham to health or the environment and the degree of public concern.
'r oroduct/faci1ity related problems, violation history and
equency of past establishment inspections may be pertinent
c r i t e r i a.
Ranking of Specific Problems
Once the information has been reviewed and criteria have been
established for setting priorities, each State should develop
its list of priority problems. Using the selected criteria, the
State can develop a hierarchy of areas of priority concern. The
level of priority will provide a basis for the allocation of
resources 1n the State's Action Plan.
The above mentioned elements are general guidelines to be followed
by the States in developing priorities. .-The Compliance Monitoring
Staff (CMS) of the Office of Pesticides and Toxic Substances
(OPTS) has also developed documents outlining a step by step
approach for setting use and product/faci1ity related priorities.
(See Appendix I and addendum) Each State is free to follow these
models, to modify them, or to establish its own similarly objective
priority setting methodology.
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In any case, however, the State should include in its application
not only a listing of its general program objectives and specific
areas of priority concern, but also a discussion of the methodology
used to develop' and rank its priorities. All State priorities
should be as specific as possible, but must either be placed into
one of the following (fixed) broad types of pesticides problem
areas under each activilx for use-related priorities (See also
Appendix I p.29) or one..of the 5 broad types of pesticide problems
areas under each activity for product/facility-related priorities
(See also Addendum to Appendix I).
Use-related Priorities
Home/Yard Incidents
- Involving PCO's
- Involving homeowner's personal use of pesticides
Other Urban Incidents
Agricultural Incidents —
- Involving Aerial Application
- Involving Ground Application
- Mot Involving Application
•ion-Urban, Right-of-Way Incidents
- Involving Aerial Application
- Involving Ground Application
Woodland Incidents
Incidents at Other Sites
Product/Faci1ity-related Priorities
Violators within the State
Establishments not visited within the State
I nspected Establishments with no violations detected
Others (from Action Plan activity categories)
Educa t i ona1 Act i vi ty
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Enforcement Work Program
he Work Program must specify the workyears and the source of
funding for each program element, Including any outputs and an
Identification of the agency responsible for each of the elements
and outputs. (40 CFR Part 35.130)
Action Plan __
Once the State has developed Its list of priorities for both use-
related and product/facility-related priorities, 1t should describe
its plan for carrying out a balanced program that addresses each
of these areas during the agreement period. Outputs the State
proposes to accomplish during the agreement period must be aimed
primarily at solving and dealing with pesticide problems identified
by the priority setting process. However, the plan may also
include any other activities not identified by priority setting
such as responding to non-priority complaints provided these
activities relate to violations of FIFRA.
A pesticides enforcement program that consists of elements from
both State pesticide statutes and FIFRA should contain outputs
for the activity categories which are defined as follows:
Use/Misuse Inspection 1s a FIFRA or State inspection. FIFRA
use/mi sus'e inspections are conducted to discover violations
escribed in FIFRA Sections 12(a)(2)(F,& G). State use/misuse
nspections would be conducted under State statutes. A State or
Federal use inspection 1s an inspection identified under a neutral
or routine inspection scheme to monitor or observe the use of
pesticides. A State,of Federal misuse Inspection is an inspection
identified as a "for cause" Inspection such as a follow-up to a
complaint, referral or tip.
Monitoring the Certification Program 1s a FIFRA or State
1) inspection at pesticide dealers to "cTetermlne 1f Restricted
Use Pesticides are being sold 1n violation of FIFRA Section
12(a)(2)(F) or State statute; 2) inspection of applicators
to determine if they are properly licensed and maintaining
records.
Producer Establishment Inspection Is a FIFRA Inspection of an
establishment where pesticides or devices are held for distri-
bution or sale for the purpose of inspecting and obtaining
samples. While conducting pesticide producer establishment
inspections States should review product labels for compliance
with the Label Improvement Program (LIP). The Office of Pesti-
cide Programs (OPP) has issued guidelines for the upgrading of
pesticide product labels for several classes of pesticides as
well as replacing or modifying certain labeling requirements.
(See Appendix XI) The States should also inspect pesticide pro-
ducts that are subject to the Child Resistant Packaging (CRP)
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regulatlons issued by 0PP.1 CRP Inspections should be conductf
in accordance with enforcement strategy (See Appendix XII) and
the inspection guidelines previously issued by CMS.^
Marketplace Inspection is a FIFRA or State inspection at the
retail sale, distribution or wholesale level for determination
of product registration, labeling violations, or product decom-
position. Marketplace inspection samples must be samples of
unregistered products, products with violative labeling, pro-
ducts subject to decomposition, or products unavailable at
producer establishment inspections. States should give market-
place inspections a low level of priority unless product violation
rates and compliance ratios show that such inspections will
prevent significant harm.
Other Inspection is a FIFRA or State inspection. Under FIFRA
this would include custom blender and import inspections,
section 18 and 24(c) inspections etc. Under the State program,
this might include bulk tank sampling at repackaging establish-
ments, inspection of the calibration of application equipment,
etc.
Experimental Use Inspection is a FIFRA or State inspection to
monitor experimental use permits. Samples should only be
collected if a violation is suspected. Inspections must be
conducted on site; telephone inspections or nonitorings will no*
be credited under the cooperative
agreement.
Educational Activity is a State outreach or related activity
directed towards educating or providing additional inferna-
tion to consumers of pesticides or pesticide services designed
to increase compliance with State pesticide laws and FiFRA.
Nonfunded Priority Program
The Agency is aware that not all States' pesticide priority
problems are addressed in the Federal cooperative agreement.
Some States' current pesticide programs may already address
pesticide problems identified through priority setting. In
such cases, States are requested to provide this information as
a supplement to their cooperative agreement applications so that
EPA will have a complete picture of how a State is addressing
all its pesticide problems. This will aid the Regions in
evaluating the State's application.
40 C F R Part 16 2.16 Final Rule for Child Resistant Packaging,
March 19, 1979, FR Notice pages 13019 through 13024.
2 CRP Inspection Guidelines issued by A. E. Conroy II, dated
March 29, 1982.
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Proposed Budget
Each application must contain the State's proposed budget for
the program. Expenditures for personnel, fringe benefits, travel,
equipment, and supplies must be supported by Itemized statements
or fact sheets detailing their necessity.
When funding act1v1t1ies under Vfri s agreement, EPA will give
priority to ongoing operating expenses that are directly related
to the enforcement of pesticide law, e.g., Inspections, Invest-
igations, sample analyses, and^ravel.
EPA's share of the "total project cost" should not exceed 85% of
the total award. The State's sirare may be paid 1n direct or
allowable indirect or 1n-kind contributions.
The application must also contain a summary of work hours or
work years devoted to each of the following activity categories:
Administration, Supervisory, Inspectional (non-pr1or1ty and
priority, broken down by specific use-related and product/faci1ity-
related activities as identified under priority setting for the
State), Analytical, Analytical Support, Clerical and Legal.
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Enforcement Conditions of the Cooperative Agreement
Pesticides enforcement cooperative agreement awards are subject
to the regulations found at 40 CFR Part 35.001 through 35.605,
entitled "State and Local Assistance", as well as the "EPA General
Grant Regulations and Procedures" (40 CFR Part 30). In addition,
the applicant must agree to the conditions described below before
obtaining an award.
Quality Assurance & Procedures
Quality Assurance Plan
For FY84 States are required by the EPA Grants Administration
Division (GAD) to include quality assurance plans for analytical
laboratories under the cooperative agreement; All analytical
laboratories involved in environmental monitoring must have
submitted a quality assurance plan within 90 days of award of the
F Y 34 cooperative agreements. To assist States in complying with
this requirement, CMS has developed model quality assurance
guidelines. The States nay use these guidelines or develop
their own. Each Region has an individual assigned as quality
assurance officer and that person will be available to assist'
the State in development of a quality assurance program,
(see Appendix XIII)
FIFSA Forms and Procedures. During all inspections and sample
collections performed under the authority of FIFRA, inspectors
shall use standard forms and procedures as outlined in the EPA
Pesticides Inspection Manual. To assure sample integrity, EPA
chain-of-custody procedures shall be adopted during sampling,
handling, shipping, storage, and analysis of pesticides collected
under Federal law.
State Forms and Procedures. During all inspections, observations,
and sample collections performed under authority of State law,
State procedures and forms should be used. During sampling,
handling, shipping, storage and analysis of pesticides collected
under State law, State chain-of-custody procedures should be
fo11 owed.
Referral and Inspection Procedures under FIFRA $26. Under the
Final Interpretive Rule governing FIFRA Sections 26 and 27 (40
CFR Part 173), EPA and each State will annually define significant
cases to be tracked by EPA after referral to the State.
(FIFRA State Primary Enforcement Responsibilities, Final Inter-
pretive Rule, J a n u a ry 5, 1983, 48 FR Notice pages 404-411)
After EPA formally refers a significant case to a State, the Agency
will contact the State to learn the results of the investigation.
The Region should determine whether the State has conducted an
adequate investigation. An investigation should be considered
adequate if the State has 1) followed proper sampling and other
evidence gathering techniques, 2)responded expeditiously to the
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referral, and 3)documented all Inculpatory or exculpatory events
Information. If the Region cannot negotiate an adequate
testlgatlon with the State, the Region may pursue Its own
vestigatlon after notice to the State. That notice should
summarize the facts relating to the State Investigation, discuss
the reasons for EPA's determination that the action 1s Inadequate,
and state that the EPA will Initiate Its own Investigation.
Analytical Methods. Pesticide samples collected shall be analyzed
by tne State laboratory, or other laboratories specified in the
agreement, using the EPA Manual of Chemical Methods for Pesticides,
Association Of Analytical Chemists (AOAC), The State laboratory
may use the Collaborative International Pesticides Analytical
Council Limited (CIPAC) Handbook, the FDA -Pest 1 clde Analytica 1
Manual (PAM), or other approved analytical methods for sample
analysis. All violative samples shall be verified by a check
analysis performed by a second chemist.
Cross Contamination Screening. States shall establish a cross
contami nation screening program in accordance with EPA Cross
Contamination Guidelines. (See revised Appendix III.)
Check Sample. The State shall participate 1n the EPA (NEIC)
Check Sample Program. Under this program, EPA submits known
pesticide samples to State laboratories for analysis and cross
contamination screening. The States will submit a report
indicating the methodology used and results of the analysis to
A. EPA will review the report and inform the States regarding
¦ i accuracy of their analysis and the methodology selected. If
State failed to obtain the correct results, EPA will assess
the problem and provide assistance to the State laboratory, if
requested. This program also,assists in determining if the States
are screening pesticides for cross contamination., since the
check sample may be contaminated with another pesticide.
Check Analysis Procedure. The State shall participate in the
Sample Check Analysis Procedure. A check analysis is a second
analysis of a sample originally analyzed by a State laboratory.
It 1s usually done when:
o A State which 1s unsure of the results of an analysis
requests an impartial.or second analysts before
initiating an enforcement action.
o A State requests that EPA take the enforcement action
and EPA desires to check the State's analysis.
Samples in these instances would be sent to either another State
laboratory or EPA for a check analysis.
Training of Analytical Chemists. EPA will provide knowledgeable
personnel for the training of analytical chemists. The States
ould avail themselves of EPA courses offering training to
mists on proper analytical procedures, instrumentation, and
hodology. Personnel from EPA are available, if requested, to
review State laboratories and discuss areas of Improvement.
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States are also encouraged to participate on their own in profes-
sional association meetings such as those held by AO'AC, as well
as other professional training courses.
Provision of Analysis Results. The State shall send a copy of
the results o? any sample.analysis made under the authority of
FIFRA to the person from whom the sample was collected.
Submission/RetentionofReports. Copies of all inspectional and
analytical reports shall be retained by the State for examination
by EPA or forwarded to the Regional office.
Training of Case Preparation Officers and Inspectors. EPA will
provide for the training of State case preparation officers,
attorneys and inspectors.
Speci a 1 Projects. The EPA/National Environmental Investigation
Center ( N E IC) wTT 1 provide, on a limited basis, investigation
and laboratory support for special State pesticide problems
such as:
o Affirmative compliance monitoring of major pesticide
spray programs; and
o Response to pesticide incidents for which States did
not include resources in the cooperative agreement
application.^
r
ase Preparation and Enforcement
The State shall review the quality and adequacy of evidence
gathered in the course of all investigatory activities performed
under the cooperative agreement. For misuse cases, the States
could establish a committee to review inspectors' findings and
determine if any violations of State or Federal law exist. This
committee would provide the States with an objective enforcement
framework for all misuse cases.
State Cases
The State must review the quality and sufficiency of evidence
gathered in the course of all investigative activities performed
under the cooperative agreement.
If the evidence reveals a violation of only the State's pesticide
laws, the State shall pursue an appropriate remedy provided by
State law.
^ A1 1 special projects ass i stance request s shall b~i submi tted
to the appropriate Regional Office as soon as the State
determines a need for such assistance. EPA Headquarters in
conjunction with the Regions wiTl evaluate each request based
on the seriousness of the problem and the amount of EPA resources
a va i 1 a b 1 e .
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If evidence reveals a violation of both State and Federal law,
the state may bring appropriate enforcement action under State
law or refer the case to EPA for action under FIFRA. In the event
that a case 1s referred to EPA for action, the Agency -case
preparation officer should review the case file to ensure that
the State inspection procedures adhere to basic constitutional
guarantees. If the State evidence gathered, by State Inspectors
was legally obtained and Is within the scope of admissible evidence,
EPA should proceed with the case.
Since States with cooperative agreements have primary enforcement
respons1b111ty for pesticide use violations, the Regions and States
should follow the Final Interpretive Rule governing Sections 26
and 2 7.(48FR pages 404-411 ^ January 5, 1983)
Under the Final Interpretive Rule [governing FIFRA Sections 26 and
27 (40 CFR Part 173)], EPA and each State will annually define
significant cases to be tracked by EPA after referral to the State.
The State must commence appropriate enforcement action for cases
tracked under the Interpretive Rule within 30 days after completion
of the investigation. The Region may, after negotiation with
the State, extend this period, if required by the procedural
characteristics of the State's regulatory structure.
If the Region determines that the State's intended enforcement
response to the violation is inappropriate, EPA should first
attempt to negotiate an appropriate State enforcement response.
If a State is unwilling or unable to alter its original enforce-
ment response, EPA may bringits own action after notice to the
State. That notice should summarize the facts relating to the
State's enforcement response, discuss reasons for EPA's determin-
ation that the enforcement action 1s inadequate and state that
EPA will initiate its own enforcement action. (See the Final
Interpretive Rule governing Sections 26 and 27, 48FR pages 404-411,
January 5, 1983, Section 5B for criteria) Regional attorneys
should not, however, initiate an enforcement action sooner than
30 days after the matter was referred to the State.
For all pesticide cases, if a State feels that the most appropriate
enforcement action 1s not available under State law, It may
refer the case to EPA for enforcement under FIFRA.
Federal Cases
Where evidence reveals a possible violation of Federal law only,
the State shall immediately forward the information to the EPA
Regional office and prepare testimony and provide witnesses as
necessary.
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State Records and Reports
Semi-Annual Reports
The State should submit semi-annual reports to the Regional Office
within 15 working days after the end of the second and fourth
quarters. Each report should compare actual accomplishments
with the projections as specified in the cooperative agreement.
Records of Enforcement Actions
The State should maintain records regarding enforcement actions.
These records should include the type of violation, who was
involved (e.g. applicator, producer, homeowner), certification
status of the applicator, name of the pesticide, application
site and method, compliance history of the violator, and the
type of enforcement action taken. This information will be
used in developing the State's future enforcement priorities.
EPA Report of Enforcement Actions
EPA shall furnish the State with copies of all enforcement actions
taken as a result of inspections conducted by the State and
referred to EPA for action. This information will be useful to
the State in future priority setting.
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Appllcator Certification and Training Management Plan Development
Defining State Program Objectives
The States should define objectives which support the achievement
of the national goa.l of tra/iping applicators 1n the safe handling
and use of pesticides, especially restricted use pesticides.
State objectives may include management oriented objectives such
as: 1) improvlng, p1ann1ng of the certification program; and 2)
recommending areas of addlSYbnal training because of use problems
encountered through -tb« pesticides enforcement cooperative agree-
ment or to provide applicators with information regarding the
Impact of other Federal statutes on applicators.
Applicator Certification and Training Work Program
The work program must specify the work years and amount and
source of funding estimated to be needed for each program element
including any outputs required, a schedule for accomplishment of
outputs and an identification of the agency responsible for each
of the elements and outputs (40 CFR Part 35.130).
Action Plan
Once the State has identified its program objectives, It nest
describe its plan for carrying out a balanced program that addresses
each of the program objectives under the agreement.
A pesticide applicator certification and training program that
meets the requirements of both State pesticide statutes and
FIFRA should contain at least the following elements/outputs.
o Number of training sessions 1n which the State will
part 1e1pate.4
o Number of training sessions which the State will monitor,
o Number of Individuals to be examined for certification,
o Number of applicators to be examined for recertlf1 cation.
o Number of certification sessions the State will conduct,
o Number of recertification sessions the State will conduct,
o Any changes the State will make to training materials.
4 EPA Region VII has developed a training slide and tape presentation
on how disposal of pesticide wastes and used pesticide containers
by applicators 1s regulated under the Resource Conservation and
Recovery Act (RCRA). This presentation can be obtained for State
training sessions by contacting Roger Gold, Ph.d., University of
•Nebraska, Institute of Agriculture and Natural Resources, 101 Former
Vet Science Building, East Campus, Lincoln, Nebraska 68583.
Additional training slide and tape presentations can be obtained
for State training sess1ons by contacting Dr. James Parochetti,
Program Leader -- Pesticides, Applicator Training and Weed Science,
U. S. Department of Agriculture, Extension Service, Washington,
0. C. 20250
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These outputs should be listed separately for private applicators
and for commercial applicators. For commercial applicators, the
outputs should be broken down by certification category as well.
Proposed Budget
Each application must contain the State's proposed budget for
the program. Expenditures for personnel, fringe benefits, travel,
equipment, and supplies must be supported by itemized statements
or fact sheets detailing their necessity.
The EPA's share of the "total project cost" shall not exceed,-
50% of the total award. The State's share may be paid in direct
or allowable indirect or in-kind contributions.
Applicator Certification and Training
Conditions of the Cooperative Agreement
Pesticide applicator certification and training cooperative
agreement awards are subject to the regulations found at 40 CFR
Part 35.001 through 35.605, entitled State and Local Assistance,
as will as the EPA General Grant Regulations and Procedures (40
CFR Part 30). In addition the applicant must agree to the
conditions described below before obtaining an award.
State Reports
The States will submit a semi-annual report corresponding to
the project and budget period of the cooperative agreement.
This semi-annual report must be submitted within 30 days after
the end of the second and fourth quarters of the Cooperative
Agreement outputs and will include:
1. The total number of applicators, private and commercial,
by category, currently certified.
2. The number of applicators, private and commercial, by
category, certified during the last reporting period.
3. The nunber of applicators, private and commercial, by
category, recertified during the last reporting period.
The States are required to submit an annual report corresponding
to the project and budget period of the cooperative agreement.
This annual report for both the State plan and Cooperative
Agreement outputs will include:
1. The total number of applicators, private and commercial,
by category, currently certified.
2. The number of applicators, private and commercial, by
category, certified during the last reporting period.
3. The number of applicators, private and commercial, by
category, recertified during the last reporting period.
4. Any changes in commercial applicator subcategories.
^ Certification and Training Program Directive #81-2 issued by
A. E. Conrov II, dated 9-10-81.
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5. A summary of enforcement activities related to use of
restricted use pesticides during the last reporting period.
6. Any significant proposed changes 1n required standards of
competency.
7. Proposed changes in plans and procedures for enforcement
activities related to use of restricted use pesticides for
the next reporting period.
8. Any other proposed changes from the State plan that would
significantly affect the State certification program.2
The States nay combine the Annual FI.FRA §4 State Plan report
and the final report of outputs accomplished under the cooperative
agreement, since the first three reported Items under the State
Plan annual report are Identical to the outputs reported under
the cooperative agreement.
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EPA APPLICATION AND AWARD PROCEDURES
Summary of EPA Role
EPA Headquarters has the primary responsibility for:
o Developing national priorities and strategies for
the pesticides enforcement program and applicator
certification and training program;
o Preparing guidance for implementing and managing
the programs;
o Making funds available to the Regions for
disbursement to t+fe~€t ates ;
o Providing a special review of applications
upon written request from the Regional offices; and
o Developing laboratory support for State personnel.
EPA Regional Offices have primary responsibility for:
o Providing applicants with annual guidance and
application criteria to be used in awarding
cooperative agreements;
o Notifying eligible State agencies of the availability
of funds;
o Working closely with the States to develop a
complementary Federal/State program which considers
State as well as EPA priorities and resources;
o Negotiating outputs with applicants;
o Reviewing and approving applications;
o Developing training for State personnel; and
o Conducting Mid-year and End-of-year program
eva1uat1ons.
Each participating Region should establish a cooperative agreement
Review Panel to review and evaluate all pesticides enforcement and
applicator certification and training cooperative agreement
applications. This panel should consist of at least one member
from each of the following offices:
o Regional Air and Waste Management Division/or
Waste Management Division
o Regional Grants Administration Office, and
o CMS {Grants and Evaluation Group).
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Application Submission
To apply for a cooperative agreement under FIFRA, a State must
submit an "Application for Federal Assistance", EPA Form No.
5700-33 complete with all elements required by the guidance.
(See Appendix V)
Applications must be submitted at least 60 days prior to the
beginning of the budget period. (40 CFR Part 35.140)
Application Review
The Reg1onal Adm1nistrator w111 review each completed cooperative
agreement application and should approve, conditionally approve,
or disapprove the application within 60 days of receipt. (40 CFR
Part 35.141)
The Agency will allocate funding for cooperative agreements on
the basis of the appropriateness of the State's program plan
when compared to the criteria set forth 1n the Required Application
Elements section of this guidance and the State and Local Assistance
regulations. (40 CFR Part 35.001 through 35.605)
Each application will be subject to two reviews:
Technical and Program Review
A technical and program review will be made by the Cooperative
Agreement Review Panel to determine the merit of the proposed
outputs In view of the objectives and priorities of the cooperative
pesticides enforcement program and applicator certification and
training program. For the pesticides enforcement cooperative
agreement applications, CMS has developed a form for use by the
review panel 1n determining answers to basic evaluation questions.
(See Appendi x VI. )
CMS has also developed Output Time Factors for use 1n evaluating
pesticides enforcement cooperative agreement applications for
financial assistance. The following time factors were obtained
by averaging figures submitted to CMS by the States:
o T-echnical and Program Review; and
o Administrative Review.
Act 1 vl ty
Work Hours to
Complete Act1v1tv
Agricultural Use Inspection
Non-agr1cultural Use Inspection
Experimental Use Inspection
Producer Establishment Inspection
Marketplace Inspection
20
20
15
15
5
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Act i vi ty
Impo rt in spec ti on
Dealer Record Inspection
Work Hours to
CompleteActivity
nr
5
5
5
11
Applicator License and Record Inspection
Sample Collection and Preparation
Sample Analysis (Formulation and Residue)
These figures take into account all inspectional or analytical
time spent to complete an activity, including supervisory time,
travel tlnie, document preparation, sample shipment, etc. The
work hours given also include the prorated time for administrative
activities of inspectors and chemists. Additional time for
administrative, case preparation, legal, clerical, and program
planning activities time may be charged if the State can show
that such activities are prerequisites to conducting the program.
The Regional office should compare each State's proposed outputs
and the personnel requested in the pesticides enforcement cooper-
ative agreement application with the work years computed by
using the output time factors amounts shown above. The purpose
of these computations is to determine if the State's requested
work hour levels (or work years) for inspectional and analytical
outputs are consistent with the work hours computed for each
activity using the above output time factors. An Output Time
Factors Computations Worksheet has been developed to assist the
Regions in this comparison. (See Appendix VII.)
he Regions should use these time factors as a guide in negotiating
and evaluating pesticides enforcement cooperative agreement
applications. The number of inspections, samples, and analyses
multiplied by the appropriate time factors should equal the
approximate number of work hours which each State requested to
complete the projected outputs under the cooperative agreement.
To ensure equal treatment of all States, CMS has identified a
normal work year as consisting of 1800 hours after allowing for
leave and ho 1i days.
Deviations from these time factors can be expected due to differ-
ences in travel time, local procedures, etc. However, the Regions
should not permit work hours grossly in excess of these computed
levels. Significant differences between the amount requested
and the amount computed must be justified, e.g., the need for
extensive travel time. If an applicant's commit ments are in
excess of those indicated by the computations, the Regional
Office must assure itself that the quality of work is not suf-
fering at the expense of the quantity of outputs.
The Review Panel will evaluate both pesticides enforcement and
applicator certification and training cooperative agreement
applications to determine whether:
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-21-
o The application contains all elements outlined In
the Required Application Elements section of this-
guidance;
o The applicant's priority-setting process is adequate;
(for pesticides enforcement agreements only)
o The outputs are appropriate based on the priorities
or objectives set—by the Stat^;
o The applicant's ob jectl ves <-w*d expected results are
consistent and compatible with EPA priorities
and policies; and
o It Is feaslbile to achleve^uch objectives In view of
the State's existing problems, program authority, and
resources.
Administrative Review
The Regional Grants Administration Office will perform an
adninistratlve evaluation to determine whether the application
meets the requirements of the EPA General Grant Regulations (40
CFR Part 30) and regulations for State and Local Assistance (40
CFR Part 35.001 through 35.605 Appendix VIII). At each stage of
tne evaluation, the State may be required to provide further
information or to amend the application to satisfy the concerns
of the Agency.
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22-
PROGRAM MANAGEMENT AND ACCOUNTABILITY
After award of the cooperative agreements, both States and the
Regions will have program management responsibilities in the
areas of accountability, training, reporting, evaluation and
agreement modification.
Accountability under the Cooperative Agreement ~
States must maintain accounting records for funds awarded under
each agreement (including receipts,-State matching contributions,
and expenditures) in accordance with all applicable EPA grant
regulations and with generally accepted accounting principles.
Headquarters suggests that the Regional Grants Administration
Office review State accounting practices and procedures prior to
award of funding to assure the State's ability to maintain
appropriate records.
State expenditures under the agreement must follow cost categories
(i.e., budget line item or program elements) established in the
original agreement. Deviations may be made by the State from the
proposed budget as long as they are in accordance with the general
grant regulations or approved by the EPA Regional project officer.
Training
Training under the pesticides enforcement program will be conducted
by the EPA Regional Office with support from EPA Headquarters.
Training will consist of instruction in inspectional and sample
collection techniques, sample analysis, and case preparation, in
both classroom and on-the-job form. The cooperative agreement
should contain a schedule for conducting training activities
agreed upon by EPA Regions, Headquarters or NEIC and the State.
Regional Reporting
The Regions must forward copies of all agreement applications
and all mid-year, and/or annual reports to CMS for review.
CMS should also be kept informed of any problem areas or
serious deficiencies that develop within a State program.
The Regions must also enter into the FIFRA And TSCA Enforcement
System (FATES) all State enforcement and certification and
training projections from the completed cooperative agreement
applications, as well as mid-year, if appropriate, and end-of-year
accomplishments. The Regions must enter this data into FATES
within 30 working days after the award of the cooperative agreement
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-23-
and within 30 working days of the end of the second and fourth
quarters. For certlf1cation.and training cooperative agreements
data must be entered within 30 working days after the award of
the agreement and within 30 working days of the end of the forth
quarter. (See attachment X)
The Regions are responsible for reporting to the Administrator
data from the State applications and reports for the following:
(See attachment XIV)
o Indicators for Environmental Results
o Administrators Accountability System
o Environmental Management Report
Program Evaluation
Program evaluation by EPA is an essential ingredient of the
management of the cooperative agreement program. Regional
personnel must meet with appropriate State officials on a semi-
annual basis to conduct mid-year and end-of-year evaluations of
the cooperative programs. Mid-year and end-of-year evaluations
must be conducted within 30 days following the end of the quarter.
The Compliance Monitoring Staff (CMS) of- the Office of Pesticides
and Toxic Substances (OPTS) developed an evaluation protocol for
use by the Regions in evaluating State programs. CMS developed
the protocol to standardize the Regional evaluation reports of
State programs. The Regions shall use the evaluation protocol
for all State FIFRA enforcement and pesticide applicator certi-
fication and training cooperative agreement end-of-year evalua-
tions. (See Appendix IX.)
Mid-year Evaluations
At mid-year, the Regions shall conduct a general review of each
State's outputs and accounting procedures. During the general
review, evaluators should, where appropriate:
o Compare actual accomplishments with output commitments;
o Review selected sample collection documents. Inspection
reports, Investigation reports, and results of sample
analyses for accuracy and quality, and review
appropriateness of enforcement actions;
o Review, with State accounting personnel, the following
accounting Information:
a. Employee time and attendance reports;
b. Records for one-time non-expendable property
expenditures;
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-24-
c. Estimate, (excluding one-time non-expendable
property expenditures), of the amount of funds
expected to be remaining at the end of budget
period.
If the review i ndi cat e-s-areas for improvement or change, the
Region is expected to sf.fer the State suggestions and guidance
1n those areas.
End-of-year Evaluations
The scope of the program evaluation conducted by the Region at
the end of the year will differ from that of the mid-year evalua-
tion. The end-of-year evaluation will be an in-depth qualitative
review of the Federa1/State cooperative enforcement program and
the pesticide applicator certification training program.
The Regions shall use the evaluation protocol, found in Appendix
IX, to conduct all cooperative agreement program end-of-year
evaluations.
When conducting an evaluation using the protocol, the Regions
shall answer all questions. The Regions can fill out certain
parts of the protocol in advance from the application and quarterly
reports; other parts must be completed during the on-site visit
in the State. The Regions should plan on a minimum of three
days to conduct the on-site evaluation in the State.
Evaluation Reports
The Regional office shall prepare a written report of each evaluation
and send a copy to the State within 20 working days of completion
of the on-site evaluation. If the evaluation protocol is completed
properly, it could serve as the basis of the evalution report.
The report should Include a discussion of suggested program
improvements. The State shall be allowed 15 working days from
the date of receipt of the report to comment on the findings
contained in the evaluation report. The Regions shall send a '
copy of the Regional evaluation report and the State's response
to Headquarters.
Evaluations of both the pesticides enforcement and the applicator
certification and training agreements are especially important
in FY84 because State applications for continuing assistance must
contain a discussion of their performance under the existing award.
(40 CFR Part 35.140) Funding levels for the next cooperative
agreement project period could be affected if a State's performance
is less than satisfactory.
Modification, Suspension, or Termination of the Agreement
The provisions and funding of the agreement must be modified by
EPA and the State if 1t is found that actual accomplishments
differ s gnificantly from the planned accomplishments. These
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-25-
changes may Include, but are not limited to, changes 1n the
outputs, changes in the date of performance for specific outputs,
or changes 1n the budget for the period of the agreement. Changes
1n the agreement are effective only upon the execution of a
written amendment. If performance by the State does not Improve
after modification of the agreement, steps may be taken by EPA
to suspend or terminate the agreement.
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APPENDICES
TABLE OF CONTENTS
Appendix I
Appendix II
Appendix III
Appendix IV
Appendix V
Appendix VI
Appendix VII
Ranking Procedure to Establish Pesticide Enforcement
Priorities And Allocate Enforcement Resources
(revised 1/83)
Deleted
Contaminant Scae«-n1ng Guidelines (revised / )
Deleted
EPA Application for Federal Assistance - EPA Form
5700-33~(Revised 1/83 to Include examples for
completing form to apply for a consolidated
cooperative agreement.)
Pesticides Enforcement Cooperative Agreement
Application Technical Review Form
Output Time Factors Computations Worksheet
(Revised 1/83)
Appendix VIII Revised 40 CFR Part 35.001 - 35.605 Subpart A,
EPA regulations governing State and Local Assistance
(Replaces 40 CFR Part 35.750 - 35.786)
Appendi x
Appendix
Appendix XI
IX Evaluation Protocol
X Pesticides Enforcement Cooperative Agreement and
Applicator Certification and Training Output
Projections and Accomplishments Forms for Input
into FATES (Revised 1/83)
Label Improvement Program (LIP):
Dec. 4, 1980 letter from H. Harrison re: LIP
with attachments: PR Notice 80-1, Storage
and Disposal Statements and Sample Label.
PR Notice 80-2 re. deletion of Salt Water Emesls
Term1t1c1des Label Improvement Program
Ant1-foul1ng Paints Label Improvement Program
Funlgants Label Improvement Program
Appendix XII CMS Strategy for the Enforcement of CRP from
A. E. Conroy II dated June 8, 1981 and the
OPP listing of product types subject to CRP from
Reto Engler, Chief Disinfectants Branch dated 2-26-81
Appendix XIII Model Quality Assurance Project Plan for State
Pesticide Laboratories from A.E. Conroy II,
dated 12/14/82.
Appendix XIV Developing Indicators for Env1ronmenta1 Results
memorandum from T.E. Hunt dated 9/28/82.
Appendix XV Final Interpretive Rule governing FIFRA §26 & 27
(48 FEDERAL REGISTER, Pages 404-411, jan. 5, 1983)
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^tosr%
*1 PRO4*-
UNITEO STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MEMORANDUM
('
r
&
/=-/Fnu^
>^33
¦4j*.
DEC 4 1990
OFFICE OF
PESTICIDES AND TOXIC
SUBSTANCES
SUBJECT: Guidance to Regions on FIFRA Fund Resource Trackint
FROM:
TO:
Connie A. Musgrove, Acting Direct
Office of Compliance Monitorin
Regional Division Directors
Regional Financial Management Personnel
The purpose of this memorandum is to establish programmatic and financial
management guidance for the use of the Federal Insecticide, Fungicide ..and
Rodenticide Act (FIFRA) .revolving funds by Regions. The attached procedures
provide in-depth, specific programmatic and financial guidance which your staff
should follow when using FIFRA revolving funds. We expect careful scrutiny r;of'
our usage of FIFRA revolving funds and it is essential that we conform at all
levels with the procedures.
Congress authorized the collection of industry fees in the 1988 Amendments
to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA 88) to
supplement base appropriated resources for the reregistrati on program and
dircci-ly related enforcement. These fees are deposited in a revolving Fund
(FIFRA Fund) which may only be used for activities which support reregistration
and expedited processing programs.
At present, Regional FIFRA Fund resources include 12 FTE and associated
Salaries and Expenses (S&E) Funding for enforcing the reregistration provisions
of FIFRA 88 which will be provided through the Operating Plan process as part
of individual Regional allowances. The allocation among Regions of these FTE
was determined at the March 1990 Seattle Regional Division Directors' meeting.
Contract/extramural funding for Regions, if made available in the future by the
Office of Management and Budget (0MB) are intended to be used to establish links
with the Headquarters compliance data base tracking the suspended and cancelled
pesticides. These funds will be placed in a reserve account and transferred as
needed to individual Regions through the Office of Compliance Monitoring (OCM).
Specific procedures for applying for these funds will be provided at a later date
since at this time their availability is unknown.
If you have any questions about the use of FIFRA Fund FTE and resources,
please contact Sherry Sterling at FTS 382-5567 if it concerns the programmatic
activities of FIFRA Fund resources or Roberta Miller at FTE -382-7691 if it
concerns financial management. r_2 ^
cc: Tina Parker 2^
Kathleen Knox
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Office of Pesticides and Toxic Substances
Regional Operating Procedures
for Using FIFRA'88 Revolving Funds
Summary
General
o The procedures contained in this document pertain to the use of FIFRA Fund
resources by Regions. These resources are provided to Regions as part of the
1988 Amendments to FIFRA to supplement base appropriated funds, and may only
be used for activities which support compliance and enforcement of the
reregistration and expedited registration program.
o Base funds must be used if there is doubt that the intramural or extramural
funding action is eligible for the FIFRA Fund.
o Each intramural or extramural funding action that uses the FIFRA Fund must
be supported by a justification explaining the eligibility for use of FIFRA
Fund resources. Examples are attached.
o Use of FIFRA Fund resources will receive intense scrutiny. You should expect
to be audited at any time and retain all records and justifications.
FTE
o Due to the small number of resources provided, Regions may, for purposes for
accounting convenience, assi-gn personnel to a fixed FIFRA Fund account
although that individual's time may not be 100% devoted to FIFRA Fund
activities. However, the total FIFRA Fund FTE utilized by the Region must
actually reflect the amount of time spent by all individuals on Fund-eligible
activities up to the FTE ceiling. You may use CPARS or payroll
redistributions to keep this in balance. The FIFRA Fund FTE ceiling may not
be exceeded.
1
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Office of Pesticides and Toxic Substances
Regional Operating Procedures
for Using FIFRA'88 Revolving Funds
Purpose
These procedures establish guidance for use of reregistrati on and expedited
processing revolving fund resources to support eligible Regional compliance and
enforcement activities. This fund will be called the FIFRA revolving funds
(FIFRA Fund) in these operating procedures. Congress authorized the collection
of industry fees in the 1988 Amendments to the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA 88) to supplement base appropriated resources for the
reregistration program and directly related enforcement. Revolving Fund
resources may only be used for compliance and enforcement activities which
directly support reregistration and expedited processing programs. These will
be referred to as Fund eligible activities. It is the policy of OPTS to manage
the reregistration and expedited registration fund resources in accordance with
the requirements of FIFRA 88 and proper financial management practices, as
described in these operating procedures.
Scope
The procedures in this document are applicable to the use of FIFRA Fund
compliance and enforcement resources by Regional Offices.
Background
On October 25, 1988, FIFRA 88 was signed into law. The amendments require
a substantial acceleration of the reregistration process for previously
registered pesticides, and the expedited processing of product applications that
are similar to pesticides already registered with EPA. To help pay for these
efforts, Congress authorized the collection of two kinds of fees to be paid by
the pesticide industry: an annual fee for registration maintenance to be paid
for each registered product; and a reregistration fee for each active ingredient.
These funds are deposited to the reregistration and expedited processing
revolving fund (FIFRA Fund), and are to supplement base resources for these
programs which are appropriated annually by Congress.
2
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Legislative Authority
The applicable requirements of FIFRA 88 concerning revolving fund resources
are contained in the following subsections of section 4:
Section 4 (k) Reregistration and Expedited Processing Fund
¦ (1) Establishment - There shall be established in the Treasury of the United
States a reregistration and expedited processing fund.
(2) Source and Use - All fees collected by the Administrator . . . shall
be deposited in the Fund. . .
(3) Expedited processing of Similar Applications
(A) The Administrator shall use each fiscal year not more than $2,000,000
of the amounts in the Fund to obtain sufficient personnel and
resources to assure the expedited processing and review of any
application that
(i) proposes the initial or amended registration of an end-use
pesticide that, if registered as proposed, would be identical or
substantially similar. . .
(5) Accounting - The Administrator shall
(A) provide an annual accounting of the fees collected and disbursed
from the Fund; and
(B) take all steps necessary to ensure that expenditures from such fund
are used only to carry out this section.
Regional Reregistration and Expedited Processing Enforcement Activities
Regional compliance and enforcement program activities that implement the
following sections of FIFRA 88 shall be considered eligible for FIFRA Fund
resources:
o Products cancelled or suspended as the result of FIFRA reregistration reviews.
Section 4(i)(5) of FIFRA 88 required the payment of annual pesticide
registration fees by March 1 of each year to maintain registrations. During
the first fee collection period ending March 1, 1989, there were approximately
13,500 products registered under section 3 and approximately 6,000 products
registered under section 24(c) for which registrants did not pay the required
fee. Cancellation orders were issued to cancel the majority of the unpaid
registrations.
3
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Specific section 4(i)(5) activities include:
— Prior to establishment inspections, check production records to see if
any cancelled products have been produced since cancellation;
During routine inspections, Issue Stop Sale, Use and Removal orders
(SSURO) an all cancelled products found at producing establishments
after cancellation;
~ Check all notices of arrival for imports against the listing of
cancelled products before releasing such products.
o Products recalled as the result of a suspension or cancellation action.
Section 19 allows for the Administrator to recall any pesticides that have
been suspended and cancelled, when it is necessary to protect human health
and the environment. FIFRA 88 activities include monitoring compliance with
the provisions any recalls, whether voluntary or mandatory. This may include
inspection of storage and disposal facilities to ensure compliance.
Specific activities include:
-- Identify and locate the universe of persons affected by the rules or
orders;
— Coordinate activities with Regional/State CERCLA/RCRA offices;
— Coordinate with OPP/Disposal Office on disposal issues;
— Monitor compliance with requirements of the recall order.
o Notices for stored pesticides with cancelled or suspended registrations.
Section 6(g) generally requires that anyone holding a pesticide which has
had its registration suspended or cancelled must notify EPA and State and
local officials of this possession, the quantity and place where it is stored.
The requirements of the reporting will be specified in the cancellation or
suspension order and will therefore vary according to the individual order.
Specific 6(g) activities include:
— Identify universe of holders and determine whether all affected persons
submitted information;
— Determine whether all state and local agencies that must be informed
received 6(g) information;
— Compile the list of holders and delineate information in the following
fashion ~ by state, by holder (name and location), by quantity, and
by product name and registration number;
— Coordinate with OPP on indemnification issues;
— Monitor compliance with specific requirements of the order.
4
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Activities common to all areas Include:
o Coordinate with states to provide guidance, strategies, and requisite
information and oversight;
o Monitor compliance with SSUROs issued by EPA and the states;
o Monitor and coordinate compliance with U. S. Customs on imported products
affected by rules or orders;
o Assist states with any outreach or targeting activities associated with
FIFRA 88 activity;
o Coordinate with EPA Headquarters, particularly OPP for technical guidance
and OCM for program guidance and case support;
o Coordinate with other Regional program offices as necessary;
o Conduct compliance monitoring activities in states that have not negotiated
cooperative agreements;
o Monitor and track compliance activities, including the number of
inspections, locations of inspections; inspection dates; enforcement
actions; follow-up actions; and periodic reinspections;
o Conduct quality checks on routine state compliance monitoring activities;
o Follow-up all monitoring activities to ensure compliance with appropriate
rules or orders;
o Coordinate with Regional Counsels on case development as necessary;
o Ensure appropriate enforcement actions are taken when warranted.
Any questions regarding what programmatic activities are eligible should be
directed to Sherry Sterling of OCM at FTS 382-5567.
5
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Procedures: The following procedures will apply to the use of FIFRA revolving
funds.
A. general
1. FIFRA revolving funds can be used for either intramural or extramural
purposes. Regions will need to carefully track these resources, since
FIFRA Fund resources may only be used for compliance and enforcement
activities which support the rereglstration and expedited 'processing
programs, as provided in FIFRA 88. These operating procedures are intended
to provided for an additional measure of assurance that these funds are
being properly utilized. It will be the responsibility of each Region to
determine if a particular funding action supports the rereglstration or
expedited processing programs and, therefore, is eligible for revolving
fund resources. If you have any questions regarding these procedures,
contact Roberta Miller of OCM at FTS 382-7691.
2. FIFRA 88 does not directly address the use of base funds for the
reregistrati on and expedited processing programs. Good financial
management practices dictate, however, that Regions should fully utilize
base pesticide enforcement resources since base appropriated funds expire
after one or two years, depending on type of appropriation. Revolving fund
monies are "no year" funds and do not require annual Congressional
appropriations. An annual apportionment from the Office of Management and
Budget and a related allowance for each Region is required annually prior
to use of FIFRA revolving funds.
3. Revolving funds should not be used for general support or general policy
issue development activities, unless an activity is expected to result in
a significant change in procedures and/or increase in productivity in the
FIFRA 88 activities.
4. If there is doubt that the intramural or extramural expenditure is for a
FIFRA Fund eligible activity, base funds must be used.
5. The FIFRA revolving fund is a separate appropriation (68X4310). Account
numbers, containing the PFK designation identifying them as FIFRA revolving
funds, have been assigned to the Regions.
6. Each intramural or extramural funding action that uses the FIFRA Fund must
be supported by a justification explaining the eligibility of the activity
for use of FIFRA revolving funds. A copy must be retained in Regional
files and the branch chief must sign the funding document to indicated
concurrence with the justification for and use of FIFRA revolving funds.
All justifications should be maintained in a central file as you should
expect to be audited at any time.
6
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B. FTE and Timekeeping Procedures
1. Due to the small number of resources provided, Regions may, for purposes
for accounting convenience, assign personnel to a fixed FIFRA Fund account
although that individual's time may not be 100% devoted to FIFRA Fund
activities.
2. The individual who is charged to a fixed account, however, should spend
the majority of his/her time on Fund eligible activities.
3. The total FIFRA Fund RE utilized by the Region must actually reflect the
amount of time spent by all individuals on Fund-eligible activities up to
the FTE celling which may not be exceeded.
4. You should keep FTE utilization between accounts in balance at all times
by using CPARS or payroll distributions.
C.. Intramural Travel and Other Expense Charges
1. Travel
(1) The Agency has determined that a separate travel ceiling is not
necessary for revolving funds since the FIFRA Fund is not part of
the annual Congressional appropriation. FIFRA Fund resources,
however, may only be used for travel which supports the
reregistration and expedited processing programs.
(2) When a travel authorization is prepared using revolving funds, a
justification is required. If the space in block 100 is not
sufficient, the justification may be placed on a separate piece of
bond paper with a signature block for the branch chief. The
justification must specifically state how the travel supports FIFRA
Fund eligible activities. Examples are presented below:
(a) Travel to Recruit FIFRA 88 Staff — "Jane Doe is traveling to
Idaho State University to recruit individuals for. FIFRA 88
positions."
(b) Travel to Attend Training, Conferences, or General Staff
Development Related to FIFRA 88 Program Activities — "John Doe
works primarily on FIFRA 88 compliance and enforcement activities
and this authorizes travel and training fees to attend the case
officers' training course."
(c) Travel for FIFRA 88 Program Activities — "Jane Doe is traveling
7
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to conduct Inspections in support of F1FRA 88 regulations."
(d) Travel and Transportation of FIFRA 88 Employees, Their Families
and Goods to Their Permanent Duty Station -- "John Doe has been
hired by Region 111 to perform FIFRA 88 program activities and
this authorizes travel and transportation of household goods."
(3) If there is doubt that the travel is for a FIFRA Fund eligible
activity, base travel funds must be used.
(4) If the travel is for both Fund eligible and ineligible activities,
the branch chief should determine the principal purpose of the
travel- If the principal purpose is to support Fund eligible
activities, this should be explained in the justification.
2. Training
(1) FIFRA Funds may only be used for training which supports the
reregistration and expedited processing programs.
(2) When a training request is prepared that uses FIFRA funds, a
justification is required. The justification should specifically
state how the training is related to FIFRA Fund eligible activities.
Examples are listed as follows:
(a) Training course directly related to FIFRA Fund el igible activities
— "This course, Pesticide Inspector Training, is directly related
to John Doe's work activities in support of FIFRA 88 compliance."
(b) General Staff Development or Conference — "Jane Doe works
primarily on FIFRA 88 enforcement and compliance activities and
this conference/course is appropriate for use of FIFRA Fund
resources."
(3) The training may be directly related to FIFRA fund eligible
activities, or may be for general staff development for an employee
who primarily works on Fund eligible activities.
(4) If there is doubt that the training is eligible for use of FIFRA
revolving funds, use base funds.
8
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3. Other Intramural Expenses
(1) Revolving funds may also be used for other types of intramural
expenses (e.g., rent, communications, printing, other contractual
services, supplies, equipment) when the justification establishes
that the funding action principally supports Fund eligible
activities. In all cases where FIFRA funds are use, a justification
must be provided.
(2) As for previously explained expense items, if there is a question
whether or not the expense is to support a FIFRA fund activity, then
base funds should be used.
D. Extramural
1. FIFRA Funds may be used for extramural purposes if the funded action or
service directly supports implementation of the reregistration and
expedited processing provisions of FIFRA 88. If there is doubt that the
action or service is FIFRA 88 related, base funds must be used.
2. When Regional extramural funds under FIFRA 88 are made available, OCM will
issue detailed procedures for the allocation process for these funds.
3. Each procurement request form using FIFRA Fund accounts must include a
justification for the use of these funds.
9
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ste! this docu
Enforcemei
Monitorial to FIFRA
Headqua^ers Divisioi1
Septeqj^r 1, 1992.
say not be identical to original document
Key Uord
Date
Bromide, Strut
September 1, 1992
End of document reached**
Item 6
8/6/92
ddressee List includi
Directors, Branch C
ce of Complia
onal and
d Section Chifff
ural Fumigants
act Sheet
John J. Ne
an III
JOHN J. NE^AN III, mrecto
Policy andnrants Dvision
Office of Appliance Monitori
Office of Prevention, Pesticides
and Toxi exuberances
ACCESSION NUNBER
DOCUNENT NUNBER
DOCUMENT CATEGORY
DATE
TITLE
ISSUING OFFICE
ADDRESSEE
OMITTED TEXT
LAW
REGULATION
STATUS
RELEASABLE
DOCUMENT LENGTH
4434
FIFRA;GH;PG557
Policy
04/24/91
Final FY 1992 Consolidated Pesticide Cooperative Agreement Guidance
office of Pesticide Programs; Office of Compliance Monitoring
Regional Pesticides and Toxics Division Directors; Regional Pesticides and Toxics Branch Chiefs
VI Summary of FY 92 Cooperative Agreement Allotments
FIFRA Sections 2,3,6,9,11,12,23,26,27
40CFR31.01-31.6,31.10,31.20,31.30,31.35,31.45,35.001-35.155,35.140, 35.141,35.600-35.605,156.10
Active
Yes
161 Screens
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MEMORANDUM
SUBJECT: Final FY 1992 Consolidated Pesticide Cooperative
Agreement Guidance
FROM: /s/ Stephen L. Johnson, Director
Field Operations Division
Office of Pesticide Programs
/s/ John J. Neylan III, Director
Policy and Grants Division
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* note! this document may not be identical to original document
Order number 930528-081520-PLC -001-001
page 28 set 11 with 3 of 6 items
Office of Compliance Monitoring
TO: Regional Pesticides and Toxics Division Directors
Regional Pesticides and Toxics Branch Chiefs
Attached is the final guidance for preparation of State pesticide
cooperative agreements in FY 1992. The package includes the guidance and
a complete set of appendices to the document.
Thank you for your comments on draft versions of the guidance and
for facilitating State comment. Many comments were incorporated into the
final guidance. However, others raised issues that could not be addressed
through the guidance this year. Ue will retain all comments and attempt
to address tnem through action items for further consideration.
A number of comments expressed concern with the implementation
schedule for the Worker Protection Program. After further discussion with
program staff, we have scheduled a longer lead time for dissemination of
educational materials in the first phase of the program. However, the
remaining schedule for implementing the program nas not been changed
because of the importance of completing these tasks within the stated time
periods. Ue will make every effort to ensure that guidance and materials
needed from Headquarters on the Worker Protection Program are available so
that schedules can be met.
Another section of concern to commentors was the proposal to move up
the due dates for quarterly reporting under the cooperative agreements.
Based on opposition to this proposal, reporting dates will remain the same
as in previous years.
Included in this final guidance is a section on the Office of
Compliance Monitoring1s lawn care initiative. This section was sent
separately for review by Regions and States, and the final language
adopted reflects those comments. Several States reported that they have
lawn care programs in place and that the activities proposed would be
easily incorporated into current programs. We are asking for the support
of the States with this initiative to gather systematic information
about the use of lawn care products so that we can report to the General
Accounting Office on our assessment of the need for a long-term lawn care
enforcement strategy.
Finally, those Regions that issue Region-specific guidance are
reminded to circulate draft guidance to their States for review and
comment before fInalization. Copies of final Regional guidance should be
sent to the Office of Compliance Monitoring and to the Field Operations
Division.
If you have any questions regarding the certification and/or the
pesticide program sections of the guidance ( pages 18-35 ), please
contact Therese Hurtagh, 0PP Field Operations Division, on FTS 557-7410.
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Questions regarding the compliance sections of the guidance ( pages
36-70 ) should be referred to Linda Flick, Office of Compliance
Monitoring, on FTS 382-7841.
Again, thank you for your input to the guidance.
Attachment
FY92 CONSOLIDATED PESTICIDE COOPERATIVE AGREEMENT GUIDANCE
INTRODUCTION
A. PURPOSE OF GUIDANCE
Section 23 of the Federal Insecticide, Fungicide, and Rodenticide Act
( FIFRA ) as amended authorizes the U.S. Environmental Protection Agency
to enter Into cooperative agreements with the states and Indian tribes for
pesticides enforcement and to train and certify applicators. ( Under
FIFRA Section 2(aa), "the term 'state' means a state, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the
Trust Territory of the Pacific Islands and American Samoa." ) Regulations
governing financial assistance to participants in the cooperative
pesticides program are found at 40 CFR Part 35.001 - 35:155, 35.600
- 35.605 and 40 CFR Part 31.1 to 31.6. This guidance document, developed
by the Office of Compliance Monitoring ( 0CH ; and the Office of Pesticide
Programs ( OPP ), supplements the above regulations by setting forth in
more detail the required elements of cooperative agreement applications,
procedures for reviewing applications and awarding funding allotments, and
guidance for program evaluation and management.
This document is specifically directed to the EPA regional offices,
which are responsible for issuing program guidance to the applicants.
Regional guidance to the states and Indian tribes must contain all the key
provisions of the national guidance. Including all work program items.
However, the national guidance may be modified or supplemented to reflect
special environmental or managerial conditions in each region. The
regions should send to the Chief of OCH's Grants and Evaluation Branch a
copy of the draft and final guidance which they send to their states,
assuming that it is not identical to the national guidance; a copy should
be sent at the same time as the mailing to the states.
For FY 92, this document was developed as a "Consolidated Cooperative
Agreement Guidance" covering all pesticide activities for which financial
aid will be available. These activities are categorized in the following
five components of the pesticide cooperative agreement program: 1) all of
the enforcement activities; 2) certification of pesticide applicators; 3)
ground water program activities; 4) endangered species program activities;
and 5) worker protection program activities. ( Components # 2-5 are
considered "pesticide program activities". )
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In relation to above, the enforcement funds will be available for the
enforcement component, certification funds will be available for the
certification component and distinct pesticide program funds will be
available for worker protection program activities, ground water program
activities and endangered species program activities.
- 1 -
Section II of the consolidated guidance discusses application
requirements which apply to all components of the pesticide cooperative
agreement program. The remaining sections deal with work program
activities, and specifically address each of the five individual
components outlined previously. The funding section cannot be distributed
until after the President's Ft 92 budget 1s released.
The consolidated guidance was developed, in part, to encourage states
to prepare one cooperative agreement application for assistance for all
components ( enforcement, certification, worker protection program, ground
water program and endangered species program activities ). However, it is
recognized that due to unique circumstances or timing, this will not be
feasible in every case. The guidance allows for the state lead agency
/ tribe to submit more than one application or amended applications to
address the five components, if this is more practical, as agreed between
the applicant and EPA regional office.
In submitting a consolidated cooperative agreement application,
the applicant must submit three budgets at a minimum: 1) one for the
enforcement component ( Including worker protection enforcement activities
and all the enforcement activities ); 2) one budget for the certification
component; and 3) one budget for the pesticide program activities
( addressing the groundwater, endangered species and worker protection
program activities together ).
Under the consolidated cooperative agreement, the recipient must
separately track the expenditure of funds under three components at a
minimum: 1) all of the enforcement funds; 2) the certification funds;
and 3) the pesticide program funds for the new initiatives ( groundwater
program activities, endangered species program activities and worker
protection program activities ).
The regions and states are strongly encouraged to read through the
first 64 pages ( section I-IV ) of tne guidance. Ue have highlighted the
major changes from the FY 91 guidance.
B. NATIONAL PRIORITIES
Note: This is a new section of the introduction. This information was
previously included in the work program section
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1. ENFORCEMENT NATIONAL PRIORITIES
In developing the compliance cooperative agreement work programs,
applicants need to address the national pesticide enforcement priorities,
along with State / Tribal priorities. For FY 92, the two national
priorities are: A) helping to ensure compliance with pesticide
cancellations, suspensions and other major regulatory actions; and B)
planning for and conducting enforcement activities for the revised worker
protection standards and associated labeling requirements, based on
publication of the final rule.
2. CERTIFICATION AND TRAINING OF PESTICIDE APPLICATOR - NATIONAL
PRIORITIES
a. Program Goals. In FY92, the Agency will work with the state / tribes
to address the changes to certification plans which will be required as a
result of revised provisions in the regulations concerning "Certification
of Pesticide Applicators," 40 CFR 171. The revisions to 40 CFR 171 should
be final and in effect in FY92. Working with USDA and others, EPA will
develop new training modules and upgrade training materials to assist in
meeting the more stringent pesticide applicator competency standards
contained in the revised regulations.
b. National Program Priorities. In the area of certification and
training of pesticide applicators, the Agency has identified five program
areas for priority activities in FY92 at the national and/or regional
levels. These activities will be undertaken in cooperation with the
states, tribes, territories, and with USDA:
1. Encourage Interaction between State Agencies and Cooperative
Extension Services in the States
EPA will continue to encourage frequent interaction between the
Lead Agency for pesticide programs and Cooperative Extension
Service in each State, particularly where the training offered
by the Extension Service is a means of obtaining certification
or recertification credit.
2. Training
EPA will address state / tribal needs in the area of training
material. EPA will continue to work with USDA to identify
needed training programs and materials and to develop these
programs and materials at the national level, and facilitate
such development at the regional and state level, as
appropriate.
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EPA will cooperate with the private sector to encourage
development of training materials.
EPA will encourage states / tribes and facilitate their efforts
to ensure that training is made available to applicators in
situations where the state / tribe itself cannot offer training.
EPA will continue to develop train-the-trainer programs that
address new regulations, emerging issues, and innovative CUT
materials.
EPA will encourage and assist in the development of methods
/ programs for verifying that training has occurred in cases
where the state / tribe itself does not administer the training.
EPA will continue to cooperate with USDA to upgrade state
private applicator training programs and certification
mechanisms based on the Joint EPA-USDA / CBS reviews which were
completed in FY 89.
3. Publication of Revised Federal Regulations
EPA will promulgate, in FY 92, revised regulations for the
certification of pesticide applicators.
4. State Certification Programs
EPA will encourage states / tribes to maintain their state
/ tribal plans, in accordance with FIFRA Section 11 and 40 CFR
171. Uhen the revised regulations are promulgated, EPA will
assist in the transition from existing certification programs to
programs that meet the requirements of the regulations.
5. Cooperation and Interaction
EPA will facilitate cooperation and interaction between federal
a emerging issue
Dal and regional
crn riii lawibiiaic wuupeiai iuii aiiu unci awi
and state / tribal agencies for identifying emerging issues, and
in developing and implementing state / trios'
programs to address those issues.
3. GROUND UATER PROTECTION PROGRAM - NATIONAL PRIORITIES
a. Program Goals. EPA's environmental goal in its Pesticides and Ground
Uater Strategy is to manage the use of pesticides to protect ground water
resources. The strategy provides states, tribes, and territories the
opportunity to take the lead role in meeting this goal by designing and
implementing plans to manage pesticides for the prevention of ground
water contamination. This approach allows for tne tailoring of pesticide
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management measures to meet specific local ground water protection needs.
Resources devoted to protecting ground water from pesticide
contamination will be focused on those areas that have the most serious
agrochemicals in ground water problems or with the potential for such
problems. The Regional Program Offices will provide technical assistance
to states, tribes and territories on pesticide management plan development
and review of state and tribe management plans, ensuring cooperation among
key state / tribal agencies, sharing information and reviewing grant
plans.
Protection of ground water requires a localized protection approach
which require a greatly expanded / strengthened state / tribe role in
problem identification and in the management of pesticide use with a focus
on prevention of contamination.
At the regional level, the pesticides, ground water and non-point
source programs will need to work closely together to develop consistent
state and tribal work plans to support program specific grants. At the
state and tribal level, there is the same need for cooperation and
coordination between involved agencies.
b. National Program Priorities. In the area of ground water protection,
the Agency has identified program areas for priority activities in FY92 at
the national and^or regional levels. These activities will be undertaken
in cooperation with the states, tribes, territories, and with USDA and
USGS:
1. Implementation of the Final Hanagement Plan Guidance Document
and Technical Support Documents
EPA will provide guidance to states, tribes, and territories
in their efforts to develop management plans and to promote
national consistency in using these plans as a key element of
the foundation for pesticide registrations. EPA also will
provide technical assistance to those preparing to develop
management plans.
- 5 -
2. Oversee the Development and Implementation of Both Generic and
Chemical-Specific State Hanagement Plans
EPA will develop plans to strengthen the Agency's foundation
for the Federal registration of pesticides posing ground water
contamination concerns. These plans should be developed in
close coordination with state ground water programs. The EPA
Office of 6round Water Protection ( OGWP ) also is providing
funds to state / tribal ground water programs for the
development of pesticide management plans.
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3. Resolution of Organizational Roles and Responsibilities with
Respect to OPP, 0DU, 0GUP, USDA, and USGS
EPA will foster communication and harmony among these
organizations and their regional / state counterparts. Uith
respect to the Office of Ground Water Protection ( 0GUP ),
the Comprehensive State Ground Water Protection Programs
( CSGWPP's ) will be the vehicle for addressing organizational
roles and responsibilities. EPA will develop and implement NOUs
with USGS and USDA ( Soil Conservation Service, Cooperative
Extension Service, Agricultural Research Service, and
Cooperative States Research Service ).
4. Review of Management Practices
EPA will facilitate the transfer of technology among states,
tribes, and territories. EPA will determine what is and is
not working and share that information with those In similar
situations.
5. Outreach to Pesticide Users and the Public
EPA will develop public information materials such as brochures,
fact sheets, ana audio-visual materials to aid in outreach.
4. ENDANGERED SPECIES PROTECTION PROGRAM - NATIONAL PRIORITIES
a. Program Goals. The Endangered Species Protection Program focuses on
providing the best protection for listed species while minimizing any
unnecessary Impacts on pesticide users. During the 1992 growing season,
OPP anticipates the continuation of the voluntary and pilot programs begun
in 1990 and 1991.
- 6 -
During FY92t the Agency will begin requiring registrants to relabel
some products with endangered species precautions and reference to county
-specific bulletins to conform with the Endangered Species program.
Because approximately twelve months will be allowed for relabeling, few
products at the end-use level will bear the revised labeling during the
1992 growing season.
The Region's focus will be on providing technical assistance to the
states / tribes. This assistance will include coordinating the review of
habitat maps with the states and other interested parties, ensuring
coordination between State agriculture and fish / game agencies, and
reviewing State plans.
b. National Program Priorities. In the area of endangered species
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protection, the Aaency has identified program areas for priority
activities in FY92 at the National and/or regional levels. These
activities will be undertaken in cooperation with the states, tribes,
territories, and with USDA:
1. Voluntary Programs Including Pilot Programs
EPA will assist with on-going pilot programs and work to
establish new pilot programs in the states / tribes during the
1992 growing season. Results from the pilot programs will be
used to revise the Endangered Species Protection Program as
necessary.
2. Customized State-Initiated Plans
Through the Regional Offices, EPA will provide technical
assistance to states / tribes developing their own state / tribe
-initiated plans. Regions will participate in the first level
of review for state / tribe-initiated plans. EPA Headquarters
will assist in reviewing state / tribe-initiated plans submitted
through the Regions, ana in obtaining concurrence from the Fish
and Wildlife Services ( FUS ).
3. Outreach to Pesticide Users and the Public
EPA will develop educational materials for use in the field as
well as to inform the public about the Endangered Species
Protection Program.
EPA will provide program informational materials ( including
bulletins, brochures, fact sheets, videos / slides ) to the
Cooperative Extension Service, Regional Offices, etc., as these
materials are developed by EPA.
- 7 -
4. Coordination with the Federal and State Lead Agencies
EPA will promote cooperation with other Federal and state
/ tribal agencies including USDA, FUS, Regional Office, State
Agriculture and Fish and Game departments. This cooperation
will result in (a) the development of educational materials and
habitat maps, (b) review of program outreach activities, and (c)
the development of technical aspects of the program.
5. Review of Habitat Haps
Through the Regions, EPA will coordinate the review of habitat
maps with the states and other interested parties.
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S. WORKER PROTECTION PROGRAH - NATIONAL PRIORITIES
a. Program Goals. In FY92, the Agency goal will be to disseminate on the
new Worker Protection Standards ( WPS ) and to continue to develop and
disseminate training materials required by the program.
Successful implementation of the WPS and related product label changes
will require continued public outreach to inform workers and employers
about requirements that will be initiated in FY91. The complexity of
reaching so many groups and individuals requires a decentralized Federal
program. Training materials and technical assistance will be directed
through regional and state / tribes programs to tailor them to local
conditions and programs.
The pesticides worker protection compliance monitoring and enforcement
activities will focus on ensuring compliance with the pesticide worker
protection rule, through routine comprehensive inspections, and follow-up
to Incidents and complaint reports. Training seminars for states and
technical assistance for public and private groups will also be an
important part of compliance monitoring and enforcement efforts.
b. National Program Priorities. In the area of worker protection, EPA
has identified program areas for priority activities in FY92 at the
national and/or regional levels. These activities will be undertaken in
cooperation with tne states, tribes, territories, and with USDA:
- 8 -
1. Continued Development of Program Implementation Strategies by
the States, Tribes, and Territories
EPA, through the regions, will provide information and
assistance for finalizing individual worker protection program
implementation strategies for states, tribes, and territories.
2. Outreach to Pesticide Users and Workers Potentially Exposed to
Pesticides
To assist the state, tribes, and territories in their outreach
programs, EPA will provide information on the WPS to the
regulated and affected communities. These communities
will be identified in individual worker protection program
implementation strategies. EPA will develop materials to inform
users of the new WPS requirements. Headquarters will facilitate
regional interaction through Informational meetings and
workshops.
3. Coordination of Activities with the States, Tribes, and Other
Agencies and Organizations
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EPA will promote cooperation between USDA, 0SHA. the Cooperative
Extension Services, and the private sector in the development
of educational materials and dissemination of information and
training efforts. EPA encourages states / tribes to include
groups / coalitions representing migrant workers when naming
organizations to work with in implementing Uorker Protection
Standards ( i.e., utilize organizations representing or
concerned with migrant issues ). EPA will also promote
cooperation between states and tribes.
4. Publicizing the Uorker Program
EPA will develop materials, such as brochures, fact sheets, and
guides, for informing the public of the new UPS. EPA, through
the regions, will also use the media to announce the UPS and
inform the public of its requirements.
5. Management of Cooperative Agreements with the States, Tribes,
and Territories for the UPS
EPA will review the focus and progress of the FY92 Pesticide
Cooperative Agreements. Improvements and corrections will be
suggested, as necessary.
- 9 -
Head-quarters, through the Regional Program Offices, will issue
and transmit guidance to the states / tribes.
6. Training Programs and Materials
EPA will develop a national set of guidance documents on basic
occupational safety that meets the minimum requirements set out
in tne UPS. Then, in cooperation with the private sector and
other state agencies ( the Cooperative Extension Service,
OSHA ), EPA will help states, tribes, and territories tailor
programs and materials to meet specific needs.
Using EPA / state / tribe / employer "train-the-tra1ner" type
programs, EPA will also prepare persons who can offer training
or distribute information about the UPS.
II. COOPERATIVE AGREEMENT APPLICATION REQUIREMENTS
To ensure an orderly administrative review, programmatic evaluation,
and funding of cooperative agreement applications, the applications must
be received by the regional Grants Management Offices at least 60 days
prior to the beginning of the proposed budget period. This is a federal
requirement which must be adhered to in accordance with 40 CFR Part
35.140. This requirement may be addressed in any audits conducted of a
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state / tribal cooperative agreement program.
We recommend that states / tribes operating pesticide enforcement
rant programs under the Federal fiscal year cycle ( October 1- September
0 ) submit their cooperative agreement application 90 days prior to the
beginning of the proposed budget period. This will allow additional lead
time and help to avoid cooperative agreements not being awarded on time.
Funds will be awarded as promptly as possible following release of FY 92
federal funds.
For FY 92, applicants for pesticide enforcement cooperative agreement
funds are urged to complete and submit an enforcement application review
checklist with their applications; this checklist 1s provided in appendix
V. The checklist will aid the applicant in submitting a complete package
and help to streamline processing.
In accordance with 40 CFR Part 35.141, EPA will not reimburse
applicants for costs incurred before the date of award, unless it is a
continuation award and the application was submitted by the state prior
to the expiration of the prior budget period. If applications for
continuation awards are not received in a timely manner, it will be
- 10 -
necessary to request a formal deviation request approved by the Grants
Administration Division before any pre-award costs may be approved.
In addition to this guidance document, regional and state / tribal
staff should consult the appropriate regulations in 40 CFR Parts 31 and
35, the Administrator's Policy on Performance-Based Assistance, and the
Assistance Administration Manual, previously distributed, when preparing,
negotiating, and evaluating cooperative agreement applications.
Listed below are the principal elements needed in an application to
enable EPA to perform a proper review and evaluation of the proposed
program and to make a timely award of funds. The outline below is a
suggested format for applications.
A. STANDARD APPLICATION FORMS
The regulations ( 40 CFR Part 31.10 ) require applicants for
assistance to use Standard Form 424 ( revised 4/88 ). Application kits
including all the necessary application forms, may be obtained from the
EPA regional Grants Management Office. ( A copy of the application form
can also be found in appendix I of this guidance. )
It Is recommended that applicants submit one consolidated application,
for EPA review and approval, with a distinct work program component for
each of the five activities ( namely enforcement, certification, worker
protection program activities, endangered species, and groundwater program
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activities ).
If submitting one application is not feasible, the state lead agency
/ tribe may submit separate or amended applications which address each
component for which funding is available as described in this document.
In submitting a consolidated cooperative agreement application, for
EPA review and approval, the applicant must submit three budgets at
a minimum: 1) one for the enforcement component ( including worker
protection enforcement activities and all the enforcement activities );
2) one budget for the certification component; and 3) one budget for the
pesticide program activities ( addressing the groundwater, endangered
species and worker protection program activities together ). ( Appendix
IX includes an example of a partially completed application form showing
how at least three individual budget components could be entered on one
application form SF 424. )
- 11 -
B. BUDGET REQUIREMENTS
1. Cost Sharing
a. Enforcement Component
EPA's share of the "total project costs" for the FIFRA enforcement
component should not exceed 85% of the total funding level.
b. Certification Component
FIFRA Section 23 limits EPA's share of the "total project costs" to
not more than SOX of the total funding level.
c. Pesticide Program Component ( Addressing Worker
Protection Program Activities, Groundwater Program
Activities and Endangered Species Program
Activities )
EPA's share of the "total project costs" for the worker protection
program activities, groundwater program and endangered species program
activities should not exceed 85% of the total funding level.
2. Itemized Budget Detail
The applicant should include supportive itemized statements or fact
sheets to expand upon the expenditures proposed for at least each of
the three components ( namely enforcement, certification, and pesticide
program activities ) for the cost categories listed below. Any additional
cost categories that may appear to be out of the ordinary should be
itemized, as well.
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a. Personnel
Personnel costs should be itemized to show the type of work activity,
number of persons involved, number of work years involved and the total
cost for each of the major categories of personnel ( e.g., inspectional,
analytical, etc. ) for which funding is requested.
b. Travel
Travel costs must be adequately described to show the basis for the
total travel cost estimate.
- 12 -
c. Equipment and Supplies
Each item costing $25,000 or more should be listed separately. Items
costing less than $25,000 may be grouped, as appropriate.
C. NARRATIVE STATEMENT
Each cooperative agreement application must be accompanied by a
narrative statement covering the subject areas listed below ( addressing
background information, ability to implement the program, objectives of
the project, benefits of the project to the applicant and EPA, and the
work program ). If a subject has been adequately documented in previous
applications, project reports, etc., a reference to the earlier document
will suffice, as long as the pertinent pages of the earlier document are
attached.
A new work program narrative for each component, for review and
approval, must be submitted annually along with the application. Uith
changing conditions and priorities ( both nationally and locally ), it is
expected that work program activities will change from year-to-year.
1. Background
40 CFR Part 35.140 requires all applications to include a discussion
of performance to date under the existing award.
2. Ability to Implement Program
Each applicant oust certify that there are no impediments to the
state's / tribe's ability to carry out the proposed program or programs.
Applicants with continuing cooperative agreement programs are not
required to annually certify their ability to carry out the proposed
programs, unless one or more of the areas described below has changed.
The applicant should address the areas described below, as well as any
others, which might pose problems.
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a. Authority to Conduct the Proposed Program
State Authority
The state oust have enacted legislation which empowers it to enter
into a cooperative agreement with EPA and conduct specific activities
proposed under the cooperative agreement.
- 13 -
Tribal Authority
The tribe must have established a governmental body to execute a
cooperative agreement with EPA. Most reservations are covered by tribal
governments, recognized by the Department of the Interior in the Federal
Register and organized pursuant to treatise and/or Acts of Congress.
b. Authority to Accept Federal Funds
A state / tribe, which can only implement a program under a
cooperative agreement with prior authorization by its legislature to
spend federal funds, must include a statement indicating the date on which
such authorization will be obtained. Commitment of EPA funds will be
contingent upon such authorization by the state legislature or Tribal
CounciI.
c. Designation of Lead Agency for Enforcement
Although several agencies within a state / tribe may be responsible
for regulating various aspects of pesticide manufacture, handling, and
use, EPA will continue to enter into only one cooperative agreement with
the state / tribe for pesticides enforcement, as nas been done in the
past. It is a necessity for a coordinated enforcement program for this
practice to continue.
The Governor of the state or the Tribal Chairman ( or equivalent ),
through a letter to the regional office, should designate a lead agency
which will be responsible for the cooperative enforcement agreement
program. The designated lead agency must have the authority to enter
into contracts or interagency agreements with other agencies for the
performance of all necessary activities. The lead agency must follow
through on their "lead" responsibilities, as outlined in the work program
section of this guidance document, as the recipient of cooperative
agreement funds.
3. Objectives of the Project
Each applicant should clearly define the principal objectives which
support the achievement of the national and individual state / tribal
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priorities.
4. Benefits of Project to the Applicant and EPA
The applicant oust identify expected results and benefits to be
derived from the project, including all primary and secondary benefits to
the applicant. This statement should clearly establish the project as a
cooperative agreement with benefits accruing to both the applicant and
EPA.
- 14 -
5. Work Program
The applicant oust develop, for EPA review and approval, a proposed
work program for each component including a narrative description of the
projected outputs and work to be accomplished, along with a schedule for
accomplishing these activities. The cooperative agreement work programs
for each component are discussed in sections III and IV.
Additionally, while developing the work program, the applicant should
identify and consider the concerns of persons in the state / tribe who
may be exposed to pesticides or otherwise affected by the pesticides
enforcement program. The EPA considers public participation in the
planning process to be an important element of the program. Each
applicant may use a variety of means to identify the concerns of the
public and involve the public in the planning process. As a reference,
applicants may wish to use EPA's Public Participation Policy, January
19, 1981, 46 Fed. Reg. 5736, ( included in appendix X ). This policy
discusses the following factors: outreach, dialogue, assimilation,
feedback and associated methods.
D. ACCOUNTABILITY UNDER THE COOPERATIVE AGREEHENT
According to 40 CFR Part 31.20, recipients must expend and account
for funds awarded in accordance with state / tribal laws and procedures
for expending and accounting for its own funds. Fiscal control and
accounting procedures must be sufficient to: 1) track the expenditure of
funds separately for at least each of three components ( enforcement,
certification, and pesticide program activities ) of a consolidated
pesticide agreement; 2) permit preparation of Financial Status Reports
( FSRs ) required by the regulations; and 3) permit the tracing of funds
to a level of expenditure adequate to establish that such funds have not
been used in violation of the restrictions and prohibitions of applicable
statutes.
The recipients expenditures under the agreement must follow cost
categories ( i.e., budget line item or program elements ) established in
the original agreement. Except as provided for under 40 CFR 31.30 ( in
appendix XI ), recipients and sub-recipients can rebudget within the
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approved direct cost budget. Certain types of changes require prior
approval ( see 31.30(c) through 31.30(f). )
E. REQUIRED CERTIFICATION FOR DRUG FREE WORK PLACE
On May 25, 1990, the Office of Hanagement and Budget published "Drug
-Free Workplace Requirements; Notice ana Final Rules." For EPA, this
new rule is included in AO CFR Part 32 ( See appendix XII ), Government
Debarment and Suspension
- 15 -
( Nonprocureoent ) and Governmentwide Requirements for Drug-Free Workplace
( Grants ). This rule was effective July 24, 1990 except for the
certification requirements of section 32.630(c) and (d) for states and
state agencies which was effective on June 25, 1990. The rule requires
all recipients to certify that they will maintain a drug-free workplace.
The regional Grants Office must make sure that each application includes
a properly executed certification. The rule provides for suspension of
payments, suspension or termination of grants, or suspension or debarment
of the recipient for violation of the rule.
F. CERTIFICATION CONCERNING AND DISCLOSURE OF "INFLUENCING
ACTIVITIES"
Note: This is not a new requirement, but it is a revision to the
guidance.
Persons ( including states and municipalities ) who reguest or receive
grants or cooperative agreements exceeding $100,000 shall Tile with the
awarding agency a certification that the person has not used, and will not
use, federal funds to influence the award of the grant or cooperative
agreement. Such persons shall also file a disclosure form if they used,
or have agreed to use, non-federal funds to influence the award of the
cooperative agreement. Both the certification and the disclosure form
should be in the application kit supplied by EPA. If the documents are
not in the kit, please contact the regional Grants Hanagement Office.
G. DEBARMENT AND SUSPENSION CERTIFICATION
Note: This is not a new requirement, but it is a revision to the
guidance.
The applicant oust include EPA Form 5700-49, the Certification
Regarding Debarment, Suspension, and Other Responsibility Hatters. This
form certifies that applicant currently is not ineligible for assistance
due to a disbarment, suspension, or otner infraction.
H. STATE APPLICATION REVIEW CHECKLIST, REGIONAL REVIEW PROCEDURES
AND SEHI-ANNUAL EVALUATIONS
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The responsibilities and requirements associated with application
review procedures and semi-annual evaluations are discussed in Appendices
III and IV respectively. The national evaluation protocol is being
updated in FY 91 to reflect changes in the grant guidance, increased
emphasis on follow-up to compliance monitoring strategies, findings from
recent audits of the state enforcement grant program, and pertinent
findings from the National Qualitative Review of the FY 89 Pesticide
Enforcement Cooperative
- 16 -
Agreement Program. The protocol will be circulated to the EPA regions
for comment prior to being finalized. Some highlights in the application
review process are discussed below.
State application checklist: For FY 92, the pesticide enforcement
applicant may wish to complete a cooperative agreement application review
checklist ( in appendix V ) and submit it along with the application for
enforcement cooperative agreement funds. This should help ensure that the
applications address all of the required enforcement work program elements
and reduce the number of comments on the applications by EPA. ( Regions
may revise or add to this checklist. )
Regional review and submittal of applications: When state
applications are submitted, regions should review the checklist, if
provided, and the application to ensure all of the required elements have
been addressed. ( A suggested review checklist for regional use appears
in appendix VII ). The enforcement applications should be sent by the
regions to the appropriate regional liaison in OCH's Grants and Evaluation
Branch within two weeks of the region's receipt of the documents. This
allows for OCR review and comment early in the negotiation of a final
agreement. ( If they are available, any comments from the regions on the
applications should also be included. Checklists may also be sent along
with the application ).
OCH'S Grants and Evaluation Branch will review a representative number
of the enforcement applications from all regions in order to: 1) help
ensure national consistency and adherence, as appropriate, to the national
guidance; 2) assist in ensuring that recurring comments made in recent
Inspector General audits are addressed from the national perspective; we
fully expect that follow-up audits may occur, and finally, 3) remain aware
of what the states and tribes are actually proposing to do under their
enforcement agreement and help identify areas for next year's guidance
which need to be revised in order to address consistent problems if any.
Such knowledge and awareness is essential to developing and updating tnis
guidance. It OCN has any comments they will be relayed via telephone or
in writing. Comments from the regions or HQ should be reduced for the
states and tribes completing checklists themselves to Identify gaps in
their applications.
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Additional aids to processing applications are provided in the
appendix. Appendix VII is the suggested regional review checklist. This
checklist may be used instead of or to supplement a checklist submitted by
the applicant. In addition, a one-page time line / chart is found in
appendix VI. Regions may choose to adapt the time line for tracking due
dates in the grant award process.
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III. PESTICIDE PROGRAH ACTIVITIES FOR THE FY 92 U0RK PROGRAH
Note: The format of this section was revised from the last draft.
A. INTRODUCTION
1. General
For FY92, program development in the new pesticide initiatives will
continue. Pesticide applicator certification programs, that have
been in place in the States for several years, will be updated and
maintained.
2. Uork Program Components
Each state / tribe applying for FY92 pesticide program cooperative
agreement funds must prepare a proposed work program that includes the
following five components, at a minimum:
a. A description of the work, as outlined in the specific sections
on work program activities in this chapter of tne grant guidance
b. A schedule for accomplishing the work program activities
c. Reporting
d. Accounting records and filing system
e. Evaluation plans
3. Program Flexibility
EPA recognizes that the states / tribes will be designing programs
particular to specific concerns in their areas, and work programs may
vary from State to State.
The guidance for the new initiatives may lack some degree of
specificity by design, to allow the states / tribes flexibility in
developing their programs and to allow for states / tribes that have
progressed further in some of these areas as well as those who are in
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the initial stages of addressing them.
- 18 -
4. Cooperation Between States / Tribes and the EPA Regional Offices
The state / tribe and the Regional Program Office should work
closely together to develop complementary EPA / state or EPA / tribal
pesticide programs, especially as they address the new initiatives.
Cooperation between EPA and the applicants is essential in developing
effective programs. Discussions between the states / tribes and the
Regional Program Offices with regard to priorities, planning and
the extent of different program activities to be conducted are
particularly important.
5. Renegotiation of Uork Programs for Program Initiatives
Since the new program initiatives are in developmental stages, the
guidelines set by EPA for these activities may change during the year.
There can be a renegotiation of the work program for ground water,
endangered species, and worker protection program activities after
regulations or guidelines are issued in final form. The Regional
Program Office will work with the states / tribes to determine if
there is a need to change the specifications of the work program after
final regulations or strategies are available.
B. CERTIFICATION AND TRAINING OF PESTICIDE APPLICATORS - UORK PROGRAM
ACTIVITIES
1. Introduction
Seven core elements are needed in the applicant's work plan. These
elements are described below. The work program elements should be
prioritized based on discussions with the EPA Regional Program Office.
2. Uork Program Requirements
a. Revisions to State Mechanisms for Certification
The State will implement revisions to State mechanisms for
certification ( including examinations, training sessions and/or
self-study packets if applicable ) as previously agreed upon
between the EPA project officer and the State. This effort also
applies to any revisions agreed upon as a result of the FY 88/89
joint reviews, but not fully implemented by FY 91.
The State Lead Agency ( SLA ) should provide oversight and
assistance as appropriate in implementing changes to training
programs which were discussed as a result of joint reviews, and
the SLA should cooperate with the
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- 19 -
State Cooperative Extension Service ( SCES ) in implementing
required changes to certification mechanisms as a consequence of
such training changes.
b. Implementation of Changes to State Certification Programs
The State will implement any remaining changes to State
certification programs / plans which were agreed upon between
the State and EPA as a result of the FY 87 and subsequent
discussions on State Certification Plans. ( These changes
should have been implemented or should be implemented according
to a schedule agreed upon and approved by the EPA Regional
Program Office and the State. )
c. Review by the EPA Regional Program Office of Revisions of
Certification / Recertification Examinations
Revisions to state / tribal certification / recertification
examinations will include review by the EPA Regional Program
Office to assure that, in addition to the other topics required
by federal regulations, the exams include information on: 1)
chronic health effects; 2) ground water contamination; 3)
endangered species; 4) disposal methods; 5) calibration of
dispersal equipment; 6) proper use, maintenance and disposal of
personal protective equipment and clothing; 7) applicator laws
and responsibilities; 8) significant pesticide use problems
identified through enforcement actions. When the EPA identifies
areas in the examinations that need amendment, the State will
work with EPA to make needed changes.
d. Meetings with the State Cooperative Extension Service
States / tribes must meet a minimum of twice each year with the
state Cooperative Extension Service to discuss and evaluate the
state / tribal pesticide applicator certification and training
program. EPA Regional Program Offices should be notified of
meetings in advance. At least twice a year, states / tribes
will submit a report of points of agreement and decisions to the
EPA Regional Program Office. These reports may be submitted by
states / tribes with their mid-year reports and end-of-year
reports.
- 20 -
e. Reporting of Certification and Training Projections and
Accomplishments on EPA Form S700-33H
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On a semi-annual basis, the state / tribe will submit
information on the number of training sessions participated
in or monitored and the number of applicators certified and
recertified ( including the numbers certified and recertified
for each category ).
These reports showing certification accomplishments should be
submitted by the State within 30 calendar days following the
completion of the Federal fiscal year, second and fourth
quarters. Semiannual reports are due April 30 and October 30
of each year. The end of year Form 5700-33H should include
the number of applicators holding valid certification as of
September 30, and the recertification period, in years, for each
commercial category.
