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NOTICES '. ..-_'..' ^ ..-;.::. '- 52513
frM-S] v
x PEST CONTROL DEVICES PROCEDURES
Consolidation and Clarification of '
":-. .. ....-. Requirements
'"-- -'I':' Correction
'In PRJ3oc. 7ft-3<119 appearing on pa^e
51065 ta the Jssae for Friday. NoTember^
IS. 1878. on page -SlCSSrcmacDf column. '
third TuU paragraph. In the 12Ui toe.
"January 18, 1976'.' should have read
January 18. 1977". ;.
«0,STH. VOU o. NO.»,-AT N ,,76
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
24 .ISM 'P77
OFFICE CF ENFORCEMENT
MEMORANDUM
TO:
FROM:
Regional Administrators
Stanley W. Legro
Assistant Administrator
for Enforcement
SUBJECT:
Enforcement Priorities in Structural Pest Control
a) Establisnment Inspections of Pest Control Firms
b) Pesticide Use Inspections
c) Prosecutorial Discretion in Pesticide Use
Enforcement
I. Purpose.
This memorandum (a) provides supplemental guidance to the FY 77
Regional Plan and Program Guidance with regard to the performance
of establishment inspections of structural pest control firms, and the
inspection of pesticide use by structural pest control operators, (b) sets
forth criteria to be applied by the Regional Offices in determining which
pest control establishments should be the object of establishment inspec-
tions, (c) sets forth criteria to be applied by the Regional Offices in deter-
mining whether to perform a pesticide use inspection of structural pest
control activities, and (d) informs the regions of the manner in which the
Office of Enforcement will exercise its prosecutorial discretion in regu-
lating the sale, distribution or. use of pesticides in the structural pest
control industry.
II. Background.
The implementation of a comprehensive program to regulate pesticide
use and to perform pesticide use inspections continues to be an important
emphasis of the Agency's pesticide use enforcement program during FY 77.'
The Agency has determined that its limited inspectional resources should
be utilized primarily to observe those activities which present the greatest
risks of harm. The Agency intends to exercise its prosecutorial discretion
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in a "common sense" manner which will prevent unreasonable adverse
effects upon people and the environment, and will foster professionalism
and compliance with the law among structural pest control operators.
The Office of Enforcement is developing similar supplemental guidance
to direct inspectional activities and establish enforcement priorities in
agricultural and other non-structural pest control.
*
All structural pest control firms which supply and apply pesticides
for hire are deemed by the Agency to engage in two distinct activities
which are subject to regulation under the FIFRA. First, in contracting
to perform pest control services, they are deemed to hold pesticides
"for distribution or sale" within the meaning of FIFRA section 9(a).
Indeed, the price paid by the customer for the application necessarily
reflects the cost of the service and the cost of the pesticide. Secondly,
while actually applying the use-dilution preparation of the pesticide,
they are deemed to "use" pesticides. A relatively small number
of these structural pest control firms also engage in a third type of
activity, i.e., in the .production,, formulation, or. repackaging.and . -
sale of pesticides for use by other persons.
A structural pest control firm which simply supplies and applies
pesticides (i. e., a firm which is engaged in the distribution or sale of
pesticides while performing pest control applications for hire is subject
to enforcement liability as an "other distributor" under the provisions
of FIFRA section 14(a)(l), but is exempted from the establishment regis-
tration requirements of FIFRA section 7 under the provision of 40 CFR
167. 2(a). A structural pest control firm which also engages in the pro-
duction, formulation, or repackaging and sale of pesticides for use by
others, is subject to enforcement liability as a "registrant . . . wholesale^
dealer, (or) retailer" under the provisions of FIFRA section 14(a)(l), and
is subject to the establishment registration requirements of FIFRA section
7 as implemented in 40 CFR Part 167.
m. Supplemental Guidance to the FY 77 Regional Guidance and Program
Plan.
The FY 77 Regional Program Plan specifies the number of establish-
ment inspections and use observations to be performed by each Region.
The Regional Guidance notes that one aspect of the Agency's use enforce-
ment program is the "audit of professional pesticide users such as struc-
tural and agricultural pest control operators. " The Guidance also provides
that the Regions should "devote approximately thirty percent of their
pesticide enforcement resources toward ensuring compliance with all use
requirements...." Elsewhere, the guidance provides that another, thirty
percent of the Regional resources will be devoted to assuring industry
compliance by performing establishment inspections and other surveillance
activities.
Structural pest control operators are constituents of both the pesticide
distributing and pesticide using populations. Accordingly, some percentage
of each Region's inspectional activities should be devoted to the performance
of establishment inspections and use inspections of structural pest control
activities. The Office of Enforcement has determined that approximately
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- 3 -
fifteen percent of the Region's industry compliance activities should be.
devoted to the inspection of establishments of structural pest control '
operators, and that approximately fifteen percent of the Region's audit
of professional pesticide users should be devoted to the performance
of use inspections of structural pest control activities. This allocation
of resources will result in each region expending approximately five
percent of its pesticide enforcement resources in performing establish-
ment inspections of structural pest control firms and five percent of its
resources in performing use investigations of structural pest control
activities. Accordingly, the following number of the establishment
inspections and use inspections performed in a Region by EPA personnel
or by State personnel functioning pursuant to a Cooperative Agreement
should involve structural pest control operators:
ACTIVITY NUMBER OF INSPECTIONS BY REGION
Establishment
Inspection
Use Inspections
I
8
10
II
15
7
ni
20
9
rv
44
30
V
24
12
VI
27
9
VII
26
11
vm
5
5
EX
30
12
X
15
18
IV.. Establishment Inspection of Structural Pest Control Firms Whicft
Produce, Formulate or Repackage Pesticides.
A. Establishment Inspection of Structural Pest Control Firms Which
Engage in Production Activities.
FIFRA Section 9(a) authorizes officers or employees duly designated
by the Administrator to conduct administrative inspections of places where
pesticides are "held for distribution or sale. ".. Pest control firms which
produce, formulate, or repackage pesticides for use by other persons
have long been a party to the regulatory process. The pesticides which
they produce, formulate, or repackage for use by others are subject
to the pesticide registration requirement of FIFRA section 3. Further-
more, their establishments have been subject to the establishment
registration requirement of FIFRA section 7 since early 1974.
Inspections of their establishments are conducted for the purpose
of inspecting books and records which are required to be maintained
under FIFRA section 8(a), and of obtaining samples of pesticides or de-
vices which are packaged, labeled, and released for shipment pursuant
to FIFRA section 9(a).
The establishment inspection of such pest control firms is designed
to assure compliance with product registration, formulation, packaging,
and labeling requirements, to collect and develop evidence to support
enforcement actions when violations are found, to determine whether
the required books and records are being maintained, and to determine
whether procedures for the disposal and storage of pesticides, pesticide
wastes, and pesticide containers are being complied with.
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The establishment inspection of pest control firms must conform in
all respects to the procedures for establishment inspections provided in
Chapter 9 of the EPA Inspection Manual. The Consumer Safety Officer
(CSO) should discuss with the owner, operator, or agent in charge of -
the establishment the purpose and potential enforcement ramifications '
of the inspection.
B. Criteria for Determining Whether to Perform an Establish-
ment Inspection of Structural Pesf Control Firms Which"
Engage in Production Activities.
During FY 77, each region will be expected to conduct establishment
inspections of some structural pest control firms which produce, formulate
or repackage pesticides. In determining which firms to visit, the region
should consider: '
1. No Prior Establishment Inspection. The implementation of
the registration requirement witn respect to pesticides which
are sold only in intrastate commerce materially increased the
number of establishments which are subject to establishment
inspection under FIFRA by virture of their production, formu-
lation or repackaging activities. The Regional Guidance
provides that firms which have not previously been inspected
will be inspected on a routine basis. Unless re-inspection is
dictated by the other criteria, establishments which have once
been inspected shall not be re-inspected until other establish-
ments have once been inspected.
2. Suspected Violations. If, on the basis of prior inspections, or
of reports from other Federal or State agencies or from the
general public, the Region has reason to believe that evidence
of violations may be discovered thereby, an establishment
inspection of a firm which produces, formulates, or repack-
ages pesticides may be undertaken. Such firms may be
inspected as frequently as necessary to assure compliance
with registration, formulation, packaging and labeling re-
quirements. As appropriate, the Notice of Inspection must
specify that a violation is suspected.
3. Specific Assignment. An establishment inspection should be
conducted wnenever EPA headquarters, another Region, or
another governmental agency requests that such an inspection
be performed.
V. Establishment Inspection qflstructural Pest Control Firms Which Supply
and Apply Pesticides for Hire.
A. Establishment Inspection of Structural Pest Control Firms Which
Supply and Apply Pesticides for Hire"!
All structural pest control firms which produce, formulate, or
repackage pesticides also engage in the sale or distribution of pesticides
in the course of supplying and applying pesticides for hire. Such firms
are also subject to administrative inspection in their status as distri-
butors. Even though numerous structural pest control firms do not
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engage in the production, formulation, or packaging of pesticides for use -
by others, they nevertheless supply and apply pesticides for hire and are,
thus, subject to administrative inspection under the authority of FIFRA
section 9(a). Such distributor inspections may be conducted for the :
purpose of inspecting books and records which are being maintained by
the firm as authorized by FIFRA section 8(b), and of obtaining samples
of pesticides or devices which are packaged, labeled and released for
shipment. I/
The establishment inspection of such pest control firms is designed
to determine whether pesticides which are packaged, labeled, and released
for shipment conform with all applicable packaging and labeling require-
ments, to collect and develop evidence to support enforcement actions when
violations are found, and to gather information which may be voluntarily
supplied by the firm regarding the scope and nature of the firm's program
to train and provide technical assistance to its service technicians.
Insofar as the establishment inspection of a firm which only distri-
butes pesticides conforms with the establishment inspection of a firm
which produces, formulates, or repackages pesticides for use by others,
the procedures for establishment inspections provided in Chapter 9 of the
EPA Inspection Manual must be followed. The CSO should discuss with the
owner, operator, or agent in charge of the establishment the purpose and
potential enforcement ramifications of the inspection. Additional instruction
in performing these inspections is provided in part V. C. of this document.
B. Criteria for Determining Whether to Perform an Establishment
Inspection of Structural Pest Control Firms Which Supply and
Apply Pesticides for
During FY 77, each region will be expected to conduct establishment
inspections of some firms which supply and apply pesticides in the course
JLJ
~~ FIFRA section 9(a) does not authorize inspection of any place where
pesticides are being held for use or are being used. Accordingly, such
places cannot be inspected except pursuant to a search warrant obtained
upon a showing of probable cause that a provision of FIFRA has been or
is being violated, or pursuant to the voluntary consent of the person in
charge of the premises, e.g., the homeowner or restauranteur. The
pest control operator who only applies pesticides provided by the cus-
tomer likewise is not subject to inspection by the Agency under the
authority of FIFRA section 9(a).
. . It.is.the'opinion of the Agency that pesticide concentrates or. use-
dilution preparations of end use products which have been transferred
into service containers are "released for shipment" within the meaning
of FIFRA section 9(a). Service containers utilized for the temporary
transportation or storage of pesticides must comply with abbreviated
labeling requirements of PEPS No. 6. Failure of the service container
to bear such abbreviated labeling will constitute a violation of FIFRA
section 12(a)(l)(E) which makes it unlawful for any person "to sell . . .
offer for sale, (or) hold for sale-. . . any pesticide which is ...
misbranded. " Under the provisions of PEPS No. 6, such a violation
would subject the violator to civil or criminal penalties.
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of providing pest control services for hire, but which do not engage in the
production, formulation, or re-packaging of pesticides. In determining
which firms to visit, the region should consider:
1. No Prior Establishment Inspection. Relatively few establishment'
inspections of structural pest control firms have been performed
since the implementation of the 1972 amendments to FIFRA. The
Regional Guidance provides that firms which have not previously
been inspected will be inspected on a routine basis. Unless re-
inspection is dictated by other criteria, establishments which have
once been inspected will not be re-inspected until other establish-
ments have once been inspected.
2. Suspected Violations. If, on the basis of prior inspections, or of
reports from other Federal or State agencies or from the general
public, the Region has reason to believe that evidence of violations
may be discovered thereby, an establishment inspection of a pest
control firm which distributes pesticides may be undertaken. .As
appropriate, the Notice of Inspection must specify that a violation
is suspected.
3. Nature of the Pest Control Business. Firms frequently engaging
in those pest control activities which are identified in Section VI
below as priority areas of enforcement concern should be selected
for inspection first. The regional office may have no knowledge c:'
the principal type of pest control business engaged in by the fjrm
prior to its first visit to the firm. Where such information is known,
the Regional Offices should assign inspectional priority to firms
utilizing the pesticides (or active ingredients), or the application
practices outlined in Section VI below.
4. Size of the Pest Control Firm. Regions should seek to inspect
firms representing a wide range of business sizes. The inspection
of larger firms.will maximize the coverage and exposure of our
inspectional activities. The inspection of smaller firms will estab-
lish an enforcement presence among such firms.
5. Specific Assignment. An establishment inspection should be con-
ducted, whenever .EPA headquarters, another Region, or another
governmental .agency requests that such an inspection be performed.
C. Elements of an Establishment Inspection of Structural Pest Control
Firms Wnica Supply, and Apply Pesticides for-Hire..
1. Elements 'of Establishment Inspections Which are. AutHbrized by _.
Section
The following elements of an establishment inspection are
authorized purusant to FIFRA Section 9(a), and constitute an
integral part of an establishment inspection. All of the procedures
for performing establishment inspections provided in Chapter 9 of
the EPA Inspection Manual must be complied with in all details,
particularly with respect to the requirement to provide proper
identification, to give a proper Notice of Inspection, and Receipt
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for any samples collected. The results of the analysis will be
returned to the establishment from which the sample was collected.
a. Inspection of Books and Records. As needed, the CSO should
inspect the books and records which the firm may be maintaining
as required by FIFRA to collect and develop evidence to support
enforcement actions. Upon specific request for information relevant
to an Agency suspension or cancellation proceeding, an in-depth
inspection may be undertaken of records showing the delivery,
movement or holding of pesticides, as provided in FIFRA section
8(b).
b. Sampling of Pesticide Products. While performing an inspection
of a pest control firm, the CSO may collect samples of pesticides
which have been packaged, labeled and released for shipment in
accordance with the procedures outlined in Chapter 12 of the EPA
Inspection Manual.
c. Review of Abbreviated Labeling. The CSO should specifically
review the abbreviated labeling which the firm has placed on any
service containers containing pesticides which have been released
for shipment and which are being used to temporarily store or
transport pre-measured quantities of pesticide concentrates, or
pre-mixed use-dilution preparations of pesticides. The abbreviated
labeling must conform with the standards contained in PEPS No. 6.
2. Discretionary Inspectional Activities Which are Voluntary With the
Firm and Which "May "be Engaged in Only with the Consent of trie"
Company^ ' '
The following activities are not a regular part of the establish-
ment inspection conducted pursuant to FIFRA section 9(a). They
constitute discretionary activities which the CSO may engage in only
with the voluntary consent of the owner, operator, or agent in charge
of the establishment.
a. Review of Company Training and Educational Programs. While
performing an inspection, the CSO should discuss with company
officials whether the company (or its liability carrier) sponsors
an on-going training program. The CSO should also determine
the extent to which the company has participated in programs
to certify appropriate personnel to use restricted use pesticides.
This review should be conducted to stress the need to train service
technicians regarding-such matters as the necessity for use consistent
with labeling provisions, pesticide toxicity and hazards to man and
common routes of exposure, potential environmental consequences
of pesticide use and misuse, factors influencing pest recognition,
pesticide formulation and dilution procedures, and factors influenc-
ing pesticide toxicity, compatibility, synergism and efficacy, appli-
cation equipment and methods of procedure. [See 39 FR 36450-51]
The CSO should request to receive any available information regarding
the company's training and educational program so that appropriate
officials at the Regional Office may review the training program to
»
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- 8 - .
determine its nature and scope, and to evaluate its general adequacy.
The CSO should explicitly advise company officials that the review .of.
the company's training program is voluntary with the company.
b. Collection of Company Technical Bulletins or Manuals. While per-
forming an inspection, the CSO should discuss with company officials
their procedures for supplying their service technicians with adequate
technical bulletins and manuals to inform them of precise procedures
to be followed in performing particular pest control activities. This
review should be conducted to stress the need to provide service
technicians with technical bulletins or manuals regarding such matters
as precautions necessary to guard against injury to people or the
environment, factors influencing pest recognition, factors influencing
pesticide toxicity, compatibility, synergism and efficacy, the use,
calibration and maintenance of application equipment, and specific
application procedures used to apply various formulations of pesti-
cides, solutions and. gases, appropriate -to- the-pest-eontrol-problem
at hand. [See 39 FR 36450-51]. If the company has prepared technical
bulletins or manuals, the CSO should request to receive all available
materials so that appropriate officials at the Regional Office may
determine their nature and scope, and may evaluate their general
adequacy. The CSO should explicitly advise company offficials that
'the review of the company's technical bulletins or manuals is voluntary
with the company.
VI. Pesticide Use Inspection of Structural Pest Control Activities.
The Regional Office should perform a pesticide misuse investigation
whenever there is reason to believe that provisions of the Act have been (or
are being) violated. In the absence of a suspected violation (and as resources
permit), the determination to perform a pesticide use inspection will typi-
cally be made after the establishment inspection has been completed, and
upon a review at the Regional Office of the Establishment Inspection Report.
In performing use inspections of structural pest control treatments,
the CSO must follow the procedures provided in Chapter 15 of the EPA
Inspection Manual, particularly with respect to the requirement to give
a Notice of Use/Misuse Inspection. In determining whether to perform a
pesticide use inspection, the Regional Office shall consider:
A. Nature and Scope of the Training and Technical Support Program.
The sponsorship by the firm (or its liability carrier) of a training and
technical support program which is adequate, if complied with-by the service
technicians, to foster good pest control practice will generally mitigate EPA's'
desire to perform pesticide use inspections. The absence of such a training
and technical support program will increase the value to EPA (and to the firm)
of performing use investigations. Furthermore, failure by the firm to have
performed the training and testing necessary to certify appropriate personnel
to use restricted use pesticides will increase the value to EPA of performing
pesticide use inspections. Persons who engage in structural pest control as
a secondary (or "moonlighting") occupation may warrant particular scrutiny.
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B. Nature of Pest Control Activities Engaged In By The Firm.
The Agency intends to scrutinize most carefully the use of (a) those
particular active ingredients, or (b) those particular application techniques
or methods which pose unique risks of harm or which have been the source
of pesticide misuse in the past. . '
1. Pesticides (or Active Ingredients) Which Warrant Particular
Emphasis"!
The use of the pesticide class or active ingredient listed below is deemed
to warrant particular scrutiny because (a) the products are widely used in
structural pest control and have been involved in prior misuse cases, (b)
the pesticide is registered for use by application methods which pose inherent
risks of harm to children, adults, or domestic animals, or (c) the pesticide
or active ingredient is particularly toxic to humans or domestic animals.
The following pesticides "have: been identified "by PTSED ~as'warranting '
particular emphasis. Accordingly, the CSO should seek to accompany the
service technician to observe pest control applications which involve the
use of the following pesticides:
a. Phosphorus Paste Products
b. 1080; Sodium monofluoracetate
c. 1081: Fluoracetamide
d. 'Res'tricted Use Pesticides " *
e. Category I Pesticides
[This list may be revised by PTSED, or by a Region upon the concurrent
of PTSED, as dictated by the regulatory objectives of the Agency, or by local
pest control practices within the Region).
2. Enforcement of Particular Structural Pest Control Activities
or Pesticide Treatment Methods!
The Agency particularly desires to scrutinize application methods
which pose serious risks of harm to people or the environment. Accordingly,
the CSO should seek to accompany the service technician to observe pest
control applications which involve the following pest control activities or
treatment methods:
a. Fumigation Treatments; The use of fumigants in the treatment
of buildings or other structures such as storage elevators or
grain bins;
b. Treatments of Areas or Establishments in Which Food is
Processed, Prepared or Handled*;The use of appropriately
registered pesticides in residential or commerical kitchens
or other places where food is processed, prepared or other-
wise handled;
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c.
- 10 -
Rodent Control Treatments; The use of rodent control prod-
ucts in household or public health baiting applications.
[This list may be revised by PTSED, or by a Region upon the concurrent
of PTSED, as dictated by the regulatory objectives of the Agency, or by local
pest control practices within the Region].
C. History of Compliance, or Report of Pesticide Misuse.
When the establishment inspection arises out of a history of violations or
a report of suspected pesticide misuse, the CSO should seek to accompany
the service technician to observe those pest control applications which are
similar in nature to those involving prior misuse, or which involve the treat-
ment methods noted above.
Vn. Prosecutprial Discretion in Initiating Enforcement Action for Violations
..... ' of Particular 'labeling Fro" visions 'By ^'StrAicturarT'e'st'Co'mroT'Dpier'atoFs'."'
The Agency's mandate to protect people and the environment from unrea-
sonable adverse effects of pesticides is the overriding Consideration in the
development of enforcement policy. Any use of pesticides in a manner which
results in harm or which poses an unreasonable risk of harm will subject th-.-
user to enforcement liability.
PTSED has identified a number of provisions of the Act relating to pro-
duct registration and labeling which are of particular importance in structural
pest control. The -violation of these, labeling provisions would generally pose
particular risks of harm, and have in the past resulted in serious injur^^
persons exposed to these risks. It is the policy of the Office of Enforce:!Uk
that any violation of the following provisions will, in most cases, subject the
violator to civil or criminal enforcement sanctions:
1. Unregistered Pesticide: The sale or distribution of any unregistered
pesticide.
2. Cancelled or Suspended Pesticide; The use, sale, or distribution
of any pesticide which contains an active ingredient whose regis-
tration has been cancelled or suspended because of human health,
environmental or efficacy considerations in a manner inconsistent
with the terras of the Final Order.
3. Specific Prohibitions; The use of any registered pesticide in any
manner which is specifically prohibited on the label.
4. Use Site; The use of a registered pesticide at a use site not provided
on the label.
5. Dosage Rate; The use of a registered pesticide at a higher dosage
rate than tnat provided on the label.
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-11 -
For example, a pesticide is used at a use site which is inconsistent
with the labeling if it is used indoors when the label bears use instructions
for outdoor applications only, if it is used in hopper cars when the label
bears no instructions for use in hopper cars, or if it is applied by a
broadcast mechanism when the label provides for use only in cracks and
crevices. Additionally, a pesticide will be deemed to have'been applied
at a higher dosage rate than that provided on the label whenever the amount
of active ingredient disbursed (per unit area or per unit time) exceeds that
provided on the label.
Most EPA labels bear only affirmative use instructions. Since pro-
hibitory statements are used only where the activity mentioned is strictly
prohibited, the violation of any prohibitory statement will, in most cases,
subject the user to enforcement sanctions.
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UNITED STATES -ENVIRONMENTAL PROTECTION AGENCY
. WASHINGTON, D.C. 20460
JUL11
'OFFICE O/ ENFORCEMENT
SUBJECT: Enforcement Policy Applicable to Bulk Shipments of Pesticides
TO: Regional Enforcement Division Directors
Pesticide Branch Chiefs
I.
It has come to our attention that an increasing practice among
manufacturers and distributors of pesticides involves the transport and
transfer of pesticides in large guantities, i.e., "bulk". I/ Among the
reasons that manufacturers and distributors prefer to handle pesticides
in bulk rather than in small individual containers are the following: 1)
the need to properly dispose of excess numbers of containers is eliminated;
2) less warehouse space is required: 3) labor and handling costs are re-»
duced; and 4) inventories can be more accurately controlled.
In the interest of energy and resource conservation and ofm improved
safety measures in pesticide handling, it is incumbent upon the'Agency to
encourage and endorse these practices in so far as they are consistent with
the broad purposes of FIFRA. Because the practices involved in "bulk" ship-
ment and transfer are in some cases unclear in or are unaddressed by the Act
and regulations, the development of an enforcement policy to define the
limits of the "bulk" shipment and transfer practice is needed.
17For purposes of this policy, the term "bulk" refers to any volume of
pesticide greater than 55 gallons or 100 pounds held in an individual con-
tainer. Examples of bulk quantities of pesticides are: creosote in barges,
weed oil in tank cars, liquid herbicide in tank trucks or rail cars, or
any of these in standing storage tanks.
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II. Policy and Rationale
A. Policy Summary
For purposes of enforcement of the Act, it is the policy of.the
Agency that so long as the transfer of a registered pesticide in "bulk*
involves only the changing of the product container with no change 1) .
to the pesticide formulation, 2) to the product's acceptetTlabeling
(with exceptions noted in Part III B and C below, and 3) to the iden-
tity of the party accountable for the product's integrity, the new
product resulting from transfer will be considered as encompassed
within the terms of the registration of the product which was trans-
ferred. This rationale applies to the transfer of supplementally
registered products, as well as to the basic registered product.
B. Rationale
The basis for this policy is published in the Appendix to PEPS
No. 6 (41 Fed. Reg. 55932) as follows:
FIFRA section 3(a) [7 CJ.S.C. 136a(a)] provides in pertinent
part that
* * * no person * * * may distribute, sell, offer for
sale, hold for sale, * * * to any person any pesticide
-which is not registered with the Administrator.
Before a pesticide product which is not encompassed
within the terms of an existing registration enters .
the channels of trade, a separate registration must
be obtained. Changes in the formulation of a regis-
tered product, changes in accepted labeling, as well
as any repackaging of a pesticide into another con-
tainer will activate the registration requirement,
unless the purposes of product registration would be
fully met by carrying forward the Federal registra-
tion of the constituent product.
The broad purposes of the registration process are
four fold. First registration of a product provides
a mechanism for the review of information regarding
the safety and efficacy of the pesticide as proposed
for use (and as likely to be used) under widespread
and commonly recognized practice. Second, registra-
tion of a product provides EPA with tne opportunity
to review the proposed label and labeling of the
product. To support registration, such labeling must
clearly communicate the directions for use for the
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-3-
product and such warnings and precautions as are neces-
sary for the safe and efficacious use of the pesticide.
Third, registration of a product identifies the party
accountable for its integrity of composition, labeling
and effects resulting from use. Fourth, registration
of a product is the mechanism which assures that this
relevant information is communicated to the ultijnate
user of the product.
III. Elaboration of Policy Relating to Specific FIFRA Regairements
A. Section3
The commercial transfer of a pesticide in "bulk" may, at various
stages of-..the_shipping_nc_dis.triJbutiori_pr:.ocess,, ,.iayQ.lv.e_chajQging_the
container of the pesticide. Because "changing the container" or
"repackaging" amounts to production within the meaning of 40 CFR
167.l(c), and because the resulting product is a pesticide and is
being held for sale and distribution within the channels of trade,
it is subject to the registration requirements of section 3. The key
to determining the applicability of section 3 to a repackaged bulk
product is whether the purposes of registration continue to be satis-
fied upon further sale and distribution after transfer. These pur-
poses outlined above include: safety and efficacy review, label review,
identification of the accountable party, and communication to the user
of relevant information. Thus, to the extent.that-a bulk transfer
involves changing the container, e;_£., repackaging a registered end-
use pesticide with no change to the pesticide formulation, its labeling,
or the accountable party, the repackaged product is encompassed within
the terms of the original registration. This means that the original
registration will have satisfed the purposes of section 3 as to the
repackaged pesticide. Conversely/ if any of these factors change, the
corresponding purpose of registration will be unsatisfied, thereby
activating the registration requirement for the repackaged product.