For Regions encompassing States that operate on a fiscal year
that is different from the Federal fiscal year ( e.g. July 1
- June 30 vs. October 1 - September 30 ), States must provide
most current reporting data available at the time required
reports are due.
In addition, the States are required under 40 CFR Part 171.7(d)
to submit an annual report at a time to be specified by the
State. The State may choose to have an annual State Plan report
period that corresponds to their cooperative agreement budget
period.
The states / tribes may consider using completed EPA Forms
5700-33H as part of their State Plan reports because the data
reported on Form 5700-33H are the same as the first three items
required in State Plan annual reports. This can be done only
when the State chooses to have an annual State Plan report
period that corresponds to their cooperative agreement budget
period.
f. Information About High Quality Training Programs and Training
Materials; Information about Training Needs
The EPA and USDA are working together to ensure maximum program
utility in the area of training materials. To assist in this
effort, states / tribes are asked to include the following
information in mid- and end-of-year reports:
- 21 -
o State / tribes will provide information about specific
training programs and/or training materials identified as
being of nigh quality.
o Uhen states / tribes are involved in development of
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training programs and/or materials, a detailed description
of these programs and/or materials will be Included in
reports.
o States / tribes are asked to identify specific programs
and/or materials needed for the training of certified
applicators 1n the state / tribe.
g. State / Tribal Specific Activities
The State / Tribal work program will address any unresolved
problem areas identified in old-year and end-of-year evaluation
reports of current and past project periods.
h. State / Tribal Plan for Implementing the Revised 40 CFR 171
The proposed revised certification and training regulation,
40 CFR Part 171, was published as a notice of proposed rule
making in the Federal Register on November 7, 1990. The final
regulation is scheduled for publication in FY 92. States
/ tribes will compare their FY92 CST requirements with the
proposed Federal regulation to Identify changes that will be
needed to implement the regulation. Uithin six months after the
revised 40 CFR 171 becomes final. States / Tribes will submit a
plan and schedule to implement tne changes in Part 171.
C. GROUND WATER PROTECTION PROGRAM - U0RK PROGRAM ACTIVITIES
1. Introduction
The Regional Program Offices and the states / tribes need to work
together to utilize funds effectively in developing programs.
The flexibility needed to implement priority tasks such as those
identified by the Comprehensive State Ground Water Protection
Programs, as well as the flexibility provided in this guidance,
should allow for a degree of creativity and uniqueness in designing
ground water protection programs. Uhere States / Tribes have already
completed some/all of these work goals, new or expanded work goals can
be negotiated.
- 22 -
2. The Work Program
a. Establishing a State / Tribal Ground Water Protection Program
Schedule
For FY92, the State / Tribe will develop a program schedule
for accomplishing the work program activities described in this
section. The state / tribe ana the Regional Program Office must
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agree upon a work program schedule.
Work toward completion of these activities will be pursued in
FY92 according to the established schedule. Completion of the
work on all components may not occur in FY92, owing to the
complexity of certain activities.
b. Work Program Requirements
1. Completion of the 6round Water Protection Program
Implementation Plan
The state / tribe will complete the implementation plan
for ground water protection. The state / tribe will submit
the implementation plan to the Regional Program Office
according to the established ground water protection
program schedule.
The implementation plan will include the following
components:
a. An outline of how states / tribes will accomplish the
provision and/or requirements of the EPA Pesticides
and Ground Water Strategy pending the receipt of final
guidance documents from EPA
b. A framework for conducting ground water activities,
including whether the state / tribe will opt to
develop a generic state management plan or chemical
-specific management plans
c. An estimated time line for the development of either
type of plan within EPA guidelines
d. A description of preparations for communicating
the strategy to users and to the public, such as
identifying target audiences, establishing mechanisms
for the dissemination of information, and conducting
public meetings
- 23 -
e. A description of plans to develop appropriate
infrastructures, and/or memoranda of understanding
with other State agencies
f. A description of preliminary monitoring
g. A description of any other preliminary activities that
should be undertaken to prepare for implementing the
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strategy
2. Implementation
After approval of the implementation plan and schedule by
the EPA Regional Program Office, the state / tribe will
initiate tne activities defined in the plan.
3. Development of 6eneric Management Plans
States / tribes opting to develop a generic state
management plan in their implementation plan should begin
work on the various generic components. EPA strongly
encourages states / tribes to develop generic management
plans and to submit them for review ana preliminary
approval prior to the 1992 use season. 6eneric plans would
contain the basic components common to all management
plans and could then be modified and expanded to address
management of specific pesticides. A copy of the generic
management plan should be submitted to tne EPA Regional
Office according to ground water protection program
schedule.
4. Assessment and Identification of Areas Host Vulnerable to
Ground Hater Contamination by Pesticides
The state / tribe will begin to assess and identify the
areas most vulnerable to ground water contamination by
pesticides in the State or within tribal lands. This
effort may require monitoring and mapping activities, and
may also require coordination with other State agencies
and/or the development of statutory authorities which may
not currently be in place to carry out these activities.
A portion of cooperative agreement funds, as agreed upon
with the Regional Program Office, can be used toward these
efforts, ana the development should occur according to an
agreed upon schedule with the Regional Program Office.
- 24 -
To the extent possible, the state / tribe will identify
those aquifers where protection is most critical based
on available criteria, which may include use, proximity
to the surface, well location, population density, etc.
Vulnerability may also be dependent upon climate, type of
soil, extent of irrigation, range in pesticide type and
application rates, point source contamination and other
factors.
5. Outreach Activities
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The state / tribe will conduct an outreach campaign to
explain to users and to the public how the EPA ground water
strategy affects them, how the strategy works, what the
state / tribe is doing to respond to the strategy, and how
they may be involved.
6. Development of Chemical-Specific Management Plan Components
The state / tribe will develop the chemical-specific
components ( for those developing generic management
plans ) or a chemical-specific management plan in response
to designation from EPA regarding a particular pesticide.
The chemical-specific management plan or components should
be developed and submitted to the EPA Regional Program
Office on a case-by-case basis as specified by EPA, and
according to the state / tribal ground water protection
program schedule.
7. State / Tribe Developed Projects
States / tribes / tribal consortia are encouraged to
propose an expanded work program in cases where the state
/ tribe / tribal consortia has an active ground water
protection program and has already addressed many of the
other work program requirements. Again, the flexibility
provided in the guidance allows for creativity and
uniqueness in the design of ground water protection
programs.
D. ENDANGERED SPECIES PROTECTION PROGRAM - WORK PROGRAM ACTIVITIES
1. Introduction
The Regional Program Offices and states / tribes need to work
together to utilize funds to develop state / tribal specific
programs, whether the State / Tribe
- 25 -
is participating in a pilot or devising its own plan
/ procedures. The flexibility provided in this guidance should
allow for a degree of creativity and uniqueness in designing
state / tribal programs.
2. Work Program requirements
a. General
Uhere states have already completed some or all of the work
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goals described in this section, new or expanded work goals
should be negotiated. All activities in tne work program
should be prioritized within each state / tribe based on
discussions with the EPA Regional Program Office.
b. Work Programs for Base Programs
States I tribes participating in a base endangered species
protection program are eligible to receive the base
allocation. The base work program must outline how the
state / tribe will address the following activities, to the
extent of the resources available:
1. Information Response System
The state / tribe will develop a framework for an
information response system wnich will be used to
disseminate EPA-developed educational materials, such
as maps, bulletins, and fact sheets, to individuals
and groups affected by the program and in response to
public inquiries.
Suggested components for the information response
system are:
a. A telephone information service for
agricultural and home pesticide users
b. State / tribal development and dissemination
of public outreach materials where needed to
deal with particular local situations
c. State / tribal solicitation of public
comment on review maps and pesticide tables
- 26 -
2. Compilation / Dissemination of Information on
Federally-Listed Endangered Species
The work program will also address the following
activities concerning Federally-listed endangered
species:
a. Habitat identification
b. Happing of endangered species habitats
c. Disseminating information regarding newly
-identified / listed species
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This activity may include the review of habitat maps
to ensure that they provide accurate descriptions of
where endangered species must be protected and on
-going collection of information for map development
and revision as well as information on pesticide use
by county.
c. Additional Work Program Activities
1. General
A state / tribe may elect to participate in activities
beyond base program activities.
Participation in these activities will require the state
/ tribe to obtain any necessary information on agricultural
land uses in areas Inhabited by endangered species and
determine alternate pesticides and/or use limitations to
achieve the goal of protecting species while minimizing
impacts on pesticide users. These efforts should
incorporate agricultural, fish and wildlife, and
conservation interests. For the activity selected, the
state / tribe should outline the criteria to evaluate the
program's effectiveness, the economic and environmental
impacts on the recommendations, and plans or pilots they
may have, including any benefits to the species. State
/ tribal-initiated plans or pilot programs can be evaluated
after implementation.
- 27 -
2. Additional Activities
a. Outline of State / Tribal Endangered Species
Protection Program
The state / tribe can outline its own program
with specific measures for the protection of
endangered species. The state / tribal outline
should include a schedule for implementing the
state / tribal-initiated plan and for conducting
a pilot using the approved plan.
b. Participation in the Federal Program as a Pilot
The state / tribe can outline their participation
in a pilot program of the Federal Endangered
Species Protection Program. The outline should
include the method the state / tribe will follow
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to implement the use of the habitat maps and
bulletins in their counties to protect endangered
species and track the results.
c. States / Tribes Conducting Public Review of Haps
States / tribes are strongly encouraged to obtain
public comment on review maps and pesticide
tables. A review would be announced ( perhaps
jointly by EPA and the state / tribe ) and a
location to obtain review materials identified.
All comments would be coordinated by the state
/ tribe.
d. State / Tribe Developed Projects
States / tribes are encouraged to propose
an expanded work program in cases where the
state / tribe has an active endangered species
protection program and has already addressed many
of the other work program requirements. Again,
the flexibility provided in the guidance allows
for creativity and uniqueness in the design of
endangered species protection program.
- 28 -
E. WORKER PROTECTION PR0SRAN - WORK PROGRAM ACTIVITIES
1. Introduction
a. General
This section identifies the elements required for inclusion
in the state / tribal work program in the area of worker
protection.
b. Overlap with 0CH Worker Protection Enforcement Program
OCH's guidance for worker protection enforcement activities
is described in the Enforcement Component of the FY92 work
program. The OCH guidance addresses planning for and
initial Implementation of a worker protection enforcement
program. The inherent relationship between the program
activities required in this section by 0PP and the 0CN
-required enforcement activities results in some necessary
overlap.
For example, a worker protection program requirement is
the development of an Implementation Strategy, which must
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include several chapters as discussed 1n the following
section. One chapter and one enforcement requirement
is the development and subsequent implementation of a
Compliance Monitoring Strategy. Uorlc program requirements
may Involve inter-agency coordination as well as outreach
ana communication activities. Uhere there is such overlap,
the applicant may decide to coordinate and jointly develop
the particular activities. However, the Implementation
Strategy and the Compliance Monitoring Strategy must be
presented as distinct documents.
2. Work program Requirements
a. General
The applicant will develop a work program for worker
protection program activities and submit the proposed work
program to the EPA Regional Program Office.
The work program will include, at a minimum, these three
program components:
- 29 -
(1) An initial outreach / communication effort
(2) A final implementation strategy for the worker
protection program
(3) An implementation schedule
b. Initial Outreach / Communication Effort
Uithin three to six months after the UPS is published in
the Federal Register, the state / tribe will reproduce and
distribute informational materials which will be provided
by the EPA Regional Program Office. These materials will
be directed at employers, employee organizations, and
other interested parties. For quick distribution, the
State / Tribe will have prepared a distribution list of
employers and employee organizations that will receive the
information, and submit it along with the approved work
program submitted with the grant application.
c. Implementation Strategy
1. Submission Time table / EPA Review
The strategy should be submitted by the applicant to
the EPA Regional Office within eignt months after
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the final Worker Protection Standards ( UPS ) are
published.
Uithin one month after receipt; the EPA Regional
Office will provide the applicant with comments, if
any. The state / tribe will address any comments
within one month of their receipt and forward the
revised implementation strategy to the EPA Regional
Program Office.
2. Implementation Strategy Components
The Implementation Strategy explains how the state
i tribe will implement the provisions of the new
orker Protection Standards ( UPS ) in the regulated
and affected communities.
The Implementation Strategy will include, at a
minimum, distinct chapters that address:
- 30 -
(a) Outreach / communication
(b) Training
(c) Establishing cooperative relationship with
other agencies, where applicable
(d) A compliance monitoring strategy ( See Note
below )
The Regional Program Office and states / tribes are
to work together to utilize funds to develop state
specific programs. The flexibility provided in the
guidance should allow for a degree of creativity and
uniqueness in designing programs. Uhere states
/ tribes have already completed some or all of these
three work goals, new or expanded work goals will be
negotiated.
Note: The requirement of a compliance monitoring
strategy is discussed further in the enforcement section
of this guidance. The applicant's compliance monitoring
strategy must be included as a distinct section of the
implementation strategy.
a. Outreach / Communication
The major focus of the worker protection program in
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FY92 is outreach. The development of an outreach
/ communication program as part of the implementation
strategy is key to the success of the program. 0PP is
developing outreach materials in the form of camera
-ready copy and master video / slide programs that
will be made available to states / tribes in a format
for easy duplication and dissemination.
The applicant will present a detailed, organized
method for distributing educational materials and
providing information relevant to the UPS to the
public and the regulated community. The state
/ tribal plan for disseminating such Information
will include provisions for duplicating materials.
Outreach / communication efforts should include
cooperative efforts with other state agencies, user
groups, and the Cooperative Extension Service. The
plan also will specify which
- 31 -
groups will be targeted, and the methods / activities
that will be used to relay the information.
The outreach program will include briefing workshops
to educate the affected public about the WPS. States
/ tribes may want to utilize funds to organize
meetings in different parts of the state and to
send participants to EPA-sponsored regional briefing
meetings about the WPS.
b. Training
EPA is developing national training / educational
materials and guidance documents that will meet the
requirements of the WPS. These materials will be made
available to states / tribes in the form of camera
-ready copy for written materials and masters for
audio-visual materials. These materials are designed
to promote consistent standards among state / tribal
WPS programs and to avoid duplication of effort that
would result if each state / tribe developed their
own materials. A catalog of these materials will be
forwarded to state / tribal agencies as soon as they
are available. The applicant should plan for training
sessions that will be held when the WPS are final.
The applicant may wish to make provisions for
modifying the EPA-produced training materials to
include state / tribal-specific provisions. The
applicant may also wish to make provisions for
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duplication and dissemination of the training
materials.
c. Cooperative Relationship with Other Agencies
The applicant will outline the cooperative
relationships established with other state agencies,
or Federal agencies, where applicable, to coordinate
program activities where duplication of effort or
conflict may occur. Uhere appropriate, states and
tribes will outline how they plan to coordinate
activities and explain how the state / tribe will
work cooperatively among the different agencies to
identify areas of overlap and define inter-agency
responsibilities.
- 32 -
d. Compliance Monitoring Strategy
The applicant oust develop, complete and submit the
compliance monitoring strategy as discussed in the
enforcement section of this guidance.
3. Implementation Schedule
Within ten months of the publication date of the final
revised WPS, at the latest, the states / tribes must begin
putting their implementation strategies into effect.
States / tribes should'carry out the activities contained
in the strategy in the order of their priority and
according to schedule.
The 10-month requirement is based on this calculation:
8 months State / Tribe development of implementation
plan
+ 1 month Regional review and comment
+ 1 month State / Tribe incorporates comments
10 months Total.
See section E(2)(c)(1) above.
F. SCHEDULING
The state / tribe prepares and submits a schedule of activities and
accomplishments planned for the grant period.
G. REPORTING
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States I tribes report on pesticide program activities and
accomplishments conducted under cooperative agreements.
1. Certification and Training Program
The reports concerning the State / Tribal program for
certification and training of pesticide applicators are
submitted semi-annually according to the specifications outlined
in item "e" of the Certification and Training Work program
section and in the protocol for certification mid-year and
end-of-year evaluations.
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2. Program Initiatives
Reports on activities and accomplishments in the program
initiative areas of worker protection, ground water, and
endangered species also are required at mid-year and end-of
-year. These reports are submitted by the State / Tribe to the
EPA Regional Program Office within 30 calendar days following
the completion of the second and fourth Federal fiscal year
quarters.
3. Report Format
Reports consist of a narrative summary of the activities
and accomplishments during the reporting period. Projected
accomplishments, updated schedules, and activities are reported
according to the quarter in which they occurred ( or will occur
for the upcoming six month period ). The reports describe how
the state / tribe has progressed in developing the program
( implementation strategies, management plans, etc. ), as well
as how they have put their strategies and plans into effect and
what has resulted. The summary includes:
(1) Tangible outputs completed
(2) Possible outputs in the up-coming quarter
(3) An updated schedule for the up-coming quarter ( noting
anv changes made from the original accomplishments
schedule )
(4) Problems and proposed resolutions
(5) Utilization of funds ( not an accounting of where
funds have been spent, but an indication of how well
funding is being utilized, e.g., if the State / Tribe
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expects to have a surplus that could be used for
additional activities, or if funding may be
insufficient for planned activities )
The EPA Regional Program Office submits the mid-and end-of-year
reports to the Field Operations Division ( H7506C ), EPA Office
of Pesticide Programs.
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H. ACCOUNTING RECORDS AND FILING SYSTEMS
According to 40 CFR Part 31.20, applicants must expend and account
for funds awarded in accordance with state / tribal laws and
procedures for expending and accounting for its own funds. Fiscal
control and accounting procedures must be sufficient to: 1) track the
expenditure of funds separately for at least each of three components
( enforcement, certification and pesticide program activities ) of a
consolidated pesticide agreement; 2) permit preparation of financial
reports required by the regulations; and 3) permit the tracing of
funds to a level of expenditures adequate to establish that such funds
have not been used in violation of the restrictions and prohibitions
of applicable statutes.
For continuing programs, a proper filing system should be in place to
maintain accounting information at the start of the project period.
New applicants oust submit a description of the accounting filing
system with their cooperative agreement application and the system
should be evident within three months of tne start of the project
period.
I. EVALUATION PLAN
The cooperative agreement should include an evaluation plan mutually
acceptable to EPA and the state / tribe. As a minimum, the plan
should Include a schedule for conducting the mid-year and end-of-year
evaluations. Appendix VII describes program evaluations. The mia-and
end-of-year evaluations of pesticide program activities are provided
with the state reports to tne Field Operations Division ( H7506C ),
EPA Office of Pesticide Programs.
J. PROGRAM FUNDING
Appendix XXIV provides information of FY92 funding for the
Certification Program, the Ground Uater Protection Program, the
Endangered Species Protection Program, and the Uorker Protection
Program.
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IV. ENFORCEMENT ACTIVITIES FOR FY 92 WORK PROGRAM
A. INTRODUCTION
Each application for FY 92 enforcement cooperative agreement funds
must include a proposed work program consisting of a description of the
work to be conducted and a schedule for accomplishment of the outputs and
activities. In order to be eligible for enforcement funds, applicants
must be able to demonstrate a need for an enforcement program of at least
one half of a work year of inspectional / enforcement activities.
The applicant and regional office should work closely together to
develop a complementary EPA / state or EPA / tribal compliance program.
EPA and the applicants need to work together to effectively target
compliance monitoring and enforcement efforts towards the areas which
may pose the greatest risk to health and the environment. Targeting for
environmental results must be an everyday part of the enforcement program
1n the field.
The two national enforcement priorities for FY 92 ( follow-up on
major pesticide regulatory actions, and planning for and conducting worker
protection enforcement activities ), once Implemented in the field, should
help yield environmental results.
In order to help focus specific compliance monitoring efforts across
the country, Compliance Monitoring Strategies are developed by the Office
of Compliance Monitoring as major pesticide regulatory actions are taken
by EPA throughout the year. These strategies directly impact the work
conducted under cooperative agreements ana will be forwarded to the state
/ tribes by the regional offices. Additional outputs required by new or
revised strategies may require the renogatiation. during the project
period, of the outputs agreed upon prior to the beginning of the project
period; this may include substituting newly required outputs for similar
type outputs 1n the original agreement. Follow-up on these compliance
monitoring strategies is essential if their intended purpose is to be met.
EPA will place increased emphasis on follow-up to compliance strategies in
FY 92 through semi-annual evaluations and more frequent follow-up after
the issuance of specific enforcement strategies.
To assist pesticide enforcement grantees, a sample core enforcement
work program for FY 92 is included 1n appendix VIII. The sample core work
program outlines the activities which must be addressed as a minimum in
every application. It could be used by interested pesticide enforcement
grantees as a starting point for developing their FY 92 pesticide
enforcement grant work programs. The EPA regional offices have also
received computer discs containing this sample core work program.
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B. WORK PROGRAM ACTIVITIES
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As a minimum. each compliance cooperative agreement work program
must address: 1) each of the eight national issue-specific compliance
monitoring activities discussed below (a-h); 2) priority setting; 3)
inspection and sample collection activities; 4) quality assurance; S)
formal referrals; 6) enforcement response, and case development; 7)
tracking requirements; 8) reporting; 9) accounting records and filing
systems; 10) evaluationsi; 11) unresolved problems; and 12) EPA support.
1. Issue-specific Compliance Monitoring Activities
Thi3 section addresses the following compliance monitoring activities:
a) cancellation, suspensions and other major regulatory actions; b) worker
protection enforcement activities; c) enforcement activities for the
pesticide removal regulations; d) enforcement activities for groundwater
protection; e) enforcement activities for endangered species protection;
f) Section 6(9) Information submittal and pesticide recalls; g) exports;
and h) certification and training.
a. Cancellations, Suspensions and Other Major Regulatory Actions
For FY 92, a national enforcement priority will be following up on
cancellations and suspensions of pesticide products, and other major
regulatory actions. States will conduct cancellation / suspension
inspections and other compliance monitoring activities to assure
compliance with major pesticide regulatory actions within the time frames
specified in the nationally issued Compliance Monitoring Strategies.
Inspections and other compliance monitoring activities for this priority
area will address: 1) major cancellation actions: 2) all suspensions
under FIFRA Section 6; 3) FIFRA Section 3(c)(2)(B) suspensions; and 4)
other major pesticide regulatory actions ( i.e. label improvement
programs, etc. )
On the quarterly reporting form ( EPA form 5700-33H ), the recipients
must document that compliance monitoring for cancellation / suspensions
was completed as a component of their comprehensive inspections. ( There
is a reporting block under each type of inspection on the reporting form
for this purpose. ) As discussed under the "tracking" section of this
guidance, recipients must track the inspections, violations found and
enforcement actions taken in follow-up to cancellations and suspensions.
Narrative reports will be prepared on the inspections and enforcement
actions taken as specified in the applicable compliance monitoring
strategies.
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b. Uorker Protection Enforcement Activities
Another national enforcement priority for FY 92 will be planning for
and conducting enforcement activities for the revised worker protection
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standards and associated labeling requirements. This will be based on
publication of the final rule as described below. ( Required worker
protection enforcement activities are discussed in items "I" through D6U
and continue through page 43. )
1. Notification to Prospective Constituents
Between the publication date of the Final Rule and effective dates
for compliance, states and tribes must use the opportunity of inspections
conducted under the cooperative agreement ( with the exceptions noted
below ) to notify prospective constituents of the provisions of the final
rule and to ensure compliance with current worker protection requirements.
This would be in addition to any other methods for notification used by
the state. ( Export and dealer inspections would tend to be the only
inspections which would not facilitate notification of prospective
constituents. )
2. Compliance Monitoring Strategy
States and tribes must submit to their EPA regional office a
Compliance Monitoring Strategy for worker protection within six months of
the publication date of the final rule. This is part of the overall
implementation strategy discussed in Part III. E. of this guidance.
OCN's Pesticide Enforcement Policy Branch will issue the draft
national Compliance Monitoring Strategy upon publication of the rule
or shortly thereafter, giving states a chance to study it and begin
developing their own. The state strategy should be consistent with the
national strategy.
The state's strategy will then be reviewed and commented on by the EPA
regional office within one month of receipt. ( The region's review should
focus on whether the state's strategy adequately follows the national
strategy and whether the proposed strategy is appropriate, given the
state's particular situation. ) The state or tribe will then address the
region's comments, if any, within one month of receipt and forward the
revised strategy to the regional office.
If a state / tribe cannot submit the strategy within six months of the
publication date of the final rule, the regional office and state should
reach agreement on a new date for submittal. In the meantime, the state
must follow the national Compliance Monitoring Strategy. The regional
office shall then request, in writing, concurrence from OCM's
- 38 -
Grants and Evaluation Branch on the new date, explaining the reason for
the delay. ( Such requests are expected to be the exception rather than
the rule. )
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For informational purposes, the regional office shall send a copy of
the state / tribe's final strategy to OCH's Grants and Evaluation Branch.
( Appendix XIV provides two outlines which the state may use for OCH's
Compliance Monitoring Strategy and for OPP's Implementation Strategy. )
As a minimum, the compliance monitoring strategy must include a
compliance communication strategy, a description of interagency
coordination, and a targeting scheme as distinct components, as discussed
below.
a) Compliance Communication Strategy
The applicant must develop and submit a compliance communication
strategy for worker protection. This will describe the actions which
the applicant will take using enforcement funds to communicate the
enforceable provisions and effective dates of the worker protection
rule.
( If an applicant is concerned about the distinction between the
"outreach / communication" section of the Implementation plan required
by 0PP, ana the compliance communication strategy, keep the following
point in mind. The compliance communication strategy shall focus on
the types of communication activities to be supported with enforcement
funds. If no such activities will be supported with enforcement
funds, then this section of the compliance monitoring strategy
should simply state so and refer to the outreach section of the
Implementation Plan. Otherwise, this section should describe the
actions to be taken in FY 92 to communicate the enforceable
provisions. )
The applicant must identify in the Compliance Communication Strategy
the specific sectors of the regulated community that will be affected,
explaining how and when the state / tribe plans to inform each sector
of the requirements of the revised rules.
The applicant shall gather information available on the number and
location of the pesticide users and regulated community in the
state or on the reservation within the various sectors likely to be
affected. ( The national Compliance Monitoring Strategy will provide
further guidance on where a state might find information outside
of the lead agency to help identify the sectors of the regulated
community that will be most affected by the new standards ). The
applicant should discuss with the region the extent and quality of the
information gathered, based on the
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information resources available. This information is necessary to
give the state / tribe an objective basis from which to better target
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worker protection inspections. It could also help the applicant
decide where to concentrate efforts to inform the affected regulated
community. ( The national Compliance Monitoring Strategy for Worker
Protection will give further guidance on priorities for targeting. )
The applicant oust inform the regulated community of its
responsibility to comply with the Worker Protection Rule. Apart
from inspections, the applicant will need to develop other means of
communicating this information. The state / tribe might, for example,
hire a communications expert to develop a media strategy, post
compliance notices in pesticide dealerships or develop compliance
newsletters of "compliance articles" for inclusion in appropriate
journals. These and other approaches could be considered by the
applicant in developing their enforcement compliance strategy. The
approaches and actions to be taken to communicate the enforceable
provisions of the final rule and to be supported with enforcement
funds must be described in the compliance communication strategy.
b) Inter-Agency Coordination
Some agencies other than the recipient of enforcement cooperative
agreement funds may have jurisdiction and responsibility for enforcing
the worker protection standards for pesticides and associated labeling
requirements. The recipient of the enforcement cooperative agreement
funds is the lead agency for enforcement and must develop a mechanism
for coordination with tne other agencies involved. The lead agency
must clarify in writing this mechanism and specific roles and
responsibilities of each agency. The applicant may want to consider
entering into a sub-grant with the other agency involved and pass
through a portion of the worker protection enforcement cooperative
agreement funds, as appropriate. As soon as the final revisions to
the worker protection regulations are published, cooperative agreement
recipients should begin discussions with other appropriate agencies.
The Inter-Agency component of the compliance monitoring strategy must
include:
1. A clarification of the specific roles and responsibilities of
each agency which has jurisdiction and responsibility for
enforcing the worker protection standards in the state;
2. A description of the mechanism for coordinating with the other
agency / agencies involved; and
- 40 -
3. A copy of any sub-agreement package negotiated and approved.
Development and submittal of the above only applies to applicants
in situations where more than one agency has jurisdiction and
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responsibility for enforcing the worker protection standards. ( It
is important to address this topic specifically within the enforcement
context since 1t may be the case in some states that worker protection
enforcement responsibilities are shared, but program responsibilities
are not shared, or vice versa. )
c) Targeting Scheme to Ensure Compliance with the Uorker Protection
Rule
The applicant must develop and submit a scheme specifically for
targeting inspections to ensure compliance with the worker protection
rule. Targeting will not be Implemented until the effective dates
for compliance nave passed. The dates will be specified in the Final
Rule. ( 0CN recognizes that if a state requires more than six months
to complete their compliance monitoring strategy, it will probably be
due to the development of a targeting scheme. If it is necessary to
renegotiate a date for submittal, the region might want to require
timely submittal of the first two components while allowing the state
more time to develop a targeting scheme. )
These inspections should be comprehensive, targeted specifically for
when and where activities regulated by the worker protection rule are most
likely to take place. (Specific guidance on the priorities to consider
in targeting worker protection inspections will be included in the
national Compliance Monitoring Strategy, which applicants will use to
help identify the priorities applicable within tneir state / tribe. )
3. Implementation of Compliance Monitoring Strategy
Uithin eight months of the publication date of the final Revised
Uorker Protection Standards, or before, states / tribes must begin to
Implement the compliance communication strategy and Inter-agency
coordination components of their Compliance Monitoring Strategies.
( If the state / tribe does not have a compliance monitoring strategy
in place eight months after the publication date of the rule, it
must begin implementing the National Compliance Monitoring Strategy
until tne state strategy is in place. ) This eight month time frame
takes into account submittal of the strategy, review by EPA and the
aforementioned time for making changes, if any, to the strategy.
Once the effective dates for compliance with the Final Rule have
passed, the targeting scheme must be implemented.
- 41 -
4. Inspectional Activity
(a) Conducting Inspections
Once the compliance dates for the revised worker protection rule
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have passed, the state / tribe's pesticide inspection activities
will need to include monitoring for compliance with the new
worker protection labeling requirements. Honitoring for
compliance with worker protection requirements shall be another
element of comprehensive inspections.
(b) Incident and Complaint Investigations
Applicants will also conduct investigations in response to
incident and complaint reports.
(c) Tracking
EPA will track Sections 26 and 27 referrals; applicants will
track tips and complaints not referred by EPA.
(d) Inspection Checklist
It is recommended that the applicant use the national Checklists
now under development. The Checklists will include a section
for monitoring compliance with Worker Protection requirements
once the compliance dates are effective. The checklist may be
expanded or modified to suit state / tribe requirements, as
appropriate.
5. Training
Using funds received for worker protection enforcement, states
tribes should send appropriate personnel to available EPA-sponsored
raining sessions on the new Uorker Protection Rule, provided that the
state lead agency can obtain approval for employees to travel out-of
-state, if necessary. The number and type of personnel to be sent should
be discussed with the region. If the state or tribe needs to supplement
federal training with their own training, the development of this training
should be coordinated and discussed with the regions.
- 42 -
6. Reporting
Applicants will need to specifically report on the implementation
of their compliance monitoring strategy and the other worker protection
enforcement activities described in this section. Two reporting
mechanisms will be used to document the state / tribe's worker protection
compliance monitoring activity.
1. Evaluation Reports
The regions will document the state / tribe's worker protection
compliance efforts as part of the mia-year and end-of-year evaluation
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reports. ( As a minimum, evaluations must address the topics listed
in OCN's core protocol for FY 92 mid-year and end-of-year reviews of
worker protection enforcement activities. This evaluation protocol is
being updated during FY 91. )
A thorough discussion and evaluation of activities will be necessary
in order to provide useful information to Congress.
2. Quarterly Accomplishment Reports
The second mechanism will be through the quarterly reporting
mechanism. Following the effective dates for compliance, the
state's inspections performed under the cooperative agreement must
Include monitoring for compliance with the worker protection rule.
( Export, certified applicator records and dealer inspections are
not applicable in this case. ) If monitoring for worker protection
requirements was not included as part of every remaining type of
inspection, the grantee must explain why in tne narrative section of
the quarterly report.
Once the compliance dates are effective, this information will be
used in reporting to Congress and responding to Congressional requests for
specific information on the number of inspections performed to monitor
compliance with the worker protection rule and to ascertain the status of
enforcement efforts and implementation of worker protection compliance
strategies.
c. Planning Enforcement Activities for Residue Removal
For FY 92, states will need to plan for enforcement activities
to ensure compliance with the pesticide residue removal regulations.
( Implementation of these activities is expected to be a national
enforcement priority for FY 93. )
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Under Section 19(f) of the amended FIFRA, by December 24, 1991 ( the
end of the first quarter of FY 92 ), EPA must promulgate regulations that
prescribe procedures and standards for removing pesticides from containers
before disposal. Effective December 24, 1993, a state may not exercise
primary enforcement responsibility under Section 26, or certify an
applicator under Section 11, unless the Administrator determines that the
state is carrying out an adequate enforcement program to ensure compliance
with the aforementioned regulations.
In preparation for this deadline, states must plan for the
state enforcement activities which will ensure compliance with these
regulations. To this end, by the end of FY 92 eacn state must, as a
minimum, submit an outline detailing specific proposed activities
which will be conducted to ensure compliance with the residue removal
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regulations. ( The national enforcement guidance to be issued with these
regulations should assist the states in identifying and carrying out these
enforcement activities. )
d. Enforcement Activities for Groundwater Protection
1. In FY 92, states / tribes will continue to monitor compliance
with and enforce labeling as part of their routine inspections
based on priorities agreed upon between the region and the
state.
In targeting use inspections, states / tribes will take into
account areas of high risk for groundwater contamination, along
with how these areas overlap with locations of pesticide use.
In their quarterly reports, states / tribes will document the
number of inspections which included compliance monitoring for
groundwater-related requirements or groundwater sampling.
2. As part of the enforcement activities associated with a
groundwater protection implementation plan or state / tribal
Hanagement Plan, states / tribes may conduct the following
activities in FY 92:
These activities relate to enforcement elements that may make
up a particular state's / tribe's groundwater management plan. These
activities may be part of either a generic or pesticide-specific
management plan that may be funded by 0CH enforcement monies.
a. For those states / tribes that have not already done so,
they must plan for, identify and describe their enforcement
authorities, capabilities and activities which will be used
to ensure compliance with the provisions of their ground
water management plan ( or groundwater protection
implementation plan ); they must also include a clear
statement of the
- 44 -
roles of different agencies if more than one agency within
a state / reservation will potentially be involved with
enforcement activities for protection of ground water from
pesticide contamination.
This identification / description must occur according
to a schedule agreed upon with the regional office and
the aforementioned description must be submitted to the
regional office for review and approval.
b. States / tribes will implement the aforementioned
enforcement activities.
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c. If applicable within a state, FY 92 funds may be used by
states / tribes to develop any Hemoranda of Understanding
with other agencies to coordinate specific enforcement
responsibilities and actions.
d. If states / tribes need to develop enforcement authorities
and/or prohibitions which are more stringent than those
currently in place for the protection of ground water from
pesticides, then a portion of cooperative agreement funds,
as agreed upon with the regional office, can be used
for development of such enforcement authorities. The
development should occur according to a schedule agreed
upon with the regional office.
3. Several existing federal statutes currently provide
enforcement authorities in cases where water supplies have been
contaminated and are posing imminent and substantial risks to
the health of those using the effected water system.
For example, when contamination is detected within a public
water supply and exceeds a Maximum Contaminant Level ( HCL ),
the contamination constitutes a violation of the Safe Drinking
Water Act ( SDWA ) regulations for which the public water
system is responsible. The SDUA includes emergency powers to
respond to contamination, of either public water supplies or
underground sources of drinking water, that present an imminent
and substantial endangerment to the health of persons. Under
this expanded authority, EPA may issue orders requiring the
provision of alternative water supplies by persons who caused
or contributed to the endangerment. Under CERCLA, EPA has the
authority to require corrective action by parties responsible
for ground water contamination. The Agency can also recover the
costs of cleaning up a site resulting from illegal disposal or
leaks and spills. EPA and the states needs to take advantage of
the CERCLA
- 45 -
enforcement authorities by closely coordinating their efforts
under FIFRA and the SDUA with those of CERCLA. In general, EPA
and the states should place more emphasis on coordinating FIFRA,
SDUA, RCRA and CERCLA enforcement activities to identify parties
responsible for groundwater contamination as a result of misuse
of pesticides, including illegal disposal or leaks and spills.
When developing either the generic or pesticide-specific
management plan, states / tribes should consider the enforcement
authorities available under other federal / state statutes, when
it comes to contamination of ground water or drinking water
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supplies, and coordinate enforcement activities with EPA and
other state agencies, as appropriate, to make full use of other
statutes where applicable.
In relation to the above, it is recommended ( but not required )
that the state lead agency ( SLA ) develop for their own use an
"enforcement authorities chart" which indicates the enforcement
authorities of each of the state agencies associated with
enforcement for pesticide contamination of ground water or
drinking water supplies. This chart would also contain the name
of the state agency contact and his/her phone number. The state
inspectors and managers could use this as one tool in developing
the best enforcement approach with regard to preventing or
follow-up to ground-water contamination.
e. Enforcement Activities for Endangered Species Protection
Please note: EPA anticipates that sometime 1n FY 92 the Agency will
issue Pesticide Registration ( PR ) Notices to registrants of affected
products. The Notices will require pesticide registrants to modify the
labeling of products affected by the Endangered Species Protection
Program. All affected products "sold or distributed" after a specified
date will be required to carry a label statement directing the user of the
product to comply with the limitations in the bulletin.
1. Enforcement of the use limitations to be imposed to protect
listed species will be carried out under the provisions of FIFRA
addressing misbranding and misuse. Products whose use required
limitations to protect listed species and which do not carry the
necessary information on the product labeling, may be identified
through routine inspections of manufacturing facilities and
pesticide distributors and dealers or through information
received regarding suspected misbranding. Products found to be
misbranded ( i.e., do not carry the required label language to
protect listed species ) may be subject to
- 46 -
enforcement action. In the field, pesticide misuse will be
identified similarly through routine inspection and information
provided regarding alleged misuse of a pesticide product. In
targeting use inspections, states / tribes will take into
account areas inhabited by endangered species, along with how
these areas overlap with locations of pesticide use.
2. Once the final Endangered Species Protection Program is
published by the Agency, the states / tribes will need to plan
for and Implement appropriate enforcement measures. The states
/ tribes will need to comply with the national Compliance
Monitoring Strategy for the Endangered Species Protection
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Program to be issued in FY 1992.
f. Section 6(g) Information Submittal and Pesticide Recalls
Section 6(g): Under FIFRA Section 6(g). EPA may require all persons
who produce, sell, distribute or commercially use a suspended or cancelled
pesticide to notify EPA, state and/or local officials of the quantities
in their possession and their location. Time frames for submission of the
section 6(g) information will be stated in each cancellation or suspension
order or in a FIFRA section 6(g) notice. Failure to submit accurate
section 6(g) information, and/or failure to submit information in the
required time frames, is a violation of FIFRA section 12(a)(2)(K) and Is
subject to civil penalties up to the statutory maximum.
As part of their routine Inspections, states and tribes will help
to.enforce the information submittal requirements. States will consider
the information they receive on quantities and locations of suspended
or cancelled pesticides ( received either directly from the regulated
community or from the region ) in targeting future inspections.
Additionally, the region may refer inspections to the states, although
the number that the state may be asked to perform in support of the
information submittal requirements is impossible to project and may
require some adjustments to other projected inspectional activities.
Note: 0CH plans to track information submitted by the regulated
community. 0CH plans to then send a report to each regional office
indicating the quantity and location of cancelled or suspended pesticides
stored within the jurisdiction of that region. It has not yet been
determined if the region will be required to submit this information
to the affected states. How the state plans to track the information
necessary to enforce the 6(g) information requirements — whether using
information provided by the region or through the state's own tracking
efforts - should be clarified in the cooperative agreement.
- 47 -
Pesticide Recalls: EPA may also require registrants and distributors
to recall pesticide products which have been both suspended and cancelled.
Once these recall requirements are effective, states / tribes will need to
enforce where applicable. ( This applies only to pesticides suspended
under section 6. ) Once these requirements are effective, the states
/ tribes and regional offices should discuss the relative priority of the
different activities being conducted under their enforcement cooperative
agreement. ( For both section 6(g) and section 19, 0CN plans to issue
either generic or chemical specific national strategies, which also
address the suspension / cancellation. )
g. Exports
In order to enhance enforcement in this area, the states were
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requested to conduct pesticide export inspections in FY 91, the number for
which was negotiated with the regions. In FY 92, the states will continue
this effort by conducting a number of pesticide export inspections; the
specific number will continue to be negotiated with the regions. 0CN will
provide specific information for targeting facilities by early FY92.
( For your background information, an explanation of the pesticide
export requirements is included in appendix XV. 0CH previously provided
guidance on conducting and targeting facilities for export inspections.
Compliance checks dealing with the export of a newly cancelled product
will be included in all chemical specific cancellation strategies. In
addition, since a new export policy is expected to be issued in FY 91,
the states and the regions should be aware that a compliance monitoring
strategy dealing with exports will follow shortly thereafter. )
h. Certification and Training
States will enforce the revised final certification and training
regulations to be issued in FY 92. The new certification and training
regulations will cover minimum standards for training and certifying
pesticide applicators and minimum record-keeping requirements.
2. Priority-Setting
The work program should include a priority-setting plan for
compliance-related activities.
New applicants need to submit a priority-setting plan with their
cooperative agreement application; the plan should be based on the best
available data. Applications for continuing programs need to: 1)
reference their existing priority-setting plan; 2) indicate any changes
in the plan and include a copy of their plan, if it has been amended or
changed; and 3) list the priorities for the year being addressed.
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Each priority-setting plan should include the following elements: 1)
establishment of criteria for setting priorities; 2) review of information
sources and listing of problem areas; 3) ranking of problem areas to be
dealt with; and 4) a distribution of the available resources to the
problem areas based upon the magnitude of the problem. The priority
-setting process should enable a state to concentrate its training,
compliance monitoring, and enforcement programs on specific pesticide
manufacturing, distribution and use activities that pose the greatest risk
to health ana the environment. The outline for priority-setting plans,
provided in appendix XIX, is recommended, not required; states may use
their own outline, provided that the four basic elements listed above are
addressed. Appendix XIX also includes a model priority-setting plan,
based on the recommended outline.
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During FY 91, a work group on priority-setting is proposing a standard
method for organizing data that serves as the basis for priority-setting.
A full description of this proposal will be circulated for comment. As
part of FY 92 cooperative agreement activities, states and tribes may be
asked to begin planning and implementing a mechanism to collect and track
this violation information. The costs Tor gathering and submitting this
information may be negotiable under the cooperative agreement.
3. Inspection and Sample Collection Activities
Applicants will project and conduct inspections and sample collection
activities. Once the applicant has determined its priorities ( taking
into account the national enforcement priorities ), the state / tribe
shall describe its proposal for carrying out a balanced program that
addresses these priorities during the agreement period. The outputs,
which the applicant proposes to accomplish during the agreement period,
must be aimed at solving and dealing with the pesticide problems
identified by the priority-setting process.
Uith regard to sample-related projections, prior to negotiations with
EPA, the state lead agency shall consult with tneir colleagues in the
state laboratory which will be conducting sample analyses under the
cooperative agreement. This should help facilitate input from the state
laboratories into the cooperative agreement program, in a coordinated
manner within the state. Where appropriate, the state lead agency ( SLA )
is encouraged to Invite their state laboratory representative to the
negotiation session with EPA.
Categories of Inspections: Inspections must be conducted in
accordance with the procedures set forth in the updated Pesticides
Inspectors Manual ( or comparable state procedures ). The categories of
inspections and investigations to be conducted include:
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o agricultural use;
o non-agricultural use;
o experimental use;
o producer establishments;
o marketplace;
o imports;
o exports;
o certified applicator records;
o restricted use pesticide dealer.
Federal facility inspections would be sub-sets of these.
Federal Facility Inspections: Uith regard to federal facility
inspections, as stated in the EPA Federal Facility Compliance Strategy,
November 1988, "... with the exception of very limited presidential
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exemptions federal agencies must generally comply with all
provisions of federal environmental statutes and regulations as well as
all applicable state requirements 0 The state / tribe and region
should agree on a plan to ensure adequate inspection coverage of federal
facilities in each state. In most cases the regional office will
negotiate a commitment for the recipient to conduct an agreed upon number
of federal facility Inspections. These inspections should be sub-sets of
the categories of inspections routinely conducted and outlined above.
Comprehensive Inspections: It is expected that the states / tribes
will conduct comprehensive inspections, addressing every element of each
type of inspection. As part of comprehensive inspections, we want to
highlight the Importance of specifically checking for cancellations
/ suspensions, child resistant packaging and any labeling or other
requirements affecting groundwater, endangered species and worker
protection, once the compliance dates are effective.
Strategies: States / tribes need to follow requirements related to
inspections which are included in national Compliance Monitoring
Strategies.
In FY 92 EPA will be placing increased emphasis on follow-up of
compliance monitoring strategies through semi-annual evaluations and more
frequent / detailed follow-up after the issuance of specific compliance
monitoring strategies. State / tribes should continue to prepare
narrative reports on the inspections and enforcement actions taken as
specified in the applicable compliance monitoring strategies.
EPA Form 5700-33H: EPA Form S700-33H must be completed and
include projections for the categories of inspections listed on the form.
( Detailed instructions for completing the form are in appendix XVIII. )
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Inspiection Time frames: Appendix II on "Application Review
Procedures" contains the time frames for inspection and sample collections
/ analyses to be used in evaluating pesticide enforcement cooperative
agreement applications. During the application negotiation the grantee
will commit to 1n3pectional, sampling, and analytical time-frames agreed
upon. ( They are the same as those included in the FY 91 guidance.
During FY 92. the time frames will be reviewed to determine how they
need to be changed, if at all, to address disposal-related compliance
monitoring efforts. )
Documentation of Inspections: Inspections must be conducted in
accordance with the procedures set forth in the updated EPA Pesticides
Inspection Manual ( or comparable state procedures ).
Among other things, it 1s critical to ensure proper documentation of
inspections ( affidavits, maps, photos, etc. ). This has been recently
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identified as an area of concern in several states. States need to ensure
that proper documentation is completed for each inspection.
Inspection Reports: Copies of all inspectional reports shall be
retained by the state / tribe for a reasonable period of time, but at
least until any associated enforcement cases are resolved and closed, or
until the close-out of a grant cycle. These reports must be available
for examination by EPA or be forwarded to the EPA regional office. EPA
Headquarters recommends that inspectional reports be retained for a
minimum of three years.
Applicants with partial or no enforcement capability must develop
procedures for forwarding inspection reports to EPA for enforcement
determination and action. These procedures must be submitted for review
with the cooperative agreement application and must be approved.
A. Lawn Care Activities
A March 1990 SAO report entitled, "Lawn Care Pesticides: Risks Remain
Uncertain While Prohibited Safely Claims Continue", recommended that EPA
pursue an enforcement strategy for monitoring lawn care pesticide industry
compliance with misbranding and "claims differ" provisions of FIFRA
section 12(a)(1)(B) and (E).
The Environmental Protection Agency has determined that labeling
claims like "environment friendly", "environment conscious", "chemicals
EPA approved", "environmentally sound", or the unsupported statement of
"biodegradable" constitute misbranding. These claims are prohibited
because they are safety claims, or non
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-numerical comparative statements. The Agency believes these terms are
relative, not definite, and therefore could be misleading to the product
user. A claim for a product which is substantially different from claims
made for the product at the time of registration constitute a 12(a)(1)(B)
violation or labeling which meets the definition of false or misleading
under 40 CFR, Part 156.10(a)(5) constitutes a 12(a)(1)(E) violation.
Collection and analysis of data is needed in FY 92, as well as follow
-up on any identified problems, to determine whether a long-term lawn care
enforcement strategy is appropriate. As part of the one-year FY 92
enforcement strategy, each state pesticide enforcement grantee will:
1) Review all possible literature from lawn care pesticide
registrants, manufacturers, distributors and professional
applicators, and pesticide advertisements 1n magazines,
newspaper, and telephone yellow pages to identify potential
violations of FIFRA section 12(a)(1)(B) and (E). In the course
of doing so, potential violations of state advertising
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regulations and/or the Federal Trade Commission ( FTC ) Act
may be identified as well;
2) Maintain a log of the names, issues and/or dates of literature
or any periodicals reviewed. ( This is to be provided to
Congress at the end of FY 92 to demonstrate the scope of the
review. );
3) Identify potential violations of section 12(a)(1)(B) and (E).
Document enforcement actions or referrals as follows:
A. Enforcement taken under section 12(a)(1)(B) or (E)
( Product Violations )
B. Enforcement taken under state law
C. Referral to FTC region ( Service Violations )
D. Referral to other state agency
4) Refer to the FTC Regional offices, or appropriate state
agencies, prohibited safety claims made by professional
pesticide applicators or any identified violations of the FTC
Act. A Brief background information is included in appendix
XXII. Additional information will also be included in the
compliance monitoring guidance to be issued by OCN.
5) Within the category of non-agricultural use inspections,
negotiate and
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incorporate Into regularly scheduled Inspections, a specific
number of lawn care use inspections, e.g., professional and
private applicators, golf courses and turf farms. The number of
lawn care inspections should be no less than ten (10) in a state
and be written into the cooperative agreement.
6) During the mid-year FY 92 evaluations, the states will submit
the documentation to date on review of periodicals. Included
will be the number of inspections focusing on lawn care as of
the end of the second quarter, any enforcement actions taken
under FIFRA or state laws, and any referrals to FTC / state
agency as of that date. The data for the third and fourth
quarters of FY 92 will be submitted with the fourth quarter
report on inspections. To facilitate consistency in
documentation, the states should create a format similar to
appendix XXIII documenting the results of their activities. The
appendix contains the acceptable minimum requirements for a log.
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To facilitate these use inspections and the aforementioned review of
advertising and periodicals, separate FY 92 compliance monitoring guidance
will be sent to the States, through the Regions, during FY91. The results
of the FY 92 initiative will be analyzed and distributed during the second
quarter of FY 93.
Producer Establishment Inspections: An agreed upon number of routine
producer establishment inspections should be negotiated with the region so
that all producer establishments in any given state are inspected over a
specified time-frame on a routine basis.
S. Quality Assurance
Applicants are responsible for analytical activities under their
compliance cooperative agreements and therefore must establish and
implement Quality Assurance Practices as described below. Analytical
procedures conducted for enforcement purposes under conditions specified
by the cooperative agreement are not subject to Good Laboratory Practices
( GLPs ). Laboratories performing analytical services under tnis
cooperative agreement must follow practices and methodologies as agreed
upon in their approved OA Project Plan.
All cooperative agreements involving environmentally related
measurements or data generation are required by the EPA Grant regulations
( 40 CFR Part 31.45 ) to develop and implement quality assurance practices
consisting of policies, procedures, specifications,
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standards and documentation sufficient to produce data of quality adequate
to meet project objectives and to minimize loss of data due to out of
control conditions or malfunctions.
a. Quality Assurance Project Plan
For FIFRA Enforcement Cooperative Agreement, a Quality Assurance Plan
is required for sampling / analytical activities conducted under the
agreement. Sampling activities are not allowed until an EPA-approved
Quality Assurance Plan is in place. The EPA Quality Assurance Management
Staff ( QAHS ) recommends that Quality Assurance ( QA ) Project Plans,
rather than QA Program Plans, be developed for FIFRA Enforcement
Cooperative Agreements.
QAHS has issued a document titled, "Interim Guidelines and
Specifications for Preparing Quality Assurance Project Plans" ( QAHS
- 005/80, December 29, 1980 ) to assist applicants in complying with the
quality assurance requirements. In addition, to assist applicants, NEIC
has developed a model quality assurance project plan for pesticides
sampling and analytical activities. The states / tribes may use this
model or develop their own. ( See appendix XVI. )
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Each region has an individual assigned as the Quality Assurance
Officer and that person will be available to assist the state / tribe in
development of a quality assurance program. Copies of the documents
referenced above will be obtained from the regional Quality Assurance
Officer, who is responsible for approval of the Quality Assurance Plan.
For continuing cooperative agreements, applicants conducting sampling
/ analytical activities under the agreement must have in place a current
approved OA Project Plan. If a Quality Assurance Project Plan submitted
in previous years continues to reflect the sampling and analytical
activities proposed for the current year, reference to the approved plan
on file in the EPA regional office will suffice. Any significant changes
1n content ( Including signatories ), however, requires submittal of
updated pages, or the entire plan as appropriate, with their cooperative
agreement application. For FY 91 every recipient which did not update
tnelr QA plan in FY 90 was required to review and update their plan ( as
appropriate ) and resubmit it to the regional QA officer for approval by
the end of FY 91. Therefore, we would expect, in the majority of cases,
submittal of updated pages or the entire updated plan during the first
month of FY 92.
New applicants, including both states and tribes, which will conduct
sampling / analytical activities under their FY 92 enforcement cooperative
agreement must submit their Quality Assurance Project Plans for approval
and implement these plans prior to conducting sampling activities under
the agreement. EPA Headquarters recommends
- 54 -
that this be done within the three months of the start of the project
period if not before the start. Sampling activities are not allowed until
an EPA-approved Quality Assurance Plan is in place. The schedule for
submittal of the QA Plan must be included in the FY 92 cooperative
agreement as agreed upon between the applicant and EPA.
b. Analytical Methods
Pesticide formulation samples collected for determination of product
compliance will be analyzed by the applicant's laboratory, or other
laboratory specified in the agreement, using the EPA Manual of Chemical
Methods for Pesticides and Devices. Association of Official Analytical
Chemists ( AOAC ) analytical manual ( 14th Ed. ), the Collaborative
International Pesticide Analytical Council Manual ( CIPAC ), or other
standard analytical methods. All potentially volatile samples will be
verified by procedures spelled out in the NEIC Pesticide Products
Procedures Manual or as otherwise specified in the Quality Assurance
Project Plan.
Pesticide residue samples in support of misuse investigations will
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also be analyzed by the applicant's designated laboratory, using available
FDA, EPA, USGS or other accepted methods available in the scientific
literature or by the pesticide industry. All reported results will be
accompanied by appropriate quality control parameters so as to allow
evaluation of precision, accuracy, freedom from interferences and
confirmation of pesticide ( or metabolite ) identity.
c. Cross Contamination Screening
Applicants conducting sampling activities will establish and utilize
a cross contamination screening program for pesticide formulations in
accordance with the EPA Cross Contamination Guidelines. ( See appendix
XVII. )
d. Check Sample Program
Each applicant conducting sampling activities will participate in the
EPA's National Enforcement Investigations Center ( NEIC ) Check Sample
Program. . Under this program, EPA submits pesticide formulations and
residue samples to applicant's laboratories for analysis and Cross
contamination screening, as appropriate.
The applicant must submit a report indicating the methodology used
and the results of the analysis to EPA. EPA will review the report and
inform the state / tribe regarding the accuracy of their analysis and
the methodology selected. If a state / tribe fails to obtain the
correct results, EPA will assess the problem, provide assistance to the
applicant's laboratory as appropriate and/or conduct other follow-up
activities. This program will also
- 55 -
help assess whether the states / tribes are screening pesticide
formulations for cross contamination, since some check samples may be
contaminated with another pesticide. NEIC currently notifies each
laboratory and regional office of the check sample results. The regional
offices will provide a copy of these results to each state lead agency or
tribal agency / Chairman in their region which utilizes that particular
laboratory for sample analysis.
e. Back up Analysis Procedure
The applicant can request back-up analyses from NEIC or other NEIC
recommended laboratories, if necessary or requested by the region.
Examples where backup analysis may be requested are:
o A state / tribe, which is unsure of the results of an analysis,
reguests an impartial or second analysis before initiating an
enforcement action;
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o A state / tribe requests that EPA take the enforcement action
and EPA desires to check the state's / tribe's analysis.
o A reference analysis is required due to conflicting results
between the state / tribe and the regulated party.
f. Training of Analytical Chemists
EPA will provide training of state inspectors and analytical chemist,
as necessary. Using cooperative agreement or other funds, the states
should avail themselves of EPA workshops, seminars and meetings on proper
sampling, analytical procedures, instrumentation, methodology and quality
assurance. The regions will work closely with the states to assist in
identifying needed training opportunities and help in coordinating
participation.
g. Laboratory Reviews
Personnel from EPA will also be available, if requested by the state
or EPA regional office, to review state laboratory analytical capability
and procedures, and to discuss areas needing improvement. Requests for
these visits, which will usually be made by representatives from NEIC or
the regional Quality Assurance Section, may be initiated by the state or
the EPA regional office; they will be arranged by the regional office. A
formal report of findings ana recommendations will be prepared by EPA for
the state upon completion of the on-site visit.
- 56 -
h. Provisions of Analysis Results
The applicant will send a copy of the results of any sample analysis
made under the authority of FIFRA to that person from whom the sample was
collected. This is a statutory requirement under section 9(a) of FIFRA.
i. Submission / Retention of Reports
Copies of all analytical reports, associated raw data and other
necessary records for samples collected will be obtained by the state
/ tribe and be available for examination by EPA, or be forwarded to the
EPA Regional Program Office.
The analytical reports must be retained by the applicant or the
EPA Regional Prograo Office until the associated enforcement cases are
resolved and closed out. It is recommended that analytical reports be
retained for a minimum of five years.
6. Formal Referrals
States / tribes will conduct activities under FIFRA Section 26 and 27.
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Section 27(a) of FIFRA requires EPA to refer to the states / tribes any
information the Agency receives indicating a significant violation of
pesticide use laws. In accordance with tne Final Interpretive Rule
governing FIFRA Section 26 and 27 and the 1985 policy memoranda from A.E.
Conroy II, EPA in consultation with each state / tribe will identify,
in writing, priority areas for formal referral to the state. These
priority areas will consist of those pesticide activities in the state
/ tribes which present the greatest potential for harm to health and the
environment. Tne priority areas will be revised annually, based upon
the effectiveness of the programs in reducing the harm associated with
pesticide use in the state / tribe. The negotiated written agreement
between the state / tribes and the region will contain the criteria for
the selection of significant pesticide use cases. Pesticide use cases
Involving worker protection, groundwater and endangered species will be
among those considered significant within the context of the agreed upon
criteria for significant pesticide use cases.
All pesticide use cases, identified as significant, will be referred
to the state / tribe by EPA in writing, and will be formally tracked
as set forth In the Final Interpretive Rule. All other cases will be
referred to the state / tribe for information purposes and will not be
formally tracked.
The EPA regional offices will formally track all significant pesticide
use cases, which are formally referred to the state / tribes under the
Final Interpretive Rule governing FIFRA Sections 26 and 27. The state
/ tribe must commence appropriate enforcement
- 57 -
action for cases, so tracked, within 30 days after completion of the
Investigation. This period may be extended, after negotiation, if
required by the procedural characteristics of the state / tribe regulatory
structure or the complexity of the case.
If the state / tribe has not reported on the investigative status
within 30 days of the date of referral, EPA will contact the state / tribe
to learn the results of the investigation and the intended enforcement
response to any violations detected. An investigation should be
considered adequate if the state / tribe has: (1) followed proper
sampling and other evidence gathering techniques; (2) responded
expeditiously to the referral; and (3) documented all inculpatory or
exculpatory events or Information.
If the region determines that the Intended enforcement response to
the violation is Inappropriate, EPA will first attempt to negotiate an
appropriate state / tribe enforcement response. If the state / tribe is
unwilling or unable to alter its original enforcement response, EPA may
bring its own enforcement action after notice to the state / tribe. That
notice will summarize the facts relating to the state / tribes enforcement
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response, discuss reasons for EPA's determination that the enforcement
action is inadequate and state that EPA will initiate its own enforcement
action. The region will not initiate an enforcement action sooner than
thirty (30) days after the state / tribe was notified.
7. Enforcement Response and Case Development
Applicants without state pesticide laws or tribal pesticide codes and
associated regulations must conduct inspections under federal authority-
State pesticide laws and tribal pesticide codes empower the state / tribe
to conduct both pesticide inspections and enforcement activities as
authorized by their laws or codes.
It is understood that most states have pesticide laws and
regulations in place. However, many states do not have civil penalty
authority. Such states are encouraged to take the necessary steps to
develop a civil penalty program and set a goal for completion of the law
/ regulations. Enforcement grant funds can be used toward this effort
based on discussions with the regional offices. It is also understood
that most tribe9 have not, to date, developed tribal laws or codes
including civil penalty authority. Tribes are encouraged to initiate
this activity and set a schedule for completion of the law / code and
initiation of implementation.
Work programs must address each of the following items (a-c) in this
section.
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a. Enforcement Response Policy
Each applicant conducting enforcement activities under the FY 92 grant
must have an up-to-date Enforcement Response Policy ( ERP ) in place
before the regional office approves funding for a cooperative pesticides
enforcement agreement. The timing of this guidance document should
provide sufficient lead time to affected applicants so that they can
update their ERPs, if necessary, prior to their submittal of the FY 92
enforcement cooperative agreement application.
In their applications, states / tribes must agree to follow
their ERPs. The regions and applicants should closely monitor the
implementation of each state's / tribe's Enforcement Response Policy to
determine its effectiveness and appropriateness. ( If the SLA does not
follow the ERP, then this problem oust be addressed during the semi-annual
evaluations. ) A properly prepared Enforcement Response Policy ( ERP )
will provide the applicant with a mechanism to evaluate the gravity of
each violation encountered, and to respond in a predictable, uniform, and
timely manner with an appropriate enforcement action.
A copy of the up-to-date ERP must be submitted along with the
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application, to OCH's Grants and Evaluation Branch in order to develop a
national repository of state ERPs.
As a minimum, each state's Enforcement Response Policy should include
the following:
o List of violations likely to be encountered;
o Mechanism for determining level of gravity for each type of
violation;
o List of enforcement remedies available for each type and level
of violation ( include both state / tribal and federal action );
o Escalation of penalties for second and subsequent violations;
o Consideration of potential pollution prevention enforcement
penalties and/or in settlement of enforcement cases; and
o Timetable which the state / tribe will follow to insure the
timely investigation of complaints and the timely issuance of
enforcement actions when violations are detected.
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In determining enforcement penalties and/or in negotiating settlement
agreements, applicants are encouraged to consider potential pollution
prevention activities which a violator could undertake in exchange for
an appropriate reduction in the enforcement penalty. States are also
encouraged to consider the inclusion of single or cross-media pollution
prevention conditions, as either the means of correcting the violation or
as additional conditions incidental to injunctive relief. Such conditions
are appropriate when they discourage recurring or future violations, have
no negative cross-media impacts, and are technologically and economically
feasible.
b. Case Development
As part of their work programs, applicants with enforcement capability
are responsible for preparing cases and taking appropriate enforcement
actions.
Applicants with partial or no enforcement capability must develop
procedures for forwarding inspection reports to EPA for enforcement
determination and action. These procedures must be submitted with the
Cooperative agreement application for review and approval.
Once an applicant chooses to develop a pesticide law or code,
standardized case preparation and enforcement procedures should be
developed concurrently with the law or code. These procedures must be
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developed according to a time line mutually agreed upon between the
applicant and EPA, and cited in the cooperative agreement prior to
approval of the agreement.
The review of all inspection reports for the detection of possible
violations and the initiation of appropriate enforcement action, is an
important part of every comprehensive pesticide enforcement program.
Applicants with enforcement capability will review the quality and
adequacy of evidence gathered during the course of all investigatory
activities performed under the cooperative agreement. Each cooperative
agreement should include sufficient resources, for this activity, to
ensure an adequate level of case development and enforcement, violations
of the applicant's and federal laws are discussed below.
1. Violations of Applicant's Law Only
The state / tribe oust review the quality and sufficiency of evidence
gathered in the course of all investigative activities performed under the
cooperative agreement. If the evidence reveals a violation of only the
state's / tribe's pesticide laws / codes, the state / tribal shall pursue
ah appropriate remedy provided by state / tribal Law.
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2. Violations of Federal Law Only
Where evidence reveals a possible violation of federal law only, the
state / tribe shall forward the information to the EPA Regional Program
Office within 30 days after completion of the investigation. All cases
forwarded to EPA shall include all evidence, inspection reports and/or
forms, a brief narrative of the case, and a recommended enforcement
response. The regional offices should have established time frames for
processing state referrals and a tracking system for referrals to the
states. Regions are encouraged to provide status reports to states
/ tribes on cases referred.
. The state / tribe will prepare and make available to EPA, when
requested, testimony and other evidence pursuant to the procedures adopted
by EPA. The state / tribe will provide witnesses for informal settlement
conferences, public hearings, and appearances in a court of law, as the
EPA requests.
3. Violations of Both the Applicant's and Federal Law
If evidence reveals a violation of both state / tribal and federal
law, the state / tribe may bring appropriate enforcement action under
state / tribal law of refer the case to EPA for action under FIFRA. In
the event that a case is referred to EPA for action, the EPA case
preparation officer should review the case file to ensure that state
/ tribal inspection procedures adhere to basic constitutional guarantees
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and EPA should proceed with the case.
For all pesticide cases, for which the state / tribe determines that
the most appropriate enforcement action is not available under state
/ tribal law, the state / tribe may refer such cases to EPA for
enforcement action under F1FRA.
c. Cross Jurisdictional Situations
For a successful cooperative pesticide enforcement program, there
should be cooperation between the tribe(s) and the state(s) in which a
tribe is located. Because many of the distributors and applicators of
pesticides on tribal lands are not located on the reservation, it is
important that tribe(s) and state(s) Involved be agreeable to developing
procedures for cooperative enforcement of problems involving cross
-jurisdictional situations. As a goal, EPA Headquarters recommends
establishment of such procedures. EPA regional Project Officers can
facilitate coordination between tribal representatives and state
representatives of the state in which the tribe is located by negotiating
time lines, where appropriate, to be included in both the tribe's and the
state's work programs.
- 61 -
8. Tracking Requirements
The applicant will establish and utilize a management system for
tracking all inspections, violations found, and enforcement actions
initiated. The tracking system should, at a minimum, include the
following elements:
Date of inspection
Reason for inspection ( routine complaint )
Name of person or firm inspected
Violation found
Summary of past compliance history ( or reference to
an appropriate case file number )
Enforcement action taken
Date of enforcement actions
Disposition of action
The tracking system must constitute a system for allowing the rapid
Identification of the status of a case and an information resource for
informing citizens of the ultimate disposition of their complaints.
Maintenance of the tracking documents and associated files and the
length of time that such files will be maintained must be addressed in the
cooperative agreement work program.
New applicants must submit a description of the tracking system with
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their cooperative agreement application and the system must be evident
within three months of the start of the project period.
Under the aforementioned or a separate tracking system, states
/ tribes will document and track the inspections, violations found and
enforcement actions taken in follow-up to cancellations and suspensions of
pesticides. Reports will be prepared on the inspections and enforcement
actions taken after the suspensions and cancellations as a specified in
the applicable compliance monitoring strategies.
9. Reporting
Applicants need to use EPA Form 5700-33H ( in appendix XVIII ) for
reporting inspection and sample collection accomplishments under the FIFRA
Enforcement Cooperative Agreement. A narrative report may need to
accompany the revised reporting
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form to discuss any pertinent state / tribal enforcement activities not
addressed on the form, any program highlights and/or any program problem
areas.
Completed compliance monitoring reporting forms are required
quarterly. These reports showing inspectional activities and enforcement
actions accomplished will be submitted by the state / tribe to the EPA
regional office within 30 calendar days following the completion of each
federal fiscal year quarter. Quarterly reports are due by January 30,
April 30, July 30 ana October 30 of each year. States with fiscal years
that do not begin on October 1, should still report accomplishments as of
these dates.
Reports will be prepared on inspections and enforcement actions taken
after "major pesticide regulatory actions" as specified in the applicable
compliance monitoring strategy.
The regional offices' requirements for reporting cooperative agreement
projections and accomplishments to Headquarters are discussed at tne end
of appendix XVIII.
10. Accounting Records and Filing Systems
Applicants oust maintain accounting records for funds awarded
for each component under each agreement ( including receipts, state
/ tribal matching contributions, and expenditures T in accordance with all
applicable EPA regulations and generally accepted accounting principles.
For continuing programs, a proper filing system should be in place to
maintain accounting information at the start of the project period. New
applicants oust submit a description of the accounting TiLing system with
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Order number 930528-081520-PLC -001-001
page 89 set 11 with 3 of 6 items
their cooperative agreement application and the system should be evident
within three months of the start of the project period.
11. Evaluation Plan
The cooperative agreement should include an evaluation plan mutually
acceptable to EPA and the state / tribe. As a minimum, the plan should
include a schedule for conducting timely mid-year and end-of-year on-site
evaluations. During, or in follow-up to, evaluations the states and tribe
should be prepared to discuss strengths and problems in the program,
negotiate a corrective action plan as necessary, and discuss specific
recommendations for follow-up activities. Appendix IV will describe
program evaluations. ( The national evaluation protocol is being updated
to reflect changes 1n the grant guidance, increased emphasis on Tollow-up
to compliance monitoring strategies, findings from recent audits of the
enforcement grant program, and pertinent findings from the national
Qualitative Review of the FY 89 state Pesticide Enforcement Cooperative
- 63 -
Agreement Program. It will be circulated to the EPA regions for comment
prior to being finalized. )
12. Unresolved Problems
The cooperative agreement work program must address any unresolved
problem areas identified in the most recent end-of-year evaluation and
the mid-year evaluations for the current project period and indicate how
the state / tribe and/or EPA will address the problem(s). The plan for
addressing the problem(s) must include a schedule / time frame for
implementing the plan.
13. EPA Support to States / Tribes
The cooperative agreement should describe the types of support
( inspector training, NEIC laboratory analysis training, technical
assistance, contractor assistance^ expert witnesses for state enforcement
proceedings, etc. ) that the applicant expects EPA to provide and is or
will be available to assist the state / tribe in meeting its commitments.
The cooperative agreement should describe any negotiated agreement
between the state / tribe and EPA for the handling ot referrals and
requests for Information from the state / tribe. The agreement should
include any time frames that are mutually agreeable to the state / tribe
and EPA.
V. ALLOTMENT OF COOPERATIVE AGREEMENT FUNDS
This section addresses how specific funding allotments were determined
for the components of the cooperative agreement program dealing with
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Order number 930528-081520-PLC -001-001
page 90 set 11 with 3 of 6 Items
enforcement, certification, worker protection program activities, ground
water program activities and endangered species program activities. A
summary of funding allotments for all components is provided on the chart
at the end of this section.
The Pesticides Program annual budget submission to Congress request
an overall program appropriation for pesticides enforcement cooperative
agreements. Applicants are to use the initial allotments as a basis for
developing, with their respective regional offices, work programs that
meet both the applicant's and the Agency's needs.
0CN expects to receive $15,803,400 for funding the cooperative
enforcement program. This is the same funding level as that received in
FY 91.
If the budget is not approved by Congress, the proposed allotments
will be readjusted. The majority of the Agency's appropriation is
allotted to the regions and
- 64 -
cooperative agreement applicants through a base and formula funding system
described in sections "a" and °b" below.
Sections "a" and "b" which follow address the enforcement cooperative
agreement budget minus the following: a) $500,000 in funds for possible
continuance ot a Pesticide Officials Pilot Program, location as yet
undetermined; b) $1,000,000 for worker protection, groundwater and
endangered species enforcement-related activities; c) the $2,000,000
budget for worker protection enforcement-related activities; d) $500,000
for addressing some of the laboratory-related needs, in consultation
with the U.S. Department of Agriculture, which has related activities
underway 1n the area of food safety. The funds specifically set aside for
laboratory-related needs will be discussed in separate correspondence to
the regions and states, who will be asked to work with EPA in continuing
this effort; and e) approximately $300,000 in funds set aside in case
fovernment-wide budget reductions are necessary in FY 92; rather than ask
or the return of funds in the event such government-wide reductions
occur, 1t seemed prudent instead to set aside some funds up front to cover
potential reductions. If such reductions are not mandated in FY 92, the
funds set aside will be redistributed to the states.
The $2 million budget for worker protection enforcement is addressed
separately under section 2, and the $1 million budget for groundwater,
endangered species and worker protection enforcement related activities is
discussed under section 4.
A. Base Funding
A base funding level is established for each state, territory
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Order number 930528-081520-PLC -001-001
page 91 set 11 with 3 of 6 items
and Indian tribe expected to participate in the cooperative
agreement program. For FY 92, the following base funding levels
have been established: $107,100 for each participating state,
the District of Columbia and Puerto Rico ( 51 entities );
$56,700 for the Virgin Islands; $42,600 for Guam; $28,500 for
American Samoa; $28,500 for the Commonwealth of the Northern
Mariana Islands ( CNHI ); $22,300 for the Trust territories of
the Pacific Islands; $140,500 for five Indian tribes in Region
VIII; $280,000 for the Inter-tribal Council of Arizona and the
nine Indian tribes under ITCA which receive enforcement funds;
$81,500 for the Navajos; and $30,000 for the Shoshone-Bannock
Indian tribe in Region X.
Please note that the funding levels listed above for the Virgin
Islands, Guam, American Samoa, CNNI, the Trust Territories and
Indian tribes are derived from both the core enforcement and
worker protection enforcement budgets.
- 65 -
The FY 92 enforcement base funding level will continue at
$107,100 per state. Ue will continue to provide a $20,000 base
for worker protection enforcement activities ( with funds from
the worker protection enforcement budget, discussed in section
For FY 92, the guideline used in determining the base funding
level for an enforcement cooperative agreement with a tribe
is $30,000. Budgets must be submitted and approved for all
enforcement cooperative agreement programs. Tribal programs
requiring less than the $30,000 guideline will receive funding
based on approved budget submittal. Any tribal program
requesting more than the base funding level for FY 92 must
submit a detailed budget to EPA clearly justifying the need for
the proposed funding level, this budget must be approved by the
EPA regional office and OCH's Grants and Evaluation Branch.
Funds nave been set-aside for new tribal grantees which may
apply for enforcement cooperative agreements in FY 92. These
funds will be redistributed if applications are not received.
The total base funding for the basic enforcement program is
$6,030,100.
1. Formula Funding
Total formula funding available is determined by subtracting the
total base amounts from the total appropriation. The total
amount of funds available for distribution by formula in FY 92
is $5,551,500. The formula funds for the enforcement base
program will be divided among 49 states, the District of
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Order number 930528-081520-PLC -001-001
page 92 set 11 with 3 of 6 items
Columbia and Puerto Rico using the following factors and
weights:
January 7, 1991, Estimates of Population, U.S. 20%
Department of Census, December 30, 1990.
Number of Pesticide Producing Establishments 20X
Per state - FIFRA and TSCA Enforcement
System printout, March 4, 1991, OCH
( Numbers do not include custom blenders. )
Number of Certified Private Applicators
Rer state holding a valid certification on
arch 6, 1991, 0PP
- 66 -
Number of Certified Commercial Applicators
Rer state holding a valid certification on
arch 6, 1991, 0PP. ( Total number of
Individuals certified. )
Estimated number of Farms Per state-
Agricultural Statistics Board, national
Agricultural Statistics Service, USDA
Farm Numbers, August 1989
Estimated Farm Acreage Per state-
Agricultural Statistics Board, national
Agricultural Statistics Service, USDA
Farm Numbers, August 1989
2. Allotment Schedule
Allotments for regions and states are obtained by combining the
appropriate base and formula funding levels for each state. The
FY 92 Allotment Schedule for the pesticide enforcement component
is summarized on the chart at the end of this section. More
detailed information can be found in appendix XX.
B. Worker Protection Enforcement
The Office of Compliance Monitoring expects to receive $2,000,000
in FY 92 compliance cooperative agreement funds to help support worker
protection enforcement activities in FY 92. Individual funding allotments
for worker protection enforcement activities were determined as described
below.
1. Base Funding
102
20X
20X
10Z
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Order number 930528-081520-PLC -001-001
page 93 set 11 with 3 of 6 items
A base funding level is established for each participating state
for worker protection enforcement activities conducted under
enforcement grants. ( Territories and Indian tribes will
receive funds for worker protection enforcement as previously
discussed. ) For FY 92, the base funding level is $20,000 for
each participating state.
- 67 -
2. Formula Funding
Total formula funding available for worker protection is
determined by subtracting the total base amounts from the total
funding amount dedicated towards worker protection enforcement.
The total amount of funds available for distribution by formula
in FY 92 is $579,600.
Formula funds for the worker protection enforcement program will
be divided among the 50 states in the program, the District of
Columbia and Puerto Rico using the factors and weights described
below. These factors were selected based on the best available
and appropriate data.
Estimated number of Farm Laborers Per 25X
state - Bureau of the Census, U.S. Dept.
of Commerce, 1982 Census of Agriculture.
( Host recent data compiled state by state. )
Estimated number of Farms Per 3tate - 25X
Agricultural Statistics Board, national
Agricultural Statistics Service, USDA
Faro Numbers, August 1989.
Estimated number of nursery and greenhouse 25X
sites Per state - Bureau of the Census, U.S.
/ Dept. of Commerce, 1982 Census of Agriculture.
( Most recent data compiled state by state. )
Number of Certified Private Applicators 10X
per state holding a valid certification on
Narch 6, 1991, 0PP.
Number of Certified Commercial Applicators 15X
per state holding a valid certification on
Narch 6, 1991, 0PP. ( Total number of
individuals certified. )
3. Allotment Schedule
Allotments for regions and states are obtained by combining the
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Order number 930S28-081520-PLC -001-001
page 94 set 11 with 3 of 6 items
appropriate base and formula funding levels for each state. The
FY 92 Allotment
- 68 -
Schedule for the worker protection enforcement component is
provided at the end of this section.
C. Adjustments to Initial Allotments
Regions should not award funds based solely on a state's / tribe's initial
allotment, but rather based on the negotiated need of the applicant. The
region will base final state / tribal funding decisions for applications
on the Initial allotment, the demonstrated pesticide enforcement program
needs of the applicant, and the exceptional nature of a program.
The Regional Administrator may modify any allotment for an applicant, as
necessary, as long as total funding for all states / tribes does not
exceed the regional allotment. 40 CFR Part 35.155(a) states that the
Administrator or the Regional Administrator may use funds not awarded or
committed to an applicant for supplementing awards to other applicants
within the same program.
OCN will contact the regions at mid-year to determine the status of
available grant funds. An evaluation of the information obtained in this
survey will be made by OCN. A reallotment of funds between regions will
be made if it is determined that some regions do not need their entire
initial allotment while states in other regions demonstrate a need for
additional funding.
D. Regional Allotments for State Worker Protection, Groundwater
ana/or Endangered Species Enforcement-Related Activities
One million dollars is included in the President's FY 92 budget for state
worker protection, groundwater, and endangered species enforcement-related
activities.
These funds are allocated to the regions based on the formula for
distribution of the program grants for the aforementioned initiatives.
The formula allocation is outlined in appendix XXI.
The resulting distribution per region is as follows:
Region I: $73,900 Region VI: $96,400
II: $52,900 VII: $93,800
III: $87,600 VIII: $90,700
IV: $201,300 IX: $95,600
V: $149,000 X: $58,800
- 69 -
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Order number 930S28-081S20-PLC -001-001
page 95 set 11 with 3 of 6 items
The regions will have discretion in allocating these funds to the
states for enforcement-related activities addressing worker protection,
groundwater and/or endangered species.
Given the above, we will not initiate an FY 92 process for national
enforcement special projects.
- 70 -
OMITTED TEXT: VI. Summary of FY 92 Cooperative Agreement Allotments
**End of document reached**
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This list of prints is based on:
.ITEMS, line
SET 1:0
SET 2: 0
SET 3: 765
request
law^general enforcement
law3(generaI enforcement)
general
enforcement
within 1 generaI;enforcement
title=general enforcement
law=general enforcement
date=01/01/91:05/28/93
SET 4: 1033
SET 5: 344
SET 6: 9
SET 7: 121
SET 8: 47
SET 9: 3
7 and 8
law=fifra
8 and 10
SET 10: 158
SET 11: 6
Please mail this printout to:
pat strougal
ore law library
345 court land st
atlanta, ga 30365
404-347-2335, x 2133
Order number 930528-081520-PLC -001 (1 prints).
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Vv/-/ i
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
JAN l o 1975
To:
Re
mi Auaunistratoi* lor av
F rom:
A s ^ra^m^tuaunistr a tor^for^V ater
and Hazardous Materials (WH-556)
Assistant Administrator for Eiifbrcemen
and General Counsel (EG-329)
Subject:
Continuing Slate Regi stration of Products Containing
Aidrin and Dieldrin for Which Uses Have Been Suspended
Late in December, 1974, the Agency became aware of the existence of
activity in the above referenced matter, first in the State of California,
and subsequently in several other States in other Regionso Preliminary
investigation into the magnitude of the problem suggests that there may
be significant continuing activity on a national scale, that there is con-
fusion as to the extent of Federal jurisdiction over such activity by States,
and that the economic, political and regulatory considerations involved
require additional action by the Agencye
Accordingly, our joint staffs are preparing a Federal Register notice,
v/hieh, upon publication, will formally assert FecIeVai jurisdiction over
non-Fedcrally registered products containing Aidrin and Dieldrin by
implementing Section 3 of the Federal Insecticide., Fungicide and
Rodenticide Act (FIFRA), as amended '7 U.S. C. 136 et seq.). Attached
is a strategy paper which explains the background cf this matter in greater
detail and provides an explanation of how these Aidrin and Dieldrin pro-
ducts should be treated upon the activation of Section 3. In addition,
proposed enforcement activities by the Agency, anticipated in cooperation
with involved States, is discussed,
We shall expedite publication of this notice in the Federal Register,
Pending formal publication, you should proceed with confidence ir. the
proposed substance of the notice as outlined above and iri the attached
paper to inform affected States in your Region of these developments,
'Further, we trust you will encourage their support and cooperation in our
effort to achieve orderly and equitable disposition of existing State-reg-
istered products together with even-handed and comprehensive enforce-
ment of the Aldrin-Dieldrin cancellation and suspension orders. The
Enforcement Division of each region will be contacted by the Pesticides
Enforcement Division in Washington which will provide additional details
and support, where needed, to achieve Federal-State cooperation in pro-
viding notice-.'of these developments and in proceeding with enforcement
of the Administrator's orders relating to cancellation and suspension of
Aidrin and Dieldrin,,
Enclosure:
-------
5 *
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D C. 20460
Strategy Paper:
State Registration of Products Containing Aldrin and Dieldrin
for Which Uses Have Been Suspended
Background;
Late in December, 1974 Headquarters v/as informed by Region IX
and the Stale of California that,products containing Aldrin and Dieldrin
were being registered by the State in possible contravention of the intent
of the Administrator's Order of December 7, 1972 (37 F.R« 26463, 25-165).
That order provided that henceforth all technical Aldrin and Dieldrin
must bear the label restriction: "For use only in formulating products
bearing EPA-approved FIFRA registrations. " It v/as thought that such a
restriction on use of the technical material, which is available only
through import and .therefore subject to Federal jurisdiction, would pre-
clude further formulation of finished products for State registration
and thereby provide de facto Federal control of all products containing
Aldrin or. Dieldrin. Investigations by California and Region IX (confirmed
now by several other Regions and State.-.) have revealed that many State-
re,f.fi stored Aldrin-Dieldrin products were: 1) formulated from technical
material held prior to December 7, 1972 and therefore not subject to the
restrictive labeling requirement, 2) formulated from so-called "end-
use" or finished Aldrin-Dieldrin products bearing State or Federal
registrations and lacking any stated restrictions concerning refor-
mulation, 3) formulated from technical meterial sold after December 2,
1972 which failed to bear the required restriction, 4) formulated from
technical material restrict1! vely labeled and ignored by the formulator.
States, having lately become aware, of the intent of the Decemoer, 1972
order, arefaced with a dilemma: pressure to reregister for continued
shipment, sale and use products formerly approved by then and the
likelihood that such registration contravenes at least the spirit, and in
some cases possibly the letter, of a Federal cancellation order.
In order to clarify existing ambiguities concerning the legal status of
these non-Federally registered products with respect to Federal jurisdic-
tion ove r their production, shipment, sale, and use, and to insure jion-
handsd enforcement of the Aldrin and Dieldrin cancellation and sus;;t v^ion
orders, the Agency will formally implement Section 3 of the Federal Insec-
ticide, Fungicide, and Rodenticide Act, as amended (7 U. S.C. 136 ct scq.)
by notice in the Federal Register. This notice will contain an exemption,
Action:
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-2-
pursuant to the provisions of Sections 6(a)(1) and 15(b)(2) of the Act, allow-
ing States to register for orderly disposition through shipment, sale and
use in that State, existing stocks of products containing Al'drin and
Dieldrin produced on or before the date of signature by the Administrator
of the order implementing Section 3 of the Act as to these State-registered
products. Effective the day following signature of the order implementing
Section 3 of the Act, production of products containing Aldrin and Dieldrin
must cease, and States must cease to register for shipment, sale and use
any but existing stocks of such products,,
Regional offices should arrange to advise appropriate authorities in
States in that Region, in advance, of the planned activation of Section 3
and its attendant prohibitions, and should request State authorities to
noti"y all State registrants and any other potentially affected parties of
the activation of Section 3 and of the effective date of related prohibitions,
Staies are to be asked to provide to the appropriate Regional Offices lists
of State registrants or persons with registration applications pending for
products containing Aldrin or Dieldrin0 information relating to location
and relative amounts of these State-registered products also is to be
SOUghto
The Agency's pesticides enforcement personnel will enlist State coope-
ration in continuing its on-going investigation of the formuiation since
December 7, 1972, of products containing Aldrin or Dieldrin for State
registration^ Should it be the case that Federal registrants of technical
A.ldrin or Dieldrin have not r^labeled their products in con: ormancc with
the Administrator's Order of December 7, 1972, or thai pesticide pro-
ducers have formulated products containing Aldrin or Dieldrin in con-
travention of labeling prohibitions against xise in non-Fcderally registered
products, such violations will be prosecuted in accordance with the appro-
priate provisions of the Acte
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? /?7\
i
u'I TED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C. 20460
JAM U US
To: [Enforcement Division Directors]
From: A. E. Conroy^H-, Director /} £ T
Pesticides Enforcement Division
C. '
Subject: Non-Federalljtjlegistered Products Containing Aldrin or Dieldrin
Background:
, In his memorandum of December 10, 1974, Point #4, the Director
advised that production of non-Federally registered products containing
Aldrin and Dieldrin contravened the December 7, 1972 Order of the
Administrator (37 F.R. 25463, 26465). The intent of that order was to
restrict use of technical Aldrin and Dieldrin to use in EPA-registered
products only. The Director's memorandum continued that production
of non-Fedcrally registered products containing Aldrin and Dieldrin
could subject such products to stop sale and their producers to liability
under Sections 12(a)(2)(G) and (K) of the Act.
Subsequent to the Director's memorandum, it has come to the
Agency's attention that numerous products containing Aldrin and Dieldrin
r".3,r have.be-n produced since December 7. 1972 and rpaistpr-ori Hy =
under circumstances not strictly contravening the December, 1972 Order.
.Details concerning this production and questions relating to the scone of
Federal jurisdiction over such production under the December, 1972
Ord**** a»*e elaborated in-the attached memorandum and strategy paper,
which Arere sent to all Regional Administrators on January 10, 1975.
Action:
For purposes of I? ederal enforcement activity, the following develop-
ments are important:
1) The Agency has determined to implement Section 3 of the
Act with respect to products containing Aldrin and Dield: in
intended for intrastate shipment. States will be permitted
to register and allow shipment, sale and use in that State
of stocks of products containing Aldrin or Dieldrin in exis-
tence on the date of the signature by the Administrate- of
the order activating Section 3. After that date, all c-
tion of products containing Aldrin or Dieldrin must cease.
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-2-
and States must cease to permit registration or to allow
shipment, sale or use of any but existing stocks. Viola-
tions of the Act will be subject to prosecution GO days
after Federal Register publication of the Administrator's
order. (This of course will not apply to those products
registered Federally and by States for uses which have
not been suspended: 1) subsurface ground insertion for
termite control; 2) dipping of non-food roots and tops; 3)
moth-proofing in a closed system.)
2) It is the obligation of each Region to notify, in advance,
appropriate State authorities of this development and its
attendant prohibitions and to enlist their aid in notifying
registrants and other affected persons in their State.
Attached is a sample letter which States may wish to
employ as a guide in the notification process.
3) Immediately upon signature, of the Section 3 order, Head-
quarters staff will notify Regional officials who should con-
tact the State authorities directly.
4) Cooperation and aid of State authorities is to be enlisted in
obtaining for Federal use:
- lists of State registrants or persons with applications
pending for Aldrin-Dielarin product registration;
- information on location anH relative ammintc o'* such.
ducts within the State;
- assistance of State enforcement authority to achieve com-
pliance with the production, registration, and shipment,
sale and use cut-off.
5) EPA regional personnel are to continue their investigations
of production since December 7, 1972 of products contain-
ing Aldrin and Dieldrin for State registration. Should ii be
determined :hat Federal registrants of technical Aldrin or
Dieldrin have not relabeled their products in conformance
with the Administrator's Order of December 7, 1972, or
that pesticide producers have formulated products contain-
ing Aldrin or Dieldrin in contravention of labeling prohi-
bitions against use in non-Federally registered products,
such violations are to be prosecuted in accordance with the
appropriate provisions of the Act.
Shorld you have questions or encounter difficulty with regaro to any
of these matters, please notify the appropriate Regional Coordinator.
Attachments:
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Attachment I
Aldrin - Dieldrin Strategy
1. R.C. 's phone Region in advance of order - inform of strategy
2. R. C«'s send Director's enforcement package to Regions
3. Regions inform States of pending action and request names of
State registrants
4. PEP sends Administrator's order to Regions
5. HDQ sends Administrator's order to States
6. States or Regions notify State registrants of order
(See Attachment ii).
7. Regions follow-up at each State registrant.
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Attachment II SAMPLE LETTER
State Registrant
(Address)
Gentlemen:
On (date), the Administrator of the United States Environmental
Protection Agency issued an Order asserting Federal jurisdiction over
all non-Federally registered Aldrin-Dieldrin products in intrastate
commerce by invoking Section 3 of the Federal Insecticide Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 et seq. ).
As a result of this Order, the shipment, sale, and use of non-Feder-
ally registered Aldrin-Dieldrin products, produced after the effective
date of the Order will be prohibited. Accordingly, the State of (name)
can register or cop^Lr^e registrations only of non-Federally registered
Aldrin-Dieldrin products which were produced on or before the date
of the Order. Such registrations are being permitted to allow the
orderly disposition of non-Federally registered products through
shipment, sale, and use in the registering State.
Any further questions regarding the Order should be directed to
Mr. , EPA, Region , street ,
city, , State , telephone number
Sincerely,
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Attachment III
Types of Violations Involving Non-Federally Registered products
containing Aldriri or Dieldrin
1. Failure of a Federal registrant to place a statement such as "For
use only in formulating products bearing EPA-approved FIFRA
registrations" on manufacturing use only labels.
Violation: Misbranded, inadequate directions
Section 12(a)(1)(E)
Action: Civil/Criminal/Stop Sale
2. Use of a "manufacturing use only"*product bearing a statement such
as "For use only in formulating products bearing EPA-approved
FIFRA registrations" on the label in a non-Federally registered
Aldrin - Dieldrin product.
Violation: Misuse Section 12(a)(2)(G)
Action: Civil/Criminal/Stop Use
3. Sale of a non-Federally registered Aldr-in - Dieldrin product pro-
duced alter the effective date of the Order, but before violations
are actionable (CO days after publication in the Federal Register).
Action: Stop Sal*-
4. Sale cf a non-Federally registered Aldrin-Dieldrin product pro-
duced after the effective date of the Administrator's Order (day
after signature) and after the date violations become enforceable
(60 days after publication in the Federal Register).
Violation: Non registration Sec. 12(a)(1)(A)
Action: Civil/Criminal/Stop Sale
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X,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
JAN 15 1976
OFFICE OF ENFORCEMENT
SUBJECT:
TO:
FROM:
Enforcement of Administrator's Decision and
Order Suspending Most Uses of Heptachlor and
Chlordane
Enforcement Division Directors
Pesticide Branch Chiefs
A. E. Conroy n. Director
Pesticides Enforcement Division (EN-342)
I. LEGAL DEVELOPMENTS
istrator on the Suspension of Heptachlor-Chlordane (In re Velsijcol
Chemical Corporation, et al. , FIFRA Docket No. 384) orderea rhe
suspension 01 registrations of all pesticide products containing hepta-
chlor or chlordane for use on corn, household, garden, lawn, and
turf pests, use against ticks and chiggers, and use as a constituent
in shelf paper. This Final Order reversed the December 12, 1975,
"Recommended Decision" of Chief Administrative Law Judge Herbert L.
Perlman dismissing the Administrator's July 29, 1975, "Notice of
Intent to Suspend. "*
On January 8, 1976, the Agency filed a "Suggestion for Clarifcation"
(attached) requesting the Administrator to adopt the Agency's interpre-
tation of the meaning and limitations of the Final Order. The Admin-
istrator has requested briefs on the issue of the appropriateness of a
clarification.
Finally, appeals have been filed by the Environmental Defense
Fund (in the Court of Appeals for the District of Columbia Circuit)
and by Velsicol (in the Court of Appeals for the Sixth Circuit). The
Velsicol appeal of the District Court's denial of its motion for pre-
liminary injunction against the Administrator's issuance of the July
* Copies of the Administrator's "Conclusions" and the "Order" are
attached.
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-2-
29, 1975, "Notice of Intent to Suspend" remains in abeyance in the
Sixth Circuit as well.
H. CURRENT AGENCY ACTIVITY
The office of the Hearing Clerk is preparing to serve by
certified mail copies of the Final Order on all parties to the suspen-
sion proceeding. In addition, the Registration Division is preparing
to notify all registrants by letter of their status under the Order and
of what label amendments, if any, are necessary for them to continue
the registration of their products in accordance with the Order.
HI. ENFORCEMENT
The Pesticides Enforcement Division is preparing a general
strategy to enforce the Administrator's Order. This strategy will
provide status of registrants vis a vis the cancellation and suspension
proceedings, lists of formulatorjand distributors of chlordane and
heptachlor products, and status of product uses as clarified by any
subsequent Orders.
Pending the completion of this strategy, regions should pro-
ceed with normal surveillance and inspection activities relating to
chlordane and heptachlor products. Enforcement actions should await
official notice of suspension to subject registrants.
Until that time you may find it helpful to deal with general
inquiries as follows.
1) So far as PED is able to determine at this time, stocks
of rrodnrti: -or gi^ppnHpH hcpc; which were formulated after
July 29. 1975, are illegal for further r"'lQ t
2) Persons desiring to dispose of illegal stocks may arrange
with involved regions to ship the products for assorted disposal, includ-
ing for return to a supplier, for export, or in accordance vath directions
provided by the Office of Solid Waste Management. Disposal questions
maybe referred to Ray Kreuger in Washington at (202) 755-8050. Regional
offices should cooperate in every way possible with responsible efforts to
dispose of suspended chlordane/heptachlor stocks.
3) Questions relating to label status should be referred to
Tim Gardner of the Registration Division, Washington, (202) 426-9425.
As soon as firm policy exists as to this issue you will be informed of
its substance.
Should you have questions concerning any facet of the
chlordane/heptachlor suspension, please contact the appropriate regional
coordinator.
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5* \3
^ ...
i ? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\lPQ0t.C'*> WASHINGTON. D.C. 20460
JAN rr 1976
OFFICE OF ENFORCEMENT
SUBJECT: of K eptachlor/Chlordane
Suspension Order
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy n. Director
Pesticides Enforcement Division (EN-342)
Please find attached a copy of the Administrator's "Clarification
of Order of December 24, 1975 (In re Velsicol Chemical Corporation
et al., FIFRA Docket No. 384), " dated January 19, 1975. Although
the Administrator did not adopt per se Respondent EPA's proposed
order and table for clarification (see my January 15th memorandum
and enclosures), this document makes patent that all registrations
(Federal and State) of pesticide products containing heptachlor and
chlordane for uses not specifically continued (as set forth in paragraph
4 of the Conclusion to the December 24th Decision) were suspended.
For purposes of enforcement, "Attachment A" will be used as the
list of uses not suspended.
Should questions arise concerning the Clarification, or any other
matter relating to the heptachlor/chlordane proceedings, please con-
tact the appropriate regional coordinator.
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UNITED STATES OF AMERICA
rNVIRONMEMTAL PROTECTION AGENCY
UFFORE THE ADMINISTRATOR
HWtcol Chemical Corporation ) FIFRA Docket Ho. 384
• tjfJj.. I
Registrants. ;
CLARIFICATION OF
ORDER OF DECEMBER 24, 1975
C*\ January 7, 1975, Respondent EPA filed a Suggestion for
purification of the Order of December 24, 1975, in the above-
u/'.irr.cd proceeding, seeking clarification of the uses of
•r^.'Cts containing heptachlor and chlordane for which
»r.;• trjtions are not suspended by the December 24 Decision
t'-i Crier. Respondent also submitted a Proposed Order, including
4lucKr.cnt setting forth a proposed list of uses not suspended,
with certain explanatory notes.
On January 13, 1976, I issued a notice of the filing of
''-.jcnJent's Suggestion for Clarification and Proposed Order
r«>
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2
Agriculture of the State of Hawaii; counsel for some 300
registrants of various products containing heptachlor or chlordane;
the Environmental Defense Fund; the U.S. Department of Agriculture;
and Respondent EPA. All of the foregoing parties, except the
Environmental Defense Fund, oppose Respondent's suggested
clarification of the December 24 Order, both on grounds tNat the
Administrator lacks jurisdiction or authority to clarify, modify,
or alter the Order and that the Order is final and cannot now be
changed in the runner proposed by respondent.
Even though not expressly provided for in the Rules of
Practice governing expedited hearings under the FIFRA, I have
determined that authority does exist to clarify the December 24
Order and that some clarification is warranted, in view of the
apparent possibility that its provisions may be unclear. In my
view., the December 24 Decision and Order are clear and specific
in their terms and should not require any further elaboration.
Implicit in Respondent's suggested clarification, however, is the
notion that proper administration of the Decision and Order by
the Agency and explicit understanding thereof by all the parties
require a clear statement of the uses of products containing
heptachlor and chlordane for which registrations have not been
suspended. In an abundance of caution and concern, therefore,
I believe proper administration of the Decision and Order will be
served and facilitated by the following clarification of the.
December 24 Order.
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3
In reviewing the Decision and Order and the possible need
for clarification, I have not considered any new eviJusCss or
argumentation. 1 have sought only to discern any possible source
or sources of any ^ack of clarity in the expression of my
intentions at the time i issued the Decision and Order. Ccnvnents
received from the parties haytjJjeen most helpFul- in determining
¦whether or not my intentions were clearly expressed. T!ic sole
purpose of this clarification is to add clarity to the expression
of my intentions at the time 1 issued the December 24 Decision
and Order.
The December 24 Order, by its terms, provides that all
pestievde products containing heptachlor or chlordane for use
(1) on corn pests, (2) on household, garden, lawn, and turf pests
(both by private homeowners and by pesticide control operators),
(3) against ticks and chiggers, and (4)as a constituent in
shelf paper, are suspended [the suspension of products for use on
corn having a post-effective date of August 1, 1976]. The Order
further provides that any stocks of technical grade heptachlor
or chlordane formulated into products intended for such uses
[after July-29, 1975] may not be placed in commerce, sold, or used
for such purposes or any other purpose not specifically
exempted [in the November 18, 1974, cancellation order] or
specifically permitted in accordance-with the Decision of the
Administrator attached thereto.
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4
Th2 uses specifically permitted or continued by the
Decision accompanying the December 24 Order include only those set
forth in paragraph 4 of the Conclusions contained in the Decision*
and, therefore, these uses (together with the exempted uses for
subsurface ground injection for termite control and dipping of
roots or tops of nonfood plants) are the only uses not suspended
by the December 24 Decision and Order. All other registrations
for uses "of products containing hoptachlor or chlordans are
suspended. Because the words "intended for such uses" in line 12
of the Order might be interpreted as limiting the suspended, uses
to the four uses enumerated in the first sentence of the Order,
the v/ords "intended for such uses" are hereby deleted from the
December 24 Order..
The reasons for the specific enumeration of four uses
suspended in the first sentence of the Order, while suspending uses
for "any other purpose" in blanket form in the second sentence, are
twofold: (1) other than an occasional reference to certain
fruits and vegetables and other miscellaneous crops, the record
(including the Recommended Decision.of the Administrative Law
Judge) does not adequately address many other (presumably minor)
uses of heptachlor and chlordane, as to--which little or no benefits
evidence was presented at the hearing, and, indeed, because the
record was so inadequate in this regard, the Administrative Law
Judge recommended that such other uses not be continued, and
* Decision of the Administrator, p. 76
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5
(2) the four .uses enumerated specifically in the December 24
Order nro Kinon?; f - i.
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6
"any other purpose" generally, i.e. that, in view of the
evidence on carcinogenicity risk, and in the absence of sufficient
benefits evidence, these uses are suspended, even though they
could not be enumerated s-pscifical ly in the Order. Thus, there is
no inconsistency between paragraph 5 of the Conclusions in the
Decision and the provisions of the,Order.
In view of the foregoing, I do not find it necessary to
either adopt or reject the Proposed Order submitted by Respondent.
Russell li. Train
Dated: January 19, 1976
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ATTACHMENT A
I
Specific uses or ciilordank k nn:PTACin.oii
NOT SUSPKNOISU BY ADMINISTRATOR'S OltOUIl OF 12/24/75
COMPOUNDS)
USE(a)
•STATUS OF USE(s)
chlordanc &
hcptachlor -
Subsurface ground insertion for termite control
4
continued
chlordane &
hcptachlor
i
Dipping of root3 or tops of non food plants
continued
chlordanc &
A
Control of cutworms on corn (both pre and post
continued until
hcptachlor
emergence)
8/1 /7G only
4
heptachlor
Control of narcissus bulb fly
continued
hcptachlor
Seed treatment
continued
heptachlor
Ant control to achieve pineapple mealy bug
5
control in Hawaii
continued
chlordane
In Federal /State quarantine programs for
6 5.6
Japanese Beetle and imported fire ant
continued
dilordane
Control of black vine v/eevil on Japanese Yew
in Michigan
continued
chlordane
Control of Texas harvester ant in Oklahoma
continued
chlordane
Control of imported fire ant by private
6.7
individuals
continued
. chlordane
Control of white fringed beetle attacking food
8
crops in 8 S. E. States (AL.FL.GA.LA.MS.NC,
SC. TN)
continued
dilordane
a
Control of soil insects attacking Florida citrus
continued
chlordane
Control of strawberry root^pests by prc-plant
treatments
continued
chlordane
'» aii —
Control of white grubs in Michiean
continued
chlordanc for uses not specifically continued are suspended by the Administrator's
Decision and Order on the Suspension of Hcptachlor-Chlordanc.. The effect of the
Order Is/to further prohibit the manufacture, formulation or reformulation of products
containing Heptachlor or Chlordane for any purpose other than for those registered
uses which have been exempted in the Order and for manufacturing uses as an
interim step in the. ultimate, formulation for such registered uses. Sale and use of
existing stocks-of rcgistercd''products Which-were formulated prior to July 30. 1975
are permitted for both continucd'and suspendcd uses.
2. PR Notice.74-11 (39 FR 4f298) exempted this.tisc from cancellation. Such use
was "similarly exempted from the Notice of Intention to Suspend. 40 FR 34456
(7/29/75). ,
3. Clarified at 40 FR 30522 (7/21/75) to apply to the use of emulsifiablc or.oil
concentrate formulations for controlling subterranean termites on-structural
.sites such as buildings, houses, barns, and sheds, using current control
practices. «
4. Vclsicol has represented that it would voluntarily suspend domestic shipments
of hcptachlor for this use pending resolution of the cancellation proceedings.
5. On the assumption that Mirex is not available. •'
0. To include treatments required to certify to pest free conditions as well as for
use in suppression and control programs.
7. To include use on both public and private property by diner owner, agent,
employee..or contractor.
8. Not intended to preclude use on cotton. However; use oh'tobacco is suspended.
9. Restricted to citrus root weevils.
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| JSTJ 9 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
1 s J976
OFfltfE OF ENFORCEMENT
SUBJECT:
TO:
FROM:
Straus Report .on the Heptachlor/Chlordane Suspension
Enforcement Division Directors
Pesticides Branch Chiefs
A. E. Conroy n, Director
Pesticides Enforcement Division
The purpose of this informational memorandum is to keep you
abreast of Agency activity relating to the Administrator's suspension
of most heptachlor/chlordane registrations.
The Office of the Hearing Clerk has completed an uncertified mail
service of the final order and the clarification in the heptachlor/chlor-
dane proceeding to the approximately 425 parties involved. The Agency
has sent to the. Federal Register the "Notice of Intent to Suspend, 1 the
"Initial Decision, " the "Administrator's Decision and Order," and the
"Clarification" for publication. An expedited publication is expected.
The Registration Division is currently in the process of serving'
by certified mail a notice of suspension to all affected registrants of
heptachlor/chlordane products. Please find attached three form letters
being used to notify registrants of their products' status under the
December 24 Order. These letters will apprise the particular registrant
that it's products registration (1) has been finally suspended, (2) was
suspended, but by discontinuing the use of heptachlor and chlordane in
the product's formulation, continued registration is permitted, or (3)
wa§ suspended, but may continue tQ_bc sold and distributed if the reg-
istration is provisionally amended.
You will be receiving shortly a region specific.list of all suspended
registrations on the basis of which you may begin surveillance and
enforcement activities' to ensure compliance with the Administrator's
order.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20450
CERTIFIED MAIL
Gentlemen:
Subject : Notice of Suspension for:
This is to notify you that on December 24, 1975, the Administrator
issued his-Decision and Order on the suspension of Chlordane and
Heptachlor.
This document provides that all uses of Chlordane and Heptachlor are
suspended except those set forth on the enclosure. Your subject regis-
tration was suspended effective December 24, 1975.
As stipulated in the Administrator's Notice of Intent to Suspend, issued
on July. 29, 1975, the product under this registration may not be formu-
lated, shipped, sold or used after July_29; 1975.
The Administrator's Decision and Order wil] be published in the Federal
Register in the near future.
Sincerely yours,
John B. Ritch, Jr.
Director
Registration Division (WH-567).
Enclosure
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9 && \
I V ui ilTED -STATES ENVIRONMENTAL PROTECTION AGENCY
% ^ WASHINGTON. D.C. 20460
CERTIFIED MAIL
Gentlemen:
Subject : Notice of Suspension for:
On December 24, 1975, the Administrator issued his Decision and Order
tin the suspension of Heptacjilor and Chlordane. Host federal and state
registrations of Heptachlor and Chlordane were suspended although
certain uses v/ere specifically exempted, (Refer to theenclosure). Any
registration which included a suspended use was suspended effective
December 24, 1975. This letter is to notify you that your above
registration contained a use suspended by the Order and therefore has
been suspended effective December 24, 1975.
If you wish to be permitted to continue your registration, you have two
alternatives. First, you may fimply discontinue the use of Chlordane
or Heptachlor in the formulation of your product. "If.you select this
approach you will not be required to submit ^ petition for an amendment
if your product contains no other insecticides and all insecticide claims
are eliminated. If other Insecticides are contained you must apply for
an amended label which in certain instances jiiay require new efficacy
data. If you wish to continue to formulate your product with either
Heptachlor or Chlordane you may continue to do s,o only for uses not
suspended and only after you have submitted a petition for a label
amendment in which all references to suspended uses have been deleted.
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-2-
It is sufficient to send a cover letter with an airc-ndod label or lr.br
'in which the suspended uses including any claims referring to these
uses have been blocked out. The granting by the Agency of such a
petition will permit you to continue formulation and/or sale of Hepta-
chlor and/or Chlordane for exempted uses. Petitions for a provisional
labeling amendment in accordance with the enclosure must be received
within 30 days of receipt of this letter at the follov/ing address:
Mr; Timothy A. Gardner
Product Manager (15)
Registration Division (WH-567)
Environmental Protection Agency
Washington, D.C. 20460.
The amendment will not abrogate your right to defend both suspended or
nonsuspended uses in the continuing cancellation proceeding.
Existing stocks of EPA registered pesticides containing Heptachlor or
Chlordane may be distributed and sold for suspended uses on 1y if the
stocks were formulated prior to July 30, 1975. This date was stipulated
in the Administrator's Notice of Intent to Suspend, issued on July 29,
1975. Stocks of Heptachlor or Chlordane formulated after July 29, 1975,
may only be distributed and sold for those exempted uses included in the
enclosure and under labels containing no suspended uses. Stocks which
you may presently have on hand, if manufactured or formulated after
July 29, 1975, m3y not be shipped or sold until you receive EPA appro-
of your amended label.
The Administrator's Decision and Order will be published in the Federal
Register in the near future.
Sincerely yours,
John B. Ritch, Jr.
Director
Registration Division (WH-567)
Enclosure
-------
"v,
*
j
i
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. n.C. 20<60
CERTIFIED MAIL
Gentlemen:
Subject : Notice of Suspension for:
On December 24, 1975, the Administrator issued his Decision and Order
on the suspension of Heptachlor and Chlordane. Most federal and state
registrations of Heptachlor and Chlordane were suspended although
certain uses v/ere specifically exempted (Refer to the enclosure). -Any
registration which included-a suspended use was suspended effective
December 24, 1975. This letter is to notify you that your subject
registration contained a use suspended by the Order and therefore has
been suspended effective December 24, 1975.
If you wish to be permitted to continue to formulate and/or sell Hepta-
chlor and/or Chlordane for uses not suspended, you will be required to
petition for a provisional amendment of registration. Such petition
should request the'elimination from-your labels of any reference to
suspended uses. It is sufficient to: send a cover-letter with an amended
label or label in which the suspended uses including any claims referrin
to these uses have been blocked-outv The granting by the Agency of such
a petition "wi 11 permit;^Q^p^nttnue-;;fprnu1 ation and/or sale of Hepta-
chlor and/or Chiord^h^folrrexefiipted.-*us.es:"" Petitions for a provisional
labeling amendment in accordance with the enclosure must be received
within 30 days of receipt of this letter at the following address:
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-2-
Mr. Timothy A. Gardner
Product Manager (15)
Registration Division (WH-567)
Environmental Protection Agency
Washington, D.C. 20460.
The amendment v/ill not abrogate your right to defend both suspended or
nonsuspended uses in the continuing cancellation proceeding.
Existing stocks of EPA registered pesti-cides containing Heptachlor or
Chlordane may be distributed and sold for suspended uses only if the
stocks were formulated prior to July 30, 1975. This date v/as stipulated
in the Administrator's Notice of Intent to Suspend, issued on July 29,
1975. Stocks of Heptachlor or Chlordane formulated after July 29, 1975,
toay only be distributed and sold for those exempted uses included in the
enclosure and under labels containing no suspended uses. Stocks which
you may presently have on hand, if manufactured or formulated after
July 29, 1975, may not be shipped or sold until you receive EPA approval
of your amended label.
The Administrator's Decision and Order v/ill be published in the Federal
Register in the near future.
Sincerely yours,
John B. Ritch, Jr.
Director
Registration Division (WH-567)
Enclosure
-------
si'KCinc U5ES or chloroank t nr.rTACUUOR
NOT SUSPENDED BY AD.MIN'ISTJIATO11j OMJjl.it OF 12/2-1/75
COMrOUNDCs)
USE(s)
STATUS Ol' OSEfs)
Chlordane &
heotachlor
Subsurface ground insertion for termite control
continued
chlordane U
heptachlor
i
Dipping of roots or tops of non food plants
continued
chlordane &
Control of cutv.-orms on corn (both pre and post
continued until
A
heptachlor
emergence)
8/1/76 only
4
heptachlor
Control of narcissus bulb fly
continued
heptachlor
Seed treatment' *
continued
heptachlor
Ant control to achieve pineapple mealy bug
S
control in Hawaii
continued
chlordane
In Federal/State quarantine programs for
6 5,6
Japanese Beetle and imported fire ant
continued
eMordane
Control of black vine weevil on Japanese Yew
in Michigan
continued
chlordane
Control of Texas harvester ant fn Oklahoma
continued
chlordane
Control of imported fire ant by private
5,7
individuals
continued
chlordane
Control of white fringed beetle attacking food
S ¦
crops in 3 S. E. States CAL.FL,GA,LA, MS.NC,
SC. TN)
continued
chlordanc -
a
Control of soil insects attacking Florida citrus
continued
chlordane
Control of strawberry root pests by pre-plarit
• treatments
continued
chlordane
Control-of white erubsin Michigan
continued
a.
4*
5.
6.
1,
B.
B.
chlordane for uses not specifically continued arc suspended by the Administrator's
Decision and Order on the Suspension of Heptachlor-Chiordane. The effect of the
Order Is to further prohibit the manufacture, formulation or reformulation of products
containing Heptachlor or Chlordanc for any purpose other than for those registered
uses which have been exempted in the Order and for manufacturing uses as an
interim step in the ultimate formulation for such registered uses. Sale and use of
existing stocks of registered products which were formulated prior to July 30, 1975
•re permitted for both continued and suspended uses.
PR Notice 74-11 (39 FR 412?3J exempted this use from cancellation. Such use
was similarly exempted from the Notice of Intention to Suspend, 40 FR 3445B
(7/23/7S). •
Clarified at 40 FR 30522 (7/21/75) to apply to the use of cmulsiflable or oil
concentrate formulations for controlling Mtbtcrraaean termites on structural
sites such as buildings, houses, barns, and sheds, using current control
practices.
Velsicol has represented tint it would voluntarily suspend domestic shipments
of heptachlor for this use. pending resolution of the cancellation proceedings.
On the assumption that i\(trex is not available.
To Include treatments required to certify to pest free conditions as well as for
use In suppression and control programs. *
To Include use on both public and private property by cither owner, agent,
employee, or contractor."
' Not intended to preclude use on cotton. However, use en tobacco is suspended.
Restricted to_citrus root weevils. _
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f=38
*
3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
"V _
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-2-
(2) By invoking the "Special Rule" provision of section
15(b)(2), the Administrator has provided that stciCks of
EPA registered pesticides containing heptachlor or
chlordane formulated prior to July 30, 1975, may be sold,
distributed, or used Jor suspended uses.
(3) Stocks of heptc-oMcr pr chlordane products formulated
riter July 20, 1375 may be sold, distributed, or used
only for exempted uses, as per "Attachment A,:.
H. CATEGORIES OF HEPTACHLOR/CHLORDANE PRODUCTS
As stated aboVe, there are three categories of heptachlor/chlor-
dane products:
(A) Federally registered products, all uses of which have been
suspended The Registration Division/Office of Pesticide Programs
has notified, by certified mail, all affected registrants that-their prod-
ucts have been finally suspended by the December 24th Order. 1 / An
example of a product in this category would be a product regisfered
for use only on ticks and chiggers. There are approximately 644 prod-
ucts registered by over 300 registrants which have been so suspended.
You will find attached to this memorandum a list of suspended product
registration numbers, product names, registrant names, and the names
and addresses where such heptachlor/chlordane products have been pro-
duced.
(B) Federally registered products, some uses of which have been
suspendecT As noted in the introduction and in previous memoranda,
there is a large category of registered products whose uses were sus-
pended in part by the December 24th Order, but whose sale and distri-
bution may continue upon ["provisional-] amendment of the product's
registration and labeling to delete all suspended uses. A typical product
in this category would be one registered and labeled for indoor roach con-
trol and for subterranean termite uses (the former being a suspended use,
while the latter is a permitted use). Pending the decisions by the regis-
trants to amend or not [such decision must be made within 30 days of
receipt of the notice of suspension], it is not possible to determine
the registration status of products in this category. Upon RD's comple-
tion of the necessary registratioareview, a region specific list will
be forwarded to you noting the status of individual products ia this category.
(C) Intrastate products. Although this third category is comprised
of products similariy situated to those in above categories (A) and (B),
for purposes of this enforcement strategy, "intrastate products" are
being-treated separately. The Registration Division has notified the
i/ bee my ±> ebruary 19, 1976 memorandum entitled "Status Report on the
"ETeptachlor/Chlordane Suspension, " and its attachments.
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3
registrants of 140 "intrastate" products as to the impact of the
December 24th Order on their heptachlor/chlordane products.
These products wer;e being sold only in intrastate commerce when
they became subject to the FEPGA registration requirements by
the accelerated activation oT^ection 3 in November 1974. Sub-
sequently, all applications for Federal registration were denied
and the applicants who timely requested a hearing were made
parties to the cancellatioiT'proceeding and the subsequent1 suspen-
sion hearings. Accordingly/ these products were equally affected
by the December 24th Order in that to continue marketing them,
registrants must delete suspended uses from'their labeling. Please
note the attached three Eegistration Division form'letters used to
apprise this category of registrants as to their products' status.
You will find an attached list,of forty-eight-products in this cate-
gory whose sale, distribution, and use was prohibited as of Decem-
ber 24, 1975, for formulations made after July 29, .1975. As soon as
the suspension status of the remaining products in this category is
available, you will be advised.
m. ENFORCEMENT POLICY
The Agency intends to ensure that the-Administrator's Order
of December 24th is strictly complied with by all affected persons,
including manufacturers, for mutators, registrants, wholesalers,
retailers, and users. The Administrator, in his December 24th
Order, provided that products formulated prior to July 29, 1975,
should be permitted distribution and use.through normal channels
of trade until the stocks are exhaused. Affected persons were
informed of the consequences of formulating after July 29th—those
that chose to continue formulation despite the Notice of Intent
to Suspend did so at their own risk. The Agency wants to ensure
that the pesticide producing industry does not interpret a Notice
of Intent Xo Suspend as a signal to increase production of the subject
product during the pendency of the suspension proceeding.
It has been the general policy of the Agency to request national
recaU where product registrations have been suspended in order
to prevent an imminent hazard to man or. his environment. That
policy will be applied in the instant case;.- As the initial step in ....
implementing this policy, EPA has requested the recall, down to
and including the retail level,, of all heptachlor/chlordane products
for which all uses were suspended and which were formulated
after July 29, 1975 [category A products]. In addition, the Agency
Intends to request the recall—in some instances fox* relabeling—of
all heptachlor/chlordane products formulated after. July 29, 1975
-------
-4-
whose labels contain both suspended and non-suspended uses [category
B products], "Intrastate" products [category C products] will be treated
in a manner consistent with similarity situated Federally registered
products.
IV. ENFORCEMENT ACTIONS.
As has been the established policy in such matters, enforcement
actions will be taken, in accordance with normal procedures and at
levels consistent with those provided for in the Pesticides Enforcement
Division Case Proceedings Manual, against all persons found in viola-
tion of the heptachlor/chlordane suspension order.
There exist a number of enforcement action options available to
ensure compliance with the Administrator's Suspension Order. As
previously stated, the Agency has determined that a national recall
of violative products would be the most effective and efficient means
-of ensuring compliance with the suspension-order. Because of the
-extra-ordinary number of products and firms which are affecte'd by
the December 24th Order and the commensurate amount of Agency
resources which would be involved in-conducting a formal recall, -the
Agency feels that the procedures outlined in the Case Proceedings
Manual, Chapter 12, for informal recalls would be more appropriate
in this matter. Information and guidance with respect to specific en-
forcement related actions which may be directed toward each of the
aforementioned categories of heptachlor/chlordane products follows:
(A) Federally registered products, all uses of which were sus-
pended and which were formulated after July ^9. 1975. As per recall
initiation procedures, the Pesticide Enforcement Division has notified
by certified mail those registrants who had all uses of their heptachlor/
chlordane product(s) suspended by the December 24th Order, that EPA
is requesting that all subject products formulated after July 29, 1975;
be recalled immediately. This letter,- & copy of which is attached to
this memorandum, refers the addressee to the Registration Division
suspension letter informing the registrant of the registration status of
his product(s), and continues by specifically requesting that (a) the
company initiate procedures to determine the locations of all quantities-
of their finally suspended product and the amount of such product at
each such product location, (b) that the product be returned to the
registrant from all locations, and (c) that the named regional contact
person be informed of all actions taken in connection with the recall.
In your follow-up to determine compliance with the recall request, you
should:
(1) be assured that the registrant has recalled the product
from the retail level, and either
(i) disposed uf the product.
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5-
(il) exported product in accordance with section 17, or 2/
(iii) sought new registration for continued uses;
(3) stop sale any such product found in consumer channels
under section 13; and
(4) where appropriate, initiate enforcement action under
section 14. 3/
(B) F ederally registered products with both suspended and con-
tinued uses and which were formulated alter July As soon
as these products can be iaentiiied as to their registration status, PED
will request each registrant to contact all known distributors, whole-
salers, and retailers that the subject product should not be sold or
otherwise distributed. Registrants will be instructed that they should
recall from retail level as set forth above for category A products.
When following-up to determine^ compliance with the recall of these pro-
ducts, you should:
(1) be assured that the registrant has recalled the product
from the retail level, and either
(i) disposed of product if amendment to labeling is not
made,
(ii) exported product in accordance with section 17,
(iii) relabeled product with amended label deleting sus-
pended uses, or
(iv) in accordance with EPA approved instructions,
overlaid product with approved sticker labels,
masked out suspended uses, or used other means to
delete suspended uses from the labels;
2/ Registrants should be informed that~the Agency would interpose
no objection to the export of: products affected by. the suspension order,
but wishes to caution, registraiits concerning the recent stipulation
signed by the Department of State concerning the utilization^bf US funds
for USAlD procurements of such products. See USA1D regulation entitled
"Pest Management Program, Interim Pesticide Procedures," published
in the Federal Register on January 7, 1976.
3/ Those persons who distribute or sell a suspended heptachlor/
chlordane product in violation of the terms of the December 24th
Suspension Order mil be in violation of section 12(a)(1)(A) for non-
registration, as well as section 12(a)(2)( J) for violation of a Section
6 suspension, order.
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(2) stop sale* any such product found in consumer channels
under section 13; and
(3) where appropriate, will initiate enforcement action under
section 14. 3/
(C) Intrastate products. The policies outlined above will also
apply, as appropriate, to intrastate products as they become identified.
At present, the 48 products thus far identified will be treated the same
as Federally registered products, all uses of which have been suspended
[category A products J.
Now that all parties affected by-the Administrator's Decision and
Order in the heptachlor/chlordane suspension proceedings have been
duly notified of this action and of their obligations attendant thereto,
the Agency places the highest priority on assuring full and immediate
compliance. The initiation and follow-up of the heptachlor/chlordane
recall herein authorized will represent a significant addition to-exist-
ing regional enforcement burdens. It is anticipated that regions will
exercise initiative and energy in performing,, in addition to program-
med outputs, the surveillance, inspections,- enforcement actions, and
routine follow-up necessary to implement this recall.
The region should report the.following information to the appro-
priate regional coordinator as soon as available:
(1) the number of firms subject to-recall;
(2) the amount of each product recalled; and
(3) the methods of actual or planned disposal
of recalled material.
V. DISPOSAL OF HEPTACHLOR/CHLORDANE PRODUCTS
Persons desiring to dispose of stocks , of heptachlor/chlordane
should be apprised'vthat they may arrange with the appropriate regions
to ship the product:for disposal, including return to.a supplier, for
export, or in accordance with directions provided by the Office of
Solid Waste Management. Disposal questions may be referred to. .
Mr. Ray Kreuger, Operations Divison, Office of Pesticide' Programs
[(202) 755-8050]. Regional offices are encouraged to cooperate in every
way possible with responsible efforts to dispose of suspended heptachlor/
chlordane stocks.
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VI. INDEMNITIES
The Office of Enforcement has been advised by th^ Office of
General Counsel that the registrants of heptachlor/chlordane products
suspended by the December 24th Order are not eligible for indemni-
fication under section 15 of the amended FIFRA.
VH. INQUIRES
Should you have any questions concerning any facet of this memor-
andum and the heptachlor /chlordane suspension order, please contact..
the appropriate regional coordinator. -Questions relating to registration
and lapel status should be referred to Mr. 'Tim Gardner, Registration -
Division, Office of Pesticide Programs [(202) 426-9425].
Vm. ATTACHMENTS
Please find attached the following:
(1) "Attachment A -- Specific Uses of Chlordane and
Heptachlor Not Suspended by Administrator's Order
of 12/24/75 7*""
(2) Copies of recall request letters sent to registrants by
PED.
(3) Three form letters sent by RD/OPP to "intrastate"
heptachlor/chlordane registrants.
(4) 41 FR 7552 (February 19, 1976) — "Velsicol Chemical
Co. et al., Consolidated Heptachlor/Chlordane Hearing.
(5) List of Federally registered heptachlor/chlordane pro-
ducts, all uses of which have.been suspended [category
-JV products] was mailed by PED to the regional pesticide
branch chiefs under separate cover,March 17, 1976.
(6) List c?f the 48 "intrastate", heptachlor /chlordane products,
all use of which were suspended [category C products].
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
2 7 AUG 1976
OFFICE OF ENFORCEMENT
RE: Heptachlor/Chlordane Suspension (
Enforcement Strategy — CORN USE
FROM: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division (EN-3i42)
TO: Enforcement Division^Ulrectors
Pesticides Branch Chiefs
Some confusion has arisen concerning the enforcement response
to certain heptachlor/chlordane products now on the market which are
labeled for use on corn pests. The Administrator concluded in In re
Velsicol Chemical Corporation, et al. (Expedited Hearing On Heptachlor-
Chlordane), 41 Fed. Reg. 7552 (February 19, 1976) that
the benefits of continued use of heptachlor and chlordane to
control-cutworms on corn crops during the tirrie which may
be required to reach a final decision in the cancellation
proceeding are not sufficient to outweigh the human health
risks identified; provided„ however that particularly in 3view
of the difficult transition required to implement alternative
cutworm control methods, the use of heptachlor and chlordane
to control cutworm on corn crops should be permitted during
the 1976 corn growing season. Accordingly, I have concluded
that the registration for use pf heptachlor and chlordane to
control cutworms on corn crops should be suspended effective
August 1, 1976. */
As you are aware, the Administrator's heptachlor/chlordane orders
provide the following concerning the legal status of. the various products:
*/ See also, "Clarification of Order of December 24, 1975," 41
Fed."Keg. 7552 (February 19, 1976).
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1. With the exception of the corn use, all registrations of pesticide
products containing heptachlor and chlordane for uses not specifically
continued (e. g. , chlordane to control black vine weevil on Japanese yew
in Michigan), were suspended as of December 24, 1975.
2. By invoking the "Special Rule" provision of FEFRA section 15(b)
(2), the Administrator has provided that stocks of EPA registered pesti-
cides containing heptachlor/chlordane formulated prior to JrJy 30, 1975,
may be sold, distributed, or used for suspended uses, including use on
corn.
3. Stocks of heptachlor or chlordane products formulated after
July 29, 1975, may be sold, distributed, or used only for exempted uses
[see "Attachment A," enclosed]. Thus, for example, a chlordane product
whose sole registered use was for cutworm control on corn could legally be
produced, distributed, sold, and used without violating the December 24
suspension order until this product became finally suspended on August 1,
1976.
You will remember that prior to our request for the recall of violative
heptachlor/chlordane products, Registration Division, Office of Pesticide
Programs advised affected registrants that if amended labeling which deleted
all reference to suspended uses was submitted and approved by EPA, the
relabeled product could continue in commerce. To accomodate those pro-
ducers of agricultural products listing corn uses, a decision was made to
allow the registrant to continue to displa3r the directions for use on corn,
provided the following disclaimer was inserted immediately after the crop
designation: "USE SUSPENDED EFFECTIVE AUGUST 1, 1976, " Ten com-
panies exercised their option to relabel accordingly; the 19 products areas
follows:
279-2656
279-2904
449-123
449-74
876-55
876-89
876-99
876-102
876-172
148-139
226-178
226-219
228-92
NIAGARA CHLORDANE 5 COATED GRANULES
CHLOR KIL 10 DUST INSECTICIDE
SURE DEATH BRAND HEPTACHLOR 3E
SURE DEATH BRAND HEPTACHLOR 2E
VELSICOL CHLORDANE 72EC SOIL INSECTICIDE
VELSICOL BELT 72 ECF
VELSICOL BELT 33. 3 G AGRICULTURAL INSECTICIDE
GRANULARS FOR SOIL INSECT CONTROL
VELSICOL BELT 72 EC AGRICULTURAL INSECTICIDE
BELT 40% WP AGRICULTURAL INSECTICIDE
CHLORDANE E-8
TASCO BRAND CHLORDANE 20 GRANULAR
TOBACCO STATES 50% CHLORDANE WETTABLE POWDER
RIVERDALE 25% CHLORDANE GRANULES
• **/ To arrive, at a result consistent with the Administrator's intent to
suspend all use of chlordane/heptachlor.on corn, regardless of target pest,
the use oi these pesticides to control the white fringed beetle attacking corn
crops in eight southeastern states (AL, FL, GA, LA, MS, NC. SC, and TN)
and to control white grubs on corn in Michigan is also precluded.
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A!HEX CiTLORDANE 8E
RED TOP CHLORDANE 8 SPRAY
CHLORDANE 10 GRANULAR
CHLORDANE 5 GRANULAR
CHLORDANE 25 GRANULAR
CHLORDANE-TOXAPHENE BAIT NO. 11 (Florida "intrastate"
--Asgrow Florida Company, P. O. Drawer D, Plant City, FL)
Therefore, alter December 24, 1975, no product produced after July 29,
1975 for corn use could be legally distributed or sold without the above men-
tioned disclaimer. The detection of such violative product will continue to
receive Agency response in the form of a FIFRA section 13(a) Stop Sale, Use
or Removal Order and section 14 action, as appropriate. It is the Office of
Enforcement view that enforcement action, including SSURO's, should not be
taken against the sale and distribution after August 1, 1976 of products bearing
the disclaimer. The use of such product on corn after August 1, 1976 is in vio-
lation of the suspension order [§12(a)(2)(J)], as well as a misuse (§12(a)(2)(G)].
To summarize: (1) products formulated prior to July 30, 1975, includ-
ing those with directions for use on corn, may continue to be sold, distributed,
and used; (2) products formulated after July 29, 1975, may be sold, distri-
buted, and used only with labeling amended to include only continued uses;
and (3) products formulated after July 29, 1975, with directions for use on
corn, must bear the following disclaimer immediately after the corn use
directions: "USE SUSPENDED EFFECTIVE AUGUST 1, 1976. "
The Agency is not contemplating at this time She recall of the above
products for relabeling to delete reference to corn vises. At the conclusion
of the cancellation proceeding, heptachlor/chlordane labels will be revised
to conform with the Administrator's final order.
All inquiries in this matter should be referred to the appropriate regional
coordinator.
1029-77
2935-151
9859-51
9859-53
9859-55
14775
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fMD
'¦'•F
Q '$¦ l-T-;; ¦: ,\j STATES EN v I RON t/i ETNT al protection agency
WASHINGTON. D.C. 20*60
2?: NOV mi
OFFICE OF ENFORCEMENT
To: Enforcement Division Directors
and Pesticide Branch Chiefs
From: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
Re: Continued Enforcement of the Suspension of Registration
for Certain Products Containing Chlordane and Heptachlor
On August 1, 1976, the suspension of existing registrations of
heptachlor/chlordane products for use on corn was effective as to
all products formulated-after July 29, 1975.. Thus, the Admini-
strator's suspension ;oirder of December 24, 1975 became completely
effective as to all.subject products formulated after August 29, 1975
and not already cancelled. The recall of subject products initiated in
March 1976 is now essentially complete and a final report should be
submitted to PTSED for inclusion in the heptachlor/chlordane file.
Therefore, each region should prepare a Recall Final Report (Exhibit
14-E, Pesticides Inspection Manual) for each product subject to our
recall request which was produced after July 29, 1975.. This report
should be submitted to the appropriate Regional Coordinator no later
than December 31, 1976.
Recently the Court of Appeals for the D.C. Circuit sustained the
Administrator's decision to suspend certain uses of chlordane and
heptachlor in all but one important respect. (Environmental Defense
Fund v. EPA, No. 76-1247 (D.C. Cir., decided Nov. 10, 197tf)). With
respect to the Administrator's decision to allow use of existing stocks,
the court remanded for reconsideration of such issues as amounts of
existing stocks and the problems involved in their return or disposal.
How the Agency will proceed in meeting the requirements of the
remand has not been determined.
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Future surveillance for compliance with the Administrator's
order should bo routine except in the e^~e of firms revising to rr.-cill.
Additional visits to producers and/or distributors niuy oe necessary
to assure compliance in these situations. Regarding enforcement
actions, pending a final outcome on the issue of the remand, the fol-
lowing should be pursued. "Any suspended heptachlor/chlordane pro-
duct produced after July 29, 1975, and remaining in commerce should
be stop saled. Additionally, since all but retail distributors should
have b^en notified to return the violative products, any suspended
products found in channels'of trade above the retail level should be
sampled and civil penalty actions issued to the distributor and/or the
producer, as appropriate. Civil penalty actions should also be issued
for any violative samples previously collected above the retail level.
Beyond stop sale, decisions on the level of action to be applied at the
retail level are left .to regional discretion, though any repetition of
violation or evidence of bad faith should warrant civil penalty action.
This policy is reiterated now because a period of grace was previously
allowed for return or disposal of violative stocks. Now that the recall
is complete and the suspension order close to a year old, such leniency
is no longer appropriate.
Finally, in several instances recently, questions have arisen con-
cerning indemnities. The Agency's position has been that such requests
pursuant to section 15 of the Act are inappropriate in the absence of a
final order of cancellation. (See letter attached).
Enclosures:
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UNITED STATES ENVIRONMENTAL PROTECTION viOY
.Jt ? t
/ ' 1/
1^2 OCT 1976
Mr. italpti Ld-ieJ
Executive Director
Chemical Specialties riar.ufacturors
Associaticnj Incorcora tad
XO'Jl Connecticut Avanuc, N.i-:.
Suite 1120
Washington, r:. C. 20036
Dear Mr. Enqel:
Vour latter of August 30, 1975, hat; lioen referred; to
this office i'or rev-ly.. because of, tue administrator' s
ongoing role tn the chlordans/heytscnlor proceedings, it
would ° in proper under tha Agency's rules of practice
for tVim to respond to your inquiry.
Your letter asks that the Adrainiutrator invoke the
"special rul'i"/under 510(b)(2), in order to allow inven-
tories of'. chlor^anc. products foratulatod between July 29,
1975, and ttecemiier 24, 197r>, and currently on dealer
shelves, to be sold until such. &tocfcs: i»re exhausted.
Your request would necessitate «o.Jii'icaticn of the
order Issued by the Administrator on 'Oeceipoer 2-J-, 1975.
Reouasts tor such modifications must toe r.:ade in conformance
with the rules of practice set forth in 40 CFR Part 164.
Se>t especially 40 CIr'fc lo4.6(t>), concerning enlargement of
filing periods: 40 >FR lti4.3L, concerning intervention;
ani 40 CFU 1C4.11Q, concerning motions for reconsideration
of orders.
AMI
amwu {~
OAU ^
A
ft-n1-
¦ib+ht.
Ju/y
t m
Y S.y*
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2
finally, condor requires that I inform you that the
Aqency statt would oppose cucu -.notic.-, to modify trie
suspension order, snould one in tact.be £i.lac;. fcenr-ntia.lly,
this is because the suspension order in a temporary order,
wfiich ultimately v/ill be sncprcoJed. by an order at the
termination of the. cancellation proceedinq. The question
of tkft extent' to v.-hich distriouticn of existing stocks ol
chJ ovo-ino oror'-.cts otiou.ld be ailcwed can and /should be
adrrossed in tho cancellation proceedi-'nq, and resolved in
the order at the conclusion of that proceeding. Sound
considerations of procedural man&cien'Jnt .militate against
interruption of the cancellation proceeding to consider
this question at this time.
G. William Prick
General Counsel (A-130)
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niS^LIuOdO
rOwpCD
CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
CJ«CCiJ!r.i 1> 1 . SU:»ei12U» HJOI COnnICTICU' AVE.. H.«V^WASH;NG10N. O.C. 2003G • I702|fl?2(m0
August 30, 1976
Ilr. Rv.sseli E. Train
Administrator, EPA
•401 M Street, S.W., Room V71200
Washington, D.C. 204 60
Dear Mr. Train:
On August 16, CSMA counsel Robert Ackerly and Roger
Copland of my staff met with several Agency officials,
including those from the Enforcement Division and the
Office of General Counsel, to discuss the situation
pertaining to products containing chlordane.
Pursuant to that meeting, I hereby request that you
invoke the Special Rule of §15(b)(2) and allow inven-
tories of chlordane products fonnulated between July 29, 1975
and December 24, 1975 and currently on dealer shelves to
be sold until such stocks are exhausted.
There are several reasons for this request:
1) Recall is in most cases a practical impossibility
and constitutes an economic hardship, particularly
to smaller formulators. There are literally thou-
sands of small retailers who may have a few units
of chlordane products in stock. It is not always
possible for the formulator to ascertain where
such products are being sold* If stocks are dis-
covered, compliance with Department of Transpor-
tation regulations governing the shipment of
hazardous materials becomes a major problem,
especially in view of the fact that substantial
numbers of retailers will have only a few units
of various brands.
2) Invocation of the Special Rule will not create a
health hazard. Use of the products as directed
may be the safest way of disposing of remaining
stocks. The remaining supply of chlordane pro-
ducts does not, in relative terms, constitute a
large amount. Wo estimate that between 1,800,000
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-2-
to . 3,600,000 units remain on the shelves of some
75,000 retail dealers. While the recall or stop-
sale of these units would have an adverse economic
impact_p© many formulators, their normal, generally
outdoor..use v/ould not significantly exacerbate a
situation that has been ongoing for some 26 years.
Furthermore, we have heard that some dealers are
simply flushing unmarketable units away, thereby
possibly creating a potential hazard more pro-
nounced than that created by accepted uses before
suspension. Indeed, safe disposal remains a pro-
blem for the formulator.
3) There has been some ambiguity concerning the sale
of chlOTdaftie that has left a number of formulators
confused and uncertain. On July 29, 1975 you, in
your notice of Intent to Suspend, announced that
you were invoking the Special Rule for those pro-
ducts formulated as of the date of the notice.
We believe that this action should have been, taken
when the registrations of chlordane for most uses
was suspended on December 24, 197 5. Had you is-
sued an emergency suspension order on July 29th,
the Special Rule could have been invoked. By
letter dated September 23, 1975, the Office of
General Counsel indicated that the sale of pro-
ducts formulated after July 29th was legal until
final suspension decision was made. On December 24,
you suspended most registrations and stated that
products formulated after July 29th could not be
sold. On March 23, 197 6 the Enforcement Division
requested formulators to undertake a voluntary
recall of products formulated after July 29th.
The net effect of these actions has been to en-
gender confusion in many people over the mandatory
nature of a ban on sales. While perhaps not de-
cisive, we believe this factor should in good faith
be considered.
4) Harassment of dealers by some Enforcement officials,
especially in the Northeast, has fostered resent-
ment of the Agency as a' whole and, in some cases,
strained relations along the distribution chain.
The orderly sale of remaining inventories would
reverse these counterproductive tensions.
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Of course, should you invoke the Special Rule, it would
alleviate indemnification problems that will arise wJth
respect to products formulated prior to the Suspension
Order.
I look forward to hearing from you concerning this import
tant matter.
RE:kas
cc: A.E. Conroy
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o
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
% WASHINGTON. D.C. 20460
28 OCT 1976
OFFICE OF ENFORCEMENT
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy n, Director
Pesticides and'Toxic Substances
Enforcement Divison
RE: Conclusion of the Mercury Cancellation Proceeding
On August 19, 1976, . the Administrator concluded the four year old
mercurial pesticide, product cancellation case by approving a settlement
in In re Chapman Chemical Company, et al. between the registrants
and EPA. The purpose of this memorandum is to briefly renew back-
ground events, to explain the terms and conditions of the settlement
order, and to provide you with a revised mercury cancellation enforce-
ment strategy.
I. BACKGROUND
The mercury hearings were initiated on March 22, 1972, when EPA
Administrator Ruekelshaus issued PR Notice 72-5 announcing the Agency's
intent to cancel the registrations of all mercurial pesticide products, and
the immediate suspension of all alkyl mercury compound registrations
and of all nonalkyl products registered for use on rice seed, in laundries,
and in marine antifouling paint. In March of 1972, there were twenty
registrants with thirty-seven alkyl mercury products registered, and
four hundred eighty-four registered non-alkyl mercury products held by
one hundred sixty-five registrants. None of the registrants of the sus-
pended mercury pesticides opposed the Administrator's order and the
products were therefore suspended and finally cancelled. Twenty-three
registrants sought administrative review of the notice of intent to cancel;
these registrants contested-the cancellation of mercury as a bactericide/
fungicide for use on turf, in paints and coatings, as a seed treatment, in
dry formulations, in fabrics, on .wood, and as a treatment for the control
of the Dutch elm disease.
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The formal adjudicatory hearings were held between October 1974 and
September 1975. On December 12, 1975, Administrative Law Judge Ber-
nard D. Levinson issued an initial decision, concluding that the follow-
ing pesticides containing mercury should be cancelled because they create
an unreasonable adverse effect on the environment:
(1) all uses in paints and coatings, except as an in-can preservative
in water-based paints and coatings and as a fungicide in water-
based paints and coatings used for exterior applications;
(2) all uses as a.fungicide on golf courses, .except .as used on greens,
tees, and aprons for the control of fungi of the snow mold complex;
(3) all uses for seed treatment;
(4) as a treatment for control of the Dutch elm disease; and
(5) all uses for any material that could be used in wearing apparel
and other uses for textiles and fabrics, except as a fungicide in
the treatment of textiles and fabrics for out-of-door use.
On February 17, 1976, the Administrator issued his decision and order
in the consolidated mercury hearings (In re Chapman Chemical Company
et al., FIFRA Docket No. 246, et al.). The Administrator found that the
benefits from the continued use of mercurial pesticides for use as bacteri-
cides or fungicides "(1) in paints and coatings, (2) on turf, including golf
course greens and all other areas of golf courses, (3) for seed treatment,
and (4) for any other use not specifically identified and permitted" by the
decision did not sufficiently outweigh the risks to man and the environment
and were, therefore, cancelled. The decision and order cancelled the
registrations for all remaining mercurial products, except for use
(1) as fungicides in the treatment of textiles and fabrics intended
for continuous outdoor use;
(2) to control brown mold on freshly sawn lumber; and
(3) as a treatment for the control of Dutch elm disease.
As to the existing stocks issue, the Administrator provided that the
sale and use of cancelled mercury products which were formulated
on or before February 17, 1976, were permitted.
Several mercury registrants sought review in the United States
Federal Court of the Administrator's cancellation of the seed treatment
and the turf fungicide uses of their products. On March 2, 1976, the
Administrator ordered that the effectiveness of the February 17th
Cancellation Order be temporarily stayed pending judicial review in
several United States Courts of Appeals. This order applied to all
existing mercurial registrations and the stay was to continue through
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June 30, 1976, or the conclusion of judicial review proceedings, which
ever occurred first. An important feature of the March 2nd Order was
that it prohibited the parties to the cancellation proceeding from' increas-
ing production of subject products or from stockpiling.
On March 26, 1976, the Administrator granted registrants' petition
for reconsideration of the decision and order to cancel the registrations
of mercurial pesticides for use in water-based paints and coatings.
The Administrator modified the February 17 cancellation order on
May 27, 1976, to reinstate the registrations for certain-mercurial water-
based paints and coatings; and, he extended the stay of the effective
date of the cancellation until November 30, 1976 (or until the conclusion
of judicial review; if earlier).
On August 19, 1976, the Administrator .approved a settlement in
In re Chapman Chemical Company, et al. between respondent-EPA
and registrant-appellants Parsons Chemical Works, Inc.; Troy
Chemical Corporation; Gustafson, Inc.; Mallinckrodt, Inc.; W.vA. Cleary
Corporation; and O. M. Scott & Sons Company, concerning certain contested
uses awaiting review in the Eighth Circuit, U. S. Court of.Appeals, as the
result of an appeal filed following the February 17 cancellation order. In
brief, the settlement will terminate the mercury case contingent upon the
completion of necessary regulatory activities by the Registration Division,
Office of Pesticide Programs, According to the following terms:
(1) Registrations for mercurial seed disinfectants and for
mercurial turf fungicides for use against summer turf
diseases will be finally cancelled on or before August
31, 19.78. Production of these products in the interim
is limited to prevent stockpiling; total permitted pro-
duction will not exceed the equivalent of two yeiars of
production, as determined by production data for recent
years. These uses involve 20, 000-25, 000 pounds of
production of technical mercury annually.
(2) The cancellation of registrations for mercurial fungicides
for use against winter turf diseases (10, 000-15, 000 pounds
production of technical mercury annually) is vacated. Use
of these products within 25 feet of water bodies where fish
are taken for human consumption is prohibited. /The pro-
ducts may be applied only by or "under the direct supervi-
sion of "golf course superintendents. The registrants will
request that these products be classified as restricted use
pesticides.
(3) Mercury products produced before the effective date of final
cancellation (August 31, 1978 or the date on which maximum
allowed quanitity is reached) will become "existing stocks, "
the.sale, distribution, and use of which wttl be permitted.
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The Administrator has concluded that the terms and conditions of settle-
ment agreed to by the parties to the cancellation proceeding satisfy
appplicable statutory standards under FIFRA and that the settlement is
in the public interest. See attached "Chapman Chemical Company, et
al. . Consolidated Mercury Cancellation Hearing, Settlement and Order
(41 Fed. Reg, 36068, "August 26, 1976) [hereinafter. Settlement and
Order]. "
Until such time as RD/OPP notifies the registrants of cancelled
mercurial pesticide registrations of the status of these products under
FEFRA §3, PTSED cannot be confident in the accuracy of any list of
continued mercury registrations that this office might construct. At
this juncture, it appears that all uses of mercury were cancelled on
August 31, 1976, except as follows:
(a) for seed treaifn^t (cancellation stayed by August 19
Settlement and Order),
(b) for control of summer turf disease (cancellation stayed
by August 19 Settlement and Order),
(c) in the treatment of textiles and fabrics intended for
continuous outdoor use,
(d) as a treatment for control of the Dutch Elm disease,
(e) as an in-can preservative in water—based paints and
coatings,
(f) as a fungicide in water-based paints and coatings used
for exterior application,
(g) as a fungicide for use against winter turf diseases, and
(h) to control brown mold on freshly sawn lumber.
II, ENFORCEMENT STRATEGY.
A. ENFORCEMENT OF THE STAY ORDER -- STATUS.
In my memorandum to you of May 14, 1976, entitled "Consolidated
Mercury Hearing—March 2 Stay of the Febraury 17 Cancellation Order, "
I outlined the Agency's enforcement strategy concerning the manufacture
of mercurial pesticides during the pendency of the stay of the cancella-
tion's effective date. The order staying the final cancellation could have
been dissolved if the Administrator found that a party to the proceeding
was increasing production and/or stockpiling mercurials during the pen-
dency of the stay. Affected regions (II, III, IV, and V) were requested
to initiate section 8 books and records inspections at all producer estab-
lishments, twenty in all, to determine the level of compliance with the
Administrator's order. Your cooperation in ensuring that the terms
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of the Administrator's/orders—particularly, the "average monthly amount"
restriction—were complied with by affected registrants is appreciated.
The further need to monitor and to advise the Administrator as to the level
of compliance by the. registrants with the conditions of the stay order has
been mooted tjy the issuance of his most, recent order announcing the con-
clusion of the mercury proceedings.
B.. TERMS OF THE "SETTLEMENT AND ORDER. "
1. Registration Status of Mercury Products. The Administrator's
August 31, 1976, Settlement and Order provides the following:
(a) the cancellation order.provision cancelling the
registrations of the following mercurial seed
treatment products isjstayed until August 31,
1978, or until the registrant has produced the
maximum allowed quantity of the product under
the conditions of the particular settlement agree-
ment, whichever occurs first:
(ij Parsons Chemical Works (1969-MI-Ol) --
1969-57 PARSONS SLURRY CONCENTRATE "60"
1969-58 PARSONS LIQUID SEED SAVER
1969-91 PARSONS SEED SAVER DUST
(ii) Gustafson, Inc. (2079-NJ-01; 36209-NJ-01)
7501-2 MIST-O-MATIC LIQUID SEED DISINFECTANT
7501-5 MIST-O-MATIC DRILL BOX TREATMENT
(iii) Troy Chemical Corporation (5383-NJ-01) —
605-37 GALLOTOX LIQUID SEED DISINFECTANT
(b) the cancellation order'provision cancelling the registrations
of the following mercurial fungicide products for use against
summer turf diseases is stayed until August 31, 1978, or
until the registrant has produced the maximum allowed
quantity of the product under conditions of the particular
settlement agreement, whichever occurs first 1/:
\J As part of the settlement agreement, O. M. Scott, and W. A. Cleary
have agreed to apply to the Registration Division, Office of Pesticides Pro-
grams on or before September 1, 1976, to amend the registrations of subject
products to establish separate registraiIcr.o for (i) products for use against
summer turf diseases and (ii) products i'ov tso against winter turf diseases.
You will be notified and supplied with the necessary information as soon as
PTSED is apprised of the completion of this action by RD/OPP.
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(i) O. M. Scott & Sons Company (538-OH-Ol) —
538-27 PRO-TURF BROAD SPECTRUM FUNGICIDE
538-36 PRO-TURF FERTILIZER PLUS FUNGICIDE
538-56 CALIFORNIA FERTILIZER PLUS FUNGICIDE
(ii) W. A. Cleary Corporation (1001-NJ-01) —
1001-4 PMAS CRABGRASS KILLER AND FUNGICIDE
(c) the cancellation order provision cancelling the registrations
of the following^Mallinckrodt, Inc. (372-PA-01; 372-NJ-01)
mercurial fungicide products for use-against-winter turf dis-
eases 2/ is vacated in accordance with the terms of the
settlement agreement and production, sale, and distribution
may resume unimpeded 3_ /:
372-5 CALO-CLOR
372-33 CALO-GRAN
(d) the order of March 2, 1976, staying the cancellation
order of February 17, 1976, is dissolved effective
August 31, 1976.
2. Enforcement Responsibilities Under Settlement and Order. Pur-
suant to the terms of the settlement agreements, registrant-appellants must
fulfill certain substantive requirements to be afforded a stay of the effective
date of the cancellation of the seed treatment and summer turf disease pro-
duct registrations. The conditions impacting on the Office of Enforcement
include:
(a) During the pendency of the stay, the registrants must limit
production of the subject mercurials for use against summer
turf disease to the amount determined by multiplying the
average monthly production rate during the base period (in
most cases, April 1, 1972 to September 1, 1976) times the
number of months the cancellation is stayed (24). If this
total production figure is reached prior to August 31, 1978,
the subject product's registration become immediately
2} "Winter turf diseases" consist of Fusarium nivale (pink snow mold,
pink patch, or fusarium patch), Typhula incarna, Typhula ishikariensis, and
Sclerotinia borealis.
3/ As part of the settlement agreement, Mallinckrodt has agreed to
amend the subject products' labeling to include the caution "Do not apply
within twenty-five (25) feet of any body of vater where fish are taken for
human consumption" and the direction thct the product may be used . .
only by or under the direct supervision c-'. coarse superintendents. "
These label additions will also be made to tko O.M. Scott and W. A. Cleary
products for use against winter turf diseases (see footnote 1/, supra).
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7
cancelled, and the registrants must notify the Director
of the Pesticides and Toxic Substances Division of such
fact immediately.
(bj On or Dei ore September 1# 1976, the registrants were to
provide; PTSED with (a) production figures by product
fop-4he base period, (b) the total existing inventories
of subject prdetects as of September 1» 1976, and (c) a
list of immediate customers likely to purchase the
subject products. As of now, these data have not
been fully submitted. PTSED is corresponding with
the subject registrants, noting "their deflinquency and
the necessity for delivery of toe required information.
(c) Beginning on September 30, 1976, the registrants must
submit quarterly production reports on subject regis-
tered products to PTSED (plus other reports and /or
additional information necessary to effecutate the
intended purpose of the agreement). As of now, these
data are also incomplete.
C. ENFORCEMENT ACTIVITIES.
The Agency's enforcement strategy concerning mercurial pesticide
products will .have two -general areas of .emphasis: (1) the monitoring of
the production limitation provisions of the settlement agreements for
compliance by all affected registrants, and (2) the exercise of standard
enforcement actions against persons who are discovered violating the
terms of the mercury cancellation order.
1. Monitoring. The monitoring of settlement agreement com-
pliance will be the joint enterprise of regional personnel with pesticide
enforcement responsibilities and the Pesticide and Toxic Substances
Enforcement Division. Initially, PTSED will review data submitted by
the mercury registrants subject to the Settlement and Order, and will
independently calculate and corroborate the figures submitted by subject
companies as the "maximum allowed quantity for each product to the
final August 31, 1978 cancellation deadline. The official figures will be
transmitted to the regions who will then be able to determine whether
and when inspection of mercury producing establishments is warranted
under the particular circumstances of each case. Deviations from the
Administrator's Settlement and Order will be dealt with as appropriate.
2. Enforcement actions. As soon as PTSED is provided with an
official list of those mercury products cancelled and those mercury regis-
trations surviving the cancellation proceedings, you will be so advised.
Additionally, as soon as there is a change in the registration status of
those products whose effective dates of cancellation have been stayed by
the Settlement and Order, regions will b'-1 notified.. Violations of the
cancellation order will be handled as routine enforcement matters. As
the Administrator has provided for the use of existing stocks of products
subject to the August 19 order, there will be no recall program initiated.
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HI. INQUIRIES.
Inquires concerning any facet of the mercury cancellation proceedings
and the Agency's enforcement strategy should be referred to the appropriate
regional coordinator.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C. 20460
JAN 6 1377
OFFICE OF ENFORCEMENT
TO
Enforr—«nt rivisicn Directors
Pesticides Branch Chiefs
FROM: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
a
RE:
Enforcement of Mercury Settlement
In a memorandum of October 28, 1976, entitled "Conclusion of the
Mercury Cancellation Proceeding" (attached)* I outlined the background
and cdriclusion of In Re Chacman Chemical Company, et al., including,
at pp-5-7, the terns of the settlement and order and the Agency's pro-
jected enforcement, thereof. Review of the compliance with the order'by
the six registrants affected indicates that there exist degrees of com-
pliance activities, varying from none to complete.
On December 24, 1976, five registrants (not including Mallinckrodt)
were advised by registered letter (copies attached) of the Agency's record
of their compliance, of those activities required to be completed, of a
general deadline of Jahuary 14, 1977, for initial compliance, and of EPA's
intention to immediately enforce against non-compliance.
As a follow-up to these letters, you are requested to make plans
to inspect, between January 19 and 21, 1977 those manufacturing facilities
in your region where section 7 records indicate subject products are pro-
duced for the purpose of placing stop sales against those products whose
registrations are no longer valid in that information was not submitted
as required by the "Settlement and Order". Attached is a list of affected
products, labels, producing establishments and addresses. On the afternoon
of January 18, 1977, your Regional Coordinator will contact you to indicate
which producers and products have attained an acceptable level of conpliance
and which ones have not.
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You may use the revised stop sale form provided at p. 13 in the
new section 13 (10-76) of the Case Proceedings Manual. In the paragraph
specifiying the violation, it is suggested you insert the following:
. . . there .is reason to believe that (product
name) is in violation of section 12(a)(2) (K)
of the Act in that the registration of said ¦
product was continued subject to the terms of
the "Settlement and Order" signed August 19,
1976, in Re Chapman Chemical Company, et al.,
and said registration is no longer valid in
that [base period production reports, calcu-
lation of total allowable production, customer
lists, existing inventories, and quarterly
production-reports) were not submitted as
required by the Settlement.
This is the first of several so-called "phased cancellations" which
the Agency is handling. It is of great importance that we enforce
compliance firmly and swiftly in this intial order to build an awareness
of and appreciation for the Agency's intentions to enforce similar
cases in the future. Should you have questions, please contact the
appropriate Regional Coordinator.
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i-
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-t-
You rrsy use the revised step sale fcrr prc-viccS at 13 in thr?
new section 13 (10-76) of the Case Frocoeaings .Vanual. In the i^regraph
cpecifiying the violation, it is suggested you insect the following:
... there is reason to believe that (product
name) ie in violation of section 12(a)(2)(K)
of thu Act in thit the registration of said
product was continued subject to the terms of
the "Settlement and C-rdec" signed August 19,
1976, in Pe Chgcran Chemical Company, et al.,
and said registration is no longer valia in
that [base period production reports, calcu-
lation of total allowable production, customer
lists, existing inventories, and quarterly
production reports] were not submitted as
required by the Settlement.
This is the first of several so-called "phased cancellations" which
the Agency is handling. It is of great importance that we enforce
cappliar.ce firrrly and swiftly in this intial order to build an awareness
of and appreciation for the Agency's intentions to enforce similar
cases in the future. Should you have questions, please contact the
appropriate Kegional Coordinator.
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Region V Pesticide Products and
Company Addresses Involved In
The Mercury Settlement
1 • 0- " Sco-tt ' -r.r.i:- Company
a. Corresponding Address
Mr. John P. KerineSyi General Counsel
0. M. Scott 1 Sons
Kar.>-iviiiii, Ohio 43040
b. Establishment Address B Est. #:
0. M. Scott & Sons Company
Marysville,.Ohio
Est. #538-QH-01
c. Product Involved:
1) Pro-Turf Broad Spectrum Fungicide; EPA Reg. No. 538-27
2) Pro-Turf Fertilizer Plus Fungicide; EPA Reg. No. 538-36
3) Pro-Turf California Fertilizer Plus Fungicide; EPA Reg.
No. 538-55
Note: 0. M. Scott 1s currently in compliance with settlement agree-
ment and enforcement-actios? are not anticipated during
January 77.
2. Parsons Chemical Works, Inc.
a. Corresponding Address:
Mr. C. R. Parsons, President
Parsons Chemical Works, Inc.
P.O. Box 146
Grand Ledge, Michigan 48837
b. Establishment Address & Est. i:
Parsons Chemical Works, Inc.
Grand Ledge, S1ch:'gar.
Est. § 1555-MID;
c. Products Involved:
1) Parsons Slurry Concentrate "60"; EPA Reg. No. 196957
2) Parsons Liquid Seed Saver; EPA Reg. No. 1969-53
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- 2 -
3) Parsons Seed Saver Dust; EPA Reg. No. 1969-91
Note: Parsons Seed Saver Dust was included in the settlement
agreement, but a search of EPA records has revealed that
it was never registered. It carries the file symbol
No. 19Gc„;-kR.
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ENVIRONS L".NTAl. PilOT ECTION AC1IKCV
Utu ^7 iy/6
Mr. John P. Kennedy, General .Counsel
0. I). Scoct u Sous
Karysville, Ohio 43040
Dear l:r. Kennedy;
Thank you for your timely submission of tlic quarterly report for
the period of July 1, 1976 through Septenber 30, 197G.
Wo arc attaching for your convenience, a schedule shov/1 ng when the
next quarterly reports arc due in this office. The reports should be
sent by certified rail and addressed as follows:
A. E. Conroy II, Director
Pesticides and Tor.ic Substances
Enforcement Division {L'J-342)
U.S. Cnvir omental Protection Agency
401 II Street, S.W.
Washington,' D.C. 2C460
The data you sutnit will bz treatc-i as confidential, unless yea-
advise otherwise.
We appreciate the promptness v;ith which you have responded to the
requirs-ients or the Sc-ttlor.Ent Order end hops that you will continue to
poet the conditions enu rcquiregents inipcsed upon you, Hcv/evor, ve
should criphasij.e that failure to uukriit th'j reports in a timely r«ar.ner
will result in the initiation of step scle and seizure actions as well
as thi» i::?':e^iji-.e cptscoT larion of registrations for U12 products involved
in ti:o Sett'ics.icnt Ordsr.
Slncoivaly yc/'.:rs,
A. E. Conroy II, Director
Pesticides a*:c Toxic 5slices
ifi?z-rzxr,:::z I'ivisicn
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ENVIRONMENTAL PROTECTION AG?
" Sect:', t Sons
sciiiDi;:.: !:o:. suriiciit/. or ultop.ts.
Period Due To PTSED
Oct. 1 - Doc. 31, 1976 Jan. 15, 1977
J-II. 1 - 3i, 197'/ Apr. 13, 1277
April. 1'- Jusis 30, 1?77 July 13, 1977
Jul. 1 - Sept. 30, 1977 Oct. 17, 1977
Oct. 1 - Dec. 31, 1977 Jan. 17, 1973
Jan. 1 - Kar. 31, 1973 Apr. 17, 1078
Apr. 1 - Jane 30, 1973 July 13, 1578
July. 1 - Aug. 31 , 1278 Sept. 18, 1378
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DEC 27 187G
Mr. C.-H. Parsons, President
Parsons Chemical Works, Inc.
P. 0. Box 146
Grand Ledge, Michigan 48G37
Dear Mr. Parsons:
This letter 1s to acknowledge receipt of your September 10, 1976,
communication containing the signed settlement agreement and order
pursuant to:the Administrator's Order and Settlement of August 19, 1976,
(41 PR 3CG6S), 1n In re Chelan Chemical Company.' et al., tha mercury
pesticide cancellation.case.
As you are well aware, the settlement to which you agreed specified,
in part, that Parsons Chcaical V.'orhs, Inc. vould provide th2 Director of
tire Pesticides and Toxic Substances Enforcement Division (P7SED) with
(a) certain production records eh your mercurial products, Parsons
Slurry Concentrate "CO" (EPA Reg. No. 1 £59-57)., Parsons Liquid Seed
Sever (EPA Keg. No. 1SG9-58), and Parsons Seed Saver Dust (EPA Reg. Mo.
1S52-91), (b) a computation of the total maximum amounts of production
of these products that are allowed under the terms of the settlement
agreement, (c) a list of irr.ediate customers, and (d) an inventory of
the quantities of thsse products on hand. PuTSED has not yet received
tills information. In addition, your first quarterly report, due on
September 30, 1S76, has not yet arrived. Wa would-also remind you that
the next quarterly P^port covering tha period through December 31, 197G,
is also due to be submitted.
The above information and the quarterly reports for Scptsmbsr and
Decrr.Ler Eiust ba suteittcd ly Onru^ry K, 1C-77. Tr,-. v;::-k period
hstween Occt-iLir 31st r.:;d Ocfiuzry Ktl; should allow eople t;';r» to co:n-
pl«.te the production'reports for" chc December quartsr and still provide*
sufficient t'ir.o for nailing tho information. If there is no production
curing reporting periods, then zero production figures-should be re-
ported.
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The infers tion should be serve by certified rail and addressed as
follows:
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division (EN-342)
U. S. Environmental Protection Agency
401 M Street* S.'.i.
Washington, D. C. 20s60
You may rest assured that the data ycti submit will be treated as
confidential, unless you advise otherwise.
Attached for your convenience 1s a schedule shovring when the various
reports are due. There will be no further reminders from this Agency.
The conditions and requirements imposed upon ycu by the August 19j 1976,
Settlement and Order are salv-ex<;-cutinn. Your strict compliance with
these terms is rot only anticipated, but required. Failure to subi.iit
the required reports in a tir,oly wanner will result 1n initiation of
Stop sale and seizure action on all products affected by tills Order and
the inrr.ediate cancellation cf the registrations for these products.
We are also attaching a ccny of the Settlement Order entitled
"Proposed Terns of Settlement of Certain Portion of FIFRA Docket Uos.
246 et al.: Mercury Pesticide Cancellation Case", sicned by you on
September 10, H»7i>. We surest ycu review the document.
Sincerely yours,
A. E. Conroy II, Director
Pesticides aprd Toxic Substances
Enforcement Division
cc: Col burn T. Cherney
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PARSONS CHEMICAL V.'ORKS, IKC
SCHEDULE FOR SUBMISSION OF REPORTS.
PERIOD DUE TO PuTSED
Amount forrsuloted each iranth
during period betv/sen April 1,
1972 and July 31, 1576.
Computation of total ililUTtJ Jan. 14, 1977
amount of .production.'
Inventory of quantity of
product cn hand as of
Sept. I, 127G.
List of irraediatc customers
July 1 - Sept. 30, 1976 Jan. 14, 1977
Oct. 1 - Dec. 31, 1976 Jan. 14. 1977
Jan. 1 - far. 31 , 1977 Apr. 15, 1977
Apr. 1 - Jun. 30, 1977 Jul. ID, 1977
Jul. 1 - Sept. 30, 1977 Oct. 17, 1977
Oct. 1 - Dac. 31, 1977 Jon. 17, 1973
Jan. i - Mar. 31, 1978 Apr. 17, IS/3
Apr. 1 - Jun. 30,.1570 Jul. 13, 1978
Jul. 1 - Aug. 31, 1978 Sept. 18, 197
O
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Z T.
Km;
V/"t
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
2 8 OCT 1976
OFFICE OF ENFORCCMEIJT
TO:. Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Divison
7P
RE: Conclusion of the Mercury Cancellation Proceeding
On August 19, 197G, the Administrator concluded the four year old
mercurial pesticide product cancellation case by approving a settlement
in In rc Chapman Chemical Company, et al. between the registrants,
and EPA. The purpose 01 ims menioranclum is to briefly review back-
ground events, to explain the terms and conditions of the settlement
order, and to provide you with a revised mercury cancellation enforce-
ment strategy.
I. BACKGROUND
The mercury hearings were initiated on March 22, 1972, when EPA
Administrator Ruckelshaus issued PR Notice 72-5 announcing the Agency's
intent to cancel the registrations of all mercurial pesticide products, and
the immediate suspension of all slkyl mercury compound registrations
and of all nonalkyl products registered for use on rice seed, in laundries,
and in marine antifouling paint. En March of 1972, there wcr.e twenty
registrants with thirty-seven alkyl mercury products registered, and
four hundred eighty-four registered non-aikyl mercury products held by
one hundred sircty-five registrants. None of the registrant's 01* the sus-
pended mercury pesticides opposed the Administrator's order-dnd the
products v/erc therefore suspended fir.ally ':anceUec3. Twenty-three
registrants sought administrative ?-*rr.z\" ai the nczice c:' ir.tcr.: to cancel;
these registrants contcst-id the cancellation of mercury as a bactericide/
fungicide for use on turf, in paints and coatings, as a seed treatment, in
dry formulations, in fabrics, 011 wood, and as a treatment for the control
of the Dutch elm disease.
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The "formal adjudicatory hearings were held between October 1974 and
September 1975. On December 12, 1975, Administrative Lav/ Jud?;c Ber-
nard D. Levinson iss\ied an initial decision, concluding that the follow-
ing pesticides containing mercury should be cancelled because they create
an unreasonable adverse effect on the environment:
(1) all uses in paints and coatings, except as an i.n-can preservative
in water-based paints and coatings and as a fungicide in water-
based paints and coatings used for exterior applications;
(2) all uses as a fungicide on golf courses, .except as vised on greens,
tees, and aprons for the control of fungi of the snow mold complex
{3) all uses for seed treatment;
(4) as a treatment for control of the Dutch elm disease; and
(5) all uses for any material that could be used in wearing apparel
and other uses for textiles and fabrics, except as a fungicide in
the treatment of textiles and fabrics for out-of-door use.
On February 17, 197G, the Administrator issued his decision and order
in the consolidated mercury hearings (In re Chapman Chemical Company
et al., FIFRA Docket No. 246, et al.). Tne Administrator iounci that liie
benefits from the continued use oi mercurial pesticides for use as bacteri-
cides or fungicides "(1) in paints and coatings, (2) on turf, including golf
course greens and all other areas of golf courses, (3) for seed treatment,
and (4) for any other use not specifically identified and permitted" by the
decision did not sufficiently outweigh the risks to man and the environment
and were, therefore, cancelled. The decision and order cancelled the
registrations for all remaining mercurial products, except for use
(1) as fungicides in the treatment of textiles and fabrics intended
for continuous outdoor use;
(2) to.control brov.ii mold on freshly sawn lumber; and
(3) as a treatment for the control of Dutch elm disease.
As to the existing stocks issje, "hAdministrl.:er provided that th?
sale and t:se of cancelled mercury products which were formulated
on or before February 17, 1970, were permitted.
Several mercury registrants sought review in the United States
Federal Court of the Administrate-r's* ear-e^Uation of the seed treatment
and the tur: fungicide u.cos oi :hoir products. On March 2, iD76, tne
Administ rator ordered that th>:- e:t" of the Februarv 17th
Cancellation Or do r h- u-wnor: :*.• ".y . .v'-ening judicial re\iew hi
several Unit*.-:.' Stole;; Courts ot .A'..-;.k i.:-. : order applied to rU
existing mercurial rr£; stmt ions and the y v.-ris lo continue through
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June 30, 1970, or the conclusion of judicial review proceedings, which
ever occur: i 3 l. A.-.i jmporltnf- feature of the March 2nd Order was
that it prohibited the parties to the cancellation proceeding from increas-
ing production of subject products or from stockpiling.
On March 2G, 197G, the Administrator granted registrants' petition
for rcconnidern.!;-" - of arid order to cancel the registration^
of iru rcur " .1 p:-stic:ido;r for use in water-based paints and coatings.
. The Adjninistr ator modifiedvthe February 17 cancellation order on
-May 27, 197G, .to reinstate the registrations for certain mercurial water-
based paints and coatings; and, he ortended the* stay of the effective
date of the cancellation until November 30, 1976 (or until the conclusion
of judicial review; if eeriier).
On August 19, 1976,' the Administrator approved a settlement in
In re Chapman-Chemical Company, et al. beitween respondent-EPA
and registrant-appellants Pp.rsons Chemical. Works, Inc.; Troy
Chemical Corporation; Gustafson, Inc. ; Mallinckrodt, Inc.; W. A. Cleary
Corporation; and O. IVI. Scott & Sons Company concerning certain contested
uses awaiting review in the Eighth Circuit, U. S. Court of Appeals, as the
result of an appeal filed following the February 17 cancellation order. In
brief, the settlement will terminate the mercury case contingent upon the
completion of necessary regulatory activities by the Registration Division,
Office of Pesticide Programs, according to the following terms:
(1) Registrations for mercurial seed disinfectants and for
mercurial turf fungicides for use against summer turf
diseases will be finally cancelled on or before August
31, 1978. Production of these products in the interim
is limited to prevent stockpiling; total permitted pro-
duction will not exceed the equivalent of two years of
production, as determined by production data for recent
years. These uses involve 20, 000-25, 000 pounds of
production of technical mercury annually.