In the context of the bulk transfer practice the most difficult
of these criteria to satisfy is accountability. For purposes of this
policy, the accountability requirement will be considered as met when
a pesticide 1) is transfered in bulk at an establishment owned by the
registrant as specified in 40 CFR 162.3(dd)(l), 2/ 2} is transferred
2740CFR 162.3(dd) provides:
(dd) The term "operated by the same producer" means (1) another regis-
tered establishment owned by the registrant of the pesticide product or
(2) another registered establishment operated under contact with the regis-
trant of the pesticide either to package the pesticide product or to use
the pesticide as a constituent part of another pesticide product provided
that the final pesticide product is registered by the transferor establish-
ment.
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-4-
at a registered establishment operated under contract with the regis-
trant within the meaning of 40 CFR 162.3(dd)(2), or 3) is transferred
at a registered establishment owned by a party not under contract to
the product registrant, but who has been furnished writt'en authoriza-
tion for use of the product label by the registrant. The written
authorization may apply to a supplemental registrant's label as; well
as to a basic product label. If a supplemental registrant's label is
involved, the written authorization must still be supplied to all trans-
fer points by the basic registrant. The supplemental registrant cannot
satisfy the written authorization requirement.
This provision for satisfying accountability may be utilized at
as many points down the chain of distribution as the product regis-
trant cares to authorize. However, at any point where a pesticide is
transferred and-^r-epackaged jj>buIk--by-'a-personj^th^rg1Eh'ah'' the" regis"-
trant, his agent as provided in 40 CFR 162. 3(dd)(2) or one authorized
by the registrant under written agreement with the registrant to
transfer the product and to retain use of the registrant's label,
the requirement of accountability has not been met. The resulting
transferred and repackaged pesticide is considered a different pesti-
cide no longer encompassed within the terms of the original registra-
tion and is subject to separate registration under section 3.
Sale and distribution of a pesticide transferred and held for sale
under conditions other than the three outlined above and therefore
in a manner which fails to satisfy the conditions of registration,
will subject the party responsible for such transfer, and for subse-
quent sale and distribution, to the sanctions of section 12(a)(l)(A)
of the Act for sale and distribution of an unregistered pesticide.
Failure to supply the required label, with each sale will subject
the seller to enforcement liability under section 12(a)(l)(E) for sale
and distribution of a misbranded pesticide.
B. Section 2(g)
Section 2(q) lists various types of information which must appear
on each pesticide label. In those cases (outlined in Part A above)
where the conditions of transferal repackaging do not activate the
section 3 registration requirement/ the original registered label
will, be attached to the transferred product; 3_/ however, this label
must reflect the establishment number of the establishment at which
V Label placement must conform to the requirements of 40 CFR 162.10 (a)
T4)(ii)(A) and (B)
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-5-
the product was transferred (unless otherwise specified in part C
below) and the appropriate net content statement. Failure to include
accurate establishment registration and net content information on
the label subjects the tranferor to enforcement liability under
section 12(a)(l)(E).
C. Section 7
Regulations pursuant to section 7 (40 CFRPart 167) provide that
the act of repackaging constitutes production and thereby activates
the need for establishment registration. All establishments, there-
fore, in which bulk pesticides are transferred or repackaged are sub-
ject to section 7.
The Agency has determined, however, that the purposes of the Act
are not substantially furthered by enforcing the establishment regis-
tration requirement for repackaging or transfer establishments when
such repackaging or transfer is performed by an establishment owned by
the same person who previously produced the product within the meaning
of 40 CFR 162.3(dd)(l). Thus, for purposes of this policy, establish-
ments owned bythe registrant which ^.ngage..only..ln.. transfer _and. gppack-
agirrg'j!rrbuiK hejed-^fibOSe registered, gursuant to section 7 and products
ETSrSsTerred andrepa'ckaged insuch establishments may retain the. label
showing the number of the establishment in which the original product?
subject to transfer and repackaging was produced.
However, when the repackaging or transfer is performed in an
establishirent owned by a person other than the__reg.is:txant e.j., by
"a~p"erson operating under contract t"o~th!Tr"egTsitr"ant pursuant to 40
CFR 162.3 (dd)(2) or by a person authorized by the registrant,.to use
his label on the transferred and repackaged pesticide, that establish-
ment must be registered and the product label must show that establish-
ment number. This label modification may be accomplished by sticker-
ing. Failure to register producing transferring establishments as de-
fined at 40 CFR 167 (other than those specifically exempted in this
policy statement) and to reflect the establishment number on transferred
products, may subject repackagers to the sanctions of section 12(a)(2)(L)
of the Act for violation of section 7 and section 12(a)(l)(E) for
and distribution of a misbranded product.
IV. Examples
A. A registrant ships a bulk pesticide to a new owner (dealer/distri-
butor). The dealer holds the pesticide in labeled storage tanks until
the material is sold in bulk quantities to end-use applicators, with
the original label accompanying. The dealer's establishment number
is on the label or container. The basic registrant has furnished
the new owner (dealer) written authorization for use.of the regis-
trant's label. The purposes of Section 3 registration are satisfied.
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-6-
B. A registrant ships a balk pesticide directly .to an end user (cus-
tom applicator, farmer, etc.)- The label accompanies the shipment
and is placed on the user's tank. No new establishment or product
registration is needed for the bulk container since the labeled
product is fully registered and has been sold intact to the user.
C. A registrant ships a bulk pesticide to a new owner (dealer/
distributor). The registrant furnishes the dealer written authori-
zation for use of the registrant's label only to accompany material
from the dealer's tanks to end-use applicators. If the dealer sells
from his tanks to a second dealer for subsequent sale to an end user,
the purposes of registration are not served by the sale to the second
dealer. The accountability requirement will not be considered met by
virtue of non-authorization of the registrant's label for such an
action. The product will be considered not registered and the dealers
will be subject to enforcement sanctions under sections 12(a)(l)(A)
and 12 (a)(l)(E) for selling and distributing unregistered and mis-
branded pesticides.
Responsibility for movement of a product from the registrant to
Dealer A to Dealer B and to the user is considered analogous to a
registrant that sells a sealed 55-gallon drum of a pesticide to a
dealer who sells the drum to another dealer. If the drum was then
decanted into 11/5-gallon cans, the registrant could not be held
accountable for his product, nor would the decanted product be con-
sidered registered.
D. A registrant may wish to have a dealer "operate under contract"
for him as a producer. 40 CFR 162.3(dd) allows the registrant to enter
formal contractural agreements that, in effect, make the contract pro-
ducer an extension of the registrant's own production facilities, and
both share enforcement liability for the product intergrity. Under
this arrangement, the registrant's label would be placed on the bulk
pesticide produced and released for shipment by the contract producer
(dealer) establishment. Any further transfer of the pesticide in bulk
quantities would be subject to the provisions of this policy.
E. A registrant ships a bulk pesticide to a new owner (dealer/ dis-
tributor) and refuses to furnish written authorization to use his
label. If the dealer sells the pesticide, he will be considered to
have sold an unregistered pesticide in violation of Section 12(a)(l)(A)
and a misbranded pesticide in violation of Section 12(a)(l)(E). Without
such written authorization for the use of the registrant's label, there
is no identification of the party accountable for its integrity of
composition, labeling, and effects resulting from use.
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-7-
F. A tank car of pesticide from which commercial applicators meter
off into their own tanks, without being put into a dealer's holding
tank, would be exempt from new producer establishment registration.
It is considered that the original container has not been changed
in delivery to the applicator and the tank car label (placard) will
bear the producer's establishment number. The commercial applicator
would be bound by the general labeling requirements of PEPS VI if
the pesticide is transported or stored. The application of PEPS VI
to agricultural pest control operators will be elaborated in the
enforcement policy for custom blenders and custom applicators.
A. E. Conroy II,
Pesticides and Toxic Substances
Enforcement Division
-------
WEDNESDAY .AUGUST 23,1978
^ PART IV
I
I .
iNVIRONMENfAL
PROTECTION
AGENCY -
PESTICIDE REGISTRANT
REPORTING
REQUIREMENTS
Agency interpretation and
Revocation of fnferaretafive Rule
-------
Title 40Prelection of Environment
CHAPTER IENVIRONMENTAL
PROTECTION AGENCY
, [FRL 052-2)
PART 162REGULATIONS FOR THE
ENFORCEMENT OF THE FEDERAL
INSECTICIDE, FUNGICIDE, AND RO-
DENTICIDE ACT
Revocation of Interpretative Rule
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Revocation of Interpretative
rule.
SUMMARY: EPA revokes a regulation
containing an Agency interpretation
of the reporting requirement imposed
on registrants by section 6(a)(2) of the
Federal Insecticide. Fungicide, and
Rodenticidc-Act. as anrendrd tFIFRAO.'
This revocation is issued because the
Agency has concluded that the regula-
tion inadequately expresses the Agen-
cy's interpretation of the requirement
imposed by FIFRA section 6, which the Agency has
adopted as its interpretation of those
requirements. That memorandum ap-
pears in this same separate part of the
FEDERAL REGISTER.
'Notice'-an"d:commenf "procedures" are
not being used in connection with this
action because (1) the regulation being
revoked is an Interpretative rule, (2)
the public interest would be served by
prompt revocation of an interpreta-
tion which Inadequately reflects the
Agency's views, and (3) the expedi-
tious resolution of the previously-men-
tioned litigation depends on prompt
revocation of the regulation. For the
same reasons, the effective date of this
action shall be August 23. 1978.
me u.cs. ucpartmcnt of Agriculture
has reviewed this regulation In accord-
ance with FIFRA section 25fa)(2HB>.
By letter dated July 31. 1978. the De-
partment informed the Accncy thai it
did not object to publication of the
regulation, and that the reporting con-
templated by the interpretative memo-
randum did not appear to be unrea-
sonable. Copies of the regulation and
accompanying memorandum also were
submitted to the Senate Committee on
Agriculture* pursuant to FIFRA sec-
tion 25(a)(3). In accordance with
FIFRA section 25(d). copies of the reg-
ulation and memorandum were fur-
nished to the FIFRA Scientific Adviso-
ry Panel; by letter dated July 18, 1978.
the Panel notified the Agency that it
would not conduct scientific review
and comment on the regulation.
The Agency has determined that
this document is not a "significant*
regulation under the Agency's criteria
for Implementing Executive Order
12044.
This action Is authorized Jjjt EIFRA-
section 25(a). 7 U.S.C. 136w(a>. and by
5 U.S.C. 552, 553.
Accordingly. Part 162. Chapter I.
Title 40 of the Code of Federal Regu-
lations, is hereby amended by deleting
the text of section 162.8(d)(2) and by-
designating that paragraph as "Re-
served."
Dated: August 14,1978.
DODGLAS M. COSTLE. '
Administrator.
IFH Doc. 78-23552 Filed 8-22-78: 8:45 am:
FEDERAL REGISTER, VOL 43, No. 164WEDNESDAY, AUGUST 23, 1978
-------
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[6560-01]
ENVIRONMENTAL PROTECTION
AGENCY
tFRL 852-3)
PESTICIDE REGISTRANT REPORTING
REQUIREMENTS
Agency Interpretation of (tquircmcnrt Im-
pend on RcgictranU by Section 6(a)(2) of
the federal Inieclicide, fungicide, and Ro-
u'enticide Act
This notice sets forth the Environ-
mental Protection Agency's interpre-
tation of the reporting requirements
imposed on registrants of pesticides by
section G(a)(2) of the Federal Insecti-
cide, Fungicide, and Rodenticidc Act,
as amended (FIFRA), 7 U.S.C.
13Gd(a)(2). The memorandum of the
Agency's General Counsel dated June
30. 1978. which is set forth below, is
hereby adopted as the Agency's posi-
tion.
Dated: August 14.1978.
DOUGLAS M. COSTLE.
Administrator.
[Memorandum]
Subject: Nature of reporting require-
ment under FIFRA section 6(a)(2).
From: Joan Z. Bernstein, General
Counsel (A-130).
To: The Administrator (A-100).
Through: AX(A-lOl).
JUNE 30,1978.
BACKGROUTO
This memorandum sets forth in
detail this Office's views concerning
the proper interpretation of the regis-
trant reporting requirements imposed
by Section 6(a)(2) of the Federal In-
secticide, Fungicide, and Rodcnticide
Act. as amended (FIFRA). It responds
to your May 10 directive that such a
discussion be prepared. Since we
merely state here what we believe the
statute requires, publication of this
memorandum would not by itself
impose any new or additional require-
ments, but would constitute a state-
ment of. the Agency's position with re-
spect to the matter.
QUESTION
What information must a registrant
submit to EPA In order to comply with
the requirement of FIFRA Section
6(a)(2>?
ANSWER
In our opinion. FIFRA Section
G(a)(2) imposes the following require-
ment:
A registrant must submit an item of
information to EPA if:
(1) The registrant possesses the in-
! formation and It pertains to n. ;>csii-
'cide for which that reentrant holds a
I registration under FIFHA; and
(2) The Information, If true, would
be relevant to an Agency decision re-
gardlnp the risks and benefits of the
pesticide. I.e., an Agency decision re-
garding the registrablllty of the pesti-
cide or regarding the proper terms and
conditions of the registration of the
pesticide.
(b) Notwltlistandint? (a) above. Infor-
mation need not be submitted to the
Agency to the extent that It consists
solely of opinion(s) or conclusion^)
expressed by persons other than any
person:
(1) who was employed or retained
(directly or Indirectly) by the regis-
trant to express an opinion or conclu-
sion which relates In any way to the
pesticide's properties, effects, risks or
benefits; or
(2) from whom the registrant re-
quested the opinion(s) or conclusion(s)
in question: or
(3) who by virtue of his knowledge.
skill, experience, training or education
would be permitted to testify to the..
oplnlon(s) or conclusion(s) under Rule
702 of the Federal Rules of Evidence,1
(c) Notwithstanding (a) and (b)
above. Information need not be sub-
mitted to the Agency if it has previ-
ously been submitted to the Agency in
writing or If it has been accurately
tabulated or summarized in a previous
written submission to the Agency.
DISCUSSION
I. THE STRUCTURE OF FIFRA AND THE ROLE
OF SECTION 6(a)(2)
The Federal Insecticide. Fungicide,
and Rodcnticide Act. as amended in
1972 by the Federal Environmental
Pesticide Control Act (hereafter re-
ferred to as "FIFRA"). completely re-
structured the Federal pesticide regu-
latory scheme and redefined its thrust.
FIFRA was changed "from a labeling
law imo a comprehensive regulatory
statute that will henceforth more
carefully control the manufacture, dis-
tribution, and use of pesticides."* As
the House Committee on Agriculture
summarized in its Committee Report:
The Committee found the greatest need
for revision of existing laws to be in the
areas of strengthening regulatory controls
on the uses and users of pesticides, speeding
up procedures for barring pesticides found
to be undesirable: streamlining procedures
for making vaJuaDle new control measures,
procedures, and materials broadly available:
strengthening enforcement procedures to
protect against misuse of these biologically
'Rule 702 provides: If scientific, technical.
or oilier specialized knowledge will assist
the trier of fact to ur.iicr.Uar.d the evidence
or to determine n fact in issue, a witness
qualified as an expert by knowledge, skill,
experience, training, or education, may tes-
tify thereto in the form of aji opinion or
otherwise.
'Hnii.sc Committee on Agriculture. H.
Ropt. No. OC-S11, Old Corss.. 1st sess. 4
US71) (hereafter "House Ruyort").
effective materials: and creating an admlnls.
tratlve and Iccnl framework unrter which
continued research can produce more
knowledge about belter ways to usr existing
pesticides a.i well as developing alternative
materials and methods of pest control
It Is clear 'that Congress' pr
purpose In enacting the 1972 arnc
ments was to Insure that pesticicde use
would be subject to a thorough envi-
ronmental 2nd human health hazard
review.4 .
Under FIFRA. with certain excep-
tions no pesticide may be distributed.
sold or otherwise placed in commerce
unless It has been registered. FIFRA
section 3(a). § 12(a)(l)(A). Extensive
Information on the risks and benefits
of using the pesticide must be submit*
ted to the Administrator before It can
be registered. FIFRA section 3(c). A
pesticide is eligible for registration
only" if the Administrator determines
that it will perform Its intended func-
tion without "unreasonable adverse ef-
fects1 on the environment," particular-
ly "when used In accordance with
widespread and commonly recognized
practice," and that it is otherwise ef-
fective and properly labelled, FIFRA
section 3(c)(5).
If It appears to the Administrator
that a registered pesticide no longer
meets the registration requirements,
he may Initiate proceedings to either
cancel the registration or change iu
classification if he fin'ds that the pesti-
cide "generally causes unrewonab!..-
adverse effects on the environment,"
FIFRA section 6!b). The Administra-
tor also may suspend the resistrat
of a pesticide pending complctio/
cancellation proceedings, if he
that an "imminent hazard" exists,
FIFRA section 6(c)(l). An immminent
harard is defined as "a situation which
exists when the continued use of a
pesticide during the time required for
cancellation proceeding would be
likely to result in unreasonable ad-
verse effects on the environment cr
will involve an unreasonable har.ard to
the survival of Can endangered
species]." FIFRA section £(!). In sorr.o
cases of emergency, the Administrator
may even issue a suspension order
which takes effect immediately, prior
to a hearing. FIFRA section 6(c)(3).
In each instance where a determina-
tion is required for registration; can-
cellation or suspension, the controlling
standard is the same, i.e., whether the
pesticide causes or is likely to cr.use
"unreasonable adverse effects on the
environment." A pesticide which was
originally registered on the basis that
It would perform iis intended function
without unreasonable adverse effects
'House Report at 4.
'House Report at 13. 20. and Senate Com-
mittee on Agriculture and Forestry. S. Ri-r;t.
No. 02-033. Old Coil!:.. 2d soss. 5 UU7I2)
(hereafter "Scnaie Agriculture Report").
FEDERAL REGISTER, VOl. 43, NO. 164WEDNESDAY, AUGUST 23, 1978
-------
. on the environment might subsequent-
ly bo fouiul to violate that standard If
the registration was based on an Incor-
rect cv.iluation of the information
available at the time registration oc-
curred or if new Information raised
questiohs about the continued rcgis-
trability of the pesticide. The need for
information relating to the risks and
benefits of a pesticide after resistra-
tion is, therefore, just as important for
effective administration of FIFRA as
the- need for Information to Initially
register a pesticide.
Accordingly. FIFRA provides the
Administrator with ,1 variety of tools
to insure that he is kept current on in-
formation relating to the risks and
benefits of registered pesticides. One
of those is section 6(a)(2). which re-
quires registrants to submit Informa-
tion after registration to the Adminis-
trator.5 Sir.ce approximately 35,000
pesticide products are currently regis-
tered with EPA. it is not difficult to
understand why Congress imposed
sucira du'fy "to keep' the Administrator""
informed on registrants. Section
6(a)(2) of FIFRA prescribes the regis-
trant's responsibility as follows:
InformationIf at any time after the reg-
Istra'.ion of a pesticide the registrant has ad-
ditional factual Information regarding un-
reasonable adverse effects on the environ-
ment of the pesticide, he sh.ill submit such
ir.fornution to the Administrator.
It is an accepted canon of statutory
construction to interpret the language
of a statute in a manner which is con-
sistent with the overall goals of the
statute. The U.S. Court of Appeals for
the District of Columbia, in interpret-
ing a statute administered by the Fed-
eral Trade Commission, expressed this
principle as follows:
In determining the legislative intent, our
duty is to favor an interpretation which
would render tha statutory design effective
in terr.-,.-; of the policies behind Its enact-
ment and to avoid an interpretation which
would make such policies more difficult cf
ful.'iUmcnt. particularly where ' that in-
terpretation is consistent with the plain Ian-
sua;? cf the statute. See Bird v. United
S.'c.Ys. 187 U.S. 118. 124. 23 S. Ct. 42. 47 L.
Ed. 100 (1902); United States v. Blcsius, 2d
Clr.. 397 P. 2d 203. 207 n. 9 (1363). cert, dis-
rr.:s,-ed. 393 U.S. 1008. 89 S..Ct. 615. 21 L. Ed.
2d 557 (19CS). "(lln the absence of an un-
mistakable directive." we cannot "construe
the Act in a manner which runs counter to
the broad goals which Congress intended It
to effectuate." FTC v. Fred Meyer, Inc., 390
U.S. 341. 349. 83 S. Ct. 904. 908 19 L. Ed 2d
1222 U968). National Petroleum Refiners
Association v. FTC. 482 F. 2d 672. 6J19 (D.C.
Cir. 1973).
From the plain lancuace of section
Cia)(2) we know that the submission
requirement of that section applies to
persons holding registrations: that it
refers to Information concerning the
registered pesticides; that if refers to
"additional" Information. I.e., Informa-
tion which has not previously been
submitted to the Agency; and that it
refers only to information which the
registrant itself possesses. From there
the Inquiry must focus on the meaning
of the terms "regarding unreasonable
adverse effects on the environment"
and "factual information."
II. WHAT IS "INFORMATION REGARDING
UNKT.ASONABI.E ADVERSE EFTECTS ON THE
ENVIRONMENT"?
Some registrants have argued for a
restrictive interpretation of the sec-
tion 6(2)
in the FIFRA statutory scheme.
The language of § 6(a)<2) plainly
states that the information to be sub-
mitted is factual information "regard-
ing" unreasonable adverse effects on
the environment. In other words, to be
covered by the requirement, the infor-
mation need only pertain or relate to
unreasonable adverse effects on the
environment; it does not have to indi-
cate, establish, or prove the existence
of such effects.
The statutory scheme clearly re-
quires the determination of whether
'The Administrator also has authority to
require rc-eistrants to conduct studios rele-
vant to assessing the risks .ind benefits of a
pesticide, and to report tho rrsulu: thereof
to the Agency. See 40 CKR 162.8 ar.d
KIFRA section 6(bHl). See also FIFRA sec-
tion 20. which authorizes the Administrator
to conduct research to carry out the pur-
poses of the Act and to undertake monitor-
Ing.
The legislative history Is clear on this
point. According to the Senate Committee
on Commerce. "Paragraph (2) of subsection
la) requires a registrant to furnish-informa-
tion to the Administrator regarding unrea-
sonable adverse effects on the environment
after his pesticide is registered. While this
provision alioas the registrant to judsc
whether the information pertains to any
unreasonable adverse effect, he will be sub-
ject to the penalties of section 14 should he
possess such informatior, and not make It
available to the Administrator. Senate Com-
mittee on Commerce, S. Rept. No. 92-970.
92d Cong.. 2d sess. 37 (1972) (hereafter
"Senate Commerce Report")." A proposal
by the National Agricultural Chemicals As-
sociation (NACA). which would have re-
quired the registrant to submit "factual In-
formation inttictitiny that the registered
pesticide has substantial adverse environ-
mental or health effects." was adopted in
one of the early House Committee prints
but was later dropped in favor of the pres-
ent "regarding" language. Committee Print
No. 2. H.R. 4152 (June 22. 1971 (emphasis
added). Had Congress adopted the NACA
proposal, the restrictive Interpretation of
section 6(a)(2> advanced by some registrants
would be more worthy of consideration.
effects are unreasonably advorsc to be
made by the Administrator, not by the
individual registrant. The term "un-
reasonable adverse effects on the envi-
ronment" is defined in §3bb> of
FIFRA as "any unreasonable risk lo
man or the environment, taking into
account the economic, social, and envi-
ronmental costs and benefits of the
use of any pesticide." In other words. -
it calls for the Administrator to bal-
ance the benefits of use of a pesticide
against the risks of its use.' Plainly
there is no finite scale for measuring
where the balance should be struck. In
Interpreting the Administrator's au-
thority to conduct a risk-benefit as-
sessment under FIFRA. the U.S. Court
of Appeals for the District of Colum-
bia has emphasized repeatedly that
" 'FIFRA confers broad discretion' on
the Administrator to find facts and 'to
set policy in the public interest.' Well-
ford v. Ruckclshavs. 142 U.S. App. D.C.
86. 91. 439 F.2d 59H, 601 (1971). See,
also. EOF v. EPA. 150 U.S. App.
D:er-at-354;-4Q5"F-;2d"at' 534 < 1972)."--
Environmental Defense Fund Chereaf-
ter "EOF"] v. Environmental Protec-
tion Agency [hereafter "EPA"J. 510
F.2d 1292. 1297 (D.C. Cir. 1975; EOF v.
EPA. 548 F.2d 998. 1005 (D.C. Cir.
1976); and see EDF v. Ruckelshaus,
439F. 2d 584 (D.C. Cir. 1971). This'
broad discretion is necessary in part
because there is frequently great un-
certainty concerning jtist what the
risks and benefits are.* Even more im-
portant, however, is the fact that in
balancing risks and benefits the Ad-
ministrator is performing a task which
is intrir-sically policyu:aking in nature.
In deciding, for example, whether a
health risk should be borne by one
group in order for another group to
enjoy the benefits of a pesticide prod-
uct, the Administrator is performing a
public, official function which no pri-
vate group is qualified to perform.*
'House Report at 14; and Senate Agricul-
ture Report at 4.
The Administrator must often rely on
extrapolations from laboratory data, pnimal
studies, and clinical studies in order to
assess the risks, and he must rely on esti-
mates of economic impact in order to assess
the benefits. The risks and benefits (with
their associated uncertainties) must then be
balanced to arrive at a final decision.
Various practical considerations abo
point out the fallacy of the idea that the In-
dividual registrant is to make a risk/benefit
balancinc decision in order to know, whether
an item of Information the registrant pos-
sesses must be submitted under section
6(a><2). For instance, if a registrant were re-
quired to submit information under section
6!2> only if he had first concluded liiaC
the Information showed that his pesticide
caused unreasonable adverse effects on the
environment, he would In effect be conced-
ing that the pesticide should be cancelled.
and there would be no need for further ad-
versary proceedings of the type contemplat-
ed by section 6(b)-(d). Cl*:arly the statute is
not intended to function in this manner.
FEDERAl REGISTER, VOL 43, NO. 164WEDNESDAY, AUGUST 23, 1978
-------
lo bd
y thij
"unj
cnvi.;
) ot
;k tc"
1
vidsj
. bal
urina
:k. IH
i 2U
t as
5lum
ihati
n' ori
id'tQ
\Vcll-
.D.C
See
Appj
-fT-2*'
;reaf
rated
. sid
DFvl
CirJ
haus,
Thid
part
i im-
. the
e im-
.at in
: Ad-
vhich
iture.
' ' " a
c
o
...od-
ling a
o pri-
pricul-
;!> on
inmul
!cr to
n cst;-
assess
(with
nen be
the in-
/er.Mit
ricthcr
it pos-
.ection
ore re-
;ectio".
d t:>M
stic:dc
:n t!ie
i::r ad-
mpi.v.-
lute is
Moreover, pesticide regulatory deci-
sions Involve much more than whether
or not a prsticide should be registered
at all: the Administrator Is required to
make a number of decisions about the
terms and conditions of registration
which are not expressly stated In
terms of "unreasonable adverse effects
on the environment." Among these are
decisions concerning the pesticide's la-
beling and packaging." and decisions
concerning whether additional restric-
tions beyond labeling should be Ira-
posed," Decisions concerning these
and other terms of registration must
be made when the Administrator reg-
isters a pesticide product in the first
Instance. However, the Administrator
has the option of changing some or all
of these terms or conditions after reg-
istration, as remedies short of outright
cancellation, in situations where he
determines that without such changes.
the pesticide would generally cause
unreasonable adverse effects."
""Tt'ls~Ih~th'IS" context that' the re'gis-'"
trant must decide " whether to submit
the information. If the information
would be relevant to an Agency deci-
sion on the continued registrability of
the pesticide or to the proper terms
and conditions of the pesticide's regis-
tration, and the other requirements of
section 6(a)(2) are satisfied, the regis-
trant is required by section 6(a)(2) to
submit, the information to the
Agency." Naturally the registrant is
under a duty to make such decisions
about the relevance of the information
in an objective manner and to be in-
formed concerning the kir.ds of infor-
mation upon which the Agency may
wish to reiy in making regulatory deci-
sions.
A broad range of Information nor-
mally would be relevant to the Admin-
istrator's decisions concerning the re-
gistrability of a pesticide product, in-
cluding the terms and conditions of
registration. As discussed above, the
basic test of registrability under
FIFRA is whether the pesticide causes
"unreasonable adverse effects on the
environment"in other words, wheth-
er use of the pesticide poses ricks
which are greater than its benefits.
Accordingly, any information on
either risks or benefits relevant either
to the terms and conditions of regis-
tration or to the question whether the
"See, e.g.. FIFRA sections 2(q>. 3Cc)(5)(B).
and 25(0(3).
"S^e FIFRA sections 3(d) and A.
"See. e.g.. FIFKA sections 3tJ> and 6(d).
"S^e footr.ot;1 0. supra.
"Tl-.ls docs :;ot require a registrant to an-
ticipate future advances In scientific l:nowl-
ertge, however. The relcvar.ce of Informa-
tion Is lo be assessed by contemporary
standards. Nonet lick i». an advance in scien-
tific knowledge may reauire the submission
under section C(n)<2) of older information
which xas not previously relevant. For ex-
ample. see t.yputhi'ticaj number 5. infra.
pesticide should be registered at all Is
Information "regarding unrcsonable
adverse effects" which must be sub-
mitted If the .other requirements of
section 6(a)(2) are satisfied.
III. WHAT IS "FACTUAL INFORMATION"?
This term Is not defined In the Act.
and Its meaning must therefore be de-
rived from ordinary usage In light of
the broad goals which Congress In-
tended to effectuate by passage of the
1972 amendments.
Unfortunately, the legislative histo-
ry does not contribute much to the
analysis. An early version of what
eventually became section 6(a)(2) re-
quired the registrant to submit "any
information."" Thereafter, the Na-
tional Agricultural Chemicals Associ-
ation sponsored an amendment chang-
ing the wording to "factual informa-
tion." " This change was eventually
adopted by the House without expla-
nation," and the entire section under-
"went"further revision' 'In other respects'
before enactment. Thus, there is no
recorded legislative history that ex-
plains what Congress intended by the
term "factual information."
The legislative history also does not
Indicate whether these changes were
made in conjunction with changes in
the companion provisions governing
the preregistration disclosure require-
ments imposed on the registration ap-
plicant. Although the terms "informa-
tion" and "scientific information"
appear elsewhere In the Act, there is
no indication that Congress attached
any particular significance to the word
"factual" in section 6taX2). Section
3(c). which prescribes procedures for
registration, authorizes the Adminis-
trator to specify the kinds of "infor-
mation" required to support registra-
tion and to require t!iat "additional in-
formation" be submitted. Within 30
days after registration the Administra-
tor must make public the data called
for in the registration statement to-
gether with such ether "scientific in-
formation" he deems relevant to his
decision. Congress never discussed the
wording differences in the two provi-
sions, so there Is no indication that it
Intended any significant distinction
between the type of Information the
two provisions require. On the con-
trary, there are sound reasons for
reading sections 3(c) and 6(a)(2) to-
gether. Concress clearly intended that
the Administrator's evaluation of a
"H.R. 4152. 92d Conn.. 1st sess.. section
5>
pesticide's effects on the environment
be a continuing process. The language
of section C(a)(2) emphasizes this by
requiring the registrant to submit In-
formation "additional" to that previ-
ously submitted under section 3(cJ
Nor Is the dictionary of much
ance. One dictionary defines fad
as "of or containing facts" and infor-
mation as "something told: news: In-
telligence; w«rd" or "knowledge ac-
quired in any manner, facts: data:
learning; lore." ' Fact, Itself Is defined
as "a thing that has actually hap-
pened or that is really true" or "the
state of things as they are; reality: ac-
tuality: truth (/act as distinct from
fancy}."" However, in the present
context, these approaches arc too ab-
'stract to provide meaningful distinc-
tions between the Information that
must be submitted under section
6(aX2) and the information that need
not be. For example, some of these
definitions might be interpreted as
-su2gesting--the--exclusion- -of- expert
opinion from the scope of section
6(a)(2). However, since such opinions
form a large part, if not the prepon-
derance, of the information upon
which EPA routinely relies in rr.akir.g
regulatory decisions under FIFRA,
such an interpretation Is utterly Im-
plausible and clearly not Intended by
Congress.
Accordingly, the appropriate inter*
prefation Is one baied upon the funr-
tion of section 6(a)(2) in the context, ci
the FTFRA regulatory scheme. The
proper focus is.not the scope of the
phrase "factual information" as an ab
stract concept, b'.it the iru'ormatfi|
needs of EPA in regulating postisf
to protect the public health and
environment. As a result, the standard
stated in this memorandum defines
the scope of section 6(a)(2) in terms of
Information which, either by itself or
in conjunction with other information,
might, be relevant and probative in
regulatory decteiorur.aking. Since EPA
considers a wide range of information
and FIFRA provides a wide variety of
regulatory options, the standard set
forth above excludes only the unsoli-
cited opinions of persons who are not
employed or retained by the registrant
to express the opinion and whose opin-
ions would not be admissible under the
Federal Rules of Evider.ee as "expert"
opinion. This approach is premised on
the factf'that if a registrant solicits an
opinion it may be entitled to some
weight with respect to a regulatory de-
cision. If the registrant employs or re-
tains the person giving the opinion to
express such an opinion, the same
losic applies. Finally, if r. person's
opinion would be admissible under the
Federal Rules of Evidence, it may pro-
if the
ui ab-
ti^rre
"Webster's New World Dictionary (Com-
plete Reference Edition U072)).
"Id.
FEDERAL REGISTER, VOL «, MO. IS*WEDNESDAY. AUGUST 23. 1979
-------
vide .-xn appropriate basis for regula-
tory decision by the Apency.
This approach requires the submis-
sion of information which EHA may
ultimately determine to DP insuffi-
cient, when considered in linht of all
other information bearing on risks and
benefits, to warrant regulatory action.
In this connection. It has been argued
that the registrant should be permit-
ted to delay submission until it has
verified the accuracy or reliability of
the information. That argument ig-
nores a fundamental aspect of the reg-
ulatory scheme: the assessment of the
accuracy or reliability of information
as a basis for regulatory action is to be
made by the Administrator, not the
reRistrant.
Moreover, in providing procedures
for the suspension and cancellation of
pesticide registrations, Congress recog-
nized that protection of the health of
the public and the environment
cannot wait until evidence of unrea-
sonable adverse effects becomes "con-'"
elusive or universally accepted. By
granting the Administrator authority
to suspend pesticide registrants to pre-
vent an "imminent hazard", Congress
clearly anticipated that the Adminis-
trator would have to act swiftly
(either before a hearing or after an ex-
pedited hearing) upon new informa-
tion, even before the information
could be definitively evaluated. The
Ac: defines an imminent hazard as a
situation that "would be likely to
result in unreasonable adverse ef-
fects", FIFRA sections 2(1) and 6(c).
and the courts have repeatedly recog-
nized that "the function of the sus-
pension decision is to make a prelimi-
nary assessment of evidence, and prob-
abilities, not an ultimate resolution of
difficult issuer". EOF v. EPA, 510 F. 2d
at 1298, quoting EDF v. EPA, 465 F. 2d
528. 537 (D.C. Cir. 1972).
Congress imposed on registrants the
responsibility to submit to the Admin-
istrator information he may need to
prevent iiv.minent hazards. The Act
would be subverted if registrants were
permitted to withhold information
merely because, they doubted its valid-
ity, or because the information had
not yet been verified to their own sat-
isfaction, or because the information
was contained in a "preliminary", "in-
terim" or "partial" report.
The same principles apply to deter-
minations the Administrator must
make resarding cancellation. The Act
does not permit the Administrator to
wait until Conclusive proof on adverse
effects has been developed. Rather,
cancellation proceedings (or hearings
to determine whether a pesticide regis-.
tration should be cancelled or
changed) must be initiated "[ilf it ap-
pears to the Administrator that a pes-
ticide generally causes unreasonable
adverse effects on the environment,"
FIFRA. section 6
opinion to be admissible under tlsr
Federal Rules of Evidence.
6. Two registrants jointly sponsor A
study and each receives a copy of th-*
final report: both recognize that »if
study is subject to the reporting re-
quirement of section 6(aX2). One ret
istrant submits the final report to til--
appropriate official at EPA and srn..«
a copy of the cover letter, which at.^
quately identifies the study »'
report, to the second registrant. Tt-f
second resistr.-nt need not submit t.-r
report, since it has been proving.)
submitted; It is not "additional" f
matlon.
fEDERAl REGISTER. VOl. 43, NO. J64WEDNESDAY, AUGUST 23, 1978
-------
V. INFORMATION THE AGENCY DETERMINES
REGISTRANTS NEED NOT SUBMIT
The agency mteht conclude that al-
though Information of a certain kind
Is subject to the section 6(a)<2) report-
ing requirement (as Interpreted by
this memorandum), registrant report-
ing of that kind of Information Is not
essential to the Agency's functions.
(The Agency might, for instance, con-
clude that information ot a certain
kind available from sources other than
registrants is sufficient for Agency de-
cision-making, and thus that Informa-
tion of that kind which registrants
may also possess is not needed by the
Agency.) In such a case, it would be
appropriate for the Agency to an-
nounce publicly (by FEDERAL REGISTER
notice or otherwise) that it will not
consider a registrant's failure to
submit that kind of information to be
an actionable violation of section
6(a)(2).
Of course. It is for the Agency, not
~the registrant, to decide that a'ltefria-
tive information sources are adequate
for the Agency's needs. Until the
Agency announces that it will not seek
to enforce its section 6(a)(2) right to
obtain a particular kind of informa-
tion, that information must be report-
ed by registrants.
CFR Doc. 78-23553 Filed 8-22-78: 8:45 am]
FEDERAL REGISTER, VOL. 43, NO. 164 WEDNESDAY, AUGUST 23, 1978
-------
[FRL UO-2]
Federal Register / Vol. 44. No.-112 / Friday. June a. 1979 / Notices
or ostnoutor for any violation of FIFRA.
and subject to the higher penalties set
forth jn sections i;(a|(i) and 14';blj(t).
Because of the Cj.-.zrsssicrtaliy
rr.ar.ca'.jd charts' in ±e status of "for
V
J
Pesticides and Toxic Substances
Enforcement
On September 30. 1978. the President
signed into law S. 1573. the Federal
Pesticide Act of 1972 (Pub. L 35-096. 92
Stat. 319: hereaitar "FPA"]. which
amends ths Federal Insecticide.
Fungicide, and Rodenticide Act- as
'amended (?cb. L 92-516. 33 Siat. 970:
Pub. L 94-140. 39 Slat. 731: 7 USC 128 ef
«C7 hereafter re/erred »-M '-7I?SA"].
As a result of the new amendments.
According to :he language of the new
subsecr.cn. it is a violation of section
12(a](2)(C] to use a ragis:a:ed pesticida
"!n a manner not permitiM-by ths
labeling" with the excapuoa of four
spea'sc areas. The areas specifically
exdaded frsm enforcement under
J 12(9)(2!(C] include: (a) the use of s .
pestic'da at less thaa label dosage (FE?£ (3) Caattsuauor of Pesticide
1) h fo) the cse of a pesa'dda far ±a
contrel of target-pests nst named en ±e;
labelina. if stUl consistent vA± site
hire applicators." ?E?S No. 3. "L'se- ir.d
Labeling of Servica Containers fcr ±e _
T;ar.spcr:atioa or Temporary Sicrags of.
pesticides'* is'no longer applicable to.ths
activities of the "foe hir» arrj
|W/ -MM..M..MMV.. -f
Ssfcrseaent Policy1 S'.cie.r.s.'iU (PEPS)
ffos.2 and 4
Policy Statements (PEPS), whicL.
established aa sdaJinisaicVa
isachanira to permit certain pe* '-dde
asas which otherwise would have been
la violatiaa of FEFRA. ara no longer
'' necsssary.-Tac purpose cf this Notice is
to ancouaca the rescission of the .
affected PEPS and ?o dk.-urs some of
the amendment? in tha .'-PA that affect
pesticide enforcement pj .'Uy. .
'
(3) Rescission ofPsstic&j Eafot cement
Policy Statexen'j (PEPS) toy. L ,?. S.
and? ..'..
,. On May 5,1975, the unvironrnental'
Protection Agency (EPA) published in
tha Federal Register a document eati'Jed
"Institution of Pesndae En/ailament
Policy Statements" (40 ~sd. ."*?. ISSa
. (1373H. It was the Agsnsy's pur:
Jastitatmg this series s:
Enforcement Policy State::ar.u
to inform tha gene
engaged in the fonauliticn. diarr.bction,
sale, application or other use of i
paSiiddes. of the polices adopted by the:
Agency in the enfareetnent of Aa , ;
provisions cf ths FTF3A. The ?£?S'wera
prepared and published by E?A'.« Gfsca
cf Enforcement.
F-ederal. regulation of theusa-of -: ;
pestiddas was established for tie first
time with the enacfsea: cf the 1972
amendments, specifically through the
provisions of FIFRA sozlion 3Lu)(l).
section 4 and seston l2(aJ(2)(CJ. Section
12(a)(2;(G) made it unlawfai far any
person to use a registered yestiede in a
manner iacsa^isrsnt with ia laaeiuur.
Howevec. zs set forth in the legislative
history. Csngrsss intended that £?A
enforce the prahihiticr. of Meson'
12(a)(2!(G) in a "coition ssnse maaaer"
and left opes ia many inst2.-icn exacuy
what constituted a "use iacr^istgat
with (a pesticdc'sj Ijbciiaa."
The FPA broadens the constracrian of
section 12(aJ(2;(Gy of FIFrwA by adding a
new subsaction 2(ee) which for the orst
toe derihes the term "to use any ,
registered pesticids ia a aunnsr
inconsistent with its
and (c) the use of any application :
method not prohibited by labeling (?E?S
TV ' ' - :
Thus, the new section 2(ee) defines by
law certain uses which will not be
considered inconsistent with labeling j
that previously were defined by ?£?S. J
The new definition provides exemptions
fronvthe strict label language for asers/
applicators only. Persons who distribute
1 Whilt PE?5 No. 1 tzdvetd urtiin ptwiuLU
wtncii oeuld aa« bt nud tc Uu thta Ucei dai«t»
.'tnic* enoroi jrtduca. ted
Mefloa U(t)(!,1C) don not
MI should b« ooud'Oul weitt th* F?A imtnd*
xiittnj Ftstnl Uw eonci'minj pt mait nuuia. it
Joti not u~«ct Suit Uwi. Ti«rt;cre- tu'an
praett«ls4 -«d by '±3 atw
iiendsenn. ;i>ueist tu«a uid ispiiaton ir.ouM
ctiu araia Cut U-.iy wiil aot b4 m VIOUCBO ef
Siaalax.^ , _____ . .
. or sell pesticides still may notmaJce oral
substzatiaily differ a*cm any «-!aif-<
made for the procuct as a part of the-
statement required ia canr.ccaca with
its regissation under section 3 of J!T?
(eg. claims for use not listed on tha
labeling), or they will be subject to
enforcement acton under section
[2] Actions effecting pes^cide sssrs:
rescission of PEPS Wo. a
, Tha Office of Eaforsement issued a
policy statecient on March 23.1S75
which stated that pestidde applicators
who supply and apply registered.
pesticide's etas course of performing '
pest control services (hereafter "£ariirc
applicators") were considered sellers
and discibctcrsaf pesticidss. Section
2f«)(:j of the FIFSA has tcsc aaancsd
so as to generally axniacs "for br«
applicators" crcm being considsrsd
sailers sr disnbutcra of p*sticiaes
where they provide tie service of
caarcilicg ?c3ts witacut csiir.-ering ary
unapplied pestidde ta any rtraoa :o
served, "For hirs appilcaaorr;" ars =o
longer cansi-it-T-a seilcrs or disc^rctair
(and thus suhiucz to thi hither ami
penalties in § 14(aUD) u^r_'s: (a! ±ey
hold or apply aaunreysiereu pesticae.'
or (b) they deliver any unnpplieti
pesticide to ths customer. Li either of
tha above situaooos a "tor hire
applicator" would b« censiderad a
Two of the existing PEPS are not
affected by the amendments in the FPA
and. therefore, are no: rescinded by this
Notice. They are PEPS No. 3. entitled
"Certain Enforcement Pciiciss To Be
Followed During the Phased
Implementation-of r ir cu-% Section 3" (41
fed. Re?. 132W (1376)). and' ?E?S Mo. 4.
entitled "Preventive Psst Control
Treatments in the Absence of Tarjst
Pests" (41 FJl 23003 (1973)).
(4) CoaciereialAFpliczisrs
The FPA also amends ihs definition of
"commercial applicator" in lection
2(e}(3) of FIFK.Al.The new da;ir.:t:on
pravidas-dat the tana "carr-msrcai
applicator" meara arry icpiicardr"
(except a privata appiicaar) who u5n::
or super/ises"±e use of a r?ssic:sd >:ts
pesticide, whether sr not iat isptiaatcr
iscartiCed. Such persons v/so -^oiaa
FffrlA while aiir.g eyi-;r.vc us*
pesticides are caar.iarsci commercial
appiicalcrs azd subjsct :s (he higher
penalties of section l-i(a)C-) 2nd :4(b!(lJ.
On the other hand, aay person
(excluding those psrscr.s subject :a rhs
penalty previsions ot'se-:t:n i-ifal.':',).
as described in section Z of this Notice)
who holds or applies a pestidt*
registered far jsnar/use. or i dilution
of a pesticide registsrsd fcr je-eral use
and who violates FITR.A. v/culc be
subject to the lower aar.airias ss :et
Jori in secticns 14(a>(2) and :-?{ij(;; cf
'
(S) Oeffrj'tioa of "Prcs'ucer"
The FPA amends the dat'r.itian of
"prsducsr" to add the following:
Th- dilution 1
Jciuded ia rh« iencir.on of "jroaucar" *-r
the pisposes of ajj Act.
This asendasent xakes s:sr;s:pr *e
A;ency» lors-sfard:.-.? -olic-/ of r.st"
es«i
-------
thcrcfnrc entitled lo purrhisr the voL.ue of
moiorg-nolir^ cijunl lo the amount furnished
by Audit dunrv; ihr corresponding month* of
:he Nov.-mhrr W! llmnifih Orl.ibcr | Maemillan Ring-Free Oil
Co.. Inc.. 9U Park Avenue. New York. New
York 13T.S. filed a Notice of Objection to ao
Intenir. Remedial Order for Immediate
Coirpuar.ce which the DOE Southwest
Distiict Office of Special Counsel Issued to
Ttnr.eco Oii Company on May 24.1979. In the
Ir.tsnm Remedial Order for Immediate
Cu.Tipiianec. the Office of Special Counsel
orSircd Tenneco to make available to Kem
County Ki:f:ncry 5.000 barrels per day of
crude oi: from its Yowlumne Field properties,
in uddiucn to the 2.000 barrels per day of
crude oi! which Tenneco is already supplying
to Kem.
Wikhire Oil Co.. of Tex.. Oklahoma City,
GA/a.. DKO-OS2S. crude oil
On June S. 1979. Wilshire Oil Company of
Texas. (Wilshire). 7th Floor. 200 North
Harvey. Oklahoma City. Oklahoma 73102. '
filed a Notice of Objection to a Proposed
Remedial Order which the DOE Southwest
Enforcement District issued on April 27.1978.
In the Proposed Remedial Order, the
Enforcement District found thai during the
pe.-.eii from February 1076 through December
1V'6. XViishtre committed pricing violations in
connection with the production and site of
crude oil. According to the Proposed
Remedial Order. Wilshire's violations
resulted in overcharges lo its customers of
S119.065.
i« Due r^-ns?; FIM r-n-
MLMG coot MM-OI-W
ENVIRONMENTAL PROTECTION
AGENCY
IFRL 1270-5)
Enforcement Policy Regarding
Failures To Report Information Under
Section 6(aK2) of the Federal
Insecticide, Fungicide, and
Rodentlclde Act
AoeNcr Environmental Protection
Agency.
ACTION: Notice setting forth general
latement of the Agency's policy
concerning the exercise of its
enforcement discretion to regard as
unactionable some failures to report, or
delays in reporting, information required
to be reported by Section 6(a)(2) of the
Federal Insecticide. Fungicide, and
Rodenticide Act as amended (FIFRA). 7
U.S.C. 8136 d(a)[2). (
. .SUMMARY; This Notice.dascribea.-a-.
number of circumstances in which the
Agency will not seek or recommend civil
or criminal penalties against pesticide
registrants who fail to report
information concerning the risks or
benefits of their registered pesticide
products, despite the fact that reporting
is required according the Agency's
interpretation of FIFRA § 6(a}(2).
DATES: July 12.1979.
Effective Date:
Comments will be most hejpful if they
are received on or before October 10.
1979.
FOR FURTHER INFORMATION CONTACT
John J. Nej'lan III. Office of Enforcement (EN-
342). Fjivironmentai Protection Agyncy. 491
M Street. S.W.. Room 3632. Washington.
D.C. 20460. Telephone: (202) 755-0630.
or
Edward C Cray. Office of General Counsel
(A-132). Environmental Protection Agency.
401 M Street. S.W. Room S3S. Washington.
D.C. 20460. Telephone: (202) 7SS-0618.
SUBMIT COMMENTS TO: John). Neylan III.
Office of Enforcement (EN-342).
Environmental Protection Agency, '
Washington. D.C 20460.
SUPPLEMENTARY INFORMATION:
Introduction
Section 6fa)ff) of the Federal
Insecticide. Fungicide, and Rodenticide
Act. 7 U.S.C. 136d[a](2), provides that. -
If at any time after the registration of a
pesticide the rvj-vstrnnt has additional factual
information regarding unreasonable adverso
effects un (he environment of the pesticide.
he jh.-ili submit such information to the
Administrator.
On August 23.1978. EPA published in
the Federal Kacislcr n memorandum
prcp.irc.-d by tht- Ei'A General Counsel
and adopted by the Administrator
entitled "A^..ncy Interpretation of
Requirements Imposed onRegislrants
by Section 6(a)(2) of the Federal
Insecticide. Fungicide, and. Rodfenticide
Act." 43 FR 37611 el 5*7. The
memorandum, which was prepared la
response to a directive by the
Administrator, explained in detail the.
Agency's views concerning proper '
interpretation of the statutory reporting
requirement established by Section
The conclusions in the August, 1878
memorandum were baaed on the
pertinent legislative history and on the
principle that the language of Section
6(a)(2) should be construed consistently
with the overall regulatory approach
established by Congress. The General
' Counsel concluded that section 6Xa)(2)
requires each registrant to submit any
item of information in his possession
. _i«hich. pertains -taa-pes*icid is subject to the
i 6(a)(2) reporting requirement (a« interpreted
by this memorandum), regit'rant reporting of
that kind of information is not essinu'a! to the
Agency's functions * ' * In such a case. It
would be appropriate for the Agency to
announce publicly (by Federal Register nonet .
or otherwise j thel il will not consider a
registrant's failure to submit that kind of
information to be aa actionable violation of
I
-------
The provisions of this Notice ire
j in a iurje extent on assumptions
I t!;e rrwjrrcs FPA will li.ivt
p.vie»v ol' ir.'rjrmation submitted under
rIFKA, J i»[a)U|. ai.d on the Agency's
plans concerning review of the
continued n;c,i£tral»ility of currently-
registered pesticides. We have
jtiernpicu1 in this Notice to discriminate
between information we feel can be
usefuliy reviewed, given currently-
veilablc resources, and information
which could only be properly reviewed
if the Agency had considerably more
resource:. Routine examination of all
information concerning a registered
pesticide's risks and benefits would
lerve useful purposes. However, given a
level of resources which does not permit
this degree of day-to-day scrutiny, it
would not be appropriate to require
registrants to submit information that
could not be reviewed promptly because
~oIrrer'maltersaje"oT EigKefpriorlty.
This Notice is designed to give clear
ind explicit guidance to registrants in
Determining whether or not EPA will
regard failure to submit a given item of
information concerning any
lexicological study, incomplete
lexicological study, epidemioiogjca!
study, efficacy siudy. incident involving
toxic or adverse effects, incident
involving failure of efficacy, or other
matter as an actionable violation of
section 6(a)(2). EPA may issue
supplementary notices later concerning
ivpes of information not specifically
considered in this Notice.
A registrant who violates FIFRA
5 6(s )(2) commits an unlawful act. see
FJFRA Jl2(a)(2[N].?U.S.C.
]36j(a)(2)(N). and is subject to civil or
criminal penalties under FIFRA § 14. 7
U.S.C. 1361. Whenever this Notice states
the! a given failure to submit
information will not be treated by EPA
>s an actionable violation of Section
6(a)(2), ii means that EPA will not
rccommerd or seek to impose a civil or
criminal penalty, under Section 14 or
otherwise, on the grounds that such a
failure to submit information violates
Section 6(a){2).
Effective immediately, in exercise of
its enforcement discretion. EPA'will not
commence any civil penalty action
based on FIFRA § 6(a)f2). or seek
criminal prosecution of any registrant
based on FIFRA § C[a)(2). with regard to
jiny fnilure by a registrant to submit any
information which this Notice says need
lot ho submitted, until at least 30 days
*'ter modification or revocation of this
Nice. This Notice will be modified or
Jl-'vpl-.ed on!y by publication in Lhe
1 Register of a supplementary
notice whir.ri clearly slates which
fiiilnr<>s to submit information which
were previously permitted will
sul'.«equc.iiiy be treated as actionable
viol.ttinns of section 6|a)(2). Any
modification of this Notice will be
applied prospcctively only.
This policy will he effective on July 12.
1979. Because this Notice ii a "general
statement of policy." it Is exempted from
the notice and comment provisions of
the Administrative Procedure Act by 5
U.S.C. 5S3(bK3)(A). Nevertheless.
interested parties are encouraged to
submit comments on or suggested
modifications of this policy. We are
especially interested in receiving
comments and recommendations
pertaining to the types of information
discussed in Section III of this Notice.
Comments will be most helpful if they
are received on or before October 10.
1979. After expiration of the ninety day
-.-
which have been received and consider
appropriate modifications of this Notice.