(2) The cancellation of registrations for mercurial fungicides
for use against winter turf diseases (10, 000-15, COO pounds
production of teclir.ical mercury a:\r.u2Hy) is vacs tec. "Use
of t]\»?so prc-.iucts vi:r~irA-5 :eci o: waisr bodies \vh?ve zish
are taken for human consumption is prohibited. The pT*--
duets may be- applied only by or""iwcor the direct supervi-
sion of" golf course superintendents. The registrants will
request that, these products be classified as restricted use
pesticides.
(3) Morcury product.? p-c'"ccd bc'o'-e *>.r effective d:\te- ci final
:cancon.';licii (August ii, o.* :•><• virto on which maximum
allov/ed is v. :' - ''exist iiu* s:ioc!"
the r;:ile, distribution, and i:;~e t-.l' /.-hiclx vill be pei-miLtoti.
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The Administrator has concluded that the terms and conditions of soil!
mcnt agreed to by the parties to the cancellation proceeding i;ictisfy
appplieable statutory standards under F1FRA and that the seUiemen- is
in the public interest. See attached "Chapman Chemical Co.nnnny. cl
al. , Consolidated Mercury Cancellation Hearing, Se'tUcmiuu and Orde
(41 Fed. Reg. 36068, August 26, 1076) [hereinafter, Settlement and
Order]. "
Until such time as RD/OPP notifies the registrants of cancelled
mercurial pesticide registrations ox the status of these.products under
FIFRA §3, PTSED cannot be confident in the accuracy of any .list of
continued mercury registrations that this office might construct. At
this juncture, it appears that all uses of mercury were cancelled on
August 31, 1976, except as follows:
(a) for seed treatment (cancellation stayed by August 19
Settlement and Order),
(b) for control of summer turf disease (cancellation stayed
by August 19 Settlement and Order),
(c) in the treatment of textiles and fabrics intended for
continuous outdoor use,
(d) as a treatment for control of the Dutch Elm disease,
(e) as an in-can preservative in water-based paints and
coatings,
(f) as a fungicide in water-based paints and coatings used
for exterior application,
(g) as a fungicide for use against winter turf diseases, and
(h) to control brown mold on freshly sawn lumber.
n. EN F OR CE IE NT ST RATE G Y .
A. ENFORCEMENT OF TaZ stay crder -- STATUS.
In my rr,smorar.di?m to you of May 1*1, 1976, _enliiied "Ccnsol!
Mercury He.iring--rv!p.rcii 2 Stay of the February 17 .Cancellation Order
I outlined iho A^cncy's-enforcemenl strategy concerning the manufactu
of mercurial pesticides during the pendency of the stay c: the canceUa
tion's of^eeiiv Th-e or-ier *.he zir.al cancellation could ha
been dissolved if the Adminisirnror found that a navty to the proe® v:lin
vas ii:erea.vi--4..: tiers :r mercurials during is.e y.o
dcncy of the .-u Affeote-J region:; {:!. Ml. IV, and V) were vccjunr-ic;
to initiate sec'ion t! bookr. and re cord,-; ioyj.K-ciions at all prodmu'r v.".r.
lisbmoats, twonly in nil, to determine the } f.-vel of com;?] i.r.c v:ii ,;>•
Administrator's order. Your cooperation it: ensuring thai the '."v -l
-------
of the /^urwuiUrutin 's orders—particxilarly, the "average monthly amount"
rcrtrirfjV i--v.--r'- 1 -;-*2 v.-ilh by iifXccted 'registrants is appreciated.
The fui-Lh-r ntj..d to i^onUor and to advise the Administrator as to the level
of compliance by the registrants with the conditions of the stay order has
been mooted l;_y the issuance of'his most recent order announcing the con-
clusion of the mercury proceedings.
B. TERMS OF iJ.3C 'TTIiEMENT AND ORDER. "
1. Reri^tyrtidii Status of'Mercury Products. The Administrator's
August "ticvticrmeni sua Order provides ihc following:
(a) the cancellation order provision cancelling the
registrations of the following mercurial seed
treatment products is stayed until August 31,
1S78, or until the registrant has produced the
maximum allowed quantity of the product under
the conditions of the particular settlement agree-
ment, whichever, occurs first:
{i} Parsons Chemical Works (1969-MI-01) —
1963-57 PARSONS SLURRY CONCENTRATE "60"
1969-53 PARSONS. LIQUID SEED SAVER
¦1869-91 PARSONS-SEED. SAVER DUST
(ii) Gustafson, Inc. {2079-NJ-01; 3S209-NJ-01) —
¦7501-2 MIST-O-HLA.TIC LIQUID SEED DISINFECTANT
7501-5 MIS T- O- MA TIC DRILL BOX TREATMENT
(iii) Troy Chemical Corporation (53S3-NJ-Q1) —
605-37 GALLOTOX LIQUID SEED DISINFECTANT
(b) the cancellation order provision cancelling the registrations
of the following mercurial.fungicide products for use against
summer turf diseases is stayed until August 31, 1978, or
until the rc-sjisirartt h&s produced Hie maximum allowed
quantity of the product tuidur conditions of the particular
settlement w-iiichever occurs first 1/:
As par: oi the settlement agreement, O. M. Scott, and \V. A. Clenry
hz.\s a^v-iod *c L" :c- th* :.*u:v.:n Division, Office of P-'sticices Pro-
£rsms on or before September I. 107£, to arrs^nd the rcqistvntl.'.nj -¦:* sir-k".:
¦ ¦it!'.*1,.K: 11 v 0 * . I.V ¦ ' u 2 O t* fj/ j J''CiJVlCt 13 j Oi' II ;.¦* C' * 1* : Vl J"* -
Summer ttsi-r • ^V-jasvs (ii) pvoouv'.;: fov ur-o a«r.ui«?t winter t\:<.;f
You will be no:.-i'K:U una .-;nppiio-J with the ncca:-y information as ^i i:
P'i'SEP is appi i.-.t-d of the completion of this actum by RD/OTI'.
-------
- 0 -
(i) O. M. Scott &. Sons Company (530-OH-Oi) —
538-27 PRO-TURF BROAD SPECTRUM FUNGICIDE
53C-3G PRO-TURF FERTILIZER PLUS FUNGICIDE
533-56 CALIFORNIA FERTILIZER PI,US FUNGICIDE
(ii) W. A. Cieary Corporation (1001-NJ-01)
1001-4 P3VIAS CRABGRASS KILLER, AND FUNGICIDE
(c) the cancellation order pr^wision cancelling the registrations
of the following Mallinckrodt, Inc. (3Y2-PA-01; 372-NJ-01)
-mercurial fungicide-products for-use-against winter turf dis-
eases 2/ is vacated in accordance with the terms of the
settlement agreement and production, sale, and distribution
may resume unimpeded 3/:
372-5 CALO-CLOR
372-33 CALO-GRAN
(d) the order of March 2, 1976, staying the cancellation
order of February 17, 1976, is dissolved effective
August 31, 1976.
2. Enforcement Responsibilities Under Settlement and Order. Pur-
suit to the terms oi ine setrie-meni agreements, rc-gistrant-ap;;oiiants must
f'^ certain substantive requirements to be afforded a stay of the effective
da. of the cancellation of the seed treatment and summer turf disease pro-
duct registrations. The conditions impacting on the Office of Enforcement
include;
¦ (a) During the pendency of the stay, the registrants must limit
production of the subject mercurials for use against summer
turf disease to the amount determined by multiplying the
average monthly production rate during the base period (in
most cases, April 1, 1C72 to September 1, 1976) times the
number of months the cancellation i? stayed (24). If this
total production fJrurc is readied prici- to August 31, 1973,
the subject product's registration become immediately
27 ""v/lnier cur: 3 - =: :: Fusariuni r.ivale Cpir.k snow moid,
ink patch, or fusarium tTvphuir. iucartiS, Typhula ishiknviensis, and
clercn!'¦ ;a horeal.'y.
3/ As y.art of the settlement agreement, Mallinckrodt has agreed to
"¦aeivJ the subject pv : ducts1 • s"-s:r .r.c'.ude ~au~lcn "Do not apply
ithin twenty-live (~5) feci oi any L^ociy oi water where risii are tal:en t'or
iman eon:-ump:io = : ! d ih-_ : ¦¦ .¦¦ ' .-.;d ;e: may be r.sed . .
dy by or v.nder th.-1 drrvct rrsi'-ei'vi.--' ^ni'.r;e yuperinl erideius. "
lnbc.' additions will ai.^o be O. M. Scolt and \V. A. Cleary
¦b 3 fci-- use against whiter turf diseni-es (see footnote JV, suprr.).
-------
-7-
ctc-.ic;-:'< r?f r>,rl the registrants must notify-the Director
cr 1! : ' r:.-r> aud Toxic Substances Division of such
fact immediately.
(l^) On or before September 1, 1976, the registrants were to
provide PTSED v/ith (a) production figures lay product
for the base period, (b) the total existing inventories
of subject produces as of September 1, 197G, and (c) a
list c" cu. tomcrs likely to purchase the
subject. }>; ejects. As of now, these data have not
been fully submitted. PTSED is corresponding with
the subject registrants, noting their delinquency and
the necessity for delivery of the required information.
(c) Beginning on September 30, 1976, the registrants must
submit quarterly production reports on subject regis-
tered products to PTSED (plus other reports and/or
additional information necessary to effecutate the
intended purpose of the agreement). As of now, these
data are also incomplete.
G. ENFORCEMENT ACTIVITIES.
The Agency's enforcement strategy concerning mercurial pesticide
products will .have two general, areas of emphasis: (1)..the monitoring of
the production limitation provisions of the settlement agreements for
compliance by all affected registrants, and <2) the exercise of standard
enforcement actions against persons who are discovered violating the
terms of the mercury cancellation order.
Monitoring. The monitoring of settlement agreement com-
pliance will be the joint enterprise of regional personnel with pesticide
enforcement responsibilities and the Pesticide and Toxic Substances
Enforcement Division. Initially, PTSED will review data submitted by
the mercury registrants subject to the Settlement and Order, and will
independently calculate arid corroborate the figures submitted by subject
companies as the "maximum allowed quantity'1 for each product to the
final August 31, 1078 cancellation deadline. The official figures will be
transmitted to the regions who will then be able to determine whether
and when inspection of mercury .producing establishments is warranted
under the particular circurr.stances of each c-sc. Deviations from the
Administrator:5 Setilerr.er;: ana Crier v.*ill be dealt with as appro~.ria:5.
2. J.;.i-;Covcc-rr;rp'. actions. As soon as FTSED is provided viih -nn
official list ci7"lI:oso mercury products cancelled and those mercury regis-
trations surviving the cancellation proceedings, you will be so advised.
Additionally, as scon as ihors is i chan-e in the registration staius o:'
those products whose effective catas of cancellation have been stayed by
t'"»c Settlement ?.r.c 0-d?r, r«?c:c-:v.s v.:!' I - notified. Violations of the
cancellation o;-
-------
-8-
III. INQUIRIES.
Inquires concerning any facet of the mercury cancellation proceedings
anil the Agency's enforcement strategy should be referred to the appropriate
regional coordinator.
-------
O.I*!. Scott & Sons Ccsipany
ATTN: Gary \u CHrh
Harysville, OH 43C40
Gentlenen:
Subject: PROTURF BROOD SPECTRCt* FJIIGICIDE
(For Use oh Winter Turf Diseases)
EPA Reg. No. 533-27
Letter of Noveober 12,' 1976
The labeling referred to above', rsubc.1ttea 1n connection with registration
under the Federal Insecticide, Fungicide, and F.odenticlde Act, as anended,
is acceptable, and a stamped copy is enclosed for your records.
John H. Lee
Product l-ianager (22)
Fungicide Herbicide Branch
Registration Division
Enclosure
WH-567: Fh'B: JKLee: n 1 o: acs: 638-676T: 11 /2S/76
-------
SCQTTS
0 M Scott S Sons
A Subsidiary of ITT
McrysvUk. Ohio ''3040
(513)642-6015
THE LAWN PEOPLE
November 12, 1976
EPA Registration Division (WH-567)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Attn: Mr. John Lee, PH-22
Subject: ProTurf Broad Spectrum Fungicide
EPA Reg. No. 538-27
Resubmission
Gentlemen:
Enclosed are fivercopies of finished labeling for subject
product including the following revisions:
1) "EPA Est. 538-OH-l" has been added to the
front panel below the ingredient statement.
2) "EPA Reg. No. 538-27-AA" has been changed to
"EPA Reg. No. 538-27".
If you have any questions concerning this matter, please
give me a call at 513/644-0011, extension 2104.
Respectfully yours,
// t
ca
enc.
-------
I! -¦1
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FOR USE ON
WINTER TUaF DISEASES
FOR PROFESSIONAL USE ONLY
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••••'oHT >i _ {S'j.i =\ i)
¦ - VN : .""N ' '!
.;
O.M. £: Sons
ATTN: U-.ry M; r-rlc V"-:-: : * ,T. •. •' * 'v \1-."": -
Ma^'sviri^Su-cC-- ¦...<¦>¦.'** ¦..-'v.:v.v^;
iX'^, ;vvvs'•*"•>£*
Gentler.en:;? . vf .* r--.v
'* * -•:*
Subject::: PRQTURF CALIFORNIA FERTILIZER plus FUHSICIDSj ^
'J;(For Use cn Winter "Diseasfis)'^^
-EPA Reg. Mo i-;53S-£5.->'^';-:: * •,^'i £=.
•-'.'Letter of Hov." ^^>>=,1,.^ ro
r-. ' « • • - -
The labeling referred to above; Submitted in connection with registration
under the Federal Insecticide, Fungicide, end- Rodenticide Act, as'trended,
is acceptable, and a stamped copy is enclosed for your records.
_» * ,? '\ % ' • . *¦ *>
-t " "* - - . ••' « • 1
..." - . %• . • /. ¦ -i
_*¦*.* \ t
John H. Lee " r . :• ¦
Product Manager (22)' ' v""~i - ' :
Fungicide Herbicide Branch ¦'¦ i" £ ' -¦•.'j'--
Registration Division ""
.; ¦ " ¦" ;7.-: :S •: '
Enclosure " ¦"—¦•w.**.-.?¦»
VIH-567: FHB: JHLee: nl o: acs: 63S-6757:11/29/76
ro.
f : iow
v :m -
* ~ > c/
-------
SCOTTS
THE WWN PtiOPLE
0 ScCkt u Sons
AS-L-tf-r/r'fTT
MarysviHe. Ohio 43040
(513)642-60)5
** P <*,
November 12, 1976
EPA Registration Division (WH-567)
Office of Pesticide Programs
Environmental Protraction Agency
Washington, D.C. 20460
Attn: Mr. John Lee, PK-22
Subject: ProTurf California Fertilizer Plus Fungicide
EPA Reg. No. 533-56
Gentlecen:
Enclosed are five copies of finished labeling for subject
product including the following revisions:
1) "EPA Est. 538-0H-1" has been added to the front
panel below the ingredient statement.
2) "EPA Reg. No. 538-56-AA" has been changed to
"EPA Reg. No. 538-56".
If you have any questions concerning this matter, please
give rae a call at 513/644-0011, extension 2104.
Resubmission
Respectfully yours
ca
enc.
-------
NET WEIGHT 45 LBS. (20.-; Ko)
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FOR USE ON WINTER TURF DISEASES
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DIRECTIONS FOR USE
This product shall be used only by or*under the direct supervision of golf
course superintendents.
for use on winter turf diseases
Fertilizes turfgrasses. Controls fungus activity causing pink snowmold
(Fusarium nivale) and gray snowmold (Typhula spp)
SUGGESTED SPREADER SETTINGS
to provide proper distribution calibrate spreader before application.
45 LBS (20.4 Kg) TREATS 11.000 SQ FT (% ACRE/1022 SQ W) AT NORMAL RATE
45 LBS (20.4 Kg) TREATS 5,500 SQ FT (1/8 ACRE/511 SQ M) AT DOUBLE RATE
GROUND OR WIDTH OF SPREADER SETTING
SPREADER PTO SPEED COVERAGE NORMAL RATE DQU3LE RATE
Scotts (Drop Type) 3 mph overlap wheels 6Y* 8!4
Scotts Rotary 3 mph 8 feet 1 N
Lely-WTR &
WFR Models 4.5 mph 16 feet 5111 ¦ 6% III
Lely-HR 450 rpm 16 feet 5111 6% III
(PTO Model) @ 4.5 mph
Gandy 8 ft
A Series Model 4.5 mph overlap wheels 20 27
«1 • «
» I i
>
FOR USE ON GREENS, TEES. AND APRONS
Apply to moist or dry grass..
To control snowmold — apply DOUBLE RATE in fall, laie winter and
early spring.
» •• •
> »
) 1
ProTurf Division. O M Scott & Sons, Marysville. Ohio 43040
-------
NET WEIGHT 45 LBS. (2U.4 Kg)
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FOR USE ON SUMMER TURF DISEASES
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/i-s-S
CrJ&s-nia ferci'izer plus fungicids
DIRECTIONS FOR USE
for tue on summer turf diseases
Fertilizes turfgrsssos. Controls furyjus activity causing brownpatch, leaf spot,
dollarspoi, rt J thread ami copper.cpot. Alio controls moss.
SUGGESTED SPREADER SETTINGS
To provide proper distribution calibrate spreader before application.
45 LBS (20.4 Kg} TREATS 11,000 SQ FT VA ACRE/1022 SQ M> AT NO'RMAL RATE
45 LBS (20.4 Kg) TREATS 5.500 SQ FT (1/C ACRE/511 SQ M) AT DOUSLE RATE
GROUND OR WIDTH OF SPREADER SETTING
SPREADER HTO SFEED COVERAGE NORMAL RATE DOUGLE RATE
Scotts (Drop Type)
3 mph
overlap wheels
6V2
BVi
Scotts Rotary
3 mph
8 feet
1
N
Lely-WTR 81
WFR Models
4.5 mph
16 feet
5 III
6Vi III
Lely-HR
450 rpm
1G feet
5 Id
6% til
(PTO Model)
@ 4.5 mph
Gandy 8 ft
A Series Model
4.5 mph
overlap wheels
20
27
Apply to moist or «lry grass. On dichondra apply to dry leaves and
then sprinkle lightly xo wjsii off partic?eirition or control, l.itcrim protection
can be aenL-ved with.ProTurf Groad Spectrum Fungicide. Klnss surface
lightly afttr application to avoid pickup on shoes, fiolf balls or maintenance
equipment.
For ail ctlior a-."-* -- >iig before djm-.qe appears or v.-.V?n syr.iptoms
are first noticed. May ho repeated evory other ?r.onth at NQP.V.AL. RATE.
!f disease is s®*?ri r.r • ;; i.-ic.'uaiv-;; appiy at Oul.-BLE RATE.
To control moss — apply .myximo CAL RATE to mo'V. foliage.
Follow up at two week intervals with PiuTurf Btoati Spectrum Fungicide
as needed.
-------
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m vtzM mz&Xu..y^a
DIRECTIONS FOR USE
for uie on summer turf diseases
Prvventt or arrests fungus activity causing disease such as brownpatch. leaf-
spot, dollarspot, red thread and copparspot. Also controls moss.
SUGGESTED SPREADER SETTINGS
to provide proper distribution calibrate spreader before application.
26 LBS (11.8 Kq) TREATS 11.C00 5Q FT (M ACRE/1022 SQ M) AT NORMAL RATE
26 LBS (11.8 Kg) TREATS 5.500 SO FT (1/3 ACRE/511 SQM) AT DOUBLE RATE
SPREADER SETITil
NORMAL (50U31S-
8PPJACCR CROUNO SPTSD COVERASE RATE RATS
Scotts (Drcp Type) 3 mph overlap wheels 7
Candy 8 ft A Series Mode] 4.5 mph overlap wheels 26
42 In Model 2.5 mph overlap whoclt 37
FOR USE ON TURFGRASSES OR D1CKONDRA
Use before disease 3ppaars or when symptoms are first
noticed. Kepr.nt ss necessary. To arrest severe infection
089 double rat9.
Foliage may bs either moist or dry when making applica-
tion (except moss control requires application to moist
foliage only). On golf groans, rinse surface Hghtiy after
application to :woi:i p:c!:up en s!toes, gc!f baiis or rnain-
tenancy
ProTurf Division, 0 M Scott &. Sens Marysvillc, Ohio 43040
I•« i t *
• • • it
• • «
• •
• 99
4
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• * . •
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-------
0,J5. Scott i- lor.s Company
ATT71: Gary CTtrfe
MsrySvUle, CH 43C40
Gentlemen:
Subject: PROTURF FERTILIZER plu> FUSSTCIDE
(For Use on Winter Turf Diseases)
EPA P.eg. Ko. 53S-36 * '
Letter of November 12,* 1976
• «•
Tha labeling referred to above'; submitted in connection ylth registration
ur.dar the Federal Insecticide, Fungicida, and Todenticidc Act, as Branded,
1s acceptable» and a stamped ccpy is enclosed for your records.
John H. Lee
Product Manager (22)
Fungicide Herbicide Branch
Registration Division
Enclosure
WH-567:FKB:JHLee:nlo:acs:638-6767:11/29/76
-------
THE LAWN f»e*_:P>UE
Q n't oifOa c> oUitS
A Svizfi: ",'eTHT
Marysvilfe. Qhio43Q4Q
(513)642-6015
wi»^N i j i /i *i' i.
Noveraber 12, 1976
EPA Registration Division (WH-567)
Office of Pesticide Programs
Environcental Protection Agency
Washington, D. C. .20460
Attn: Mr. John Lee, PM-22
Subject: ProTurf Fertilizer Plus Fungicide
EPA Reg. No. 538-36
Resubmission
Gentlemen:
Enclosed are five copLes of finished labeling for subject
product including the following revision:
If you have any questions concerning this catter, please give
sie a call at 513/644-0011, extension 2104.
"EPA Reg. No. 538-36-AA" has been changed
to "EPA Reg. No. 538-36".
Gary'il. yli:rk . ^
Federal /lasulatory Specialist'
/
ca
er,c.
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FOR USE 0\' \71.\TFR TURF DISEASES
-yj.^w!Cf=-arT.ira-- J
D T
FOR Pa07HS3;0?JAL USE ONLY
^ NET WEIGHT 45'/: LBS (21.1 Kg)
CA'JNO* •:? CUT 0f sEiCH CF CHiLC^tN
rai~c»«4 i/rl c:—set <• •*» '.-n r* >o c*>*r'i-i-p?n.*«»t»e
ye>t s-i <*KC2- *"•.*::v~tr* a*.^ u« *< * }^*» a • i«:r* »r s».-»a»f »i
i^orotfi""/ C**# •*;** r*jf :< vie; < w*.» »io wa ";n> '*#* -i<* i "-oij^rri
Oo oc» *re«» t»%• test c* jnr «•««•» ocor i»o *rt iiktn
to» n^min coPiainstirt.
Icuc o !.d lie i-.y
Att«v* F^rT-T.-': 0$0%
Tht/im(T-!i»«r«rf>;r^-^mcw'^r|
•«errjfr>ft *J£ y\
EFUfi?jMS^3Jb C**&tf*:<30* I Ut*> twee*:
N*t ^frs"t -J**v',v^
XoiaI »v,t—rc—»^N) ... ^4%
i rfrr*-
U vi <: ».* • *• " '¦,**•. •»- • »- -. «,**< wet* ••
BC^i .7 *. * V »Vn " • ~ ~*'•' ¦ -'*
*»: :jr-; •-v.*:-' 5*^
S ¦'»*•::' •%* *••-" T.'i' \ . - l. *4'- . . i%
•V»-r j a.-.i »m t-; c*-:»- ;4-ti»yto*
l'S »V Jri'.-Jtj j.-'ti-'ii ?'c2jaoit£*
p"lT.-« : .•%* \ .1 U e;:- », :«*-,%•¦ 4 Cro4J^iO
•:r. M<- ioiCjv:# t*:i -to
D
DEC i
Wf>
.: ix-cliC
d.-.!t :i;-
P*-
;J \ * -1 JT'J (' 0 /-
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-------
1
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t-J u r* /n$.0•» cj*f» ^ ¦
IT'
DIRECTIONS FOR USE
Thii product iiife't Im used only by or under the direct uipsrvitlon of sotf
courio ttipcrintsnd^nts.
tor uie on winter turf disease*
Ferti'iTx; tuKf:ra:s«. Controls funrvt activity esrj%ir.g f^ink inowmold
("utflrium r.iv.:'el ami jrsy »r.owmolri (Tvnivila rp:?)
• • • •
• • •
SUGGESTED SPRCAOER SETTINGS
to provide proper distribution calibrate tpreader before application.
•» - v «
46'A LBS (21.1 Kg) TREATS 22,050 SG FT (V, ACRE/2044 SO M) AT NORMAL RATE
4656 LBS (21.1 Kg) TREATS 11.000 SO FT ('4 ACRE/1022 SO Ml AT DOUBLE RATE
46Vj LBS (21.1 Kg) TREATS 44.000 SQ Ft (1 ACRE/4088 SQ M) AT HALF RATE
VKiftno
CWjMe*
rioryro
fPPtWJJ SRT1H4
•WviNPf Miui friii« Hiii
CWH --
Scsnx (Drop Tftui
Scons Puijm>
L«i(-vnf> t
*>s vodcis
Lcly-HR
(PTO Mutitlj
Ganiiy 8 fi A Strict 4.5 rjh
Mud«l 42' n:c;H 2.S r.pS
3 fnpn
3 rrjfi
4.1 fft;h
450 ren
tti.5 1117.1
ovenao ntntit 4'.*.
6 feet O
6
C
•IS
3V.
8
16 feet
16 .'col
2'.'.tr 3v.tr I'/, ic
2'/in 3 >a l»«c
overlap wheels 13 y, I7v, 10'A
overlap wheels 24 30 19
FOR USE ON GREENS, TEES, AND APRONS
Apply tu moist or dry grass.
To control snowmold—apply DOUBLE RATE in fall (before
first snow), late winter and early spring.
ProTurf Oivision.OM Scott & Sons. Marysvilfe. Ohio 43040
~ * » •
• • I
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1 I
V>
L
C^~LJ-
n r.?nn
c; ;:rv inc^^rya
'.: I i • : •: • //; "r: <
U O'lJ Lji~
n
^¦.J %»SS
ffi n in n
C J ~\ p rir\ r^' ¦ ' :•': /7^\ r• '
: ' }' ¦ r I \ 'i \ Si ~\\
Li | , ' «. j ! , - ! • ; : r~*
i LJ I.J; Li L< vL'.J "v_S?
I FOR USE ON SU.W5S TL'RF DISEASES
» • — « -y.—_ - 'T- r^^-*wTK'_T • . . H,f KSS
fclFfJv'a". F0" professional use c?:ly
NET WEIGHT 4G'/: LBS (21.1 Kg)
CA'JTCV K5!?CyT C* : tACn *?? C^'iC* ?N
Hannluf if Tei?v?**4, *«c.j c:-r»:t»•*» v«i ?« ,*»r .-'3 ?\*j !o r;vrcf i-mrc-v%r~*
li fto.' *yt r-j:cr. J.-^vvi *#i*» :'i e«rri<; »• n jtm
rivoufYCrfrf 3V» ^ j«*iyifcn iem,-a 'oacu.Tv
t:»< »vj »••¦*.•: *--^cvt *:•#-> ?r- > d
Act** "5'K<^*r fj'C k»* «:e . q SJ*"*
(i?:n"*?ir7.:- . i^c r- -c«» jf7*i
. T, - . • , vc.:*^
trAflri Ka 5>i"V -V>^ Er. S^C"-1 lc*«i K\" CC-n
r ;r.-flk .• • i "TV#- —« kth
|CT».-v. f :- •»; i .vi.
j^".;:t'r","*.'-.7V:.:L,r>".'.,.''r.-_r'"1 ' *•
- ;•' :.i
05-r: .* , N .»:.. . Ci'~
P'9T.-?r o ^ ^ rrt I :-m
•trt : inn fj:i —
-------
DIRECTIONS FOR USC
for use on turnover turf disecte?
e°Tt,cl* fur'"A'1 "*"'*¦/ er»ii"1 hrownpateh. IcaUpot,
Co.Hripot, red thread and capiXMspot. Alto controlsmos*.
SUGGESTED SrREADcR SETTINGS'
To provide proper diitribution calibrate tpreader before application.
46't Lnl kS! Z2^Zf ?2-°°0 SQ FT'W ACRE/20W SQ M| AT NOFIMA' RATE
<6% LBslil'i Tftc^Zf j1'°°0SQ FT c.'l<9 wheals 24 33 19
Apply to moist or dry grass.
0 ATjTf ^"PS-may bc used every two weeks at NORMAL
i '!"S. *row,ftS 4«as°n 'or prevention or control, in-
terim protection can be ac.i:eved ivim ProTart Erosd Spec-
trum Fungicide. Synnf e surlace lightly after application to
avoid pickup on shoes, gait balls or maintenance equipment.
All other areas—use before fundus damape aaoears or
when symptoms are first noticed* May be rijo«ated everv
S J! 'J0RM^ RATE, if disease is severe or more
feeding is desired apply st OOUBLE RATE.
an'/lime a* NOPW.iL RATE to moist
fOiia^e. Follw.-v up at t-.vo wo'.'k Intervals as r.ejded.
ProTurf Division,CM Scor. & Sons. MarySville.Ohio43040
* »
I
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-------
Parson Clinical Vterfat
Poet Officer Exc ite
Crasd Lrtd£39 2£Lc£slfl5» WSc37
Attcntici: i>. / . Be ros
oct i o :s
ESBSS23 ESS 2A.7T2 SIUHTCJ CCTTCEBTEAIIE "CO"
S53A Kssr, "ffa, IS05-57
Tear Irttcr oS Se^'Saaber 3* 1S&3
Siitalt two copies of the finished 2Kb«L vlysa pristiss
ccapletsd.
iioAo^s. osf^K
Earold G. Alfcrd, \
yw
Ecjilcsurt—sfcaaood label
5K FO^i 9=255
AfcS:?2:2Sw:els
10-10-58
-------
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i-
,:,;i)iin:( "iions roit i:si-:
Kr.rtl shc.uU be clf-mo-ii an.) well rur-ii |iriorc in islin^. 1.1"'
SLIJKKY (.ONCI-.N'l HA I'K "liO" nur'-l li»; ilm>|—r dilution for n«c uf S.M^U SAVIM "i.
Troalcr: ^
SM:«IvV j Sl-I '
I'.UCKJT I C .VI •
jj)
1 ;i*-
»,v;' v '
V. \i WiLU-.a
OATS
fP. V '
rJal\on\\ |
r-'-y.l«
This IVi!! Dye Sctu! Grain flal J
r "i a n ~ l
! !
(
|.
Si": nli o!: statement j:iJ ciiic. required warning statements on |
liic Qi:oc$lon poncl » (
At.: E INv-.iUIENIS: PHINVI MUCURIC AMMONIUM ACETATE IJ.30% " J
It.! KT INC-.'. TjIENTSi '..'06.50% 'I
CONTAINS: MfcTAUIC ,V.:"CUfcY 7.0% • |
[S
J - '
. |
aJ^-' >
0'
/ty
si:i:d
si. i-:»*
savi:» "co"
f.'.nllnli
WATI.lt
fiall'in
v.rii;rr
Of (1)
2u
OATS
On.- (i)
12
Ailililioiuil ily may Im' nM.'i-d If <|pvii< .l
U:iC only rPconiniciidvil ilnsnui*. KlNi'ivr
nmnunl.i ore usid.
n cr.
2u :
WAn.MICC . /
ANTIHOTK— If .'."•v:illo\-nlI jrivr mI'U •>; v. I ¦ :' «¦;¦;:» l'i al.."n '•
llll>leS]v.ifMl{»l\ III" S'.lil in I> r.liir.r. i'f Willi" v.nli : . • ;~p'j;.t !;¦ ;il •
Rcpc.it D'ii!; or vliitc ci i:cc liriitcn Ui'li \v..'. •. ('.ill u fl.y:;ir.:
"-Wiirnilip; — May rnxliic" JJrl:iyi-i| Clii-ifi-i.! :!:nn'i. J)n i.et 1 I
Tliin ))i n(liirt :.1irniiit !-o • ¦n<|>i>i '•mc;ir' ii;:n¦ 11 ¦ -,! v ii!
quale vuntilnlion ,rcr tii|n i:»ttc.vfi, flush v.;l!i v.:.V"i' fm- r.l. lc:ir,t :
nicdicnl alien lion. Tlii.s |" "il i 1. ro:ilniii3 n i| rnn;j ii'.inn uf j
il!o with cmc bcciiuso il »\ill ily hinub OI in lir'i*:. ll.:tt roiv.L' i:ito c
i.<) lip.nl to wiifl; off. fjiu ico.-.l wr:>iiti|: r.l'ivrs xtt.il ul>i !
Sloro in a ci!. Ivirp .•im'.niiit'r i i'-'H'il. !<• t p • i. | ¦ i i • I nw;i-'
spnrk-proilncI.T^ t.i.'.ipiiiPiil, e :;inl/oi- Jian.l'.;!
wlicn ouch use iind/cr liandlinp is contrary to label insti u-.-lion.". '
\
X
\
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-------
"-IMUIHTIONS FOU USB
oi*-
A
r.oil anil well curt t lifi'tv trcutinj:. I.(QUID SI-'KD RAVEIl
ATK "tiU" nwsi !.s diluted with wntcr before use. The f oi-
lier dilution for ico of .>lvl\D SAVEK "liO" in a Slurry Seed
¦1)
1
: •¦i-.O"
WATi:: SMIItUY
Ki'ru
II ATI! l'KU
¦m
Cidhii. 1 MX'KKT
<;.\tk
HUSIUiL
tn
20 i 2:i cc. ~1
ir»
~ W 'fL 02. "
O)
12 ¦! 2.1 cc.
iU
Vi fl. oz.
:iddi-d if d<'.*ir IhnUiii with w.itor. Ciill » physician immediately.
rc Delayed Cliei.'.icul llurns. Da nr. I breatho spiuy mist
- <(.rv.di.-rcd \Kiis -nous ;itul luuull.rd with cave. Allow uUe-
o operator. If s; illcd i>n skin, immediately wash thoroughly
May bo fata, if Mvuliokvi'd, Do jiiit i:.-t in cycf, on skin orr
into eyes. flr.slk with waltir ftr {it least 15 minutes and pet"
luo.lucl ctinl:iinu.;i stmni; conclntruUtm of dyo, therefore lifli]
M il? dye IiiiniJs or iiiiicU's thufc come iiUo cor.tnct with it an
woiiiinir gloves and old clothing
."rc;i (or.t;: iur di/sc !. Keep liquid siivny from open flajne,
.'.-.lit. or toil suri'au-s. Do not reuse empty contnipcr.
ik »r r ni.shin^. fJury or discard in <|i in' -
liejilcr. After llow of yrain hus been shut c|T (or b^urh «iir «Ui'oii;rh), let in«<'« iiiii -
operate u few seconds to empty reinuiniit|r infill fi';ni| tnnii'i im > |i&^( Iht-n inrjt
motor olf. Alwuys ukc fresh, dean wuter.whcii ninUiri^ pi»pti dilution.
i. viiKi. thi:a'H-i» si:i:uk
Tix'iitel, ct:iu'cri:iiic the use of Uiis product other thai/ SP-R teo«OMic fDi .iji, «r'rio^Cr
USD A REG, NQ.
¦ —\
1 GALLON
iyvr as.hUv.ii'j all risk cf use nnd/or handling of this mulfe
anJlinc is contrary to label instructions.
jP.- "-ur
-------
Persons Chedc&l Works —
Attention: Mr. A, R. Foa
Poet Office Sos l-:6
Grand Lec'-c, Michigan ^8837
Gentlemen:
The labeling; referred to above, submitted In connection «ith
registracicn under t&s Federal Insecticide, Furt3icide» end
Rodenticida Act is acceptable, and a otamped copy is enclosed
for your records.
It Is assused that tha word "Poison" will be printed in red.
Subject:
PARSONS SHED SAVER BRAND LIQUID READY MIX
USDA Reg. Ka. 1969-56
Your letter of September 4, 1963
Sincerely yours,
kaxxna u. Aitoro
Assistant Director
for Registration
Enclosure
Stamped Label
A-4
ARS:PR.:HSH:ibf/9-25-68
-------
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i/*K 1 ii,'!/¦'<''* - i « : : flOJ Hi.b; :!.'d'jjijl.tlj '
/'f-y /-/~y
jii:
M-m .Cr-ftMiY, IVK5AT Mi'SR,)
'^'""5% ' FLO* OATS
f- mm rirr-'jAt fumgici&e
WARNJNG - - ;> (I
; .ln t\,*J u
Q- -4 ¦ ¦ x l;l
laJ I'l 9. r. 6
NS6*!
6giJ0°
srj:i)
Alisl C-"Ialic
Ad-'ipliirs i>r
('outersinn Kils
I'r. •"
win; at
tl. nr.. per l>u.
2 '-i ri1. cun to (1
|><• 111 ii 1pint tnail.
ihinips |>vr bu.
-1; n.«z.
pii in.
"1 r
p.i
oats
J} Si. 0/.. pur Int.
2'.!i 't. clip to :i V»
piMiii l'i jiiill I'iriil.
1' 'lumps p< r In 1,
y, n.
ItAKLIIY
/ II. < fi '•(
]hiiiiii|s pun liimi.
'.I iliiiupri jxi" !>ii.
1I.17;.
|i':r hi.
•\ r
j:ci
I'LAX
1 Vi fl. (17.. prr 'ill.
ft cr. ciip lo Ii J:'i
[ii'umls p:m |n:iil.
'.1 iluinps per bu.
1 11. )/..
pfl l>i.
!!:• 1
p»i
*Sco machine mini jnl for cup «ifc mxl nuul.iad.
IN»MMri|r
1 • I '.» • 1 1 v * O
A VI IPO't l,S --If MVitilm* r«|. (3I\t i«»i'Ii or « IH" / i rt« In -1,-fi
|l!.IM of W.IM.I IVulri. It * -1 1irtr.il imlllVMlll! Il-»il i • *• t f. |ii;», i*
(!:ill A mill ii'i i< !• ! If on vl'u. \\ r ^1. »• ti« (i »k .4 K
vvllh iViUcr for d( li 'i\| I . mi:ii'i* 1'., n«ul »,» l •• ' iJ:« 1! . '• ii" «
H'lif m'nj: M.I> I'kjii>.«•»• P I »j r«! f In in 11 .1 J' .. u I I , i.».| | M '
m W «' U (|»»;»^!kl> ult\l
Mmic In n t t;« I ii 4-
|ii|ili«l imuv HjM ii ll.iiMt'. nk-pn- lit! in »ir
sNiint' i'f iim el * I r til ti mi nf (*«<>, llitfcl^'*' '•'•mII'" \oi». . •«> •.. ii
I'ifiiliil I h\ 111» ll ii"il 'I I* lfir,| lo x\ ii-I< S" :i'< ' - 'h : ^
NH IK 1 iii it fir ; m j u — pi«Mi-ii< f It.-utit ,,in . s. ... k. \t
t onrr*iiti>c |lir H'f "I (tit IhmiI'hI «*l !)*,'•< • •. • I > • ¦ J |
It.ithlluil! of ilil^ iiMti |>. -II'.k 1 * » • -.1.1
•,< 4 —..
-------
nit:i:< i' >.\¦; i'ou- i^i-:
.1 and cur>.l lii'Ni.'o Inn ting. Not to l:c* diluted with
tiilit*- shows pi' |n*i ..H.oum.s:
.\il:i;il'us >r |
.c
.•a.
li-i
.id.
• U.
.ul.
¦il.
I.L
''.I.
I'.l.
• d.
II.
('•in*i-rnimi .¦.its' i'uiuiBPn*
- - j
il. <•*. :>i II. ox.
|ii-r Int. |)i'l' bit.
M II.
liv;" V.i,
!l.
Jivl 1>.I.
I; .• :!. i'/.
(>. i i'.i.
r to i;.r> pounds
1 Vi pi. per gal. wiiter
_ Seed CaJe_U0_
'.ii ll. ok. per III.
I':cup lo 10 pounds
us-¦ I '.I pi. per gul. wutcr
Seed liutc IH
I '.i II. oz. per bu.
H-'l CC. nip lo 'J IIOUIIlU
uso 3 pi. per »;ni. water
Seed «ule 10
site and p.':i lead.
WiliJ'llKG
v«* ic;li or «'l r.:ji l»..,!.*n wtlli w.itn, thro o l.iliti*«|iutinful uf tall In o
• .. til iftinl ll>ii«l (irji. milk or wluiu 'A t*)iit Ih'.iIi'U will) w.ilt'r,
»!.«»». \V.»»I» *«i.ii« !> v. iili «uul w.tim \vrtl**r. Il In Mmli
. .tisl p t i.kJu .iI .»lt
i.l ritiiiiu.il bum. I>«» ii>t! Wtallie fc|nuy iimt. Do not cd In cycrf, on skin
..;u-f li.itii!l>ii»t.
•iii|.ii«trr vln«:'«l. w<» »ol i!>*l In eyn, im >kIn nr rMMiitf. \V«h tltoroitchly,
>. •jMik'in H)iitin| «¦ or liritnl %tirl.«<<<». TliU iinuliitl (-(mtiuiik a
ii* It.ii.il.i i;Ji imi ' Ihv:.c liui»;l\ or urlini'k iliut comu Inla
...h I'll. S unj nlj cl«*llii»«i*.
On i.Mi.il V\'iiU. Inc. .*rr imnmc* nil ri»k of u*o and/or
I. iih aiiil/or u uiUrjr)' lo liibt'l imUuilitiiU.
CKNKKAI. JNI-'OHMATJi) \:
wii.i. not iiii:i:/k a no vi''. to i>i:r:iti:i-:s lii'u.w zr.uo
Otic Callou Will Trent 170 HukIicIm of Seed Groin According to Type of Seed Ti cnt.J
I'AliSONS LIQUID SL'i£l) SAVER is recommended /or tho control of diseases cuitHcd
by oi'Kiinisnu carried on the bccd.aiid In the soil, such us: teed-borne stinking smut
or bunt of wheat, oat amut undYeed-borna oat blight.
Kor bent rusults, treated grain kIiouIiI be stored In sacks or in a covered pile for at least
L'l hour*. Trotted gruin may then bu planted.
NOTICIi: llt'iid fi:tiut of Hor|;huiuu, brown loo.-iu Himit ct burluy, and loose of whfdt
inn net bu controlled by buy known chemical seed trcutmeut,
I'AIISONR I.IQ'III) SliKI) SAVER will dyp eord red and compiles with tho "Sctd
t.iiws" iej;urdiiiK' the detection of trcntcd sciy Kiaius.
••For trcnliiifr seed grnln use PARSONS LKJUIU SKED SAVLIt according to li.llc
on "(lim tiun:) fur use." It is important that machine run u few minutes before ticuiin^.
Set! thiil inui-hine is dean and in good operalinj; condition before ticulii./. Do not let
solution stand in Ircatcr fur extended periods' of time.
CAUTION
This product should be considered poisonous find bundled with cure. Allow cdi^ur.ta
ventilation for the operator. If spilled on skin, wash thoroughly with soup and water.
May be futul if swallowed. l)o not reuse empty container. Destroy it by perforating or
crushing, liury or discard in a sufc place.
laiii:i. TKU.vrai SKI-OS
Treotcd seeds nhould be plainly labeled or tagged hs| follows:
"DISINFECTED SEED — POISONOUS TO ANIMAL AND MAN.
DO NOT USE FOR FOOD, FEED OR OIL."
USDA REG. NO. 1969-50
1 GALLON
PAHSOflS CSSSfiilCAL WDf.KS, Inc.
Jla&wafo'UeA - tfoaud ^eefye. "uiiCKiyan
-------
i3L $ Api( i
Parsons Chcnlcal Vfcrks
Attn: A. R. Fox
P.O. Bnx K6
Grand Led$e, Michigan 48837
Gent! en«n:
Subject : PARSONS SEED SAVER DUST DRILL BOX SEED TREATMENT
File Symbo1_12{j9-RR
Your letter of May 18, 1970
Please refer to the enclosed PR .Notice 72-5.
Since the subject product contains r.ercuryt and subject to cancel*
latlon v/e cannot process your submission.
S1 ncerely.
T. E. Adarcczyfc
Chief,
Fungicide-Herbicide Branch
Enclosure
PR Hot. 72-5
EPA:PR:RFV:je 4-V.-72
-------
u.';. mli*am 11 \;.n r L>r / r.mcuti unL
AC- iflCULl *<1 \ S'/.HCM ;.£(tviCC
I'^iTicmi % nccwLAvioN oivir.f^n
t). c. :o?.oo
ArpucATioN i:or; jK'iv/j ration of lconomic poisons
(UtuL r tin- V. .'/ in . 1 j h\ i:t.-:-:nii:-iu'c A < :j
• C'.-.! f\ti T: fi r
* to: i\, f.;j r;.
. TYHt Of rtSTf|',r '/!.
RODENTICtPCl 1
t'.U
* »; f-rouurr..
lTJD
I. (jML Oi M i'LII.ATICN
Anril 7_,_ 19 70
2. f«AM L CF TCOrJOMic POi:*ON/,1/uj/ /«• M/TfC pru:tuct t.znii c:
ort fabcl-dv not Hit uanc in^n-Jicnii}
•Seed Saver Dust
11 P.nv Treatment
othcr
CFHMtCIDE-DIGINrECTANiTl I
4.INAME a MAILIUC ADDRESS
1 (Include Zij> O -Jet
OF F^riM
TO WHOM R EG 1ST RAT ION IS TC DE ISSUED
5. IS THE REGISTRANT SHCWfl IN
ITCM 4 THE. MANUFACTURER?
PAH SO
Njr
rrMTf*''' vr^rM^c
ye^CD noO
P. 0 .
Grand
1
P.o:;
Led-
: 'i c .
c, Michigan 4 88 3 7
(If "no", ice instruction j o*«
reverse)
6.TYre or rOHMU'LATk'fl
Pust^H w^i-taclg fowncrt! 1
pReecuRiiED productd]
OTHER (Specify)
CRANULAHf
EMULSIFIAOLE LIOUICQ
BAIT^
PAPERm
[other (Specify)
7. TYPE OF CONTAIN KR
KeTAic£*x
PLAS1 ICf^J
?. MAN NEQ IN WHICH LABEL IS AFFIXETO TO PROOUSf
UTHOGRAPHEDO PAPER. GLUEOl I
8. NET CONTENTS OR CONTAINER SIZES
2"ib. and 6-lb.
STENCILED! 1
I other (SpecifyJ
•".0. I^LACE VVHESE DIRECTIONS FOR USE APPEAR
T
dn us:l [3j-
IN PRINTED MATTER ACCOMPANYING PRODUCT I I
I.DATA SUE V ITTLCj V.'iTM THIS AM'LIC/.TICM (/tltlilify end S'.tbllit ill IripHcU)
'erncAcv da.taq toxicology dataQ . residue data I I
OTHER (Specify);
PETITION FOR TOLERANCE I i
any additional pc/itinent INFORMATION (Do not enter confidential ferrule Kcrt-iee item I J, below)
following MUST #ucni:;i:s
• ® Five £S) tcpics of f.ropoird ioijCMng, inc^~i.-.g oil printed ct graiv.> nat:or v/lvcli
— • ""-ay otcompany 1 li— jo!e-of this frcdutl. Cc^icJ mjjt b." clearly le^ib!^ onj ;c.'ini.col.
* *"» of ?lw c:-roic:^ "'w.'rijln. r*e;:*c zr
d
/
!:t i • • c
T/y
C.-( L'
o
Tcc?ui i r p. 1 'V p t.
v/ / './/£¦•
- /Y-i.'---
id L',\-\C C«C:iLL«
4-7-70
I *
I • V t'JGO
txisiJfV- croo: iif f-k? oi:m • jui n
v/ii t 1.1. iji~r> it?j i ii. l::i;au .*i h.*!
-------
CliiiSMECAEa
ntt/uc/«r('n<7- c, Hm ~.'////
/ t'
P.O. SOX 1*6—GhAiiD LEDGE. KICHICAH
April 7, 1970
Mr. Harold (V. Alford
Assistant Director for Registration
U. S. Dept. of Agriculture
Agricultural Research Service
Pesticides Regulation Division
Washington D. C. 20250
Dear Mr. Alford:
V.re are enclosing five (S)corrected SEED SAVEP DIJST
(Drill Box Seed Treatment) labels. Also enclosed is
five (5) copies of the fornula for your information.
We trust that this product will now be in line for
registration.
Yours truly,
PARSON'S CHEMICAL WORKS, Inc.
1.7 , A j? '
A: R'. 'Fox, Tecnnfcal Dept.
/
ARF/pr
enc.
if.'ttuii-.; • ¦ ,:i -. ¦ . • -..-iti ,v. • ivi
i.'.iO?* • f02lr:i1>
-------
71
, » «¦
:'/ Ayjj\f&&V'$U? r
i
-*'t\ i :s /;v^-r.v
\ <:
;]
F-i ;/.:j
f. ¦ f . • ^-: •-' - v-
: 3 ? V' - <¦?: '" 7
\
•5
¦ :i
i?.!jv'iii!:-'
« mil or *S«u j: . "i I.cf([* wiIK
r:i; ..i s. *. g( *orm [ " '
Ur.lil vjT.if fijiJ it .I'd,1. H.,;: :-t ti.i!* »' '%
hcclctt fcit.S we:.--. Col' i* ."Jij-jicMfl j«'-*
i '<
it
! DAKG£S
¦ •; KEEr OLT OF REACH C'.: CHILDREN
!,¦ j, ' See C- icr *r.rvcli for Add.iicrvr.! Ccjuons
: ' n'et .vitignt z .-'cu.^os i
t :::ats jg qu' . i ~ls 1 j
r . |
1
J
I J T ITATS JG QU' il~LS 1 J
¦ \ vc ¦ i.l 'j (jt i' i..\j) ' 'y •' ^ |
1 LJ'U:, I'Mi -'j'i.'iat /- . J
•
*9 *• « » » • » •
*t • • • * 4 «
• * f * * 0 ' •
• • • » i * * i* • 4 • • o •
THE EASY MODERN
METHOD TO TREAT
SEED GRAIN
V.'ARNIIJG:
May Produce Dcfcycd Chcmi.
cnl Owns! Do nat breathe dust.
Do not get in eyes, on skin or on
tlclhmg. Wosb thoroughly aflev
hondjing.
WHEAT
KAItl.KY
OATS
KYTS
LUsnll; »
i#;« cu*u •
«>r l.'unf
Clmrrrd Sniul
hlnr«t ?Snitif —— S'-r 1 p<•
SniuiH
SlPl.i SUHI*H
{'ovrrd S i ,iti
S\*r ii #\i ".i.l!
To irnf i'rt
Or u.*e p<>uml w k l#n>n.*U n{ #rr I JUNCTIONS
He iure ~C'vrl U v.ri; nr.it irrroutOily fK,%n ucf-^rc
trrntiu;* UUST, Do ,i»| f*r 0<*ivir..*I:r-»i
test si'i'it.o or Ai'1'.J,^ t)»; l.il DUST dirftily to Jiy tcc*l*
»n pLinlcv* cr (friJI luix \ml.l thccou«l»ly
NQY'.CE TO CURCHAScS
« y.0 r»f .t;t C.Wil nj.-jt
Tlitf b:'C of this pro'liHt
.«n.ftj.L''.tyr' v.erl ur .>
f { ike to b1' oN'.
prnclicc. Th(» Uuvxr wur-1 • >n»M: r.H rv.;;>or.^lh'liSy. ln-tlu'll*»•?
injury ur damn^r. icatiiu w fi'n.i ili mnuw m nt in
cnjnlfln.itJon uiih Dihrr •)'.
Our vecommijiJ.ilifcn'i
tests btlicvi-il^lo be
ht-ynni) our conLru! >.<>
nr.iiijr a* |o IliP rSTfcl" 1
it n^t *isc<5 in «cc"»tliin>
CAUTION
Trov?dc cdr4|i/2te rcrtiJ4fj(/f». /.vcr:«," b."Cjr\i^,T <'
<3ohI, Advi*;it>!c to ^;; ih?
nor.c cl lo U ahiilu'A^.
Do not jrciisr cmplT conUuirr> .r>*!rf<-> i( oT pvrfor4tir; cr
or di^cird in a * .fe pttc«.
MGIiTtRlD IH U.S. PMJHT OFfTCC KO.
ladel t;::;.',t£:o Si;ED5
Treated sccris should lu* j^air.ly l^hcfcd or ta^vci
f.u follows:
"DisiNrECTED STCED—po'rsoxous to an;mah
and mam. i>o not usk top. yocnf
k:;::d on oil.1
Mcnufoctufin;; C'-< Si«co lfl'i
USr " NO.
1 L?
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MAR T 1979
OFFICE OF ENFORCEMENT
SUBJECT: Deforcement of the Administrator'- ~ J
Suspending 2,4,5-T and Siivex Reg
FROM: A. E. Conroy II, Director
Pesticides and itoxic Substances
Enforcement Division
TO
Enforcement Division Directors
Pesticide Branch Chiefs
On February 23, 1979, the Administrator signed Emergency Suspansion
Orders pursuant to FIFPA section 6(c)(3) inmediately suspending the
registrations of all pesticide products containing 2,4,5-T for fores-
try uses (including site preparation, conifer release, and brush and
weed control), rights-of-way uses (including brush and weed control),
and pasture uses */, and of all pesticide products containing Siivex
for forestry uses (including site preparation, conifer release, and
brush and weed control), rights-of-way uses (including brush and weed
control), pasture uses, home and garden uses, commercial/ornamental
turf uses (including recreational area uses), and aquatic weed control/
ditch bank uses (use on. rice riot suspended), pending the final outcome
of Agency cancellation proceedings which were also initiated by Order
of the Administrator on February 2Sth. Copies of these Orders are
being mailed under separate cover. The purpose of this memorandum is
to set forth the Agency's enforcement strategy concerning products
suspended by the February 28th Orders. It is the Agency's intention
to ensure that the Administrator's Orders are strictly complied with
by all affected persons, including manufacturers, formulators, regis-
trants, wholesalers, retailers, distributors, government agencies,
and users.
V Pasture is defined as land producing forage for animal consumption,
Harvested by grazing, which has annual or more frequent cultivation,
seeding, fertilization, irrigation, pesticide application, and other
similar practices applied to it. Fencerows enclosing pastures are in-
cluded as part of the pasture.
-------
-2-
I. SUSPENSION ORDER PRCVISIOHS
The February 28th Orders provide:
(1) As of February 28, 1979/ all registrations of pesticide
products containing 2,4,5-T and Silvex for the uses described
above are suspended. For 2,4,5-T this means that in addition
to the uses cancelled in 1970, all pasture land, right-of-way
and forestry uses are now suspended. For Silvex this means
that all aquatic (except for use on rice), home and garden,
recreation area, as well as. pasture land, right-of-way and
forestry uses are now suspended. None of the products with
any of the suspended uses may be sold or distributed in the
United States. The Agency is officially notifying by certi-
fied mail all affected registrants of products any use of which
has been suspended by the February 28th Orders (hereafter referred
to as suspended products).
(2) As of February 28, 1979, all 2,4,5-T and Silvex
products, regardless of how and \-ihen they were obtained, may
only be used or applied for non-suspended uses, and only if-
the particular product in the user's possession is currently
labeled for one of the allowable uses.
II. CATEGORIES OF 2,4,5-T AND SILVEX PRODUCTS
The following is a numerical breakdown of producers and registrants
of the suspended products:
Producers
2,4,5-T: 43
Silvex: 58
TOTAL 101 */
Registrants
2,4,5-T: 80
Silvex: 87
TOTAL 167
V There is an overlap in the production of suspended 2,4,5-T and
Silvex products. As a result, t±iere is only a total of 81 individual
producers of such products.
-------
-3-
Distributor Registrants
2,4,5-Ti 376
Silvex: 382
TOTAL 758
There are seven (7) 2,4,5-T registrants and fifteen (15) Silvex registrants
not affected by the Administrator's Suspension Orders.
There are three categories of 2,4,5-T and Silvex products:
(A) Federally registered products, all uses of which have been
suspended. An exantole of a product in this category would be a
product registered for use only in forests. None of the products
in this category may be sold, distributed or used in the United
States during the duration of the Administrator's Suspension Orders.
(B) Federally registered products, some uses of-which have been
suspended. There is a category of registered products sane pf but
not all of whose uses were suspended by-the February 28th-Orders.
An example of a product in this category would be a product registered
for use on range land as well as for forest use (the former being
a permitted use, the latter being a suspended one). Until the
completion of certain initial procedural steps resulting from the
Notices of Cancellation.as well'as the Suspension Orders, which will
help clarify the future status of products in this category, such
products may not be sold or distributed for use in the United States.
PTSED '.wil-l be preparing further guidance on the status of these
products after discussions with OGC and QPP. Products in this
category may only be used or applied for non-suspended uses,
and only if the particular product in" the user's possession is
currently labeled for an allowable use.
(C) Federally registered products, no uses of which have been
suspended. There is a saall number of federally registered 2,4,5-T
and Silvex products none of whose uses were suspended by the
February 28th Orders, and whose sale, distribution and use may con-
tinue. An example of a product in this category would be a product
registered for use only on rice. Also included in this category
are 2,4,5-T and Silvex technicals, which are registered for manufac-
turing use only.
You will be receiving shortly a list of suspended product
registration numbers, product names, registrant names, and the
names and addresses of establishments where 2,4,5-T and Silvex
products with suspended uses have been produced. You will also
receive a copy of the site/registration listing, in order to
-------
-4-
determine whether a particular product fits into category A or
B, you will only need to look uo the product by its registration
number and determine whether all or only some of its listed uses
have been suspended.
In addition to the federally registered products discussed
in paragraphs A through C above, all products being sold pursuant
to State 24(c) registrations are subject to the requirements of
the Administrator's February 23th Suspension Orders. A final list
of these products is not yet available. As soon as this infor-
mation is prepared, it will be forwarded to the regional offices.
In the meantime, the regional offices should inform the States in
their regions that State registrations for suspended uses of 2,4,5-T
and Silvex issued pursuant to FIFRA section 24(c) have also been
suspended by the Administrator's February 23th Orders, and that no
further State 24(c) registrations may ba issued for suspended uses
of the affected products.
Intrastate registrations with assigned accession numbers are not
included in the Administrator's February 23th Orders. A listing of
these products and the States in which they are registered is being
mailed under separate cover. The regional offices should contact
the State agencies responsible for the original registrations to see
that appropriate steps are taken by the States to limit the possible
distribution, sale and use of these products consistent with the
Administrator's Suspension Orders of February 28th.
III. ENFORCEMENT POLICY AND STRATEGY „
A. POLICY
The Office of Enforcement intends to ensure that the Administrator's
February 28th Orders are strictly complied with. The Agency's enforcement
policy has a two-fold objective: 1) to prevent the distribution and
sale of suspended 2,4,5-T and Silvex products; and 2) to prevent any
use of these products for other than non-suspended uses.
The general policy of the Agency has been to request a national
recall \Aiere product registrations have been suspended in order to prevent
an imminent hazard to man or the environment. However, because of the
emergency nature of the Administrator's actions and the fact that such
a recall approach would not have the effect of immediately halting sales,
distribution, and use, the Office of Enforcement is issuing Stop Sale,
Use and Removal Orders as quickly as possible to all registrants, distri-
butor registrants and producers of 2,4,5-T and Silvex products subject to
the Administrator's Orders, as well as to all identifiable large scale
users of these products. In addition, the Aiency is taking special steps
to notify interest groups who represent orcducers, sellers and user/appii-
cators of the suspended products of the Administrator's Orders and the
resulting legal obligations.
-------
-5-
B. STRATEGY
The initial Stop Sale, Use, or Removal Orders, directed at 2,4,5-T
and Silvex registrants, producers, distributor registrants, identifiable
large scale users and federal government agencies;.£/ .have been prepared
arri sent by certified mail by. PTSED. A copy of the Stop Sale Order forms
and cover letter being used are being mailed under separate cover. Each
region will be sent a copy of.each Stop Sale Order issued to any person
within their region. A regional contact has been named at the bottom
of each Stop Sale Order. This contact person should be able to assist
the recipients of the Stop Sale, Use, or Removal Orders with any ques-
tions that migKfc'arise. In addition, the cover letter accompanying the
Stop Sale Orders requests that certain information be provided to the
regional contact person specified on the Stop Sale Ordet. Note that
certain information from producers of the suspended products is manda-
tory in accordance with section 7(c)(2) of FIFRA. The information
requested is intended to assist the Agency in tracking shipments of
the suspended products through the channels of trade. Additional
information is requested of all recipients of;the Stop Sale Orders to
assist EPA in monitoring compliance. The.regional offices who will be
receiving information from Stop Sale recipients should maintain the
information about stocks on hand and report monthly and cimulati
-------
-6-
Since the time for annual spraying with some of the suspended
products is imminent, regional offices and the States should take
immediate steps to inform users and applicators of the Administrator's
February 28th Orders. Although the regional offices and cooperating
State parsonne] should first-seek voluntary compliance, they should
not hesitate to issue Stop-Sale, Use, or Removal Orders to persons who
are holding quantities of the suspended products for application. Such
orders may be issued to applicators who are in the process of making
an application with a susggpded product. An inspection of the appli-
cator's business establishment is not required for the issuance of such
an order. A copy of the Stop Sale, Use, or Removal Order form applicable
to users (as opposed to producers or registrants) is being mailed under
separate cover for your information and/or use.
Once final action has been concluded on requests for an expedited
hearing pursuant to the provisions of section 6(c), and the status of
2,4,5-T and Silvex products pending the outcome of the future cancella-
tion proceedings has been settled, the Agency will review the need for
a possible request for a voluntary recall of the suspended products by
the registrants and producers. Until that time the Stop Sale, Use or
Removal Orders vail remain in effect, subject to suggestions from the
affected parties about possible disposition of the current stocks of
suspended products.
C. SU'^IARY OF PROPOSED ENFORCEMENT RESPONSIBILITIES
1. Headquarter's Responsibility
a. Issue Stop Sale, Use, or Removal Orders via certified mail
to all registrants, distributor registrants and producers of
all suspended 2,4,5-T and Silvex products.
b. Issue Stop Sale, Use, or Removal Orders to Federal agencies
involved with the use or application of the suspended products.
c. Issue Stop Sale, Use, or Removal Orders to identifiable large
scale users of the suspended products after conferring with the
regional office.
d. Supply regional offices with copies of the following:
1) The Administrator's Suspension and Cancellation Orders.
2) Copies of the Stop Sale, Use, or Renoval Order forms and
accompanying cover letter.
3) Stop Sale, Use, or Removal Orders mailed by EPA Hdqrs.
2. Regional office Responsibility
a. Notify States of the Administrator's Suspension Orders and
Agency enforcement strategy, and develop cooperative approach
to implementation of the enforcement strategy.
-------
-7-
b. Compile information supplied by producers concerning 1978-79
distribution, as well as additional information reouested from
all Stop Sale, Use, or Removal Order recipients. Report data to
PTSED on monthly' basis.
c. Conduct books and records inspections at those major producer
establishments, who do not supply the requested information, to
update information about quantities of production and locations
of shipments.
d. Review information obtained from producers (per b. and c. above)
to identify recipients of shipments of the suspended products in
order to target distributor and marketplace inspections.
e. Contact headquarters offices or major distribution points of
food, drug, hardware, lurriber, garden supplies, variety stores etc.
to inform them of the Suspension Orders and to solicit their coopera-
tion in informing their customers of the Suspension Orders.
f. Conduct marketplace inspections in order to locate possible
improper retail sale or distribution of suspended products.
g. Undertake special efforts to inform State pesticide user associa-
tions, applicators and other users about the Suspension Orders and
their legal requirements.
h. Issue SSUHOs v&en appropriate.
i. Undertake appropriate enforcement action against any persons
violating the terms of the Administrator's Suspension Orders or
SSUROs.
j. Regional contact person, with assistance from EPA Headquarters,
should be prepared to answer questions about the Agency's actions
and to assist persons directly affected (e.g. producers, registrants,
sellers, users, applicators, etc.) with compliance.
3. State Responsibility
States, especially those with Cooperative Enforcement Agreements,
are expected to cooperate fully with the enforcement efforts outlined
in' this memorandum. Specifically, they will be asked to assist
in items c, d, e, f, g, h, and i above.
IV. ENFORCEMENT!1 ACTIONS
Enforcement actions will be taken in accordance with normal procedures
and at levels consistent with those set forth in the Case Proceedings Manual
against any person found in violation of the 2,4,5-T and Silvex Suspension
Orders or Agency SSUROs. Mote; Section 26 of the amended FIFRA, which
grants to the States the primary enforcement responsibility for pesticide
use violations, does not extend to situations involving the use of a
s spended product in violation of Sections 12(a)(2)(J) or 12(a)(2)(I).
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-8-
V. DISPOSAL OF 2,4,5-T AND SILVEX PROPCJCTS
Until the conclusion of Agency cancellation proceedings involving
2,4,5-T and Silvex registrations, persons requesting information about
the possible disposal of quantities of the suspended products should be
advised to place the materia£*in storage in accordance with label direc-
tions .
VI. INDEMNITIES
PTSED has been advised by the Office of General Counsel that con-
sideration of requests for indemnification under section 15 of FIFRA
by persons possessing quantities of the suspended products will not
take place until the conclusion of Agency cancellation proceedings for
the suspended products.
VII. INQUIRIES
Any questions about this memorandum and the 2,4,5-T or Silvex
Suspension Orders should be directed to the appropriate regional
coordinator.
VIII. SENT UNDER SEPARATE CCVER
(1) Administrator's Suspension Orders, Feb. 28, 1979.
(2) Administrator's Notices of Cancellation, Feb. 28, 1979.
(3) ET3ED Stop Sale Order forms and cover letter.
(4) List of Intrastate 2,4,5-T arid Silvex Products.
(5) Copies of Headquarters-Issued Stop Sale, Use, or Removal
Orders.
(6) List of federal agencies sent Stop Sale Order.
(7) List of federally registered 2,4,5-T and Silvex products
suspended by the Administrator' s Feb. 28, 1979 Orders.
(8) Site/registration listing.
-------
^ ? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
C* WASHINGTON. DC 2CM60
OFFICE OF ENFORCEMENT
APR o 5 ^
SUBJECT:
FROM:
TO:
Further Guidance Concerning Enforcement of the Administrator's
Emergency Orders Suspending 2,4,5-$ and Silvex Registrations
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
Enforcement Division Directors
Pesticide Branch Chiefs
In a iremo rand urn dated March 7, 1979, I explained the Agency's
enforcement strategy concerning 2,4,5-T and Silvex products suspended
by *-he Administrator on February 28th. in that memorandum I indicated
tJ v:ould provide, you with additions! guidance concerning the status
o| i'orally registered 2,4,5-T and Silvex products vdiich have both sus-
pe,. c and non-suspended uses on their labels. In the meantime, such
products ccu-l'd not be sold or distributed for use in the United States.
However, affected products in the user's or applicator's possession could
be used or applied for non-suspsrried uses, if the particular product
in the user's possession was currently labeled for an allowable use.
In a letter dated March 22, 1979, the Agency advised registrants of
2,4,5-T and Silvex products,with both suspended anf non-suspended uses
on their labels that they would be allowed to distribute .and sell such
products for use in the United States once they hcd prepared adequate
interim labeling designed to inform the purchaser that certain of the
uses on the label are allowable, but that others are suspended. I have
attached a copy of the letter, v«hich is self explanatory, and do not
plan to summarize it in this memorandum.
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-2-
As you will see, registrants of such products have been instructed
to send copies of their interim labeling to the appropriate regional
office along with information about what steps they have taken to com-
ply with the letter. Since many of the products are distributed and
sold throughout the United States, as each regional office receives
copies of the interim labeling, they should forward copies to all
the other EPA regional offices. A list of regional contacts who are
responsible for matters relating to 2,4,5-T ard Silvex products is
attached to the March 22nd letter. Although the Agency is not re-
quiring advance approval for each registrant's interim labeling, the
regional office receiving the original of the interim labeling should
briefly revi&v each label as it is received to make certain that on
its face it appears adequate to inform purchasers of the product that
certain of its uses are no longer allowable. Any questions about
specific interim labeling should be directed to Mr. A. J. Dellavecchia,
Chief of PTSED's Policy and Guidance Branch, and his staff.
As you know, immediately following' the release of the Administrator's
February 23th Orders, PI'S ED issued over 1,000 Stop Sale, Use, or Removal
Orders to ali affected 2,4,5-T and Silvex registrants, producers and
distributor registrants. As a result of the Agency's subsequent decision
to allow certain of the registrants to prepare interim labeling so they
can sell arc distribute their products which have sore non-suspended
uses on their labels, it vail be necessary to formally vacate.,or lift
the Stop Sale Orders affecting those products which can be properly
relabeled. In other words, registrants vfto have prepared interim label-
ing can only begin to sell arid distribute their products as soon as the
interim labeling is attached and after they have notified EPA of their
actions. Other 2,4,5-T and Silvex products in their custody or control
which were subject to the Stop Sale Order and/or which have not been
properly relabeled still may not be moved in commerce without advance
approval from the appropriate EPA regional office.
A question has been raised whether the Stop Sale, Use, or Removal
Orders issued by PTSED should be amended, vacated, etc. by PTSED or by
the appropriate regional office. Once the Stop Sale Order has been
issued, it is the responsibility of the regional office listed on the
Order to take whatever future action is appropriate in connection with
that Order. For example, if a distributor registrant is able to arrange
for the return of a particular, product to the registrant or producer, it
will be the regional office's responsibility to amend or vacate bhe Stop
Sale Order to allow the pesticide to be returned.
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~3~
A question has also been raised about the possible violation of
the Administrator's Suspension Orders if a pesticide dealer attempts to
return quantities of the suspended products to the distributor, producer
or registrant. Although the Administrator's Orders state that "the sale,
distribution, or other movement in commerce (emphasis added) art! the use
of all such pesticide products ... is prohibited", it is not the Agency's
intention to prevent the return by a dealer of suspended products to a
registrant, producer, or distributor. However, it is necessary for the
Agency to know whether quantities of the suspended, products are going to
be moved in commerce, -to whom, in what quantities and for. what purposes.
Therefore, if a dealer plans to return unsold quantities of suspended
products to a producer or distributor he should first contact the approp-
riate EPA regional office in writing notifying than of his plans and
wait for confirmation before actually shipping the material. If the
same dealer is subject to a federal Stop Sale, Use, or Removal Order,
it will be necessary for him to have the Order vacated or lifted before
he ships the pesticide. Similarly, if the products under his control
have been detained pursuant to a State order, it will be necessary for
him to contact the appropriate State officials about his plans to return
the pesticide(s).
Finally, based on an extensive computer listing provided by the
Office of Pesticide Programs of possible users of suspended 2,4,5-T or
Silvex products, PTSED is about to begin issuing approximately 24,000
Stop Sale, Use, or Removal Orders. These Orders will be sent directly
to various persons v>ho might be holding suspended products for use or
planning to use such products including timber tract owners, aerial
applicators, lawn service companies, electric power companies, pipeline
operators, railroads, irrigation operators, etc. A complete listing of
the persons receiving such Orders, broken down alphabetically, by State,
will be sent to each regional office along with a copy of the cover
letter and Stop Sale forms as soon as the Orders have been mailed.
Attachment
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AUG 2 0 1979 office or enforcement
SUBJECT: Further Guidance on the Cancellation and Suspension of 2,4,5-T
and Silvex
10: Enforcement Division Directors
Pesticides 3ranch Chiefs
On July 9, 1979, the Assistant Administrator for Toxic Substances
signed two notices of intent to hold hearings pursuant to FIFRA section
6(b)(2) to determine whether or not the uses of 2,4,5-T and silvex not
subject to the Emergency Suspension Orders of February 23, 1979 should
be cancelled (copies attached). Tius essentially neans that all uses
of 2,4,5-T arc silvex will now be reviewed as pj»rt of the ongoing can-
cellation proceedings.
In preparing the two notices the Office of General Counsel concluded
that the list of non-suspsnded uses of both 2,4,5-T and silvex products
was croader than originally assured. In my earlier guidance merabranda
I expressed the Agency's view thar only rice, rangeland, sugarcane and
certain orchard uses of these products were riot affected by the February 23,
1979 Suspension Orders. This sere view was expressed in the Registration
Division/Pesticides and Toxic Substances Enforce.itent Division March 22, 1979
letter to all 2,4,5-T and silvex registrants.
It is now the Agency's view that a nutber of uses of both 2,4,5-T and
silvex that v,*ere previously considered to be suspended are not suspended
and products with these additional uses on their labeling can be sold and
used in the United States p2ncing the outcp.re of the cancellation proceed-
ings. According to the 6(b)(2) notice, in addition to use on rice and
rangeland, non-crop uses of 2,4,5-T at the following sites are not suspended:
( .
/ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' • WASHINGTON. DC. 20460
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-2-
airport:;; fences, he^c/jrov/s (not ul:^--i wi>:o incl'i^cd in suspended uses, e.g.,
rights-of-way/ pasture:); lurrcer yart-s; refineries; non-food crop areas;
storage areas; wastelands (not otherwise included in suspended uses, e.g.,
forestry); vacant lots; tank farrcs; industrial sites and areas (not other-
wise included in suspended uses, e.g., rights-of—way).
Similarly, accordirrj to the 6(b)(2) notice, in addition to use on rice,
rangeland, sugarcane and orchards, nQfi-crop uses of silvex at the following
sites are not suspended: fencerows, hedgerows, fences (not otherwise included
in the suspended uses, e.g. rights-of-way, pasture, home and garden);
industrial sites or buildings (not otherwise included in suspended uses,
e.g. rights-of-way, cancercial/ornaTeJital turf); storage areas; waste
areas; vacant lots; ar.d parking areas. Attached to this memorandum is
a revised version (dated July 24, 1979) of the list of suspended and
non-suspended uses for 2,4,5-T and silvex products. This list supersedes
the version provided to you in connection with iny guidance of April
5th and the- March 22nd letter to affected registrants.
A. E. Conroy II,/Director
Pesticide and Itoxic Substances
Enforcement Division
\ /
Attachment
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SUSL i-^OED USES
2,4,5-T 1/
SILVEX
{2,4,5-trichlorophenoxy acetic acid,
esters, amine salts]
Firetrails and lanes
Forest lands, management areas,
plantations, and stumplands
Rights-of-way: highways," pipelines
powerlines, utilities, roadsides,
roadways, etc.
Pasture
[2-(2,4,5-tr ichlorophenoxy) propionic
acid, estersamine salts]
Farm buildings
Forestlands and management areas
Golf courses
Home use, lawns, grass, ornamental
turf, patios, sidewalks, drive-
ways, farmyards
Ditchbanks, drainage ditchbanks
Ponds, pond margins, standing
water
Lake, lake margins
Rights-of-way, all; roadsides,
roadways, etc.
Pasture
Ditches - water
Parks, athletic fields
Marshlands, canals, aquatic sites
NCN-SUSPEtfDED USES
2,4,5-T
Rice
Rangelard
Airports
Fences, hedgerows {not otherwise
included in suspended uses, e.g.
rights-of-way, pasture)
Lumberyards
Refineries
Nonfood crops
Storage areas
Noncrop areas
Wastelands (not otherwise included
in suspended uses, e.g., forestry)
Vacant lots
Industrial sites and areas (not
otherwise included in suspended
uses, e.g., rights-of-way)
SILVEX
Rice
Rangeland
Sugarcane
Preharvest fruit drop of apples,
prunes and pears
Fence rows, hedgerows, fences (not otherwise
included in suspended uses, e.g., rights-
of-way, pasture, home and garden)
Nonfood crop areas
Noncrop areas
Storage areas
Waste areas
Vacant lots, parking areas, etc.
Industrial sites or buildings (not
otherwise included in suspended
uses, e.g., r ights-of-way,
oocmercial/ornanental turf)
1/ Certain uses of 2,4,5-T were suspended and cancelled in 1970. P. R. Notice
70-11, April 20, 1970, suspended the registrations for products containing
2,4,5-T and bearing directions for all uses in lakes, oonds and ditchbanks, and
liquid formulations for use around the home, recreation areas, and similar sites.
P. R. Notice 70-13, May 1, 1970, cancelled the registrations of 2,i,5-T projects
including all granular formulations for use arounj the home, recreation areas
and similar sites,.and all uses on food crops intended for human consumption,
except for products whose labeling could be modified by deleting such ciaims.
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.szz;
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
NOV 7 1979
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: EBCP Suspension Order Enforcement Strategy
TO
Enforcement Division Directors
Pesticides Branch Chiefs
Background
On September 8, 1977, the Administrator announced his intention to take
two separate suspension actions with respect to pesticide products containing
dibromochloropropane (DBCP). These actions were taken pursuant to his autho-
rity under Section 6(c) of the Federal Insecticide, Fungicide and Rodenticide
Act, as amended (FIFRA). Cn October 27, 1977, because .no registrants invoked
their right to a hearing pursuant to Section 6(c)(2) ; the Administrator
issued a Suspension Order concerning DBCP products. The order was based on
the findings that DBCP is carcinogenic and also found to damage human repro-
ductive Unctions and may cause sterility in males. The October 27, 1977,
Suspension Order therefore.proposed, two separate actions: (1) the
"Unconditional" or "Specific Food Use" Suspension of all products registered
for use on nineteen (19) specific food crops in which DBCP residues occurred,
or appeared likely to occur in the edible portion of the treated crop; and
(2) A "Conditional" Suspension of DBCP products registered for all other end
uses. The conditionally suspended uses were: cotton, soybeans, citrus, grapes,
pineapples, peaches, nectarines, plums, almonds, commercial okra, coannercial
lima beans, oommercial snap beans, conxnercial southern peas, berries (black-
berries, Blueberries, loganberries, dewberries, boysenberries, raspberries),
strawberry nursery stock, apricots, cherries, figs, walnuts, bananas, turf
(commercial and residential) and ornamentals (commercial and residential). Foe
the conditionally registered uses it was thought that risks to applicators
could be sufficiently reduced on an interim basis by placing restrictions on
the product, such as, limiting use to certified applicators using respirators
and protective clothing.
On July 18, 1979, the Administrator announced his intention to suspend
all remaining uses of pesticide products containing dibrcmochloropropane
(DBCP). This Notice of Intent to Suspend is based on additional information
showing that the conditional suspension is not adequate to reduce, the risks
associated with continued use of DBCP, and in turn prevent an Imminent hazard
during the time required to complete full scale cancellation proceedings which
are now'pending pursuant to Section 6(b) of FIFRA. The new findings reveal
that DBCP residues may occur even in crops which sure not grown in contact with
or - in close proximity to treated soil; that treatment with DBCP may result in
contamination of water supplies, including drinking water sources; and that
application of DBCP may result in ambient air levels of DBCP at sites outside
the application area and may result in ambient air levels of DBCP at the site
of application several days after application.
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-2-
Pursuant to Section 6(c)(2) of FIFRA, each registrant of a DBCP product
was given the opportunity to request an expedited hearing on the question
of whether an inminent hazard existed. Three registrants requested such a
hearing and following these proceedings the Administrative Law Judge presiding
on the issue, ruled that an inminent hazard did in fact exist and recommended
to the Administrator that remaining uses of pesticide products containing
dibranochloropropane be suspended.
On October 29, 1979, the Administrator issued a Suspension Order suspend-
ing all products containing dibroraochloropropane with the exception of those
products bearing directions for use on pineapples. This usage was strictly
limited to the State of Hawaii.
A copy of the Notice of Intent to Suspend, the Recoranended Decision by
Administrative Law Judge, Gerald Harwood, the Suspension Order, a copy of
the recall letters sent to registrants of DBCP products, and a list of reg-
istrants and registered DBGP pioducts are enclosed.
This memorandum represents EPA1 s Enforcement Strategy to be used in
relation to this Suspension Action.
Enforcement Policy
The Agency intends to ensure that the Administrator's Order is strictly
complied with by all affected persons, including manufacturers, formulators,
registrants, Wholesalers, retailers and users.
On Noventoer 5, 1979, the Pesticides and Toxic Substances Enforce-
ment Division notified by certified mail all registrants and/or
producers of products containing DBCP requesting that they:
a. remove from sale down to and including the retail level
all existing stocks of products bearing suspended uses?
b. recall those products which do not bear directions for use
on pineapple;
c. relabel with interim or amended labeling those products
bearing directions for use on pineapple.
The interim labeling we proposed would bear the statement "For
Sale for Use on Pineapples in Hawaii Only". No product may
be legally shipped after March 1, 1980, without approved amended
labeling. Those products in the state of Hawaii bearing directions
for use on pineapples shall be removed from sale until they have
been relabeled with interim or approved amended labeling. Under
no circumstances shall relabeled products be sold at the retail
level in any state other than Hawaii.
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-3-
Enforcement Procedures
1. After initial oontact with the registrant, an inspector from the
Regional Office or State should visit affected registrants to
discuss the recall action and monitor the steps taken bp cxxnply
with the recall. Proper storage of recalled products should
be stressed. See Section 14 of the Pesticides Inspection Manual
for information on procedures to be followed in monitoring the
recall.
2. If a firm refuses to recall its products, the Regional Office in
cooperation with the. States shall issue Stop Sale, Use or Removal
Orders and/or seizures to effect removal of the products from the
channels of trade.
3. Vfoen necessary the Regional Offices and States will take
appropriate enforcement action against those persons found
in violation of the DBCP Suspension Order.
Regional Offices shall request States to identify and recall products
bearing intrastate labels since intrastate products represent a major share
of those registrations which are currently active. The Regions should also
inform the States that only products bearing federal registrations were
sent recall letters by PTSQ). Those Hawaiian intrastate products bearing
directions for use on pineapples may be relabeled if the state so wishes.
Dse of Existing Stocks and Disposal
As stated in the Administrator1 s Suspension Order, the use of existing
stocks of DBCP (except those products bearing directions for use on pineapples
in Hawaii) is prohibited and would be in violation of the Suspension Order aid
subject to enforcement action. Persons desiring to dispose of stocks of DBCP
products should be apprised that they may arrange with the appropriate regions
to ship their products for disposal. This may include returning the product
to the supplier, or disposal in accordance" with directions provided by the
Office of Solid Waste. Disposal questions may be referred to Mr. Ray Krueger
(202-472-9403).
Export
CBCP products nay be exported. Exportation must be in accordance with
PIFRA Section 17(a) which includes a requirement that the product must
bear specific labeling. Registrants exporting CBCP products affected
by the Suspension Order should also be cautioned in relation to the
stipulation signed by the Department of State concerning the utilization
of U.S. funds for U.S. AID regulation entitled "Pest Management Program,
Interim Pesticides Procedures', published in the Federal Register on
January 7, 1976. The notice states that AID will not provide assistance
for tiie procurement or use of a pesticide which has been finally suspended
or: cancelled by EPA.
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Indemnification
The Office of Enforcement has been advised by the Office of General Counsel
that registrants of DBCP products would not be eligible to make any claim for
an indeminity payment until the registration of their pesticide is canceled,
(See section. 15(a) of FIFRA). Any questions concerning indemnities should
be directed to Mr. Mitchell Bernstein, Office of General Counsel (202-426-9448).
Should you have any questions concerning any facet of this memorandum and
the DBCP Suspension Order, please contact the appropriate Regional Coordinator.
Inquiries
Pei
Enforcement Division
Enclosures
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xtosr">,
7
^ WASHINGTON. O.C. 20460
USE 3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
2 JUL 1982
OFFICE or
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
TO: Air and Waste Management Division Directors
Pesticide Branch Chiefs
SUBJECT: General Compliance Strategy for Products Suspended
Under §3(C)(2)(B) of FIFRA
Attached Is the final General Compliance Strategy for
products suspended under §3(c){2)(8) of FIFRA. The final
strategy Incorporates comments received on the May 10, 1982,
draft. Also attached is a complete Vist of suspension actions
initiated or accomplished under section 3(c)(2)(B) of FIFRA by
OPP. This 11st will be updated as needed by OPP.
A. E. Conroy rector
Pesticides and yoxlc Substances
Enforcement D/vislon
Attachments
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GENERAL COMPLIANCE STRATEGY FOR PRODUCTS SUSPENDED UNPER
33(c)(2)(B) OF FIFRA
Ov e rv i ew
Section 3(c)(2)(B) of the Federal Insect!c1de, Fungicide, and
Rodenticide Act (FIFRA) authorizes the Admfn1strator to request
additional data on registered products In order to allow EPA to
further evaluate the product's active Ingredients Registrants
who fail to produce the data requested face suspension of their
product. A Notice of Intent to Suspend (NOIS) 1s Issued by the
Office of Pesticide Programs (0PP) for specific products produced
by a registrant 1f the registrant falls to take steps to produce the
data requested. The NOIS is sent by certified mall to the affected
registrants. Effective suspension of a product 1s accomplished
through the issuance of a Stop Sale, Use or Removal Order (SS'JRO)
timely coordination between Headquarters, Regions and States.
Regulated Industry
Requests for additional data made pursuant to Section 3(c)(2)(B)
are directed to all registrants whc produce a product containing the
specific active ingredient.