I. Study and Experimental Data
Reporting
A. ToxicologicaJ Stud/a
Policy
Failure to submit information to EPA
which concerns the results of a
completed study of the toxicily to arty
organism of a registered pesticide
product or any of its ingredients.
impurities, metabolites, or degradation
products and which is otherwise
reportable according to the "Agency
Interpretation of Requirements Imposed
on Registrants by Section 6(a](2) of the
Federal Insecticide. Fungicide, and
Rodcnticide Act." 43 FR 37611. will not
be considered an actionable violation of
FIFRA i 6(a)(2) unless the information
. concerns any study in which:
(1) The substance tested was
associated with a kind of toxic or
adverse effect, or an effect on an organ
or tissue type, not observed in any study
concerning the substance previously
reported to EPA;
(2) The substance tested was
associated with any toxic or adverse
effect at a lower dosage, after a shorter
exposure period, or after a shorter
latency period than in any study
concerning that effect of the substance
previously reported to EPA;
(3) The substance tested was
associoted with a more severe toxic or
adverse effect, or a higher incidence or
frequency of a toxic or adverse effect.
than in any study concerning that effect
of the substance previously reported to
EPA:
(4) The substance tested was
associated with a toxic or adverse effect
In a different species. «irp:r. «e». or
generation of test organism t'i.«n in uny
study concerning thai effort of the
substance previously reported to EPA;
(S) The substance tested was
associated with a toxic or advcrne effect
involving, a route or medium of exposure
not associated, with such an effect in
any study concerning the substance
previously reported to EPA, if humans or
other non-target organisms could
conceivably be exposed to the
substance by that route or medium
during manufacture or distribution, or by
an approved manner of use. of the
pesticide product;
(6) It appears that a substance
produced a toxic or adverse effect by
means of a pharmacokinetic. metabolic.
or biological mechanism different than
any mechanism postulated or proposed
-forthatTrTuuMnimysrudyconecTrling
the substance previously reported to
EPA; or
(7) The substance tested was
associated with any toxic or adverse
effect if the substance is a pesticide, or
aa ingredient, impurity, metabolite, or
degradation product of a pesticide.
which is the subject of a ^registration
proceeding, generic standard
proceeding, Rebuttable Presumption
Against Registration proceeding.
suspension proceeding, or cancellation
proceeding.
EPA will not consider a delay in
submission of information on a
completed study which is otherwise
reportable under paragraphs UH7)
above to be an actionable violation of
FIFRA $ 6{a)(2) if the delay is for a
reasonable period, no longer than 30
days from the date the registrant first
receives the apparently reportable
information. In addition. EPA will not
' consider failure to submit such
information to be an actionable
violation of FIFRA $ 6(a)(2) if. prior to
the expiration of the period mentioned
in the preceding sentence:
(1) The registrant discovers thaFany
analysis, conclusion, or opinion which
would have caused the information to
be reportable was predicated on dcta
that were erroneously generated.
recorded, or transmitted, or on
computational errors; ,
(ii) Every author of each such
analysis, conclusion, or opinion has
acknowledged in writing that the
analysis, conclusion, or opinion was
improper because of the use of the
erroneous data, and has corrected t!ie
original analysis, conclusion, or opinion
accordingly; and
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(iii) After such corrections. Ihc
information no'Jonper need be reported
under any provision of this Notice.
Discussion . .
The .result of any controlled study in
which exposure to a pesticide!
substance is associated with a toxic or
adverse effect are clearly pertinent to
evaluation of risk and arc thus legally
rcportabie under Section 6(a)(2).
However, unless new lexicological
information suggccts that reliance on
material previously submitted to EPA
may have resulted in underestimation of
risk, or that prior information was
otherwise inaccurate, misleading, or
incomplete, submission of such new
information Is not likely to materially
affect the registration status of products
containing the substance tested. EPA
will not treat failure to submit
toxicological information which is
essentially corroborative as an
"ffctiohablel^olation'orSecTlo'n B(a)[2)r "
but will insist on submission of any
toxicological data which indicates that a
pesticide may present different or
greater hazards than previously
identified.
However, when a particular pesticide
product is involved in an RPAR
proceeding under 40 CFR 162.11. or in
suspension or cancellation proceedings
u.-.der FIFRA § 6(b] or 6(c). or where
^registration is underway, the scope of
EPA's ir.formation needs is considerably
broader. In such circumstances, the
ultimate status of the pesticide depends
on a comprehensive Agency
reevaluation of the pesticide's risks and
benefits, including an assessment of the
reliability of previously submitted
material and extent to which it has been
corroborated. Thus, if a particular
substance is the subject of a
reregistration. RPAR. suspension, or
cancellation proceeding. EPA will treat
failure to submit any toxicological
information linking that substance with
any toxic or adverse effect as an
actionable violation of Section 6(a)(2).
regardless of whether or not such
information merely confirms or
corroborates prior data.
By thejime a study Is "completed",
checking and validation of data should
normally also be complete. We will
nonetheless allow the registrant a
reasonable period, not to exceed 30
days, to check for data errors which the
registrant believes may have formed the
basis for an opinion about what the data
signify, and to ssek a corresponding
modification of the opinion.
On the other hand, if it is not 'he data,
bi:t the expert analysis, conclusion, or
opinion itsei'fvtilh which the rcgistrnnt
disagrees, the registrant's remedy is m.
to withhold the information from EPA,
but to submit with the 5 6(n)(2) report
his own analysis of the information's
significance.
B. Incomplete Toxicoloyical Studies
Policy
Failure to submit information to EPA
which concerns the results of an
incomplete study of the toxicity to any
organism of a registered pesticide
product or any of its ingredients,
impurities, metabolites, or degradation
products and which is otherwise
reportable according to the "Agency
Interpretation of Requirements Imposed
on Registrants by Section 6(a)(2) of the
Federal Insecticide. Fungicide, and
Rodenticide Act." 43 FR 37611. will not
be considered an actionable violation of
FIFRA § 6(a)(2) unless the information
...concerns* - ._-« .
(1) An acute effects study or other
study utilizing a testing regimen lasting
90 days or less, in which all testing has
been completed, a preliminary data
analysis or gross pathological analysis
has been conducted, final analysis has
not been completed, and a reasonable
period for completion of the final
analysis (not longer than 90 days
following completion of testing) has
elapsed, if comparable Information
concerning the results of a complete
controlled study would be reportable
under paragraphs I. A(lH7) of this
Section:
(2) A chronic effects study or other
study utilizing a testing regimen lasting
more than 90 days, in which all testing
has been completed, a preliminary data
analysis or gross pathological analysis
has been conducted, final analysis has
not been completed, and a reasonable
period for completion of final analysis
(not longer than one year following
completion of testing) has elapsed if -
comparable information concerning the-
results of a completed controlled study
would be reportebla under paragraphs I
A(1H7) of this Section: or
(3) Any study in which testing or
analysis of results is not yet complete
but in which serious advene effects
have already been observed which .may
reasonably be attributed to exposure to
the substance tested, because the affects
observed in exposed organisms differ
from effects observed in control
organisms, are atypical in view of
historical experience with the organism
tested, or otherwise support a
reasonable inference of causation.
Discussion
In developing a policy rcgtirding
which failures to submit otherwise
reportable information from incomplete
toxicological studies should be treated
as actionable violations of Section
6(a)(2). EPA has determined that it U not
necessary at this time to require
submission of preliminary or incomplete
toxicoiogicaUnformatton, except in
certain specific circumstances. The
criteria selected are designed to
accomplish two fundamental regulatory
objectives. The first objective U to
provide an incentive to registrants to
complete analysis of toxicological data *
within a reasonable time, especially if a
preliminary appraisal suggest that a
pesticide may present different or
greater hazards than previously
identified. The second objective is to
insure that any preliminary findings are
reported to EPA as soon as there U a
reasonablo-bacis-for-cencenti eweo
though further testing or analysis may
be necessary before the observed
hazard can be defined or quantified.
We do not believe that it would be
currently useful to insist on submission
of preliminary or inconclusive data on a
routine basis. On the other hand, no
registrant who fears that submission of
a completed study might jeopardize any
of its registrations should be permitted
to indefinitely defer or postpone
completion of analysis of potentially
significant data. Accordingly, we have
designated an appropriate periodup to
90 days for acute studies, up to one year
for chronic studiesduring which the
registrant may engage in further
analysis designed to refine the data
prior to submission.
Example
A registrant conduct* the first study of the
cute effects of ingestion of certain
pesticide on rabbits. A prior acute study of
the tame pesticide using mice found that
exposed mice experienced increased
mortality due to liver damage. The registrant
notes increased mortality of unknown origin
In the exposed rabbit*. Following completion
of the test regimen, the registrant may take
reasonable period, not exceeding an
additional 90 day*, for investigation of the
significance and cause of the increased
mortality. After that period ha* elapsed.
failure to submit information concerning the
study to EPA will Be treated as an actionable
violation of Section 6(a)(2). regardless of
whether or not the analysis is yet complete.
because information concerning a completed
study in which toxic effects have been
observed in a different species than
previously reported would be reportable. Of
course, the registrant will always be entitled
to supplement any initial submission with 'J-6
results of subsequent analysis.
-------
Certain types of preliminary
experimental 'observations and findings
ore sufficiently icrious that they should
be reported to EPA immediately. In
general, we will not treat failure to
lubrait information concerning any
incomplete study in which testing it dill
underway, or for which the prescribed
period for analysis of results has not yet
expired, as an actionable violation of
Section 6(a)[2) unless serious adverse
effects have been observed which are
sufficiently different from effects
observed in control organisms or in prior
experience with the species tested that
the registrant may reasonably assume
that the advene effects are associated
with the pesticidal substance being
tested. Even though preliminary
information may not always be
sufficiently complete or definitive to
warrant immediate regulatory action,
preliminary data may indicate a need
Jor_imn«diate_mpdifications
~
registered pesticide (or any of its
ingredients, impurities, metabolites, or
dof;r.nd:ition product) und adverse
effects in humans, and which is
reportuble according to Ihc "Agency
Interpretation of Requirements imposed
on Registrants by Section C(a)f2) of the
Federal insecticide. Fungicide, and
Rodenticide Act." 43 FR 37611. will be
considered an actionable violation of
FIFRA § 6(a}(2) regardless of whether or
not the registrant considers any
observed correlation or association to
be significant
Discussion
Unlike most studies, which can be
__
additions to the study protocol, provide
a basis for requests for further
information under F1FRA i 3(c)[2)(B), or
convince EPA to conduct or sponsor
additional research.
Examples
(1) A registrant conduct* a two-year study
of the effects of chronic exposure to a certain
pesticide on rats. Nir.t months after the study
commences, study personnel observe that
targe percentage of the exposed rats have
developed ocular opacity of the type
associated with formation of cataracts. None
of the control mice exhibit a comparable
abnormality. Though the test is incomplete
ind the evidence that the pesticide is
inducing cataracts is not yet definitive, the
registrant may reasonably conclude that the
ocular abnormalities ere attributable to
exposure to the pesticide, and the observed
effects must be reported to EPA.
(2) A registrant conducts a two-year
controlled study of the effects of chronic
exposure to a certain pesticide on mice. Six
months after the study commences, several of
the exposed animals die. Upon dissection.
study personnel observe that the dead
animals have developed a type of tumor
which is rarely observed in the strain of mice
being tested. Though a substantial portion of
the test regimen has not been completed.
pathological evaluation of the tumors is also
incomplete, and the evidence that the
pesticide is tumorogcnic is not definitive, a
reasonable inference arises that the unusual
tumors are attributable to exposure to the
pesticide, and the observed effects must be
"ported to EPA.
£ Epidemiological Studies
Policy
Failure to submit information to EPA
*hich concerns eny completed
cpidemiological study (or portion
'hereof) involving correlation or
association between exposure to a
designed and controlled in advance.
. .epidemiologies! studies are generally
retrospective in character. As a
consequence, it is often difficult to
assess the impact of various
uncontrolled variables on the magnitude
ef-any observed-correlfrtranrend-
competent experts can reasonably
disagree regarding the practical
significance of epidemiological findings.
On the other hand, epidemiological
studies can be an indispensable source
of information on the critical issue of the
risks associated with human exposure.
Thus, it is important that EPA be able to
independently examine for relevance
any epidemiological information
concerning pesticide exposure, and we
will consider any failure to submit such
information to be an actionable
violation of Section 6(a](2). Registrants
may supplement any submission of
epidemiological information with a
statement describing any reservations
they might have concerning the
information's validity or significance.
D. Efficacy Studies
r
Policy
Failure to submit information to EPA
which concerns eny study of the
efficacy of a registered pesticide product
and which is otherwise reportable
according to the "Agency Interpretation
of Requirements Imposed on Registrants
by Section £(a](2) of the Federal
Insecticide. Fungicide, and Rodenticide
Act." 43 FR 37611. will not be considered
an actionable violation of FIFRA
{ 6(a}(2) unless:
(1) The information demonstrates that
the pesticide may not perform in
accordance with any claim by the
registrant regarding use to control
organisms which may pose a risk to
human health, including any of the uses
identified in 40 CFR 132.10-2(d)(2). (3)(i).
44 FR 27932, 27W2. May 11.1973: or
(2) The information concerns ut:y
deficiency or reduction in the claimed
efficacy of any use of a registered
pesticide, if such use is subject to a
Rcbultable Presumption Against
Registration proceeding, suspension
proceeding, or cancellation proceeding.
EPA will not consider a delay in
submission of information which is
otherwise reportable under paragraph
(1) or (2) above to be an actionable *
violation oLFIFRA S 6(a)(2) if the delay
is for a reasonable period, no longer
than 30 days from the date the registrant
first receives the apparently reportable
Information. In addition. EPA will not
consider failure to submit such
information to be an actionable
violation of FIFRA { 6(i)(2) if. prior to
the expiration of the period mentioned
in the preceding sentence:
(i) The registrant discovers that any
analysis, conclusion, or opinion which
would have caused the information to
be reportable was predicated on data __
-tiiarwereirroneWlsly^eherated.
recorded, or transmitted, or on
computational errors:
(ii) Every author of each such
analysis, conclusion, or opinion has
acknowledged in writing that the
analysis, conclusion, or opinion was
improper because of the use of the
erroneous data, and has corrected the
original analysis, conclusion, or opinic.
accordingly; and
(iii) After such corrections, the
information no longer need be reported
under any provision of this Notice.
Discussion:
In most instances. EPA will not treat
the failure to submit information
concerning the efficacy of a registered
pesticide product as an actionable
violation of Section 6(a)(2) unless such
information indicates that the pesticide
may not perform as claimed when used
to control organisms which pose a
potential threat to human health. We
have taken the position that the utility
and efficacy of many pesticide products
can best be verified by the mechanism
of the marketplace. See 44 FR 27932,
2793WO. May 11,1979. However in
come instances where use of a
particular pesticide appears to involve
substantial hazards. EPA must evaluate
the efficacy of the pesticide, in addition
to the magnitude and value of its use
and the feasibility of substitutes, before
determining whether or not the risks
associated with use of the pesticide are
acceptable. Accordingly, whenever any
use of a registered pesticide is (he
subject of an RPAR. suspension, or
cancellation proceeding. EPA will treat
failure to submit any study which
concerns any deficiency or reduction in -
the efficacy of the product for the use in
-------
rvsiion -IB an actionable violation *ii
S,n:iion 6(a)l2).
II. inuuVnl Reporting
A. Tnv:c or Adverse Effects
Policy'
Registrant: may receive information,
other than the result!* of controlled
studies, concerning specific incident* in
which toxic or adverse effects have
been attributed to exposure to the
registrant's pesticide product. This
information may come to the registrant's
attention through a variety of sources,
including but not limited to: product
linbility.cjaims and complaints: **
information obtained directly, or
through field representatives, from
dealers, growers and pesticide users:
reports from agricultural extension
agents and federal and state regulatory
agencies: information received from the
. .gfinerajjjubjic: Information received
from a poison control center; and
information reported by plant manager!
and employees. Failure to submit
information of this type which is
otherwise reportable according to the
"Agency Interpretation of Requirements
Imposed, on Registrants by Section
Gf«.![2) of the Federal Insecticide.
Fune-r.ida. amJ Rodenticide Act." 43 FR
27611. will noi be considered an
actior.abie violaiion of FIFRA ! 6(a)(2)
unless one cf the following three set* of
criteria apply:
(1) Human incidents. The information
concern? an incident in which: fa) The
reentrant has been informed that some
person suffered an adverse
physiological or behavioral effect (other
than local damage to or irritation of the
skin of the type commonly associated
with dermal exposure, when the table
provides adequate notice of such a
hazard):
(b) The registrant has been informed
that ihc affected person may have been
exposed to the pesticide, or to one or
more of its ingredients:
(c)|i) The registrant has verified that
the person did suf:'er an adverse effect
and was exposed to the pesticide, or
(ii) The registrant has received
sufficient information to enable
investigation of whether or not the
reported adverse effect and exposure
occurred, a reasonable period of time for
inv<;si;j*-i:ion has elapsed, and the
rrpistM.it is not aware of facts which
es'.ablisij that the reported adverse
effect or reported exposure did not
occur: and
H!?:) Th;! ri'^istran! has concluded
h.r !.(: t-:"r-'c! r.ay have risulted from
(ii) The registrant has been advised b>
any individual whose opinion is
reportable under Section 0{<0(2}i.e.-
and employee, consultant, or qualified
expertthat the effect may have
resulted Irom the exposure, and is not
aware of facts which conciuiively
establish that the reported adverse
effect and reported exposure were
unrelated.
(2) incidents Involving Other Non-
Target Organisms. The information
concerns an incident in which:
(a) The registrant has been informed
of an adverse effect on non-target fish or
wildlife, domestic animals, or plants:
(b) The registrant has been informed
that the affected fish, wildlife, domestic
animals, or plants may have been
exposed to the pesticide, or to one or
more of its ingredients;
(c)(i) The registrant has verified that.
the reported adverse effect and
-exposure did occur.*oi
(ii) The registrant has received
sufficent information to enable
investigation of whether or not the
reported adverse effect and exposure
occurred, a reasonable period of time for
investigation has elapsed, and the
registrant is not aware of facts which
establish that the reported adverse
effect or reported exposure did not
occur; and
(d)(i) The registrant has concluded
that the effect may- have rcsuUed from
the exposure, or
(ii) The registrant has been advised by
any individual whose opinion is
reportable under Section 6(a)(C)i.e. an
employee, consultant, or qualified
expertthat the effect may have _
resulted from the exposure, and is not
aware of facts which conclusively
establish IhaV the reported adverse
effect and reported exposure were
unrelated; and
(e)(i) The registrant cannot
demonstrated that the pesticide
exposure resulted from improper use. or \.
(ii) The labeling of the pesticide does
not provide reasonable notice of the risk
of adverse effects of the.kind reported.
(3) Serves of Incidents. The
information concerns any series or
pattern of individual incidents as to
which:
fa) The registrant has been informed
of the same kind of adverse effect on
humans, non-target fish and wildlife,
domestic animals, or plants:
(b) The registrant has been informed
that the affected organisms may have
been exposed to the s.ime pesticide or to
one or more of its ingredients:
(c) For each individual incident, either
(i)The registrant has verified that the
rtported adverse effect and reported
cxpo.'ura >iid occur, or
(ii) Tho. rexis'rant has received
sufficient information to en.-ibic
investigation of whether or not the .
reportud adverse effect and exposure
occurred, a reasonable period of time for
investigation has elapsed, and the
registrant is hot aware of facts which
establish thanhe reported adverse
effect or reported exposure did not
occur
(d) For each individual incident the
registrant is not aware of facts which
conclusively establish that the reported
adverse effect and reported exposure
were unrelated; and
(e) The series or pattern of incidents
would not be expected unless the
reported adverse effects were caused by
the reported exposures.
Discussion
Information concerning incidents in
which toxic or adverse effects are
attributed to pesticide exposure varies
considerably in specificity and
accuracy. Some reports received by
registrants are so vague or implausible
that they would be unlikely to provide a
basis for administrative action. On the
other hand, some incident reports may
contain unique and valuable information
on the hazards and environmental
impacts associated with actual use and
practice, information which cannot be
readily derived from laboratory data
alone. Thus, we have endeavored to
select sets of criteria which will give
practical assistance to each registrant in
identifying those types of incident
information which are curror.tly needed
by EPA in order to properly discharge its
statutory responsibilities. Each set
criteria contains the following elements:
(1) a report of a toxic or adverse effect
(2) a report of pesticide exposure, (3) an
opportunity for investigation of the
accuracy of the reports, and (4) a basis
for an inference that the toxic effect and
the pesticide exposure were related.
Oemonstrab'y inaccurate incident
information need not be submitted to
EPA under Section 6(a)(2). If a registrant
can clearly demonstrate that a reported
toxic effect or pesticide exposure did
not occur, or that the effect and
exposure were unrelated, we will not
treat any failure to report an alleged
incident as an actionable violation of
Section 6(a)(2j. However, failure: to
investigate the accuracy of any report or
allegation which could be investigated
will not be considered lo excuse non-
compliance with Section 6fa)!2). Dy
adopting this policy. EPA docs n-t
intend to attempt to iir.pusc any sort cf
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-------
duly of obligation on the registrant lo
investigate incident reports, but rnlhcr
to accord the registrant u reasonable
opportunity to investigate incident
Information. In any event, the
responsibility for determining the
significance of any potentially useful
incident information which has not been
either verified or rebutted must
ultimately reside with EPA.
Information concerning incidents in
. which humans exposed to a pesticide
have experienced toxic or advene
effects is extremely useful in. e.g.,
evaluating the occupational risks
associated with pesticide use. or
deciding whether a method of applying
the pesticide should be prohibited.
Receipt of incident information
regarding adverse effects in humans is
particularly important because of the
ethical unacceptabilily of deliberate
clinical exposure and the difficulties
..jssaciBted.tvilh .predicting human.
toxicity on the basis of animal data.
Thus, we may consider any failure to
submit incident information concerning
any toxic or adverse effect in humans
(except for local skin damage or
irritation warned against on the label)
which includes the basic elements
previously identified and which is
.otherwise reportable under Section
6|a)(2) to be an actionable violation of
FIFRA. regardless of the circumstances
which resulted in the pesticide
exposure. In contrast, we will not treat
failure to submit information on any
single incident involving toxic or
adverse effects on other non-target
organisms as an actionable violation of
Section 6(a)(2) if the registrant can
demonstrate that (1) the pesticide was
used improperly, and (2) the label
provides reasonable notice of the risk of
adverse effects of the kind reported.
Incident information concerning toxic
or adverse effects has little current
utility for regulatory purposes and need
not be submitted to EPA under Section
6(a)(2) unless the information is
predicated on a conclusion, opinion, or
reasonable inference that the reported
effects were related to pesticide
exposure. Failure to submit information
regarding any single incident of this type
will not be treated as a violation of
Section 6(a)(2) unless the registrant has
concluded that the reported effect may
have been caused by the reported
pesticide exposure, or has been advised
by any individual whose opinion is
reportable (according to the "Agency
Interpretation of Requirements Impo'sed
on Registrants by Section 6(a)(2) of the
federal Insecticide, Fungicide, and
Rodenlicidc Act." 43 FR 37811) that a
causal relationship may heve existed.
Examples
(t) A rrsistrant receives report from an
iinulrnii.'icd source indicating that in
j!ri<.ulluml employee experienced
respiratory difficulties after working in field
where pesticide manufactured by the
registrant had recently been applied. The
report it sufficiently detailed to enable
investigation of It* accuracy. A few days
Uicr. the registrant discusses the alleged
Incident with a lexicologist, who stairs that.
in hit opinion, the reported respiratory
aymptons could hive been caused by
exposure to the registrant's pesticide. The
registrant will be given a reasonable time to
Investigate the Incident. If the registrant
subsequently discovers fact* which establish
that the reported adverse effects or reported
exposure did not occur, or which conclusively
establish that the respiratory difficulties
experienced by the exposed Individual wen
caused exclusively by some factor other than
pesticide esposure. the incident need not be
reported. Otherwise, information concerning
the incident must be submitted lo EPA.
failure lo report such information in an
aggregate form as an actionable
violation of Section 0(a)(2). EPA needs
this type of incident inform." tion
because the existence of widespread or
routine misuse of pesticide products
may be a basis for changes in labeling,
additional restrictions on use. or other
regulator}1 action.
Example
The registrant has received a number of .
reports, from various sources, of unusually
high mortality in birds feeding in or near
fields where the registrant's pesticide has
been applied. Though some of these reports
were not specific enough to enable
Investigation of their accuracy, the registrant
has Identified a series of specific investigate
Incidents in which It appean that an unusual
number of birds died following use of the
registrant's pesticide. However, the registrant
has not determined whether or not the
pesticide was responsible for the observed
increase in bird mortality, and no employee.
became tii« toueotogist is TTrnattfied'expert ""neonsflltiflt'Bf (juatlfifctf expSrt"h»s Indicated
whose opinion is reportable under Section
8(8)(2).
(2)A registrant receives a report from an
agricultural extension agent indicating that
fish were killed in a creek adjacen' to a field
where a pesticide manufacture by the
registrant had recently been applied. After
Investigation, the registrant concludes that
the reported fish kill probably resulted from
exposure to the registrant's pesticide.
However, the registrant also discovers facts
which cstablich that the pesticide was
improperly applied, by an individual who
disregarded a statement on the label
expressly warning against use in
circumstances where contamination of
surface waters might result. Any tingle
incident of this sort need cot be reported
under Section 6(a)(2).
If a registrant has been informed of a
aeries or pattern of incidents in which
the tame kind of toxic or adverse effects
have followed exposure to the same
pesticide, a reasonable inference of a
causal relationship may arise from the
existance of the scries or pattern itself.
even in the absence of a specific
conclusion or expert opinion to that
effect. In such circumstances, any
requirement that the registrant
specifically conclude or be advised that
a causal relationship exists is
superflous. and registrants will be held
legally accountable under Section 6(a]{2)
for failure to submit information
regarding any significant series or
pattern of incidents involving the same
kind of toxic or adverse effect and the
same pcsticidal substance. Moreover,
even if a series or pattern consists of
incidents which would otherwise not be
reportable under this policy, because
each incident involves predictable
effects on nontarget organisms resulting
from improper use. we will likely treat
that a causal relationihip may exist.
Nevertheless, if the existence of the series of
unexplained Incidents is sufficient to support
a reasonable inference of i causal
relationship, failure to submit information
concerning the incidents will be considered
an actionable violation of Section 6(a)(2J.
B. Failure of Efficacy
Policy
Registrants may also receive
information concerning specifc incidents
in which it is asserted that the
registrant's pesticide product failed to
perform as claimed against designated
target organisms. Failure to submit
information of this type which is
otherwise reportable according Ic the
"Agency Interpretation of Requirements
Imposed on Registrants by Section
6(a](2) of the Federal insecticide.
Fungicide, and Rodenticide Act." 43 FR
37011. will not be considered an
actionable violation of FIFRA J 6(a)(2)
unless one of the following two sets of
criteria apply.
(1) Immediate Hazard to Life. The
information concerns an incident in
which: . ^..
(a) The registrant has been informed
that a pesticide product did not perform
as claimed against target organisms:
(b](i) The registrant has verified that
the reported failure of efficacy did
occur, or .
(ii) The registrant has received
aufficient information to enable
investigation of whether or not the
reported failure of efficacy occurred, a
reasonable period of time for
investigation has elnpsed. and the
registrant is not aware of facts which
establish that the reported fniiure of
efficacy did not occur and
-------
|i.| lire lUiMMCVl u.l- pCSUClUC >.
perform as clnimed involved any use
.ip.iinv orc.inisms whir.h. unless
controlled may pusi: an immediate
h.iZfirJ lo human life.
(21 Health Risk. The information
concerns any series ot pattern, of
individuHl incidents 83 to which:
(n) The registrant has been informed
of the same type of failure tn perform as
cioimcd against target organisms:
(b) For each individual incident, either
(i) Thr? resistranl has verified that the
reported failure of efficacy did occur, or
(iij The registrant has received
sufficient information lo enable
investrsaiion of whether or not the
reported failure of efficacy occurred, a
retisonnble period of time for
investigation has elapsed, and the
registrant is not aware of facts which
establish that the reported failure of
efficacy did not occur and
r) The farlure-of thepestlcrde-to .....
perform as claimed involved any use to
control organisms which may pose a
risk to human health, including any of
the uses identified in 40 CFR 152.18-
2|d)(2J. (
Discussion
We will not treat any failure to submit
information concerning incidents in
which a pesticide did not perform as .
claimed against target organisms as an
actionable violation of Section 6(a)(2)
unless the reported failure of efficacy
involved organisms which pose a
potential threat to human health. This
policy reflects a judgement by EPA that
the efficacy of pesticide products which
are not used to protect public health can
usually be adequately tested by the
dictates of a competitive marketplace.
See 44 FR 27332. 2r938-40. May 11. 1979.
Moreover, except in those instances
where a reported failure of efficacy
involved use against organisms which
may pose an immediate hazard to
human life, it is not likely that we would
consider any single reported incident of
failure of efficacy to be a proper basis
for regulatory action. Therefore, we will
not treat any failure to submit incident
information concemingjailure of
efficacy against organisms which may
pose a risk to public health, but do not
pose an immediate hazard to human life,
as an actionable violation of Section
6(aj(2) unless such information concerns
any significant series or pattern of
comparable failures of efficacy. As in
the case of incident information
involving toxic or adverse effects.
registrants will be afforded a reasonable
opportunity lo investigate any reported
failure of efficacy before such
information will tic considered
rtporUblt.
III. K«:|»fif rin» of Other Infnrnulion
Policy
EPA will nut consider failure to
ubmit information of any kind other
than those kinds of information
described in Sections I and II of this
Notice a* an actionable violation of
FIKRA § 6(a)(2) even though such
information would otherwise be
reportablc according lo fhe "Agency
Interpretation of Requirements imposed
on Registrants by Section 6(a)(2) of the
Federal Insecticide. Fungicide, and
Rodenticide Act" 43 FR 37611. unless:
(1) After a reasonable period of time '
for verification or investigation of the
Information has elapsed, the registrant
is not aware of facts which establish
that the information is incorrect and
(2] The registrant Knows, or
-reasonably-shoutd-knowrthatlfthe
Information should prove to be correct
EPA would regard the information,
alone or in conjunction with other
information about the pesticide, as
raising serious questions about the
continued registrability of one or more
uses of any of the registrant's pesticide
products, or about the proper terms and
conditions of registration of any such
product
Discussion
In Sections I and I! of (has Notice, we
have established policies concerning the
types of information which, insofar as
we ere aware, have been the subject of
most of the inquiries made and concern
expressed by registrants with regard to
FIKRA i 6(a)(2). There are. however.
many other categories of information
which may be reportable under F1FRA
{ 6(a)(2). including additional
information concerning: the identity and
amount of impurities and degradates of
pesticide products .in the product as
sold: degradation and fate of pesticides
in the environment after application or *'
use: soil, plant, and animal metabolism;
bioaccumulation by various life forms:
identity and quantity of pesticide
residues on raw and processed
agricultural commodities and foods;
levels of exposure to applicators, farm
workers, bystanders', food consumers,.
and other persons: drift of pesticides to
ncn-iarjcl areas*, and a variety of other
information which might affect EPA
decisions concerning the continued
registrability of .1 product or the
appropriate terms and conditions of
registration.
lit this Notice we have not attempted
to establish wi:h specificity, for each
category of such information, which
failures lo rc.iort information we will
not treat a* actionable violations of
FIPRA § G(iij(2). In part, this is became
we are interested in receiving the viewi
of the pesticide Industry and other
interested persons concerning what our
policy regarding such information
should be. it is likely that we will
modify this Notice in the future lo
announce a more specific Section G(a)(2]
enforcement policy concerning some or
all of these types of information.
However, in order to provide some
immediate guidance to registrants, we
have set forth in this Notice a general
policy covering all information not
described by Sections I and II of the
Notice. It allows registrants a
reasonable period lo verify or
investigate apparently importable
information, prior to actual submission.
In deciding whether a delay in reporting
_was reasonable. we_wilHake into
~eccdunl the seriousness of the problem
suggested by the information, as well as
the kind and amount of verification that
would be desirable. If. during this
period, the registrant leams of facts
showing that the information is
incorrect, the information need not be
submitted and failure to report will not
be considered an actionable violation of
Section 6(a)(2).
In addition, we will not treat a failu.'-
to report information as an actionab!
violation of F1FRA { 6(a)(2) unless thr:
.registrant knew, or reasonably shouiu
have known, that EPA would regard the
information as pertinent !o the question
of whether the product's registrations
should be cancelled, suspended, or
modified in some respect.
Example
The registrant knows that the original EPA
decision to register his product for use as a
toil intecticide in corn fields (the only
registered use) was based on the belief that
no residues of a particular, highly .toxic
metabolite of the product would appear In
corn planted in fields treated with the
product during the spring. In January '.he
registrant Icams of o study conducted by a
university idealist showing that residues of
the metabolite in question have appeared in
com grown in fields which were properly
treated with the product. If true, this report
would indicate that use of the product may
pose serious hatard to food consumers.
Accordingly, the information must be
reported to EPA unless, during « reasonable
period of lime for investigation or
verification, the registrant learn* of fact*
establishing it is untrue. One me^ns of
verification would be lo conduct independent
field trials during the coming growing season.
However, waiting for thr results of field trials
would require a drlny of at least ft-10 months
in reporting. Given the serious import of the
information already available. 9-fncmth
-------
w&nli Ji« unrmionably long.
T.niivi'ly. the i»g-rirjni could contact i|,f
liii v.-r-n ron:luc!?d the ii-j.ly ami rwii>w
ihc ra.» u .'.j Vr v:rnr>. A r?vi;-.v of lint ijpo
miuM prj!«i!i!y rvqairi: lOdavi or lot. The
Agrocy HGUQ regard irw Utter delay at
reasonable. since/even though the
infonration rould conceivably warrant an
rm:rgem:y luupension of the product I
iff i»L-alun. Ihii coiilrf be accomplished In
lirr.e to prevent ute of the product during the
seaion.
IV. Previously Reported Infonnatioo
Any information shall be considered
to have been previously reported to EPA
under Section 6(a)(2) of FIFRA for the
purposes of this notice if such
information is contained completely in:
(1) Document* previously submitted to
EPA by the registrant;
(2) Any scientific article or publication
which has been abstracted in Biological
Abstracts. Chemical Abstracts. Index
Medicus. or Pesticides Abstracts., if the. .
"abstract in question clearly identified
the active ingredient or the registered
pesticide(s) to which the information
pertains, [information received by or
known, to the registrant prior to
publication of an abstract concerning
the information must be reported and
may net be withheld pending such
publication.]:
(3) EPA publications. EPA hearing
records, or publications cited in EPA
Federal Register notices:
(4) Reports or publications which have
been made available to the public by
any of the following federal agencies:
Center for Disease Control, Consumer
Products Safety Commission,
Department of Agriculture. Department
of Interior, Food and Drug
Administration. National Institutes of
Health, or Occupational Safety and
Health Administration. [Otherwise
reportable information concerning
research which was performed.
sponsored, or funded by the registrant
which may also appear in a forthcoming
government report or publication must
be reported and may not be withheld
pending publication.]; or
(5) Any other documents which are
contained in the official files and
records of the EPA Office of Pesticide
Programs.
Discussion
Section 0(a)(2) applies only to
"additional" information. Thus, if a
registrant has previously submitted
informs tiun concerning a given study,
document, or incident, the sane
information need not be submitted
again, in addition, we do not belirve
that it would serve «r.y useful purpose to
insist thai registrants submit
information which is already in EPA
files or it otlii'fwise readily accessible to
ri'.Y .-V-Liinlii-yiv. we have specified a
nunili.rr of objectively defined categories
of information which need not be
submitted. Failure to submit information
in any of these categories will not be
treated aa on actionable violation of
Section 0(a)(2). While the specified
categories are not intended to
encompass all information which could
conceivably come to the attention of
Agency personnel, they do indicate
which types of information are most
likely to be routinely examined or __
reviewed by EPA.
V. Casc-by-Caso Exercise of
Proieculorial Discretion
' EPA will not automatically seek or
recommend civil or criminal penalties
whenever it discovers an apparent
violation of F1FRA J 6(a)(2) of a type
wh.ichjs. considered a.ctionab!e_under
this Notice. Decisions in such cases will
be based on a careful evaluation of all
pertinent information, including any
explanation offered by the registrant
Dated: July 6.1878. .
Marvin B. Owning,
Auiiiant Administrator for Enforcement.
ire Dot n-tatt FIM MM* 145 IB)
KUJNO COM U*O-OMI
(FRL «70-«)
Illinois State Implementation Plan;
Notice of Deficiency
AGENCY: U.S. Environmental Protection
Agency.
ACTION: Notice of Deficiency; Illinois
State Implementation Plan.
SUMMARY: As a result of Illinois
Appellate Court action on September 27,
1976 which vacated regulations
pertaining to paniculate and sulfur
dioxide emission standards USEPA
finds the Illinois Slate Implementation
Plan to be deficient.
FOR FURTHER INFORMATION CONTACT:
Maxine Borcherding. Air Programs
Branch. Air and Hazardous Materials
Division, U.S. Environmental Protection
Agency, 230 South Dearborn Street,
Chicago. Illinois 60604. (312) 354-2205.
SUPPLEMENTAL INFORMATION: This
notice contains a summary of the
findings of the EPA Regional
Administrator for Region V from an
assessment of deficiency of the
implementation plan for the State of
Illinois.
On May 31.1972 (37 FR 10862) under
Section 110 of the Clean Air Act and 40
CFR .Part 51, the Administrator
substantially approved Illinois' control
strategy for Ute attainment and
maintenance of I'm nulinr..,! ;-.rir.;;iry
and secondary itaniiard.« i-.ir snliur
dioxide emissions ttnd |>,,r':r.i.!;itr
emissions in the State of Illinois. In
April of 1972, the Illinois Pollution
Control Board (PCD) initially adopted
regulations numbers 203 (particulate .
emission standards) end 204 (sulfur
dioxide emilsion standards). These
regulations were adopted pursuant to '
the Illinois Environmental Protection
Act of 1970. //;. Rev. StoL. ch. Ill 1/2
ections 1001 et seq. (197S) and
superseded other air quality regulations
promulgated under prior acts.
The validation, of Rules 203(g)(l).
204(a)(l) and 204(c)(l](A) was
challenged in court and. as a result the
Illinois Appellate Court found that the
PCB had not followed the correct
procedure in Its adoption of those Rules.
...TheXourtxernaoded ihe-caute-lo tha -
PCB for further consideration.
(Commonwealth Edison Co. v. Pollution
Control Board. 25 III. App. 3d 271.323
N.E. 2d 04.) The Illinois Supreme Court
affirmed the Illinois Appellate Court's
decision instructing PCB to validate
Rules 203(g)(l). 204(a)(l) and
204(c)(l)(A) according to Section 27 of
the Illinois Environmental Protection
Act or to prepare proper rules as
substitutes. (Commonwealth Ediion Co.
\:PCB. 62 III. 2d 494. 943 N.E. 2d 459
(January. 1976).)
On August 2,1976. the EPA Regional
Administrator. Region V, formally
issued a Notice of Deficiency requesting
that a revision to the Illinois State
Implementation Plan (SIP) be developed
or that appropriate action be taken to
correct the SIP deficiencies noted by the
Illinois courts. (41 FR 149. August 2.
1976.) Authority for the Notice of
Deficiency was provided in Sections
110(a)(2)(H) and 110(c) of the Clean Air
Act.
On July 7.1977. the Illinois PCB issued
an order "validating" Rules 203(g)(l),
204(a)(l) and 2M(c)(l)(A). to become
effective September 1.1977. The..
validation of the regulation was subject
to a public comment period running 45
days from the dale of the order. This
action by the PCB was challenged by
Ashland Chemical Company, one of the
sources affected by the Rules.
On September 27.1978. the Illinois
Chemical Company v. Pollution Control
Board (No. 77-362), II). App. 3d
. The Court held that the HCB did
not follow the instructions of the Illinois
Supreme Court in Commonwealth
Edison Co..-supra, for either
"revalidating" the ru.'es or adopting
"substitute" rules. The Court found that
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ENVIRONMENTAL PROTECTION
AGENCY .................
1OPP-OOC35A; FRL 13KM]
Pesticide Use and Production by
Veterinarians; Statement of Policy on
the Applicability of the Federal
Insecticide. Fungicide, sod
Rodenttekie Act to Veterinartani
AGEWCY: Office of Pesticide Programs/
Of/ice of Enforcement. Envirorjaental
Protection Agency (EPA).
ACTION: Notice of a policy for
implementation of the Federal
e. Fungicide, and Rodenticide
with respect to
SUMMARY: This notice explains EPA's
poii'cy for e-forcement of various
provisions of the Federal Insecticide.
Fungicide, and Rodenticide Act, as
amended (FIFRA) (7 U.S.C. 136 et seq.).
and reruiatioss thereunder, with regard
;o D-;::o:s of Veterinary Medicine
(veterinarians) who use. mix or
prescirbe pesticides.
FOfl FUBTHEfl INFORMATION CONTACT:
Ralph Colleli (TS-766). OfTice of
Pesticide Programs. (202) 755-8030.
SUPPLEMENTARY WFOAUATK>.1: On
Thursday, March IS. 1979, EPA's Office
of Pesticide Program* and Office of
Enforcement published a proposed
statement of policy for the regulation of
veterinarians who u«e or dispente
pesticides in the course of their practice
(« FR 1576S). That proposed policy
statement pointed out that veterinarians
who deaJ with pesticides are subject, to
some extent, to legal responsibilities
imposed by FIFRA and regulations
thereunder, including regulations for
pesticide applies tor certification.
product registration, establishment
re?'"~3tion. a_nd special (child-real slant)
p/ ^^kg- The March 15 notice also
. stated that the purpose of the propose
, policy w-as to describe EPA's plan for
i applying these statutory and regulator
) requirements to veterinarians. This plan
would allow veterinarians to continue
their usual practices without having to
. conxpiy with all the procedural
requirements to which they are
technically subiect. provided that they
comply with certain minimal safety
precautions specified in the policy
statement. These conditions would not
extent or augment in any way the legal
responsibilities or liabilities of
veterinarians. However, compliance
with these precautions would permit
EPA to allow beneficial and customary
veterinary practices to continue, free
from restraints which would otherwise
apply.
Tne March IS notice invited the public
to comment on the proposed policy. The
deadline for submitting comments was
April 30. 1979. Only two commenters
responded to this notice. One
comnenter (No. 1(00086)), speaking for
me California Department of Food and
Agriculture, objected generally to the
idea that veterinarians should be treated
any differently under this policy than
other pesticide users. The commenler
specifically stated that "Veterinarians
should comply with applicator
certification requirements and use
registered pesticides in accordance with
registered labeling."
EPA must reject this objection since.
as the March 15 notice pointed out.
veterinarians are exempted from
certification requirements by regulations
promulgated in 1975 (40 CFR 171.4(e)).
and not by this policy. Also, as the
proposed policy statement, and this final
notice, expressly state, "veterinarians.
like all other persons, must use all
pesticides . . . consistently with their
registered labeling."
the other commenter (No. 2(00083))
raised several points. First he stated
that mis policy might set a precedent for
other pesticide user and producer
groups, and that the policy statement
should be written with that
consideration in mind. EPA has
considered this issue and notes that this
policy is not intended as a precedent for
treatment of any persons other than
practicing veterinarians. This policy was
specifically developed to recognize the
special status granted to veterinarians
by regulation, and to obtain for the
public the unique benefits this group can
provide, while maintaining an
acceptable level .of safety in the use.
production, and distribution of
peitotides by veterinarians. This
statement cannot therefore, be
extended to any other groups.
The same commenter also suggested
that veterinarians who mix and
dispense special pesticide blends for
treating unusual cases should be .
required to keep special records on such
treatments. This comment was rejected
since most of the information specified
by the commenter is routinely kept by
veterinarian* tn their office files, and
since the incremental benefits
obtainable from such retords would not
justify imposing such a requirement on
veterinarians.
These comments are available for
public inspection in the Chemical
Information Division (TS-793). Office of
Toxic Substances. EPA. Room E-44T. 401
M Street, S.W.. Washington. D.C. 20024.
from 9:00 a.m. to 4:00 p.m.. Monday
through Friday.
Certain minor changes rn the policy
statement have been made since its
proposal, however, in order to clarify or
correct certain deficiencies in the
proposed policy. For example:'the
sections relating to Repackaging and
Dispensing of Pesticides and Production
of Special Pesticide Formulas have been
modified to require that the basic
labeling information described therein
be physically attached to the pesticide
package, if space permits, in addition, in
cases where the size of the package
precludes insertion of human safety
precautionary statements on the
package itself, certain specific
precautions must appear on a tag
attached.to the package.
Also, the final policy statement
clarifies that veterinarians dispensing
special pesticides formulations will be
covered by the exemptions described
herein only when the special blend is
formulated for use on an affected
animal. Special blends intended for
other purposes (e.g.. space sprays) are
not covered by the exemption and must
be registered by the veterinarian.
Accordinsly. non>e is hereby given
.that the Office of Pesticide Programs
and the Office of Enforcement intend to
implement immediately a policy on th*-
subject of veterinarians using and
dispensing pesticides, as described
below.
Use of Restricted Use Pectidde*
Under sections 3. 4. and 12(a)(2)(F) of
FIFRA. no individual may use a
restricted use pesticide unless he is an
applicator certified under a plan
approved by EPA. of is under the direct
supervision of a certified applicator, or
is expressly exempted from the
certification requirement Regulations
promulgated under section 4 in 1974
established an exemption from the
certification requirement for
veterinarians who use restricted use
pesticides in "the course of their normal
practice" (40 CFR m.4(e)). The
regulations explained, however, that this
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Federal Pryislcr / Vol. 4-J. No. 213 / Thursday, Novnmber 1, 1979 / Notices
G2M1
exemption dous not apply to
veterinarians who .-ire "in Ilie business
of applying pesticides for hire, publicly
".Idinjj themselves out as pesticide
plica tors, or enc^god in large-scale
uW of pesticides" (-40 CFR
iri.3(b)(l)(ii)). Activities such as these
would not be part of "norm.il practice."
and veterinarians would have to be
certified tc use restricted use pesticides
for such purposes. Although the meaning
of a "normal practice" is broad and may
vary according to local needs, some
activities clearly do not come within the
scope of that term. For instance,
application of pesticides by a
veterinarian as o "principal or regular
occupation" (30 FR 3D447 {October 1.
'974)), or solicitation of pesticide
application business by veterinarians, is
not considered part of aj'normal _
'"practice." Veterinarians who use
restricted use pesticides for such
purposes, or in any other manner which
is not part of their "normal practice,"
arc required to become certified under
an appropriate npproved State or
Federal certificiation plan, unless they
us? such pesticides under the direct
supervision of a certified applicator.
Although EPA strongly recommends
that veterinarians keep abreast of
advances in pesticide use and
technology throush appropriate
. professional continuing education.
erir.arians who practice within the
jids of-10 CFR iri.4{e) are exempt
..era the certification requirement. LPA
interprets this exemption as also
extending to regular employees of a
veterinarian when applying restricted
use pesticides "undsr the direct,
supervision" of the veterinarian. Such
supervision requires, unless the
pesticide labeling specifies otherwise.
that the employee bo a competent
individual, acting under the supervision
fend control of a veterinarian who is
available if and when r.eedfid, even
though the veterinarian is not physically
present at the time (section 2(e)(4) of
FIFRA). Veterinarians are. however.
subject to civil and criminal penalties
for violations of FIFRA, including
misusa of pesticides, committed by
em[i!o)-fies under thoir supervision (see
section 14{b)(4) of FIFPA). Additionally,
veterinarians (unless they have become
certified applicators) are not authorized
to supervise the use of restricted use
pesticides by uncertified persons other
than their employees.
Similarly, under section 12(a)(2](F] of
FIFP.A, veterinarians, as all other
persons, crc forbiddur. to dispense
restricted use pesHcic'ns (o uncertified
ter-.ons, including thoir clients. ur.Vss
ssly allowed by EPA regulations.
However. liPA will consider the need of
veterinarians in dispense a particular
pesticide to clients as part of any future
decision on whether to restrict use of
such a pesticide-.
Finally, veterinarians, like all other
persons, must use all pesticides.
including those not classified for
restricted use, consistently with their
registered labeling. As authorized by
section 2(ue) of FIFRA. this includes use
against a pest not specified on the
labeling as long as the animal or site
treated is to specifiad. unless use
against that pest is expressly forbidden
by the Administrator of EPA.
Any veterinarian who uses or
dispenses pesticides in violation of the
provisions of FIFRA. as described
above, may be penalized under section
14.of PIFRA for .such .actions .
Repackaging and Dispensing of
Pesticides
Sections 3(a) and 7(a) of FIFRA, and
regulations thereunder, require every
"producer" of pesticides to register all
pesticides produced by him, and to
register the establishment in which they
are produced, prior to sale or
distribution of such pesticides. By
regulation, the term "producer" includes
all persons who "repackage or .
otherwise change the container of any
pesticide (40 CFR 167.1(c) and (u)J.
Therefore, a veterinarian who prescribes
or otherwise dispenses a pesticide in a
new container, or a container which he
has altered by changing the package or
its labeling, after receipt of the original
product, is considered a "producer." The
veterinarian is then legally responsible
for registering such a product with EPA
(even though the .original product may
already have been registered by its
producer); for registering his
establishment: for complying with all
applicable labeling and packaging
standards established by EPA; end for
keeping all records required of
producers under section 7(c] of FIFRA
and 40 CFK 167.5. .
Hoxvever. EPA rccogni/.es the
substantial benefits which may be
gained by permitting veterinarians who
obtain pesticides in bulk containers to
dispense such pesticides to clients in
individual containers better suited to the
specific case for wh'ch each pesticide is
prescribed. EPA also recognizes the care
with which most veterinarians
prescribe, repackage, end distribute
pesticides. Therefore. EI'A.'ns a matter
of policy, will not subject veterinarians
who prescribe and dispense- repackacctl
pc'Sticidns in tfie rt'quireir.t'nts imposed
on "producers." provided :li,,t the
following minima! conditions are met:
1. The repackaged pesticide is
registered by EPA for a use consistent
with the HSR Tor which the pesticide is
prescribed, and the EPA registered use
is not classified as restricted.
'I. The veterinarian supplies the client
with labeling for the pesticide which
contains:
(a) The common or trade name(s) and
percenlagc(s) of the active ingredient(s);
(b) The EPA product registration
number;
(c) Use directions for the use
prescribed; ,
(d) The name and address of the
veterinarian;
(e) An antidote statement;
(f) Directions for disposal of the
pesticide and the package dispensed to
the client; and
(g) Human safet-y-procrutionary-
statements, including but not limited to:
(i) "For application to animals only."
fii) "Keep out of reach of children."
(iii) "In case of accident, contact local
physician immediately."
If there is sufficient space on the
package dispensed to the client, a!! of
the information specified in (a)-fj)
above must be physically attached !o
the package.
If space on the package is not
sufficient to permit direct attnchneni of
labeling containing «!1 the inform;-.lion in
fa Ms), then, at a minimum, the
information specified >n (a), (b}. (>.:}. nr.d
(d) must be physically attach 3d to '.he
package. In addition, in such u case, the
human safety precautionary staterr.urif
specified in (g) above must ba physically
affixed to the container by wire, plastic.
or similar means.
The information required by (e) and
(f) above may be supplied to the client
in the fcrm of supplemental labeling.
which may, if appropriate, consist of the
original labeling of the pesticide as
received by the veterinarian.
3. The container in which the
pesticide is dispersed to the client is a
chiid-resistant package as described in
40 CFR 162.16 of the "Special
Packaging" rule (44 FR 7695), unless the
veterinarian Las determined that there-
is no reasonable possibility that ths
package will come within the reach of
crr'ldren.
4. The pesticide is prescribed anc!
dispensed to ihc client for tha trft^imenl
of a £pi!ci*>s pest problem, on a ensu-by-
case basis, as part cf tha veti'riiujrinn's
"normal practice."
In addition to meeting the above
rj'iuirorr.t-nts, all velcrinnrians
disiri.')iiii:ig pesticides are urpnJ to
discuss labeling directions with the
client at liit- tin!* L'ie p2yt.;ciue :s
dispensed.
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C2942
Federal Register / Vol. <», No. 213 / Thursday. November 1. 1979 / Notices
Any veterinarian who repackages and
^spe.-.ses pesticides. and who does not
s:y ccr.itions (1) through (4) above.
1'. crrrpiy with all federal registration
-'?rrir" rec'-irernents for
"producers." and r.ey be penalized
ur.d?r section 14 of FLFRA for failure to
d: «;.
FivJucin;: and Dispensing Special
Formulas
Veterinarians who prepare their own
special products for treatment of pests,
other than by mere dilution of a
reris'.ered pesticide in accordance with
its labeling. may also be "producers." If
the product formulated by the
veterinarian is a "new animal drug" (as
dcfir.sd in 21 U.S.C. 321(w) and
32l(g)(l)). the product and the
.....
£.: U.S. Food and Drug Administration.
U. however. the product is not a "new
animal drug." or an animal feed
containing a new animal drug, and is
intended to prevent, repel, mitigate, or
destroy any pest, it is a pesticide
(section 2(u) of FIFRA) and is subject to
the primary jurisdiction of EPA. The
veterinarian is then considered a
"producer" under FIFRA section 2(w).
As described above, "producers" are '
ordinarily required to register products
and establishments, to keep records,
to c-.eei labeling and packaging
ards. If. however, the veterinarian
uces a special pesticide blend
solely for his own use, or use by persons
in his presence and under his immediate
supervision, then the veterinarian is
exempt from these requirements (see.
e.g., 40 CTF. 162.3;:;): I62.5[a); 167.2(a)J.
Nevertheless, when mixing or using
special pesticide blends, veterinarians
p.r? s'-ili required to comply with the
l:bc!Lr..- directions of any registered
pesticides used. In addition. EPA
recommends that labeling meeting the
minimum standards of 40 CFR Part 162
accompany the special blend, in order to
promote safe use. storage, and disposal
of such pesticides by the veterinarian
and his employees. Also, when applying
a special blend which may leave a
residue in or on an animal intended for
use as food, the veterinarian must
ensure that the ingredients used have
been granted necessary clearances
under the Federal Food. Drug, and
''Cocmctic Act.
On the other hand, veterinarians who
formulate special pesticide mixtures for
distribution to others are legally subject
to all registration, labeling, and
packaging requirements imposed on
producers. However, EPA recognizes the
Befits which may be obtained by
,ving veterinarians to formulate
lucts to meet unusual cases.
Therefore, EPA will not subject
veterinarians who dispense such
products to these requirements if:
1. The special pesticide blend is
produced by mixing two or more
pesticides a'lready registered by EPA. or
by adding new substances to an EPA
registered persticide.
2. Special blends made from
registered pesticides classified for
restricted use by EPA are not dispensed
to uncertified persons.
3. The special blend is formulated and
dispensed in accordance with
recognized clinical practices and not
primarily for purposes of
experimentation.
4. The product is prescribed solely for
application to an affected animal
consistent with the labeling of any
....registered .produc,t,,us£d,a.s .ajtMngredient
and the use directions in the Ip'o'eiing for
the registered ingredient do not prohibit
the mixing performed by the
veterinarian.
.5. The special product is prescribed
and dispensed to individual clients of
the veterinarian on a case-by-case basis
to meet specific pest problems.