Requfre"m~ents of The Rule .
Section 3 (c) ( 2) (3).. o f the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA):
- Authorizes the Administrator to require additional data on
^ chemical to further evaluate the chemical and to support
existing registrations .
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-2-
- Requires registrants to take appropriate steps to secure the
addit1onal data within 90 days or face suspension.
- Grants EPA the authority to issue a Notice of Intent to Suspend
If a registrant falls to take steps to secure the required data.
- Allows a registrant and other parties to request a hearing
within 30 days of receipt of the NOIS by the registrant regarding
whether (11 the registrant diligently took one of the listed
steps to develop the data, or whether (2) the Agency's decision
on disposition of existing stocks is consistent with the Act.
The effective date of the suspension is affected by the
registrant's request for a hearing.
Each registrant originally is given the following options for
complying with the data request:
1} develop the required data himself or jointly with other
reg i strants;
2) certify that the product is exempt because it is an end-
use product formulated from a registered, non-suspended
^ianufacturi ng use or technical grade product purchased
from another producer;
3) request and receive a waiver of some or all of the data
requirements; cr
$) voluntarily request cancellation.
Failure to exercise any of these options within certain
specified time periods results in the suspension of the r eg i s-
tran t's product.
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-3-
Enforcement Objectives
The aim of the compliance strategy Is to stop the manufacture,
and possibly the distribution, of products subject to the suspen-
sion. This can be accomplished through the Issuance of a SSURO to
the registrant at the point of manufacture. Because suspensions
initiated pursuant to §3(c)(2)(B) are based on a failure to submit
data rather than on product deficiencies, 1t is not necessary to
recal1 suspended products from the marketplace.
1
The sale and use of existing stocks of suspended products which
are already in the marketplace is allowed to continue for a period
deemed appropriate by the Adm1nlstrator. Production is commonly
permitted for 120 days after receipt of the NOIS by the registrant.
Types of Violations
Section 12(a) (2) (J) of the Act prohibits the violation of a
suspension order Issued under §6. There Is, however, no specific
unlawful act under §12 for the violation of a"§3(c)(2)(5) suspension
order. Under §13 of the Act, the Administrator may Issue a SS'JRO
when a product is suspended. By Issuing a SSURO, any person viola-
ting the 53(c)(2)(B) suspension order would there fore be 1n violation
of § 12(a ) (2 ) (I), which prohibits violation of a SSURO, and subject
to the penalties thereunder. It 1s essential that each registrant
of a suspended product be issued a SSURO 1n order for the 53(c)(2)(B)
suspension to have the force of law.
1 Existing stocks are those packaged, labeled and released for
shipment at the time production 1s suspended.
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-4-
Administrative Considerations
Program Management
Upon final suspension, PTSED will send the regions:
1) A copy of the NOIS issued by OPP including,
a) a list of companies and specific products affected
b) the Agency's dec1si=on on the disposition of existing
s tock s ;
c) dates when production must cease; and
2) Any pertinent supporting documents.
The NOIS will allow the registrant a period of time, determined
by OPP, after the effective date of the suspension notice to stop
production of the suspended product(s). Additionally, registrants
will, generally, be allowed a period of t i ne to dispose of existinq
stocks of the suspended product(s).
Prior to the d-itJ? when all production nust stop, the region
will send any affected registrants a copy of the NOIS and a SSJRO,
effective the day after the production termination date. The cover
letter which accompanies the NOIS and SSU30 should include a
discussion of the options available to the registrant to remove
the suspension. 0pP shall be contacted by the Region to discuss
what options are available to the registrant of the suspended
product. States should be notified by the region of the suspension
action upon the region's receipt of the PTSED transmittal and should
be provided with copies of all the information the region has received
from PTSED.
-------
The Regions should also work with the States In which the
affected registrants are headquartered to schedule inspections of
the affected registrants- Production facilities of affected regis-
trants should be visited by the State after termination of the time
period allowed by the NOIS for production. Normally, only one
inspection should be necessary »for each registrant. States should
determine that production of the suspended product has been halted
and that the registrant understands the options available to lift
the suspension, should the registrant so desire. States should
explain that the EPA will allow existing stocks of the suspended
products to be sold for the period of time authorized by the
Admin1strator. States should also determine the amount of existing
stocks of suspended products in the control of the registrant and
report this information to EPA. Dealers, possessing products*
produced prior to the production termination date, will not he
affected by any time It.iit for the sa">e of existing stocks.
Intrastate products included 1n a §3(c)£2)(0) action are to
be treated as federally registered products. States nay take
action against these products and are encouraged to do so. Regions
are expected to assist in any State effort to suspend or restrict
the sale and distribution of suspended intrastate products.
Allocation ot' Responsibilities
1) Headquarters Responsibility.
a) Provide Regions with strategy for 53(c)(2)(B) suspensions.
b) Provide Regions with copies of all pertinent correspondence
in this suspension action.
c) Effective dates of suspension actions.
2
PEPS No. 3, 40 CFR 162.1?
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-6-
2) Regional Responsibility
a) Send copies of Notice of Intent to Suspend and the SSURO
by certified mail to all registrants of suspended products.
b) Provide guidance for State enforcement efforts.
c) Encourage States to suspend intrastate registrations.
3 ) State Responsibility
a) Conduct follow-up inspections to ensure compliance
with the SSURO.
b) Suspend intrastate registrations if possible.
Penalties ~ ~~ ~
Violation of th-3 SSURO is a violation of Section 1 2 ( a ) f 2 ) (I )
and subject to the penalties found under section 14(a)(1) and
14(b)(1).
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Sprout-Stop
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Fat mount
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10/76/A0
See memo of 12/31/60 And list attached. List attached.
-------
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"4/3*70? vym~TrfWM Ti^:-lir;<:ilit'.' Mlliciik' Irv;(»rLinltV;
0027 -i<) -(III 2<'.l
KtliUii Ti-rtmU-.i I Kir.ii't Ictilc
00'.»74-oo
Tc-tr.nli fori Torhn1r.il Hiticiik;
00274<)-fln2H5
Totr.uli f<r.inul,ir Selective Wr.-ort Killer Aeoto Agricultural Chemicals Corp.
002749-or>2r>4
Mcrvxrrotcphnc 5720702 FI71H7B3 ET7r87SZ Al'iucT'"irSter" M1 ?,c i lilo 1 nscct 1ciiY? 8 " 8
002749-00 nn '
-------
IJjfCc S**Urnt Effective Stocks Hay he CrrTucta Af forte, i Caifany llnire
Date IMckaijcd Sold by
by Registrant
Until
fcwun
action pendint]
Demox Spray (.'otic. Syntcralc InsectIrlilc Acoto Agricultural Chemicals
002749-00115
Dewox fi Uo/q,il
Concentrate Systemic IrviectIclifc " " *
002749-A0192
Ocnnx 2 Iho.Apl * " "
002749-00200
Cinitr.iminc
action pending
Cohcx Herbicide
001624-00104
Cche*
flOlf.24-00107
Dlnltrnmtrc
flO1624-00107
Cohcx I'ptam
001624-09041
Cc*>cx Eptam
no 1C24-01044
Uflikd StaUi Oort/daj Cfy&rizj!
-------
TOXAPHENE CANCELLATION COMPLIANCE STRATEGY
Overview
On May 25, 1977 EPA issued- a Notice of Rebuttable Presump-
tion Against Reg1 s'tration Continued Registration of Pesticide
Products Containing Toxaphene. This RPAR notice was issued pri-
marily on the basis of studies showing that toxaphene causes
tumors 1n laboratory animals, acute toxicity of toxaphene to
aquatic organisms, and the TTfghl1kelihoodthattoxaphene causes
reductions In the populations of nontarget animal species. Fur-
ther examination of the data available to the Agency showed that
toxaphene 1s extremely persistent, moves readily through the
environment, contaminates habitats of vulnerable aquatic and avian
species at levels sufficient to reduce their populations, and that
humans are exposed to toxaphene through occupational contact
and contamination of a range of food products, particularly fish.
On October 18, 1982 the Agency announced it's decision to
cancel most uses of toxaphene. This action was taken pursuant to
Section 6 of the Federal Insecticide, Fungicide and Rodenticide
Act, as amended (FIFRA). On November 29, 1982,' the Agency pub-
lished in the Federal Regi ster. 47 FR 53784 the notice
cancelling most uses of toxaphene, the conditions for continued
registration of toxaphene for certain uses, disposition of
existing stocks and hearing rights of affected registrants.- The
cancellation is effective 30 days after notification by the
Registration Division.
Requirements of the Rule ~
AT 1owable Uses
The order cancels all uses of toxaphene with the following
•a-, cap-, ions:
1) Dipping of beef cattle and sheep to control scabies.
2) Use on cotton, corn or small grains to control armyworms,
cutworms or grasshoppers. Use is restricted to 9I8 emer-
gency exemptions only.
3) Use on pineapples to control mealybug and pineapple gummosis
moth and use on bananas for weevil control in the Virgin
Islands and Puerto Rico only.
4) Manufacturing use only for formulating to products listed
above.
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- 2 -
The order further restricts use to certified applicators, speci-
fies protective clothing to be worn when mixing or applying the
pesticide, and mandates improved directions for use, disposal,
and to reduce exposure.
Used dip solutions must be disposed of in accordance with the
Resource Conservation and Recovery Act (RCRA). If the owner
generates more than 1000 kg of used dip solution per month or
more than 1000 kg of used dip solution in combination with other
hazardous waste, the material must be treated as a hazardous
waste subject to subpart C of RCRA. Any "user who wishes to manage
the disposal of this material as a hazardous waste must obtain a
permit to serve as a hazardous wa^ste facility pursuant to RCRA.
The label may exempt from these disposal requirements any farmer/
rancher who uses the product solely to treat beef cattle or sheep
which he and/or his immediate family owns as individuals.
Exi sting Stocks
Existing stocks are defined in the order a those stocks of
cancelled toxaphene products existing within the territorial
United States on or before November 29, 1982.
The rule allows the use of existing stocks of toxaphene
in the following manner:
1 ) Existing stocks within the physical possession of
registrants, (i.e., stock s stored in facilities
owned o7 Teased by the registrant or within the
the registrants direct control):
a) If the formulation is of a type that permits label
conversion to one of the following uses, the re-
labeled product may be sold and used until December 31,
1986. Existing stock may be relabeled for:
1) control of sicklepod in soybeans and peanuts
only in States with this use as a current or
future §24 ;c) registration,
2) use on insects in no-till corn,
3) use on dry or southern peas, or
4) §13 emergency use exemptions,
b) If tne formulation is of a type that does not permit
label conversion, the product may be sold for one
(1) year (until December 31, 1983) utilizing amended
1 aDeli ng .
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c) Registrants wishing to qualify for the existing stocks
provisions of the order must notify EPA, within 30 days
of receipt of the notice, of their decision regarding
disposition of extstlng stocks and provide EPA with
an Itemized Inventory of their stocks. Failure by a
registrant to notify EPA of their decision to attempt
to qualify for the provisions for existing stocks
will cancel the product and require the registrant
to dispose of existing stocks of that product within
90 days of publication of the order. Cancelled
existing stocks must be disposed of as required by
the Resource Conservaton and Recovery Act (RCRA).
d) Any registrant wishing to selt or dl strl bute~ any
existing stocks in their possession must either
relabel or apply supplemental labeling to the product
as required by the Notice sent by Registration Divi-
sion, OPP.
Existing stocks of registered technical products must be used
in the formulation of products with registered uses prior to manu-
facturing any new toxaphene technical chemical.
Existing stocks of any type may not be sold, distributed or
used after December 31, 1986.
2) Existing stocks outside the physical possession of regis-
trants (i.e., products already in the channels of trade
or in the possession of dealers and retailers).
a) Existing stocks already 1n the channels of trade or
in the possession of dealers retailers may be sold,
shipped or distributed for use tn accordance with
the labeling accompanying the product until Decem-
ber 31, 1983. These products may be used until Decem-
ber 31, 19 36 utilizing existing labeling. Any existing
stocks of t*.is type unsold as of December 31, 1983
must be disoosed of according to RCRA regulations.
3) Existing stocks ir tie nands of users.
a) Existiii in the hands of users may
be jsad vj existing labeling until Decem-
ber it,
Hearing R i ght •
The o r-.o* ^ : r : r-vrrants the opportunity for
a hearing p-j ;> j; . •" J-jch a hearing will consider
only whether " i .• ed and pursued appropriate
action to . • ¦ •: -the time provided or whether
the Admin' ' *-*-11 ng the disposition of
existing s r *•.; • " : - • * '• • : Act.
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- 4 -
Any action concerning the registrant's product swill be held
in abeyance pending the outcome of the hearing.
Regulated Industry *
Appendix A of this strategy lists those registrants affected
by this order.
Enforcement
The Agency's efforts to achieve compliance with this order
shall be directed towards assuring that cancelled products are
disposed of properly and that proper labeling is affixed to those
products introduced taof remaining in the marketplace.
Compliance Monitoring
Compliance monitoring of this order will be achieved first
through inspections of affected producer establishments and
secondarily, dealer inspections and marketplace surveillance.
Producer establishment inspections shall be conducted to
determine if the registrant is complying with the order. Producer
establishment inspections will be conducted in the following order
of p r'i o r i t y :
1) Inspection of registrants with cancelled products.
2) Inspection of registrants with non-con vertible existing
stocks, i.e. products which cannot be relabeled and
must be sold within one year.
3) Inspection of registrants with existing sr. ^ c k s which
can be relabeled to one of the allowable existing
stock, s uses.
4) Inspection of registrants with products .iiich will
remai n regi stared.
It is likely that registrants may have products -^i-:h fall
into some or all of the categories listed above. Tre Agency
is most concerned that cancelled products are disposed of
properly. For products which may be sold after relabeling, the
inspector should determine what types of toxaphene products are
in the registrant's possession (i.e., products with registered
uses, relabeled existing stocks or existing stocks that cannot be
relabelea} and whether they are properly labeled. , The inspector
should also determine whether the manufacturing use product used
in the formulation of registered products is a new chemical or
previously manufactured. Registrants must use existing stocks of
manufacturing use product to manufacture registered products until
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- 5 -
such stocks are depleted. Registrants may not sell or distribute
any toxaphene not labeled for a registered use or not labeled 1n
accordance with the existing stocks provisions of this order.
Regions will provide the States with all pertinent materials
regarding the order and work closely with the States to develop a
compliance monitoring schedule.
After Initial producer establishment inspections have been
conducted, regions will coordinate marketplace inspections with
the States to determine compliance with the existing stocks pro-
visions of the order.
Dealer inspect!ons,and marketplace surveillance will be
conducted to assure that products are properly labeled and sold.
Existing stocks of toxaphene already on dealer1s shelves may be
sold without label modification until December 31, 1983, provided
the registrant has notified EPA within 30 days of their decision
to attempt to qualify for the existing stocks provisions of the
order. Dealer inspections will become a major activity after
Oecember 31 , 1 983, the last date existing stocks which do-not
have allowable uses on the label may be sold.
Use Inspections will become critical after the December 31,
1986 cut-off date for all uses of existing stocks. Use inspec-
tions may be conducted before then at the option of the Region
and the State or if problems regarding the use of toxaphene are
not ed.
Administrative Cons i de rati o"nT
Allocation of Resources
1) EPA Headquarters - EPA headquarters shall:
a) Provide Regions with a copy of the cancellation
order, compliance strategy and a list of names and
addresses of affected registrants.
b) Provide the Regions with a list of those registrants
who intend to amend their regisration and remain
registered, registrants who intend to relabel their
existing stocks of toxaphene for permitted uses, and
those who took no action and therefore face cancel-
lation of their product.
c) Provide the Regions with the yearly inventory of
existing stocks of toxaphene.
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6 -
d) Provide additional support and guidance as the
Regions may require.
2) Regions - The regions shall:
a) Provide the States with copies of the materials
received from headquarters.
b) Coordinate inspectional activities related to this
order with the States.
c) Provide support and guidance as the States may
requi re.
3) States - The States shall:
a) Conduct producer establishment inspections of
registrants affected by this order.
b) Conduct dealer inspections and marketplace surveil
lance to determine compliance with existing stock
provisions of this order.
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5/10/82
FIFRA COMPLIANCE PROGRAM POLICY COMPENDIUM
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
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The Compliance Program Policies contained in this compendium
and tne Policy and Criteria Notices published by the Office of
Pesticide Programs nave been cross referenced by subject matter
ir a "Key Wora Index" located at the end of this compendium.
Copies of tne Policy and Criteria Notices are not provided but
a list of all current Notices is attached.
These Compliance Program Policies will supersede all existing
P o I ici.es.
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FIFRA COMPLIANCE PROGRAM POLICY INDEX PAGE
TITLE NUMBER
Use Recommendations 2.1
Labeling of Outer Containers 2.2
Shipment Prior to Registration 3.1
Distributor Registrations 3.2
Fumigation of Truck Vans on Flatbed Rail Cars 3.3
Custom Blenders 3.4
Production of Pesticides for Personal Use 3.5
Contract Manufacturing 3.6
Written Examinations for Private Pesticide 4.1
Applicators
Custom Blenders 7.1
Release of Pesticide Production Data 10.1
Using Registered Or Experimental Use Permit 12.1
Pesticides In A Manner Not Included On
The Label Or Permit
Pesticides Closed Transfer, Mixing/Loading and 12.2
Application Equipment (Closed Systems)
Authority for Use Inspections 12.3
Making Restricted Use Pesticides Available 12.4
to Persons Without Pesticide Applicator
Certification
Pesticide Processing in Foreign-Trade Zones 17.1
Waiver of Notice of Arrival Requirements 17.2
Special Local Needs Labeling 24.1
Child Resistant Packaging 25.1
Transfer of Use Enforcement Primacy to the States 26.1
Referral of State Misuse Cases to EPA 26.2
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 2 INDEX PAGE
TITLE NUMBER
Use Recommendations 2.1
Labeling of Outer Containers 2.2
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FIFRA COMPLIANCE PROGRAM POLICY No. 2.1
Use Recommendations
FIFRA Section: 2(ee)
Issue:
Should the Agency allow the advocacy of Section 2(ee) uses
by any person without regard to his financial Interest 1n the
sale of pesticides?
Pol icy:
To the extent that Section 2(ee) allows a particular use, any
person, regardless of his financial Interest 1n the sale of pesti-
cides, may legally recommend or advertise such uses provided that
recommendations made under Section 2{ee) pertaining to the amount
of diluent used 1n applying pesticides for forestry or agricultural
purposes 1s 1n accordance with the Advisory Opinion issued March 3(
1981 (46 FR 14965).!
?i scussi on :
Back ground
Federal jurisdiction over-the use of pesticides was established
through the'1972 amendments to the Federal Insecticide,. Fungicide,
and Rodenticide Act (FIFRA), Sections 3(d)(1); 4; 12(a)(2)(G).
Acceptance of the label submlttedvwith the registration of a pesti-
cide product by the U.S. Environmental Protection A,gency (jiPA) is a-
central part of the pesticide registration process. The pesticide
label dictates the approved uses fpr each registered pesticide. Any
use of a registered pesticide which 1s Inconsistent with its labeling
1s unlawful, (Section 12(a)(2)(G)).
In 1975, the Pesticides and Toxic Substances Enforcement Division
(PTSED) initiated a series of Pesticide Enforcement Policy Statements
(PEPS). The PEPS are designed to Inform Interested members of the
public about the policies adopted by the Agency In the exercise of
its prosecutorial discretion 1n the enforcement of FIFRA (40 FR
19526). Such exercise of prosecutorlal discretion has been- guided
in each Instance by the legislative history of the 1972 FIFRA amend-
ments which states that 1t was the intent of Congress to ensure that
the Agency evaluate the meaning of the term "inconsistent with the
label" in a common sense manner,
TI Supersedes Federal RegTster Notice, (Vol. 44, No. 112, Friday,
June 8, 197TI p. 33151), wh 1 ch limited Section 2(ee) recom-
mendations to user/applicators. This Policy does not prospec-
tively amend any existing pesticide labeling; all changes 1n
a registered pesticide label must still be -approved by the
Agency.
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(H.R. Rep. No. 92-511, 92d Cong. 1st Sess., 16 (1971)). In
accord with this Congressional direction, the PTSED determined
that some uses or applications which were not expressly stated on
the label were, nonetheless, to be allowed. In particular, the
following uses were not subject to prosecution:
1) Use of registered pesticides at less than the label
dosage rate (40 FR 19529; 40 FR 42914); (PEPS #1).
2) Use of registered pestrcides for the control of unnamed
target pests in structural pest control (40 FR 41175);
(PEPS #2).
3) Use of registered pesticides for the control of pests
not named on the label 1n agriculture and other non-
structural pest control (41 FR 41142); (PEPS #5).
4) Use of aerial application techniques where the label
Instruction does not specifically prohibit such use
(42 FR 21 496) ; (PEPS #7) .
The PEPS permitted these limited deviations from the
language of the registered pesticide label only where the label
does not explicitly proscribe such uses. Thus the question of
"what" nonlabel uses were permissible was addressed by the PEPS.
The second issue of "who" could recommend these uses was also-
answered by the PEPS.
All of the deviations permitted under the PEPS were subject
to the restriction that only "knowledgeable experts" could
recommend them. Under the PEPS, States could designate know-
ledgeable experts subject to certain educational and experiential
standards. For example, knowledgeable experts could include
persons employed by State Cooperative Extension Services, State
Land Grant Colleges, and State Agriculture Departments.
The PEPS denied the designation of "knowledgeable expert"
to individuals whose primary source of personal income is
directly derived from the sale or distribution of pesticides.
This limitation precluded pesticide sales representatives,
marketing employees, or advertising agents from advocating PEPS
deviations. The PEPS justified this position by reliance on
Section 12(a)(1)(B) which makes it unlawful for any person with
a financial interest in pesticide marketing to make a claim which
differs substantially from registered pesticide labeling.
In short, the PEPS have had two consequences. First, they
made certain pesticide use deviations permissible even though
the uses do not appear on the registered pesticide label. Secondly,
all persons with a direct financial interest in the sale of
pesticides were forbidden under Section 12(a)(1)(B) from recom-
mending any of the pesticide uses permitted by the PEPS.
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3 - 2.1
Federal Pesticide Act of 1978
FIFRA was again amended by enactment of the Federal Pesticide
Act of 1978 (FPA). The FPA broadened the construction of Section
12(a)(2)(G) of FIFRA by adding Subsection 2(ee). Section 2(ee)
defines the term "to use any registered pesticide in a manner
Inconsistent w1th 1fcs- 1 abel 1 ng.Accordlng to the language of
this new,/section, It Is a v1ot-fft1on of Section 12(a)(2)(G) to use
a registered pesticide a1n a manner not permitted by the labeling"
with the exception of four specific areas. The areas specifically
excluded from enforcement are^*1most identical to those previously
listed 1n the PEPS.? .Under Section 2(ee) 1t Is not a misuse to:
1) Apply a pesticide at amy dosage, concentration, or
frequency less than that specified on the labeling
(PEPS- #1) ;
2) Apply a pesticide against any target pest not specified
on the labeling 1f the application 1s to the crop*
animal, or site specified on the labeling (unless the
label states that the pesticide may be used only against
pests specified on the label) (PEPS #2,5);
3) Employ any method of application not prohibited by the
labeling (PEPS #7); and
4) Mix a pesticide or' pesticides with a fertilizer when
such mixture 1s not prohibited by the labeling. (This
issue was not expressly dealt with by PEPS but was
covered by Policy and Criteria Notice 2000.1, Fertilizer-
Pesticide Combinations.)
Thus, Section 2(ee) defines by lay certain uses which will
not be considered Inconsistent with labeling even though these
uses are not listed. The PTSEO responded to Section 2(ee) by
publishing a Federal Register Notice which rescinded PE-PS numbers
1, 2, 5, and 7 (Vol. 44, No. 112, p. 33151). As explained in
the Federal Regi ster, the PTSED restricted the advocacy of Section
2(ee) uses to user/appl1cators. The PTSED has now reconsidered
its earlier position and has decided to remove this restriction.
Experience has demonstrated that the earlier policy prevented
certain qualified Individuals from recommending authorized
deviations from the express terms of the label. The following
examples Illustrate the problem:
° In States with farm cooperatives there are Individuals
who both use and sell pesticides. These Individuals
were prevented from recommending authorized uses.
2~I It should be noted that while the FPA amends existing Federal
law concerning pesticide misuse, 1t does not purport to affect
State laws.
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4 - 2.1
° Likewise, pest advisors who serve as IPM consultants
or farm management consultants were prevented from
recommending Section 2(ee) uses solely because they
may also be directly or indirectly connected to the
sale of pesticides.
The new PTSED position 1s also supported by the statutory
language of Section 2(ee). Since Section 2(ee) uses are no
longer considered misuse, any recommendations made regarding
these uses will not be viewed as substantially different from
use directions appearing on the label. Accordingly, 1t is
PTSED policy that Section 12(a)(1)(B) no longer prohibits
financially interested persons from recommending or advertising
such uses. Thus, to the extent that Section 2(ee) allows a
particular use, any person may advocate that use, provided
that recommendations made under Section 2(ee)(l) pertaining
to the amount of diluent used in applying pesticides for forestry
or agricultural purposes 1s made in accordance with the Advisory
Opinion issued March 3, 1981 (46 FR 14965).
This new policy not only implements the Congressional
intent of Section 2(ee) to allow beneficial nonlabel pesticid-e
uses but also provides for strong enforcement to ensure appropriate
recommendations of such uses. The policy statement in no way
relaxes the administrative or other civil liability of persons
who recommend pesticide uses. The only change is that the PTSED
no longer limits the advocacy of permitted uses on the basis of
financial interest in the use. The Agency will, however, take
enforcement action under Section 12(a)(1)(B) against any person
with a financial interest who makes pesticide use recommendations
which exceed the limits of Section 2(ee). Additionally, any
person who recommends Section 2(ee) uses, of course, remains
liable for possible civil damages arising out of his own negligence.
See Also:
FIFRA Compliance Program Policy No. 12.1 Using Registered or
Experimental Use Pesticides in a Manner not Included on the Label",
Po1i cy and Criteria Notice 2000.1 , Ferti 1 izer-Pesticide Combinations.
Key Words:
Fertilizer-Pesticide Mixture, Knowledge Expert, Misuse, Target
Pest, 2(ee), Use Inconsistent with the Labeling, Use Recommendations.
Civil Liability
A. E. Conroy IV, Ch rector
Pesticides and/Taaic Substances
Enforcements Q/ivision
W I0BP
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 2.2
Labeling of Outer Containers
FIFRA Section: 2(q)
Issue:
When must a label be attached to a shipping container of a
pesticide product?
Pol 1cy:
A label must be attached to a shipping container of a
pesticide 1f the customary practice of the manufacturer 1s
to retail the product to consumers without opening the outer
shipping container to sell the product 1n Individual units.
Pi scusslon:
Section 2(q)(2)(C) of FIFRA states that a pesticide 1s
misbranded unless a label 1s affixed to Its container and to
the outside container or wrapper of the retail package.
The regulations at 40 CFR .162.1 0(a) ( 4) (1J state in part:
The label shall appear on or be securely attached
to the Immediate container of the pesticide product.
... If the immediate container is enclosed within
a wrapper or outside container through which the
label cannot be clearly read, the label must also
be securely attached to such outside wrapper or con-
tainer, if 1t is part of the package as customarlly
distributed or sold, (emphasis added)
The preamble to these regulations clearly states EPA's
intention to continue Its policy which requires labeling on
retail packages for sale but not on shipping containers. If
it 1s customary to sell a product 1n Its shipping container
rather than 1n Individual units, the outer container must also
bear a full end use label. If a product Is generally sold 1n
Individual units and only occasionally by the case, the outer
container would not be required to bear labeling, since the outer
container is not Intended to serve as a retail unit.
The purpose of requiring labeling on the retail package, be
1t the shipping container or individual units, is to allow the
person who uses the pesticide to read the entire label and be
fully Informed about the product. Failure to properly label
the retail package 1s considered to be misbranding and 1s a
violation of Section 12(a)(1)(E).
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2 - 2.2
References:
Letter of June 16, 1976, from A. E. Conroy II, to
Mr. C. M. Ei nhorn of USS Agri-Chemicals.
Memorandum of September 10, 1976, from A. E. Conroy II to
Pesticide Branch Chiefs and Enforcement Division Directors.
Key Words:
Labeling, Outer Containers, Shipping Containers.
A. E. Conroy II/Director
Pesticides and (Tox/c Substances
Enforcement Dvxrsion
W » 0 BR?
Date
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FIFKA COMPLIANCE PROGRAM POLICY SECTIUN 3 INDEX PAGt
TITLE NUMBER
Shipment Prior to Registration 3.1
Distributor Registrations 3.2
Fumigation of Truck Vans on Flatbed Rail Cars 3.3
Custom Blenders 3.4
Production of Pesticides for Personal Use 3.5
Contract Manufacturing 3.6
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MFKA COMPLIANCE PROGRAM POLICY No. 3.1
Shipment Prior to Registration
FIFRA Section: 3
Issue:
May a pesticide product which 1s not sold under an
Experimental Us_e_Permit (EUP) be shipped to distributors prior
to being registered w1th^&PA?
Pol icy:
A pesticide product not sold under bn EUP may be shipped
prior to final approval of Its EPA registration under certain
circumstances. The registrant must apply to EPA for a temporary
exemption to registration requlrements; demonstrate a compelling
need for the distributor to receive the product before Its EPA
registration Is finalized; detail a plan for control of the
product prior to registration; and receive EPA approval of the
exemption request.
Discussion:
Section 3(a) of FIFRA states:
... no person 1n any State may distribute,
sell, offer for sale, hold for sale, ship,,
deliver for shipment, or receive and (having
so received) deliver[y]' (s1c) or offer to
deliver, to any person any pesticide which
is not registered with the Administrator.
The exemptions to this requirement found in Section 3(b) do not
address delivery of an unregistered pesticide to a distributor.
However, the Agency will consider granting an exemption of this
type as a matter of policy 1f certain conditions are met. When
granting such exemptions, the Agency will consider: whether regis-
tration is imminent (final printed labeling waiting approval);
the type of pesticide; the need for such action; and the regis-
trant's ability to maintain control over the product to prevent
its sale prior to registratlon.
Upon receiving EPA approval of the exemption request, the
registrant must contact each EPA Region and State Involved and
inform them of the shipments. The registrant must provide the
Regions and States with exact shipping data Including the point
of origin, the date of shipment, the name of the carrier, the
name and address of the consignee, the name and telephone number
of the responsible person at the consignee's, and the expected
date of arrival. The registrant must also provide the Regions
wltn a plan for control and handling of the product to prevent
Its sale or use prior to registration. If the product does not
become registered as anticipated, the registrant must notify the
Regions and States Immediately and no further shipment or dis-
tribution of the product is allowed until it is fully registered.
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2 - 3.1
Failure to fulfill the conditions of the exemption or sale
of the product at the distributor level prior to registration
is a violation of Section 12(a)(1)(A) of FIFRA.
See Also:
Regi strati on.
References:
March 21, 1978 letter from A. E. Conroy II, Director, PTSED,
to Ingrid K. Allen, Registration Coordinator, Agricultural
Chemicals Division, Fisons, Inc.
Key Words:
Exemptions, Shipment, Unregistered Pesticides.
A.VE. Conroy 11ctor
Pesticides and /Toxic Substances
Enforcement Division
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 3.2
Distributor Registrations
FIFRA Section; 3
Issue:
May a distributor repackage a pesticide which 1t Intends to
sell under a supplemental registration?
Policy:
A distributor may repackage a pesticide 1t sells under a
supplemental registration only if 1t Is under contract to the
basic registrant to do so.
Discussion:
Manufacturing or packaging a pesticide under contract and
distributing a pesticide under a supplemental registration are
two separate activities.
Section 3(b)(1) of FIFRA and the regulations at 40 CFR
162.5(d)(1) allow for the transfer of an unregistered pesticide
from one registered establishment to another registered establish-
ment operated, by the same producer .solely for packaging or use as
a constituent part of another pesticide produced at tthe second
establishment. The term "operated by the same producer" is
defined at 40 CFR 162.3(dd) to mean another establishment owned
by the registrant or an establishment operated by a person under
contract to the registrant.
Under supplemental registration, a distributor of a registered
pesticide product is permitted to market that pesticide product
under the di stributor's brand name If It adheres to the conditions
described at 40 CFR 162.6(b)(4)(1 ). The regulations require, 1n
part, that distributor products be manufactured and packaged by the
same person who manufactures and packagesthe previously registered
pesticide product (40 CFR Part 162.6 (b)(4)(i)(B)). Labeling Is
considered as part of packaging for the purposes of these regula-
tions. . These provisions preclude more than one person from producing
a product.
The contract manufacturlng policy may be applied to situations
where a person, under contract to a manufacturer to produce or
repackage a product, also wishes to distribute the product under
a supplemental registration, a supplemental registrant (distributor)
may repackage a pesticide, which 1t intends to sell under its own
brand name, only 1f 1t is under contract to the basic registrant to
do so. Where such a contractual arrangement exists, the supplemental
registrant acts as an agent for the basic registrant and is held
to the same standards of adulteration and misbranding imposed on the
registrant at the time of registration.
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2 - 3.2
A supplemental registrant under contract to the basic registrant
may also label or repackage the product for other distributors.
However, the product must bear the contractor's (supplemental regis-
trant's) establishment number and the distributor number assigned to
the firm whose brand rvawe appears on the label.
Any supplemental registrant's (distributor's) name appearing
on the label must be qualified by terms such as "packed for",
"distributed by", or "sold by".
The Agency feels that this policy protects both the public and
the environment for several reasons. The product produced by the
contractor is fully registered with EPA by the basic registrant.
In, addition the product must conform to the standards held for the
basic registration and to the requirements for supplemental regis-
t rati ons . ~
Liability for any violation of Section 12 in such a contractual
arrangement may rest with either or both parties to the contract
depending upon the circumstances associated with the violation.
FIFRA Compliance .Program Policy No. 3.6., Contract Manufacturing.
References:
40 CFR Part 1 62. 26 (b)(4)(i), (ii), (iii).
Memo of August i9, 1977, from A. E. Conroy II to Ed Johnson,
OPP, titled "Contract Manufacturers".
Memo of December 13, 1976, from A. E. Conroy II, PTSED, to
Regional Enforcement Division Directors and Pesticide Branch
Chiefs titled "Relation 8etween Contract Manufacturers and
Packagers and Distributors of Supplementally Registered Products".
Key Words:
Contract Manufacturing, Distributor Registrations, Repackaging,
Supplemental Registrations.
See Also:
A.
Pe< tances
i'fll i 0 ISa?
. Da t e
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FIFRA COMPLIANCE PROGRAM POLICY No. 3.3
Fumigation of Truck Vans on Flatbed Rail Cars
FIFRA Section: 3
Issue:
Will EPA, In the absence of specific label directions, allow
the fumigation of truck vans with pesticide products that generate
phosphlne gas while the vans are being transported on flatbed rail-
road cars?
Pol Icy:
EPA will allow truck vans being transported on flatbed
rail cars to be fumigated provided:
1) the pesticide label contains directions which allow
the use of the product 1n sealed boxcars and hopper
cars while 1n transit, on the commodity being carried
In the truck van, and these directions are followed;
2) the truck vans are sealed and placarded during
fumigation; and
3) the truck vans are fully aerated in accordance with label
di rect i ons" pr1 or to removal from the flatbed rail car.
For the purposes of this policy, a truck van is defined
as the container portion of any highway truck, trailer or semi-
trailer having a demountable chassis.
Oiscussion:
The Agency finds that the use of aluminum phosphide products to
fumigate truck vans while the vans^are being transported on flatbed
rail cars is allowable provided the conditions mentioned above are
met.
This policy also applies to all other registered products which
generate phosphlne gas and bear directions for use in sealed boxcars
and hopper cars. The Agency feels that the construction of truck
vans 1s sufficiently similar to the construction of boxcars and
hopper cars that there 1s no greater risk of exposure to phosphlne
gas during and after fumigation on rail cars provided that care is
taken to properly seal, label, and aerate the truck vans. EPA
feels that fumigation of truck vans while on rail cars provides
the least risk of exposure when compared to other alternatives.
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2 - 3.3
The Agency will not extend this interpretation to allow
the fumigation of truck vans being transported over the highway
because of concerns that the driver and other members of the public
could be exposed to phosphine gas.
Key Words:
Aluminum Phosphide Products, Fumigation, Labeling, Phosphine
Gas, Phostoxin, Rail Cars, Truck Fumigation, Truck Vans,
A. t- • uuiiiujt 11 / u yrei.i.ui
Pesticides and Tbxi/c Substances
Enforcement Di\(j^s1on
feH
m 10 B6e
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 3.4
Custom Blenders
FIFRA Section: 3
Issue:
Are custom blenders of pesticides subject to the requlrements
of Section 3 of FIFRA?
Pol 1cy:
Although custom blenders-of pesticides are subject to the
registration requirements of Section 3, they need not meet these
requirements when certain prescribed conditions are met.
D1 scusslon:
Section 3 of FIFRA requires any person who produces a pesticide
to register that pesticide w
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a) a copy of the end-use labeling of the
pesticide used in the blend, and
b} a statement specifying the composition
of the mixture.
The Agency feels that the public will be adequately protected without
Section 3 registration of custom blends 1f custom blenders meet these
criteria.
If a custom blend does not meet the criteria listed above, it
must be registered as a pesticide in accordance with the requirements
of Sectlon 3.
The limited obligations of custom blenders under Section 3
are independent of their obligations under FIFRA Sections 7 and 8.
See Also:
Custom Blenders - FIFRA Compliance Program Policy No. 7.1,
Policy and Criteria Notice 2000.1
References:
Memo to Pesticide Branch Chiefs and Enforcement Division
Directors from Edwin L. Johnson and A. E. Conroy II, dated
September 3, 1975, titled "Interim Regulations Regarding
Registration of Custom Blends and Custom Blending Establish-
ment s . u
Memo to Pesticide Branch Chiefs from A. E. Conroy II, dated
September 10, 1980, titled "Custom Blender's Identification
for ERSS."
PR Notice 73-1
Key Words:
Custom Blenders, Fertilizer-Pesticide Mixtures, Registration.
A.
Pesticides and Cd'xic Substances
Enforcement Division
1 o 198?
Date
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FIFRA COMPLIANCE PROGRAM POLICY NO. 3.5
Production of Pesticides for Persona] Use
FIFRA Sections: 3, 7
Issue:
May a person lawfully produce a pesticide for his own use
without registering his product or establishment?
Pol 1cy:
Generally, a person may lawfully produce a pesticide for
his own use without registering his product or establishment.
D1scusslon:
Section 3 of FIFRA requires a pesticide producer to register
his product only if he sells or distributes the pesticide.
Furthermore, the regulations (40 CFR Part 167) which address the
registration of pesticide producing establ1shments under FIFKA
Section 7 state that persons who produce pesticides solely for
application by themselves are not required to register thjalr
establishments. Thus, a person who produces a pesticide solely
for personal use is not required under FIFRA to register the
pesticide or th'e producing establishment.
The Agency considers any application of an unregistered
pesticide for other than personal use to be distribution of an
unregistered pesticide, a violation under Section 12(a)(1)(A)
of FIFRA. This Includes applying an unregistered pesticide to
another person's property for other than monetary consideration.
Furthermore, a person applying an unregistered pesticide for
hire, only to provide a service of controlling pests without
delivering any unapplied pesticide to any person so served, would
be considered a distributor and, 1s therefore, subject to the
higher penalties set forth In section 14(a)(1) and 14(b)(1) of
FIFRA. (see S. Re?. No. 95-1138, 95th Cong., 2nd Sess. 44-45
(1978)).
References:
Memorandum to Roy Clark, Region IV, dated April 9, 1981
titled M Interpretation of FIFRA $162.4(c) (6).
Senate Report No. 95-1188, 95th Congress, 2nd Session
44-45 (1978).
-------
2 - 3.5
Key Words:
Establishment Registration, Product Registration.
A. E. Conroy II, Dfreo'tor
Pesticides and To^ic/Substances
Enforcement Oivi^>/on
•-.Mr I 0 1982
Date
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FIFRA COMPLIANCE PROGRAM POLICY NO. 3.6
Contract 'Manufacturing
FIFRA Section: 3(b)(1)
Issue:
May an unregistered pesticide be lawfully transferred
between two separately owned registered establishments?
Pol 1cy:
An unregistered pesticide may be lawfully transferred
between two separately owned registered establishments 1f
one establishment Is operating under contract to the other.
Under such a contractual arrangement, the establishment under
contract must produce the product 1n question solely for the
company to, whom it Is under contract.
Oi scusslon:
Section 3(b) of FIFRA provides an exception to the general
requirement of Section 3(a) that all pesticides moving 1n commerce
be registered. Specifically, Section 3(b)(1) of FIFRA provides
that an unregistered pesticide may be transferred if:
. . . the transfer is from one registered establishment
to another registered establishment operated by the same
producer solely for packaging at the second establishment
or for use as a constituent part of another pesticide
produced at the second establ1shment ....
The phrase "operated by the same producer" as used in
Section 3(b)(1) has been defined in 40 CFR 162.3(dd) to mean:
... (1) another reglstered^establ1shment owned by
the registrant of the pesticide product or (2) another
registered establishment operated under contract with
the registrant of the pesticide either to package
the pesticide product or to use the pesticide as a
constituent part of another pesticide product, pro-
vided that the final pesticide product 1s registered
by the transferor establishment.
Under such a contractual arrangement, the establishment
under contract must produce the product solely for the company
to whom it is under contract.
-------
2 - 3.5
Any attempt by the estabT1shment under contract to sell or
distribute the product to another person would be considered
saTe or distribution of an unregistered pesticide under Section
12(a)(1)(A) of FIFRA. The basic registrant Is responsible for
any product produced by an establishment under contract.
The following are acceptable activities under the contract
manufacturing policy:
Company A, the end use registrant may contract with Company 8
to manufacture an end use product or process an Intermediate
formulation Into an end use" product. Company A may also contract"
with company B to produce a technical substance which company A
then processes Into an end-use product. Company B may contract
with Company C to perform some or all of its contract obligations
with Company A. At no time, however, may Company B'or C sell or
distribute the end use product to anyone other than Company A.
Company A may also contract with Companies 0 and £ to produce the
same technical substance or the same end use product or to process
the same intermediate into the same end use product.
The Agency feels that this contract manufacturer policy
protects both the public and the environment for several reasons.
The product is fully registered with EPA by the company letting
the contract, and the product must conform to the standards held
for the basic registration. Both companies may be held liable
for any product found in violation of FIFRA.
See Also:
FIFRA Compliance Program Policy No. 3.2, Pi stri butor
Registrations.
References:
Memo of August 19, 1977, from A. E. Conroy II, PTSED to
Ed Johnson, OPP titled "Contract Manufacturers.u
Key Words:
Contract Manufacturing, Distributor Registrations,
Establishment Transfer, Unregistered Pesticides.
A. E . Conroy A I ,/d i r
Pesticides andVoxic
EnforcementN-Sn vi s 1
A. E. Conroy Al ,/d i rector
Pesticides arfd Vox 1c Substances
EnforcementN-Sn vision
MAY I 0 (982
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 4 INDEX PAGE
IIT.LE NUMBER
Written Examinations for Private Pesticide 4.1
Applicators
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 4.1
Written Examinations for Private Pesticide Applicators
FIFRA Section: 4(a)(1)
Issue:
May a State Certification Plan approved by EPA under FIFRA
require a private pesticide applicator to pass a written examina-
tion to become certified or recertified?
Poli cy:
A State Certification Plan may require a private applicator
to pass a written examination or other equivalent method of
evaluating competency as a prerequisite to becoming certified or
recertified.
Pi scussi on:
Under FIFRA Sections 3(d) and 12(a)(2)(F), applicators must
be certified before they may legally obtain and use pesticides
classified for restricted use. FIFRA Section 4 establishes two
different routes for certification: certification by a State
pursuant to a Plan approved by the Administrator, or certification
by the Administrator 1n cases where States have chosen not to
submit a Plan. Only two States, Colorado* and Nebraska, do not
have plans for certification of pesticide applicators.
FIFRA Section 4(a)(2) describes the criteria used by the
Administrator in deciding whether to approve a State-submitted
Certification Plan. Section 4(a)(2)(E) states that a Plan sub-
mitted by a State must contain "satisfactory assurances that State
standards for the certification of applicators of, pestlcides con-
form with those standards prescribed by the Administrator" under
FIFRA Section 4(a)(1). Section 4(a)(1) provides that a State
Certification Plan must specify a method by which an applicator
will establish his competency.
Under FIFRA, the Admin1strator may not require a private
applicator to pass an examination to establish competency for
certification or require a State Plan to contain such a provision.
* Colorado i s in the process of developing a certification plan,
which will Initially cover only commercial applicators.
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- 2 -
FIF R A Section 4(a)(1) prohibits the Administrator from requiring
private applicators to pass an examination to establish competency
for certification in EPA-administered certification programs.
Section 4(a)(1) also specifies "... That the certification standard -
for a private applicator shall, under a State plan submitted for
approval, be deemed fulfilled by his completing a certification form
..." However, a State may wish to adopt a certification program
which is more stringent than that prescribed under FIFRA Section 4
and related regulations. A State may on its own initiative choose
to require a private applicator to pass an examination to establish
competency for certification.
EPA's policy of accepting State Certification Plans which require
private applicators to pass written examinations is supported by the
lack of a statutory prohibition against such an action and the legis-
lative history. The Senate and House conference report clearly
affirmed the right AT '3 State to require the passing of a written
examination by a private applicator. The right of a State to require
the passing of a written examination by a private applicator has
been official EPA policy since the passage of FIFRA. Pursuant to
this policy the Administrator has approved State Plans requiring the
passing of a written examination by a private applicator as well as
State Plans using methods other than written examinations to establish
private applicator competency.
See Also:
Reference:
Letter dated August 30, 1982 from Edward C. Gray, Acting
Associate General Counsel, Pesticides Division to Mr. Frank
Graham, Florida Department of Agriculture, re: State - -imposed
Requirement for Examination of Private Applicators.
Letter dated November 16, 1982 from Robert M. Perry, Associate
Administrator for Legal and Enforcement Counsel and General Counsel
to J. T. Griffiths, the Citrus Growers Association, subject: State
- Imposed Requirements for Examination of Private Applicators.
Key Words :
Establish competency, written examinati-on, private applicator
cert i fi cat i on .
A. E. Conroy II, Director
Compliance Monitoring Staff
Office of Pesticij^s Toxic Substances
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 7 INDEX PAGE
TITLE NUMBER
Custom Blenders 7.1
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FIFRA COMPLIANCE PROGRAM POLICY No. 7.1
Custom Blenders
FIFRA Section; 7
Issue:
Are custom blenders of pesticides subject to the requirements
of Section 7?
Pol 1cy:
Although custom b1end€TC of pest/icides are subject to the
Section 7 establishment registration requlrements they are not
required to meet the reporting requlrements of Section 7 1f they
meet certain conditions.
Discussion:
Section 7 of FIFRA requires that all pesticide producers must
register those establishments 1n which they produce pesticides.
They must also submit to the Agency annual reports concerning pro-
duction and distribution of the pesticides. The regulations promul-
gated pursuant to this section (40 CFR 167) provide that a custom
blender 1s a producer and 1s thus subject to the requirements of
Section 7.
Custom blenders provide the service of mixing pesticides
to a customer's specifications. The custom blend 1s usually a
pesticide(s)-ferti11zer(s) mixture or a mixture of pesticides
derived from an end-use formulation.
The Agency has, however, determined that subjecting custom
blending establishments to all provisions of Section 7 is not
necessary for effective regulation of the industry. Therefore
the Agency will not require producers of those bleeds exempt
from Section 3* to meet certain Section 7 requirements.
*To be exempt from Section 3, a custom blend must meet the following
requlrements:
1) the blend 1s prepared to the order of the user and 1s
not held 1n inventory by the blender, and
2) the pesticide(s) used 1n the blend bear(s) end-use labeling
directions which do not prohibit use of the product 1n such
a blend, and
3) the blend 1s prepared In a registered establishment, and
4) the blend 1s delivered to the user together with:
a) a copy of the end-use labeling of the pesticide
used In the blend, and
b) a statement sped fyi ng the composition of the mixture.
-------
2 - 7.1
All custom blenders, whether or not their blends must meet
Section 3 requirements, must register their establishments with A
This is necessary to provide the Agency with the locations of pes-
ticide blending operations. The Agency will use this information in
scheduling Sect ion 3 inspections and in tracing contaminated or oth
pesticides in violation of the law.
Custom blenders whose blends need not meet Section 3
requirements are not required to report on amount produced at
the establishment or to place their establishment number on the
pesticide produced. Normally, the Agency requires the establish-
ment number to be placed on a product in order to allow EPA to
trace a shipment of pesticides which may be in violation of the
Act. Since a custom blend is used within a day or two of purchase
and the user knows the person who manufactured the blend, placing
the estabTishment number on the blend has little value.
Production data is required for registered pesticides, so
the Agency knows how much of a pesticide is produced and who pro-
duces it. This information is useful not only to know the total
production of pesticides but to assist EPA in recall actions or
other actions where knowledge of production is essential. Because
EPA does not require custom blenders to meet the Section 3 require-
ments of FIFRA, the Agency would not be consistent in asking for
production information on a blend which does not require registratic
Custom blenders remain subject to the provisions of Sectior
of FIFRA as well as to all requirements relating to proper use o^
pesticides including transport, storage and disposal.
See Also:
Custom Blenders - FIFRA Compliance Program Policy No. 3.4
References:
See references in FIFRA Compliance Program Policy No. 3.4
Key Words:
Custom Blenders, Establishment Registration, Reporting.
tf. E. Conroy 11/Di/ector
Pesticides and /Tox/c Substances
Enforcement VDi^ision
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 10 INDEX PA'r.
TITLE NUMBER
Release of Pesticide Production Data 10.1
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FIFRA COMPLIANCE PROGRAM POLICY No. 10.1
Release of Pesticide Production Data
FIFRA Section: 10
Issue:
Under what circumstances will EPA release yearly production
data for particular pesticides?
Pol 1cy:
The EPA will not release an Individual producer's production
data for a specific pesticide. The Agency will release production
data 1n the aggregate, without Individual producer Identification,
at the request or order of an EPA Administrative Law Judge in a
data compensation proceeding under FIFRA Section 3(c)(1)(D). In
such a case, the EPA will Indicate the confidential nature of the
data to the Judge. When EPA responds to a Congressional request
for confidential data, the Office of Legal Counsel will decide
whether to release the data.
Discussion:
Production data which producers submit under FIFRA Section
7(c)(1) 1s confidential (Section 7(d)) and thus may not be released
by EPA (Section 10(b)). In many cases, aggregate yearly data which
does not identify Individual producers may not be confidential.
However, there 1s a risk, 1n some vcases, that the requestor may
ascertain the identities of Individual producers when combining
the aggregate data with other information 1n his possession.
The Freedom of Information Act (F0IA)(5 U.S.C. Section 552)
does not require an Agency to create'a record in response to an
FOIA request. The EPA regulations state: "The Freedom of Infor-
mation Act does not require the creation of new records 1n response
to a request ... The Act establishes requirements for disclosure
of ex1sting records" (40 CFR Section 2.105(a), emphasis added).
The United States Supreme Court has endorsed this reading of FOIA;
NLRB v. Sears Roebuck, 421 U.S. 132, 161-162. Aggregation of
pesticide production data submitted to EPA 1s clearly the creation
of new records.
While EPA could choose to release aggregate pesticide production
data even where not required by FOIA, It has decided not to do so
due to the risk of unintended disclosure of confidential data.
-------
2 - 10.1
FIFRA Section 10(b) authorizes the release of certain
confidential pesticide data to other Federal agencies; however,
production data is not Included. Also, FIFRA does not authorize
the release of production data to States. Therefore, EPA will
not routinely release individual or aggregate production data to
other Federal Agencies or Statas. Release of confidential pesti-
cide data to Congress, Including the General Accounting Office,
is governed by EPA-wide policy.(40 CFR Part 2). When EPA responds
to a Congressional request for confidential pesticide data, the
Office of Legal Counsel must b=e contacted, since that Office will
decide whether to release the data.
Reference:
Protective Order.-October 2-2, 19 81, Union - G-ar-b i d e -v-. Thompson
Hayward, FIFRA COMP. Docket Nos. 27 & 45 , 40 CFR Part 2.
Key Words:
Confidentiality, Establishment Registration, Production Data.
A. E. Conroy, 11, Ofrector
Pesticides and/Tox.rc Substances
Enforcement Qj'v/sion
¦•'•ni I 0 1982
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 12 INDEX PAGE
TITLE NUMBER
Using Registered Or Exper'+inental Use Permit 12.1
Pesticides In A Manner Not Included On
The La be 1 Or Pe rmi t
Pesticides Closed Transfer, Mixing/Loading and 12.2
Application Equipment (Closed Systems)
Authority for Use Inspections 12.3
Making Restricted Use Pesticides Available 12.4
to Persons Without Pesticide Applicator
Certi fi cati on
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FIFRA COMPLIANCE PROGRAM POLICY NO. 12.1
Using Registered Orv Experimental Use Permit Pesticides
In A Manner Not Included On The Label Or Permit
FIFRA Section: 12
Issue:
May a person legally use a registered or experimental use
pesticide for testing purposes^ not authorized by the label or
permit?
Pol 1cy:
A person may legally use a registered or experimental use
-pest 1 c1 de -for t^stl rvg p
-------
2 - 12.1
However, those regulations also provide at 40 CFR Part
172.3(a) that a person does not need an EUP to test a substance
or mixture of substances where the only purpose of the test
is to determine Its pestlcldal value, its toxicity or other
properties, and where the persons conducting the test do not
expect to receive any pest control benefit from the tests.
The regulations at.-40 CFR Part 172.3(a)(1) state that such
a purpose is presumed f.Qr land use tests if:
o The total cumulative acreage treated does not exceed
10 acres for a particular substance or mixture of
substances against a particular pest, and
o The food or feed crops Involved 1n, or affected by
such tests shall be destroyed or consumed only by
experimental animals unless a tolerance or exemption
from the need for a tolerance has been established.
These crops 1nc^ud« crops subsequently grown on
such land which may reasonably be expected to contain
residues of such substances or mixtures of substances.
The regulations at 40 CFR Part 172.3(a)(2) state that such
a purpose is presumed for aquatic use tests if:
o The total area treated does not exceed 1 surface acre
of water for a particular substance or mixture of
substances against a particular pest,
o The waters used in such tests will not be used for
irrigation purposes, drinking water supplies or body
contact recreational activities, and
o No such tests may be conducted in any waters which
contain, or which would affect, any fish, shellfish
or other plants or animals taken for recreational or
commercial purposes unless a tolerance or exemption
from tolerance has been established.
The regulations at 40 CFR Part 172.3(a)(3) state such a
purpose is presumed for animal treatments if:
o The tests are conducted only on experimental animals,
and
o No animals may be tested if they may be used in food
or feed unless a tolerance or an exemption from tolerance
has been established.
2 This poTTcy does not limit, but rather supplements the existing
policy regarding uses not authorized by the label but allowed under
FIFRA §2(ee).
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3 - 12.1
The regulations also state at 40 CFR Part 172.3(c) that an
EUP 1s not required 1f a registered pesticide Is used 1n a
test to determine Its pestlcldal value for a use not set forth
on the label ff the requirements at 40 CFR Part 173(a) are met.2
It 1s not a misuse violation of FIFRA to use a
non-registered substance 1n tests to determine pestlcldal
value, toxicity or other properties under the previously-cited
restrictions. Therefore, 1t is also not a violation to use
a substance with an EUP 1n a manner contrary to the provisions
of the permit, 1f the use 1s In tests which meet the conditions
at 40 CFR Parts 172.3(a), 172.3(a)(1), 172.3(a)(2) and 172.3(a)(3)
as set forth above.
See A1sot
FIFRA Compliance Program Policy No. 2.2 - Use Recommendations
Key Words:
Experimental Use Permit (EUP), 2(ee), Use Recommendations.
E. Conroy II, Director
Pesticides and Toxla Substances
Enforcement Division
W I 0 BR?
Date
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FIFRA Compliance Program Policy No. 12.2
Pesticides Closed Transfer, Mixinq/Loadinq and
Application Equipment (Closed Systems)
FIFRA Section:
12(a)(2) ^ 5")
Issue:
Will the Environmental Protection Agency take an enforce-
ment action under FIFRA Section 12(a)(2)(G) against the operator
who uses a closed system to mix, load, transfer or apply pesticides
without wearing the personal protective equipment required by
the pesticide product label?
Policy:*
The Agency will not take an enforcement action under FIFRA
Section 12(a)(2)(G) against the operator of a closed system who
does not wear the personal protective equipment required by the
pesticide product label, provided the conditions outlined In
this policy are met.
D i scussi on:
The FIFRA Compliance Program Policy No. 12.2 Issued May 10,
1982 said the Agency would take enforcement action under Section
12(a)(2)(G) against the operator for not wearing personal protec-
tive equipment required by the label if a closed system was used
in transferring, mixing, loading or applying pesticides.
The California Department of Food and Agriculture and the
Arizona Board of Pesticide Control petitioned the Agency to
reconsider the May 10 policy. They stated that the pesticide
label directs safety requirements at the most hazardous pesticide
use situations without considering less hazardous situations.
Further, the May 1982 policy may actually hinder the development
of new equipment designed to safely handle pesticides.
The Agency's position 1s that wearing the personal protective
equipment required by the pesticide label provides the greatest
level of user protection. However, the Agency recognizes that
technological and engineering advancements have made significant
contributions 1n the field of pesticide use safety. One such
advancement is the development of closed systems.
•This policy replaces FIFRA Compliance Program Policy
No. 12.2 issued May 10, 1982.
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-2-
For purposes of this policy, a closed system is hardware
designed to empty arid rinse pesticide containers, mix or dilute
the pesticide, and transfer the pesticide, its diluents, and
the container rinsing agent to the application equipment without
permitting the pesticide to escape.
Preliminary field experiences indicate that the incidents
of pesticide exposure to persons operating a closed system gen-
erally arise due to one of the following conditions:
o Pesticide leaks at seals, gaskets, hoses, or seams caused
by worn or poor quality parts, or by parts eroded when the
chemicals are allowed to stand in the container.
o Pesticide leaks at the couplings caused by high internal
pressures or incomplete coupling due to non-matching parts
or operator carelessness.
o Improper use of equipment due to disregard for proper
mixing/loading procedures or lack of training.
There are, however, many documented instances when a closed
system has been used without resulting in an exposure from its
use. Therefore, the Agency will amend its May 10, 1982, policy
and will not take an enforcement action if the operator can show
the fol1owi ng:
o Records are available for the current operating year which
show that a cleaning schedule and maintenance program (which
includes flushing the system so that pesticides are not
allowed to stand in the system for more than one work day)
has been developed and is administered.
o Records are available which indicate that the operator has
received training (when, by whom) in operating procedures as
prescribed by the closed system manufacturer and has been
informed of the potential hazards of closed system misuse
or improper maintenance before using.
o Written instructions for operating the system are posted on
or near the closed system.
o All personal protective equipment required by the label is
available for the operator at all times during mixing and
loading or transfer operations.
Notwithstanding the requirements of this policy, if all of
the personal protective equipment required by the label is not
worn while using a closed system and a pesticide exposure occurs,
the Agency may take an enforcement action under FIFRA Section
12(a)(2)(G) against the operator of the closed system.
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-3-
See Also:
FIFRA Compliance Program Policy No. 12.2 "Closed Application
System" Issued May 10, 1982.
The Pesticide Misuse Review Committee (PMRC) Advisory Opinion
Nos. 14, 18, 125, 205, 293, and 315.
October 12, 1982 letter from Ms. Lor1 Johnston, Assistant
Director, Peist Management, Environmental Protection and Worker
Safety, Department of Food and Agriculture, State of California
to Mr. Edwin Johnson, Director, Office of Pesticide Programs,
EPA.
July 1, 1982 letter from Mr. R. W. Sweet, Administrator,
Board of Pesticide Control, State of Arizona to Mr. Phillip C.
MartinelH, Director, Division of Plant Industry, Nevada Depart-
ment of Agriculture, State of Nevada.
References:
"Closed System Update" by R.W. Brazelton, N.B. Akesson, and
K.T. Maddy, January 1980.
Key Words:
Closed System, Personal Protective Equipment.
tor
i _ taff
Office of Pesticides and Toxic Substances
15 DEC 1983
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FIFRA COMPLIANCE PROGRAM POLICY No. 12.2
Closed Application Systems
FIFRA Section: 12
Issue;
Should EPA take enforcement action 1f protective equipment
required by the pesticide label 1s not worn by workers when
mixing and loading pesticides into closed application systems?
EPA will take enforcement action under Section 12(a)(2)(G)
for failure to wear protective equipment required by the label.
Pi scussion:
The term "closed application system" means a device or
combination of devices designed to empty and rinse pesticide con-
tainers, to mix and/or dilute the pesticide and to transfer the
pesticide to application equipment or a holding vessel without
permitting pesticides to escape into the surrounding environment.
Generally, any use of a registered pesticide inconsistent
with the product's label 1s a violation of FIFRA Sect 1 on 12(a)(2)(G).
In the case of a closed mixing system with an automatic ^container
opening feature, failure to wear protective clothing required by
the product label would be a violation of this section. It is
particularly Important to wear protective clothing when using
closed systems because these systems are usually used in conjunction
with especially hazardous pesticides.
Reference;
Pesticide Misuse Review Committee Advisory Opinion # 315
Key Word Heading:
Closed Application System, Misuse
Pol 1cy:
A. E. Conroy Iy% D/rector
Pesticides an
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FIFRA COMPLIANCE PROGRAM POLICY No. 12.3
Authority for Use Inspections
FIFRA Section: 12(a)(2)(G), 9.(b)
Issue:
May EPA conduct routine "use inspections" where pesticides
are not held for distribution or sale?
Poli cy:
EPA may conduct use inspections to enforce Section 12(a)(2)(G)
of FIFRA with the consent of the owner or person in charge of the
premi ses.
Discussion:
FIFRA Section 9(a) provides authority for EPA to inspect
establishments .or other places where pesticides are held for
distribution or sale. Upon a showing that the re'is reason to
believe that the provisions of FIFRA have been violated, EPA
inspectors may obtain warrants to inspect such establishments
pursuant to section 9(b).
Notwithstanding the limitation of Section 9, EPA has developed
a program of pesticide use surveillance to enforce Section
12(a)(2)(G) of FIFRA. This Section makes it unlawful to use a
pesticide in a manner inconsistent with its labeling. To enforce
this subsection and to prevent pesticide misuse, EPA may routinely
undertake "use inspections", as part of a neutral administrative
inspection scheme. However, inspectors must obtain the consent of
the owner or person in charge of the premises to be inspected.
Well established Fourth Amendment principles require that the
consent be knowing and voluntary.
Within the framework outlined above, EPA inspectors may also
obtain samples of pesticides or devices, and samples of any con-
tainers or labeling for such pesticides or devices, if necessary
for the use Inspection. Any such samples must be obtained in
accordance with the receipt procedure described in Section 9(a).
-------
2 - 12.3
Reference:
Letter from William L. Hazeltine to Congressman Harold T.
Johnson dated August 12, 1975.
Key Word Headings:
Inspections, Misuse, Use Inspections.
A. E. Conroy II,v01 rector
Pesticides and T<{x1pr Subs
Enforcement DlvrS'ion
Substances
may i o brp
Date
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iSSS
S UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
¦>
<<¦
<£ WASHINGTON, D.C. 20460
JUL 22 B86
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT:
FROM:
TO:
FIFRA Compliance Program Policy
"Making RUP's Available for Use
in Accordance With Section 3(d)
A. E. Conroy II, Director
Office of Compliance Monitoring
Addressees
No. 12.4
Other Than
of FIFRA"
Attached is FIFRA Compliance Program Policy No. 12.4
entitled "Making RUP's Available For Use Other Than In
Accordance with Section 3(d) of FIFRA". This policy is
effective immediately.
Please note that this revised Compendium Policy No. 12.4
will replace the policy of the same number issued on May 18„-
JjjR3 T Additionally, this policy is being issued as an interim
final policy, which will -be rescirided-after the Agency pro —
mulgates regulations-pertaining to the - sale-of^RUP ' s to persons
who are not ce rt i fi ed -appl i cato rs itr Stat es wi t h Federally-
approved certification and training programs.
We appreciate the comments offered on-the April 9, 1986
draft of Compendium Policy No. 12.4 and "have incorporated
many of these comments. Attached is the Office of Compliance
Monitoring's response to-these comments.
If you have any questions- concerning this policy, pi ease
contact Dan Helfgott of my staff at FTS 382-7847.
Atta chment s
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ADDRESSESS
Doug Campt (TS-766C)
Terrell Hunt (LE-134A)
Stanley Abramson (LE-132A)
John Seitz (EN-342)
Ken Shiroishl "
Phyllis Flaherty "
John Martin "
John J. Neylan III "
Ralph Turpin u
Mike Wood u
Dexter Goldman u
OCM Staff
Jake Mackenzie
Western Regional Compliance Director
A. Charles Li ncoln
Eastern Regional Compliance Director
I Louis F. Gitto, Director
Air Management Division
II Barbara Met.zger, Director
Environmental Services Div.
III Stephen R. Wassersug, Director
Hazardous Waste Management Div.
IV Winston A. Smith, Director
Air, Pest. &-Toxic Mgmt Div.
V William H. Sanders III, Director
Environmental Services Div.
VI William B. Hathaway, Director
Air, Pesticides & Toxics Div.
VII William A. Sprat-Mn-,-Director
Air & Toxics Division
VIII Irwin L. Dickstein, Director
Air & Toxic Subs. Division
IX Harry Seraydarian, Director
Toxics & Waste .Management Div.
X Gary O'Neal, Director
Ai r & Toxi c Di vi s i on
Gerald M. Levy, Chief
Office of Pesticides & Toxic Sub.
Ernest Regna, Chief
Pesticides & Toxics Sub. Branch
Larry Miller, Chief
Toxic & Pesticides Branch
H. K1rk Lucius, Chief
Pesticides & Toxie Subs, Branch
Phyllis Reed, Chief
Pesticides & Toxic Subs. Branch
Norman E. Dyer, Chief
Pesticides & Toxics Subs. Branch
Leo. Al derm an , Chief
Toxics & Pesticides Branch
-Alvin Yorke, Chief
Toxic Substances Branch
Laura Yoshi1 , Chief
Pesticides & Toxic Branch
Anita Frankel , Chief
Pesticides & Toxic Subs. Branch
cc:
Sue Vogt
Jim Lamb
Deeohn Ferris
(TS-788)
(TS-788)
(LE-134P)
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F1FRA COMPLIANCE PROGRAM POLICY No. 12.4
Making RllP's Available For Use Other Than in Accordance
With Section 3(d) of FIFRA
Section: FIFRA §12(a)(2)(F )
FIFRA §3(d)
Issue:
In States with EPA approved State certification and training
programs, when will EPA take enforcement action against pesticide
dealers who make restricted use pesticides (RUP) available to
persons who are not certified applicators?
Poli cy:*
If a pesticide dealer cannot document that a restricted use
pesticide made available to a person who is not a certified
applicator is to be applied by a certified applicator, or under
the direct supervision of a certified applicator, then EPA may
take enforcement action for the FIFRA 512(a)(2)(F) violation unless
the State takes appropriate enforcement action under its law.
Pi scussi on:
Generally, a violation involving the sale of an RUP to a
person who is not a certified applicator is a violation of
State law, and the State would take enforcement action.. Under
current policy, States wishing to make RUP's available to
persons other than certified applicators may only do so if
they submit to the Administrator an amendment to their State
Plan under FIFRA §4 containing the minimum standards as outlined
at 40 CFR Part 171.11(g)(2)(i i ). If a State does not have an
EPA approved plan which allows the sale of an RUP to a person who
is not a certified applicator, and enforcement action is not
taken by the State under its law, EPA may take enforcement
action under FIFRA §12 ( a) ( 2) ( F ).
Section 12(a)(2)(F) of FIFRA states:
It shall be unlawful for any person to make available
for use, or to use, any registered pesticide classified
for restricted use for some or all purposes other than
in accordance with section 3(d) and any regulations
thereunder; Provi ded , That -i t—sh al l - not be unlawful
to sell, under regulations issued by the Administrator,
a restricted use pesticide to a person who is not a
certified applicator for • a-p-pl-i cation^-by a certified-
applicator.
FIFRA Compliance Program Policy; No. 12.4 issued May 18, 1983-
was superseded by the FIFRA §4 regulations found at 40 CFR
171.11. These regulations apply-only to States with federally
operated certification and training programs. This new policy
12.4 is applicable to all other States.
-------
EPA is planning to issue regulations covering the sale of
RUP's to persons who are not certified applicators in States
where the Administrator does not conduct the pesticide applicator
certification and training'program However, in light of the
Administrative Law Judge decision on Tierra Verde Company, Inc.,
and until regulations affecting all States have been published,
the following policy will apply when federal action is appropriate
in States with federally approved State certification and training
programs:
1) If a dealer sells an RUP to a person who is not a
certified applicator, and that dealer can adequately
document^ that the RUP was to be used by, or under
the direct supervision of a certified applicator, then
the Agency will take no action against the dealer for
a violation of FIFRA §12(a)(2 ) (F).
2) If a dealer sells an RUP to a person who is not a certi-
fied applicator without documentation to prove the RUP
was to be used by a certified applicator, and the dealer
can prove the RUP was actually applied by a certified
applicator, or under the direct supervision of a certified
applicator, then this would be considered a minor viola-
tion. Under FIFRA section 9(c)(3) the EPA will issue
a notice of warning to the dealer.
3) Anytime a dealer sells an RUP to a person who is not a
certified applicator, and the dealer cannot prove that
the pesticide was used by a certified applicator, or
under a certified applicator's direct supervision, the
EPA will issue a civil complaint. The penalty will be
assessed in accordance with section 3 of the FIFRA
Enforcement Policy - Interim Penalty Guidelines, dated
June 11,-4981 from A. E. Conroy. I-I , Di nectzor, Pe^ti^ides
and Toxic Substances Enforcement Division, to Regional
Enforcement Division Directors and Pesticide Branch Chiefs.4
2 The EPA has already promulgated regul ati ons ,al 1 owi ng the
sale of RUP's to uncertified applicators in States where the
Administrator conducts.the pesticide applicator certification
program (see 40 CFR 171 ;11). Other States may presently allow
the sale of RUP's to a person who is not a certified applicator
if they have a plan approved by the Administrator containing
the minimum standards listed in 40 CFR 171.11.
3 Adequate documentation consists of all the information 1isted
at 40 CFR 171 .11(g ) (2)(i i).
4 The EPA may t-ake enforcement actiomfor _a_ violation of FIFRA
§12(a)(2)(F) against any^ un cert i-f i ed .appl i cato r that- uses an
RUP and is not under the supervision of a certified applicator.
EPA enforcement action will be in accordance with FIFRA §§26 and
27. The penalty will be assessed in accordance with the FIFRA
Enforcement Policy - Interim Penalty Guidelines, dated June
11, 1981. The June 11, 1981 Interim Penalty Guidelines are
found in the FIFRA Compliance/Enforcement Guidance Manual.
-------
See Also:
"FIFRA Enforcement Policy - Interim Penalty Guidelines",
June 11, 1981, from A. E. Conroy, Director, Pesticides and
Toxic Substances Enforcement Division to Regional Enforcement
Division Directors and Pesticide Branch Chiefs, FIFRA Compliance/
Enforcement Guidance Manual.
Reference:
FIFRA Compliance Program Policy No. 12.4, "Making Restricted
Use Pesticides Available to Persons Without Pesticide Appiicator
Certification, dated May 18, 1983.
Administrative Law Judge decision on Tierra Verde Company,
Inc-December 2, 1985, Docket No. FIFRA-09-0422-C-85-1.
40 CFR 171.11
Key Words:
Certified Applicator, Dealer, Make Available F-or Use,
Restricted Use Pesticides, RUP.
Of
Office
IV Di rector
/
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The following are OCM's response to the comments made on the
April 9, 1986 draft policy.
Comment 1
On page 1 in the Poli cy section, a commenter recommended that
we add the phrase "or under the direct supervision of a certified
applicator" after "applied by a certified applicator".*
Response
We have incorporated this comment into the policy.
Comment 2
On page 1 in the Poli cy section, a commenter recommended
that we delete the phra se "or unless the State has amended its
FIFRA §4 State Plan to allow the sale of an RUP to an uncertified
persons".
Response
This comment was incorporated into the policy.
Comment 3
A commenter asked that the -last— senteflce—of footnote 1 on
page 1 read as "This new policy 1.2:. 4. is appl i cabl e to a 11 other
States."
Response
This comment has been incorporated into the policy.
Comment 4
One commenter- recommended the term" "person who is not
a certified applicator" replace the term "uncertified applicator".
Response
This comment has been incorporated into the policy.
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-2-
Comment 5
A commenter recommended that the last sentence of footnote
2 read as follows: "Other States may presently allow the sale of
RUP's to a person who is not a certified applicator if they have a
plan approved by the Administrator containing the minimum standards
li sted at 40 CFR 171.11
Res ponse
This comment has been incorporated into the policy.
Comment 6
One commenter would like the definition of adequate documentation
to stipulate that "at least one of the items identified at 40 CFR
171.11 (g ) (2 ) (ii)(2) or (3) or their equivalent must be on file
for each transaction."
Response
OCM feels that all the items listed at 40 CFR 171.11(g)(2)
(i i) ( 2) are necessary to provide adequate documentation. Therefore,
footnote 3. now reads: "Adequate documentation consists of all
the information listed at 40 CFR 171.11(g)(2)(ii ) .
Comment 7
One commenter believed that enforcement response #2 on page—2
placed undue burden on the inspector by requiring return visits
to the dealer to confirm the RUP was applied by a certified
ap pii cator .
Response
Please note that t-he EPA shoul d proceed-wi th any-enforcement
action based on the facts available at the time of the inspection.
The inspector does not need to confirm that the RUP was applied by
a certified applicator.
In the absence of regulations the sale of an RUP to an
uncertified person is a violation. The level of action the EPA
will take depends on ^hat the dealer-can-or cannot verify in
accordance with-the policy. If the dealer can verify use by /a
certified applicator to the Region's satisfaction at anytime
prior to the—settlement of the case, the Regions should withdraw
the civil complaint and issue a Notice of Warning.
-------
Comment 8
Along these same lines, another commenter believed that
requiring the dealer to prove the RUP was applied by a certified
applicator puts the dealer in an investigative role which should
be the role of the EPA and the State.
Response
In the absence of an EPA approved amendment to their State
Plan which allows for the sale of RUPs to uncertified persons,
it is a violation for the dealer to sell an RUP to a person who
is not a certified applicator. The dealer can avoid action by
keeping the records outlined by this policy. Additionally, this
policy in no way alters the investigative role of the States or
the EPA.
Comment 9
A commenter questioned the right of the EPA to allow the sale
of RUP's to uncertified persons other than in accordance with
40 CFR 171.11(g ) (2 ) (ii ) recordkeeping requirements.
Response
The- regulation found at 40 CFR 171.11(g ) (2) (ii ) does not
affect any States other than Colorado and Nebraska. The preamble
of 40 CFR 171.11, does specify conditions in which other States
may allow the sale of RUP's to uncertified persons, however,
this preamble is merely a statement of Agency policy. FIFRA
Compendium Policy No. 12.4 has the same—status—as the preamble
to 40 CFR 171.11 "and 1V appl i cabl e to all other States. EPA
recognizes the need for regulations and is pursuing this route.
Comment 10
One commenter did not think that the enforcement response in
#2 on p-age 2 shouJd be a Notice of Warning.
Response
0CM feels that it is essential that policy decisions be made
looking at all facts including final decisions on cases. We feel
issuing a civil complaint rather than a Notice-of-Warning in circum-
stance number 2 on page two of the policy would be contrary to the
recent Tierra--Verde decision. Further, thereTare currently ,no
federal regii.la.ti ons requiring deal ers^-to -keep—records-except in
Colorado ana-Nebraska-; Therefore, failure to keep records required
by this policy is not a vi o4a-ti on-o-f-FIFRA, and a civil penalty
would be inappropriate.
Please note that this enforcement response will only be
applicable until promulgation of.the pertinent regulations.
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-4-
Comment 11
One commenter would like to see a time limit placed on the
dealer to prove the RUP was applied by a certified applicator.
Response
As stated earlier, the EPA should proceed with any enforcement
action based on the facts available at the time of the inspection.
If the dealer can verify use by a certified applicator to the
Region's satisfaction at anytime prior to the settlement of the
case, the Regions should withdraw the civil complaint and issue a
Notice of Warning.
Comment 12
One commenter thought that we should only issue a Notice of
Warning the first time a dealer made an RUP available to an
uncertified person and cannot adequately document that the RUP
was used by a certified applicator. That commenter "recommended
that the policy provide for a civil complaint for subsequent viola-
tions.
Response
See response to Comment 10.
Comment 13
A commenter thought that we should add an enforcement response
for instances when some of the information as required by 40 CFR
171.11(g ) (2)(ii ) was omitted from the deaier records.
Response
OCM feels that the important consideration is whether the Region
believes the product was applied by a certified applicator. See
response to Comment 10.
Comment 14
A commenter thought that the policy should define the terms
"ma ke a va i 1 abl e. for - use"" uncertifiedappli cator" , and " pest i c-i
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-5-
Comment 15
A commenter wanted the policy to refer to enforcement action as
"appropriate enforcement action". That commenter wanted a footnote
included which states "appropriate enforcement action will be
negotiated by the EPA Regional offices and the States and will be
included in the cooperative enforcement agreements, grant work
programs or State/EPA agreements (SEA)."
Response
This policy in no way affects or dictates State enforcement
action. In fact, the policy indicates that the Regions are to
defer to the States in most cases. To better reflect this, the
following sentence has been added to Footnote number 4: "EPA
enforcement action will be in accordance with FIFRA §§26 and 27."
Comment 16
A commenter suggested adding the following sentence to the
end of footnote 5: "Any enforcement action taken for use of a
pesticide.ineonsistent-with the labeling will be conducted in
accordance with the FIFRA section 26 and 27 Interpretive Rule
published in the Federal Register on January 5, 1983."
Response
This policy does not alter State .or-Federal enforcement
responsibilities or relationships. To clarify this, the following
sentence has bee-n. added to footnote number. 4: "EPA enforcement
action will be in accordance with FIFRA §§26 and 27."
Comment 17
One commenter felt_the policy does, not offer guidance on.how
to apply the penalty matrix with respect to action against-dealers
in Colorad.o and Nebraska.
Response
CO and NE are already covered by regulations and the 1981
Interim Penalty Guide1iries-for the sale of RUP's to-uncertified-
applicators-.- -We-recognize- that..-some. gaps- do> exist in the 1981
Interim Penalty Guideline which we plan to address in the future.
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-6-
Comment 18
A commenter wanted enforcement responses numbered (1), (2),
(3), and (5) of the May 20, 1983 policy included in the revised
poli cy.
Response
The circumstances outlined in enforcement response (1) of the
1983 policy have been addressed in the revised 1986 policy. However,
the 1986 revised policy did not address the circumstances outlined
in (2), (3), and (5) of the 1983 policy because we felt these
distinctions were unnecessary for purposes of this policy.
Comment 19
One commenter felt that if no records are kept in accordance
with 40 CFR 171.11, then a civil complaint should be issued.
Additionally, if after the fact the dealer can show the RUP was
applied by a certified applicator, then the civil penalty should
be reduced and not eliminated.
Response
OCM .feels that it is essential that policy decisions be made
looking at all facts including final decisions on cases. We feel
issuing a civil complaint rather than a Notice of Warning in circum
stance number 2 on page two of the policy would be contrary to the
recent Tierra Verde decision. Further, there are currently no
federal regulations requiring dealers to keep records except in
Col orado and Nebraslca. Therefore, failure to keep records required
by this policy is not a violation of FIFRA, and a civil penalty
would be inappropriate.
Comment 20
One commenter did not want the policy ._applyi.ng only to States
with Federally approved -cert-i fication and-tTaining programs.
Response
See response to comment 17.
Comment 21
There were a- number of-edi torial changes.
Response
We have incorporated these editorial changes where appropriate.
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 17 INDEX PAGE
TITLE NUMBEK
Pesticide Processing 1n Foreign-Trade Zones 17.1
Waiver of Notice of Arr1vair Requlrements 17.2
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FIFRA COMPLIANCE PROGRAM POLICY - No. 17.1
Pesticide Processing in Forelgn-Trade Zones
FIFRA Section: 17(c)
Issue:
Are pesticides which enter a foreign trade zone for further
processing or repackaging, subject .to tire, requirements of J-.LFJIA.?
Po11cy:
A product which legally enters a forelgn-trade zone for
processing or repackaging is not subject to the requirements of
FIFrtA.
Discussion:
Foreign-trade zones or "freeports" are areas within the United
States where products may be stored, processed, manipulated, manu-
factured and reshipped without being subject to the customs laws of
the United States governing the entry of goods and the payment of
du ty.
Foreign-trade zones are established under the Foreign-Trade
Zones Act and the general regulations and rules of procedure of
the Foreign-Trade Zones Board contained 1n 15 CFR Part 400. The
regulations contained in 19 CFR Part 146 govern adm1ss-1on of
merchandise Into a foreign-trade zone; manipulation, manufactur-
ing, processing, etc. 1n a zone; exportation of merchandise from
a zone; and transfer of merchandise from a zone Into United States
Customs territory.
In order to be considered exempt from the requirements of
Customs and FIFRA, a pest1c1.de product must be in full compliance
with the laws regarding entry Into the foreign-trade zone; be
processed within the zone; and be reshipped to foreign points.
Any product which enters the United States from a foreign-trade
zone is subject to Customs laws and the requirements of FIFRA.
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2 - 17.1
The only products legally entering a foreign-trade zone which
are subject to the requirements of FIFRA are those which were
produced in the United States or which entered Into the United
States and subsequently enter the foreign trade zone under the
custody of United States Customs for processing or repackaging.
References:
19 CFR Part 146
Key Words:
Foreign Trade Zones, Freeports, Processing, Registration,
Repackaging.
A. £. Conroy II, 01rafc-tor
Pesticides and Tcrxi c/Substances
Enforcement Divs-s^on
Date
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FIFRA COMPLIANCE PROGRAM POLICY NO. 17.2
Waiver of Notice of Arrival Requirements
FIFRA Section: 17(c), 17(e)
Issue:
Can Importers of multi-use chemicals and .pesticides Imported
for non-pest1c1dal purposes obtain a waiver from "Notice of
Arrival" requirements?
Pol1cy:
Importers of multi-use chemicals and pesticides Imported for
non-pest1c1dal purposes can be granted a waiver from "Notice of
Arrival" requirements.
Discussion:
Pesticides and devices Imported Into the United States must
be 1n compliance with Section 17(c) of FIFRA. Section 17(c)
states that pesticides or -devices which are adulterated, mis-
branded or otherwise v1 ol ate *the provi s 1 ons s.et forth In the
Act or are Injurious to health or the environment may be refused
entry into the country. The Secretary of the Treasury is
empowered by Section 17(e) of FIFRA to prescribe regulations for
the enforcement of Section 17(c). 19 CFR Part 12.110 through
12.117 regulates the Importation of pesticides and devices Into
the U.S. The regulations state Yn part that pesticides and
pesticide products Imported into the U.S. wi11 not be released
by U.S. Customs unless accompanied by a completed Notice of
Arrival of Pesticides and Devices form (EPA Form 3540-1). To
assist 1n monitoring compliance with this requirement, EPA
developed a checklist of frequently encountered pesticides and
distributed it to U.S. Customs commodity Import specialists.
Some of the pesticide chemicals which appear on the list
may be multi-use chemicals Imported for non-pest1c1dal uses or
pesticides Imported for chemical analysis or other testing. As
a matter of policy, the Agency will allow persons importing
products for such purposes to request a waiver from the Notice
of Arrival requirements. Such requests must be made 1n writing
to EPA Headquarters and must state (1) the chemical being
Imported together with its EPA registration number, 1f regis-
tered; (2) the purpose for which the product is being imported;
(3) the amount of chemical being imported; and (4) if known, the
port of entry (If there 1s more than one, all ports of entry
should be listed).
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2 - 17.2
If EPA Headquarters approves the request, a copy of the
request and the waiver granted will be sent to each affected
Region.
To expedite future shipments, the Regions should encourage
importers to file a copy of the waiver with Customs for each
subsequent entry of the product.
References:
FIFRA Compliance Program Policy No. 2.4, Multi-Use Chemicals,
19 CFR Part 12.110 through 12.117.
Key Words:
Imports, Multi-Use Products, Notice of Arrival.
A. E. Conroy ly, Director
Pesticides andjToxi
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 24 INDEX PAGE
TITLE NUMBER
Special Local Needs Labeling 24.1
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FIFRA COMPLIANCE PROGRAM POLICY No. 24.1
Special Local Needs Labeling
FIFRA Section: 24(c)
Issue:
Will the Agency permit a registrant to print or affix Section
24(c) (Special Local Need) labeling on Federal labeling?
Pollcy:
The Agency will permit Section 24(c) labeling to appear on
Federal labeling under certain conditions.
01scussi on:
Sectio.n 24(c) of FIFRA states that a State may register addi-
tional uses of federally registered pesticides for distribution and
use within that State to meet special local needs provided that
no such use has been previously denied, disapproved or cancelled
by EPA. The Agency has 90 days to review such a registration. If
the Agency does not deny a use within this time period, the use is
considered to be registered under Section 3 for distribution and
use only within that State. If the use is for a food or feed
crop, a tolerance or exemption must exist for that use. 40 CFR
Part 16 2.150-162.156 sets forth the regulations governing tne
registration of products under Section 24(c).
Part 162.153(e) requires that labeling governing any State-
registered uses of a Federally registered product be made available
at the time of use. As a matter of convenience for both the regis-
trant and the user, Section 24(c) use directions may appear on a
Federal label provided the directions are clearly Identified and
separate from Federal labeling. Either a distinct border around
the Section 24(c) uses or a sticker which does not obscure the
Information on the Federal label is an acceptable means of con-
veying Section 24(c) information. The labeling must also clearly
identify the State in which the Section 24(c) use is allowed. If
a specific identical use has been registered in a number of States,
the registrant may list all the States which have registered the
use. The registrant must use the statement "For distribution and
use only within (name of State(s)" on all Section 24(c) labeling.
A product bearing Section 24(c) uses on the label may only be sold
1n those States listed.
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2 - 24.1
This policy applies only to additional State registered uses
of a Federally registered product. It does not not apply to
State registered products.
See Also:
Section 24(c) Re-grstration Guidelines 40 CFR Part 16 2. 1 50-1 62.1
References:
Letter of June 23, 1977 from A. E. Conroy II to Mr. Arthur F.
Gohlke, Cities Service Company.
Key Words:
Intrastate Use, Labeling, Special Local Need, 24(c).
A. E. Conroy I I^/tJTrVctor
Pesticides and Toxii/ Substances
Enforcement Dpviyion
MAY I 0 13P
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 25 INDEX PAGE
THLE NUMBER
Child Resistant Packaging 25.1
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FI FRASect i c n : 2*5 ( c ) ( 3 )
Issue:
Are small packages ©4^pesticide products which are labeled
"For Agricultural use Only" or which have directions expressed
in number of pounds per acre but which are marketed for homeowner
use automatically excluded^from the Child Resistant Packaging
(CRP) requ i rercent?
Poli cy:
Labeling a pesticide "For Agricultural Use Only" or expressin
the dosage rate in pounds per acre, label language usually reserve
for "agricultural" products, does not automatically remove the
pesticide from the Child Resistant Packaging recuire~erts.
Discussion:
The Child Resistant Packaging Regulation, 40 CFR 162.13.
requires a pesticide to be in such sackagi ng if it meats certain
criteria. One c r i t s r i o n is that th a product is intended for use
in, on or a round all structures, vehicles or areas associated wit:
the household or home life.
Labeling a—product "For Agricultural Use Only" removes a
product from the CRP recuirement only if the label statement is
consistent wi tft other label language and na r'< a t.i n g practices fc r
agricultural use. If, for example, the product is marketed in
home or garden stores, or the entire net contents, if arp'iei at
the labeled dosage rate, would only cover a limited ;ria such as
a ho^.e garden, or other label language implies residential use-,
the product would require CRP if the other CR? criteria apply.
Expressing the use directions in terns of number of pounds
per acre does net in or by itself preclude residential use. This
also wo-;* d net affect whether cr not a product requires OS?.
Therefore, where the package site is s~.a"i 1 , the product is
marketed in home and garden stores, cr the entire net contents,
if applied at the labeled dosage rate, would only cover a limited
area, such as a ftc:r.e garden plot, CRP v.-oulc b; re¦;ui re-j if t:*.e
CRP criteria are met regardless of whether the label also states
""cr Atri cu'i tural Use Cr.'.y" or the d-sagi rate is expressed in
agricultural terms, such as pounds per acre.
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-2-
A d u i ^ i o n a i 1 y . a croduct ~ a y be .r; i s b r a n d e d . tccoro tz a
;he p ro o o 5 c d Registration G uid e1i n e s for Labeling, if the
dosage rate exceeds the net contents of the product.
References:
40 CFR Part 162.16
Memorandum to R o v P. Cl'ark, Region IV. from A. E. Conrov II,
dated July 27, 1982.
Key Words:
Agricultural Use Only
C h i 1 d R e s i s t a r. t ? a c '< = g i n g
Labeling ^
A . !v E . ' S-6:T"oy II. Director
Pesticides and Toxic Substances
Enforcement Division
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 26 INDEX PAGE
TITLE NUMBER
Transfer of Use Enforcement Primacy to the States 26.1
Referral of State Misuse Cases to EPA 26.2
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FIFRA COMPLIANCE PROGRAM POLICY No. 26.1
Transfer of Use Enforcement Primacy to the Staties
FIFRA Section: 26
Issue:
At what point does primary enforcement responsibility
for pesticide use violations (primacy) transfer from EPA to
a State?
Pol1cy:
Primacy authority 1s transferred to a State when the State
formally accepts a written offer by the Administrator to convey
such authority. Primacy is also transferred when a cooperative
enforcement agreement is signed by the Administrator and the
State, unless the terms of the agreement specify otherwise.
Pi scuss i on:
Section 26 of FIFRA authorizes the Admln1strator to grant
primacy to a State if the State has adopted adequate laws and
adequate procedures for Implementing such laws, or If'the State
has an approved certification plan that meets the adequate laws
and procedures criteria. In addition, States may obtain primacy
by entering Into a cooperative agreement for the enforcement of
pesticide use restrictions under Section 23 of FIFRA.
To'transfer primacy through the first two mechanisms, the
Administrator will write to the Governor offering to grant
primacy to the State. The Administrator's letter will request
a formal response to the offer of primacy. The transfer of
primary use enforcement responsibility will not be effective
until the Governor or his representative posts a written response
accepting primacy. With respect to the third mechanism, when
a State signs a cooperative agreement which calls for the State
to monitor and enforce compliance with pesticide use restrictions,
such State assumes use enforcement primacy unless the terms of
the agreement specify otherwise. Thus the signing of an agree-
ment which specifically states that the assumption by a State of
primacy depends upon the occurrence of an event does not transfer
primacy authority until the event takes place. Cooperative
enforcement agreements which do not contain such conditions
will serve to convey primacy to a State upon signature of the
Governor and the Administrator or their duly designated
Representatives.
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2 - 26.1
Key Words:
Certification Plan, Cooperative Enforcement Agreement,
Primacy, State Authority, Use Enforcement.
A . E. Co'nroy 11,. 01 r
Pesticides and Tox1
Enforcement D1v
bstances
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FIFRA COMPLIANCE PROGRAM POLICY No. 26.2
Referral of State Misuse Cases to EPA
FIFRA Section: 26
Issue:
Is it legally permissible for the Environmental Protection
Agency to prosecute Federal pesticide misuse violations which
are based on evidence collected by State inspectors following
State procedures?
Pol icy:
As long as States follow basic Constitutional evidentiary
procedures, evidence collected under State authority can be used
to prosecute violations of Federal pesticides laws.
Pi scussi on:
Pursuant to Section 26 of FIFRA, most States now exercise
primary enforcement res pons 1bi1ity for pesticide misuse violations.
Although the Federal government retains concurrent authority
with the States to prosecute misuse violations, this power is
not .ordinarily exercised.
Accordingly, States with primacy generally conduct use
inspections under the authority of State law. In the usual
pesticide misuse case, State law provides ample enforcement
authority for the State to effectively prosecute misuse violations.
Consequently, the States need not generally refer misuse cases
to the EPA for prosecution under the parallel Federal authorities.
However, there are two instances where the States may choose
to refer misuse cases to EPA for Federal prosecution:
1) When the misuse is prohibited by Federal law, but not by State
1 aw, or,
2) When both State and Federal law prohibit the misuse, but
the State lacks adequate resources to pursue prosecution.
When either of these types of misuse cases is referred
to EPA for action, the Agency will review the case file
to ensure that the State inspection procedures adhere to basic
Constitutional guarantees. Information collected by State
Inspectors is not excluded in court merely because it is
gathered by State Inspectors; instead 1t 1s subject to the
common law rules of evidence or to the Federal Rules of
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2 - 26.2
Evidence. The issue of the admissibility of evidence derived
from State inspections Involves the analysis of two questions:
(1) was the Information and evidence obtained by State inspec-
tors legally obtained, and (2) 1s that evidence within the scope
of admissible evidence. If both of these questions can be
affirmatively answered for any given information, then that
evidence may be properly Introduced into a civil or criminal
proceeding to enforce a violation of the FIFRA.
Accordingly, the wide variety of State Inspection procedures
do not affect the capacity of the Agency to accept a misuse case
for prosecution. States may follow their own inspection procedures
without regard to whether or not the misuse case will be referred
to the Agency. The eventual referral of the case to the Agency
for prosecution does not require a State Inspector to change any
existing State Inspection procedures.
Key Words:
Evidence, Misuse, Prir.acy, State Authority.
A\ E. Conroy II, Dineytbr
Pesticides and Tox/c/Substances
Enforcement Division
I 0' fS82
Date
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KEY WORD INDEX
FCPP = FIFRA Compliance Program
PCN = Office of Pesticide Prog
A
Advertlsi ng
Aerial Application
Agricultural Use Only
Aircraft, Airplane
Aluminum Phosphide Products
Amended Registration
and CIassi ficati on
B
Batch Parameters
Poli cy
ams Policy and Criteria Notices
2162.1 PCN, 2162.3 PCN
2190.1 PCN
25.1 FCPP
2190.1 PCN
3.3 FCPP
2460.2 PCN
2476.1 PCN
Certified Applicator
Certification Plan
Changed Use Patterns
Child Resistant Packaging
Chiorof1uorocarbons
CIassi fi cat i on
Classification of Disinfectant-
Type Products
Classification Statement
Clean Air Act
Clean Water Act
Closed System
12.4 FCPP
26.1 FCPP
2460.2 PCN
25.1 FCPP
2300.1 PCN
2460.2 PCN
2460.1 PCN
2165.1 PCN
2155.2 PCN
2180.1 PCN
12.2 FCPP
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Commensual Rodenticide Raits
Conditional Registration
Confidentiality
Cooperative Enforcement
Ag reement
Contract Manufacturing
Custom B1enders
2164.1 PC N , 21 fi4. 2 PCN
3068.2 PCN
10.1 FCPP
26.1 FCPP
3.2 FCPP, 3.6 FCPP
3.4 FCPP, 7.1 FCPP
Data Requirements
Dealer
Di methyl Sulfoxi de
Disclaimers
Di sinfectants
Disinfectant-Type Product
Distributor Registrations
Dome stic Use
2075.1 PCN
12.4 FCPP
2475.2 PCN
2163.1 PCN
2460.1 PCN
2460.1 PCN
3.2 FCPP, 3.6 FCPP
2460.1 PCN
Emetic
End Use Product
Environmental Hazard Label
Establish Competency
Establishment Registration
Establishment Transfer
Evidence
2161.1 PCN
2010.2 PCN
2180.1 PCN
4.1 FCPP
3.5 FCPP, 7.1 FCPP, 10.1 FCPP
3.6 FCPP
26.2 FCPP
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Exempt i ons
Experimental Use Permits
Eye Irri tati on
F
Feed and Pesticide Mixtures
Fertll1zer-Pest1c1de Mixtures
Fire Retardant
Food Fragrances
Foreign Trade Zones
F reeports
Fumi gati on
G
Gaseons Products
(Under Pressure)
H
Heli copter
I
Imports
Inspecti ons
Intra State Use
3.1 FCPP
12.1 FCPP, 2162.3 PCN
2161 .2 PC N
2000.2 PCN
2.1 FCPP, 3.4 FCPP, 2000.1 PCN
2475.1 PCN
2155.1 PCN
17.1 FCPP
17.1 FCPP
3.3 FCPP
2300.1 PCN
2190.1 PCN
17.2 FCPP
12.3 FCPP
24.1 FCPP
J
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Knowledgeable Expert
K
2.1 FCPP
Label , Labeling
Liability Limitations
Liquid Products
2.2 FCPP, 3.3 FCPP, 24.1 FCPP,
25.1 FCPP, 2010.1 PCN, 2076.1 PC:
2161.1 PC N, 2162.1 PC
2164.1 PC N, 2165.1 PC
2180.1 PCN, 2190.1 PC
3085.2 PCN
2160.1 PCN
2163.1 PCN
2170.1 PCN
2300.1 PCN
2163.1 PCN
2300. 1 PCN
Mail Order Advertisement
Make Available for Use
Misuse
Multi-Purpose or Multi-Use
Substances
Multi-Use Products
Multiple Formulations
Mult i pie Labels
Museum Use
2162.1 PCN
12.4 FCPP
2.1 FCPP, 12.2 FCPP, 12.3 FCPP,
26.2 FCPP
2.1 FCPP, 2050.1 PCN
17.2 FCPP
2000.2 PCN
2010.1 PCN
2030.2 PCN
New Use Patterns
Non-Crop Application
Non-Cropland
Non-Flammable
Non-Pesticidal Purposes
Notice of Arrival
2460.2 PCN
2160.1 PCN
2160.2 PCN
2300.1 PCN
2.1 FCPP, 2050.1 PCN
17.2 FCPP
Outer Containers
2.2 FCPP
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p
Personal Protective Equipment
Pest i cldal Use
Petitioner Eligibility ,
Phosphine Gas
P host ox in
Point Source Discharge Products
Pressurized Products
Primacy
Processi ng
Product Registration
Production Data
12.2 FCPP
2050. 1 PC N
2100.3 PCN
3.3 FCPP
3.3 FCPP
2180.1 PC N
2300.1 PC N
26.1 FCPP, 26.2 FCPP
Private Applicator Certification 4.1 FCPP
17.1 FCPP
3.5 FCPP
10.1 FCPP
Rail Cars
Reentry Statements
Reformulation
Reformulation of End-Use
Products
Regi st rati on
Released for Shipment
Repackaged End-Use Products
3.3 FCPP
2076.1 PCN
2010.2 PCN
2010.2 PCN
3.4 FCPP, 3.5 FCPP, 17.1 FCPP,
2010.2 PCN, 2460.2 PCN
2030.1 PCN
2010.2 PCN
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Repackagi ng
Reporting
Reregi stration
Restricted Use Pesticide (RUP)
Rodenti ci des
S
Safening Agent
Seed Treatment
Shipping Containers
Sh i pment
Skin Irritation
Sodium Chi orate
Sol vents
Special Local Need
State Authority
Substantially Similar Pesticide
Supplemental Registrations
T
Ta rget Pest
Tolerances
Toxi c i ty Cri teri a
Trademark Names
Truck Fumigation
Truck Vans
Twenty-four (c), [24(c)]
Two (ee), [2(ee ) ]
3.2 FCPP , 17.1 FCPP, 2010.2 PCN
7.1 FCPP
24 7 6.1 PCN
12.4 FCPP
2164.1 PCN, 2164.2 PCM
2255 PCN
2170.1 PCN
2.2 FCPP
3.1 FCPP
2161.2 PCN
2475.1 PCN
2155.2 PCN
24.1 FCPP
26.1 FCPP, 26.2 FCPP
3068.2 PCN
3.2 FCPP
2.1 FCPP
2100.1 PCN, 2100.3 PCN, 2135.1 PCr
2161.2 PCN
2162.2 PCN
3.3 FCPP
3.3 FCPP
24.1 FCPP
2.1 FCPP, 12.1 FCPP
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*s»^7'Fa^ l> «_ -
ENFORCEMENT CONFSJENTWL
ENFORCEMENT RESPONSE POLICY
FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
Office of Compliance Monitoring
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
July 2, 1990
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TABLE OF CONTENTS
INTRODUCTION
OVERVIEW OF THE POLICY .
DETERMINING THE LEVEL OF ACTION
Notices of Detention
Notices of Warning 4
Section 1-4(a) (2) Notices of Warning 4
Sections 9(c)(3) and 14(a)(4) 5
Stop Sale, (Jse, or Removal Orders (SSURO) 5
Mandatory Issuance of a SSURO
Discretionary Issuance of a SSURO 7
Use of a SSURO for Minor Violations 7
Seizures ..7
Injunctive Relief 8
Civil Administrative Penalties 9
Denials, Suspensions, Modifications, or
Revocations of Applicator Certifications 10
Denial/Revocations . 11
Suspensions .11
Criminal Proceedings 12
Parallel Criminal and Civil Proceedings 13
State and Federal Roles in Criminal Enforcement
of FIFRA 13
FIFRA*s Relationship to other Federal
Criminal Laws . 14
Recalls 14
Voluntary and Mandatory Recalls 14
Formal and Informal Recalls 15
Press Releases/Advisories 16
ASSESSING ADMINISTRATIVE CIVIL PENALTIES ....17
Computation of the Penalty 17
Use of the FIFRA Civil Penalty Matrix 13
Table 1 19
Size of Business 20
Table 2 20
Gravity of the Violation 21
Table 3 22
Gravity Adjustments for Recordkeeping and
Reporting Violations 22
Ability to Continue in Business/Ability to Pay .....23
4% of Gross Sales 2 3
ABEL 23
Independently Assessable Charges 2 5
Voluntary Disclosure 26
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-ii-
AdjuatiiSjf the Proposed Civil Penalty in Settlement 26
Factual Change# 27
Negotiations Involving Only the Amount of
the Penalty
Good Faith Adjustment 27
Special Circumstances/Extraordinary Adjustments ....28
Settlement With Conditions (SWC) 2 8
Criteria for Choosing an SWC 29
Responses to Noncompliance With an SWC 30
Penalty Payment 3 0
Reinspection and Additional Enforcement 30
Elements of an SWC 3 0
APPENDIX A - FIFRA CHARGES AtfD GRAVITY LEVELS A-l
APPENDIX B - GRAVITY ADJUSTMENT CRITERIA B-l
APPENDIX C - SUMMARY OF TABLES C-l
APPENDIX D - FIFRA CIVIL PENALTY CALCULATION WORKSHEET D-l
PROGRAM SPECIFIC SUPPLEMENTS TO THE FIFRA ERP
ERP for the FIFRA Section 7(c) Pesticide Producing
Establishment Reporting Requirements
ERP for the FIFRA Good Laboratory Practice Standards ....
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07/02/90
ENFORCEMENT RESPONSE POLICY FOR THE
FEDERAL INSECTICIDE; FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
INTRODUCTION
This document sets forth the procedures and criteria that will be used to
determine the appropriate enforcement response for violations of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FIFRA Enforcement
Response Policy (ERP) is designed to provide fair and equitable treatment of the
regulated community by ensuring that similar enforcement responses and comparable
penalty assessments will be made for comparable violations. The policy is designed to
provide for swift resolution of environmental problems and to deter future violations of
FIFRA by the respondent as well as other members of the regulated community.
This policy supersedes the previous FIFRA Civil Penalty Assessment Guidelines
published in the Federal Register on July 31, 1974 (39 FR 27711). There have been
many amendments to the statute, as well as EPA rulemaking, since the 1974 FIFRA
Civil Penalty Assessment Guidelines, which are incorporated into this revised FIFRA
ERP. Also superseded by this FIFRA ERP are: the 1983 Level of Action Policy
published as section 2 of Chapter 5 of the FIFRA Compliance/Enforcement Guidance
Manual; the June 8, 1981 Guidance for the Enforcement of the Child-Resistant
Packaging Regulation; and the June 11, 1981 FIFRA Enforcement Policy • Interim
Penalty Guidelines.
Except for the civil penalty assessment matrix, the February 10, 1986 FIFRA
Section 7(c) Enforcement Response Policy remains in effect, and is to be used to
determine the appropriate enforcement response for FIFRA section 7(c) violations.
The matrix setting forth the penalties in this policy should be used instead of the
matrix in the February 10, 1986 policy. Additional supplements to the FIFRA ERP
will be forthcoming which will more clearly discuss the appropriate enforcement
response for violations of other specific program requirements, such as the FIFRA
Good Laboratory Practice (GLP) Standards and the FIFRA section 19 regulations.
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OVERVIEW OF THE POLICY
This FIFRA Enforcement Response Policy (ERP) is divided into three main
sections. The first section, "Determining the Level of Action," briefly describes the
Agency's options for responding to violations of FIFRA. Section 2 of this ERP,
"Assessing Administrative Civil Penalties," elaborates on the Agency's policy and
procedures for calcuiating^civil penalties to be assessed.against persons who violate
FIFRA- Section 2 also contains the Agency's policy for negotiating a 'settlement with
conditions" for civil penalties issued under FIFRA. The third section of this policy
contains the appendices necessary for calculating civil penalties. The four
appendices to this ERP are: (1) Appendix A - FIFRA Charges and Gravity Levels;
(2) Appendix B - Gravity Adjustment Criteria; (3) Appendix C • The Summary of
Tables; and, (4) Appendix D • The FIFRA Civil Penalty Calculation Worksheet.
Guidance on the appropriate enforcement response for violations of specific
FIFRA programs, such as the FIFRA Good Laboratory Practice Standards,* FIFRA
section. 19 recall requests,* or FIFRA section 7(c) Pesticide Producing Establishment
Reporting Requirements, should be attached as additional appendices, and used in
conjunction with the overall FIFRA ERP.
Enforceamt rwptxae pdioo for the Good Libcnwy Practice Sunda/t*. »ad the FIFRA teatoa 19 rejuUiioft*
be (orthcoaia|.
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•3*
DETERMINING THE LEVEL OF ACTION
Once the documentation of a FIFRA violation is complete, the appropriate level
of action called for by the severity of the violation needs to be selected. These levels
of response include:
o Notices of Detention under section 17(c);
o Notices of Warning under sections 9(c)(3), 14(a)(2), and 14(a)(4);
o Stop Sale, Use, or Removal Orders under section 13(a);
o Seizures under section 13(b);
o Injunctions under section 16(c);
o Civil administrative penalties under section 14(a);
o Denials, suspensions, modifications, or revocations of
applicator certifications under 40 CFR Pan 171;
o Criminal referrals under section 14(b); and
o Recalls.
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Notices of Detention
A shipment of a pesticide or device being imported into the United States
cannot be brought into the country until EPA makes a determination of the
admissibility of that shipment. However, under the U.S. Customs' regulations for the
enforcement of section 17(c) of FIFRA (19 CFR Part 12.110 • 12.117), subsequent to
the receipt of a Notice of Arrival completed by the Administrator, the District Director
of Customs may release a shipment to the importer or the importer's agent before an
EPA inspection of the shipment. Such a release occurs only upon execution of a bond
in the amount of tfc * value of the pesticide or device, plus duty. When a shipment of
pesticides is released under bond, the shipment may not be used or otherwise disposed
of until the Administrator has determined the admissibility of that shipment. Should
the shipment subsequently be refused entry and the importer or agent fails to return
the pesticide or device, the bond is forfeited.
Section 17 of FIFRA authorizes EPA to refuse admission of a pesticide o^
device being imported into the United States if EPA determines that such pesticide q
device violates any provisions of the Act. This refusal is known as a Notice of
Detention and Hearing. Upon receiving a copy of the notice, the Department of the
Treasury, through the Customs Service, will refuse delivery to the consignee. If the
consignee has not requested a hearing, or has not exported the pesticide or device
within 90 davs from the date of the notice, the Customs Service will oversee destruction
* *
of the pesticide or device.
Notices of Warning _________
FIFRA sections 14(a)(2), 14(a)(4), and 9(c)(3) provide EPA with the authority
to respond to certain violations of FIFRA with a Notice of Warning to the violator.
Section 14faV2^ Notices of Warning
Under section 14(a)(2) of FIFRA, a written warning for a violation of FIFRA
must be issued to a private applicator or other person not covered by section 14(a)(1)
prior to the assessment of a civil penalty. Applicators who apply a registered general
use pesticide as a service in controlling pests but who do not deliver any unapplied
pesticides ("for hire" applicators), are also included in section 14(a)(2) but are not
subject to this limitation. A "for hire" applicator may be assessed a penalty up to S50
for the first offense.
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•5-
Wtionc and A4(»V4\
Section 14(a)(4) of FIFRA states that EPA may choose to issue a Notice of
Warning in lieu of a civil penalty if EPA determines that the violation occurred despite
the exercise of due care or the violation did not cause significant harm to health or the
environment Section 9(c)(3) also permits the EPA to issue a written Notice of
Warning in lieu of instituting a proceeding for minor violations of FIFRA if the
Administrator believes that the public interest will be adequately served through this
course of action.
Generally, a violation will be considered minor, and a section 9(c)(3) notice of
warning may be issued in lieu of a civil complaint if the total "gravity adjustment
value", as determined from Appendix B of this ERP, is less than three (see the section
of this ERP entitled "Gravity of the Violation" and Appendix B, "Gravity Adjustment
Criteria"). A Notice of Warning may also be appropriate for certain first-time record
keeping violations as listed in Appendix A of this ERP (e.g., late section 7 reports).
Stoo Sale. Use, or Removal Orders fSSURCtt
Section 13 of FIFRA provides EPA the authority to issue a Stop Sale, Use, or
Removal Order (SSURO) to any person who owns, controls, or has custody of a
pesticide or device, whenever EPA has reason to believe on the basis of inspection or
tests that: (1) a pesticide or device is in violation of any provision of the Act; (2) a
pesticide or device has been or is intended to be distributed in violation of the Act; or.
(3) when a registration of a pesticide has been cancelled by a final order or has been
suspended. A civil penalty should generally be assessed in addition to the SSURO
when a violation of FIFRA has occurred.
A SSURO is among the most expedient and effective remedies available to EPA
in its efforts to prevent illegal sale, distribution, and use of pesticides. Its advantages
over other actions (such as seizures) are that: (1) it may be issued whenever EPA has
reason to believe that the product is in violation of the Act; (2) it is easier to prepare
and issue than a seizure; (3) the SSURO has an effect on all of the product under the
ownership, custody, or control of the individual receiving the SSURO regardless of
where the product is located; (4) the SSURO can be written so as to include future
amounts of the product that may come into custody of the person on whom the
SSURO is served; and, (5) it can easily be adapted to particular circumstances.
-------
As per the FIFRA Compliance Program Policy Number 3.9, issued on July 6,
1987, when a SSURO is issued to a basic registrant with regard to a registered
pesticide product, the terms of the SSURO are equally applicable to the supplemental
registrants of the product
Mandatory Issuance of a SSURO
A SSURO is to be issued against persons who own, control, or have custody of
pesticides in the following^ categories:
Pesticides for which there is reason to believe that there is a potential hazard to
man or the environment because: (1) they are not registered, or are so over-
formulated, underformulated, or adulterated, as to present a serious health
hazard; or, (2) they are packaged in improper or damaged containers, or are so
inadequately labeled, as to make safe or effective use unlikely or impossible.
Pesticides or devices with labeling that is materially misleading or fraudulent
if followed by a user, is likely to cause a life-endangering health hazard or
serious adverse environmental effects (a pesticide lacking a restricted use labe
an especially serious labeling violation). This provision includes labeling for
products that: (1) are ineffective for the purposes claimed; (2) are so chemically
deficient as to affect deleteriously the product's efficacy; or, (3) bear false or
misleading safety claims.
Pesticides or hazardous devices* that are in violation of the Act and are the
subject of a recall, but which the responsible party refuses to remove, is
recalcitrant in removing, or is unable to remove from the channels of trade.
Pesticides or hazardous devices that are in violation of the Act and for which a
civil penalty has been issued but which have not been brought into compliance.
Pesticides which have been suspended under FIFRA section 6.
* A tuzvtioui device ¦ one praaiiof; • dim threw to buoua health or the environment by iU uk (*¦(-. * treatment dew
wftaM libeling CjkM, amleadJAf, or tniuduicoi ifT1* 10 punfy oc other untreated **t€T tupfMia). ror
ooobuirdcwi devics (e.g., as rtearoaucncttc rodeoi rrpetUaf dewce) itui tre eu*bonded. Afeacy policy a to complete civil pen
proceetiinp bciott wiiu| 4 SSURO. Set Oeeeabcr 19. 19^9 M *En forcemeat AO tons Coooemm| Noflftaurtoui
Peuiodc Dewica.'
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•7.
pfrq-etionarv Issuance of a SSURQ
The EPA may also issue a SSURO in cases where there is reason to believe a
product either is in violation of the Act or that the product has been or is intended to
be distributed or sold in violation of the Act, and the gravity of the violation is less
than that required for issuance of a mandatory SSURO. The EPA may also issue a
SSURO if a product has been cancelled under any section of the Act, or suspended
under FIFRA sections 4 or 3(c)(2)(B), and the existing stock deadlines have occurred
at that level of sale, distribution, or use.
Use of a SSURO for Minor Violations
While EPA will usually reserve the use of a SSURO for relatively serious
violations, the need to issue a SSURO may arise in certain cases involving minor
violations. For example, in the face of continued and repeated minor violations, or
when several minor violations appear on the label, EPA may decide to issue a SSURO
to ensure that the product will be distributed or sold in compliance with the Act.-
SffBvr« !
Section 13(b) of FIFRA gives EPA the authority to initiate in rem condemnation
proceedings in U.S. District Court. Once a Court grants the Agency's request for
authority to conduct a seizure, FIFRA section 9(b)(3) authorizes officers or emp'^vees
duly designated by the Administrator to obtain and execute warrants for the purpose of
seizing any pesticide or device that is in violation of the Act. Seizures may be
executed with the assistance of the U.S. Marshal
Under FIFRA section 13(b), EPA may initiate seizure actions in District Court
against any pesticide or device that is being transported or, having been transported,
remains unsold or in original unbroken packages, or that is sold or offered for sate in
any State, or that is imported from a foreign country, if: (1) a pesticide is adulterated
or misbranded; (2) a pesticide is unregistered; (3) a pesticide has labeling which does
not bear the information required by the Act; (4) a pesticide is not colored or
discolored as required; (S) a pesticide bean claims or directions for use that differ
from those made in connection with its registration; (6) a device is misbranded; or,
(7) a pesticide or device causes unreasonable adverse effects upon the environment,
even when used in accordance with the requirements imposed by the Act.
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The previous examples are similar to those circumstances that would lead the
Agency to issue a SSURO. Because a SSURO can be issued in less time and with less
preparation than that required for a seizure, the SSURO is the preferred enforcement
remedy in terms of expediency. Nevertheless, the Agency should consider initiating a
seizure in the following circumstances:
o The Agency has issued a SSURO, but the recipient of the order has not
complied with it;
o The Agency has reason to believe that a person, if issued a SSURO, will not
comply with it;
o There exists a pestic.de so hazardous that it should be removed from the
marketplace, place of storage, or place of use to prevent any chance of
harm to human health or the environment;
o The seizure will be used to support a recall; or
o It is necessary to dispose of products being held under a SSURO for which
the responsible party has taken no corrective action and has expressed an
intent not to take corrective action.
Injunctive Relief
Section 16(c) of FTFRA gives EPA the authority to initiate injunctive actions
before the U.S. District Court. These actions may consist of permanent injunctions,
preliminary injunctions, or temporary restraining orders.
Because an injunction is an extraordinary form of relief, the Agency's arguments
must be clear tod compelling. In initiating a permanent injunction action, EPA must
indicate to the court that: (1) the Agency's administrative or other judicial enforcement
remedies would be inadequate either at restraining the violation or at preventing
unreasonable risk to human health or the environment; (2) the Agency has already
diligently exercised all appropriate administrative remedies (such as SSUROs and
civil penalties), yet the violation or threat of a violation continues unabated; or
(3) irreparable injury, loss, or damage will result if the relief sought is not granted.
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In the case of a preliminary injunction or temporary restraining order, the
Agency must additionally demonstrate that: (1) immediate and irreparable injury, loss,
or damage will result if the requested relief is not granted; and, (2) there is a
likelihood of Agency success at trial, based on the facts before the court.
Under FIFRA, there are a number of specific circumstances that may justify
injunctive relief. These include but are not limited to:
o The violation .of a section 6 suspension or cancellation order;
o The violation of a SSURO where a civil penalty or criminal prosecution
would not provide a timely or effective remedy to deter further violations;
o There is continued production (in violation of the FIFRA section 7
requirements), shipment, sale, distribution, or use of an unregistered
pesticide after the Agency has taken civil or criminal action;
o A person continues to sell, distribute, or make available for use a restricted
use pesticide (RUP) other than in accordance with FIFRA section 3(d),.
after the Agency has already exercised an enforcement remedy,
o A person continues to violate the FIFRA section 17 import or export
requirements after the Agency has already exercised an enforcement remedy-,
and,
o A person continues to use a pesticide in a manner inconsistent with its
labeling, in a manner contrary to an experimental use permit, or repeats any
violation of FIFRA, after the Agency has already exercised an enforcement
remedy.
Civil Administrative Penalties
FIFRA section 14(a)(1) states that
Administrator to assess a
private apphcal^lSfp€fft>n up to S 1,000 for each violation of FIFRA,
subsequent to receiving a Notice of Warning or a citation for a prior violation (the
prior warning or citation may have been for the same or different FIFRA violation).
Additionally, section 14(a)(2) states that .an applicator who applies a registered general
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-10-
use or unclassified pesticide as a service in controlling pests but does not deliver any
unapplied pesticide (a "for hire applicator") may be assessed a civil penalty of not more
than $500 for the first offense of FIFRA, and $1,000 for each subsequent offense.'
A civil penalty is the preferred enforcement remedy for most violations. A civil
penalty is appropriate where the violation: (1) presents an actual or potential risk of
harm to humans or the environment (SSUROs or injunctive relief should be pursued in
addition to a civil penalty if the harm is extreme or imminent), or would impede the
Agency's ability to fulfill the goals of the statute; (2) was apparently committed as a
result of ordinary negligence (as opposed to criminal negligence), inadvertence, or
mistake; and the violation either: (a) involves a violation under the Act by any
registrant, commercial applicator, "for hire" applicator, wholesaler, dealer, retailer, or
other distributor (no prior warning is require: y FIFRA for violators in this category);
or, ^b) involves a private applicator or other . rson not listed in above and who has
received a prior warning or citation for a FIFKA violation.
Denials, Suspensions, Modifications, or Revocations
of Applicator Certifications
The regulations relating to the certification of pesticide applicators (40 CFR Pari
171) authorize EPA to deny, suspend, or revoke a federally issued applicator
certification if the holder of the certification violates FIFRA or its regulations. The
Agency' views an enforcement action affecting certification status as a very strong
measure, to be taken only when the "public health, interest or welfare warrants
immediate action" [40 CFR Section I71.11(f)(5)(i)]. Therefore, EPA will deny,
suspend, modify, or revoke a federal certification only in response to serious violations
or against persons with a history of noncompliance.
Ajtv applicator, rarturtiag ¦ Tor hire applicator", who hotd» or «pp<»e» aa unreratrred pentode to prwnde a tervwe of
controlling pew wifiout deUvcnag toy uaappiied pouadc to any pencm 10 aexved, will be nxmdcrod • dainbmor of
pestiadce and will be tubfea to the higher peuliiei ict forth m maiom l*(«Xl) FIFRA.
Am applicator, other tMfl a private applicator, who uaea of auperviaea the uae o# a reaooed ua* (fcW.
waetber.or Mutual applicator ¦••¦mriiflltf ,n<1 * w¥a 10 higher pewaUaca.irr dsnfco
tecuoae 14(aXl) tad 1«0>XD * FTFRA.
Aav applicator, inriudtag aa applicator who it certified. wbo hoida or ipplte* a wneral uae seuiodc (GUP) or aa
umiaaaificrt pooodc ta ratauoa at FTFRA for that peumdc wUl be wtojeo to the le»tr peaaluct aet forth in FIFRa
Mctmia 14(aX2) aad l«(bX2)-
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-tl-
Prni?VrgvocatiQns . . "
The denial or revocation of a certification not only deprives an applicator of the
authority to apply restricted use pesticides but also, as compared to suspension of a
certification, forces the applicator to take additional steps to acquire or reacquire
certification. In addition, the Agency will not consider an application to acquire or re-
acquire certification for at least six months following denial or revocation. Therefore. EPA
will deny or revoke a certification where: (1) a violation resulted in a fatality or created an
imminent danger of a fatality; (2) a violation resulted in severe damage to the environment
or created an imminent danger of severe damage to the environment; (3) a misuse
violation has resulted in significant contamination *of food and water; (4) the violator's
certification has been suspended as a result of a previous serious violation; or (5) a person
has maintained or submitted fraudulent records or reports.
If EPA pursues an action to deny, revoke, or modify an applicator's certification,
EPA will notify the applicant or federal certificate holder of: (1) the ground(s) upon which
the denial, revocation, or modification is based; (2) the time period during which-the
denial revocation, or modification is effective, whether permanent or otherwise; (3) the
conditions, if any, under which the individual may become certified or recertified; and
(4) any additional conditions EPA may impose. EPA must also provide the federally
certified applicator an opportunity to request a hearing prior to final Agency action to
deny, revoke, or modify the certificate.
Susp^reiQins •
Generally, the Agency will pursue the less severe alternative of suspending an
applicator's federal certification in response to violations by applicators who have
previously been issued a civil complaint for a violation of FIFRA. The Agency will
suspend an applicator's certification for up to four months for the second independent
violation of FIFRA.* For each additional violation, two months may be added to the
term of suspension up to a limit of eight months. The exact length of the suspension
(within the limits stated above) should result in an economic loss to the applicator of at
least the statutory maximum civil penalty that could have been assessed.
For pwpaa at tha Mcuoa of Uw policy, EPA will ecu dutinpuaH between coeuacraal tad privti* appiicaion.
CoAHdcnuM of ttatw • labcrcw is Lte pobcjr in ilut iu>pnuoa» hiw a not* Mbatuiial impact on
commercial tppUcaion. afTecuag iber primary buuooi activity.
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•12.
If EPA decides to suspend certification, it mast notify the applicator of the
grounds upon which the suspension is based, and the time period during which the
suspension will be in effect In order for the suspension to function as a deterrent, the
suspension should take effect during the time when the applicator is most likely to be
applying restricted use pesticides.
Generally, a suspension is pursued against an individual applicator for a
subsequent offense in addition to the issuance of a civil penalty against the employer.
EPA may also suspend certifications of commercial applicators who violate
restricted use pesticides recordkeeping requirements [see 40 CFR 171.11(c)(7); 40 CFR
171.1 l(f)(!)(*")]• The Agency will assess suspensions of up to wo months for the
second independent violation resulting from the failure to maintain restricted use
pesticides records. For each additional violation, two months may be added to the
term of the suspension up to a limit of six months. In cases where the violation
involved keeping fraudulent records (i.e., where the violator intentionally concealed or
misrepresented the true circumstances and the extent of the use of restricted use
pesticides), EPA may revoke the violator's certification in response to the initial
infraction.
Criminal Proceedings
Section 12 of FIFRA specifically lists the unlawful acts that are subject, not only
to civil and administrative enforcement, but also to criminal investigation and penalties
(see Chapter 20, "FIFRA Criminal F "orcement," of the Pesticides Inspection Manual).
Section 14(b) of FIFRA (7 t J 1361) provides the authority to proceed with
criminal sanctions against violators c -ie Act, as follows:
o A registrant, applicant for a registration, or producer who knowingly violates
the Act is subject, upon conviction, to a fine of not more than $50,000 or
imprisonment for up to 1 year, or both.
o A commercial applicator of a restricted use pesticide, or any other person
not described above who distributes or sells pesticides or devices, who
knowingly violates the Act is subject, upon conviction, to a fine of not more
than 525,000 or imprisonment for up to 1 year, or both.
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•13*
o A private applicator or other person not included above who knowingly
violates the Act is subject, upon conviction, to a fine of not more than
S1,000, or imprisonment for not more than 30 days, or both.
In addition, pursuant to the Alternatives Fines Act (18 U.S.C. 3571) the FIFRA
criminal fine amounts may be substantially increased if the violation results in death.
All acts of the regulated community exhibiting actual or suspected environmental
criminal conduct should be discussed with EPA Regional or Headquarter'; Criminal
Enforcement Counsel or to the Office of Criminal Investigations for an assessment and
possible investigation.
Parallel Criminal and Civil Proceedings
Civil/administrative and criminal enforcement actions may be conducted
simultaneously whenever deemed necessary by the EPA Assistant Administrator Jor the
Office of Enforcement in order to seek immediate relief to protect human health or
the environment. Simultaneous civil actions and criminal proceedings may be
appropriate if the environmental consequences of a violation pose a hazard requiring
remedial measures by a defendant.
The State and Federal Roles in Criminal Enforcement of FIFRA
State primacy for pesticide use violations, under FIFRA sections 26 and 27, also
applied to criminal FIFRA use violations. States are initially allowed 30 days to
commence appropriate enforcement actions for such violations. However, criminal
violations which do not constitute pesticide use violations may be investigated and
prosecuted on the Federal level without waiting for State authorities to exercise their
primary enforcement responsibility. The State should be informed of any criminal
investigation being conducted within their State.
Violations of a cancellation or suspension order, an EPA stop sale, use, or
removal order (SSURO), fraudulent labeling, advertising, or registration of a pesticide -
are among-those types of FIFRA violations for which States do not have primary
enforcement authority. Even where there is a FIFRA pesticide use violation, the States
can choose to waive their primary enforcement responsibility to allow Federal criminal
enforcement action to be undertaken.
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-14-
FIFRA's Relationship to Other Federal Criminal Laws
Possible criminal environmental offenses should be brought promptly to the
attention of EPA Criminal Enforcement Counsel, Special Agents in the Office of
Criminal Investigations, or the appropriate state authorities. This is true even if the
suspected criminal activity does not appear to be a violation of FIFRA. The criminal
conduct may also be amenable to prosecution under one of the other environmental
laws or one of the general criminal laws.
For instance, submission of false registration information may not only constitute
a violation of FIFRA, but also the Federal false Statement statute and conspiracy laws.
The unlawful disposal of pesticides may be a criminal violation of the Resource
Recovery and Conservation Act (RCRA) or, if the disposal was into a river, such
conduct could be a criminal violation of the Qean Water Act. Which statute to
proceed under may not be decided until the investigation is almost complete and may
depend on factors such as the evidence available to establish an offense and the
different penalty levels of the involved statutes.
Recalls
In general, under FIFRA sections 19(b)(3) and (4), if a registration of a
pesticide has been suspended and cancelled, and EPA finds that a recall is necessary to
protect.public health or the environment, EPA will request that a voluntary or
mandatory recall be conducted. Additionally, the EPA will continue its policy of
initiating formal and informal recalls in cases where a product is either potentially
hazardous when used as directed, ineffective for the purposes claimed, or violative in
nature. Formal and informal recalls are not authorized under the statute. Therefore,
the effectiveness of a formal or informal recall action is contingent on the cooperation
of the company involved.
voluntary ?n4 Mandatory Rtcall?
A voluntary recall may be appropriate if a product is suspended and cancelled
and the voluntary recall will be sufficient to protect human health or the environment.
If not, mandatory recall procedures issued as a regulation under FIFRA sections
19(b)(3) and (4) may require registrants, distributors, or sellers of a pesticide to recall
the pesticide; to make available storage facilities to accept and store existing stocks of
the suspended and cancelled pesticide; to inform the EPA of the location of the
storage facility; and to inform the EPA of the progress of the recall. The parties
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•15-
subject to the recall must also provide transportation of the pesticide, on request; and
take reasonable steps to inform holders of the recall and transportation provisions.
Persons conducting the recall must comply with transportation, storage and disposal
requirements. The criteria for the recall plans will be issued under FIFRA section
19(b) through the 40 CFR Part 165.
Formal and Informal Recalls ,
The Agency should consider a formal or informal recall of a product when,
among other things, its use as directed by the label is likely to result in: (1) injury to
the user or handler of the product; (2) injury to domestic animals, fish, wildlife, or
plant life; (3) physical or economic injury because of ineffectiveness or due to the
presence of actionable residues; or (4) identifiable adverse effects on the environment.
A product does not have to be suspended or cancelled in order for EPA to decide that
requesting a formal or informal recall is appropriate.
A formal or informal recall must only be requested where the evidence clearly
supports the need for such action. The initial decision that a product should be
withdrawn from the market will be based on information in the sample file including
laboratory analysis, staff evaluations and opinions, and such other information as may
be available. All information supporting a recall decision must be included in the
official file.
.• t *
^Formal recalls are used for more serious problems and when it is essential that
EPA regional personnel follow-up the recall with a visit to the company. Formal recall
involves EPA monitoring, detailed reporting by the company involved, and notification
to State officials. This type of recall is normally accompanied by another enforcement
action, generally a civil penalty.
An informal recall should be used in cases where a recall is necessary but the
level of potential hazard is not great or when it is unlikely that significant amounts of
the defective product remain in the marketplace. An informal recall is conducted
entirely by the company involved with no monitoring by EPA or State officials.
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•16.
Pr?» peleases/Advisories. Etc.
Regions may, at their discretion, issue a press release/advisory to notify the public
of a person's violation of FIFRA. However, the issuance of press release/advisory must
not be an item of negotiation during settlement.
A press release/advisory can be a useful tool 10 notify the public of a person's
noncompliance with FIFRA and to educate the public on the requirements of FIFRA.
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ASSESSING ADMINISTRATIVE CIVIL PENALTIES
FIFRA section 14(a)(1) states that a registrant, commercial applicator, wholesaler,
dealer, or other distributor may be assessed a civil penalty of up to $5,000 for each
violation of FIFRA. Section 14(a)(2) allows the Administrator to assess a private
applicator or other person up to $1,000 for each violation of FIFRA, subsequent to
receiving a Notice of Warning or a citation for a prior violation. Additionally, section
14(a)(2) states that an applicator who applies a registered general use pesticide as a
service in controlling pests but does not deliver any unapplied pesticide (a "for hire
applicator') may be assessed a civil penalty of not more than S500 for the first offense
of FEFRA, and S1*000 foe each subsequent offense.
Additionally, as the statutory definitions of "distribute or sell" and "commercial
applicator* indicate, and as the conference report for the Federal Pesticide Act of 1978
confirms (Senate Report No. 95*1188; September 12, 1978; page 44 and 45), anv
applicator, including a "for hire" applicator, who holds or applies an unregistered
pesticide to provide a service of controlling pests without delivering any unapplied
pesticide to any person so served, will be considered a distributor of pesticides and will
be subject to the higher penalties set forth in sections 14(a)(1) and 14(b)(1) of FIFRA.
Additionally, am applicator, other than a private applicator, who uses or supervises the
use of a restricted use pesticide (RUP), whether or not that applicator is certified, is a
commercial applicator and is subject to the higher penalties set forth in sections
14(a)(1) and 14(b)(1) of FIFRA. Finally, ailX applicator, even if that applicator is
certified, who holds or applies a general use pesticide (GUP) or an unclassified
pesticide in violation of FIFRA will be subject to the lower penalties set forth in
FIFRA sections 14(a)(2) and 14(b)(2).
The FIFRA Civil Penalty System - Computation of the Penalty ,
In determioiag the amount of the civil penalty, section 14(a)(4) of FIFRA requires
the Agency to consider the appropriateness of the penalty to the size of the business of
the person charged, the effect of the penalty on the person's ability to continue in
business, and the gravity of the violation.
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.17.
ASSESSING ADMINISTRATIVE CIVIL PENALTIES
FIFRA section 14(a)(1) states that a registrant, commercial applicator, wholesaler,
dealer, or other distributor may be assessed a civil penalty of up to $5,000 for each
violation of FIFRA. Section 14(a)(2) allows the Administrator to assess a private
applicator or other person up to S1,000 for each violation of FIFRA, subsequent to
receiving a Notice of Wonting or a citation for a prior violation. Additionally, section
14(a)(2) states that an applicator who applies a registered general use pesticide as a
service in controlling pests but does not deliver any unapplied pesticide (a "for hire
applicator") may be assessed a civil penalty of not more than S500 for the first offense
of FIFRA, and SI,000 for each subsequent offense.
Additionally, as the statutory definitions of "distribute or sell" and "commercial
applicator" indicate, and as the conference repon for the Federal Pesticide Act of 1978
confirms (Senate Report No. 95*1188; September 12, 1978; page 44 and 45), anv
applicator, including a "for hire" applicator, who holds or applies ait unregistered
pesticide to- provide a service of controlling pests without delivering any unapplied
pesticide to. any person so served, will be considered a distributor of pesticides and will
be subject to the higher penalties set forth in sections 14(a)(1) and 14(b)(1) of FIFRA.
Additionally, am applicator, other than a private applicator, who uses or supervises the
use of a restricted use pesticide (RUP), whether or not that applicator is certified, is a
commercial applicator and is subject to the higher penalties set forth in sections
14(a)(1) and 14(b)(1) of FIFRA. Finally, aQX applicator, even if that applicator is
certified, who holds or applies a general use pesticide (CUP) or an unclassified
pesticide in violation of FIFRA will be subject to the tower penalties set forth in
FIFRA sections 14(a)(2) and 14(bX2).
The FIFRA Civil Penalty System - Computation of the Penalty
In determining the amount of the civil ^nal^.section 14(a)(4) of rirkA requires
the Agency to consider^g§gggBgHflflsSR6£PHttg8g8^flKHBHHH88°f
the person charged, the effect of the penalty on the person's ability to continue in
business, and the gravity of the violation.
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Computation of the penalty amount is determined in a five stage process in
consideration of the FIFRA section 14(a)(4) criteria listed above. These steps are:
(1) determination of gravity or level" of the violation using Appendix A of this ERP;
(2) determination of the size of business category for the violator, found in
Table 2; (3) use of the FIFRA civil penalty matrices found in Table 1 to determine the
dollar amount associated with the gravity level of violation and the size of business
category of the violator, (4) further gravity adjustments of the base penalty in
consideration of the specific characteristics of the pesticide involved, the actual or
potential harm to human health and/or the environment,, the compliance history of the
violator, and the culpability of the violator, using the "Gravity Adjustment Criteria"
found in Appendix B; and, (5) consideration of the effect that payment of the total
civil penalty will have on the violator's ability to continue in business, in accordance
with the criteria established in this ERP. A proposed civil penalty may be further
modified during the course of settlement negotiations in accordance with the section of
this ERP entitled "Adjusting the Proposed Civil Penalty in Settlement."
Use of the FIFRA Civil Penalty Matrix
The gravity of the violation and the size of the business are considered in the
FIFRA Civil Penalty Matrices shown in Table 1. Each cell of the matrix represents the
Agency's assessment of the appropriate civi] penalty, within the statutory maximum, for
each gravity level of a violation and for each size of business category. Since FIFRA
imposes different statutory ceilings on the maximum civil penalty that may be assessed
against persons listed in FIFRA section 14(a)(1) and persons listed in section 14(a)(2).
this policy has separate penalty matrices for section 14(a)(1) violators and section
14(a)(2) violators.
The section 14(a)(2) penalty matrix will only be used by the Agency for persons
falling under FIFRA section 14(a)(2) who have previously been issued a notice of
warning or civil complaint (FIFRA section 14(a)(2) states that private applicators are
only subject to civil penalties subsequent to receiving a Notice of Warning or following
a citation for a prior violation, and "for hire" applicators are only subject to a
maximum $500 civil penalty for their first offense of FIFRA). The Agency has only
included three levels in the sectjgp^4(aX2). Civil rather than the four
3j^^;p«o«ld^&f^*ct!bnTif4(a)(l) matrix Thii is because the Agency does not
believe that the lower base penalty figure that can be obtained from a level 4" is
appropriate for violations of the statute committed after the receipt of a notice of
warning or civil complaint.
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19-
When a civil penalty is the appropriate response for a first-time violation by a
"for hire applicator" who violates any provision of FIFRA while holding or applying a
registered general use pesticide or a registered unclassified pesticide, that civil penalty
will be the statutory maximum of S50Q. Subsequent violations will be assessed using
the FIFRA section 14(a)(2) civil penalty matrix below.
I&BLEL1
It&c
-4
LEVEL.
level 1
level 2
level 3
level 4
CIVIL PENALTY MATRIX
FOR FIFRA SECTION 14(a)(1)
SIZE OP BUSINESS
5,000
5,000
4,000
3,000
II
5,000
4,000
3,000
2,000
III
5,000
3,000
2,000
1,000
CIVIL PENALTY MATRIX
FOR FIFRA SECTION 14(a)(2) •
SIZE OF BUSINESS
LEVEL
I
II
III
1ml 1
1,000
1,000
1,000
Level 2
1,000
800
600
level 3
800
600
500
Thia 14(a)(3) oaifli • oojy tar vm m dctcrmiautf emt pcoaltfca awtod tuNwqumi to i mm> ot wuntag or foUawai a
avauoo for a pnor noutioa. or m U* caw at a tar tur«* ippiicaior «ia| a rapMera* general gn paatio*. mda^ucni
io ibt anoM of a emt penally of S50A.
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W nf Business
In order to provide equitable penalties the civil penalties that will be assessed
for violations of FIFRA will generally decrease as the size of the business decreases,
and vice versa. Size of business is determined from an individual's or a company's
gross revenues from all revenue sources during the prior calendar year. If the revenue
data for the previous year appears to be unrepresentative of the general performance
of the business or the income of the individual, an average of the gross revenues for
As shown in the FIFRA Civil Penalty Matrices in Table 1, the appropriateness
of the penalty to the size of the business of the person charged is based on three'
distinct "size of business" categories. Further, because the gross revenues of the
persons listed in FIFRA section 14(a)(1) [registrants, commercial applicators,
wholesalers, dealers, retailers, or other distributors] will generally be higher than the
gross incomes of the persons listed in FIFRA section 14(a)(2) [private applicators and
other persons not listed in 14(a)(1)], the policy has separate "size of business"
categories for FIFRA section 14(a)(1) persons and section 14(a)(2) persons. The "size
of business" categories for FIFRA section 14(a)(1) and section 14(a)(2) violators are
listed ul* Table 2.
itia&$ncluding all sites owned or
TABLE ;
For section 14(a)(1) violators, the size of business categories are:
I
II
III
over $1,000,000
$300,001 - $1,000,000
$0 • $300,000
For section 14(a)(2) violators, the categories are:
I
II
III
over $200,000
$50,001 • $200,000
$0 - $50,000
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When information concerning an alleged violator's size of business is not readily
available, the penalty is to be calculated using the Category I size of business. The
Category I size of business will remain the base penalty value unless the violator can
establish, at their expense and to the Agency's satisfaction, that it should be considered
in a smaller size of business category.
Gravity of the Violation
Determination of the gravity of the violation is a two step process;
(1) determination of the appropriate "gravity lever that EPA has assigned to the
violation, and (2) the adjustment of that base penalty figure, as determined from the
gravity level, to consider the actual set of circumstances that are involved in the
violation.
The gravity "lever established for each violation of FIFRA is listed in
Appendix A of this ERP. The "levels" assigned to each violation of FIFRA represents
an assessment of the relative gravity of each violation. The relative gravity of each
violation is based on an average set of circumstances which considers the actual ;or
potential harm to human health and/or the environment which could result from tTie
violation, or the importance of the requirement to achieving the goals of the statute.
The gravity level, which & determined from the chan in Appendix A, is then used to
determine a base penalty figure from the FIFRA Civil Penalty Matrices.
As the actual circumstances of the violation differ from the "average"
circumstances assumed in each gravity level of the Civil Penalty Matrices, the dollar
amount derived from the matrix should be adjusted upward or downward. The Agency
has assigned adjustments, based on the gravity adjustment criteria listed in Appendix B,
for each violation relative to the specific characteristics of the pesticide involved, the
harm to human health and/or harm to the environment, compliance history of the
violator, and the culpability of the violator. Under the FIFRA civil penalty system, the
gravity adjustment values from each gravity category listed in Appendix B are to be
totaled. The doDar amount found in the matrix will be raised or lowered, within the
statutory maximum (55,000 for section 14(a)(1) persons and $1,000 for 14(a)(2)
persons), based oo the total gravity values in Table 3.
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-22-
TABLE3
Total Gravity Value
Enforcement Remedy
3 or betow
No action. Notice of Warning, or
50% reduction of matrix value."
4
Reduce matrix value 40%
5
Reduce matrix value 30%
6
Reduce matrix value 20%
7
Reduce matrix value 10%
8 to 12
Assess matrix value
Increase matrix value 10%**
;4
increase matrix value 15%""
15
Increase matrix value 20%"*
16
Increase matrix value 25%**
It or above
Increase matrix value 30%**
* SOU fettoaw af artmlw It mmmttnmti wfrw wtlupM oam - mew com.
** Mauti ntu a» emit tog jaaMMd to ttt jututav umui at ItW wr oOmm (Or
tmom sadv FV)A maim KtXUi aa* S1,000 tar pew uixftr FTFRa mcum t*<*K2%
Qravlty Aflwaacmi for Rcwrft«ping and Reporting violation*
The gravity of recordkeeping and reporting violations are already considered in
the dollar amounts presented in the FIFRA civil penalty matrices. Further,
recordkeeping and reporting violations do not lend themselves to utilizing the gravity
adjustments listed in Appendix B. Therefore, first-time civil penalties should be
assessec at the matrix value, while subsequent penalties should be increased by an
increment of 30% (up to the statutory maximum).
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>21-
¦; ^ vfri^
^readily
„„, _ The
Category I size of business will remain the base penally value unless the violator can
establish, at their expense and to the Agency's satisfaction, that it should be considered
in a smaller size of business category.
Gravity of the Violation
Determination of the gravity of the violation is a two step process:
(1) determination of the appropriate "gravity level" that EPA has assigned to the
violation, and (2) the adjustment of that base penalty figure, as determined from the
gravity level, to consider the actual set of circumstances that are involved in the
violation.
The gravity 'level" established for each violation of FIFRA is listed in
Appendix A of this ERP. The "levels" assigned to each violation of FIFRA represents
of the relative gravity of each violation.
achieving* the»fp8& of the statute^
The graviry level, which is determined from the chan in^Ap^n^ XTTs then used to
determine a base penalty figure from the FIFRA Civil Penalty Matrices.
As the actual circumstances of the violation differ from the "average"
circumstances assumed in each gravity level of the Civil Penalty Matrices, the dollar
amount derived from the matrix should be adjusted upward or downward- The Agency
has assigned adjustments, based on the gravity adjustment criteria listed in Appendix B.
for each violation relative to the specific characteristics of the pesticide involved, the
harm to human health and/or harm to the environment, compliance history of the
violator, and the culpability o£ the violator. Under the FIFRA civil penalty system, the
gravity adjustment values from each gravity category listed in Appendix B are to be
totaled. The dollar amount found in the matrix will be raised or lowered, within the
statutory maximum (S5,000 for section 14(a)(1) persons and S1,000 for 14(a)(2)
persons), based on the total gravity values in Table 3.
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-23-
Ability to Continue fn Busingw/Abilitv to Pav
Section 14(a)(4) of FIFRA requires the Agency to "consider" the effect of the
penalty on the person's ability to continue in business when determining the amount of
the civil penalty.
EPA will generally not collect a total civil penalty which exceeds a violator's
ability to- pay. There are three methods that EPA has chosen to determine a violator's
ability to pay, depending on the specifics, of the case: (1) a detailed tax, accounting,
and financial analysis; (2) a guideline of four percent of average gross annual income;
or, (3) ABEL (a compute? model).* The latter two are described below.
Four percent of gross sales. The average gross income (from, all source* of revenue)
for the current year and the prior three years will be calculated. Even where the net
income is negative, four percent of gross income will be used as the "ability to continue
in business/ability to pay" guidance, since companies with a positive gross income will
be presumed to have sufficient cash , flow to pay penalties even where there have been
net losses. For corporations, EPA will consider revenues from the total corporate
entity in its determination of ability to pay/ability to continue in business. Total
corporate entity refers to all sites owned and controlled by the foreign or domestic
parent company.
ABEL. ABEL is an EPA computer model that is designed to assess a for-profit
entity's ability to pay. The evaluation is based on the estimated strength of internally'
generated cash flows. The program uses standard financial ratios to evaluate a
violator's ability to borrow money and pay current and long-term operating expenses.
ABEL also projects the probable availability of future internally-generated cash flaws to
evaluate some of a violator's options for paying a civil penalty. Because the program
only focuses on a violator's cash flow, there are other sources of revenue that should
also be considered to determine if a firm is unable to pay the full penalty. These
include:
o certificates of deposit, money market funds, or other liquid assets;
o reduction in business expenses such as advertising; entertainment, or
compensation of corporate officers; or,
o sale or mortgage of non-liquid assets such as company cars, aircraft, or land.
Other toe ¦ vkiluor** atnltijr to psy auy be provided in future fiiiflinrr
-------
It can be assumed that the respondent has the ability to pay at the time the
complaint is issued if information concerning the alleged violator's ability to pay is not
readily available. The respondent will be notified in the civil complaint of their right
under the statute to have their ability to continue in business considered in the
determination of the amount of the civil penalty. Any alleged violator can raise the
issue of ability to pay/ability to continue in business in th$ir answe* civil
complaint, or during the course of settlement neg6tiations.
If an alleged violator raises the inability to pay as a defense in their answer, or
in the course of settlement negotiations, the respondent should be asked to present
appropriate documentation, such as tax returns, financial statements, etc. Such records
are to be provided to the Agency at the respondent's expense and must conform to
generally recognized accounting principles and procedures. If the proposed penalty
exceeds the ability to pay guidance, the penalty may be reduced to a level consistent
with FIFRA section 14(a)(4).
There may be some cases where a respondent argues that it cannot afford to
pay the proposed civil penalty even though the penalty as adjusted does not exceed the
ability to pay guidance. In such cases, EPA may consider a delayed payment schedule
or a "Settlement with Conditions" agreement (see the "Settlement With Conditions"
section of this Enforcement Response Policy). In exceptional circumstances, EPA may
also cQnsider further adjustment below the ability to pay guidance.
Finally, it is important that the regulated community not see the violation of
FIFRA as a way of aiding financially troubled businesses. Therefore, while EPA will
generally not collect a civil penalty which exceeds a violator's ability to pay, EPA
reserves the option, in appropriate circumstances, of seeking a penalty that might
exceed the ability to pay guidelines, cause bankruptcy, or result in a violator's inability
to continue in business. However, if the case is generated out of the EPA Regional
Offices, the ease file must contain a written explanation, signed by the Regional
Program Division Director, which explains the reasons for exceeding the civil penalty
"ability to pay" guidelines. If the case is generated out of EPA Headquarters, the case
file must contain a written explanation signed by the Director of the Compliance
Division. Additionally, to ensure full and consistent consideration of penalties that may
cause bankruptcy or closure of a business, the Regions shall consult with the Office of
Compliance Monitoring and obtain concurrence before the decision is made to settle
the case or proceed to a hearing.
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•23-
Ahjliry to Continue in Business/Ability to Pav
Section 14(a)(4) of FIFRA requires the Agency to "consider" the effect of the
penalty on the person's ability to continue in business when determining the amount of
the civil penalty.
There are three methods that EPA has chosen to determine a violator's
abimy to pay, depending on the specifics of the case: (1) a detailed tax, accounting,
and financial analysis; (2) a guideline of four percent of average gross annual income;
or, (3) ABEL (a computer model)." The latter two are described below.
Four percent of pross sales. The average gross income (from all sources of revenue)
for the current year and the prior three years will be calculated. Even where the net
income is negative, four percent of gross income will be used as the "ability to continue
in business/ability to pay" guidance, since companies with a positive gross income will
be presumed to have sufficient cash flow to pay penalties even where there have been
net losses. For corporations, EPA will consider revenues from the total corporate
entity in its determination of ability to pay/ability to continue in business. Total
corporate entity refers to all sites owned and controlled by the foreign or domestic
parent company.
ABELf ABEL is an EPA computer model that is designed to assess a for-profit
enticy's ability to pay. The evaluation is based on the estimated strength of internally-
generaied cash flows. The program uses standard financial ratios to evaluate a
violator's ability to borrow money and pay current and long-term operating expenses.
ABEL also projects the probable availability of future internally-generated cash flows to
evaluate some of a violator's options for paying a civil penalty. Because the program
only focuses on a violator's cash flow, there are other sources of revenue that should
also be considered to determine if a firm is unable to pay the full penalty. These
include:
o certificates of deposit, money market funds, or other liquid assets;
o reduction in business expenses such as advertising, entertainment, or
compensation of corporate officers; or,
o sale or mortgage of non-liquid assets such as company cars, aircraft, or land.
Other mnhodi for docrauaiaf * v-ioiitofi ability to p«y euy jj iuiui* fwliiw
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-25-
For additional information on the consideration of a violator's ability to continue
in business, see the EPA General Enforcement Policy #GM-22» entitled "A Framework
for Statute-Specific Approaches to Penalty Assessments," issued on February 16, 1984
as part of the Agency's General Enforcement Policy Compendium.
Independently Assessable Charge*
A separate civU penalty, up to the statutory maximum, shaj] be assessed for each
independent violation of the Act A violation is independent if it results from an act
(or failure to act) which is not the result of any other charge for which a civil penalty
is to be assessed, or if the- elements of proof for the violations are different
Dependent violations may be listed in the complaint, but will not result in separate civil
penalties.
Consistent with the above criteria, the Agency considers violations that occur
from each shipment of a product (by product registration number, Qgl individual
containers), or each sale of a product, or each individual application of a product to be
independent offenses of FIFRA.* Each of these independent violations of FIFRA are
subject to civil penalties up to the statutory maximum of 55,000 for section 14(aXl)*
and 51,000 for section 14(a)(2). For example, when the EPA can document that a
registrant has distributed a misbranded product (one single EPA product registration
number) in four separate shipment* (filling four orders), EPA will charge that registrant
with four counts of selling or distributing a misbranded product, and assess the
registrant civil penalties of up to 520,000. Similarly, when the EPA can document that
a registrant has shipped four separate misbranded products (four separate EPA
product registration numbers) in a single shipment, EPA will charge the registrant four
counts of selling or distributing a misbranded product, and assess civil penalties of up
to 520,000. A commercial applicator that misuses a restricted use product on three
occasions (either three distinct applications or three separate sites) will be charged with
three counts of misuse, and assessed civil penalties of up to 515,000. A dealer that
sells a restricted use pesticide (RUP) to six uncertified persons, other than in
accordance with FIFRA section 3(d), will be charged with six violations of FIFRA, and
assessed civil penalties of up to 530,000.
Independent vtoUuoca which eu b« doewnemed «a both per ule and per lfcipoest are to be calculated ooJy aa either
per tale or per tklpaau, whichever ia oore appropriate baaed oa the tupponio-f documentation, and whichever approach
yield* the higlteat dvt] penalty. For sample, if Penoa A haa a violatioa invoMig I talc and 2 thipaenu. tad Penoa B
haa a vtotaitoo invoMcj 2 aatea aad 1 thipoeat, both persona would be charted for 2 violation ot FIFRA (Penoo A ia
charged (or 2 Uiipmeoi* aad Penoa B i* charged for 2 v»ie»).
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•25-
For additional information on the consideration of a violator's ability to continue
in business, see the EPA Ceneral Enforcement Policy #GM-22, entitled "A Framework
for Statute-Specific Approaches to Penalty Assessments," issued on February 16, 1984
as part of the Agency's General Enforcement Policy Compendium.
Independently Assessable Charges _ ; ,
A separate civil penalty, up to the statutory maximum, shall be assessed for each
independent violation of the Act A violation is independent if it results from an act
(or failure to act) which is not the result of any other charge for which a civil penalty
is to be assessed, or if the elements of proof for the violations are. different
Consistent with the above criteria, the Agency considers violations that occur
from each shipment of a product (by product registration number, flfli individual
containers), or each sale of a product, or each individual application of a product to be
independent offenses of FIFRA.* Each of these independent violations of FEFRX are
subject to civil penalties up to the statutory maximum of $5,000 for section 14(a)(1)
and S1,000 for section 14(a)(2). For example, when the EPA can document that a
registrant has distributed a misbranded product (one single EPA product registration
number) in four separate shipments (filling four orders), EPA will charge that registrant
with four counts of selling or distributing a misbranded product, and assess the
registrant civil penalties of up to $20,000. Similarly, when the EPA can document that
a registrant has shipped four separate misbranded products (four separate EPA
product registration numbers) in a single shipment, EPA will charge the registrant four
counts of selling or distributing a misbranded product, and assess civil penalties of up
to $20,000. A commercial applicator that misuses a restricted use product on three
occasions (either three distinct applications or three separate sites) will be charged with
three counts of and assessed civil penalties of up to $15,000. A dealer that
sells a restricted use pesticide (RUP) to six uncertified persons, other than in
accordance with FIFRA section 3(d), will be charged with six violations of FIFRA, and
assessed civil penalties of up to $30,000.
ladtacadcM vwtauioat otac* am M feasant m tm& an ujb tat per tfeipoat M(oM tmtnrtratf oatr m attar
per ute or per ihip—i. tictigur • am appopnw mat em itat wpporugf rtnniiwmm, aod «teM«er afpoac*
y«M» tte CM port*. For if Nmi A X» » wottuca >«wo*tet 1 ute m 2 ihipinn, wd fenw B
hm • vtoteuoa iwoMaf 2 uta» m4 I stopewm. bctt penoa* utf bo eharjed for 2 of FTFRA (?oim a a
charga) Car 2 Jtapaaa ud form 8 • cfear|ad for 2 Mis).
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•26.
On the other hand, a single event or action (or lack of action) which can be
considered as two unlawful acts of FIFRA (section 12) cannot result in a civil penalty
greater than the statutory limit for one offense of FIFRA. For instance, a person can
be assessed a civil penalty of up to 55,000 for selling and distributing a product in
violation of a cancellation order. However, while the Agency considers a cancelled
product to be no longer registered, that same person should not also be assessed an
additional civil penalty of up to $5,000 for sale and distribution of the same
unregistered product. In this example the violation of the cancellation order is
dependent on the sale and distribution of the unregistered/cancelled product.
Another example of a dependent violation is multiple misbrandfftg on a single
product label! If a single product label is misbranded in one way or ten ways, as
defined by FIFRA section 2(q), it is still misbranding on a single product label and is
considered a single violation of FIFRA section 12(a)(1)(E). As a single violation of
FIFRA, the maximum civil penalty that may be assessM is $5,000. However, EPA may
assess a count of misbranding each time that a misbranded product is sold or
distributed. For example, a registrant who sells or distributes four distinct shipments ol
a misbranded pesticide product may be assessed a civil penalty of up to 520,000.
Voluntary Disclosure
In order to encourage voluntary disclosure of FIFRA violations, the Agency will
offer a 40% reduction of the civil penalty if the disclosure was made: (1) by the
violator*promptIy to EPA, or States with cooperative enforcement agreements (within
30 to 60 days of discovery by the violator]; (2) before the violation was discovered by
EPA or a State; (3) before an inspection was scheduled by EPA or a State; and, (4)
the violator immediately takes all the steps necessary to come into compliance, and
steps requested by the Agency to mitigate the violation.
The reduction for voluntary disclosure may be made prior to issuing the civil
complaint. The civil complaint should state the original penalty and the reduced
penalty and the reason for the reduction.
Adjusting the Proposed Civil Penalty in Settlement
Upon an answer to a civil complaint by the person charged (respondent), the
following circumstances may arise which may justify adjustment of the penalty proposed
in the civil complaint:
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-27-
Factual Changes . _ ;
Recalculation of the proposed penalty is appropriate if the respondent can
demonstrate that the size of business category, culpability, or other facts used to derive
the gravity adjustment values, from Appendix B are inaccurate. Adjustments to the
proposed civil penalty may also be appropriate if the respondent can demonstrate an
"inability to pay' the civil penalty (See "Ability to Continue in Business/Ability to Pay"
section of this policy). Where additional facts indicate to the Agency that the original
penalty is not appropriate, a new penalty shall be calculated consistent with the new
facts. The burden is on the respondent to raise those factors which may justify the
recalculation of the penalty.
Negotiations fnyolviiTg Chthr the Amount of the Penalty
In some cases the respondent may admit to all jurisdictional and factual
allegations charged in the complaint and may desire a settlement conference limited to
the amount of the proposed penalty. In the absence of "special circumstances," (as
discussed in the "Special Circumstances" section of this ERP), a settlement conferen&e
may be conducted to consider the amount of the proposed penalty.
Good Faith Adjustments .
During the course of settlement negotiations, the EPA may consider the
respondent's attitude or good faith efforts to comply with FIFRA to reduce the penalty
as much as_20_petcent below the proposed penalty, if such a reduction would serve the
public interest
In no case is such a reduction mandated, and in no case should such a reduction
occur in the absence of an appropriate showing by the respondent and finding by the
Agency. Additionally, any reduction on account of the attitude or good faith efforts
does not have to extend to the full 20 percent reduction. Further, the total civil
penalty may not be reduced by more than 20 percent below the proposed penalty
without a showing of "special circumstances" as discussed below.
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•27.
Factual Changes _ ,
Recalculation of the proposed penalty is appropriate if the respondent can
demonstrate that the size of business category, culpability, or other facts used to derive
the gravity adjustment values from Appendix B are inaccurate. Adjustments to the
proposed civil penalty may also be appropriate if the resoondent can demonstrate an
"inability, jo pa)& the dvfl-penalty (See "Ability toCbfiasuata BtfMfess/Ability to Pay"
section of tfciupolicy). Where additional tacts indicate urthe^Agency that the original
penalty is not appropriate, a new penalty shall be calculated consistent with the new
facts. The burden is on the respondent 10 raise those factors which may justify the
recalculation of the penalty.
Negotiations Involving Only the Amount of the Penalty
In some cases the respondent may admit to all jurisdictional and factual
allegations charged in the complaint and may desire a settlement conference limited to
the amount of the proposed penalty. In the absence of "special circumstances," (as
discussed in the "Special Circumstances" section of this ERP), a settlement conference
may be conducted to consider the amount of the proposed penalty.
Good Faith Adjustments :
In no case is such a reduction mandated, and in no case should such a reduction
occur in the absence ofan appropriate showing by the respondent and finding by the
Agency. Additionally, any reduction on account of the attitude or good faith efforts
does not have to extend to the full 20 percent reduction. Further, the total civil
penalty may not be reduced by more than 20 percent below the proposed penalty
without a showing of "special circumstances" as discussed below.
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•28-
Sp-Hal Circumstances/Extraordinary Adjustment
Should a case arise in which EPA determines that there are no grounds for
adjustment of the proposed civil penalty based on new financial information or other
facts, or on a showing of inability to continue in business, and that equity would not be
served by adjusting the proposed penalty by only the allowable 20 percent good faith
attitude adjustment, the Regional Program Division Director may approve an
With Conditions" agreement.
If a "special circumstances" reduction of the proposed civil penalty is granted,
the case file must include substantive reasons why the extraordinary reduction of the
civil penalty was appropriate, including: (1) setting forth the facts of the case; (2) why
the penalty provided from the FIFRA civil penalty matrices and gravity adjustment was
inequitable; (3) how all other methods for adjusting or revising the proposed penalty
would not adequately resolve the inequity; and, (4) the manner in which the extra-
ordinary adjustment of the penalty effectuated the purposes of the Act. The Regionaf
Program Division Director's written concurrence for the extraordinary reduction must
be incorporated into the case file. Additionally, a copy of the written justification for
the special circumstances reduction must accompany the consent agreement and final
order (CAFO), or consent agreement and consent order (CACO) which the Regions
send to the Office of Compliance Mpwooing.
Settlement With Conditions fSWCt
The Environmental Protection Agency (EPA) may choose to substitute part of a
civil penalty assessed for a violation of FIFRA for a specific environmentally beneficial
activity that would be performed by the Respondent. The Agency refers to the
settlement of a case under terms which commit the respondent to perform specified
acts in exchange for reduction of the penalty as "Settlement with Conditions (SWC)."
Under an SWC agreement, in exchange for a specified amount of the proposed
civil penalty, the violator agrees to take extensive and specific environmentally
beneficial activities, such as pollution prevention projects, risk communication,
remedying ground water hazards, clean-up operations, training, etc. These actions must
exceed those normally expected under the circumstances (actions in excess of those
required to correct the violation for which the violator was charged, and actions in
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•29-
excess of those already required by Federal/State/local laws), must be taken within a
specific time period, and will be strictly monitored by the Agency. It is the
responsibility of the Regional Program Office to monitor compliance with the SWC
agreement. Follow-up inspections should be conducted, as appropriate. If the Agency
is not satisfied that the conditions of the agreement have been met at the end of the
term, the full amount of the penalty is due.
A minimum cash penalty should always be collected from the violator regardless
of the value of the SWC activities. Further, steps must be taken to prevent a violator
from gaining an unwarranted tax advantage through income tax deductions of the cost
of the SWC activities. One method to do this is to calculate the net present after tax
value of the SWC activities (the Agency's BEN computer model may be used for this
purpose), and require that the violator pay a minimum cash penalty equal to that sum
of money, in addition to the SWC activities.
Settlements with Conditions should be employed with restraint. The SWCs
should not be used in a manner which encourages people to violate FIFRA until they
are discovered and then offer to correct actions in hope of a penalty reduction.
Further, a violator is not presumed to be entitled to an SWC and such relief is granted
at the.discretion of the Agency.
Criteria for Choosing an SWC
!
An SWC should be considered in the following circumstances:
v-
o Violations have been documented which warrant a civil penalty; and,
o The violations do not evidence wanton, knowing, or willful disregard for
regulatoiy requirements; and,
o The violator has exhibited a good-faith attitude toward solving the
noncompliance and has no history of non-compliance; and,
o .There are clear public benefits to use of an SWC; and
o An SWC acceptable to EPA can be negotiated.
An SWC should also be considered where the total proposed civil penalty
exceeds the ability to pay guidance, or when nonprofit entities are found to be in
violation of FIFRA.
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-3#-
Rixpnmea to Noncompliance with the SWC
Penalty Payment
If the respondent fails to adhere to the conditions of the SWC, the uncollected
penalty, or the uncollected portion of the penalty is due and payable within 60 days
from the date the conditions of the SWC were to be met. If the respondent refuses to
pay, the Agency may refer the action to the Department of Justice which may bring a
recovery action.
Reinspection and Additional Enforcement Action
Once the EPA determines that the conditions of the SWC have not been
fulfilled and so notifies the respondent, the EPA should reinspect the facility to
document any additional violations. When considering additional enforcement actions
in response to any violations discovered upon reinspection, the Agency may give
consideration to pursuing injunctive action. Clearly, in cases of serious violations where
administrative enforcement action cannot be expected to achieve compliance, an
injunction may be a desirable enforcement response.
Elements of an SWC
The Agency is examining the procedures for issuing SWC agreements and the
necessary contents of those agreements. When final guidance is available, we will
incorporate these guidelines into the FIFRA ERP. In the interim, the procedures
provided below should be followed:
An SWC like any FIFRA settlement, consists of: (1) a complaint and (2) a
consent agreement and final order (CAFO), or consent agreement and consent order
(CACO). It also includes: (3) a Penalty Mitigation Agreement and (4) a Penalty
Mitigation Order.
A civil complaint alleging violations of FIFRA and proposing a civil penalty must
be issued to. establish the Agency's allegations that violations have occurred and to
initiate any SWC negotiations. The complaint should be issued in the same format as
in any FIFRA administrative civil penalty action.
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The CAFO/CACO assesses a total civil penalty and disposes of the
administrative proceeding. In the CAFO/CACO, the respondent (1) admits the
jurisdictional allegations of the complaint, (2) admits the facts stipulated in the consent
agreement or neither admits nor denies specific factual allegations, (3) consents to the
assessment of a stated administrative civil penalty, and (4) waives its right to a hearing
and consents to the issuance of a final order which requires a payment of a civil
penalty.
The Penalty Mitigation Agreement sets forth the Compliance Program and
Schedule (CPS). Under this agreement and CPS, the respondent agrees to perform
specific remedial actions "by specific dates. If th» respondent successfully meets the
conditions of the penalty mitigation agreement, the EPA will not collect a specified
portion of the civil penalty.
The Penalty Mitigation Order formally mitigates a portion of the penalty and is
executed when the Agency is satisfied that the respondent has met the conditions
outlined in the CPS. If the respondent has not satisfied the conditions, the order
informs him that the payment of the previously assessed penalty is due.
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APPENDIX A
FIFRA CHARGES AND GRAVITY LEVELS
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A-l
FIFRA
SECTIQ1
FITS
JE&DE.
FIFRA CHARGES AND GRAVITY LEVELS
violation
¦LEVEL
12(a)(1)(A)
12(a)(1)(A)
12(a)(1)(B)
12(a)(1)(B)
12(a)(1)(C)
12(a)(1)(D)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(A)
12(a)(1)(E)
12(a)(1)(F)
2(q)(D(B)
1AA Sold or distributed a pesticide NOT REGISTERED
under section 3 or was CANCELLED or SUSPENDED,
which was not authorized by the Administrator.
IAB Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED or otherwise 'offered for
"sale," in any medium, a pesticide that was NOT
REGISTERED under section 3 or was CANCELLED
or SUSPENDED, other than in accordance with
Agency policy.
1BA CLAIMS made for a pesticide as part of sale or
distribution differed substantially bom those
accepted in connection with registration.
IBB Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED, or otherwise "offered for
for sale" in any medium, a REGISTERED PESTICIDE
product for an UNREGISTERED USE, other than in
accordance with Agency policy.
1CA Sold or distributed a pesticide whose COMPOSITION
DIFFERED from the composition represented in the
registration.
IDA Sold or distributed a pesticide which has not
been COLORED or DISCOLORED pursuant to
section 25(c)(3).
1EA Sold or distributed a pesticide or device which is
MISBRANDED in that the label has a statement design,
or graphic representation which is false or misleading.
1EB Sold or distributed a pesticide or device which is
MISBRANDED in that the pesticide is not contained
in a package or other container or wrapping which
conforms to the standards established pursuant to
section 29(c)(3) (e.g., not contained in child-
resistant packaging or safety containers).
-------
fifra charges and gravity levels
FIFRA
SECTION
FTTS
CODE
VIOLATION
_LE3$L
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(Q
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(D)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(E)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(F)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(G)
¦t*
12(a)(1)(E)
2(q)(l)(H)
12(a)(1)(E)
2(q)(2)(A)
12(a)(1)(E)
2(q)(2)(B)
1EC Sold or distributed a pesticide or device which is
MISBRANDED in that it is an imitation of, or is
offered for sale under the name of, another pesticide.
1ED Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not bear the
registration number assigned under section 7.
1EE Sold or distributed a pesticide or device which is
MISBRANDED in that any words, statements, or other
information required by the Act were not prominently
placed on the label in such a way as to make it
readable or understandable.
1EF Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not contain directions
for use necessary to make the product effective and to
adequately protect health and the environment
1EG Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not contain a warning
or caution statement adequate to protect health and
the environment
1EH Sold or distributed a non-registered pesticide
intended for export which is MISBRANDED in that the
label did not have a prominently displayed "Not
Registered for Use in the United States of America."
I EI Sold or distributed a pesticide which is MISBRANDED
in that the label did not bear an ingredient statement
on the immediate container which is presented or
displayed under customary conditions of purchase.
1EJ Sold or distributed a pesticide which is MISBRANDED
in that the labeling does not contain a statement
of the use classification for which the product was
registered.
-------
FIFRA CHARGES AND GRAVITY LEVELS
FIFRA FITS
SECTION CfifflE VIOLATION . L
12(a)(1)(E)
2(q)(2)(C)
12(a)(1)(E)
2(q)(2)(D)
12(a)(1)(E)
2(c)(1) -(3)
12(a)(2)(A)
12(a)(2)(B)(i)
1EK Sold or distributed a pesticide which is MISBRANDED
in that there is not a label affixed to the pesticide
container, and to the outside wrapper of the retail
package if the required information on the immediate
container cannot be clearly read, a label bearing all
of the following information: (i) the name and address
of the producer, registrant, or person for whom
produced; (ii) the name.' brand, or trademark under
which the pesticide is sold; (iii) the net weight
or measure of the content; and, when required by
regulation, (iv) the registration number assigned to
the pesticide and the use classification.
I EL Sold or distributed a pesticide which is MISBRANDED
in that the pesticide is sold in quantities highly
toxic to man and the label failed to bear a skull and
crossbones, and the word "poison" prominently in red
on a contrasting background color, and/or the label did
not bear a statement of practical treatment
1EM Sold or distributed a pesticide which is ADULTERATED
in that: (i) the strength or purity fails below the
professed standard of quality expressed on the
labeling; (2) any substance has been substituted
wholly or in part abstracted; or, (3) any valuable
constituent of the pesticide has been wholly or in
part abstracted.
2AA Penon DETACHED. ALTERED. DEFACED.
or DESTROYED, in whole or in part, any LABELING
required under the Act.
2BA Person refused to PREPARE, MAINTAIN, or SUBMIT
anv RECORDS required under sections 3, 7, 8, 11,
or 19.
12(a)(2)(B)(ii) 2BB Person refused to SUBMIT any REPORTS required by or
under section 5. 6, 7. 8, 11 or 19.
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A«4
FIFRA
SECTION
FITS
CQDE
FIFRA CHARGES AND GRAVITY LEVELS
violation
level
12(a)(2)(B)(ii)
12(a)(2)(B)(Ui)
12(a)(2)(C)
12(a)(2)(D)
12(a)(2)(E)
12(a)(2)(F)
12(a)(2)(F)
12(a)(2)(G)
12(a)(2)(H)
2BC A registrant refused to submit REPORTS under
section 6(a)(2) regarding UNREASONABLE ADVERSE
EFFECTS of their pesticide.