6. The veterinarian supplies the client
with labeling for the special product
which contains:
(a) The common or trade name(s] and
percentage(s) of active ingredient(s):
(b) The EPA registration number for
each registered product used as an
Ingredient;
(c) Use directions for the use
prescribed, which are consistent with
the directions found in the original
labeling for the registered products used
as ingredients;
(d) The name of the veterinarian:
(e) An antidote statement:
(f) Directions for disposal of the
pesticide and its container, and
(g) Human and environmental safety
precautionary statements including, but
not limited to:
(i) "For application to animals only."
(ii) "Keep out of reach of children."
(ill) "In case of accident contact local
physician immediately."
If there is sufficient space on the
package dispensed to the client all of
the information specified in (aHg)
above must be physically attached to
the package.
If space on the package is not
sufficient to permit attachment of
labeling containing all the information in
(aHg). then, at a minimum, the
information specified in (a), (b), (c). and
(d) must be physically attached to the
package. In addition, in such a case, the
human safety precautionary statements
specified in (gj above must be physically
affixed to the container by wire, plastic.
or similar means.
If the original labeling or any of the
Ingredients would satisfy the
requirements of (e) and (f). copies of t.-t
labeling may be supplied to the client to
fulfiiJ those requirements.
7. Tne container in which the special
product is sold to the client is a child-
resistant package. a*s described by the
"Special Packaging" rule, unless the
veterinarian has determined that there
is no reasonable possibility that the
package will come within the reach of
children.
In addition to meeting the above
requirements, all veterinarians
distributing their own special products
are encouraged to discuss labeling
instructions for the special product with
the client at the time the pesticide is
dispensed.
conditions when distributing specially
formulated pesticides must comply with
all registration, recordkeeping. labeling.
and packaging requirements established
for "producers." Failure to comply may
result in the imposition of penalties
under section 14 of FIFRA,
Special Packaging
As mentioned above, it is-expected
that veterinarians who "produce"
pesticides for their clients' use will
frequently be subject to the
requirements of the "Special Packaging"
rule by its own terms. That is. a
veterinarian producing a pesticide
which meets the toxicity requirements of
the "Special Packaging" rule, and which
is intended for "residential application",
as defined by that rule, must package
the product in a child-resistant container
before dispensing it to a client
In addition, in those cases where that
rule will not apply by its own terms, but
the prescribed pesticide may come
within the reach of children, use of
child-resistant packaging by the/
veterinarian is a prerequisite to
exemptions from registration,
recordkeeping. and labeling
requirements described in the preceding
sections of this policy. ,
These facts, coupled with the practical
difficulty that some veterinarians may
have in determining whether a
prescribed pesticide is subject to the
terms of the "Special Packaging" rule,
make it to the veterinarians' advantage
to comply with the rule whenever there
is a reasonable possibility that a
prescribed pesticise may come within
the reach of children. Therefore. EPA
strongly encourages veterinarians to
voluntarily comply with packaging
standards established by the rule when
dispensing any repackaged or specially
blend :d pesticides.
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Fr-tlcrn! Register / Vol. 44, No. 213 / Thiir?d;iy, November 1. 1!)79- / Notices
Stale Regulation of Veterinarians
This policy statement concerns only
EPA polity under F1FRA and federal
regulations. It dors not affect Slate or
local regulatory restrictions .covering
veterinarians who deal with pesticides.
Therefore, all veterinarians should
consult their local professional
associations, licensing offices, and Stale
and local pesticide regulatory agencies
for detailed information on local
requirements.
Dated: October 16.1979.
Edwin L Johnson.
Deputy Assistant Administrator fur Pesticide
Programs.
Daled: October 24.1979.
Richard O. Wilson,
Deputy A ssistont Administrator for General
Enforcement.
|fR Doc. 79-33.'13i Filed IO-3I-T9: 6:45 am|
BILLING CODE 6560-01-M
[OPP-30000/33A; FRL 1350-1]
Rsbuttable Presumption Against
Registration and Continued
Registration of Pesticide Products
Containing EPN; Extension of Period
for Submiscion of ncbultal Evidence
and Comments
AGENCY: EnvironT.cntpl Protection
Ai3ncy (EPA). Office of Pesticide
Programs.
ACTION: Extension of cnrr.nicnl period.
SUMMARY: EPA has extended the period
for subn)i!!al of rebuttal evidence and
other comments in regard to the
rcbuttablc presumption against
registration (RPAK) of pesticide
products containing O-ethyl O-(p-
nitrophcnyl) pbeiiylphosplionolhinute
(EPN).
DATE: The comment period closes on
December 28. 1979.
FOR FURTHER INFORMATION CONTACT:
Mr. Patrick Miller, Special Pesticide
Review Division (TS-791). Office of
Pesticide Programs. Room 722, Crystal
Mall Building =2. 1021 Jefferson Davis
Highway. Crystal Ciiy, Virginia 22202.
Telephone: 703/557-7973 Ext. 24. The file
supporting the Agency's presumption
against EPN is available for public
inspection at this location.
SUPPLEMENTARY INFORMATION: On
September 4, 1979, EPA issued an RPAR
against EPN. This notice was published
in the Federal Resistor on September '19,
1979 (44 FR 54334). The regulations
governing RPAR's provide that the
applicant or registrant of these pesticide
products shall have forty-five days from
the date this notice is sent to submit
evidence in rebuttal of the presumption.
If good cause is shown, however, an
additional sixty days may be granted in
which to submit evidence (40 CFR
The deadline for submitting rebuttal
evidence in the RPAR notir.fi was
October 29. 1979. Requests for an
additional sixty cays in which to submit
evidence to EPA have bcnn recoivt-d
from registrants and othus who were
affected by the notice of presumption.
They have specified a need for
additional time to respond to the risk
presumptions set forth in the September
19 notice (i.e., delayiul neurotoxicily in
test animals and acute toxicity to
aquatic; organisms) and to assess
properly .the benefits of EPN.
The Agency concludes that additional
time would be beneficial to ensure (he
submission of complete and accurate
responses to this notice of presumption.
Therefore, all registrants, applicants, for
registration, and other interested
persons shall have until December 26.
1979, to submit rebutt-il evidence and
other comments or information. Thcs«
submissions should hu sent to the
Document Control Officer. Chemical
Information Division (TS-7Q3J. Office of
Toxic Substances. EPA. Room 447. East
Tower. 401 M Street, SW.. Washington,
D.C. 20400.
All comments should bear the
identifying notation "OPP-30000/33A."
Comments received on or before
December 23, 1979, will be considered
before the Agency decides whether a
notice shall be issued under 40 CKR
162.11(a)(5][ii) and 7 U.S.C. 13S(d](L')f.l).
Comments received after December 28,
1979, shall be considered only to the
extent feasible, consistent with the lime.
limits imposed by 40 CFH 162.11(a)(5){i:;.
All written comments filed will be
available for public inspection in :hc
office of the Document Control Officer
at the above address -fro:;) H:jO a.m. to 4
p.m. on normal business days.
Dated: October :0. lar.l.
Edwin L. Johnson,
Deputy Assistant Adminisirelor for Pasticide
Programs.
SIU.INR CGQc biOO-Ct-U
FEDERAL COMMUNICATIONS COMMISSION
Canadian Standard Broadcast Stations; Notification List
List of new stations, proposed changes in existing stations, deletions, and corrections, in assignments of Canadian
standard broadcast stations modifying the assignments of Canadian broadcast stations contained in the appendix to the
recommendations of the North American Regional Broadcasting Agreement Engineering Meeting Jan. 30. 1941.
September 19, 1979.
Canadian List No. 3C9
Antenna Grou.io «y jt
Can lower
(iect) Nyfiitcr c! Lengili
ladies feel
o( corrmcncc-nont
ol ojxiatpo"
CEO
CHP.3
Tnuntfw Ejy. 0^'a'^. N «3'1!»39 '. ICO.'iH DA- 1
W 89 2V31" (in csoatrcn /..I1
c^afv;ed antennn rc.:ij;ion pattern)
eooun
19 17". V.'.
to r.'O-iao...- -
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
» WASHINGTON. O.C. 20460
DEC 1 £ iS~- OFFICrSF ENFORCEMENT
SUBJECT: Enforcement Actions .Concerning N'onhazarcous Pesticide Devices
TO: Pesticide Branch Chiefs
Enforceirient Division Directors
t
Section 13 of the Pesticides Case Proceedings Manual states that the
issuance of. a Step*Sale.,_Use...or Removal Qr^er._LS.Jcansa.tary.._fflc..mavises
wf.cse labeling bears false, misleading, or fraudulent claiirs. I/ This
guidance is based on section 13 of FIFPA, which grants EPA the authority
to prevent the further distribution and sale of any pesticide or device
found to be in violation of the Act. However/ the question has been raised
in a case involving an electromagnetic rodent repelling device whether a
seccicn 13 Step Sale Order is an unconstitutional seizure and deprivation
of a person's property without due process of lav because of the"absence
of an opportunity for an administrative determination as to the validity
of the Order. As a result, PTSED is developing a regulation governing the
issuance of St-.cp Sale, Use or Reroval Orders covering certain classes of
pesticide devices. The regulation being developed would provide .persons
who are distributing or selling ncnhazarccus devices which do not present
Ir.Tsdiata huran health or environmental risks, with an opportunity for an
acrniniscrative review of the validity of the Stop Sale Order. This review
would take place prior to and independent of the adjudication of the alleged
violation through the civil penalty process.
Chtil such a regulation is L-nplensnted, it is the Office of Enforcement's
policy that in any case of a irisbranding violation involving a nonhazardcus
pesticide device, it will be necessary to complete civil penalty proceedings
before issuing any Step Sale Order. Thus, in cases involving nonhazardcus
devices regulated by FIFHA, a Civil Penalty Notice should be issued and, if
a hearing is requested, the adjudicator/ proceedings corpletec before, issuing
a Stop Sale/ Use or Reroval Crcer. If the respondent fails to request a
tiTely hearing once he !;as received a Civil Penalty Notice, a Stop Sale Order
I/ Case Proceedings Manual, Section 13(1)(B)(2)(a)(3), TM 76-2 (10-76)
-------
-2-
can be iatpcsed. A stop Sale Order can also be imposed once a Final Order
has been issued pursuant to a Consent Agreement with the regional office.
ncvever, any Consent Agreement ccncerning a misbrar.ced device should require
as a minimum the immediate halt to any further sale or distribution of the
devices. If the respondent dees request a hearing pursuant to section .14
and the regulations set forth in 40 CFR Part 168, a Stop Sale Order should
not be imposed until the completion of the administrative proceedings and
the issuance of a Final Order. However, it is not necessary to wait for
the respondent to exhaust all avenues of appeal (i.e., appeal to the appro-
priate U.S. Court of Appeals) before issuing a Stop Sale Order.
It should be noted that this policy extends only to those devices found
not to pose an immediate human health or environmental risk but wiose labeling
is found to bear false, misleading, or fraudulent claims. Other classes of
.de.vi.ceg,...especially, those vfcich do pose human health or environmental risks,
will continue to be treated under the mandatory provisions of the guidance
found in section 13 of the Case Proceedings Manual. An example of*a device
^ich would still warrant the mandatory issuance of a Stop Sale Order, not-
withstanding the discretionary policy outlined in this memorandum, is a
vater treatment device whose labeling makes false, misleading, or fraudulent ..
claims to purify raw well water or other untreated water supplies. A more
detailed classification of devices subject to this policy will be outlined
in the proposed regulation.
Nevertheless, in certain cases, involving ncnhazardous devices it may be
necessary or appropriate to take further action to prevent the continued dis-
tribution and sale of the devices before the completion of the civil penalty
proceedings. In such cases it nsy be appropriate to seire the devices pur-
suant to the authority in section 13(b) and/or to seek an injunction pursuant
to the authority in section 16(c) to prevent their further distribution and'
sale pending the outcome of the civil penalty proceedings. These actions
require the prior concurrence of EPA Headquarters as outlined in sections' '"
13(11)(A) and 18(D)(3) of the Case Proceedings Manual, and must be referred
to the Department of Justice for prosecution. 2/
27The authority to institute in rem (seizure) proceedings is vested concur-
rently in the Regional Administrator and Assistant Administrator for Enforce-
ment [Chaster 10-2, EPA Delegations Manual].
-------
-J-
If you have ary questions abcut the policy or procedures outlined in this
.-^erncrar.cu.7.1, or need assistance on a case-by-case basis in prosecuting persons
fc: the sale and distribution of misbranded, ncnhazarcous pesticide devices
please ccr.cact Joseph Vircilio of PTSED at 202-472-3701.
A. E. Conroy II
Pesticides and Tox
Enforcement D
-------
JAN I 6 1980
MEMOSAKDPa.
SUEJECT: Federal Facilities Compliance
TO:
Clyde B. Eller, Director
Enforcement Division, Region IX
This is in response to your memorandum of December 19, 1979,
requesting a further determination on the issue of civil compli-
ance against Federal facilities. Your memorandum steir.ced fron
earlier telephone conversations between our staffs in which we
indicated a preference for core informal enforcement actions
when dealing with other Federal executive agencies.
Executive Order 12088 (copy attached) sets forth policies
governing compliance with environmental standards by Federal
r-cilitics. The tlu-usi: of £.0. 12083 is that the Administrator
hculd notify en Executive .".-ger.cy when it has bacn found to be
in violation of a pollution control standard. That agency, in
turn, should promptly consult with the Administrator and provide
a plan to achieve end maintain compliance with the pollution
control standard. The Administrator is directed to make every
effort to resolve ccnfl.icis regarding the violation. If the
Administrator cannot resolve the conflict, he is directed to
reruest the Office of Management end f.ucget to resolve the
co-nflict between the agencies. Section 1-604 further provides
that these conflict resolution procedures are in addition to,
and not in lieu of, other enforcement procedures.
It is the express policy of the Agency to make every
effort to resolve ciic-.h conflicts with other Executive agencies
in accordance with E.O. 12088. This policy is consistent with
the thrust of E.O. 12038,in favoring inter-agency settlement
over more formal enforcement actions. This is so in the con-
text of ecrninistrative procedings as well as in the context of
in-court litigation where the Department of Justice has indi-
cated it would net allow the EPA to file suit against another
Executive Agency.
CONCURRENCES
t*rm 1320.1 (U-70)
OFFICIAL FILE COPY
-------
- 2 -
It is the policy of the Department of Justice (DGJ)..not
to involve the Judicial Branch in resolving Executive Branch
pr.oblens. DOJ would intervene against EPA if we attempted
any such filings on our own behalf.
The- goai^in "^ggt-i-f-t-ip.g fi«**:* T "»««»"«:« i>h*n fln
is- fournl-to-bein-viol-at-ion-o£-apollution control atandard is
not to assess penalties but to obtain compliance. Expeditious
cor.pliamcre rai^h't be obtained solely on the basis of such settle-
ment between the agencies. To the extervt that every effort to
resolve such conflicts with other Executive agencies has not yet
been n^cio, the consideration of other enforcement options would
-be-inappropriate.
An example of cne such agreement is the Federal Facilities
Compliance Agreement between CPA and the Department of the
Ar.-ry (cccy enclosed). This agreement established expeditious
compliance schedules for the Department of the Army Jiaterial
Development and Keadiness Ccrrnand (DAPCC!!) facilities which
were in violation of previsions of the Clean Water Act and the
Clean Air Act. As outlined in en April 13 f 1979, raernorancu.?.
£rc:s the Director/ CE Office cf Program and Kanagercent Opera-
tions, to the Secicr.cl Enforcement Division Directors, this
:L'oc~.ont wiil servo i£ s r";c-uol iior rccc^vir.c siniiAtir picj^crrs
»h Executive ?.^sncic?s ir. th° future.
I hcpo that thi- ir.fcr-aticn cill be of help to yc-j. if
I can be of any further assistance, please contact rae at
(202) T53-OS70.
A. E. Ccnroy II, Director
Pesticides and Tcxic Substances
Enforcement Division
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OATh.: December 19, 1979 -
TSCA Civil Complaints Against Federal Facilities
Clyde B. Eller
MOM, Director
EnJEorcement Division,. Reg ion.-IX .0
tor Ai Ei Conroy-II-- --- - --
Director
Pesticides and Toxic Substances Enforcement Division
In tel-ephone--conversat-io-ns~-wrt.-h--yauir~sta'ff",' we~
ceen informed that PTSED will not concur in a civil
complaint against a federal facility. Because of Executive
Order 12088, PTSED prefers that a settlement with a.federal
facility be embodied in an informal compliance agreement.
It is our position that a federal facility should be
treated in the same manner as any private company. A civil
complaint should be issued against a federal facility which
violates TSCA and any settlement should be embodied in a
consent agreement.
Cur position is not inconsistent with Executive Crder
A2088, which states:
"These conflict resolution procedures are in
addition to, not in lieu of, other procedures,
including sanctions, for the enforcement of
applicable pollution control standards."
Because a number of completed federal facility
inspection reports are awaiting enforcement action, we
request a prompt resolution of this issue.
If you have any questions, please contact me or Keith
Takata of my staff at (415) 556-8008.
EPA FOftM 1)»-« IftfV }?«
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D. C.
Department of the Army Federal Facility
-and. . ..Compliance
~T77S. environmental" Agreement.
Protection Agency
The Environmental Protection-Agency (EPA) and the Department of
the Army (Army) are the parties to this agreement which is entered into
pursuant to Executive Order 12038, October 13, 1278 (43. FR 4770").
The Office of Management and Budget and the Department of lustice
raks ccgnicar.ee of this agreement pursuant :c their respective duties
tc assure compliance with the environmental laws under Executive
Order 12088 a"d the carticuiar statutes hersin addressed.
5cc?r
1. This agreement is entered into by Che parties to-asstsre-esapliar.ee
t
by the-Department of Army Materiel Development and. Readiness Command
(DARCOM) with the Clean Air Act (CAA) (42 USC 7401 et sec.) and the
Clear. Wacer Act (CV/A) (33 USC 1251 et seq.), and implementing
regulations.
2. This agreement is no: and shall not be construed as a permit under
the CV/A nor "shall it relieve the Army of any legal obligations under the
-------
CWA which are in addition to or different from matters covered in this-
«
agreement. This agreement does not modify the terms of the State
Implementation Plan (SIP) governing each subject facility, nor-shall it
relieve the Arny of such SIP responsibility under the CAA. This agree_
- - ~
ment Li n
appropriate SPA regional office and State cr regional environmental
agency for all applicable air quality permits.
Authorities
3. The duties of the Anr.y to operate its facilities in compliance with
the Clean Air Act and the Clean Water Act are prescribed in section 113
of the Clear. Air Act (42 USC 7413) and section 313 of the Clean Water
Act (33 USC 1323). Ixecutivp Order 1208? v/as promulgated :o ensure
Federal compliance v/i:h applicable pollution control standards. This
agreement contains s. "plan" as descri bed L- s'ection 1-501 of Execudve-
Crder 120So to achieve and maintain compliance with applicable air and.
w=:=r pollution centre! standards.
Statement of .Tacts
*
4. The following DARCCM facilities are owned, operated, or under the
control of the Anr.y:
a. Sev/age Treatment and Industrial Wastewater, Aberdeen Proving
Ground, Acercser., Mar/land.
b. Sewage Treatment and Industrial V/astav/atas Annistcn .Army
Depot, Anr.iston, Alabama.
-------
c. Industrial Waste Treatment, Hclston Army Ammunition Plant,
Kings port, Tennessee.
d. Industrial Waste Treatment, Lone Star Army Ammunition Plant,
Texarfeana, Texas. " " ~
e. ..... Pink Water Treatment r~Mtlan Anr.y A mmuni tlon-'Pla nt , Miien- ,
:.;..->
Tennessee.
Army Depot, .New Cumberland, Pennsylvania.
g. .Industrial Waste Treatment, Pine Slaff Arsenal, Pine Bluff,
Arkansas.
h. Industrial Waste Trsa-ssent, Radfcrd Army Ammunition Plant,
Racford, Virginia.
i. Sewage Traar.T.er.: ?lar.:, Redstcr.e Arsenal, Alabarr.a.
J. Sewage Treatment Plants, Seneca Army Depot, Romulus, New York,
k. Sewage Treatment Plant, Industrial Wastewater, and Boiler Plant,
Toby hanna Army Depot, Tobyhanna, Pennsylvania.
1. Industrial Waste'Treatment and Deactivation Furnace, Lake City
Army Ammunition Plant, Lr»dependence, Missouri.
m. -Contaminated Waste Process, Iowa Army Ammunition Plant,
Middletor. , Iowa.
n. Boiler Plant, Reck Island Arsenal, Rock Island, Illinois.
o. Demilitarisation Facility, Savar.r.a Army Depot, Savanna, Illinois.
-------
5. Twelve DARCOM facilities named Li paragraph. 4(a) through (1)
are presently In violation of the statutory compliance deadline 'of the
Cleen Water Act, to wit. CWA section 301 (33 USC 13111.
FourDARCOM facilities named In paragraph A(H_t3rough..(Ql
presently" hav«? at^ta~graated variance a~frcia th'g~Sfrerative~Sr?T~"Hr~we veiV - ,-- ~- J
* f
these variances have not been submitted to or approved by E?A as a
modification of the SI?. . .
The cempLLar.ce status under the CAA of the Tobyhanna AD identified
Li paragraph 4(k) is undeterrsined at this time because of measures
presently bein? undertaken a: the facility. It has been in periodic,
marginal violation in the past.
5. The Compliance Scheduiss :cr the fiftsen DARCCM facilities named
in paragraph 4 are intended, to achieve compliance as expediticusly as
practicahie , pursuant to section 1-501 of E.O. 120S8, and are set forth
as Attachments a through o to this agreement. The attachments are
incorporated into and mace, a part of this agreement. The schedules
»
were determined after consultation between the Army and EPA. The
schedules contain interim requirements reflecting design, and construction
milestone dates. Wherever reasonably possible, the Army will expedite
the schedules.
-------
Fundinc
7. The Army shall request all funds and/or authorizations from the
Congress necessary to achieve the compliance schedules. These
schedules are fixed and definite except-to the extent that-the-
cf the-Unitsd-3catas-may fail to approve bud^efr
requests for these projects. StepS to be taken in seeking funding shall
. >*»? rnrKlsrcnr wir^ Canons.. 1-4 and 1-5 nf FvaenHvP Cr~t>r I2Q93 ag
implemented by the Office cf Management and Budget Circular A-IQ6 (as
amended).
Reeorrir.c Retirements
3. The Army shall submit a progress rapcrt r.o later than ten days after
tr.e date for achievement cf each incremental step in the-ccmpliance
schedules and upon the final compliance ca:a as se: forth in the Attach-
ments. The progress reports will be submitted to the EPA Regional
office responsible for the particular facility and the -appropriate State
or regional environmental agency, as identified en the Attachments.
The status reports shall indicate compliance or non-compliance with
the schedule. In the event of non-compliance, the report shall include
the cause cf non-compliance and any remedial actions taken.
If delay is anticipated in meeting any schedule data the Army shall
immediately notify the EPA Regional office and the State or regional
environmental agency, in writing, cf the anticipated delay, describing
in detail the anticipated length of delay, the precise cause cr causes
-------
of the delay, the measures taken and to be taken by the Army to
prevent or minimize the delay and the^ timetable by which the measures
shan be implemented. The Army will take action to minimise any d?^y.
The Regional Administratcr shall malce-a-determinatlon.
eampIisnce-sc-he
-------
10. Cr. the date for final compliance as shown on the attachments,
^
compliance with air and water standards must be demonstrable by
testing and positive reporting of the achievement of compliance, rather
than by the mere completion of construction of pollution abatement
facilities.! -
Upon the Army's demonstration of compliance, there will be a
continuing obligation to comply with applicable discharge and emission
limitations under the C.v7> and CAA respectively. These limitations are
embodied in each facility's National Pollutant Discharge Elimination
System pen^it under the OV/A and in the pertinent State Implementation.
Plan under the CAA.
Conflict Resolution
Li. Antici °*s tsd ncncompliance with cr silecsci violations of t.~_i5
.agreement shall be brought to the attention of the Administrator of the
Environmental Protection Agency,for resolution by EPA and the Army.
If necessary, the Diractcr, Office of Management and sudget shall be
notified pursuant to sections 1-602 and 1-603 of Executive Order 12088.
9
The- Director, Office of Management and Budget shall consider such staps-
as are necessary to resolve any conflicts and remedy the violations.
Sanctions
12. In the event of violations of air cr water standards cr the tsrr.s of'
this agreement by the Army, sanctions under the authcrity of section
1-604 of Executive Order 12033, as well as enforcement procedures
-------
established by the Clean Air Act and the Clean Water Act are available
as enforcement mechanisms .Li addition to the conflict resolution
procedures cited in paragraph II.
13. Provided that the Compliance Schedules, as attached, are met.
this acroecignt is conaidergd-to be-iarlieu of any-other EPA or-Fadaral
enforcement action with recard_tc«=:2 DARCOM facilities named in
paragraph 4, fcr the pollution Indicated in paragraph 5. This agreement
in no way modifies section 303 of the CAA and section 504 of the CWA.
14. This agreement Lr. no way addresses potential liability of the Army
regarding non-compliance penalties under section 120 CAA by the
facilities subject to this agreement.
iigr.ec:
Alan J. Gibes
Assistant Secretary of the Army
for Installations, Logistics
and Financial Management
MAR 1S7S
Marvin SJ Duming
Assistant AcmL'iistratcr fcr s>
Enforcement
Environmental Protection Agency
-------
Tacilitv
Attachment a
NPDES Pemrii
Aberdeen Proving Ground Earford Go, .MD MD0021237
Project Description
This" projecVixrTolveJsr-ungrading-o^- tJismain-sewage
of 57
]'. Final design start ' May 1978
2. Final design ccaplets March 1979
3. Ccnstructicn award . ' June 1979
4. Ccns-trcctien cctapleta .June 1981"
^ .
5. Achisve cczplianca Sep tenser 1931
NCNZ
Prccress Reports
EPA, Region III
Curtis Building
6th & Walnut Streets';
Philadelphia, Pennsylvania 19106
Water Resource Administration
Thoraas Andrews, Director
Tawes State Office Building
Annapolis, Maryland 21401
-------
Facility
Annistoa . Arsy Depot Lcwndes Co./ AL
«
Project: Description
NPDES Permit
ALQQQ2553
This project involves upgrading of the industrial
waste__trs_atgejit facility and the existing jewaga treatment
plant. - .... .... .. . __._
.Compliance Schedule .
.......... }-.-- T-ia^i-dasdgn -start- ......
* <
2. Final design ccaplets
3. Ccnstrzcticn award
4 . Construction complete
5. 2.chieT2 cxrrpliance
?.sr.ar:
-------
Hols ton Arnr/ Anna Plant Kingsport, Til
Project Description
NPDES Permit i
TN0002381
Tliis project will-involve construction of a new treatnent
'facility for collection and treatment of all liquid industrial
wastas a-t Ebls'tnn '
Ccmgli'ance' Schedule
*
]'". Final design, start
2. Jinal" design ccaplete
3. Construction- award
4. Construction ccnpiete
5. Achieve cc=:t:liance
August 1975
April 1979
September 1979
May 1982
NoveirJber 1932
3 a a V
Sone
Progress Reports
SPA, Psgion TV-
345 Courtland Street> N.E.
Atlanta, Georgia 30308
Division of Water Quality Control
Tennessee Desartnent of Public Health
621 Cordell Hull Building
Nashville, Tennessee 37219
-------
NPDES Perrdt 5
...*c Texarkana, TX TXQQ21768
.Jtion ' . '
This project consists of the. upgrading of the waste
treatment- f nci li-ty-for-lead removal frcn-electroplating ;dis-
charges, in addition - to r*-^ -~m^ r*° ^ rtxi S^?Q ^ % an
-------
A*. *»-3 f* W^o f*
^ w«*w«^i*C*» w
e
Facility
Milan. Array Anno Plan ' Milan, TN
Project Description
NPDES Permit !