2BD Person refused to allow entry, INSPECTION, copying of
records, or sampling authorized by this Act
2CA Person gave a GUARANTY or undertaking provided for im
section 12(b) which was FALSE in any particular.
2DA Person used to their personal advantage or revealed
to persons other than those authorized by the Act any
INFORMATION acquired under the Act which is
CONFIDENTIAL
2EA Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED a RESTRICTED USE
PESTICIDE without indicating that the product was
restricted.
2FA Person DISTRIBUTED, SOLD, MADE AVAILABLE
FOR USE or USED a RESTRICTED USE PESTICIDE
for a purpose other than in accordance with section 3(d)
or regulations issued.
2FB Person distributed, sold, or made available for use,
or used, a RESTRICTED USE PESTICIDE without
fwint^imwg the RECORDS required by regulations
(A Notice of Warning should be issued for first-time
'partial" violations. Violations continuing subsequent
to the issuance of a civil complaint are to result in
a suspension - see "Denials, Suspensions, Modifications,
or Revocations of Applicator Certifications" section
of this ERP).
2GA Person USED a registered pesticide in a manner
inconsistent with its labeling.
2HA Person USED a pesticide which was under an
EXPERIMENTAL USE PERMIT contrary to the
provisions of the permit.
-------
1
1
2
1
2
1
3
2
2
A-5
FIFRA CHARGES AND GRAVITY LEVELS
FITS
£J2BE VIOLATION
2IA Person violated any order issued under section 13
(e.g.. STOP SALE USE OR REMOVAL ORDER
or SEIZURE).
2JA Person violated, any SUSPENSION ORDER issued under
section 6.
2JB Person violated any SUSPENSION ORDER issued under
section 3(c)(2)(B) or 4.
2KA Person violated any CANCELLATION ORDER issued
under the Act on the grounds of UNREASONABLE
ADVERSE EFFECTS.
2KB Person violated any CANCELLATION ORDER issued
under the Act on grounds OTHER THAN
UNREASONABLE ADVERSE EFFECTS.
2KC Person failed to submit a SECTION 6(g) NOTICE when
required.
2KD Person submitted a NOTABLY LATE SECTION 6(g)
NOTICE.
2KE Person submitted an INCOMPLETE or INCORRECT
SECTION 6(g) NOTICE.
2LA PRODUCED a pesticide or active ingredient subject to
the Act in an UNREGISTERED ESTABLISHMENT.
» Producer FAILED TO SUBMIT, or submitted
NOTABLY LATE, a REPORT to the Administrator,
under SECTION 7, which indicates the types
and amounts of pesticides or active ingredients
which they are currently producing, which they
produced during the past year, and which they
sold or distributed during the past year.
-------
A4
FTFRA CHARGES AND GRAVITY LEVELS
FIFRA FITS
crmnw CODE VIQIATON LEVE
12(a)(2)(L)
7(c)(1)
12(a)(2)(L)
7(c)(1)
2LC Producer submitted a LATE REPORT to the Administrator,
under SECTION 7, which indicates the types and amounts
of pesticides or active ingredients which they are
currently producing, which they produced during the
past year, and which they sold or distributed during
the past year (civil complaint issued only if the
producer does not respond to a Notice of Warning or
there is a subsequent violation within a three year
timeframe from the first violation).
2LD Producer submitted an INCOMPLETE SECTION 7
REPORT with MINOR OMISSIONS of the
requited information (civil complaint issued only
if the producer does not respond to a Notice
of Warning or there is a subsequent violation
within a three year timeframe from the fust
violation).
l2(a)(2)(L)
7(c)(1)
l2(a)(2)(L)
7(c)(2) *
12(a)(2)(M)
2LE Producer submitted an INCOMPLETE or a FALSE
SECTION 7 REPORT with MAJOR OMISSIONS
or ERRORS of the required information.
2LF Upon request of the Administrator for the purposes
of the issuance of section 13 Stop Sale Orders, a
PRODUCER FAILED TO PROVIDE the names and
addresses of the recipients of the pesticides
produced in any of his registered establishments.
2MA Person KNOWINGLY FALSIFIED all or any pan of an
application for registration, application for an
experimental use permit, any information submitted
under section 7, aitt records required to be maintained
by the Act, am report filed under the Act, or any
information merited as confidential and submitted to
the Administrator under anx provision of the Act
12(a)(2)(N) 2NA
A registrant, wholesaler, dealer, retailer, or other
distributor FAILED TO FILE REPORTS required
by the Act
2
-------
A-7
FIFRA
sector
I2(a)(2)(0)
12(a)(2)(P)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
i2(a)(2)(Q)
12(a)(2)(G)
12(a)(2)(R)
12(a)(2)(S)
12(a)(2)(S)
FITS
COPE
FIFRA CHARGES AND GRAVITY LEVELS
violation
20A Person ADDED A SUBSTANCE TO. or TOOK
a substance Cram a pesticide in a manner that may
defeat the purpose of this Act
2PA Person USED a pesticide in TESTS ON HUMAN BEINGS
in violation of the conditions specified by the Act.
2QA Person FALSIFIED INFORMATION RELATING to
the TESTING of any pesticide (or any of its ingredients,
rr-vabolitea, or degradation products) for which the
pe~son knows will be furnished to the Administrator,
or -will become a pan of any records required to be
maintained by this Act
2QB Person falsely represented compliance with the FIFRA
Good Laboratory Practice (GLP) regulations as a result
of a HIGH LEVEL GLP violation.
2QC Person falsely represented compliance with the FIFRA
Good Laboratory Practice (GLP) regulations as a result
of a MIDDLE LEVEL GLP violation.
2QD 14(a)(1) person falsely represented compliance with
the FIFRA Good Laboratory Practice (GLP) regulations
as a result of a LOW LEVEL GLP violation.
2QE 14(a)(2) person falsely represented compliance with
the FIFRA Good Laboratory Practice (GLP) regulations
as a result of a LOW LEVEL GLP violation.
2RA Person submitted DATA KNOWN TO BE FALSE in
support of a registration.
2SA Person sold, distributed, or used an UNREGISTERED
pesticide in violation of a REGULATION ISSUED UNDER
SECTION 3(a).
2SB Person violated any REGULATION ISSUED UNDER
SECTION 19.
XEVEI.
Gravity W*** for tltoc vtoUtma will bt tmignrri is tutacqueu ERP*.
-------
APPENDIX B
GRAVITY ADJUSTMENT CRITERIA
-------
0-1
APPENDIX 8
GRAVITY ADJUSTMENT CRITERIA
j VIOLATION »»
VALUE
| CIRCUMSTANCES
1
| GRAVITY OF HARM
1
| Pesticide
2
1
| Toxicity - Category I pesticides,
j Signal Word "Danger", restricted
j use pesticides (RUPs), pesticides
[ with flammable or explosive
| characteristics (Le., signal
| words "Extremely Flammable" or
| "Flammable"}, or pesticides that
j ape associated with chronic health
j effects (mutagenicity, oncogenicity,
j teratogenicity, etc.).
1
| Toxicity • Categories R through
j IV, signal word "Warning" and
| "Caution," no known chronic effects.
j Harm to Human
( Health
5
j Actual serious or widespread* harm
j to human health.
|
3
j Potential serious or widespread2
j harm to human health.
3
j Harm to human health is unknown.
1
1
Minor1 potential or actual harm to
human health, neither serious nor
widespread.
j Environmental
| Harm
5
i ,
) Actual serious or widespread'
j harm to the environment (e.g^
j crops, water, livestock, wildlife.
| wilderness, or other sensitive
j natural areas).
3
j Potential serious or widespread^
| harm to the environment
3
1
[ Harm to the environment is unknown.
I
j Minor' potential or actual harm to
j the environment, neither widespread
| nor substantial
.J ,
-------
B-2
VIOLATION
GRAVITY
MISCONDUCT
Compliance4
History
Culpability5
VALUE
2
2
0
CIRCUMSTANCES
If a violator is a 14(a)(1) person
with more than one prior violation
of FIFRA. and at least one prior
violation was a level 1 violation.
If a violator is a 14(a)(2) person
with more than two prior FIFRA
violations, and at least one prior
violation was a level 1 violation.
If a violator is a 14(a)(1) person
with more than one prior violation
of FIFRA. and no prior level 1
violations. If a violator is a
14(a)(2) person with more than
two prior FIFRA violations, and
no prior level 1 violations.
If a 14(a)(1) person, one prior
violation of FIFRA If a 14(a)(2)
person, two prior FIFRA violations.
No prior FIFRA violations.
Knowing or willful violation of the
statute/ Knowledge of the general
hazardousnesa of the action.
Culpability unknown.
Violation resulting from negligence.
Violation was neither knowing nor
willful and did not result from
negligence. Violator instituted
steps to correct the violation
immediately after discoveiy of
the violation.
-------
e-s
APPENDIX B FOOTNOTES
The frmiy adjotOKBl JRluia ia Appeadta B aboultf not be uied
penalties (or reoocdtaepiag or repotting violation* should be mmm
increased by as iacteoKat of JM (up to the tunuaty oanaua).
-vcordkeeping and reporting violations. Tfcerefort. firti-nae en.il
u the aiua value. while wbeequent prmliw should be
Far the purposes of Uut ERR. unow or «W«K»ad (una refers to actual or potential hana ctiicti doea aot meat ibe panoetets of
amor ham. aa iIbiiiIwI belwe.
For (be purpoaea of Uw ER?. minor ham tetoi ianoe hotory for the purpoaea of Appendix B. the violence muat have occurred wuhta (Ne yean of
the pteaeat vtoUuoo. Thia Ove-year period heps* oa the data o( a final ocder. corneal order, or psyneat of a avd penalty.
(c) Generally, mupMiw with multiple eaubMahaeata an tooudeied aa oae when compliance history. If one
eaubiiihawai at a oompany coamita a FIFRa vwtatioa. it eouau as tuetory when another eauMiahmeei of the uae
coapsay. aaywhera ia the eouauy. coomita another FTFRA vwUiml
EPA enforcement officials are aot w|uiwd to determine culpability at the tine the coapUiat ia aawd (especially if this informal tor
not readily available). EPA enforcement oflktali nay instead sssign a we^htiag (actor of 2 (culpability unk&ovn). n the uae of the
issuance of the ooapUiOL Culpability ad) u« taenia may be nco«u>dcred dunag tettleaeat negotiationa.
The Agency oav alao consider otaiaal procoedlap (or "knowing aad willful" vtolatiooa. See the "Criminal Proceedinp" teciion of :ms
ERF.
-------
APPENDIX C
SUMMARY OF TABLES
-------
CI
SUMMARY OF TABLES
nnu avn. penalty matwcex
WPRA ffignow w v»
S!ZC OP BUS 1Kits
FCFRA SECTION W.W
sue or WtUtt
LlVtU
I
II
111
IKVfL
1
It
III
level 1
5,000
S.000
S.000
level 1
1,000
1,000
1
1.000 |
level 2
S.000
4,000
3,000
level 2
1.000
800
400 |
level S
4.000
3,000
2,000
level 3
800
400
500 |
1
level 4
3.000
*7000
1,000
* Thit mam ti cmtf for uar « daofwwq
f cm/ paiaim
iautd mittwqutw to a
a 'fat Hi* oppticawf,
p*nab> of S3M
of wwiwig or in itm am of
to ttm ifrtwr* of a eml
SIZE OF BUSINESS CATEGORIES
i
n
m
over $1,000,000
$300,001 - S 1.000.000
SO • $300,000
Smftn wwwnffl »khwif
i
a
in
over $200,000
$50,001 . $200,000
SO - $50,000
••
• ••
TABLE 3
oRAvrnr aojuttvekt criteria
Tom gnwtr vnw
3 or edow
4
5
6
7
8 to 12
13
14
15
16
17 or aba*
Enforcement Remedy
No actios, Notice at Warning, or
50% reduction of maira value.*"
Reduoe matrix value 40%
Reduce matrix value 30%
Reduce matrix value 20%
Reduce matrix value 10%
Aiaeat matrix value
tocreaae matrix value 10%*"*
lacreaae matrix value 13%"**
Iocreaie matrix value 20%***
tocreaae matrix value 25%""*
Increaae matrix value 30%***
Um /tflpmdfr 8 »
50% rtducatm of
Manx Mkii em cmtf bt
Gim)t Va^ttx.
ancammatOt
to Ar actuary
-------
APPENDIX D
FIFRA CIVIL PENALTY CALCULATION
WORKSHEET
-------
D-l
FIFRA CIVIL PENALTY CALCULATION WORKSHEET
RESPONDS**
ADDRESS
DOCKET MO.
DATE
HV&iX A
1. Statutory violation
2. FITS Code
3. Violation Lavel
TaMt.2
4. Violator Category -
§14(a)(1) or 514 .) (2)
5. Size of Business -atagory
Tftfrlt 1
6. Base Penalty
h ¦ nwiH w n
7. Gravity Mjustments:
a. Pesticide Toxicity
b. Hunan Haras
c. Errvmatnental Harm
d. Ocnplianoe History
e. culpability
f. Total Gravity
Adjustment Vblue
(add item 7a - 7e)
Table 3
g. Percent Adjustnant
h. Dollar Adjustment
8. Final Penalty*
(itea 7h frcn itm 6)
Ccobined Total Penalty
(total of all Columns
for line 8, above)
PREPARED BV
count l count 2 count 3
count 4
*
:#
/.liW.V.V.V.'.V.V.W.WAViW.'
. /Vs..
' V*.
».V.'
.W.V.'." .v..-.V.', .v.
•.W.'.V.'.'.V.'.V.V.V.V.V.V.V.'/.V.W.
i V A- S AS
w vs
v>; -X
*¦ '
V ¦*
^ *
.•.v.v.v.v.v.-.'.v.'.'.v.'.'W.v'.v;.
W 7 K ' >
v
.'.V "¦>.
•>
'•iS ::::
* MOTE The Goal penalty
-------
-------
*4
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
jui 11 sa
OFFICE OF ENFORCEMENT
MEMORANDUM
Jul i 8. iS3l
SUBJECT: FIFRA Enforcement Policy - Interim Penalty Guidelines
The Pesticides and Toxic Substances Enforcement Division
is in the process of updating the current penalty guidelines
under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA). Before final revisions can be completed, however,
tnere is a need to develop interim guidelines governing the
use of remedies and the response to violations which were not
in existence at the time the current guidelines were published..
The Interim Guide!ines, attached to this memorandum,
address three areas which are not covered in the present
guidance and under which cases are currently arising:
1) The use of EPA's authority to revoke or suspend federally
issued applicator certifications;
2) The penalties which should be assessed against persons
who fail to maintain records concerning their use of restricted
use pesticides®(RUPs); and
3) The penalties which should be assessed agains.t persons
who use, or make available for use, any RUPs other than in
accordance with section 3(d) of FIFRA.
The Interim Guidelines do not represent a major departure
from the current system of determining appropriate penalties.
The Guidelines build upon existing standards for determining
the dollar amounts of civil penalties to be assessed against
TO:
Regional Enforcement Division Directors
Pesticide Branch Chiefs
-------
FIFRA ENFORCEMENT POLICY
INTERIM PENALTY GUIDELINES
Sections Affected:
FIFRA §§4 and 14
40 CFR Part 1 71.1 T
I s s Lies :
1) When, and for how long, should Federal applicator
certifications be suspended or revoked?
2) What is the appropriate penalty to assess against
certified commercial applicators who.fail to maintain
records concerning their use of restricted use
pesticides (RUPs)?
3) What is the appropriate penalty to assess against
persons who use, or make available for use, any RUP
other than in accordance with Section 3(d) of FIFRA?
Policy and Di-scussion
1 ) Suspending or Revoking Certifications
(a ) Generally.
FIFRA certification regulations (40 CFR Part 171.11) authorize
EPA to suspend, revoke, or modify federally issued applicator
certifications if the certificate holder violates FIFRA or regula-
tions promulgated thereunder.
The Offio® of Enforcement views an enforcement action
affecting certification as a strong measure, to be taken when the
"public health, interest or welfare warrants immediate action"
(40 CFR Part 171.11(f)(5)(i) ). Therefore, this policy statement
directs that actions to revoke or suspend certifications only be
taken in response to serious violations or against persons with
a history of noncomp1iance.
(b ) Rev ocati on.
The revocation of a certification not only deprives an
-------
-2-
violators of RUP-related requirements. In addition, the
criteria for deciding whether to revoke or suspend a certificate
affect only those cases arising in States, with federally
operated certification programs.
A. E. Conroy jtl ,/Oirector
Pesticides and Tloxfc .Substances
Enforcement u/v i s i on---
Attachment
-------
-2-
applicator of the authority to apply restricted use pesticides
for an indefinite period, but also, as opposed to suspension
actions, forces the applicator to take additional steps to reacquire
the certificate. Thus Regional personnel should only revoke a
certification where the violation has resulted in a fatality or
created an imminent danger of a fatality, where the violator's
certification has previously been suspended, or where a person has
made fraudulent records or reports, (40 CFR Part 171.11(f)(1)(iv)).
The term of a revocation should be not less than six months.
(c) Suspen s i on .
A Region considering invoking the less severe suspension
alternative must determine whether it is appropriate to pursue
a suspension action and for how long such suspension should
be in effect. The answers to these questions will depend upon
the gravity of the violation.
The appendix to this policy statement contains criteria for
assessing the gravity of a use violation . 1 The gravity of a use
violation is a function of (1) the risk of harm posed to human
health and the environment by the violation, (2) and the degree
of misconduct exhibited by the violator. (See Section 7C l.b.(2)(a)
of the FIFRA Case Proceedings Manual for background information on
analyzing gravity.) The Region should assign weightings, based on
the gravity criteria in the appendix, for each use violation
relative to the pesticide involved, the harm to human health
and/or the harm to the environment, the history of noncompliance,
1. For purposes of this policy, a use violation means any of the
acts described in 40 CFR Part 171.11(f)(1)(i) , (ii ) , and (v ) .
-------
-3-
and the culpability of the violator. The total gravity value thus
obtained will.be used to decide whether and for how long to
to suspend a certification, in accordance with the following
t a b T e : 2
Tota1 Grav i ty Value Enforcement Remedy
4 or below No action or Warning Citation
5-8 Suspension of u.p to 2 months
9-12 Suspension of between 2 and 4 months
13 or above Suspension of between 4 and 6 months
To determine whether the term of a suspension should be at
the higher end or at the lower end of the given ranges, the Regions
should consider any gravity-related factors not accounted for in
the appended gravity criteria. In addition, the Regions should
consider the degree to which the suspension will have an adverse
economic impact on the applicator. Applicators who will be minimally
affected by a suspension, such as those who normally apply very
little restricted use pesticides, should receive longer sus-
pensions than applicators whose day-to-day business activities
would be severely disrupted by the loss of their certifications.
Suspension actions should generally be pursued against indi-
vidual-applicators in lieu of Section 14(a) administrative money
penalties. This policy, however, does not preclude a Region from
The Office of Enforcement has decided not to distinguish between ¦
commercial and private applicators for purposes of this policy.
Consideration of applicator status is inherent in the policy in
that suspensions have a more substantial impact on commercial
applicators, affecting their primary business activity.
-------
-4-
foregoing a suspension action against the applicator in favor
of issuing a warning letter or assessing a monetary or criminal
penalty, or from assessing a monetary penalty against the firm
employing the applicator in addition to suspending the certifica-
tion of the applicator himself.
It is possible for commercial applicators to violate RUP
recordkeeping requirements in addition to use restrictions. (See
40 CFR Part 171 .1 1 (c) (7) ; 4.0 CFR Part 1 71.1 1 ( f) (1 ) (i i i ) .)
These violations do not lend themselves to analysis utilizing
gravity of harm criteria. Consequently, OE's interim policy
is to base decisions to suspend the certifications of persons
who fail to maintain RUP records solely on gravity, of conduct
considerations. Up to two month certification suspensions
may be. assessed for the second independent violation resulting
from the fai 1 ure -to. mai ntai n RUP records. For each additional
violation, two months may be added to the ter.r;- of the suspension
up to a limit of six months. As noted in Part 1(b) above, In
cases where tha violation resulted from the keeping of fraudulent
records, i.e., where the violator intentionally concealed or
misrep resented the true circumstances and extent of RUP use,
the violator's certification may be revoked in response to the
i n i t i a 1 i n f r a c t i o n .
If EPA decides to suspend a certification, the applicator
must be notified of the time period during which the suspension
will be effective. In order for the suspension to function as
a deterrent, the suspension should take effect during the time
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-5-
when the applicator is most likely to be applying restricted
use pesti ci des.3
2) Failing to Maintain RUP Records
The Office of Enforcement has not yet developed a final civil
penalty policy governing the failure to keep RUP records as
required in 40 CFR Part 171.11(c)(7), (a violation of Part
171 .11(f)(1)(i i i)). As interim guidance , Regional personnel
should utilize the matrix for Section 8(a) recordkeeping violations
found in the current penalty guidelines (Charge Code E39). This
matrix is as follows:^
Size of Business Category
I II III IV V
Penalty Amount 450 1050 2310 3570 4200
Restricted use pesticide recordkeeping violations may
result from the failure to maintain some or all of the infor-
mation required by Part 171.11(c)(7). Warning Citations
should be issued in response to first-time "partial" record-
keeping offenses. Failure to maintain any of the required RUP
records, and "partial" recordkeeping violations following a
warning, should result in assessment of a civil penalty. Continued
violations may be addressed by a suspension action in accordance
with the policy set forth above.
3. EPA may take actions affecting certification other than revo-
cations and total suspensions. Enforcement policy on the use
of such actions (i.e., modifications, partial suspensions, and
denials of certificates), will be contained in later guidance.
4. Only.one matrix is needed since this violation, by definition,
implicates only commercial applicators.
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The Agency views the making of fraudulent records, as defined
above, to be a more serious violation than the failure to maintain
RUP information. Therefore, when assessing a monetary penalty for
a violation of Part 171.11(f){1)(i v ), the Regions should utilize
the following matrix:
Size of Business Category
I II III IV V
Penalty Amount 1 250 1 850 31 fO 4370 5000
3) Using RUPs, Or Making RUPs Available For Uss, Other Than
in Accordance With Section 3(d) of FIFRA
Section 12(a)(2)(F) of FIFRA provides that "it shall be
unlawful for any person to make available for use, or to use,
any registered pesticide classified for restricted use for some
or all purposes other than in accordance with Section 3(d)."
Section 3(d) prohibits the use of RUPs by non-certified applicators.
In addition, with certain except ions,5 persons who make RUPs
available for use.by non-certified applicators are subject to
penalties under Section 12.
As- interim ' policy, we will make use of the existing matrix
governing another type of use violation, i.e., use inconsistent
with labelling (Section 12(a)(2)(G)). The Section 12(a)(2)(G)
matrix (charge code E28) in the current penalty guidelines is
divided into three levels, depending on the adverse effects
likely to result from the violation. Since Section 12(a)(2)(F)
5. See the Prov i s o in Section 12(a)(2)(F) and the preamble to
to. the RUP classification regulations, Part IX, 43 FR 5783,
February 9, 1978. To date, no States have issued regulations
which would enable persons to sell RUPs under this Proviso.
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RUP violations necessarily involve pesticides which may cause
"unreasonable adverse effects on the environment" (Section
3 ( d ) ( 1 ) ( B ) , ( C ) ) , we will utilize the uppermost level of the
matrix, which reads as follows:^
Size of Business Category
I II III IV V
Penalty Amount 500 1250 2750 4250 5000
Thus in determining whether to assess a penalty for Section
12(a)(2)(F) violations, and the amount of such penalty, the
Regions should consult existing guidelines governing Section
12(a)(2)(G) violations.
6. As is the case with RUP recordkeeping violations, only one
matrix is needed since this type of violation involves only
commercial applicators.
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
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APPENDIX
Criteria For Determining The Gravity Of A Use
Violation For Purposes Of A Certification Action
I. GRAVITY OF HARM
A. Pesticide
B. Harm to Human
Health
C. Env i ronmenta1
Ha rm
Weighting
3
1
Act i v i ty
Toxicity category I pesticides,
restricted use pesticides, or
pesticides that have been demon-
strated to be- associated with
chronic health effects (muta-
genicity, oncogenicity, terato-
genicity, e-t-c.)
Toxicity categories 11 - I V, no
known chronic effects
Serious or widespread actual harm
to human health
Serious or widespread potential
harm to human health
«
Minor potential or actual harm to
human health, neither serious nor
widespread
Substantial or widespread actual
harm to the environment, i.e.,
crops, water, livestock, wildlife,
wilderness, or other sensitive
natural areas
Substantial or widespread
potential harm to the environment
II. GRAVITY OF CONDUCT
A . Noncompli ance
H i s t o ry
Minor harm to the environment,
neither widespread nor substantial
More than one prior violation
of FIFRA by the applicator
One prior violation
No prior violations
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A-2
B. Culpabi1i ty 4
2
0
Knowing or willful violation
Violation resulted from negli-
gence
Violation was not knowing or
willful and did not result
from negligence; good faith
efforts made to comply with
t he 1 aw
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vito Sr4,)
/ "
im
mr*
\
3
V
MEMORANDUM
DATE:
SUBJECT:
FROM:
TO:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C.
jul i o wg
OFFICE OF
ENFORCEMENT
July 5,
Penalty Polic
Michael JL^Itfalker
Acting Associate Enforce:
Toxics Litigation Divisi6n
Hon. Henry 3. Frazier, III
Chief Administrative Law Judge
Attached for your review and distribution are seven copies of
the revised FIFRA penalty policy which was issued by the Office of
Compliance Monitoring (our program client office) on July 2, 1990.
This policy is immediately effective and supersedes the 1974 policy
which was published in the Federal Register. A notice of
availability for this new policy will be published in the Federal
Register shortly.
It is our expectation that cases filed after July 2, 1990 will
utilize and reference this revised penalty policy.
Attachments (7)
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ENFORCEMENT RESPONSE POLICY
FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
Office of Compliance Monitoring
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
July 2, 1990
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TABLE OF CONTENTS
INTRODUCTION
OVERVIEW OF THE POLICY 2
DETERMINING THE LEVEL OF ACTION 3
Notices of Detention 4
Notices of Warning 4
Section 14(a)(2) Notices of Warning 4
Sections 9(c)(3) and 14(a)(4) 5
Stop Sale, Use, or Removal Orders (SSURO) 5
Mandatory Issuance of a SSURO 6
Discretionary Issuance of a SSURO 7
Use of a SSURO for Minor Violations 7
Seizures 7
Injunctive Relief 8
Civil Administrative Penalties 9
Denials, Suspensions, Modifications, or
Revocations of Applicator Certifications 10
Denial/Revocations 11
Suspensions 11
Criminal Proceedings 12
Parallel Criminal and Civil Proceedings 13
State and Federal Roles in Criminal Enforcement
of FIFRA 13
FIFRA's Relationship to Other Federal
Criminal Lavs 14
Recalls 14
Voluntary and Mandatory Recalls 14
Formal and Informal Recalls 15
Press Releases/Advisories 16
ASSESSING ADMINISTRATIVE CIVIL PENALTIES 17
Computation of the Penalty 17
Use of the FIFRA Civil Penalty Matrix 18
Table 1 19
Size of Business 20
Table 2 20
Gravity of the Violation 21
Table 3 22
Gravity Adjustments for Recordkeeping and
Reporting Violations 22
Ability to Continue in Business/Ability to Pay 23
4% of Gross Sales 23
ABEL 2 3
Independently Assessable Charges 2 5
Voluntary Disclosure 26
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-ii-
Adjusting the Proposed Civil Penalty in Settlement 26
Factual Changes 27
Negotiations Involving Only the Amount of
the Penalty : 27
Good Faith Adjustment 2 7
Special Circumstances/Extraordinary Adjustments ....2 8
Settlement With Conditions (SWC) 2 8
Criteria for Choosing an SWC 29
Responses to Noncompliance With an SWC 3 0
Penalty Payment 30
Reinspection and Additional Enforcement 3 0
Elements of an SWC 30
APPENDIX A - FIFRA CHARGES AND GRAVITY LEVELS A-l
APPENDIX B - GRAVITY ADJUSTMENT CRITERIA B-l
APPENDIX C - SUMMARY OF TABLES C-l
APPENDIX D - FIFRA CIVIL PENALTY CALCULATION WORKSHEET D-l
PROGRAM SPECIFIC SUPPLEMENTS TO THE FIFRA ERP
ERP for the FIFRA Section 7(c) Pesticide Producing
Establishment Reporting Requirements
ERP for the FIFRA Good Laboratory Practice Standards
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07/02/90
ENFORCEMENT RESPONSE POLICY FOR THE
FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT (FIFRA)
INTRODUCTION
This document sets forth the procedures and criteria that will be used to
determine the appropriate enforcement response for violations of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FIFRA Enforcement
Response Policy (ERP) is designed to provide fair and equitable treatment of the
regulated community by ensuring that similar enforcement responses and comparable
penalty assessments will be made for comparable violations. The policy is designed to
provide for swift resolution of environmental problems and to deter future violations of
FIFRA by the respondent as well as other members of the regulated community.
This policy supersedes the previous FIFRA Civil Penalty Assessment Guidelines
published in the Federal Register on July 31, 1974 (39 FR 27711). There have been
many amendments to the statute, as well as EPA rulemaking, since the 1974 FIFRA
Civil Penalty Assessment Guidelines, which are incorporated into this revised FIFRA
ERP. Also superseded by this FIFRA ERP are: the 1983 Level of Action Policy
published as section 2 of Chapter 5 of the FIFRA Compliance/Enforcement Guidance
Manual; the June 8, 1981 Guidance for the Enforcement of the Child-Resistant
Packaging Regulation; and the June 11, 1981 FIFRA Enforcement Policy - Interim
Penalty Guidelines.
Except for the civil penalty assessment matrix, the February 10, 1986 FIFRA
Section 7(c) Enforcement Response Policy remains in effect, and is to be used to
determine the appropriate enforcement response forFIFRA section 7(c) violations.
The matrix setting forth the penalties in this policy should be used instead of the
matrix in the February 10, 1986 policy. Additional supplements to the FIFRA ERP
will be forthcoming which will more clearly discuss the appropriate enforcement
response for violations of other specific program requirements, such as the FIFRA
Good Laboratory Practice (GLP) Standards and the FIFRA section 19 regulations.
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OVERVIEW OF THE POLICY
This FIFRA Enforcement Response Policy (ERP) is divided into three main
sections. The first section, "Determining the Level of Action," briefly describes the
Agency's options for responding to violations of FIFRA. Section 2 of this ERP,
"Assessing Administrative Civil Penalties," elaborates on the Agency's policy and
procedures for calculating civil penalties to be assessed against, persons who violate
FIFRA. Section 2 also contains the Agency's policy for negotiating a "settlement with
conditions" for civil penalties issued under FIFRA. The third section of this policy
contains the appendices necessary for calculating civil penalties. The four
appendices to this ERP are: (1) Appendix A - FIFRA Charges and Gravity Levels;
(2) Appendix B - Gravity Adjustment Criteria; (3) Appendix C - The Summary of
Tables; and, (4) Appendix D - The FIFRA Civil Penalty Calculation Worksheet.
Guidance on the appropriate enforcement response for violations of specific
FIFRA programs, such as the FIFRA Good Laboratory Practice Standards,* FIFRA
section 19 recall requests,* or FIFRA section 7(c) Pesticide Producing Establishment
Reporting Requirements, should be attached as additional appendices, and used in
conjunction with the overall FIFRA ERP.
Enforcezaetu reapouc potidc* for the Good Laboratory Practice Standard* and the FIFRA teaioo 19 refutations
will be forthcoming
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DETERMINING THE LEVEL OF ACTION
Once the documentation of a FIFRA violatic is complete, the appropriate level
of action called for by the severity of the violation needs to be selected. These levels
of response include:
o Notices of Detention under section 17(c);
o Notices of Warning under sections 9(c)(3), 14(a)(2), and 14(a)(4);
o Stop Sale, Use, or Removal Orders under section 13(a);
o Seizures under section 13(b);
o Injunctions under section 16(c);
o Civil administrative penalties under section 14(a);
o Denials, suspensions, modifications, or revocations of
applicator certifications under 40 CFR Part 171;
o Criminal referrals under section 14(b); and
o Recalls.
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Notices of Detention
A shipment of a pesticide or device being imported into the United States
cannot be brought into the country until EPA makes a determination of the
admissibility of that shipment. However, under the U.S. Customs' regulations for the
enforcement of section 17(c) of FIFRA (19 CFR Part 12.110 - 12.117), subsequent to
the receipt of a Notice of Arrival completed by the Administrator, the District Director
of Customs may release a shipment to the importer or the importer's agent before an
EPA inspection of the shipment. Such a release occurs onJy upon execution of a bond
in the amount of the value of the pesticide or device, plus duty. When a shipment of
pesticides is released under bond, the shipment may not be used or otherwise disposed
of until the Administrator has determined the admissibility of that shipment. Should
the shipment subsequently be refused entry and the importer or agent fails to return
the pesticide or device, the bond is forfeited.
Section 17 of FIFRA authorizes EPA to refuse admission of a pesticide or
device being imported into the United States if EPA determines that such pesticide or
device violates any provisions of the Act. This refusal is known as a Notice of
Detention and Hearing. Upon receiving a copy of the notice, the Department of the
Treasury, through the Customs Service, will refuse delivery to the consignee. If the
consignee has not requested a hearing, or has not exported the pesticide or device
within 90 days from the date of the notice, the Customs Service will oversee destruction
of the pesticide or device.
Notices of Warning ;
FIFRA sections 14(a)(2), 14(a)(4), and 9(c)(3) provide EPA with the authority
to respond to certain violations of FIFRA with a Notice of Warning to the violator.
Section WaM2\ Notices of Warning ,
Under section 14(a)(2) of FIFRA, a written warning for a violation of FIFRA
must be issued to a private applicator or other person not covered by section 14(a)(1)
prior to the assessment of a civil penalty. Applicators who apply a registered general
use pesticide as a service in controlling pests but who do not deliver any unapplied
pesticides ("for hire" applicators), are also included in section 14(a)(2) but are not
subject to this limitation. A "for hire" applicator may be assessed a penalty up to $500
for the first offense.
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-s-
Sections 9rand 14faH4)
Section 14(a)(4) of FIFRA states that EPA may choose to issue a Notice of
Warning in lieu of a civil penalty if EPA determines that the violation occurred despite
the exercise of due care or the violation did not cause significant harm to health or the
environment. Section 9(c)(3) also permits the EPA to issue a written Notice of
Warning in lieu of instituting a proceeding for minor violations of FIFRA if the
Administrator believes that the public interest will be adequately served through this
course of action.
Generally, a violation will be considered minor, and a section 9(c)(3) notice of
warning may be issued in lieu of a civil complaint if the total "gravity adjustment
value", as determined from Appendix B of this ERP, is less than three (see the section
of this ERP entitled "Gravity of the Violation" and Appendix B, "Gravity Adjustment
Criteria"). A Notice of Warning may also be appropriate for certain first-time record
keeping violations as listed in Appendix A of this ERP (e.g., late section 7 reports).
Stop Sale. Use, or Removal Orders (SSURO)
Section 13 of FIFRA provides EPA the authority to issue a Stop Sale, Use, or
Removal Order (SSURO) to any person who owns, controls, or has custody of a
pesticide or device, whenever EPA has reason to believe on the basis of inspection or
tests that: (1) a pesticide or device is in violation of any provision of the Act; (2) a
pesticide or device has been or is intended to be distributed in violation of the Act; or,
(3) when a registration of a pesticide has been cancelled by a final order or has been
suspended. A civil penalty should generally be assessed in addition to the SSURO
when a violation of FIFRA has occurred.
A SSURO is among the most expedient and effective remedies available to EPA
in its efforts to prevent illegal sale, distribution, and use of pesticides. Its advantages
over other actions (such as seizures) are that: (1) it may be issued whenever EPA has
reason to believe that the product is in violation of the Act; (2) it is easier to prepare
and issue than a seizure; (3) the SSURO has an effect on all of the product under the
ownership, custody, or control of the individual receiving the SSURO regardless of
where the product is located; (4) the SSURO can be written so as to include future
amounts of the product that may come into custody of the person on whom the
SSURO is served; and, (S) it can easily be adapted to particular circumstances.
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As per the FIFRA Compliance Program Policy Number 3.9, issued on July 6,
1987, when a SSURO is issued to a basic registrant with regard to a registered
pesticide product, the terms of the SSURO are equally applicable to the supplemental
registrants of the product.
Mandatory Issuance of a SSURO
A SSURO is to be issued against persons who own, control, or have custody of
pesticides in the following categories:
Pesticides for which there is reason to believe that there is a potential hazard to
man or the environment because: (1) they are not registered, or are so over-
formulated, underformulated, or adulterated, as to present a serious health
hazard; or, (2) they are packaged in improper or damaged containers, or are so
inadequately labeled, as to make safe or effective use unlikely or impossible.
Pesticides or devices with labeling that is materially misleading or fraudulent, and
if followed by a user, is likely to cause a life-endangering health hazard or
serious adverse environmental effects (a pesticide lacking a restricted use label is
an especially serious labeling violation). This provision includes labeling for
products that: (1) are ineffective for the purposes claimed; (2) are so chemically
deficient as to affect deleteriously the product's efficacy; or, (3) bear false or
misleading safety claims.
Pesticides or hazardous devices* that are in violation of the Act and are the
subject of a recall, but which the responsible party refuses to remove, is
recalcitrant in removing, or is unable to remove from the channels of trade.
Pesticides or hazardous devices that are in violation of the Act and for which a
civil penalty has been issued but which have not been brought into compliance.
Pesticides which have been suspended under FIFRA section 6.
* A hazardous device a one pccKnting a direct threat 10 huaaa health or the environment ty its ibc (e.g_, a water treatment device
whole labeling makes fabe, or fraudulent claim to purity m well water or other* untreated water supplies). For
Doahazaidoua devices (e^ an electromagnetic rodent repelling device) that are mahtaaded. Agency policy a to ooapiete civil penalty
proceeding* before issuing a SSURO. See December 19. 1979 Memorandum: "Enforcement Actions Concerning Nonhazardoui
Pesticide Devices."
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Discretionary Issuance of a SSURO
The EPA may also issue a SSURO in cases where there is reason to believe a
product "either is in violation of the Act or that the product has been or is intended to
be distributed or sold in violation of the Act, and . the gravity of the violation is less
than that required for issuance of a mandatory SSURO. The EPA may also issue a
SSURO if a product has been cancelled under any section of the Act, or suspended
under FIFRA sections 4 or 3(c)(2)(B), and the existing stock deadlines have occurred
at that level of sale, distribution, or use.
Use of a SSURO for Minor Violations
While EPA will usually reserve the use of a SSURO for relatively serious
violations, the need to issue a SSURO may arise in certain cases involving minor
violations. For example, in the face of continued and repeated minor violations, or
when several minor violations appear on the label, EPA may decide to issue a SSURO
to ensure that the product will be distributed or sold in compliance with the Act.
Seizures ; ;
Section 13(b) of FIFRA gives EPA the authority to initiate in rem condemnation
proceedings in U.S. District Court. Once a Court grants the Agency's request for
authbrity to conduct a seizure, FIFRA section 9(b)(3) authorizes officers or employees
duly designated by the Administrator to obtain and execute warrants for the purpose of
seizing any pesticide or device that is in violation of the Act. Seizures may be
executed with the assistance of the U.S. Marshal.
Under FIFRA section 13(b), EPA may initiate seizure actions in District Court
against any pesticide or device that is being transported or, having been transported,
remains unsold or in original unbroken packages, or that is sold or offered for sale in
any State, or that is imported from a foreign country, if: (1) a pesticide is adulterated
or misbranded; (2) a pesticide is unregistered; (3) a pesticide has labeling which does
not bear the information required by the Act; (4) a pesticide is not colored or
discolored as required; (5) a pesticide bears claims or directions for use that differ
from those made in connection with its registration; (6) a device is misbranded; or,
(7) a pesticide or device causes unreasonable adverse effects upon the environment,
even when used in accordance with the requirements imposed by the Act
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The previous examples are similar to those circumstances that would lead the
Agency to issue a SSURO. Because a SSURO can be issued in less time and with less
preparation than that required for a seizure, the SSURO is the preferred enforcement
remedy in terms of expediency. Nevertheless, the Agency should consider initiating a
seizure in the following circumstances:
o The Agency has issued a SSURO, but the recipient of the order has not
complied with it;
o The Agency has reason to believe that a person, if issued a SSURO, will not
comply with it;
o There exists a pesticide so hazardous that it should be removed from the
marketplace, place of storage, or place of use to prevent any chance of
harm to human health or the environment;
o The seizure will be used to support a recall; or
o It is necessary to dispose of products being held under a SSURO for which
the responsible party has taken no corrective action and has expressed an
intent not to take corrective action.
Injunctive Relief
Section 16(c) of FIFRA gives EPA the authority to initiate injunctive actions
before the U.S. District Court. These actions may consist of permanent injunctions,
preliminary injunctions, or temporary restraining orders.
Because an injunction is an extraordinary form of relief, the Agency's arguments
must be clear and compelling. In initiating a permanent injunction action, EPA must
indicate to the court that: (1) the Agency's administrative or other judicial enforcement
remedies would be inadequate either at restraining the violation or at preventing
unreasonable risk to human health or the environment; (2) the Agency has already
diligently exercised all appropriate administrative remedies (such as SSUROs and
civil penalties), yet the violation or threat of a violation continues unabated; or
(3) irreparable injury, leas, or damage will result if the relief sought is not granted.
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In the case of a preliminary injunction or temporary restraining order, the
Agency must additionally demonstrate that: f IV immediate and irreparable injury, loss,
or damage will result if the requested relief is not granted; and, (2) there is a
likelihood of Agency success at trial, based on the facts before the court.
Under FIFRA, there are a number of specific circumstances that may justify
injunctive relief. These include but are not limited to:
o The violation of a section 6 suspension or cancellation order;
o The violation of a SSURO where a civil penalty or criminal prosecution
would not provide a timely or effective remedy to deter further violations;
o There is continued production (in violation of the FIFRA section 7
requirements), shipment, sale, distribution, or use of an unregistered
pesticide after the Agency has taken civil or criminal action;
o A person continues to sell, distribute, or make available for use a restricted
use pesticide (RUP) other than in accordance with FIFRA section 3(d),
after the Agency has already exercised an enforcement remedy;
o A person continues to violate the FIFRA section 17 import or export
requirements after the Agency has already exercised an enforcement remedy;
and,
o A person continues to use a pesticide in a manner inconsistent with its
labeling, in a manner contrary to an experimental use permit, or repeats any
violation of FIFRA, after the Agency has already exercised an enforcement
remedy.
Civil Administrative Penalties
FIFRA section 14(a)(1) states that a registrant, commercial applicator,
wholesaler, dealer, or other distributor may be assessed a civil penalty of up to $5,000
for each violation of FIFRA. Section 14(a)(2) allows the Administrator to assess a
private applicator or other person up to $1,000 for each violation of FIFRA,
subsequent to receiving a Notice of Warning or a citation for a prior violation (the
prior warning or citation may have been for the same or different FIFRA violation).
Additionally, section 14(a)(2) states that an applicator who applies a registered general
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-10-
use or unclassified pesticide as a service in controlling pests but does not deliver any
unapplied pesticide (a "for hire applicator") may be assessed a civil penalty of not more
than $500 for the first offense of FIFRA, and $1,000 for each subsequent offense.*
A civil penalty is the preferred enforcement remedy for most violations. A civil
penalty is appropriate where the violation: (1) presents an actual or potential risk of
harm to humans or the environment (SSUROs or injunctive relief should be pursued in
addition to a civil penalty if the harm is extreme or imminent), or would impede the
Agency's ability to fulfill the goals of the statute; (2) was apparently committed as a
result of ordinary negligence (as opposed to criminal negligence), inadvertence, or
mistake; and the violation either: (a) involves a violation under the Act by any
registrant, commercial applicator, "for hire" applicator, wholesaler, dealer, retailer, or
other distributor (no prior warning is required by FIFRA for violators in this category);
or, (b) involves a private applicator or other person not listed in above and who has
received a prior warning or citation for a FIFRA violation.
Denials, Suspensions, Modifications, or Revocations
of Applicator Certifications
The regulations relating to the certification of pesticide applicators (40 CFR Part
171) authorize EPA to deny, suspend, or revoke a federally issued applicator
certification if the holder of the certification violates FIFRA or its regulations. The
Agency views an enforcement action affecting certification status as a very strong
measure, to be taken only when the "public health, interest or welfare warrants
immediate action" [40 CFR Section 171.11(f)(5)(i)]. Therefore, EPA will deny,
suspend, modify, or revoke a federal certification only in response to serious violations
or against persons with a history of noncompliance.
Anv applicator, including a tot bite applicator, who bokta or applies aa unreaiatettd peniode to provide a wrrioe of
comroUini peatawithout delivering any unapplied pcaiirtde 10 any person ao aerved, will be eooaidcted a dinributor of
peiticidea and will be nibject to tbe higher penalriea aet forth in aectiona 14(aXl) FIFRA.
Arw applicator, other than a private applicator, who use* or anpetviaei U»e nae of a rettriaed uae pettiddc (RUP),
whether or not that applicator ia oeniQed, i» a own menial applicator and if subject to the higher prnaliira aet forth in
Mxtioes 14(aXl) and 14(bXl) of FIFRA.
Anv applicator, induding aa applicator who ia oeniQed, who bolda or apptiea a general uae pentode (GUP) or an
peatibde in violation of FIFRA for that pqticidc will be subject to tbe lower penahiea let forth in FIFRA
•ectioda 14(aX2) and 14(b)(2).
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-11-
Denial/revocations
The denial or revocation of a certification not only deprives an applicator of the
authority to apply restricted use pesticides but also, as compared to suspension of a
certification, forces the applicator to take additional steps to acquire or re-acquire
certification. In addition, the Agency will not consider an application to acquire or re-
acquire certification for at least six months following denial or revocation. Therefore. EPA
will deny or revoke a certification where: (1) a violation resulted in a fatality or created an
imminent danger of a fatality; (2) a violation resulted in severe damage to the environment
or created an imminent danger of severe damage to the environment; (3) a misuse
violation has resulted in significant contamination of food and water; (4) the violator's
certification has been suspended as a result of a previous serious violation; or (5) a person
has maintained or submitted fraudulent records or reports.
If EPA pursues an action to deny, revoke, or modify an applicator's certification,
EPA will notify the applicant or federal certificate holder of: (1) the ground(s) upon which
the denial, revocation, or modification is based; (2) the time period during which the
denial, revocation, or modification is effective, whether permanent or otherwise; (3) the
conditions, if any, under which the individual may become certified or recertified; and
(4) any additional conditions EPA may impose. EPA must also provide the federally
certified applicator an opportunity to request a hearing prior to final Agency action to
deny, revoke, or modify the certificate.
Suspensions ;
Generally, the Agency will pursue the less severe alternative of suspending an
applicator's federal certification in response to violations by applicators who have
previously been issued a civil complaint for a violation of FIFRA. The Agency will
suspend an applicator's certification for up to four months for the second independent
violation of FIFRA.* For each additional violation, two months may be added to the
term of suspension up to a limit of eight months. The exact length of the suspension
(within the limits stated above) should result in an economic loss to the applicator of at
least the statutoiy maximum civil penalty that could have been assessed.
For puxpoeea of (hit at the policy, EPA will not diulnguttli between commercial and private appticaton.
Cooudemioa of applicator tutus ia inherent ia the policy is that wspeaaioos K*ve a mote substantial impact on
commercial appticaton. affecting tbdr primary butioea activity.
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If EPA decides to suspend certification, it must notify the applicator of the
grounds upon which the suspension is based, and the time period during which the
suspension will be in effect. In order for the suspension to function as a deterrent, the
suspension should take effect during the time when the applicator is most likely to be
applying restricted use pesticides.
Generally, a suspension is pursued against an individual applicator for a
subsequent offense in addition to the issuance of a civil penalty against the employer.
EPA may also suspend certifications of commercial applicators who violate
restricted use pesticides recordkeeping requirements (see 40 CFR 171.11(c)(7); 40 CFR
171.11(f)(lJ(iii)]. The Agency will assess suspensions of up to two months for the
second independent violation resulting from the failure to maintain restricted use
pesticides records. For each additional violation, two months may be added to the
term of the suspension up to a limit of six months. In cases where the violation
involved keeping fraudulent records (i.e., where the violator intentionally concealed or
misrepresented the true circumstances and the extent of the use of restricted use
pesticides), EPA may revoke the violator's certification in response to the initial
infraction.
Criminal Proceedings
Section 12 of FIFRA specifically lists the unlawful acts that are subject, not only
to civil and administrative enforcement, but also to criminal investigation and penalties
(see Chapter 20, "FIFRA Criminal Enforcement," of the Pesticides Inspection ManuaD.
Section 14(b) of FIFRA (7 U.S.C 1361) provides the authority to proceed with
criminal sanctions against violators of the Act, as follows:
o A registrant, applicant for a registration, or producer who knowingly violates
the Act is subject, upon conviction, to a fine of not more than $50,000 or
imprisonment for up to 1 year, or both.
o A commercial applicator of a restricted use pesticide, or any other person
not described above who distributes or sells pesticides or devices, who
knowingly violates the Act is subject, upon conviction, to a fine of not more
than $25,000 or imprisonment for up to 1 year, or both.
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o A private applicator or other person not included above who knowingly
violates the Act is subject, upon conviction, to a fine of not more than
$1,000, or imprisonment for not more than 30 days, or both.
In addition, pursuant to the Alternatives Fines Act (.18 U.S.C. 3571) the FIFRA
criminal fine amounts may be substantially increased if the violation results in death.
All acts of the regulated community exhibiting actual or suspected environmental
criminal conduct should be discussed with EPA Regional or Headquarter's Criminal
Enforcement Counsel or to the Office of Criminal Investigations for an assessment and
possible investigation.
Parallel Criminal and Civil Proceedings
Civil/administrative and criminal enforcement actions may be conducted
simultaneously whenever deemed necessary by the EPA Assistant Administrator for the
Office of Enforcement in order to seek immediate relief to protect human health or
the environment. Simultaneous civil actions and criminal proceedings may be
appropriate if the environmental consequences pf a violation pose a hazard requiring
remedial measures by a defendant.
The State and Federal Roles in Criminal Enforcement of FIFRA
State primacy for pesticide use violations, under FIFRA sections 26 and 27, also
applies to criminal FIFRA use violations. States are initially allowed 30 days to
commence appropriate enforcement actions for such violations. However, criminal
violations which do not constitute pesticide use violations may be investigated and
prosecuted on the Federal level without waiting for State authorities to exercise their
primary enforcement responsibility. The State should be informed of any criminal
investigation being conducted within their State.
Violations of a cancellation or suspension order, an EPA stop sale, use, or
removal order (SSURO), fraudulent labeling, advertising, or registration of a pesticide
are among those types of FIFRA violations for which States do not have primary
enforcement authority. Even where there is a FIFRA pesticide use violation, the States
can choose to waive their primary enforcement responsibility to allow Federal criminal
enforcement action to be undertaken.
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FIFRA's Relationship to Other Federal Criminal Laws
Possible criminal environmental offenses should be brought promptly to the
attention of EPA Criminal Enforcement Counsel, Special Agents in the Office of
Criminal Investigations, or the appropriate state authorities. This is true even if the
suspected criminal activity does not appear to be a violation of FIFRA. The criminal
conduct may also be amenable to prosecution under one of the other environmental
laws or one of the general criminal laws.
For instance, submission of false registration information may not only constitute
a violation of FIFRA, but also the Federal false statement statute and conspiracy laws.
The unlawful disposal of pesticides may be a criminal violation of the Resource
Recovery and Conservation Act (RCRA) or, if the disposal was into a river, such
conduct could be a criminal violation of the Clean Water Act. Which statute to
proceed under may not be decided until the investigation is almost complete and may
depend on factors such as the evidence available to establish an offense and the
different penalty levels of the involved statutes.
Recalls
In general, under FIFRA sections 19(b)(3) and (4), if a registration of a
pesticide has been suspended and cancelled, and EPA finds that a recall is necessary to
protect public health or the environment, EPA will request that a voluntary or
mandatory recall be conducted. Additionally, the EPA will continue its policy of
initiating formal and informal recalls in cases where a product is either potentially
hazardous when used as directed, ineffective for the purposes claimed, or violative in
nature. Formal and informal recalls are not authorized under the statute. Therefore,
the effectiveness of a formal or informal recall action is contingent on the cooperation
of the company involved.
Voluntary and Mandatory Recalls
A voluntary recall may be appropriate if a product is suspended and cancelled
and the voluntary recall will be sufficient to protect human health or the environment.
If not, mandatory recall procedures issued as. a regulation under FIFRA sections
19(b)(3) and (4) may require registrants, distributors, or sellers of a pesticide to recall
the pesticide; to make available storage facilities to accept and store existing stocks of
the suspended and cancelled pesticide; to inform the EPA of the location of the
storage facility; and to inform the EPA of the progress of the recall. The parties
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subject to the recall must also provide transportation of the pesticide, on request; and
take reasonable steps to inform holders of the recall and transportation provisions.
Persons conducting the recall must comply with transportation, storage and disposal
requirements. The criteria for the recall plans will be issued under FIFRA section
19(b) through the 40 CFR Part 165.
Formal and Informal Recalls
The Agency should consider a formal or informal recall of a product when,
among other things, its use as directed by the label is likely to result in: (1) injury to
the user or handler of the product; (2) injury to domestic animals, fish, wildlife, or
plant life; (3) physical or economic injury because of ineffectiveness or due to the
presence of actionable residues; or (4) identifiable adverse effects on the environment.
A product does not have to be suspended or cancelled in order for EPA to decide that
requesting a formal or informal recall is appropriate.
A formal or informal recall must only be requested where the evidence clearly
supports the need for such action. The initial decision that a product should be
withdrawn from the market will be based on information in the sample file including
laboratory analysis, staff evaluations and opinions, and such other information as may
be available. All information supporting a recall decision must be included in the
official file.
Formal recalls are used for more serious problems and when it is essential that
EPA regional personnel follow-up the recall with a visit to the company. Formal recall
involves EPA monitoring, detailed reporting by the company involved, and notification
to State officials. This type of recall is normally accompanied by another enforcement
action, generally a civil penalty.
An informal recall should be used in cases where a recall is necessary but the
level of potential hazard is not great or when it is unlikely that significant amounts of
the defective product remain in the marketplace. An informal recall is conducted
entirely by the company involved with no monitoring by EPA or State officials.
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Press Releases/Advisories. Etc.
Regions may, at their discretion, issue a press release/advisory to notify the public
of a person's violation of FIFRA. However, the issuance of press release/advisory must
not be an item of negotiation during settlement.
A press release/advisory can be a useful tool to notify the public of a person's
noncompliance with FIFRA and to educate the public on the requirements of FIFRA.
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ASSESSING ADMINISTRATIVE CIVIL PENALTIES
FIFRA section 14(a)(1) states that a registrant, commercial applicator, wholesaler,
dealer, or other distributor may be assessed a civil penalty of up to $5,000 for each
violation of FIFRA. Section 14(a)(2) allows the Administrator to assess a private
applicator or other person up to $1,000 for each violation of FIFRA, subsequent to
receiving a Notice of Warning or a citation for a prior violation. Additionally, section
14(a)(2) states that an applicator who applies a registered general use pesticide as a
service in controlling pests but does not deliver any unapplied pesticide (a "for hire
applicator") may be assessed a civil penalty of not more than $500 for the first offense
of FIFRA, and $1,000 for each subsequent offense.
Additionally, as the statutory definitions of "distribute or sell" and "commercial
applicator" indicate, and as the conference report for the Federal Pesticide Act of 1978
confirms (Senate Report No. 95-1188; September 12, 1978; page 44 and 45), any
applicator, including a "for hire" applicator, who holds or applies an unregistered
pesticide to provide a service of controlling pests without delivering any unapplied
pesticide to any person so served, will be considered a distributor of pesticides and will
be subject to the higher penalties set forth in sections 14(a)(1) and 14(b)(1) of FIFRA.
Additionally, any applicator, other than a private applicator, who uses or supervises the
use of a restricted use pesticide (RUP), whether or not that applicator is certified, is a
commercial applicator and is subject to the higher penalties set forth in sections
14(a)(1) and 14(b)(1) of FIFRA. Finally, any applicator, even if that applicator is
certified, who holds or applies a general use pesticide (GUP) or an unclassified
pesticide in violation of FIFRA will be subject to the lower penalties set forth in
FIFRA sections 14(a)(2) and 14(b)(2).
The FIFRA Civil Penalty System - Computation of the Penalty
In determining the amount of the civil penalty, section 14(a)(4) of FIFRA requires
the Agency to consider the appropriateness of the penalty to the size of the business of
the person charged, the effect of the penalty on the person's ability to continue in
business, and the gravity of the violation.
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Computation of the penalty amount is determined in a five stage process in
consideration of the FIFRA section 14(a)(4) criteria listed above. These steps are:
(1) determination of gravity or "level" of the violation using Appendix A of this ERP;
(2) determination of the size of business category for the violator, found in
TT.bIe 2; (3) use of the FIFRA civil penalty matrices found in Table 1 to determine the
dollar amount associated with the gravity level of violation and the size of business
category of the violator; (4) further gravity adjustments of the base penalty in
consideration of the specific characteristics of the pesticide involved, the actual or
potential harm to human health and/or the environment, the compliance history of the
violator, and the culpability of the violator, using the "Gravity Adjustment Criteria"
found in Appendix B; and, (5) consideration of the effect that payment of the total
civil penalty will have on the violator's ability to continue in business, in accordance
with the criteria established in this ERP. A proposed civil penalty may be further
modified during the course of settlement negotiations in accordance with the section of
this ERP entitled "Adjusting the Proposed Civil Penalty in Settlement."
Use of the FIFRA Civil Penalty Matrix
The gravity of the violation and the size of the business are considered in the
FIFRA Civil Penalty Matrices shown in Table 1. Each cell of the matrix represents the
Agency's assessment of the appropriate civil penalty, within the statutory maximum, for
each gravity level of a violation and for each size of business category. Since FIFRA
imposes different statutory ceilings on the maximum civil penalty that may be assessed
against persons listed in FIFRA section 14(a)(1) and persons listed in section 14(a)(2),
this policy has separate penalty matrices for section 14(a)(1) violators and section
14(a)(2) violators.
The section 14(a)(2) penalty matrix will only be used by the Agency for persons
falling under FIFRA section 14(a)(2) who have previously been issued a notice of
warning or civil complaint (FIFRA section 14(a)(2) states that private applicators are
only subject to civil penalties subsequent to receiving a Notice of Warning or following
a citation for a prior violation, and "for hire" applicators are only subject to a
maximum $500 civil penalty for their Gist offense of FIFRA), The Agency has only
included three levels in the section 14(a)(2) Civil Penalty Matrix, rather than the four
levels provided in the section 14(a)(1) matrix. This is because'the Agency does not
believe that the lower base penalty figure that can be obtained from a "level 4" is
appropriate for violations of the statute committed after the receipt of a notice of
warning or civil complaint.
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When a civil penalty is the appropriate response for a first-time violation by a
"for hire applicator" who violates any provision of FIFRA while holding or applying a
registered general use pesticide or a registered unclassified pesticide, that civil penalty
will be the statutory maximum of $500. Subsequent violations will be assessed using
the FIFRA section 14(a)(2) civil penalty matrix below.
TABLE 1
CIVIL PENALTY MATRIX
FOR FIFRA SECTION 14(a)(1)
SIZE OF BUSINESS
LEVEL
I
II
III
level 1
5,000
5,000
5,000
level 2
5, 000
4,000
3,000
level 3
4,000
3,000
2,000
level 4
3,000
2,000
1, 000
CIVIL PENALTY MATRIX
FOR FIFRA SECTION 14(a)(2) *
SIZE OF BUSINESS
LEVEL
I
II
III
level 1
1,000
1,000
1,000
level 2
1,000
800
600
level 3
800
600
500
' This 14(a)(2) matrix it ooly for uae in determining civil penalties tuned lutaequest to a notice of waning or following a
ciutioo (or a prior violation, or in the case of a "for bire" applicator using a regtMensd general use pcsttcMe, Hitaequeni
to the wswanrr of a civil penalty of U00.
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Size of Business
In order to provide equitable penalties, the civil penalties that will be assessed
for violations of FIFRA will generally decrease as the size of the business decreases,
and vice versa. Size of business is determined from an individual's or a company's
gross revenues from all revenue sources during the prior calendar year. If the revenue
data for the previous year appears to be unrepresentative of the general performance
of the business or the income of the individual, an average of the gross revenues for
the three previous years may be used. Further, the size of business and gross revenue
figures are based on the entire corporation rather than a specific subsidiary or division
of the company which is involved with the violation (including all sites owned or
controlled by the foreign or domestic parent company), unless the subsidiary or divisior
is independently owned.
As shown in the FIFRA Civil Penalty Matrices in Table 1, the appropriateness
of the penalty to the size of the business of the person charged is based on three
distinct "size of business" categories. Further, because the gross revenues of the
persons listed in FIFRA section 14(a)(1) [registrants, commercial applicators,
wholesalers, dealers, retailers, or other distributors] will generally be higher than the
gross incomes of the persons listed in FIFRA section 14(a)(2) [private applicators and
other persons not listed in 14(a)(1)], the policy has separate "size of business"
categories for FIFRA section 14(a)(1) persons and section 14(a)(2) persons. The "size
of business" categories for FIFRA section 14(a)(1) and section 14(a)(2) violators are
listed in Table 2.
table; 2
For section 14(a)(1) violators, the size of business categories are:
I • over $1,000,000
n • $300,001 - $1,000,000
III $0 - $300,000
For section 14(a)(2) violators, the categories are:
I • over $200,000
II $50,001 • $200,000
III - $0 • $50,000
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When information concerning an alleged violator's size of business is not readily
available, the penalty is to be calculated using the Category I size of business. The
Category I size of business will remain the base penalty value unless the violator can
establish, at their expense and to the Agency's satisfaction, that it should be considered
in a smaller size of business category.
Gravity of the Violation
Determination of the gravity of the violation is a two step process:
(1) determination of the appropriate "gravity level" that EPA has assigned to the
violation, and (2) the adjustment of that base penalty figure, as determined from the
gravity level, to consider the actual set of circumstances that are involved in the
violation.
The gravity "level" established for each violation of FIFRA is listed in
Appendix A of this ERP. The "levels" assigned to each violation of FIFRA represents
an assessment of the relative gravity of each violation. The relative gravity of each
violation is based on an average set of circumstances which considers the actual or
potential harm to human health and/or the environment which could result from the
violation, or the importance of the requirement to achieving the goals of the statute.
The gravity level, which is determined from the chart in Appendix A, is then used to
determine a base penalty figure from the FIFRA Civil Penalty Matrices.
As the actual circumstances of the violation differ from the "average"
circumstances assumed in each gravity level of the Civil Penalty Matrices, the dollar
amount derived from the matrix should be adjusted upward or downward. The Agency
has assigned adjustments, based on the gravity adjustment criteria listed in Appendix B,
for each violation relative to the specific characteristics of the pesticide involved, the
harm to human health and/or harm to the environment, compliance history of the
violator, and the culpability of the violator. Under the FIFRA civil penalty system, the
gravity adjustment values from each gravity category listed in Appendix B are to be
totaled. The dollar amount found in the matrix will be raised or lowered, within the
statutory mmrinumi ($5,000 for section 14(a)(1) persons and $1,000 for 14(a)(2)
persons), based on the total gravity values in Table 3.
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TABLE 3
Total Gravity Value Enforcement Remedy
3 or below
No action. Notice of Warning, or
50% reduction of matrix value.*
4
Reduce matrix value 40%
5
Reduce matrix value 30%
6
Reduce matrix value 20%
7
Reduce matrix value 10%
8 to 12
Assess matrix value
13
Increase matrix value 10%**
14
Increase matrix value 15%**
15
Increase matrix value 20%**
16
Increase matrix value 25%**
17 or above
Increase matrix value 30%**
* 50% reduction of matrix value i> recommended where multiple count violations erisi
** Matrix value can only be increased to the uatuuxy of >5.000 pet offemc for
penoci under FTFRA acrrtna I4(aXl). SI,000 Cor peraona under FTFRA tecnoo 14(a)(2).
Gravity Adjustments for Recordkeeping and Reporting Violations
The gravity of recordkeeping and reporting violations are already considered in
the dollar amounts presented in the FIFRA civil penalty matrices. Further,
recordkeeping and reporting violations do not lend themselves to utilizing the gravity
adjustments listed in Appendix B. Therefore, first-time civil penalties should be
assessed at the matrix value, while subsequent penalties should be increased by an
increment of 30% (up to the statutory maximum).
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Ability to Continue in Business/Ability to Pay
Section 14(a)(4) of FIFRA requires the Agency to "consider" the effect of the
penalty on the person's ability to continue in business when determining the amount of
the civil penalty.
EPA will generally not collect a total civil penalty which exceeds a violator's
ability to pay. There are three methods that EPA has chosen to determine a violator's
ability to pay, depending on the specifics of the case: (1) a detailed tax, accounting,
and financial analysis; (2) a guideline of four percent of average gross annual income;
or, (3) ABEL (a computer model).* The latter two are described below.
Four percent of gross sales. The average gross income (from all sources of revenue)
for the current year and the prior three years will be calculated. Even where the net
income is negative, four percent of gross income will be used as the "ability to continue
in business/ability to pay" guidance, since companies with a positive gross income will
be presumed to have sufficient cash flow to pay penalties even where there have been
net losses. For corporations, EPA will consider revenues from the total corporate
entity in its determination of ability to pay/ability to continue in business. Total
corporate entity refers to all sites owned and controlled by the foreign or domestic
parent company.
ABEL. ABEL is an EPA computer model that is designed to assess a for-profit
entity's ability to pay. The evaluation is based on the estimated strength of internally-
generated cash flows. The program uses standard financial ratios to evaluate a
violator's ability to borrow money and pay current and long-term operating expenses.
ABEL also projects the probable availability of future internally-generated cash flows to
evaluate some of a violator's options for paying a civil penalty. Because the program
only focuses on a violator's cash flow, there are other sources of revenue that should
also be considered to determine if a firm is unable to pay the full penalty. These
include:
o certificates of deposit, money market funds, or other liquid assets;
o reduction in business expenses such as advertising, entertainment, or
compensation of corporate officers; or,
o sale or mortgage of non-liquid assets such as company cars, aircraft, or land.
Oibcr method* tor determining a viotaior'i ability to pay may be provided in future guidance.
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It can be assumed that the respondent has the ability to pay at the time the
complaint is issued if information concerning the alleged violator's ability to pay is not
readily available. The respondent will be notified in the civil complaint of their right
under the statute to have their ability to continue in business considered in the
determination of the amount of the civil penalty. Any alleged violator can raise the
issue of ability to pay/ability to continue in business in their answer to the civil
complaint, or during the course of settlement negotiations.
If an alleged violator raises the inability to pay as a defense in their answer, or
in the course of settlement negotiations, the respondent should be asked to present
appropriate documentation, such as tax returns, financial statements, etc. Such records
are to be provided to the Agency at the respondent's expense and must conform to
generally recognized accounting principles and procedures. If the proposed penalty
exceeds the ability to pay guidance, the penalty may be reduced to a level consistent
with FIFRA section 14(a)(4).
There may be some cases where a respondent argues that it cannot afford to
pay the proposed civil penalty even though the penalty as adjusted does not exceed the
ability to pay guidance. In such cases, EPA may consider a delayed payment schedule
or a "Settlement with Conditions" agreement (see the "Settlement With Conditions"
section of this Enforcement Response Policy). In exceptional circumstances, EPA may
also consider further adjustment below the ability to pay guidance.
Finally, it is important that the regulated community not see the violation of
FIFRA as a way of aiding financially troubled businesses. Therefore, while EPA will
generally not collect a civil penalty which exceeds a violator's ability to pay, EPA
reserves the option, in appropriate circumstances, of seeking a penalty that might
excieed the ability to pay guidelines, cause bankruptcy, or result in a violator's inability
to continue in business. However, if the case is generated out of the EPA Regional
Offices, the case file must contain a written explanation, signed by the Regional
Program Division Director, which explains the reasons for exceeding the civil penalty
"ability to pay" guidelines. If the case is generated out of EPA Headquarters, the case
file must contain a written explanation signed by the Director of the Compliance
Division. Additionally, to ensure full and consistent consideration of penalties that may
cause bankruptcy or closure of a business, the Regions shall consult with the Office of
Compliance Monitoring and obtain concurrence before the decision is made to settle
the case or proceed to a hearing.
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For additional information on the consideration of a violator's ability to continue
in business, see the EPA General Enforcement Policy #GM-22, entitled "A Framework
for Statute-Specific Approaches to Penalty Assessments," issued on February 16, 1984
as part of the Agency's General Enforcement Policy Compendium.
Independently Assessable Charges , ;
A separate civil penalty, up to the statutory maximum, shall be assessed for each
independent violation of the Act. A violation is independent if it results from an act
(or failure to act) which is riot the result of any other charge for which a civil penalty
is to be assessed, or if the elements of proof for the violations are different.
Dependent violations may be listed in the complaint, but will not result in separate civil
penalties.
Consistent with the above criteria, the Agency considers violations that occur
from each shipment of a product (by product registration number, QQt individual
containers), or each sale of a product, or each individual application of a product to be
independent offenses of FIFRA.* Each of these independent violations of FIFRA are
subject to civil penalties up to the statutory maximum of $5,000 for section 14(a)(1)
and $1,000 for section 14(a)(2). For example, when the EPA can document that a
registrant has distributed a misbranded product .(one single EPA product registration
number) in four separate shipments (filling four orders), EPA will charge that registrant
with four counts of selling or distributing a misbranded product, and assess the
registrant civil penalties of up to $20,000. Similarly, when the EPA can document that
a registrant has shipped four separate misbranded products (four separate EPA
product registration numbers) in a single shipment, EPA will charge the registrant four
counts of selling or distributing a misbranded product, and assess civil penalties of up
to $20,000. A commercial applicator that misuses a restricted use product on three
occasions (either three distinct applications or three separate sites) Will be charged with
three counts of misuse, and assessed civil penalties of up to $15,000. A dealer that
sells a restricted use pesticide (RUP) to six uncertified persons, other than in
accordance with FIFRA section 3(d), will be charged with six violations of FIFRA, and
assessed civil penalties of up to $30,000.
violation which cm be documented as both per sate aad per shipment are to be calcotated only aa ether
per uie or per shipment, whichever is more appropriate baaed ot> the supporting documentation, and whichever approach
yields the highest civil, penalty. For camptr, if Penoa A has a violation inwolvini 1 sale aad 2 shipments, and Penoo B
has a violation involving 2 aalea and 1 shipment, both penooa would be charged tor 2 violation of FIFRA (Penoa A a
chained for 2 shipments and Penoa B is charged (or 2 sales).
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On the other hand, a single event or action (or lack of action) which can be
considered as two unlawful acts of FIFRA (section 12) cannot result in a civil penalty
greater than the statutory limit for one offense of FIFRA. For instance, a person can
be assessed a civil penalty of up to $5,000 for selling and distributing a product in
violation of a cancellation order. However, while the Agency considers a cancelled
product to be no longer registered, that same person should not also be assessed an
additional civil penalty of up to $5,000 for sale and distribution of the same
unregistered product. In this example the violation of the cancellation order is
dependent on the sale and distribution of the unregistered/cancelled product.
Another example of a dependent violation is multiple misbranding on a single
product label. If a single product label is misbranded in one way or ten ways, as
defined by FIFRA section 2(q), it is still misbranding on a single product label and is
considered a single violation of FIFRA section 12(a)(1)(E). As a single violation of
FIFRA, the maximum civil penalty that may be assessed is $5,000. However, EPA may
assess a count of misbranding each time that a misbranded product is sold or
distributed. For example, a registrant who sells or distributes four distinct shipments of
a misbranded pesticide product may be assessed a civil penalty of up to $20,000.
Voluntary Disclosure
In order to encourage voluntary disclosure of FIFRA violations, the Agency will
offer a 40% reduction of the civil penalty if the disclosure was made: (1) by the
violator promptly to EPA, or States with cooperative enforcement agreements [within
30 to 60 days of discovery by the violatorl; (2) before the violation was discovered by
EPA or a State; (3) before an inspection was scheduled by EPA or a State; and, (4)
the violator immediately takes all the steps necessary to come into compliance, and
steps requested by the Agency to mitigate the violation.
The reduction for voluntary disclosure may be made prior to issuing the civil
complaint. The civil complaint should state the original penalty and the reduced
penalty and the reason for the reduction.
Adjusting the Proposed Civil Penalty in Settlement
Upon an answer to a civil complaint by the person charged (respondent), the
following circumstances may arise which may justify adjustment of the penalty proposed
in the civil complaint:
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Factual Changes
Recalculation of the proposed penalty is appropriate if the respondent can
demonstrate that the size of business category, culpability, or other facts used to derive
the gravity adjustment values from Appendix B are inaccurate. Adjustments to the
proposed civil penalty may also be appropriate if the respondent can demonstrate an
"inability to pay" the civil penalty (See "Ability to Continue in Business/Ability to Pay"
section of this policy). Where additional facts indicate to the Agency that the original
penalty is not appropriate, a new penalty shall be calculated consistent with the new
facts. The burden is on the respondent to raise those factors which may justify the
recalculation of the penalty.
Negotiations Involving Onlv the Amount of the Penalty
In some cases the respondent may admit to all jurisdictional and factual
allegations charged in the complaint and may desire a settlement conference limited to
the amount of the proposed penalty. In the absence of "special circumstances," (as
discussed in the "Special Circumstances" section of this ERP), a settlement conference
may be conducted to consider the amount of the proposed penalty.
Good Faith Adjustments ;
. During the course of settlement negotiations, the EPA may consider the
respondent's attirude or good faith efforts to comply with FIFRA to reduce the penalty
as much as 20 percent below the proposed penalty, if such a reduction would serve the
public interest.
In no case is such a reduction mandated, and in no case should such a reduction
occur in the absence of an appropriate showing by the respondent and finding by the
Agency. Additionally, any reduction on account of the attitude or good faith efforts
does not have to extend to the full 20 percent reduction. Further, the total civil
penalty may not be reduced by more than 20 percent below the proposed penalty
without a showing of "special circumstances" as discussed below.
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Special Circumstances/Extraordinary Adjustments
Should a case arise in which EPA determines that there are no grounds for
adjustment of the proposed civil penalty based on new financial information or other
facts, or on a showing of inability to continue in business, and that equity would not be
served by adjusting the proposed penalty by only the allowable 20 percent good faith
attitude;adjustment, the Regional Program Division Director may approve an
extraordinary adjustment to the proposed penalty for up to an additional 20%. This
adjustment is only appropriate in extraordinary circumstances and is not to be used
routinely. The EPA may also consider a delayed payment schedule or a "Settlement
With Conditions" agreement.
If a "special circumstances" reduction of the proposed civil penalty is granted,
the case file must include substantive reasons why the extraordinary reduction of the
civil penalty was appropriate, including: (1) setting forth the facts of the case; (2) why
the penalty provided from the FIFRA civil penalty matrices and gravity adjustment was
inequitable; (3) how all other methods for adjusting or revising the proposed penalty
would not adequately resolve the inequity; and, (4) the manner in which the extra-
ordinary adjustment of the peinalty effectuated the purposes of the Act. The Regional
Program Division Director's written concurrence for the extraordinary reduction must
be incorporated into the case file. Additionally, a copy of the written justification for
the special circumstances reduction must accompany the consent agreement and final
order (CAFO), or consent agreement and consent order (CACO) which the Regions
send to the Office of Compliance Monitoring.
Settlement With Conditions (SWO
The Environmental Protection Agency (EPA) may choose to substitute part of a
civil penalty assessed for a violation of FIFRA for a specific environmentally beneficial
activity that would be performed by the Respondent. The Agency refers to the
settlement of a case under terms which commit the respondent to perform specified
acts in exchange for reduction of the penalty as "Settlement with Conditions (SWC)."
Under an SWC agreement, in exchange for a specified amount of the proposed
civil penalty, the violator agrees to take extensive and specific environmentally
beneficial activities, such as pollution prevention projects, risk communication,
remedying ground water hazards, clean-up operations, training, etc. These actions must
exceed those normally expected under the circumstances (action^ in excess of those
required to correct the violation for which the violator was charged, and actions in
-------
-29-
excess of those already required by Federal/State/local laws), must be taken within a
specific time period, and will be strictly monitored by the Agency. It is the
responsibility of the Regional Program Office to monitor compliance with the SWC
agreement. Follow-up inspections should be conducted, as appropriate. If the Agency
is not satisfied that the conditions of the agreement have been met at the end of the
term, the full amount of the penalty is due.
A minimum cash penalty should always be collected from the violator regardless
of the value of the SWC activities. Further, steps must be taken to prevent a violator
from gaining an unwarranted tax advantage through income tax deductions of the cost
of the SWC activities. One method to do this is to calculate the net present after tax
value of the SWC activities (the Agency's BEN computer model may be used for this
purpose), and require that the violator pay a minimum cash penalty equal to that sum
of money, in addition to the SWC activities.
Settlements with Conditions should be employed with restraint. The SWCs
should not be used in a manner which encourages people to violate FIFRA until they
are discovered and then offer to correct actions in hope of a penalty reduction.
Further, a violator is not presumed to be entitled to an SWC and such relief is granted
at the discretion of the Agency.
Criteria for Choosing an SWC
An SWC should be considered in the following circumstances:
o Violations have been documented which warrant a civil penalty, and,
o The violations do not evidence wanton, knowing, or willful disregard for
regulatory requirements; and,
o The violator has exhibited a good-faith attitude toward solving the
noncompliance and has no history of non-compliance; and,
o There are clear public benefits to use of an SWC; and
o An SWC acceptable to EPA can be negotiated.
An SWC should also be considered where the total proposed civil penalty
exceeds the ability to pay guidance, or when nonprofit entities are found to be in
violation of FIFRA.
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-30-
Responses to Noncompliance with the SWC
Penalty Payment ^
If the respondent fails to adhere to the conditions of the SWC, the uncollected
penalty, or the l.collected portion of the penalty is due and payable within 60 days
from the date the conditions of the SWC were to be met. If the respondent refuses to
pay, the Agency may refer the action to the Department of Justice which may bring a
recovery action.
Reinspection and Additional Enforcement Action
Once the EPA determines that the conditions of the SWC have not been
fulfilled and so notifies the respondent, the EPA should reinspect the facility to
document any additional violations. When considering additional enforcement actions
in response to any violations discovered upon reinspection, the Agency may give
consideration to pursuing injunctive action. Clearly, in cases of serious violations where
administrative enforcement action cannot be expected to achieve compliance, an
injunction may be a desirable enforcement response.
Elements of an SWC
The Agency is examining the procedures for issuing SWC agreements and the
necessary contents of those agreements. When final guidance is available, we will
incorporate these guidelines into the FIFRA ERP. In the interim, the procedures
provided below should be followed:
An SWC, like any FIFRA settlement, consists of: (1) a complaint and (2) a
consent agreement and final order (CAFO), or consent agreement and consent order
(CACO). It also includes: (3) a Penalty Mitigation Agreement and (4) a Penalty
Mitigation Order.
A civil complaint alleging violations of FIFRA and proposing a civil penalty must
be issued to establish the Agency's allegations that violations have occurred and to
initiate any SWC negotiations. The complaint should be issued in the same format as
in any FIFRA administrative civil penalty action.
-------
The CAFO/CACO assesses a total civil penalty and disposes of the
administrative "proceeding. In the CAFO/CACO, the respondent (1) admits the
jurisdictional allegations of the complaint, (2) admits the facts stipulated in the consent
agreement or neither admits nor denies specific factual allegations, (3) consents to the
assessment of a stated administrative civil penalty, and (4) waives its right to a hearing
and consents to the issuance of a final order which requires a payment of a civil
penalty.
The Penalty Mitigation Agreement sets forth the Compliance Program and
Schedule (CPS). Under this agreement and CPS, the respondent agrees to perform
specific remedial actions by specific dates. If the respondent successfully meets the
conditions of the penalty mitigation agreement, the EPA will not collect a specified
portion of the civil penalty.
The Penalty Mitigation Order formally mitigates a portion of the penalty and is
executed when the Agency is satisfied that the respondent has met the conditions
outlined in the CPS. If the respondent has not satisfied the conditions, the order
informs-him that the payment of the previously assessed penalty is due.
-------
APPENDIX A
FIFRA CHARGES AND GRAVITY LEVELS
-------
A-l
FIFRA
SECTION
FTTS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
12(a)(1)(A)
12(a)(1)(A)
12(a)(1)(B)
12(a)(1)(B)
12(a)(1)(C)
12(a)(1)(D)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(A)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(B)
IAA Sold or distributed a pesticide NOT REGISTERED
under section 3 or was CANCELLED or SUSPENDED,
which was not authorized by the Administrator.
1AB Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED or otherwise "offered for
sale," in any medium, a pesticide that was NOT
REGISTERED under section 3 or was CANCELLED
or SUSPENDED, other than in accordance with
Agency policy.
1BA CLAIMS made for a pesticide as part of sale or
distribution differed substantially from those
accepted in connection with registration.
IBB Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED, or otherwise "offered for
for sale" in any medium, a REGISTERED PESTICIDE
product for an UNREGISTERED USE, other than in
accordance with Agency policy.
1CA Sold or distributed a pesticide whose COMPOSITION
DIFFERED from the composition represented in the
registration.
IDA Sold or distributed a pesticide which has not
been COLORED or DISCOLORED pursuant to
section 22(c)(5).
1EA Sold or distributed a pesticide or device which is
M1SBRANDED in that the label has a statement, design,
or graphic representation which is false or misleading.
1EB Sold or distributed a pesticide or device which is
MISBRANDED in that the pesticide is not contained
in a package or other container or wrapping which
conforms to the standards established pursuant to
section 25(c)(3) (e.g., not contained in child-
resistant packaging or safety containers).
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A-2
FIFRA CHARGES AND GRAVITY LEVELS
FIFRA
SECTION
FTTS
CODE
VIOLATION
LEVEL
12(a)(1)(E)
12(a)(1)(F)
2(q)0)(C)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(D)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(E)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(F)
12(a)(1)(E)
12(a)(1)(F)
2(q)(l)(G)
12(a)(1)(E)
2(q)(l)(H)
12(a)(1)(E)
2(q)(2)(A)
12(a)(1)(E)
2(q)(2)(B)
1EC Sold or distributed a pesticide or device which is
MISBRANDED in that it is an imitation of, or is
offered for sale under the name of, another pesticide.
1ED Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not bear the
registration number assigned under section 7.
1EE Sold or distributed a pesticide or device which is
MISBRANDED in that any words, statements, or other
information required by the Act were not prominently
placed on the label in such a way as to make it
readable or understandable.
1EF Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not contain directions
for use necessary to make the product effective and to
adequately protect health and the environment
IEG Sold or distributed a pesticide or device which is
MISBRANDED in that the label did not contain a warning
or caution statement adequate to protect health and
the environment.
1EH Sold or distributed a non-registered pesticide
intended for export which is MISBRANDED in that the
label did not have a prominently displayed, "Not
Registered for Use in the United States of America."
1EI Sold or distributed a pesticide which is MISBRANDED
in that the label did not bear an ingredient statement
on the immediate container which is presented or
displayed under customary conditions of purchase.
1EJ Sold or distributed a pesticide which is MISBRANDED
in that the labeling does not contain a statement
of the use classification for which the product was
registered.
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A-3
FIFRA
SECTION
FITS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
12(a)(1)(E)
2(q)(2)(C)
12(a)(1)(E)
2(q)(2)(D)
12(a)(1)(E)
2(c)(1) - (3)
12(a)(2)(A)
l2(a)(2)(B)(i)
1EK Sold or distributed a pesticide which is MISBRANDED
in that there is not a label affixed to the pesticide
container, and to the outside wrapper of the retail
package if the required information on the immediate
container cannot be clearly read, a label bearing all
of the following information: (i) the name and address
of the producer, registrant, or person for whom
produced; (ii) the name, brand, or trademark under
which the pesticide is sold; (iii) the net weight
or measure of the content; and, when required by
regulation, (iv) the registration number assigned to
the pesticide and the use classification.
1EL Sold or distributed a pesticide which is MISBRANDED
in that the pesticide is sold in quantities highly
toxic to man and the label failed to bear a skull and
crossbones, and the word "poison" prominently in red
on a contrasting background color, and/or the label did
not bear a statement of practical treatment
1EM Sold or distributed a pesticide which is ADULTERATED
in that: (i) the strength or purity falls below the
professed standard of quality expressed on the
labeling; (2) any substance has been substituted
wholly or in part abstracted; or, (3) any valuable
constituent of the pesticide has been wholly or in
part abstracted.
2AA Person DETACHED. ALTERED, DEFACED,
or DESTROYED, in whole or in part, any LABELING
required under the Act.
2BA Person refused to PREPARE, MAINTAIN, or SUBMIT
anv RECORDS required under sections 5, 7, 8, 11,
or 19.
l2(a)(2)(B)(ii) 2BB
Person refused to SUBMIT any REPORTS required by or 2
under section 5, 6, 7, 8, 11 or 19.