V)
K
TNOQ0006Q
project -will involve upgrading of the existing Indus-"
-triai^ was ta -treatment plant- .to. .ireatL_pln|c'. water discharges. ___ 1
Ccj.pliancg Schedule
3 . Fin'al design start
2. Final design ccapiete
3. 'Construction award
4. Construction ccaplete
5. Achieve ccnplianca .
- None
Septenber 1977
February 1979
.May 1979
«
Decerier 19 SO
March 1931
-I
Progress P.eports
SPA, Region IV
345 Courtland Street> N.E.
Atlanta, Georgia 30 303
D. Elao Lunri, Director
Division of Water Quality Con'
621 Cordell Hull Building
Nashville, Tennessee 37219
-------
Attachment f
Facility NPDES Penait 3
New Cumberland Army Depot Fair fie Id, PA PA0033385
Project Description
- project --involves -the 'upgradiag-of - the- existing
sewaga^traataaa-fc:. piante. to±^iiicraaa.flg'phqgphat»^raaQval>-^-;"
Ccspliance Schedule ' '' * .'
. ]. Final design start
*
2. Final design complete June 1979
3. Construction award . August 1379
4. 'ConstrTzctic'n ccaplets. . . &&v 1530
5. Achieve cccpliancs Julv 1CCC
None
Procrsss ?.esorts
EPA, Region III
Curtis Building
' 6th & Walnut Streets
Philadelphia, Pennsylvania 19106
Department cf Environmental Resources
Wiilian Middendorf, Director
P.O. Box 2063
Karrisburg, Pa. 17120
-------
Actacrjaer.t
Facility
%
:-.uie Bluff Arsenal Pine Bluff, Ail
Project Description
NPDES Pemit I
AK0034622
.This project involves the tie-in of drainage systenis
in 3?. b'lil^^"?" ^ the-eccisting waste .treatment- facility»-
Cctr.pliar.ee Schedule
J . Fir,a
-------
Attachnent h.
Facility NPDES Pernit
Radford Amy Anano Plant Montgomery .Co., VA VA0000248
Projec-t Description
._Th-is pjroject^will. upgrade the existing'industrial waat
treatatent:-raciJLity-to iaprove-traa tBian't'-'ft'f a'ffl'uen;ClZg3gri_._
'*' '
csitjliancs Schsculs
]. Final'design start NA
2. Final design ccnplete March 197b
3. Ccnstructicn award. . .Jane 1978
'4. Construction "ccaplets Deceirber 19 8Q
a.- Achieve ccnpliance January 19SI
None
Precrsss F.escrts
SPA, Region'III
Curtis Building
6th & Walnut Streets'.'
Philadelphia, Perm. 19106
Virginia Stats Water Control Board
Robert Davis, Director
2111 No. Easu-lton Street
Richmond, Va. 23230
-------
Attachaent
Facility
«
Redstone Arsenal Redstone, AL
Project Descriation
^- - - - - - - *
NPDES Perinit §
ALOOQQQ13
This project will upgrade three existing sewage treatment
plants and connect miscellaneous discharges to the sanitary
V8awar system..." ' " ." .'~-.- .-."" ~,- :.-_-_...
Ccnaliar.ce' -Schedule
"" """"]"." Final"'d'esica- start*
2; Final'design ccnplete
"3. 'Construction, award _
* .
4. Construction ccnplete
5.
NA
January 1980
April 1980.
November 1981
February 1932
None
?rccrsss Reports
S?Ar Region IV
345 Gourmand Street; , S. 2.
Atlanta, Georgia 30308
Alabama Water Inprovenent Ccramission
Janes W. Warr, Director
State Office 'Building
Montgomery, Alabama 36130
-------
Attachment j
NPDES Per
Seneca Ar=y Depot Romulus, NY . . NY0021296
Project Description
d is -.project. Kill «pgr&tia t-jn m-i.nnr exist in
requireaent
Ccssliar.ee Schedule
3. Final design start February 1979'
2. Final design ccsalate February 1930
3. Construction award April. 19 80
4.- Construction ccsplate Novezrber 1931
5. Acnieve ccnpliance Decerier 1981
Ncae
?rccrass Reports
SPA, Region II
26 Federal Plaza
Room 1009
Nev York, N.r. 10007
\
Dept. of Environmental Conservation
Region VII
100 Elrr./cod Davis Road
No. Sysacuse, N.-f. 13212
-------
Facility
«
Tobyhanna Aray Depot Tobyhanna, PA
Project Description
HPDES Perr.it =
PA0010987
This project will upgrade the existing sewage treatment
plant to taeet an advanced wastewater. treatment requirement.
Schecirle
] ." Final design start
2. Final design ccnplete
3. .Ccjistraction award
4.. ConstriictJ.cn ccnplete
5. Achieve ccsaliance
January 19 79
August 1979
December 1979
June 1981' '
August 1981
Noae
Prccress Reports
EPAr" Region III
Curtis Building
6th & Waln,ut Streets
Philadelphia, PA 1'9106
Air Quality .Control
James Eanbricht, Director
Fulton Building 18th Floor
P.O. Box 2C63
Harrisburg, PA. 17120
Page 1 of 2
-------
'aciiit'
NPDES Permit *
Tobyhanna Aray Depot Tcbyhanna, PA PA0010937
Project Description
This project includes. the upgrading of operational
controls and installation of particulate control devices for
the central boiler plant to effect compliance with State and'
Tederal law-s--arid-^tixidards.-- - . ..
CoCTcliar.ee Schedule -
}. Final design start ' February 1979
2. Final design ccnplste November 1979
3. Construction award _ December 1979.
4 . Construction ccnplete May 1331
5. Achieve' ccssliancs June- 1981
The final design completion shall include obtaining
all required air quality permits.
Prccress ?.e?cr±s
2PA, Region III
Curtis Building
6th s Walnut Streets
Philadelphia, PA 19106
James Eanbright, Director
Air Quality .Control
Fulton Building 18th Floor
P.O. Box 2063
Harrisburg, PA. 17120
Page 2 of 2
-------
Facility NPDSS Permit *
Lake City Arrr/ Acmo Plant MOQQ0488Q
Independence, MO
Project Description
This project includes construction of a new industrial?
'waste treatment facility to remove heavy metals, oil and 'grease1
and other pollutants; construction of new facilities to provide
' -tertiary-waatawatar treataent_and extensions of industrial
Ccmaliar.ee Schedule . '
]. Final 'design start ' -May' 1979 .
2. Final design complete February 1980
3. Construction award ' May. 1980
- 4. Construction cc=?lete _ .November 1981
5. Achisve compliance January 1982
The sccce ar.d compliance schedule ofthis project shall
" be subject to revision at the completion of a study to cs-
terniirie the r.ssd for the tertiary "raat^.snt ur.it. This shall
not exceed 120 days frora the effective date of this agreement.
Procress Rerorts
EPA, Region VII
1735 Saltimers Street
Kansas City, Missouri 64108
Iowa Dept. of Environmental Quality
Larry Crane,' Director
Henry A. Wallace Building
900. S. -Grand.
Des Moir.es, lew a 50319
Page 1 of 2
-------
-------
Facility
'Iowa Army Ammo Plant Burlington, IA
.
Project Description
^MH^MV^M^WBMMMMMMM^^^MM^^^^^ *
This project involves the construction of a contaminated
waste processor and.baghouse emission control device for a
safe and acceptable means of disposing of waste contaminated
Compliance Schedule
] ---Final design. "start
'
2. Final design complete
3. Construction award
4 .
5 . Achieve ccspliance
April 1979
July 1980
January 1981
December 1931
February 1932
' The final design completion data shall include cbtaihir.g all
required air quality permits. Maximum interim emission
reduction- shall be assured by continued storage of non-hazardc
materials consistent with safety requirement.
Prccress P.sccrts
Iowa Dept. of Environmental Quality
Larry Clane, Director
Henry A. Wallace Building
900 S. Grand
Des Moines, lew a ' 50319
SPA, Region VII
1735 Baltimore Street
Kansas City, MO. 64108
-------
r.
Facility
* t
Rock Island Arsenal Rock Island, IL
Project Description ' ';..'. " "
This project includes the installation of baghouses on 4
coal-fired- boilers to reduce particulate emissions in order
_+»n ggHHply_v i£h stag*._4pcl. Federal laws and standards. _
Compliance Schedule .- , _
" 1 -"Final ce-sigii' start " June 1S 7 3
2. Final design complete August 1979
3. Construction award DecerJser 1979
. 4. Cons-tmcticn ccaplete y^y 1981
ccrrpiiar.ca- 'June 19ai
The final design corr.platicr. data shall include obtaining a:
required, air quality perru.ts. Inreria e.ru.ssicn reduction rr.sasu;
shall include improved operation and maintenance procedures and
sequenced. operating .schedule during installation of emission
control devices to zr*iniru.2s emission.
Region V ,
230 South Dearborn'Street
Chicago, Illinois 60604
Mike Maxizi, Director
Illinois Environmental Protection Agency
2200 Churchill P.oad
Springfield, Illinois 62706
-------
Facilitv
Savanna Ar^r/ Depot Savanna . C*
Project Description __.
*" ^M^HMHM^B^^^M - - ^
This project involves the construction of an ammunition
demilitarization facility with required air quality .control
devices. ' .
Compliance Schedule
*._.].... T.v«*3,T... daS'*c"3f --start- -'-
^e-r-19-3 0~
ti
2. Final design complete July 1981
3. Construction award ' September 1981 ,' !
4. .Construction complete ' \jav 1334 - " j
" !
3. Achieve-ccripliance September 1334 "/ - - -1
* * ' . t;
!'
P.eaarks The final design completion date, shall include obtaining
all raq'iire-d air quality permits. This facility engages in r
periodic cpen. burning. However, there shall be no emissions [
from cpen burning, or otherwise, in violation of the Illinois i
SI? beyond December 31, IS32. .Maximum interim emission reduction-
shall be assured by continued storage of nonhasardous materials.-"
consistent with safety requirements.
Procress "L^^c-rts
SPA, Region V
230 South Dearborn Street
Chicago, Illinois 60504 .
Mike Mauzi, Director . .
Illinois Environmental Protection Agency . . ...
2200 Churchill Road
Springfield, Illinois 62706
-------
PART 22CONSOLIDATED RULES OF
PRACTICE GOVERNING THE AD-
MINISTRATIVE ASSESSMENT OF
CIVIL PENALTIES AND THE REVO-
CATION OR SUSPENSION OF PER-
MITS
t
Subpart AGeneral
Sec.
22.01 Scope of these rules.
22.02 Use of number and gender.
22.03 Definitions.
22.04 Powers and duties of the Administra-
tor. Regional Administrator, Judicial Of-
fleer. Regional Judicial Officer, and Pre-
siding Officer; disqualification.
22.05 Filing, service, and form of pleadings
and documents.
22.06 Filing and service of rulings, orders
and decisions.
22.07 Computation and extension of time.
22.08 Ex parte discussion of proceeding.
22.09 Examination of documents filed.
Subport BParties and Appearances
22.10 Appearances.
22.11 Intervention.
22.12 Consolidation and severance.
Subpart CPrehoaring Procedures
22.13 Issuance of complaint.
22.14 Content and amendment of the com-
plaint
22.15 Answer to the complaint.
22.16 Motions. '
22.17 Default order.
22.18 Informal settlement; consent agree-
ment and order.
22.19 Prehearing conference.
22.20 Accelerated decision; decision to dis-
miss.
Subpart DHearing Procedure
22.21 Scheduling the hearing.
22.22 Evidence.
22.23 Objections and offers of proof.
22.24 Burden of presentation: burden of
persuasion.
22.25 Filing the transcript.
22.26 Proposed findings, conclusions, and
order.
Subpart EInitial Decision and Motion to
leopen « Hearing
32.27 Initial decision.
22.28 Motion to reopen a hearing.
Subpart FAppeals and Administrative
evlew
22.29 Appeal from or review of interlocuto-
.. ry orders or rulings.
22.30 Appeal from or review of initial ded-
. don.
Subpart 6Rnal Order on Appeal
22.31 Final order on appeal.
22.32 Motion to reconsider a final order.
Subpart HSupplemental lules
22.33 Supplemental rules of practice gov-
erning the administrative assessment of
civil penalties under the Toxic Sub-
stances Control Act.
22.34 Supplemental rules of practice gov-
erning the administrative assessment of
civil penalties under Title II of the
Clean Air Act.
22.35 Supplemental rules of practice gov-
erning the administrative assessment of
civil penalties under the Federal Insecti-
cide. Fungicide, and Rodentlcide Act.
22.36 Supplemental rules of practice gov-
erning the administrative assessment of
civil penalties and the revocation or sus-
pension of permits under the Marine
Protection, Research, and Sanctuaries
Act
22.37 Supplemental rules of practice gov-
erning the administrative assessment of
civil penalties under the Solid Waste
Disposal Act
APFENDIXADDRESSES or EPA REGIONAL Or-
'- ness
AUTHORITY: Sec. 16 of the Toxic Sub-
stances Control Act; sees. 211 and 301 of the
Clean Air Act; sees. 14 and 25 of the Federal
Insecticide. Fungicide, and Rodenticide Act;
sees. 105 and 108 of the Marine Protection.
Research, and Sanctuaries Act; and sees.
2002 and 3008 of the Solid Waste Disposal
Act
SOURCE 45 FR 24363, Apr. 9. 1980. unless
otherwise noted.
-------
Subparf AGeneral
9 22.01 Scope of these rules.
(a) These rules of practice govern all
adjudicator? proceedings for
9 22.02 Use of number and fender.
As used in these rules of practice,
words in the singular also include the
plural and words in the masculine
gender also include the feminine
vice versa, as the case may require.
(1) 1 assessment of any civil pen-
alty conducted tinder section 14(a) of
the Federal Insecticide, Fungicide and
Rodenticide Act as amended (7 UJS.C.
1361(a»;
(2) The assessment of any civil pen-
alty conducted under section 211 of
the Clean Air Act as amended (42
U.S.C. 7545);
(3) The assessment of any civil pen-
alty or for the revocation or suspen-
sion of any permit conducted under
section 105 (a) and (f) of the Marine
Protection, Research, and Sanctuaries
Act as amended (33 U.S.C. 1415(a)>;
(4) The issuance of a compliance
order or the assessment of any civil
penalty conducted under section 3008
of the Solid Waste Disposal Act as
amended (42 U.S.C. 6928);
(5) The assessment of any civil pen-
alty conducted under section 16(a) of
the Toxic Substances Control Act (15
U.S.C. 2615(a)).
(b) The Supplemental rules of prac-
tice set forth in Subpart H establish
rules governing those aspects of the
proceeding in question'which are not
covered in Subparts A through G, and
also specify procedures which super-
sede any conflicting procedures set
forth in those subparts.
(c) Questions arising at any stage of
the proceeding which are not ad-
dressed in these rules or in the rele-
vant supplementary procedures shall
be resolved at the discretion of the Ad-
ministrator, Regional Administrator,
or Presiding Officer, as appropriate.
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922.03 Definitions.
(a) The following definitions apply
to Part 22:
"Act" means the particular statute
authorizing the institution of the pro-
ceeding at issue.
"Administrative Law Judge" means
an Administrative Law Judge appoint-
ed under 5 U.S.C. 3105 (see also Pub.
L. 95-251. 92 Stat. 183).
"Administrator" means the Adminis-
trator of the United States Environ-
mental Protection Agency or his dele-
gate.
"Agency" means the United States
Environmental Protection Agency.
"Complainant" means any person
authorized to issue a complaint on
behalf of the Agency to persons al-
leged to be in violation of the Act. The
complainant shall not be the Judicial
Officer, Regional Judicial Officer, or
any other person who will participate
or advise in the decision.
"Complaint" means a written com-
munication, alleging one or more viola-
tions of specific provisions of the Act,
or regulations or a permit promulgat-
ed thereunder, issued by the complain-
ant to a person under fi{ 22.13 and
22.14.
"Consent Agreement" means any
written document, signed by the par-
ties, containing stipulations or conclu-
sions of fact or law and a proposed
penalty or proposed revocation or sus-
pension acceptable to both complain-
ant and respondent.
"Final Order" means (a) an order
issued by the Administrator after an
appeal of an initial decision, acceler-
ated decision, decision to dismiss, or
default order, disposing of a matter in
controversy between the parties, or (b)
an initial decision which becomes a
final order under § 22.27(c).
"Hearing" means a hearing on the
record open to the public and conduct-
ed under these rules of practice.
"Hearing Clerk" means the Hearing
Clerk. A-110, United States Environ-
mental Protection Agency, 401 M St.
SW.. Washington. DC 20460.
"Initial Decision" means the deci-
sion issued by the Presiding Officer
based upon the record of the proceed-
ings out of which it arises.
"Judicial Officer" means the person
designated by the Administrator
under § 22.04(b) to serve as the Judi-
cial Officer.
"Party" means any person that par-
ticipates in a hearing as complainant,
respondent, or intervenor.
"Permit" means a permit issued
under section 102 of the Marine Pro-
tection. Research, and Sanctuaries
Act.
"Person" includes any individual.
partnership, association, corporation.
and any trustee, assignee, receiver or
legal successor thereof; any organized
group of persons whether incorporat-
' ed or not; and any officer, employee,
agent, department, agency or instru-
mentality of the Federal Government.
of any State or local unit of govern-
ment, or of any foreign government.
"Presiding Officer" means the Ad-
ministrative Law Judge designated by
the Chief Administrative Law Judge to
serve as Presiding Officer, unless oth-
erwise specified by any Supplemental
Rules.
"Regional Administrator" means the
Administrator of any Regional Office
of the Agency or any officer or em-
ployee thereof to whom his authority
is duly delegated. Where the Regional
Administrator has authorized the Re-
gional Judicial Officer to act, the term
"Regional Administrator" shall in-
clude the Regional Judicial Officer. In
a case where the complainant is the
Assistant Administrator for Enforce-
ment or his delegate, the term "Re-
gional Administrator" as used in these
rules shall mean the Administrator.
"Regional Hearing Clerk" means an
individual duly authorized by the Re-
gional Administrator to serve as hear-
ing clerk for a given region. Corre-
spondence may be addressed to the
Regional Hearing Clerk, United States
Environmental Protection Agency (ad-
dress of Regional Officesee Appen-
dix). In a case where the complainant
is the Assistant Administrator for En-
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forcement or his delegate, the term
"Regional Hearing Clerk" as used in
these rules shall mean the Hearing
Clerk.
"Regional Judicial Officer" means a
person designated by the Regional Ad-
ministrator under 5 22.04(b) to serve as
a Regional Judicial Officer.
"Respondent" means any person
proceeded against in the complaint.
(b) Terms defined in the Act and not
defined in these rules of practice are
used consistent with the meanings
given in the Act.
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9 22.04 Powen and duties w. the Admlnis-
tntor, Regional Administrator, Judi-
cial Officer, Regional Judicial Officer,
and Presiding Officer; disqualification.
(a) Administrator and Regional Ad-
ministrator. The Administrator and
the Regional Administrator shall exer-
cise all powers and duties as prescribed
or delegated under the Act and these
rules of practice.
(b) Judicial Officer and Regional Ju-
dicial Officer(1) Office. One or more
Judicial Officers may be designated by
the Administrator to perform the
functions described below. One or
more Regional Judicial Officers may
be designated by the Regional Admin-
istrator to perform, within the region
of their designation, the functions de-
scribed below.
<2> Qualifications. A Judicial Officer
or a Regional Judicial Officer shall be
an attorney who Is a permanent or
temporary employee of the Agency or
some other Federal agency and who
may perform other duties within the
Agency. A Regional Judicial Officer
shall not be employed by the Region's
Enforcement Division or by the Re-
gional Division directly associated
with the type of violation at issue in
the proceeding. A Judicial Officer
shall not be employed by the Office of
Enforcement or by any program office
directly associated with the type of
violation at issue In the proceeding.
Neither the Judicial Officer nor the
Regional Judicial Officer shall have
performed prosecutorial or investiga-
tive functions in connection with any
hearing in which he serves as Judicial
Officer or any factually related hear-
ing.
(3) Functions. The Administrator
may delegate to the Judicial Officer,
or the Regional Administrator may
delegate to the Regional Judicial Offi-
cer, all or part of his authority to act
in a given proceeding. This delegation
does not prevent the Judicial Officer
or Regional Judicial Officer from re-
ferring any motion or case to the Ad-
ministrator or Regional Administrator
when appropriate. The Judicial Offi-
cer and Regional Judicial Officer shall
exercise all powers and duties pre-
scribed or delegated under the Act or
these rules of practice.
(c) Presiding Ojjicer. The Presiding
Officer shall conduct a fair and impar-
tial proceeding, assure that the facts
are fully elicited, adjudicate all issues,
and avoid delay. The Presiding Officer
shall have authority to:
(1) Conduct administrative hearings
under these rules of practice;
(2) Rule upon motions, requests, and
offers of proof, dispose of procedural
requests, and Issue all necessary
orders;
(3) Administer oaths and affirma-
tions and take affidavits;
(4) Examine witnesses and receive
documentary or other evidence;
(5) For good cause, upon motion or
sua sponte, order a party, or an officer
or agent thereof, to produce testimo-
ny, documents, or other nonprivileged
evidence, and failing the production
thereof without good cause being
shown, draw adverse inferences
against that party;
(6) Admit or exclude evidence;
(7) Hear and decide questions of
facts, law, or discretion;
(8) Require parties to attend confer-
ences for the settlement or simplifica-
tion of the issues, or the expedition of
the proceedings;
(9) Issue subpoenas authorized by
the Act; and
(10) Do all other acts and take all
measures necessary for the mainte-
nance of order and for the efficient,
fair and impartial adjudication of
issues arising in proceedings governed
by these rules.
(d) Disqualification; withdrawal. (1)
The Administrator. Regional Adminis-
trator, Judicial Officer. Regional Judi-
cial Officer or Presiding Officer may
not perform functions provided for in
these rules of practice regarding any
matter in which they (1) have a finan-
cial interest or (ii) have any relation-
ship with a party or with the subject
matter which would make it inappro-
priate for them to act. Any party may
at any time by motion made to the Re-
gional Administrator request that the
Regional Judicial Officer be disquali-
fied from the proceeding. Any party
may at any time by motion to the Ad-
ministrator request that the Regional
Administrator, Judicial Officer, or
Presiding Officer be disqualified or re-
quest that the Administrator disquali-
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fy himself from the proceeding. The
Administrator. Regional Administra-
tor, Judicial Officer. Regional Judicial
Officer or Presiding Officer may at
any time withdraw from any proceed-
ing in which they deem themselves
disqualified or unable to act for any
reason.
(2) If the Administrator, Regional
Administrator, Regional Judicial Offi-
cer, Judicial Officer, or Presiding Offi-
cer is disqualified or withdraws from
the proceeding, a qualified individual
who has none of the infirmities listed
in paragraph (d)(l) of this section
shall be assigned to replace him. As-
signment of a replacement for the Re-
gional Administrator or Judicial Offi-
cer, or for the Regional Judicial Offi-
cer shall be made by the Administra-
tor or the Regional Administrator, re-
spectively. The Administrator, should
he withdraw or disqualify himself,
shall assign the Regional Administra-
tor from the region where the case
originated to replace him. If that Re-
gional Administrator would himself be.
disqualified, the Administrator shall
assign a Regional Administrator from
another region to replace the Adminis-
trator. The Regional Administrator
shall assign a new Presiding Officer if
the original Presiding Officer was not
an Administrative Law Judge. The
Chief Administrative Law Judge shall
assign a new Presiding Officer from
among available Administrative Law
Judges if the original Presiding Offi-
cer was an Administrative Law Judge.
(3) The Chief Administrative Law
Judge, at any stage in the proceeding.
may .reassign the case to an Adminis-
trative Law Judge other than the one
originally assigned in the event of the
unavailability of the Administrative
Law Judge or where reassignment will
result in efficiency in the scheduling
of hearings and would not prejudice
the parties.
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§ 22.05 Filing, sei-rice, and form of plead-
ings and documents.
(a) Filing of pleadings and docu-
ments. (1) Except as otherwise provid-
ed, the original and one copy of the
complaint, and the original of the
answer and of all other documents
served in the proceeding shall be filed
with the Regional Hearing Clerk.
(2) A certificate of service shall ac-
company each document filed or
served. Except as otherwise provided,
a party filing documents with the Re-
gional Hearing Clerk, after the filing
of the answer, shall serve copies there-
of upon all other parties and the Pre-
siding Officer. The Presiding Officer
shall maintain a duplicate file during
the course of the proceeding.
(3) When the Presiding Officer cor-
responds directly with the parties, the
original of the correspondence shall be
sent to the Regional Hearing Clerk, a
copy shall be maintained by the Pre-
siding Officer in the duplicate file, and
a copy shall be sent to all parties. Par-
ties who correspond directly with the
Presiding Officer shall in addition to
serving all other parties send a copy of
all such correspondence to the Region-
al Hearing Clerk. A certificate of serv-
ice shall accompany each document
served under this subsection.
(b) Service of pleadings and docu-
ments<1) Service of complaint, (i)
Service of a copy of the signed original
of the complaint, together with a copy
of these rules of practice, may be
made personally or by certified mail,
return receipt requested, on the re-
spondent (or his representative).
(ii) Service upon a domestic or for-
eign corporation or upon a partner-
ship or other unincorporated associa-
tion which is subject to suit under a
common name shall be made by per-
sonal service or certified mail, as pre-
scribed by paragraph (b)(l)(i) of this
section, directed to an officer, partner.
* a managing or general agent, or to any
other person authorized by appoint-
ment or by Federal or State law to re-
ceive service of process.
(ill) Service upon an officer or
agency of the United States shall be
1 made by delivering a copy of the com-
plaint to the officer or agency, or in
any manner prescribed for service by
applicable regulations. If the agency is
a corporation, the complaint shall be
served as prescribed in paragraph
(bXIXii) of this section.
(iv) Service upon a State or local
unit of government, or a State or local
officer, agency, department, corpora-
tion or other instrumentality shall be
made by serving a copy of the com-
plaint in the manner prescribed by the
law of the State .or the service of
process on any such persons, on
(A) If upon a State or local unit of
government, or a State or local depart-
ment, agency, corporation or other In-
strumentality, by delivering a copy of
the complaint to the chief executive
officer thereof;
(B) If upon a State or local officer
by delivering a copy to such officer.
(v) Proof of service of the complaint
shall be made by affidavit of the
person making personal service, or by
properly executed return receipt. Such
proof of service shall be filed with the
xmplaint immediately upon comple-
;ion of service.
(2) Service of documents other than
complaint, rulings, orders, and deci-
sions. All documents other than the
complaint, rulings, orders, and deci-
sions, may be served personally or by
certified or first class mail.
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(c) Form of pleadings and docu-
ments. (1) Except as provided herein,
: or by order of the Presiding Officer or
Administrator, there are no specific re-
quirements as to the form of docu-
ments.
(2) The first page of every pleading.
letter, or other document shall contain
a caption identifying the respondent
and the docket number which is exhib-
ited on the complaint.