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A-4
FIFRA CHARGES AND GRAVITY LEVELS
FIFRA
SECTION
FITS
CODE
VIOLATION
LEVEL
12(a)(2)(B)(ii)
12(a)(2)(B)(iii)
12(a)(2)(C)
12(a)(2)(D)
12(a)(2)(E)
12(a)(2)(F)
12(a)(2)(F)
12(a)(2)(G)
12(a)(2)(H)
2BC A registrant refused to submit REPORTS under
section 6(a)(2) regarding UNREASONABLE ADVERSE
EFFECTS of their pesticide.
2BD Person refused to allow entry, INSPECTION, copying of
records, or sampling authorized by this Act.
2CA Person gave a GUARANTY or undertaking provided for in
section 12(b) which was FALSE in any particular.
2DA Person used to their personal advantage or revealed
to persons other than those authorized by the Act any
INFORMATION acquired under the Act which is
CONFIDENTIAL.
2EA Registrant, wholesaler, dealer, retailer, or other
distributor ADVERTISED a RESTRICTED USE
PESTICIDE without indicating that the product was
restricted.
2FA Person DISTRIBUTED, SOLD, MADE AVAILABLE
FOR USE, or USED a RESTRICTED USE PESTICIDE
for a purpose other than in-accordance with section 3(d)
or regulations issued.
2FB Person distributed," sold, or made available for use,
or used, a RESTRICTED. USE PESTICIDE without
maintaining the RECORDS required by regulations
(A Notice of Warning should be issued for first-time
"partial" violations. Violations continuing subsequent
to the issuance of a civil complaint are to result in
a suspension see "Denials, Suspensions, Modifications,
or Revocations of Applicator Certifications" section
of this ERP).
2GA Person USED a registered pesticide in a manner
inconsistent with its labeling.
2HA Person USED a pesticide which was under an
EXPERIMENTAL USE PERMIT contrary to the
provisions of the permit
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A-5
F1FRA
SECTION
FTTS
CODE
FIFRA CHARGES AND GRAVITY LEVELS
VIOLATION
LEVEL
I2(a)(2)(l)
12(a)(2)(J)
l2(a)(2)(J)
12(a)(2)(K)
l2(a)(2)(K)
l2(a)(2)(K)
12(a)(2)(K)
12(a)(2)(K)
l2(a)(2)(L)
7(a)
l2(a)(2)(L)
7(c)(1)
2IA Person violated any order issued under section 13
(e.g., STOP" SALE, USE OR REMOVAL ORDER
or SEIZURE).
2JA Person violated any SUSPENSION ORDER issued under
section 6.
2JB Person violated any SUSPENSION ORDER issued under
section 3(c)(2)(B) or 4.
2KA Person violated any CANCELLATION ORDER issued
under the Act on the grounds of UNREASONABLE
ADVERSE EFFECTS.
2KB Person violated any CANCELLATION ORDER issued
under the Act on grounds OTHER THAN
UNREASONABLE ADVERSE EFFECTS.
2KC Person failed to submit a SECTION 6(g) NOTICE when
required.
2KD Person submitted a NOTABLY LATE SECTION 6(g)
NOTICE.
2KE Person submitted an INCOMPLETE or INCORRECT
SECTION 6(g) NOTICE.
2LA PRODUCED a pesticide or active ingredient subject to
the Act in an UNREGISTERED ESTABLISHMENT.
2LB Producer FAILED TO SUBMIT, or submitted
NOTABLY LATE, a REPORT to the Administrator,
under SECTION 7, which indicates the types
and amounts of pesticides or active ingredients
which they are currently producing, which they
produced during the past year, and which they
sold or distributed during, the past year.
-------
A-6
FIFRA CHARGES AND GRAVITY LEVELS
FIFRA FITS
SECTION CODE VIOLATION LEVEL
l2(a)(2)(L)
7(c)(1)
2LC Producer submitted a LATE REPORT to the Administrator,
under SECTION 7, which indicates the types and amounts
of pesticides or active ingredients which they are
currently producing, which they produced during the
past year, and which they sold or distributed during
the past year (civil complaint issued only if the
producer does not respond to a Notice of Warning or
there is a subsequent violation within a three year
timeframe from the first violation).
12(a)(2)(L)
7(c)(1)
12(a)(2)(L)
7(c)(1)
l2(a)(2)(L)
7(c)(2)
l2(a)(2)(M)
2LD Producer submitted an INCOMPLETE SECTION 7
REPORT with MINOR OMISSIONS of the
required information (civil complaint issued only
if the producer does not respond to a Notice
of Warning or there is ,a subsequent violation
within a three year timeframe from the first
violation).
2LE Producer submitted an INCOMPLETE or a FALSE
SECTION 7 REPORT with MAJOR OMISSIONS
or ERRORS of the required information.
2LF Upon request of the Administrator for the purposes
of the issuance of section 13 Stop Sale Orders, a
PRODUCER FAILED TO PROVIDE the names and
addresses of the recipients of the pesticides
produced in any of his registered establishments.
2MA Person KNOWINGLY FALSIFIED all or any part of an
application for registration, application for an
experimental use permit, any information submitted
under section 7, gQg records required to be maintained
by the Act, am report filed under the Act, or any
information marked as confidential and submitted to
the Administrator under am provision of the Act.
12(a)(2)(N) 2NA
A registrant, wholesaler, dealer, retailer, or other
distributor FAILED TO FILE REPORTS required
by the Act
2
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FIFRA CHARGES AND GRAVITY LEVELS
FIFRA FTTS
SECTION CODE VIOLATION LEVEL
12(a)(2)(0)
12(a)(2)(F)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
12(a)(2)(Q)
l2(a)(2)(R)
12(a)(2)(S)
!2(a)(2)(S)
20A Person ADDED A SUBSTANCE TO, or TOOK
a substance from a pesticide in a manner that may
defeat the purpose of this Act.
2PA Person USED a pesticide in TESTS ON HUMAN BEINGS
in violation of the conditions specified by the Act.
2QA Person FALSIFIED INFORMATION RELATING to
the. TESTING of any pesticide (or any of its ingredients,
metabolites, or degradation products) for which the
person knows will be furnished to the Administrator,
or will become a part of any records required to be
maintained by this Act
2QB Person falsely represented compliance with the FEFRA
Good Laboratory Practice (GLP) regulations as a result
of a HIGH LEVEL GLP violation.
2QC Person falsely represented compliance with the FIFRA
Good -Laboratory Practice (GLP) regulations as a result
of a MIDDLE LEVEL GLP violation.
2QD 14(a)(1) person falsely represented compliance with
the FIFRA Good Laboratory Practice (GLP) regulations
as a result of a LOW LEVEL GLP violation.
2QE 14(a)(2) person falsely represented compliance with
the FIFRA Good Laboratory Practice (GLP) regulations
as a result of a LOW LEVEL GLP violation.
2RA Person submitted DATA KNOWN TO BE FALSE in
support of a registration.
2SA Person sold, distributed, or used an UNREGISTERED
pesticide in violation of a REGULATION ISSUED UNDER
SECTION 3(a).
2SB Person violated any REGULATION ISSUED UNDER
SECTION 19.
* Orsviiy levels for these violations will be assigned in subsequent ERPs.
-------
APPENDIX B
GRAVITY ADJUSTMENT CRITERIA
-------
B-l
APPENDIX B
GRAVITY ADJUSTMENT CRITERIA
I
I VIOLATION
VALUE
1
1
CIRCUMSTANCES
| GRAVITY OF HARM
|
1
1
1
1
| Pesticide
2
1
1
Toxicity - Category I pesticides.
1
1
Signal Word "Danger", restricted
1
1
use pesticides (RUPs), pesticides
1
1
with flammable or explosive
1
characteristics (i.e., signal
1
1
words "Extremely Flammable" or
1
1
"Flammable"), or pesticides that
1
1
are associated with chronic health
1
1
effects (mutagenicity, oncogenicity,
1
1
1
teratogenicity, etc.).
1
1
1
1
1
Toxicity • Categories II through
1
1
IV, signal word "Warning" and
1
1
1
1
"Caution," no known chronic effects.
j Harm to Human
5
1
1
Actual serious or widespread12 harm
| Health
I
1
1
to human health.
1
1
3
1
1
Potential serious or widespread2
1
1
1
harm to human health.
1
1
|
3
1
1
Harm to human health is unknown.
1
1
1
1
1
Minor7 potential or actual harm to
1
human health, neither serious nor
1
1
i
widespread.
1
| Environmental
5
1
1
Actual serious or widespread2
j Harm
1
harm to the environment (e.g.,
1
i
crops, water, livestock, wildlife,
1
1
wilderness, or other sensitive
1
1
1
1
natural areas).
1
1
3
1
1
Potential serious or widespread2
1
I
1
1
harm to the environment.
1
1
I
3
1
I
|
Harm to the environment is unknown.
1
1
1
1
1
Minor* potential or actual harm to
1
1
the environment, neither widespread
1
1
1
1
nor substantial
-------
B-2
VIOLATION
GRAVITY OF
MISCONDUCT
Compliance!'
History
Culpability5
VALUE
2
2
0
CIRCUMSTANCES
If a violator is a 14(a)(1) person
with more than one prior violation
of FIFRA. and at least one prior
violation was a level I violation.
If a violator is a 14(a)(2) person
with more than two prior FIFRA
violations, and at least one prior
violation was a level 1 violation.
If a violator is a 14(a)(1) person
with more than one prior violation
of FIFRA. and ;no prior level 1
violations. If a violator is a
14(a)(2) person with more than
two prior FIFRA violations, and
no prior level 1 violations.
If a 14(a)(1) person, one prior
violation of FIFRA. If a 14(a)(2)
person, two prior FIFRA violations.
No prior FIFRA violations.
Knowing or willful violation of the
statute.® Knowledge of the general
hazardousness of the action.
Culpability unknown.
Violation resulting from negligence.
Violation was neither knowing nor
willful anddid not result from
negligence. Violator instituted
steps tt) correct the violation
immediately after discovery of
the violation.
-------
APPENDIX B FOOTNOTES
The gravity adjustment criteria in Appendix B should not be used for recordkeeping and reporting violations. Therefore, first-time civil
penalties (or recordkeeping or reporting violations should be awiwd at the matrix value, while subsequent penalties should be
increased by an increment of 30% (up to the statutory maximum).
For the purposes of this ERP. serious or widespread harm refers to actual or potential harm which does not meet ihe parameters of
minor harm, as described below.
For the purposes of this ERP. minor harm refers to actual or potential harm which is. or would be of short duration, no lasting effects
or permanent damage. effects are easily reversible, and harm does not, or would not result in significant monetary loss.
The following considerations apply when evaluating compliance history for the purposes of Appendix B:
(a) In order to constitute a prior violation, the prior violation must have resulted in: (1) a final order, either as a result of an
uncontested complaint, or as a result of a contested complaint which is finally resolved against the violator (2) a consent
order, resolving a contested or uncontested complaint by tbe execution of a consent agreement; (3) the payment of a civil
penalty by the alleged violator in response to the complaint, whether or not the violator admits to the allegations of ihe
complaint; or (4) conviction under the FIFRA's criminal prwistons.
A notice of warning (NOW) will not be considered a prior violation for the purposes of the gravity adjustment
criteria, since no opportunity has been given to contest the notice. Additionally, a stop sale, use, or removal order (SSURO)
issued under FIFRA section 13 will not be considered as compliance history.
(b) To be considered a compliance history for the purposes of Appendix B. the violation must have occurred within five years of
the present violation. This five-year period begins on the date of a final order, consent order, or payment of a civil penalty.
(c) Generally, with multiple establishments are considered as ooc when determining compliance history. If one
establishment of a company commits a FIFRA violation, it counts as history when another establishment of the same
company, anywhere in the country, commits another FIFRA violation.
EPA enforcement officials are not required to determine culpability at the time the complaint is issued (especially if this information is
not readily available). EPA enforcement officials may instead assign a weighting factor of 2 (culpability unknown), at the time of the
issuance of the complaint. Culpability adjustments may be reconsidered during settlement negotiations.
The Agency may also consider criminal proceedings for "knowing and willful* violations. See the "Criminal Proceedings" section of ihis
ERP.
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APPENDIX C
SUMMARY OF TABLES
-------
C-l
SUMMARY OF TABLES
TABLE 1
FEFRA CIVIL PENALTY MATRICES
FffRA SECTION 14
-------
APPENDIX D
FIFRA CIVIL PENALTY CALCULATION
WORKSHEET
-------
D-i
FIFRA CIVIL PENALTY CALCULATION WORKSHEET
RESPONDENT
ADDRESS
DOCKET NO.
DATE
Appendix A
1. Statutory Violation
2. FITS Code
3. Violation Level
Table 2
4. Violator Category -
§14 (a)(1) or 814(a)(2)
5. Size of Business Category
sssas-i
s. Base Penalty
iDDflndiv B
7. Gravity Adjustments:
a. Pesticide Toxicity
b. Hainan Harm
c. Environmental Harm
d. Compliance History
e. Culpability
f. Total Gravity
Adjustment Value
(add items 7a - 7e)
W.* 3
g. Percent Adjustment
h. Dollar Adjustment
Final Penalty*
( (item 7h from item 6)
9. Oarcbined Total Penalty
(total of all Columns
for line 8, above)
PREPARED BY
count 1 count 2 count 3 count 4
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> s ' , tf-
Si f:B
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SB- iff
% #
1 1
sJMi „ ''
J/ '•¦&$££' , i
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II
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• NOTE: The final penally in each column of line 8 cannot exceed I be tututory mnrtmum
-------
0-2
FIFRA CIVIL PENALTY CALCULATION WORKSHEET (conL)
count
count
count
count
Appendix A
1. Statutory Violation
2. FTPS Code
3. Violation Level
Table 2
4. Violator Category -
§14(a)(l) or §14(a)(2)
5. Size of Business Category
Table 1
6. Base Penalty
Timr14! ft
7. Gravity Adjustments:
a. Pesticide Toxicity
b. Human Harm
c. Environmental Harm
d. Cccpliance History
e. Culpability
f. Total Gravity
Adjustment Value
(add items 7a - 7e)
S£fel9_l
g. Peroent Adjustment
h. Dollar Adjustment
8. Final Penalty*
(item 7h frcn item 6)
(iiis: v |
>£¦" '¦ i
'
-
illpllllll
V.V.V.W.V. V.VW.'.'/.'.V.VV."
<•
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*
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'
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rs
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-
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WM.
PAGE
OF
* NOTE; The Bnal penalty in each ooiuma of line 8 onno* exceed the statutory nuBiffluo.
-------
SSlfcl
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
f5*'
APR I 8 I99T
OFFICE OF
ENFORCEMENT AND
COMPLIANCE ASSURANCE
MEMORANDUM
Subject: Penalty Policy supplements pursuant to the Civil Penalty Inflation Adjustment Rule
Toxics and Pesticides Enforcement Division (TPED) personnel have reviewed all civil
penalty policies within its purview to update them and ensure consistency pursuant to a new rule
published on December 31, 1996, in the Federal Register (61 FR 69360) — 40 CFR Part 19 and
27, in accordance with the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended
by the Debt Collection Improvement Act of 1996 ("DCLA"). The rule, which was efifective
January 30,1997, increases the statutory penalty provisions by ten percent (10%). A complete
list of all our existing penalty policies (Attachment A) is provided along with instructions
necessary to implement this new rule and update each specific Enforcement Response Policy
The increased maximum penalty amounts are reflected in the attached matrix supplements
for the respective penalty policies. (See attachment B for directions for incorporating the revised
matrices into the existing penalty policies. Note: These increases in the Civil Monetary Penalties
aoplv only to violations which occur after the date the increases took effect. January 30. 1997
Violations prior to this date should continue to be assessed using the matrices in the existing civil
penalty policies (Attachment A).
From:
Toxics and Pesticides Enforcement Division
To: Regional Toxics and Pesticides Division Directors
Regional Counsels
Recycled/Recyclable • Printed with Vegetable OD Based Inks on 100% Recycled Paper (40% Postconsumer)
-------
It is important that these changes be made promptly, since all Enforcement Response
Policies are sent to Respondent along with the administrative complaints issued to them. If you
have any questions, please call Robin Lancaster at (202) 564-4172.
Attachments
cc: (w/attachments)
EPCRA Regional Coordinators
FIFRA Regional Coordinators
TSCA Regional Coordinators
EPCRA Enforcement Coordinators
FIFRA Enforcement Coordinators
TSCA Enforcement Coordinators
-------
ATTACHMENT A
XSCA
Record keeping and Reporting Rules TSCX. Sections 8,12, and 13 (8/5/96)
PCB Penalty Policy (4/9/90)
TSCA Section 5 Enforcement Response Policy1 (8/5/88; and amended on 6/8/89
and 7/1/93)
TSCA Good Laboratory Practices Regulations Enforcement Policy (4/9/85)
TSCA Section 4 Test Rules (5/28/86)
TSCA Title n - Asbestos Hazard Emergency Response Act.(AHERA)
Intenm Final ERP for the Asbestos Hazard Emergency Response Act
(1/31/89)
ERP for Asbestos Abatement Projects; Worker Protection Rule (11/14/89)
EPCRA
Final Penalty Policy for Sections 302, 303,304, 311, and 312 of EPCRA and Section 103
of CERCLA (6/13/90)
Enforcement Response Policy for Section 313 of EPCRA and Section 6607 of the
Pollution Prevention Act (8/10/92)
FIFRA
General FIFRA Enforcement Response Policy (7/2/90)
FIFRA Section 7(c) ERP (2/10/86)
Enforcement Response Policy for the Federal Insecticide, Fungicide, and Rodentidde Act:
Good Laboratory Practice (GLP) Regulations (9/30/91)
-------
ATTACHMENT B
PENALTY POLICY DIRECTIONS
TSCA
Record keeping and Reporting Rules TSCA
Sections 8,12, and 13 (8/5/96)
PCB Penalty Policy (4/9/90)
TSCA Section S Enforcement Response
Policy (8/5/88 and amended on 6/8/89 and
7/1/93)
TSCA Good Laboratory Practices
Regulations Enforcement Policy (4/9/85)
TSCA Section 4 Test Rules (5/28/86).
TSCA Title II - Asbestos Hazard Emergency
Response Act (AHERA)
Interim-Final ERP for the Asbestos
Hazard Emergency Response Act
(1/31/89)-for LEAs
Interim Final ERP for the Asbestos
Hazard Emergency Response Act
(1/31/89) - for other persons
ERP for Asbestos Abatement Projects;
Worker Protection Rule
Interim final Enforcement Response Policy-
Asbestos Abatement Projects; Worker
Protection; Final Rule" (11/14/89)
Insert Matrix (p. 7-A) behind page 7
Insert matrix (p. 9-A) behind page 9
Insert matrix (p. I6-A) behind page 16
Insert matrix (p. 4-A) behind page 4
Insert matrix (p. 2-A) behind page 2
Insert matrix (p. 11-A) behind page 11
Insert matrix (p. 17-A) behind page 17
Insert matrix (p. 6-A) behind page 6
epcra
Final Penalty Policy for Sections 302, 303,
304, 311, and 312 of EPCRA and Section 103
of CERCLA (6/13/90)
Enforcement Response Policy for Section 313
Insert Matrix entitled, 'Table II, Base Penalty
Matrices for Violations which occurred after
January 30,1997, pp. 20a & 20b, behind p.
20, until such time as a revised policy is
issued. Li the alternative, attach this memo to
the penalty policy.
Insert matrix entitled "EPCRA §313 Gravity
-------
FIFRA
General FIFRA Enforcement Response Policy
(7/2/90)
FIFRA Section 7(c) ERP (2/10/86)
Enforcement ResponsePolicy for the Federal
Insecticide* Fungicide and Rodentitide Act:
Good Laboratory Practice (GLP) Regulations
(9/30/91)
Insert after page 19 in the policy and page C-
1 in the appendix
No insert.
While the FIFRA ERP (1990) does not
supersede the Section 7(c) ERP (1986), the
matrix setting forth the penalties in the 1990
ERP should be used instead of the matrix in
the 1986 policy
No Insert.
When proposing penalty amounts under the
Enforcement Response Policy for the FIFRA
GLP Regulations, dated September 30, 1991,
actual dollar amounts are determined by using
the ERP for FIFRA (7/2/90). (see directions
above for General FIFRA ERP)
-------
Page 2-A
* Gravity Based Penalty Matrix For Violations Which Occur After January 30,1997
TSCA§4
GRAVITY BASED PENALTY MATRIX
CIRCUMSTANCES
(probability of
damages) -
s
A
Major
EXTENT
B
Significant
c
Minor
UEVELS
1
High Range
2
$27,500
$18,700
$5,500
3 "
Mid Range
4
$16,500
$11,000
$11,000
$6,600
$1,650
$1,100
_
\ ; 5 ,
tow Range
6
$5,500
$2,200
$3,300
$1,430
$550
$220
* Gravity based Penalty Matrix to supplement TSCA Section 4 Test Rules Enforcement
Response Policy (5/28/86) for violations that occur after January 30,1997. Insert behind
page 4 of TSCA Section 4 Test Rules Enforcement Rsesponse Policy (5/28/86).
-------
Page 4-A
•Gravity Based Penalty Matrices For Violations Which Occur After January 30,1997
TSCA GLP
GRAVITY BASED PENALTY MATRIX
CIRCUMSTANCES
(probability of
damages)
A .
Maior
EXTENT -
B
Significant
'
'.'v .
Minor
LEVELS
1
High Range
2
$27,500
$18,700
$5,500
' -/ " 3
Mid Range
4
'
$16,500
$11,000
$1,650
' > ' ' ' / \
5
Low Range
6
$5,500
$3,300
$550
* Gravity Based Penalty Matrix to supplement TSCA Good Laboratory Practices
Regulations Enforcement Policy (4/9/85) for violations that occur after January 30,1997.
Insert behind page 4 of TSCA Good Laboratory Practices Regulations Enforcement Policy
(4/9/85)
-------
Page 6-A
Asbestos Worker Protection
*Gravity Based Penalty Matrix for Violations Which Occur After January 30,1997
Circumstances
(Levels)
Extent
LEVELA
MAJOR
Extent
LEVEL B
SIGNIFICANT
Extent
LEVEL c
MINOR
LEVEL 1
LEVEL 2
$27,500
$22,000
$18,700
$14,300
$5,500
$3,300
LEVEL3
$16,500
$11,000
$11,000
$ 6,600
$1,650
$1,100
LEVEL 5
L£VEL6
$ 5,500
$ 2,200
$ 3,300
$ 1,430
$550
$220
* Gravity Basest Penalty Matrix to snpplement Interim Final Fnforcement Response
Policy- Asbestos Abatement Projects: Worker Protection: Final Rule (11/14/89) for
violations that occur after January 30,1997. Insert behind page 6 of Interim Final
Enforcement Response Policy- Asbestos Abatement Projects: Worker Protection: Final
fifilfi (11/14/89).
-------
Page 7-A
"Gravity Based Penalty Matrix For Violations Which Occur Alter January 30,1997
TSCA §§ 8,12, & 13
GRAVITY BASED PENALTY MATRIX
' ? ' A ,
riDr'tnutcT a
"4 ' i
*
A
Major
EXTENT
B
Significant
C
Minor
UEVEIS
Wl ;
High Range
2
$27,500
$22,000
$18,700
$14,300
$5,500
$3,300
' --
Mid Range
4 ,
$16,500
$11,000
$11,000
$6,600
$1,650
$1,100
; ^ -
Low Range
6
$5,500
$2,200
$3,300
$1,430
$550
$220
'Gravity Based Penalty Matrix to supplement Recordkeeping A Reporting Rules TSCA
Sections 8.12. and 13 lor violations that occur after January 30,1997. Insert behind page
7 of Recordkeeping & Reporting Rnles TSCA Sections 8.12. and 13 (8/5196) .
-------
Page 9-A
* Gravity Based Penalty Matrix For Violations Which Occur After January 30,1997
TSCA §6 (PCB)
GRAVITY BASED PENALTY MATRIX
CIRCUMSTANCES
(probability of
damages)
A
Major
EXTENT
r / s /
B
Significant
-
•W
r
Minor
JU*/t
1
High Range
2
,-s
$27,500
$22,000
$18,700
$14,300
$5,500
$3,300
3
Mid Range
4
$16,500
$11,000
$11,000
$6,600
$1,650
$1,100
: *
Low Range
6
$5,500
$2,200
$3,300
$1,430
$550
$220
* Gravity Based Penalty Matrix to supplement PCB Penalty Policy (4/9/901 for violations
that occur after January 301997. Insert behind page 9 of PCB Penalty Policy (4/9/901
-------
Page 11-A
Base Penalty Matrices For Violations Which Occur After January 30,1997
EPCRA § 313
GRAVITY BASED PENALTY MATRIX
CmClHVfSTANCES
LEVELS
¦»
A
Major
w, EKIi&NT
- ,
B
Significant
* .
c
Minor
$27,500
$18,700
$5,500
\ ; :%
~
$22,000
$14,300
$3,300
3
$16,500
$11,000
$1,650
4
$11,000
$6,600
$1,100
\ . ¦ , -
$5,500
$3,300
$550
" V 6 . '
$2,200
$1,430
$220
* Gravity Based Penalty Matrix to supplement the "Final EPCRA §313 Enforcement Response
Policy" (8/10/92). Insertbehind page 11 of the "Final EPCRA §313 Enforcement Response
Policy" (8/10/97).
-------
Page 11-A
* Gravity BasedPenalty Matrices For Violations Which Occur After January 30,1997
for
AHERA Interim Final ERP (1/31/89)
Base Penalty for LEA's
Circumstances
(Levels)
* *
'
Extenf
LEVEL A
MAJOR
(>3,000 sq.ft.
or 1,000 linear
ft.)
~
Extent
LEVEL B
SIGNIFICANT
(> 160 sq.ft. or
260 linear ft.
but <3,000
sq.ft. or 1,000
linear ft,) A
Extent
LEVEL C
MINOR
(< or «160 sq.ft. or
260 linear ft.)
IJEVEL1
LEVEL 1
$5,500
$4,400
$3,740
$2,640
$1,100
$660
LEVEL3
; ; LEVEL 4
$3,300
$2,200
$2,200
$1,320
$ 330
$ 220
LEVELS
LEVEL 6
$1,100
$ 440
$ 660
$ 286
$110
$ 44
~Gravity Based Penalty Matrix to supplement Interim Final Enforcement Response Policy
for the Ashpstns ffa^rd Emergency Response Act (1/31/89) for violations that occur after
January 30,1997. Insert behind page 11 of Interim Final Enforcement Response Policy for
the Asbestos Hazard Emergency Response Act (1/31/89)
-------
Page 16-A
'Gravity Based Penalty Matrix For Violations Which Occur After January 30,1997
TSCA §5
GRAVITY BASED PENALTY MATRIX
CIRCUMSTANCES
*
*
Major
EXTENT
B
Significant
-
c
Minor
LEVELS
1
High Range
2
$27,500
$22,000
$18,700
$14,300
$5,500
$3,300
3
Mid Range
4
$16,500
$11,000
$11,000
$6,600
$1,650
$1,100
5
Low Range
6
$5,500
$2,200
$3,300
$1,430
$550
$220
* Gravity Based Penalty Matrix to supplement TSCA Section 5 Enforcement Response Policy
(8/5/88) for violations that occur after January 30, 1997. Insert bdiind page 7 of TSCA Section
5 Enforcement Response Policy (8/5/88).
-------
Pagevjl^-A
AMERA- "Other Persons -
* Gravity Based Penalty Matrix for Violations Which Occur After January 30,1997
Circumstances
(Levels)4
Extent
LEVEL A
MAJOR
Extent
LEVEL B'
SIGNIFICANT
Extent
LEVELC
MINOR
LEVELl
LEVEL2
$27,500
$22,000
$18,700
$14,300
$5,500
$3,300
— ; s y\ '" • ' •
LEVEL 3
$16,500
$11,000
$11,000
$6,600
$1,650
$1,100
LEVELS
LEVEL6
$ 5,500
$ 2,200
$ 3,300
$ 1,430
$550
$220
Note: >= greater than;<=less than.
* Gravity Based Penalty Matrix to supplement Interim Final Enforcement Response Policy
for the Asbestos H««ird Emergency Response Act (1/31/89) for violations that occur after
January 30,1997. Insert behind page 17 of Interim Final Enforcement Response Policy for
the Asbestos Hazard Emergency Response Act (1/31/89).
-------
Page19-A
•Gravity HasedPenalty Matrix For FTFRA Violations Which Occur After January 30,
1997
FTFRA § 14(a)(1)
SIZE OF BUSINESS
'Xlt&VMJi:
I
n
m
UEVELi
$5,500
$5,500
$5,500
f ICtrtPf t
I^kVIMLZ
$5,500
$4,400
$3,300
Vv&wpSgls'V -
$4,400
$3,300
$2,200
LEVEL4
$3,300
$2,200
$1,100
FTFRA § 14(a)(2)
SIZE OF BUSINESS
, yyyii/;
I
11
IB
LEVEL 1
$1,10C
$1,100
$1,100
> , LEVEL2 '
$1,100
$880
$660
LEVEL 3
$880
$660
$500
•Gravity Based Penalty Matrix to supplement General FTFRA Enforcement Response
Policy(ERP) (7/2/90) and the FUEKA Section 7(c> ERP (2/10/86) for violations that occur
after January 30,1997. Insert behind page 19 and page C-l in the appendix.
-------
Page 20-A
Table D
Batfe Penalty Matrices For Violations Which Occur After January 30,1997
CERCLA § 103 and EPCRA § 3041
GRAVllV (Quantity Released)
EXTENT
(timeliness of
notification)
%
LEVELA
(greater than
IS times the
RQ)
LEVELB
(greater than 10
but less than 15
times the RQ)
LEVELC
(greater than 1 but
less than 10 times
theRO)
LEVEL 1
(more than 2 hours)
$27,500
$20,626
$20,625
$13,751
$13,750
$6,876
*¦ ' , s ' ^ ";•!>
(between 1 and 2
' hours) - a
$20,625
$13,751
$13,750
$6,876
$6,875
$3,439
LEVEL 3
(within f hour, after
15 minutes)
$13,750
$6,876
$6,875
$3,439
$3,438
$1,718
EPCRA § 312
GRAVITY (Quantity Present)
EXTENT
(timeliness of MSDS
submission)
LEVELA
(greater than
. 15 times the
TPQ)
LEVELB
(greater than
10 but less than
IS times the
TPQ)
levelc
{greater than 1 bat
less flu*** 10 times
theTPQ) ' ,
LEVEL1
(more than 30 days)
$27,500
$20,626
$20,625
$13,751
$13,750
$6,876
LEVEL2
(after 20 but within
30 days)
$20,625
$13,751
$13,750
$6,876
$6,875
$3,439
LEVEL3
(after 10 but within
20 days)
$13,750
$6,876
$6,875
$3,439
$3,438
$1,718
'While the penalty amounts in this matrix apply to EPCRA § 304(c), the criteria associated
with the levels do not apply. To determine the appropriate extent level for violations of § 304,
see p. 13, infra.
-------
Page 20-B
Table n (continued)
Base Penalty Matrices For Violations Which Occur After January 30,1997
EPGRA § 311
GRAVllV (Quantity Present).
, E3OTNT V
(timeliness of MSDS
- submission)
»
D&VIXA
(greater than
15 times the
TPQ)
LEVELS
(greater than
10 but less than
15 times the
TPO)
JUft ~ IWU V
(greater than 1 but
less than 10 times
tfcelVQ)
(more than 30 days)
$11,000
$8,251
$8,250
$5,501
$5,500
$2,751
LEVEL2
(after 20 but within
30 days)
$8,250
$5,501
$5,500
$2,751
$2,750
$1,376
LEVEL3
(after 10 but within
20davs1
$5,500
$2,751
$2,750
$1,376
$1,375
$688
~Gravity Based Penalty Matrix to supplement Final Penalty Policy for Sections 302.303.
304.311. and 312 of EPCRA and Section 103 of CERCLA (6/13/90) for yiolations that
occur after January 30,1997. Insert behind page 20 of Final Penalty Policy for Sections
302.303.304.311. and 312 of EPCRA and Section 103 of CERCLA (6/13/901
-------
A
¦>« „.
AUG 30 B85
OFFICE OF ENFORCEMENT
AND COMPLIANCE
MONITORING
MEMORANDUM
SUBJECT:
PROM:
TO:
Procedures for Handling Business Confidentiality
Claims Asserted on Documents in TSCA/FIFRA
Enforcement Actions, or Investigate
Courtney M. Pricev
Assistant Administrator for Enforcement
and Compliance Monitoring
Assistant Administrator for Pesticides and
Toxic Substances
Regional Administrators, Regions I-X
Regional Counsels, Regions I-X
Director, National Enforcement Investigations Center
I. Introduction
It has become apparent in recent months that overly broad
claims of confidentiality have been received, resulting in the
withholding of, or delay in review of, much useful data from
or by Agency personnel who have not obtained clearance to review
confidential business information. The existence of CBI claims
also complicates the introduction of documents into evidence in
administrative or judicial enforcement actions.
This memorandum establishes procedures for dealing with
claims that information under the Toxic Substances Control Act
(TSCA) or the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) which has been obtained in a potential enforcement
action or investigation is confidential business information
(CBI).
This memorandum does not, however, address procedures
for dealing with the special problems raised by TSCA and FIFRA
CBI claims made during hazardous waste inspections or hazardous
waste enforcement actions. For example, a claimant may contend
that information obtained in inspections conducted under the
Resource Conservation and Recovery Act or the Comprehensive
Environmental Response, Compensation and Liability Act is
-------
-2-
entitled to TSCA CBI protection merely because the RCRA or
CERCLA inspections also uncovered information relating to disposal
of polychlorinated biphenyls. The Agency is currently considering
how to deal with unwarranted citing of "TSCA* by CBI claimants.
Once implementedr these procedures will help us identify
and challenge unwarranted TSCA and FIFRA CBI claims, avoid
delay in declassifying questionable claims, and segregate CBI
from the non-CBI portions of reports, whenever feasible.
It. Confidential Business Information Defined
Neither the environmental statutes nor the CBI regulations
at 40 C.F.R. Part 2, Subpart B, themselves define CBI. They do,
however, refer to the definition at 5 U.S.C. §552(b)(4), which
protects privileged or confidential "trade secrets and commercial
or financial information" obtained from a person.
The substantive regulatory criteria for making confidentiality
determinations are set forth in 40 C.F.R. $2,208. Business infor-
mation is entitled to confidential treatment for the benefit of
a particular business if:
° a business confidentiality claim has been submitted and
has not expired by its terms, been waived, or been with-
drawn; and
° the submitter has established that it has taken, and will
continue to maintain, reasonable measures to protect the
confidentiality of the information; and
* the information is not, and has not been, reasonably
obtainable without the submitter's consent by other persons
(other than governmental bodies) by use of legitimate means
(other than discovery based on a showing of special need in
a judicial or quasi-judicial proceeding); and
° if no statute specifically requires disclosure of the
information; and if either it has been shown that disclosure
is likely to cause harm to the submitter's competitive
position or the information is voluntarily submitted and
its disclosure would be likely to impair the Government's
ability to obtain necessary information in the future.
-------
-3-
III. The Confidentiality Determination Process
—Current Regulatory Procedures
The determination process is to be initiated whenever
a Freedom of Information Act request for information claimed to
be CBI has been received* or whenever it is desired to determine
whether business information in the Agency's possession is entitled
to confidential treatment even though there exists no request
for release of the information, or whenever it is believed that
a request for release of the information will be received at
some future date. (See 40 C.F.R. 52.204(a).)
Before initiating a confidentiality determination, the EPA
office in question should consider whether it is possible to
obtain the affected business's waiver, modification, or withdrawal
of its claim of confidentiality in a way that will allow
disclosure of the needed or requested information without the
necessity of a final determination.
Pursuant to the regulatory process for making confidentiality
determinations, formal reviews of CBI claims are commenced accord-
ing to 40 C.F.R. Part 2, Subpart B. In brief, under this procedure,
the EPA office in possession of the material claimed to be CBI
will furnish the submitter a written notice stating that EPA is
undertaking this analysis and seeking the submitter's comments
on the points enumerated in 40 C.F.R. $2.204(e)(4) in substan-
tiation of its claims. (OECM or the Office of Regional Counsel
is the initiating office for the declassification of NEIC reports.)
The submitter then has at least 15 business days within which to
submit these comments. On the basis of the comments received,
the Office of General Counsel (OGC) or the Office of the Regional
Counsel, as appropriate, will make a final determination, based
upon the criteria specified in 40 C.F.R. S2.208 and any related
criteria in SS2.306 or 2.307, as to whether the material is
entitled to continued confidential treatment. The submitter is
provided notification of OGC's or the Office of Regional
Counsel's final determination. Any submitter who objects to a
final decision to declassify may commence an action in a Federal
court, within 30 days, to obtain judicial review of the deterio-
ration, and to obtain preliminary injunctive relief against
disclosure.
IV. Affirmative Steps to Determine the Confidentiality or
Non-confidentiality of Information Submitted
As indicated above, some confidentiality claims will clearly
appear reasonable under the regulations; others clearly will
not. Still others will be doubtful.
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-4-
The following procedures are adopted for dealing with each
respective class, of claims:
A. Apparently reasonable claims will not trigger an
affirmative effort by the Agency for a final confidentiality
determination until and unless an independent need for such a
determination arises. Initial# decisive action by an EPA office
is required# pursuant to 40 C.F.R. S2.204(a), whenever there is
pending a Freedom of Information Act request for material claimed
confidential in the possession of that office, or whenever EPA
desires or is required to release the information.
B. Questionable claims are those which appear not to fall
within the coverage of the CBI privilege, or those relating to
the existence of, cause of, or responsibility for pollution or
contamination, i.e., to unlawful disposal, or to releases or
discharges to the environment, or to required cleanup. Such
claims are often not supportable, and they should immediately be
questioned by the office receiving the claimed information. As
a first step, the receiving office should, immediately upon
discovery of questionable claims, contact the submitter to attempt
to narrow or eliminate the claims. It is especially important
that this be done whenever an EPA enforcement report is to be
written which relies upon the material claimed as CBI. Section V,
below, specifies the step to be taken to segregate material
claimed confidential unless the submitter retracts its claim.
If a questionable claim remains, and if there is reason to
believe that its existence will hamper EPA's use of the informa-
tion, the receiving office shall initiate the formal confidentiality
determination process.
C. Clearly invalid claims should immediately be rejected
pursuant to the alternative procedure of 40 C.F.R. S§2.204(d)(2)
and 2.205(f) (made applicable to TSCA and FIFRA claims by §2.306
and S2.307, respectively). As with questionable claims, a first
step should be to contact the submitter to attempt to have the
claim withdrawn. A clearly invalid claim may be one which, for
example, seeks to protect information which the submitter has
already publicly disclosed, which is otherwise in the public
lomain, or which is clearly not within the protection of the CBI
privilege.
The CBI regulations cited above authorize the receiving
EPA office to issue a notice to a company submitting the claim,
advising that a final determination has been made; that the
information clearly is not entitled to confidential treatment;
and that unless the company notifies EPA of the filing of an
action in Federal court to review the Agency's determination and
to obtain a preliminary injunction against disclosure, the
information will be made publicly available on the 31st calendar
day after the submitter's receipt of the notice. This notifica-
tion should be sent to the submitter under the signature of the
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5-
Regzonal Counsel or the Assistant Administrator for Enforcement
and Compliance Monitoring. A copy should be sent to the Office
of General Counsel in the latter case.
The confidentiality regulations provide that, where the
information may be CBI, a company should be afforded the
opportunity to substantiate its claim of confidentiality under
the formal determination procedures earlier described. There_
fore, this alternative procedure should be used only when a ~
claim is clearly invalid.
V. Segregation of TSCA or FIFRA CBI in Enforcement Reports
In the preparation of an enforcement-related report
containing both claimed CBI and non-CBI data, the confidential
information should be segregated from the non-CBI data to the
extent that such segregation is possible.
VI. Release of Confidential Information to Congress
EPA is required to release CBI-claimed material to Congres-
sional committees and subcommittees upon written request of the
Chairman of such committee or subcommittee.
There are a number of special considerations which may
arise with respect to the delivery of such materials to Congress.
Consequently, you should contact the Senior Enforcement Counsel
upon receipt of any request from Congress for CBI-claimed material.
VII. Conclusion
Improving our ability to identify and reject invalid CBI
claliu while strictly preserving the confidentiality of truly
confidential information is of fundamental importance to EPA's
enforcement efforts. Therefore, it is imperative that the CBI
determination process operate as effectively and efficiently as
possible. Your cooperation in implementing the procedures set
forth in this memorandum is greatly appreciated.
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S?4,
tfh \
*
* O
PAO^
y
/-^
UNITED STATES ENVIRONMENTAL PROTECppjs/:AG^N^Vjy
Washington, d.c. 20460 K;0 CLERK
Ar
MAR 2 9 1965
85 APR 8 a9:2U
OFFICE OF
PE5TfCJOCS A NO TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Regional Pesticides and Toxic Substances Case
Set 11ement s
FROM: A. E. Conroy II, Director
Office of C omp 1-i-^an-c.^ Monitorin
Terrell E. 'HlTnt~~
Acting Associate Enforcement Counsel
for Criminal Enforcement and
Speci al Li ti gati on
TO:
Addressees
Each Region is hereby authorized to negotiate sett 1ements for
all enforcement actions issued by it under Section 16(a) of the
Toxic Substances Control Act and Section 14(a) of the Federal
Insecticide, Fungicide,~and Rodenticide Act (FIFRA) without prior
consultation with the Director, Office of Compliance Monitoring.
The requirement for Regions to obtain advance written concurrence
from Headquarters before settling pesticides or toxics cases
involving a change of more than 40% of the originally assessed
penalty is hereby waived. In exercising this authority Regions
will be expected to follow applicable program guidance on penalty
assessments and settlements. A document implementing this waiver
of prior Headquarter's consultation is attached.
Att achment
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REGIONAL PESTICIDES & TOXIC SUBSTANCES UIVlSI OH D1 RECTORS Ll^l
Louis Gitto, Director
Air Management Division
EPA Regi on I
John F. Kennedy Federal Bldg.
Boston, HA 02203
Barbara Metzger, Di rector
Environmental Services Division
EPA Regi on II
Woodbridge Avenue
Raritan Depot, Bldg. 209
Edison, NJ 08837
Stephen R. Wassersug, Director
Hazardous Waste Management Oivision
EPA Regi on III
841 Chestnut Bldg.
Philadelphia, PA 19107
Winston A. Smith, Director
Air, Pesticides and Toxics Management Division
EPA Region IV
345 Courtland Street, N.E.
Atlanta, GA
William H. Sanders III, Di rector
Environmental Services Division
EPA Region V
230 South Dearborn Street
Chicago, IL 60604
Allyn Davis, Director
Air and Waste Management Division
EPA Regi on VI
1201 Elm Street
Dallas, TX 75270
William A. Spratlin, Director
Air and Toxi(j Substances Division
EPA Regi on VIx
726 Minnesota Avenue
Kansas City, KS 66101
Irwin L. Dickstein, Director
Air and Toxic/Strbstanres Division
EPA Regi on VIII
1860 Lincoln Street
Denver, CO 80295
Harry Seraydarian, Director
Toxics and Waste Management Division
EPA Region IX
215 Freemont Street
San Francisco, .CA 94105
Gary L. O'Neal, Director
Air and Toxics Division
EPA Regi on X
1200 Si xth Avenue
Seattle, Washington 98101
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m 2 9 1935
WAIVER OF PRIOR HEADQUARTERS CONSULTATION TO SETTLE
F 1FRA & TSCA CASES
On May 29, 1980, the Pesticides and Toxic Substances
Enforcement Division [now Office of Compliance Monitoring,
(OCM)] issued a set of procedures for obtaining OCM's
concurrences on FIFRA and TSCA cases. Among other things,
these procedures required advance written concurrence from
OCM before the conclusion of any Regional F1FRA or TSCA
settlement which was changed by more than 40 percent of the
original penalty. This criteria for settling cases has been
in effect and utilized by the Regions and OCM since 1980.
Because of the experience the Regions have gained over the
past five years in settling cases, OCM has decided to relax tne
40 percent penalty adjustment criteria. However, even though
concurrences for prior consultation are being relaxed, a
substantial degree of informal communication with OCM will
continue. Regions must continue to send copies of TSCA and
FIFRA complaints, consent agreements and final orders to the
Case Support Branch, Office of Compliance Monitoring.
Consistent with the March 10, 1980, TSCA penalty policy,
Regions should continue to incorporate into settlement agreements
and consent agreements and final orders, substantive reasons why
penalties are adjusted. Written justifications for penalty
adjustments must also be included'in each case file and be in
accordance with the appropriate OCM penalty policies. Finally,
procedures must be established in each Regional Office to ensure
that the Regional Program Division Director agrees with and
concurs on every c^se adjustment below 40% of the original
penalty. This concurrence must be in writing, using a format
similar to that currently utilized by OCM and the Office of
Enforcement and Compliance Monitoring (example attached). This
written concurrence must be included in the case file.
Since OCM has the ultimate responsibility for ensuring that
pesticides and toxics penalties are assessed in a fair, uniform
and consistent manner throughout the country, there will continue
to be periodic oversight and evaluation of Regional case files.
The quality and performance of the program in the Regions will
be primarily examined through annual Regional Reviews conducted
by OCM. Additionally, OCM may request that Regional case files be
submitted to Headquarters for review.
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MAR 2 9 1985
-2-
Should this oversight program reveal that a Region(s) is
not following Agency policies for adjusting FIFRA or TSCA
settlements, written concurrence procedures between OCM and that
Region(s) may be reinstated.
In this manner OCM intends to ensure national consistency
while promoting Regional autonomy in FIFRA and TSCA case settle-
ments.
Attachment
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rsC!
V " - ^
, 1 \j / *-
S7'^30
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF THE ADMINISTRATOR
[OA- ;FRL- J
DECISION AND FINAL ORDER MODIFIYING FINAL SUSPENSION OF
PESTICIDE PRODUCTS WHICH CONTAIN DINOSEB
AGENCY: Environmental Protection Agency (EPA).
ACTION: Decision and Final Order Modifying Final Suspension of
Pesticide Products Which Contain Dinoseb
SUMMARY: This notice announces my decision to modify my October 7,
1986 Order (51 Fed. Reg. 36634. October 14, 1986) suspending the
registrations of all pesticide products containing dinoseb to permit the use
of dinoseb on dry peas, lentils and chickpeas in the States of Idaho and
Washington during the 1987 growing season. This Order is in response to
submissions by the American Dry Pea and Lentil Association (ADPLA) and
the American Frozen Food Institute (AFFI) and requests for emergency
exemptions pursuant to Section 18 of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) submitted by the Departments of Agriculture of
the States of Idaho and Washington. In a notice dated February 11, 1987
(52 Fed. Reg. 4963, February 18, 1987), I granted the requests for a
hearing under Subpart D of 40 CFR Part 164 to reconsider my October 7,
1986 Suspension Order as it applies to the use of dinoseb on dry peas,
lentils and chickpeas in Idaho and Washington. In accordance with the
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February 11, 1987 notice of a Subpart D hearing, a hearing was held before
Administrative Law Judge J. F. Greene and she submitted a Recommended
Decision on this matter to me on March 20, 1987. On March 25. 1987. two
of the parties submitted objections to Judge Greene's Recommended
Decision. On March 27, 1987, Judge Greene filed corrections to the text of
the March 20 Recommended Decision. Based on the record before me. I
have decided to modify my October 7, 1986 Suspension Order to allow
emergency exemptions to be granted under FIFRA Section 18 to the States
of Idaho and Washington during 1987. The exemptions will be granted
upon issuance of appropriate orders by EPA's Office of Pesticides and Toxic
Substances, subject to the limitations and restrictions set forth in this
notice and in accordance with applicable law and regulations under FIFRA
Section 18. Therefore, by itself today's notice does not authorize use of
dinoseb in the two States; instead, it clears the path for the requested
exemptions to be granted forthwith.
ADDRESS: The record of this proceeding is available for public inspection
from 7:30 a.m. to 4 p.m., Monday through Friday, except legal holidays, in
the Office of the Hearing Clerk (A-101), Room M3708, Environmental
Protection Agency, 401 M Street, SW, Washington. DC 20460.
Additional information supporting this action is available for public
inspection from 8 a.m. to 4. p.m., Monday through Friday, except legal
holidays in: Information and Services Section. Management and Program
Support Division (TS-757C), Office of Pesticide Programs, Environmental
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3
Protection Agency, Room 236, Crystal Mall #2,1921 Jefferson Davis
Highway, Arlington, VA.
FOR FURTHER INFORMATION CONTACT: By mail: Michael McDavit,
Registration Division (TS-767C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M Street, SW, Washington, DC
20460.
Office location and telephone number: Room 1014A, Crystal Mall *2,
1921 Jefferson Davis Highway, Arlington, VA (703-557-1787).
SUPPLEMENTAL INFORMATION:
I. Order
This Notice and Order modifies my October 7, 1986 Order suspending
the registration of each pesticide product which contains dinoseb
(2-sec-butyl-4,6-dinitrophenol) or any of its salts, to permit the use of
"v
dinoseb on dry peas, lentils and chickpeas, subject to certain limitations
and restrictions which I have determined to be both reasonable and
practical as well as necessary to reduce risks to an acceptable level during
the period of this order. In doing so, I am accepting in part the restrictions
recommended by the Administrative Law Judge, with certain modifications
and additions. (In re: Application to Modify Final Suspension of Pesticide
Products Which Contain Dinoseb: FIFRA Docket No. 612.)These restrictions
will be incorporated into the Section 18 emergency eieinptions for the
States of Washington and Idaho. The specific restrictions I am imposing
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A
are:
1. That dinoseb be sold (1) only to growers of dry peas, lentils or
chickpeas in Washington and Idaho. (2) in a quantity not to
exceed that required to treat his dry pea, lentil, and chickpea
acreage at the maximum application rates specified below.
Dealers must maintain records of sales to growers.
2. Only certified applicators may use dinoseb; other persons, even
if they are operating under the direct supervision of a certified
applicator, may not use dinoseb.
3. Women of child-bearing age, i.e., under the age of 45,
may not be involved in mixing, loading, or any aspect of dinoseb
application.
4. A warning label must appear on the product specifying that (1)
women of childbearing age may not use the product, (2) all
reasonable efforts should be made to minimize indirect
exposures to women of child-bearing age, (3) the product
also poses risks to male reproduction, (4) is acutely toxic, and (5)
the product may be applied only by certified applicators.
5. Aerial spraying is prohibited.
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5
6. Mixing/loading of dinoseb is prohibited except from closed
systems.
7. Ground application of dinoseb is prohibited except by the "barrel
sucker'Vground boom/tractor system.
8. Ground application is prohibited when wind conditions exceed ten
miles per hour.
9. Tractor cabs must be closed and equipped with positive
pressure ventilation systems.
10. Mixer/loaders and applicators must wear chemically resistant
disposable coveralls (Tyvek® suits) and chemically resistant
gloves when mixing or loading dinoseb. Applicators or other
personnel may remove such protective clothing immediately
before entering the tractor cab to avoid cab contamination, but
must carry an unused set of gloves and coveralls in their cabs, to
be used in the event of spraying equipment malfunction and
repair during application.
11. That maximum application rates for dinoseb be set as follows:
1.5 pounds of active ingredient per acre (ai/A) for lentils, 3
pounds ai/A for dry peas, and 3 pounds ai/a for chickpeas.
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6
12. That dinoseb be applied to a maximum of 80 acres per day per
applicator.
13. Any and all use of dinoseb on dry peas, lentils and chickpeas in
the States of Idaho and Washington must cease by January 1,
1988. The Agency will not consider any emergency exemption
application for the 1988 use season unless the Petitioners conduct
or sponsor adequate tests on alternative pesticides during the
1987 season. EPA's consideration of any emergency exemption
application for the 1988 use season will be influenced by any
evidence of the extent to which there is good faith compliance
with the conditions and restrictions specified herein.
II. Legal Authority and History
Information about the legal authority and procedural history of this
proceeding can be found in the February 18, 1987 notice of hearing under
Subpart D of 40 CFR Part 164 (52 Fed. Reg. 4963 et seq.) In accordance
with that notice Judge Green held a hearing and submitted a Recommended
Decision (Rec. Dec.) to me on March 20, 1987 (as well as corrections to the
text of her Recommended Decision which were submitted to me on March
27, 1987.) On March 25, 1987, two of the parties to the proceeding
submitted objections to Judge Greene's Recommended Decision.
As I stated in my February 11, 1987 notice for this Subpart D
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7
proceeding (52 Fed. Reg. 4967, February 18, 1987), the sole objective of
this proceeding has been to determine whether or not the order
suspending all sale, distribution, and use of pesticide products containing
dinoseb should be modified to permit use, and sale and distribution for use,
on dry peas, lentils, and chickpeas in Washington and Idaho while the
cancellation hearing was pending. The ultimate registrability of dinoseb
products for these uses and in these locations will be determined
exclusively in the cancellation proceeding.. Thus, this proceeding did not
consider evidence concerning long-term changes in the benefits of dinoseb
use that may be associated with introduction of new alternatives or other
factors. In addition, many generic risk issues which were beyond the
scope of this proceeding will be subject to full examination on the record in
the cancellation hearing.
Today's Order does not by itself allow sale, distribution or use of
pesticide products containing dinoseb in Washington and Idaho for use on
dry peas, lentils or chickpeas. Rather, it only modified the existing
Suspension Order to permit the U. S. Environmental Protection Agency to
grant emergency exemptions to the two States for these specific uses.
EPA's Office of Pesticides and Toxic Substances, in accordance with Agency
delegations, will prepare appropriate orders to implement my decision and
shall include such other requirements and restrictions that are reasonable
and consistent with today's decision and in accordance with Section 18 of
FIFRA. The sale, distribution and use of dinoseb will then be authorized in
accordance with OPTS's order.
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8
III. Findings Concerning Substantial New Evidence
In her Recommended Decision (as corrected). Judge Greene concluded
that substantial new evidence had been presented that was not available at
the time of the Suspension Order and recommended that the final
Suspension Order be modified to make dinoseb available for use on dry
peas, lentils and chickpeas in the States of Idaho and Washington during
the pendancy of the dinoseb cancellation proceeding subject to certain
limitations and restrictions.
I do not fully accept the findings of the Administrative Law Judge
regarding whether acceptable alternative pesticide treatments will remain
unavailable for the duration of the cancellation proceedings. While I accept
Judge Greene's finding with respect to the current unavailability of
alternatives that have been adequately demonstrated for the peculiar
climate and growing conditions in these States, I am not convinced that, if
efforts were made to test a number of the potential alternatives discussed
in these proceedings, some of these alternatives might be found suitable
before the cancellation proceedings have been completed.
Otherwise. I generally accept Judge Greene's qualitative findings
concerning substantial new evidence.
IV. Findings Concerning Imminent Hazard
Based on the substantial new evidence regarding (1) the widespread
use and efficacy of dinoseb on dry peas, lentils and chickpeas, (2) the
unavailability of and other disadvantages associated with alternative
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9
herbicide treatments, and (3) the attendant economic implications
associated with a suspension of dinoseb use for these crops in the 1987
growing season, I have reconsidered my October 7, 1986 decision and
emergency suspension order as it applies to these crops. While I accept
Judge Greene's findings of facts as regards the benefits of dinoseb on these
crops, I remain concerned that the restrictions recommended by her will
not provide sufficient protection from fetotoxicity.
I recognize that the evidentiary constraints imposed for this
proceeding have prevented the Petitioners from challenging, and the
Administrative Law Judge from considering, the validity of EPA's
evaluation of the toxicity of dinoseb or the EPA's risk and exposure
methodology. However, I continue to believe, based on the record of my
original suspension decision, that the risks to unborn children from dino.seb
are of grave concern. Because of the serious nature of these risks and
certain moral issues involved in exposures to unborn children, I am not
comfortable with margins of safety for developmental toxicity that are well
below 100. (See 51 Fed. Reg., 36642 - 36643.) This is true despite the
higher benefits demonstrated by the ADPLA. I have also determined that
insofar as EPA underestimated the extent of dinoseb use, the Agency also
underestimated the extent of exposure to dinoseb. I agree with the
statements of EPA Counsel in their objections to Judge Greene's
Recommended Decision to me, that "(ilf relief is provided, the magnitude of
the health risks requires the Agency to impose every practicable measure
which might reduce exposure or insure user compliance" (p. 7).
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10
Consequently, in addition to those measures recommended by Judge
Greene, I have decided to (1) prohibit ground application of dinoseb when
wind conditions exceed 10 mph; (2) prohibit women of child-bearing age
from involvement in mixing, loading, or applying dinoseb; (3) limit the
term of this order to the 1987 growing season and require, as a condition
to considering any petition for the 1988 growing season, that the
Petitioners conduct or sponsor adequate tests on alternative pesticides; (4)
allow applicators to remove protective clothing before entering the tractor
cab, but require that they keep a new set of gloves and coveralls (Tyvek®
suits) in the tractor cab; and (5) limit sales of dinoseb to growers of these
crops, up to the amount needed to treat each growers acreage at the
application rates specified herein.
V. Discussion of Restrictions and Limitations
A. Prohibition on ground application when wind conditions exceed ten
miles per hour.
Pesticide drift from either aerial or ground application can lead to
exposures of short duration but high intensity. Because a single exposure
to dinoseb at such levels may cause fetotoxic effects, it is necessary to
minimize exposures of pregnant women to dinoseb drift. Therefore, I am
restricting ground application to times when wind speeds are ten miles per
hour or less. I also encourage applicators to use any other reasonably
available methods to reduce drift (Rec. Dec., p. 30).
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11
B. Prohibition on female mixer/loaders and applicators.
I recognize both the potentially controversial nature of this ban and
the limited discussion of this type of restriction in the record. The
Administrative Law Judge, in her Recommended Decision of March 20.
1987, neither mentions nor discusses such a restriction, apparently because
none of the participants in the hearing seems to have suggested it. In the
emergency suspension decision of October 14, 1986, EPA considers and
then rejects several types of gender-based restrictions as "not practical for
reducing exposure to dinoseb and the risk of developmental toxicity,
reproductive toxicity, and acute toxicity." (51 Fed. Reg., 36648)
My original decision to reject a ban on female mixer/loaders and
applicators was based primarily on a concern about potential
discrimination against women desiring employment in the field of
commercial pesticide application. The Agency was concerned that a ban
on female applicator use would be impractical (i.e., infeasible or
unenforceable, as opposed to discriminatory) for crops that require large
farmworker support. (M ) Otherwise in that discussion of the feasibility
and desirability of gender-based restrictions, there was no attempt to
discuss or distinguish among the various crop use situations to see if some
types of gender-based restrictions would be workable in some situations.
The record indicates that for these crops more applications will be
made by the growers and their families rather than by commercial
applicators (51 Fed. Reg. 36641, Table 4). As to seasonal farmworkers, the
requirement in this order limiting application to only certified applicators
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12
is likely to reduce the frequency of any applications by seasonal
farmworkers, be they men or women. Further, the fact that this ban
applies only to this year is unlikely to have any significant affect on the
employment or economic status of the women in this region.
The short duration of this Order and the limited acreage to which it
applies reduce any problems of impracticability or enforceability.
While a ban on all female exposures to dinoseb would clearly be
impractical, a ban on female mixer/loader/applicators for this growing
season should be no less enforceable or more impractical than the other
restrictions in this order. EPA is well aware that the effectiveness of most
of these measures depends in large measure on voluntary compliance by
growers. Voluntary compliance, in turn, depends on (1) technical
feasibility, (2) awareness of the restrictions, and (3) grower attitudes
toward the importance and efficacy of the restrictions.
This ban, taken alone or together with the other restrictions herein,
will not eliminate risks to women. However, they should significantly
increase the the margin of safety in the majority of situations where EPA is
concerned about the risk posed by the high exposure levels. Nonapplicator
exposures of dinoseb to women (through washing dinoseb-contaminated
clothing, for example) should generally be much lower than applicator
exposure levels. The bans on aerial application and ground application at
windspeeds above 10 mph should reduce those high exposures due to drift.
In short, the ban on female mixer/loader/applicators will not eliminate
risks to unborn children, but the risks will be significantly lower with the
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13
ban than without
I conclude that similar measures are not necessary to reduce the risks
of male reproductive effects and acute toxicity to acceptable levels for the
duration of this order. The level of dinoseb exposure that causes concern
for acute toxicity is much higher than the levels that cause concern for
either developmental or reproductive toxicity. While the dose-per-day
levels of concern are similar for male reproductive effects and fetotoxic
effects, there is less concern that a one-time exposure or an exposure of
limited duration will actually cause a serious reproductive effect in males.
Also, as compared with the risks of fetoloxicity, such male reproductive
effects that might occur as a result of the 1987 dinoseb spraying season are
likely to be temporary or reversible. Because of these differences, it is
reasonable to try to reduce exposures to unborn children below those of
adult male workers.
Consequently, a separate restriction on female workers seems both
justified and necessary. At the same time, this restriction is the least
restrictive alternative, short of a continuation of the suspension, capable of
reducing the risks to levels for the duration of this order. While an action
that imposes different restrictions on men and women is unusual and not
to be taken casually, it is not unprecedented. (See Federal Radiation
Protection Guidance for Occupational Exposure, 52 Fed. Reg. 2822 et seq.,
January 27, 1987.)
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14
C Term of Order and Conditions for Extension.
Although Judge Greene recommended that dinoseb be permitted to be
used on these crops for the pendency of the cancellation proceedings (Rec.
Dec., p.32), I agree with EPA Counsel in their recommendation to limit the
term of this Order to the 1987 growing season, and to make consideration
of any Section 18 emergency exemption request for 1988 contingent on
efforts by the Petitioners to sponsor or conduct tests on alternative
pesticide treatments during 1987. Given the serious nature of the risks
posed by any use of dinoseb, and the importance of demonstrating
alternatives as soon as possible, I believe that it is reasonable to ask the
Petitioners to be at least partially responsible for demonstration testing.
Similarly, should a request for use of dinoseb for these crops in these
States be made for the 1988 growing season, my consideration of that
request will be influenced by evidence regarding good faith compliance
with the restrictions contained in this Order.
D. Protective Clothing in Tractor Cab.
I have modified Judge Greene's recommendations regarding protective
clothing in two respects. First, I find convincing Petitioner's objection that
requiring protective clothingto be worn while inside the tractor cab may
contaminate the cab with dinoseb. However, to reduce risks of acute
toxicity stemming from application equipment malfunction and repair, I
am requiring that applicators carry a new set of protective gloves and
coveralls (Tyvek® suits) in the tractor cab for use in such situations. (See
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15
Respondenent's Objections to Recommended Decision, p.7, fn.2; Petitioner's
Objections, p.5.)
R Limitations on Saies of Dinoseb
In objections filed to Judge Greene's Recommended Decision to me,
EPA Counsel recommended that restrictions be placed on the sale or
transfer of dinoseb products subject to the Section 18 emergency
expemptions. Specifically, EPA Counsel recommended "(l)a requirement
tht each purchaser of a dinoseb product subject to the §18 emergency
exemption must be a dry pea, lentil, or chickpea grower in Washington or
Idaho, and (2) a limitation that each grower who wishes to purchase a
dinoseb product subject to the §18 emergency exemption may onbly
purchase the quantity required to treat his dry pea, lentil, and chickpea
acreage at the maximum legal application rate." (p. 15)
Despite Judge Greene's concerns about such restrictions (Rec. Dec.,
p.33), I believe the need to ensure that dinoseb exposures are as low as
called for by this Order warrants the effort and inconvenience involved.
F Other Restrictions A dopted.
Based on the findings of Judge Greene, I accept the other restrictions
contained in her Recommended Decision to me.
F Other Restrictions Recommended but Not A dopted.
I have not agreed with Respondent's recommendation to lower
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16
dinoseb application rates to 1.5 ai/A for all three crops. Petitioner's
concerns about the efficacy of dinoseb at the lower levels for dry peas and
chickpeas makes this recommended measure seem unnecessary in view of
the other risk reduction measures imposed herein. Instead, I accept the
recommendations of the Administrative Law Judge on this matter.
VI. Judicial Review.
Under Section 136n(b) of FIFRA (7 U.S.C. §136n(b)), petitions for
judicial review of this action must be filed in the United States Court of
Appeals for the appropriate circuit within 60 days of the entry of this
Order. Only persons adversely affected by this Order and who have been a
party to the proceedings may obtain judicial review.
Dated: March 30. 1987
Lee M. Thomas
Administrator
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Al\ a ) I
Oi 1-3-7
rtf**
p^is
1988 FIFRA Amendments-Implementation
The 1988 FIFRA Amendments were signed into law on October
25, 1988 to take effect on December 24, 1988. A Steering
Committee has been established by Jack Moore, under the
leadership of Joseph E. Powers, and has met once to establish an
implementation plan. Of the committees proposed, the following
are of particular interest to enforcement.
1. Reregistration- The project will be handled through the
publication in the Federal Register. of "lists" of the 500-1800
chemicals subject to reregistration; all submitted data will be
tracked by OCM. The amendments propose definite time limits with
the first list of 150 chemicals to be published in 4 months and
at seven and ten months. By next November, inspections can be
begun for compliance with the resulting cancellation and
suspension orders.
2. Storage and disposal- Regulations to be developed for
labeling, storage and disposal of pesticides and pesticide
containers. Regulations to be written to handle recall of
pesticides. OECM input desirable to insure "enforceability"
3. Indemnity- EPA will determine eligibility for indemnity
payments for recalled and cancelled pesticides.
4. Reregistration fees- EPA will develop a schedule for
registration fees and for collection of same.
5. Records and Inspections- increased scope of inspections to
include locations where, and copying records for, pesticides
which are held for sale and/or registration. Once the storage
and disposal regulations are in place, inspections and records of
storage and disposal will be included.
6. Unlawful acts- expanded to include failure to submit required
data and submitting false data, violating cancellation and
suspension orders( thereby eliminating the need for SSUROs) and
refusal to allow inspections and copying of records. Once the
reregistration schedules are in place, inspections and
enforcement will be along the present lines.
7. Unlawful use of an unregistered pesticide- a new provision
which is to be implemented by regulation. Of utmost importance
to enforcement.
8. Communication and Guidance- This, committee will have the task
of drafting the data submission guidelines and must have these in
place in 7 months.
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1988 FIFRA AMENDMENTS
The Amendments set in motion an extensive program of
reregistration of pesticides, new methods of indemnification and
expand the scope of enforcement. Agency costs for personnel and
resources required for the extensive health and environmental
reviews of the dlata submitted by the registrants will be offset
by registration fees.
REREGISTRATION
Each pesticide which was registered before November 1984, or
which contains an active ingredient registered before November,
1984, must be reregistered unless the Administrator determines
that there are no outstanding data requirements and that the
requirements of section 3(c)(5) have been satisfied. The
reregistration scheme is divided into five "phases" which will be
published in the Federal Register beginning in April, 1989.
Reregistration fees for pesticides to be used on feed or
food range from $50,000 to $150,000. Other reregistration fees
and fees for small businesses vary.
STORAGE. DISPOSAL AND RECALL
The Administrator may require the registrant, as part of a
registration, to submit data on safe storage and disposal methods
for the pesticide. The Agency will then have the task of
inspecting for, and enforcing compliance with, these expanded
portions of the pesticide registration process.
BOOKS AND RECORDS INSPECTIONS
The amendments add "registrants and applicants for
registration" and expand the scope of the FIFRA inspection
authority.
INDEMNITIES
The Agency is still obligated to indemnify registrants for
suspension and /or cancellation of a pesticide. However,
registrants will no longer be indemnified if they had knowledge
that the pesticide registration did not meet the requirements of
section 3(c)(5) and continued to produce the pesticide.
Indemnification actions must now be,.reported to the House and
Senate and the will no longer come from the Agency's operating
budget but rather from the Justice Department's Judgement Fund.
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DIRECT ENFORCEMENT
The Agency is no longer required to issue SSROs but will be
able to act directly to enforce violations of a suspension or
cancellation order.
USE VIOLATION-UNREGISTERED PESTICIDE
The Agency now has the authority to promulgate regulations
restricting the use of unregistered pesticides. Up to now, the
authority was limited to preventing the sale of unregistered
pesticides.
CRIMINAL PENALTIES
The amount of criminal penalties assessable was raised to
$50,000 for registrants and $25,000 for commercial applicators.
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rt/M
FACT SHEET — THE 1988 FIFRA
AMENDMENTS
Statutory Authority for Pesticide Regulation
Under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) pesticide products must be registered by the
Environmental Protection Agency (EPA) before they are sold or
distributed in commerce. The EPA registers pesticides on the
basis of data adequate to show that, when used according to label
directions, they will not cause unreasonable adverse effects on
human health or the environment. FIFRA requires the Agency, in
making these decisions, to take into account economic, social,
and environmental costs and benefits. FIFRA was first passed in
1947. Thousands of pesticide products have been registered
since.
To ensure that previously registered pesticides meet current
scientific and regulatory standards, in 1972 Congress amended
FIFRA to require the "reregistration" of all existing pesticides.
This is a massive undertaking, and one which has drawn criticism
because EPA has not been able to review and reregister existing
pesticides as quickly as Congress originally intended. A variety
of factors contributed to impeding the Agency's progress in
carrying out the reregistration mandate, including inadequate
resources and the sheer magnitude of the task.
FIFRA authorizes cancellation of registration if a pesticide
is found to cause unreasonable adverse effects on human health or
the environment. EPA may also suspend the use of a pesticide if
necessary to prevent an imminent hazard. An emergency suspension
takes effect immediately, but under an ordinary suspension a
registrant can request a hearing before the suspension goes into
effect to determine whether registrations of the pesticide should
be suspended. Under FIFRA, EPA was required to accept suspended
and cancelled pesticides, and dispose of them at government
expense. In addition, an indemnification provision required EPA
to reimburse holders of suspended and cancelled pesticides for
any loss suffered, up to the cost of the pesticide.
FIFRA Amendments of 1988
On October , 1988, an Act to Amend the Federal Insecticide,
Fungicide, and Rodenticide Act (1988 Amendments) became law,
after passing both the Senate and House of Representatives
unanimously. The 1988 Amendments strengthen EPA*s authority in
several major areas, requiring a substantial acceleration of the
pesticide reregistration activity-, imposing statutory time limits
for processing certain types of pesticide registration
activities, and changing EPA's responsibilities and funding
requirements for the indemnification, storage and disposal of
suspended/cancelled pesticides. It also authorizes collection of
fees to support some of these new activities.
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The 1988 amendments resulted from a protracted series of
attempts for comprehensive revisions to FIFRA, starting in 1984.
The initial attempts represented a coordinated effort on the part
of industry and environmental groups to establish an accelerated
reregistration program. As negotiations proceeded, the House and
Senate versions of the bill each accumulated a number of
controversial amendments. Although bills were passed in both
houses in 1987, they died in conference.
In the spring of 1988, the Senate Agriculture Committee
reported a bill with a large number of amendments which again
proved too controversial for passage and a FIFRA reauthorization
bill was considered unlikely to pass the 100th Congress.
In late summer, however, the bill was resurrected as the
"Core" FIFRA 1988 Amendments, concentrating on: (1) reregistra-
tion, (2) fees, (3) expedited processing of certain types of
registration applications, (4) revised responsibilities for
disposal and transportation of pesticides that the Agency had
taken off the market, and (5) provisions limiting the entitlement
to indemnification to holders of cancelled and suspended
pesticides.
MAJOR PROVISIONS OF THE 1988 AMENDMENTS
Reregistration Provisions:
The reregistration provisions are the principal focus of the
1988 Amendments. These provisions establish requirements with
very tight deadlines, for both the regulated industry to generate
a complete data base and for EPA to analyze the data and make a
decision whether to reregister currently registered pesticides.
Reregistration takes place in five phases, as follows:
Phase 1: The EPA is required to publish lists of pesticide
active ingredients subject to reregistration and to ask
registrants of pesticides containing those active
ingredients if they intend to seek reregistration. These
lists will be published within 10 months of the effective
date of the Act.
Phase 2: Registrants are required to tell EPA of their
intention to seek reregistration, identify missing and
inadequate scientific studies required to support
reregistration, agree to fill these data gaps under
prescribed deadlines and pay the first portion of a
reregistration fee. Responses are required within three
months after EPA publishes each chemical list.
Phase 3: Registrants are required to summarize and reformat
existing studies to facilitate EPA review, certify that they
possess or have access to raw data supporting those studies,
"flag" studies indicating adverse effects, and pay the final
reregistration fee. They are required to accomplish this
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within 1 1/2 to 2 years after passage of the 1988
Amendments.
Phase 4: EPA is required to conduct a review of submissions
made by registrants under phases 2 and 3, independently
identify data gaps, and issue requirements for registrants
to fill those gaps. This will take place over a period of
2 to 4 years after enactment.
Phase 5; This phase is the culmination of the process
initiated by the Act. It requires EPA to conduct a
thorough, comprehensive examination of all data submitted in
support of pesticide reregistration. As a result of this
review, the Agency will either reregister the pesticide or
take other appropriate regulatory action. This phase will
occur over a span of approximately 3 to 9 years, depending
on the scheduling of individual chemicals, the complexity
of the required studies, and the time required for
registrants to complete them.
Fees:
Reregistration is a complex regulatory process which is
expected to cost about $250 million over the nine years of this
specific program. Approximately $110-120 million of that cost is
expected to come from a continuation of the current services
level of the EPA's budget for reregistration activities. The
remaining funds will be provided by the pesticide industry
through a combination of a reregistration fee for each active
ingredient and an annual fee for registration maintenance to be
paid for each registered product.
Registrants will be required to collectively pay fees of
$150,000 for major food or feed use active ingredients. For
active ingredients not yet covered by a Registration Standard, an
initial payment of $50,000 is due during Phase 2, and the balance
in Phase 3. For those pesticide active ingredients not intended
for major food or feed uses, the registrants will be required to
pay a fee of not more than $150,000 and not less than $75,000.
Active ingredient fees are apportioned among registrants based on
a market share. Fee reductions or waivers will be applied for
certain pesticides. Any antimicrobial active ingredient for
which the annual level of production does not exceed 1 million,
pounds is exempt, as is any active ingredient for which the value
or volume of use is considered minor. In addition, for any
"small business" registrant (i.e . a company with 150 or fewer
employees and average annual sales for chemicals over the 3-year
period prior to reregistration eq.ual to or less than $40 million)
the reregistration fee will be based upon a graduated rate
ranging from 0.5 to 1.5 percent of average annual pesticide
sales.
Unlike the reregistration fee, the annual maintenance fee is
assessed for each"pesticide product. While the objective of the
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maintenance fee is to generate approximately $14 million annually
in additional operating funds for the Agency,- the maximum
possible fee for any registrant is $35,000, regardless of the
number of product registrations held. For up to 50
registrations, the annual fee is targeted at $425/product, and
for 51 through 200 registrations the fee is targeted at
$l00/product, with no fee planned for more than 200
registrations. If there are not enough registrations to raise $14
million, however, EPA may raise these annual maintenance fees.
During the nine year period that these fee provisions are in
effect, the Agency is prohibited from levying any other fee for
the registration of a pesticide. The registration fees
established by regulation in May 1988 will be in abeyance during
this period. Payment of fees for the establishment of tolerances
for pesticide residues in food or feed, required by the Federal
Food, Drug and Cosmetic Act. are not affected by this Act.
Expedited Registration:
The 1988 Amendments also require EPA to give expedited
consideration to applications to initial or amended registration
of products which are similar to pesticides already registered by
EPA. Similar products include not only those which are identical
to currently registered products, but ones which differ from
registered products only in ways that would not significantly
increase the risk to public health and the environment. Under
the expedited review provisions, an applicant will be notified
within 45 days after the Agency receives an application, whether
the application is complete. Within 90 days after the Agency has
received a completed application, the registrant will be notified
in writing whether the request is granted or denied, and if it is
being denied, the specific reasons for denial. A portion of the
fees collected by EPA will be available to the Agency for the
purpose of carrying out expedited processing of similar
applications.
Storage and Disposal of Suspended or Cancelled Pesticides:
The 1988 Amendments expand EPA's authority to regulate the
storage, transportation, and disposal of pesticides. In addition
to the authority to require data on storage and disposal methods,
the 1988 Amendments authorize EPA to establish labeling
requirements for transportation, storage and disposal of the
pesticide and its container. Under the new law, EPA may also
require registrants and distributors to recall suspended and
cancelled pesticide products. EPA can require registrants to
give evidence of their financial, capacity to perform such a
recall. The 1988 Amendments also delete from current law the
requirement that EPA, upon request, accept suspended and
cancelled pesticides and dispose of them at government expense.
A registrant who wishes to become eligible for reimbursement
of storage costs.incurred as a result of a recall must submit a
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plan for storage and disposal of the pesticide that meets EPA's
established criteria. Storage costs will be reimbursed for:
1) none of the costs incurred before the date of the submission
of the plan to EPA; 2) 100 percent of the costs incurred after
the date of the submission of the plan or the date of
cancellation of the pesticide, whichever is later, but before the
approval of the plan by EPA; 3) 50 percent of the costs incurred
during the 1-year period beginning on the date of approval of
the plan or the date of cancellation of the pesticide, whichever
is later; 4) none of the costs incurred during the 3-year period
beginning on the 366th day after the approval of the plan or the
date of cancellation, whichever is later; and 5) 25 percent of
the costs incurred during the period beginning on the first day
of the 5th year following the approval of the plan or the date of
cancellation, whichever is later, and ending on the date that a
disposal plan for the pesticide can be implemented.
In order to lessen the problems associated with pesticide
container disposal, EPA is required to conduct a study to examine
options to encourage or require: 1) the return, refill, and
reuse of pesticide containers; 2) the development and use of
pesticide formulations that facilitate the removal of pesticide
residues from containers; and 3) the use of bulk storage
facilities to reduce the number of pesticide containers requiring
disposal.
The 1988 Amendments also authorize EPA to regulate
procedures for storage, transport and disposal of containers,
rinsates or other materials used to contain or collect excess or
spilled pesticide. Additionally, in order to promote the safe
storage and disposal of pesticides, EPA will promulgate
regulations for the design of pesticide containers. These
regulations will ensure that pesticide containers will allow the
removal of pesticides from the containers, and will facilitate
the safe use, disposal, and refill and reuse of the containers.
Indemnity Payments:
Prior to the 1988 Amendments, if EPA suspended and cancelled
a pesticide's registration, EPA was required to indemnify holders
of the pesticide for any loss suffered, up to the cost of the
pesticide. Persons covered by indemnification included farmers,
commercial applicators, pesticide formulators, pesticide dealers
and distributors, and registrants.
The 1988 Amendments end automatic entitlement to indemnity
payments for all persons other than certain end users, and
provide that all indemnity payments made will come from the
Judgment Fund of the Treasury and not from the operating budget
of the EPA. End users, such as farmers, will continue to be
eligible for indemnification through the Judgment Fund.
Indemnification to anyone other than an end user may be paid
under the 1988 Amendments, if Congress provides a line-item
appropriation. The 1988 Amendments also require all sellers of a
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pesticide (including registrants and wholesalers) to reimburse
the buyer for the purchase price of a product whose registration
is suspended and cancelled unless at the time of purchase the
seller told the buyer in writing that the seller would not make
such refunds. If EPA determines that a business insolvency or
bankruptcy make such reimbursements impossible, dealers and/or
distributors will also be eligible for indemnification.
Miscellaneous Provisions;
The 1988 Amendments also contain a number of other
provisions designed primarily to make it easier for EPA to
implement the three major provisions described above, including:
Penalties; Criminal penalties are increased for
registrants, applicants for registration, or other pesticide
producers who knowingly violate the pesticide law.
Unlawful acts: The 1988 Amendments provide that certain
acts, such as submitting false test data, violating
suspension or cancellation orders, failure to submit
required records or allow inspection, will be unlawful.
Records and inspection: Additional authority is provided
for EPA to request records and inspect places where
pesticides are being held, to ensure compliance with storage
and disposal provisions.
Scientific Advisory Panel (SAP): The 1988 Amendments provide
that the SAP will be permanent.
Congressional review: The 1988 Amendments shorten the
period of Congressional review of final regulations from 60
days of continuous Congressional session to 60 calendar
days.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MAR 3 0 1995
OFFICE OF
MEMORANDUM ENFORCEMENT AND
COMPLIANCE ASSURANCE
SUBJECT: Enforcement of Personal Protective Equipment (PPE)
Provisions of the FIFRA Worker Protection Standard
FROM: Jesse Baskerville, Director
Toxics and Pesticides Enforc
Office of Regulatory Enforcement
TO: Regional Toxics and Pesticides Division Directors
Regional Counsels
Phil Benedict, Chairman, SFIREG
Mary Ellen Setting, President, AAPCO
On February 13, 1995, the Agency distributed its "Summary
Guidance on Issuance of WPS Enforcement Actions" which applied to
any violations of the Worker Protection Standard (WPS).
Recently, we were asked to distribute further guidance specific
to enforcement of the personal protective equipment (PPE)
provisions of the Worker Protection Standard. In response, we
have developed the attached summary guidance which applies to PPE
violations, the ten factors which EPA recommends be considered in
determining the appropriate recipients of WPS enforcement
actions.
This guidance supercedes a similar document which the
'Regions received from me under a cover memo dated March 24, 199 5.
The reason for the replacement concerns an issue raised by
Congressional staffers and a state association regarding a
statement in the March 24th guidance which prompted some
unintended interpretations. The attached is our final summary
guidance on "Issuance of WPS Enforcement Actions in Response to
PPE Violations."
We request that you immediately provide the attached final
guidance on this topic to the State Lead Agencies for their
consideration and use. We will continue to work with the Regions
and States on any enforcement related questions which they may
have. We appreciate your assistance.
Please contact TPED attorney Patricia L. Sims (202/564-4048)
if you have questions or comments concerning this guidance.
Attachment
Recycled/Recyclable
Printed with Soy/CanoU Ink on paper thai
contains ai toast 75% rocydod (iter,
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cc: Steven Herman
Lynn Goldman
Michael Stahl
Scott Fulton
Jim Aidala
Robert Van Heuvelen
Elaine Stanley
Dan Barolo
Regional Toxics and.Pesticides Branch Chiefs
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March 30, 1995
Issuance of Worker Protection Standard (wpS^ Enforcement Actions
in Response to Personal Protective Equipment (PPE) Violations
This document is provided in response to requests made to
the Environmental Protection Agency (EPA) for specific guidance
concerning enforcement of the personal protective equipment (PPE)
provisions of the FIFRA Worker Protection Standard (WPS). This
summary guidance is organized according to the ten factors to be
considered in determining the appropriate recipients of WPS
enforcement actions, and employers/owners/operators' PPE
responsibilities.
Ten Factors for Consideration
EPA recommends that accountability for compliance with the
FIFRA Worker Protection Standard (WPS) be decided on a common
sense, case-by-case basis. "Summary Guidance on Issuance of WPS
Enforcement Actions," provided February 1995, identifies the
following ten factors which EPA recommends States consider when
they need to determine the appropriate recipient(s) of a WPS
enforcement action:
1) Who has control over pesticide use;
2) Who directs pesticide use;
3) Who has control over the agricultural establishment for
posting and other WPS-related responsibilities;
4) Who gives direction on the agricultural establishment
for posting and other WPS-related responsibilities;
5) Who has control over the practices used by agricultural
workers on the establishment;
6) Who directs the practices used by agricultural workers
on the establishment;
7) Measures taken to comply with provisions of the WPS;
8) Actions taken in response to incidents of noncompliance;
9) History of prior violations; and
10) Ability to assure continuing compliance with the WPS.
Documentation by employers/owners/operators could assist them in
demonstrating to State regulatory officials, their efforts to
comply and responses to instances of noncompliance.
The totality of the circumstances should be considered in each
case. The ten factors are not listed in any order of priority;
each factor should be appropriately considered in every case.
Emplovers/Owners/Qperators PPE Responsibilities
The ten factors should be considered if an employee
(including workers and handlers) does not use PPE required by the
WPS. It is essential for employers/owners/operators to take an
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active role to assure that personal protective equipment is used.
The employer/owner/operator bears primary responsibility for
WPS PPE compliance. Employers/owners/operators must provide,
clean and maintain PPE, and instruct employees on its proper use.
The employer/owner/operator has a responsibility to inform
employees who do not use their PPE that such clothing or
protective gear is required. In the case of pesticide handlers,
the responsibility to follow label directions and use PPE
properly is a shared one with the employer.
The employer/owner/operator also has a responsibility to
take appropriate actions if an agricultural employee does not
comply with instructions to use PPE. If an employee does not use
WPS required PPE, appropriate supervisory actions that could be
taken by the employer/owner/operator to achieve compliance
include warnings and nondiscriminatory discipline. If an
employer/owner/operator provides employees with appropriate PPE,
training and supervision per the specifications of the WPS, there
should not arise an occasion on which the employer/owner/operator
would be subject to a WPS/PPE enforcement action due to the
individual decision of an agricultural employee not to use the
PPE.
Enforcement officials will consider the facts of a case
before determining how to respond to any WPS violation,
consistent with the ten factors identified, in the Agency's
February 1995 summary WPS enforcement guidance. EPA recommends
that accountability for compliance be decided on. a common sense,
basis, and that the totality of the circumstances be considered
in each case, including enforcement actions in response to PPE
violations.
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