(3) The original of any pleading,
letter or other document (other than
exhibits) shall be signed by the party
filing or by his counsel or other repre-
sentative. The signature constitutes a
representation by the signer that he
has read the pleading, letter or other
document, that to the best of his
knowledge, information and belief, the
statements made therein are true, and
that it is not interposed for delay.
(4) The initial document filed by any
person shall contain his name, address
and telephone number. Any changes
in this information shall be communi-
cated promptly to the Regional Hear-
ing Clerk, Presiding Officer, and all
parties to the proceeding. A party who
fails to furnish such information and
any changes thereto shall be deemed
to have waived his right to notice and
service under these rules.
(5) The Administrator, Regional Ad-
ministrator. Presiding Officer, or Re-
gional Hearing Clerk may refuse to
file any uwcument which does not
comply with this paragraph. Written
notice of such refusal, stating the rea-
sons therefor, shall be promptly given
to the person submitting the docu-
ment. Such person may amend and re-
submit any document refused for
filing upon motion granted by the Ad-
ministrator, Regional Administrator,
or Presiding Officer, as appropriate.
622.06 Filing and ferric* of rulings,
order*, and decisions.
All rulings, orders, decisions.
other documents issued by the Regioi
al Administrator, Regional Judlc
Officer, or Presiding Officer, as appro-
priate, shall be filed with the Regional
Hearing Clerk. All such documents
Issued by the Administrator or Judi-
cial Officer shall be filed with the
Hearing Clerk. Copies of such rulings,
orders, decisions, or other documents
shall be served personally, or by certi-
fied mail, return receipt requested.
upon all parties by the Administrator.
Regional Administrator, Judicial Offi-
cer. Regional Judicial Officer, or Pre-
siding Officer, as appropriate.
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922.07 Computation and extension of
time.
(a) Computation. In computing any
period of time prescribed or allowed in
these rules of practice, except as oth-
erwise provided, the day of the event
from which the designated -period
begins to run shall not be included.
Saturdays, Sundays, and Federal legal
holidays shall be included. When *
stated time expires on a Saturday,
Sunday or legal holiday, the stated
time period shall be extended to in-
clude the next business day.
(b) Extensions of time. The Adminis-
trator, Regional Administrator, or Pre-
siding Officer, as appropriate, may
grant an extension of time for the
filing of any pleading, document, or
motion (1) upon timely motion of a
party to the proceeding, for good
cause shown, and after consideration
of prejudice to other parties, or (2)
upon his own motion. Such a motion
by a party may only be made after
notice to all other parties, unless the
movant can show good cause why serv-
ing notice is impracticable. The
motion shall be filed in advance of the
date on which the pleading, document
or motion is due to be filed, unless the
failure of a party to make timely
motion for extension of time was the
result of excusable neglect
(c) Service by mail Service of the
complaint is complete when the return
receipt is signed. Service of all other
pleadings and documents is complete
upon mailing. Where a pleading or
document is served by mail, five (5)
days shall be added to the time al-
lowed by these rules for the filing of a
responsive pleading or document.
6 22.08 Ex part* discussion of proceeding.
At no time after the issuance of the
complaint shall the Administrator, Re-
gional Administrator, Judicial Officer,
Regional Judicial Officer, Presiding
Officer, or any other person who is
likely to advise these officials in the
i decision on the case, discuss ex parte
the merits of the proceeding with any
interested person outside the Agency,
with any Agency staff member who
performs a prosecutorial or investiga-
tive function in such proceeding or a
factually related proceeding, or with
any representative of such person.
Any ex parte memorandum or other
communication addressed to the Ad-
ministrator, Regional Administrator.
Judicial Officer. Regional Judicial Of-
ficer, or the Presiding Officer during
the pendency of the proceeding and
relating to the merits thereof, by or on
behalf of any party shall be regarded
as argument made in the proceeding
and shall be served upon all other par-
ties. The other parties shall be given
an opportunity to reply to such memo-
randum or communication.
1 6 22.09 Examination of documents filed.
i
(a) Subject to the provisions of law
restricting the public disclosure of
confidential information, any person
may, during Agency business hours,
inspect and copy any document filed
in any proceeding. Such documents
shall be made available by the Region-
al Hearing Clerk or Hearing Clerk, as
appropriate.
(b) The cost of duplicating docu-
ments filed in any proceeding shall be
borne by the person seeking copies of
such documents, xue Agency may
waive this cost in appropriate cases.
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Subpart BParties and Appearances
6 22.10 Appearances.
Any party may appear in person or
by counsel or other representative. A
partner may appear on behalf of a
partnership and an officer may appear
on behalf of a corporation. Persons
who appear as counsel or other repre-
sentative must conform to the stand-
ards of conduct and ethics required of
practitioners before the courts of the
United States.
9 22.11 Intervention.
(a) Motion. A motion for leave to in-
tervene in any proceeding conducted
under these rules of practice must set
forth the grounds for the proposed
intervention, the position and interest
of the movant and the likely impact
that intervention will have on the ex-
peditious progress of the proceeding.
Any person already a party to the pro-
ceeding may file an answer to a
motion to intervene, making specific
reference to the factors set forth in
the foregoing sentence and paragraph
(c) of this section, within ten (10) days
after service of the motion for leave to
intervene.
(b) When filed. A motion for leave to
intervene in a proceeding must ordi-
narily be filed before the first prehear-
ing conference or. in the absence of a
prehearing conference, before the ini-
tiation of correspondence under
S 22.19(e), or If there is no such corre-
spondence, prior to the setting of a
time and place for a hearing. Any
motion filed after that time must in-
clude, in addition to the information
set forth in paragraph (a) of this sec-
tion, a statement of good cause for the
failure to file in a timely manner. The
intervenor shall be bound by any
agreements, arrangements and other
matters previously made in the pro-
ceeding.
(c) Disposition. Leave to intervene
may be granted only if the movant
demonstrates that (1) his presence in
the proceeding would not unduly pro-
long or otherwise prejudice the adjudi-
cation of the rights of the original par-
ties; (2) the movant will be adversely
affected by a final order, and (3) the
interests of the movant are not being
adequately represented by the original
parties. The intervenor shall become a
full party to the proceeding upon the
granting of leave to intervene.
(d) Amicus curiae. Persons not par-
ties to the proceeding who wish to file
briefs may so move. The motion shall
identify the interest of the applicant
and shall state the reasons why the
proposed amicus brief is desirable. If
the motion is granted, the Presiding
Officer or Administrator shall issue an
order setting the time for filing such
brief. An amicus curiae is eligible to
participate in any briefing after his
motion is granted, and shall be served
with all briefs, reply briefs, motions,
and orders relating to issues to be
briefed.
fi 22.12 Consolidation and severance.
(a) Consolidation. The Presiding Of-
ficer may, by motion or sua sponte,
consolidate any or. all matters at issue
in two or more proceedings docketed
under these rules of practice where (1)
there exists common parties or
common questions of fact or law. (2)
consolidation would expedite and sim-
plify consideration of the issues, and
(3) consolidation would not adversely
affect the rights of parties engaged in
otherwise separate proceedings.
(b) Severance. The Presiding Officer
may, by motion or sua sponte, for good
cause shown order any proceedings
severed with respect to any or all par-
ties or issues.
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Subport CPrehearing Procedures
8 22.13 Issuance of complaint
If the complainant has reason to be-
lieve that a person has violated any
provision of the Act, or regulations
promulgated or a permit Issued under
the Act. he may Institute a proceeding
for the assessment of a civil penalty by
Issuing a complaint under the Act and
these rules of practice. If the com-
plainant has reason to believe that
(a) A permittee violated any term or
condition of the permit, or
(b) A permittee misrepresented or
Inaccurately described any material
fact in the permit application or failed
to disclose all relevant facts in the
permit application, or
(c) Other good cause exists for such
action, he may Institute a proceeding
for the revocation or suspension of a
permit by issuing a complaint under
the Act and these rules of practice. A
complaint may be for the suspension
or revocation of a permit in addition
to the assessment of a civil penalty.
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922.14 Content and amendment of the
complaint.
(a) Complaint for the assessment of
a civil penalty. Each complaint for the
assessment of a civil penalty shall In-
clude:
(1) A statement reciting the
section(s) of the Act authorizing the
issuance of the complaint;
(2) Specific reference to each provi-
sion of the Act and implementing reg-
ulations which respondent is alleged
to have violated;
(3) A concise statement of the factu-
al basis for alleging the violation;
(4) The amount of the civil penalty
which is proposed to be assessed;
(5) A statement explaining the rea-
soning behind the proposed penalty;
(6) Notice of respondent's right to
request a hearing on any material fact
contained in the complaint, or on the
appropriateness of the amount of the
proposed penalty.
A copy of these rules of practice shall
accompany each complaint served.
(b) Complaint for the revocation or
suspension of a permit Each com-
plaint for the revocation or suspension
of a permit shall include:
(1) A statement reciting the
section(s) of the Act, regulations, and/
or permit authorizing the issuance of
the complaint;
(2) Specific reference to each term
or condition of the permit which the
respondent is alleged to have violated,
to each alleged inaccuracy or misrep-
resentation in respondent's permit ap-
plication, to each fact which the re-
spondent allegedly failed to disclose in
his permit application, or to other rea-
sons which form the basis for the com-
plaint;
(3) A concise statement of the factu-
al basis for such allegations;
(4) A request for an order to either
revoke or suspend the permit and a
statement of the terms and conditions
of any proposed partial suspension or
revocation;
j (5) A statement indicating the basis
! for recommending the revocation,
i rather than the suspension, of the
permit, or vice versa, as the case may
be;
(6) Notice of the respondent's right
, to request a hearing on any material
I fact contained in the complaint, or on
j the appropriateness of the proposed
I revocation or suspension.
A copy of these rules of practice shall
accomoany each complaint served.
(c) Derivation of proposed civil pen-
alty. The dollar amount of the pro-
posed civil penalty shall be determined
in accordance with any criteria set
forth in the Act relating to the proper
amount of a civil penalty and with any
civil penalty guidelines issued under
the Act.
(d) Amendment of the complaint.
The complainant may amend the com-
plaint once as a matter of right at any
time before the answer is filed. Other-
wise the complainant may amend the
complaint only upon motion granted
by the Presiding Officer or Regional
Administrator, as appropriate. Re-
spondent shall have twenty (20) addi-
tional days from the date of service of
the amended complaint to file his
answer.
(e) Withdrawal of the complaint
The complainant may withdraw the
complaint, or any part thereof, with-
out prejudice one time before the
answer has been filed. After one with-
drawal before the filing of an answer.
or after the filing of an answer, the
complainant may withdraw the com-
plaint, or any part thereof, without
prejudice, only upon motion granted
by the Presiding Officer or Regional
Administrator, as appropriate.
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8 22.15 Answer to the complaint '
(a) General Where respondent (1)
contests any material fact upon which
the complaint is based; (2) contends
that the amount of the penalty pro-
posed in'the complaint or the pro-
posed revocation or suspension, as the
case may be, is inappropriate; or (3)
contends that he is entitled to judg-
ment as a matter of law, he shall file a
written answer to the complaint with
the Regional Hearing Clerk. Any such
answer to the complaint must be filed
with the Regional Hearing Clerk
within twenty (20) days after service
of the complaint.
(b) Contents of the answer. The
answer shall clearly and directly
admit, deny or explain each of the fac-
tual allegations contained in the com-
plaint with regard to which respond-
ent has any knowledge. Where re-
spondent has no knowledge of a par-
ticular factual allegation and so states,
the allegation is deemed denied. The
answer shall also state (1) the circum-
stances or arguments which are al-
leged to constitute the grounds of de-
fense, (2) the facts which respondent
intends to place at issue, and (3)
whether a hearing is requested.
(c) Request for hearing. A hearing
upon the issues raised by the com-
plaint and answer shall be held upon
request of respondent in the answer.
In addition, a hearing may be held at
the discretion of the Presiding Officer,
sua sponte, if issues appropriate for
adjudication are raised in the answer.
(d) Failure to admit, deny, or ex-
p\ain. ^'allure of respondent to admit'.'
deny, or explain any material factual
allegation contained in the complaint
constitutes an admission of the allega-
tion.
(e) Amendment of the answer. The
respondent may amend the answer to
the complaint upon motion granted by
the Presiding Officer.
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§22.16 Motions.
(a) General All motions, except
those made orally on the record
during a hearing, shall (1) be in writ-
ing; (2) state the grounds therefor
with particularity; (3) set forth the
relief or order sought; and (4) be ac-
companied by any affidavit, certifi-
cate, other evidence, or legal memo-
randum relied upon. Such motions
shall be served as provided by
§ 22.05(b)(2).
(b) Response to motions. A party's
esponse to any written motion must
>e filed within ten (10) days after serv-
ce of such motion, unless additional
,ime is allowed for such response. The
response shall be accompanied by any
affidavit, certificate, other evidence, or
legal memorandum relied upon. If no
response is filed within the designated
period, the parties may be deemed to
have waived any objection to the
granting of the motion. The Presiding
Officer. Regional Administrator, or
Administrator, as appropriate, may set
a shorter time for response, or make
such other orders concerning the dis-
position of motions as they deem ap-
propriate.
(c) Decision. Except as provided in
522.04(d)U) and § 22.28(a), the Re-
gional Administrator shall rule on all
motions filed or made before an
answer to the complaint is filed. The
Administrator shall rule on all mo-
tions filed or made after service of the
initial decision upon the parties. The
Presiding Officer shall rule on all
other motions. Oral argument on mo-
tions will be permitted where the Pre-
siding Officer, Regional Administra-
tor, or the Administrator considers it
necessary or desirable.
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922.17 Default order.
(a) Default. A party may be found to
be In default (1) after motion, upon
failure to file a timely answer to the
complaint; (2) after motion or sua
sponte, upon failure to comply with a
prehearing or hearing order of the
Presiding Officer, or (3). after motion
or sua sponte, upon failure to appear
at a conference or hearing without
good cause being shown. No finding of
default on the basis of a failure to
appear at a hearing shall be made
against the respondent unless the
complainant presents sufficient evi-
dence to the Presiding Officer to es-
tablish a prima facie case against the
respondent. Any motion for a default
order shall include a proposed default
order and shall be served upon all par-
ties. The alleged defaulting party shall
have twenty (20) days from service to
reply to the motion. Default by re-
spondent constitutes, for purposes of
the pending action only, an admission
of all facts alleged in the complaint
and a waiver of respondent's right to a
hearing on such factual allegations. If
the complaint is for the assessment of
a civil penalty, the penalty proposed
in the complaint shall become due and
payable by respondent without fur-
ther proceedings sixty (60) days after
a final order issued upon default. If
the complaint is for the revocation or
suspension of a permit, the conditions
of revocation or suspension proposed
in the complaint shall become effec-
tive without further proceedings on
the date designated by the Adminis-
trator in his final order issued upon
default. Default by the complainant
shall result in the dismissal of the
complaint with prejudice.
(c) Contents of a default order. A de-
fault order shall include findings of
fact showing the grounds for the
order, conclusions regarding all mate-
rial issues of law or discretion, and the
penalty which is recommended to be
assessed or the terms and conditions
of permit revocation or suspension, as
appropriate.
(d) For good cause shown the Re*
gional Administrator or the Presiding
Officer, as appropriate, may set aside
a default order.
(b) Procedures upon default. When
Regional Administrator or Presiding
Officer finds a default has occurred.
he shall issue a default order against
the defaulting party. This order shall
constitute the initial decision, and
shall be filed with the Regional Hear-
ing Clerk.
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922.18 Informal settlement; consent
agreement and order.
(a) Settlement policy. The Agency
encourages settlement of a proceeding
at any time If the settlement is con-
sistent with the provisions and objec-
tives of the Act and applicable regula-
tions. The respondent may confer with
complainant concerning settlement
whether or not the respondent re-
quests a hearing. Settlement confer-
ences shall not affect the respondent's
obligation to file a timely answer
under $ 22.16.
(b) Consent agreement. The parties
shall forward a written consent agree-
ment and a proposed consent order to
the Regional Administrator whenever
settlement or compromise Is proposed.
The consent agreement shall state
that, for the purpose of this proceed-
ing, respondent (1) admits the Jurisdic-
tional allegations of the complaint; (2)
admits the facts stipulated in the con-
sent agreement or neither admits nor
denies specific factual allegations con-
tained in the complaint; and (3) con-
sents to the assessment of a stated
civil penalty or to the stated permit
revocation or suspension, as the case
may be. The consent agreement shall
include any and all terms of the agree-
ment, and shall be signed by all par-
ties or their counsel or representa-
tives.
(c) Consent order. No settlement or
consent agreement shall dispose of
any proceeding under these rules of
practice without a consent order from
the Regional Administrator. In pre-
paring such an order, the Regional Ad-
ministrator may require that the par-
ties to the settlement appear before
him to answer Inquiries relating to the
consent agreement or order.
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6 22.19 Prehearinf conference.
(a) Purpose of prehearing conference.
Unless a conference appears unneces-
sary, the Presiding Officer, at any
time before the hearing begins, shall
direct the parties and their counsel or
other representatives to appear at a
conference before him to consider
(1) The settlement of the case;
(2) The simplification of issues and
stipulation of facts not in dispute;
(3) The necessity or desirability of
amendments to pleadings;
(4) The exchange of exhibits, docu-
ments, prepared testimony, and admis-
sions or stipulations of fact which will
avoid unnecessary proof;
(5) The limitation of the number of
expert or other witnesses;
(6) Setting a time and place for. the
hearing; and
(7) Any other matters which may ex-
pedite the disposition of the proceed-
ing.
(b) Exchange of witness lists and
documents. Unless otherwise ordered
by the Presiding Officer, each party at
the prehearing conference shall make ,
available to all other parties (1) the
names of the expert and other wit-
nesses he intends to call, together with
a brief narrative summary of their ex-
pected testimony, and (2) copies of all
documents and exhibits which each
party intends to introduce into evi-
dence. Documents and exhibits shall
be marked for identification as or-
dered by the Presiding Officer. Docu-
ments that have not been exchanged
and witnesses whose names have not
been exchanged shall not be intro-
duced into evidence or allowed to testi-
fy without permission of the Presiding
Officer. The Presiding Officer shall
allow the parties reasonable opportu-
nity to review new evidence.
(c) Record of the prehearing confer-
ence. No transcript of a prehearing
conference relating to settlement shall
be made. With respect to other pre-
hearing conferences, no transcript of
any prehearing conferences shall be
made unless ordered by the Presiding
Officer upon motion of a party or sua
sponte. The Presiding Officer shall
prepare and file for the record a writ-
ten summary of the action taken at
the conference. The summary shall in-
corporate any written stipulations or
agreements of the parties and all rul-
ings and appropriate orders containing
directions to the parties.
(d) Location of prehearing confer-
ence. The prehearing conference shall
be held in the county where the re-
spondent resides or conducts the busi-
ness which the hearing concerns, in
the city in which the relevant Envi-
ronmental Protection Agency Region-
al Office is located, or in Washington,
D.C., unless (1) the Presiding Officer
determines that there is good cause to
hold it at another location in a region
or by telephone, or (2) the Supplemen-
tal rules of practice provide otherwise.
(e) Unavailability of a prehearing
conference. If a prehearing conference
is unnecessary or impracticable, the
Presiding Officer, on motion or sua
sponte, may direct the parties to corre-
spond with him to accomplish any of
the objectives set forth in this section.
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(f) Other discovery. (1) Except as
provided by paragraph (b) of this sec-
tion, further discovery, under this sec-
tion, shall be permitted only upon de-
termination by the Presiding Officer
(i) That such discovery will not in
any way unreasonably delay the pro-
ceeding;
(ii) That the information to be ob-
tained is not otherwise obtainable; and
(iii) That such information has sig-
nificant probative value.
(2) The Presiding Officer shall order
depositions upon oral questions only
upon a showing of good cause and
upon a finding that:
(1) The information sought cannot
be obtained by alternative methods; or
(ii) There Is a substantial reason to
believe that relevant and probative
evidence may otherwise not be pre-
served for presentation by a witness at
the hearing.
(3) Any party to the proceeding de-
siring an order of discovery shall make
a motion therefor. Such a motion shall
set forth;
(1) The circumstances warranting
the taking of the discovery;
(ii) The nature of the information
expected to be discovered; and
(ill) The proposed time and place
where it will be taken. If the Presiding
Officer determines that the motion
should be granted, he shall issue .an
order for the taking of such discovery
together with the conditions and
terms thereof.
(4) When the information sought to
be obtained is within the control of
one of the parties, failure to comply
with an order issued pursuant to this
paragraph may lead .to (i) the infer-
ence that the information to be discov-
ered would be adverse to the party
from whom the information was
sought, or (ii) the issuance of a default
order under I 22.17(a).
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82Z20 Accelerated decision; decision to.
dismiss.
(a) General The Presiding Officer.
upon motion of any party or sua
sponte, may at any time render an ac-
celerated decision in favor of the com-
plainant or the respondent as to all or
any part of the proceeding, without
further hearing or upon such limited
additional evidence, such as affidavits.
as he may require, if no genuine issue
of material fact exists and a party is
entitled to judgment as a matter of
law, as to all or any part of the pro-
ceeding. In addition, the Presiding Of-
ficer, upon motion of the respondent,
may at any time dismiss an action
without further hearing or upon such
limited additional evidence as he re-
quires, on the basis of failure to estab-
lish a prima fade case or other
grounds which show no right to relief
on the part of the complainant
(b) Effect. (1) If an accelerated deci-
sion or a decision to dismiss is issued
as to all the issues and claims in the
proceeding, the decision constitutes an
initial decision of the Presiding Offi-
cer, and shall be filed with the Region-.
al Hearing Clerk.
(2) If an accelerated decision or a de-
cision to dismiss is rendered on less
than all issues or claims in the pro-
ceeding, the Presiding Officer shall de-
termine, what material facts exist
without substantial controversy and
what material facts remain controvert-
ed in good faith. He shall thereupon
issue an interlocutory order specifying
the facts which appear substantially
uncontroverted, and the issues and
claims upon which the hearing wfll
proceed.
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Subpart DHtaring Procedure
§ 22.21 Scheduling the hearing.
(a) When an answer is filed, the Re-
gional Hearing Clerk shall forward the
complaint, the answer, and any other
documents filed thus far in the pro-
ceeding to the Chief Administrative
Law Judge who shall assign himself or
another Administrative Law Judge as
Presiding Officer, unless otherwise
provided In the Supplemental rules of
practice. The Presiding Officer shall
then obtain the case file from the
Chief Administrative Law Judge and
notify the parties of his assignment.
(b) Notice of hearing. If the respond-
ent requests a hearing in his answer,
or one is ordered by the Presiding Of-
ficer under 522.15(c), the Presiding
Officer shall serve upon the parties a
notice of hearing setting forth a time
and place for the hearing. The Presid-
ing Officer may issue the notice of
hearing at any appropriate time, but
not later than twenty (20) days prior
to the date set for the hearing.
(c) Postponement of hearing. No re-
quest for postponement of a hearing
shall be granted except upon motion.
and for good cause shown.
(d) Location of the hearing. The lo-
cation of the hearing shall be deter-
mined in accordance with the method
for determining the location ox a pre-
hearing conference under i 22.19(a).
§22.22 Eridence.
(a) General The Presiding Officer
shall admit all evidence which is not
irrelevant, immatertalTunduly repeti-
tious, or otherwise unreliable or of
little probative value, except that evi-
dence relating to settlement which
would be excluded in the federal
courts under Rule 408 of the Federal
Rules of Evidence is not admissible. In
the presentation, admission, disposi-
tion, and use of evidence, the Presid-
ing Officer shall preserve the confi-
dentiality of trade secrets and other
commercial and financial information.
The confidential or trade secret status
of any information shall not, however,
preclude its being introduced into evi-
dence. The Presiding Officer may
make such orders as may be necessary
to consider such evidence in camera,
including the preparation of a supple-
mental initial decision to address ques-
tions of law, fact, or discretion which
arise out of that portion of the evi-
dence which is confidential or which
includes trade secrets.
(b) Examination of witnesses. Wit-
nesses shall be examined orally, under
oath or affirmation, except as other-
wise provided in these rules of practice
or by the Presiding Officer. Parties
shall have the right to cross-examine a
witness who appears at the hearing
provided that such cross-examination
is not unduly repetitious.
(c) Verified statements. The Presid-
ing Officer may admit an insert into
the record as evidence, in lieu of oral
testimony, statements of fact or opin-
ion prepared by a witness.'The admis-
sibility of the evidence contained in
the statement shall be subject to the
same rules as if the testimony were
produced under oral examination.
Before any such statement is read or
admitted into evidence, the witness
shall deliver a copy of the statement
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to the Presiding Oflicer, the reporter,
and opposing counsel. The witness pre-
senting the statement shall swear to
or affirm the statement and shall be
subject to appropriate oral cross-exam-
ination upon the contents thereof.
(d) Admission of affidavits where the
witness is unavailable. The Presiding
Officer may admit into evidence affi-
davits of witnesses who are unavail-
able. The term "unavailable" shall
have the meaning accorded to it by
Rule 804(a) of the Federal Rules of
Evidence.
(e) Exhibits. Where practicable, an
original and one copy of each exhibit
shall be filed with the Presiding Ofli-
cer for the record and a copy shall be
furnished to each party. A true copy
of any exhibit may be substituted for
the original.
(f) Official notice. Official notice
may be taken of any matter judicially
noticed in the Federal courts and of
other facts within the specialized
knowledge and experience of the
Agency. Opposing parties shall be
given adequate opportunity to show
that such facts are erroneously no-
ticed.
proof for excluded oral testimony
shall consist of a brief statement de-
scribing the nature of the evidence ex-
cluded. The offer of proof for ex-
cluded documents or exhibits shall
consist of the insertion in the record
of the documents or exhibits excluded.
Where the Administrator decides that
the ruling of the Presiding Officer in
excluding the evidence was both erro-
neous and prejudicial, the hearing
may be reopened to permit the taking
of such evidence.
9 22.23 Objections and offers of proof.
(a) Objection. Any objection con-
cerning the conduct of the hearing
may be stated orally or in writing
during the hearing. The party raising
the objection must supply a short
statement of its grounds. The ruling
by the Presiding Officer on any objec-
tion and the reasons given for it shall
be part of the record. An exception to
each objection overruled shall be auto-
matic and is not waived by further
participation in the hearing.
(b) Offer of proof. Whenever evi-
dence is excluded from the record, the
party offering the evidence may make
an offer of proof, which shall be in-
cluded in the record. The offer of
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0 22.24 Burden of presentation; burden of
persuasion.
The complainant has the burden of
going forward with and of proving
that the violation occurred as set forth
in the complaint and that the pro-
posed civil penalty, revocation, or sus-
pension, as the case may be, is appro-
priate. Following the establishment of
a prima facie case, respondent shall
have the burden of presenting and of
going forward with any defense to the.
allegations set forth in the complaint
Each matter of controversy shall be
determined by the Presiding Officer
upon a preponderance of the evidence.
922.25 Filing the transcript
The hearing shall be transcribed ver-
batim. Promptly following the taking
of the last evidence, the reporter shall
transmit to the Regional Hearing
Clerk the original and as many copies
of the transcript of testimony as are
called for In the reporter's contract
with the Agency, and also shall trans-
mit to the Presiding Officer a copy of
the transcript. A certificate of service
shall accompany each copy of the
transcript The Regional Hearing
Clerk shall notify all parties of the
availability of the transcript and shall
furnish the parties with a copy of the
transcript upon payment of the cost of
reproduction, unless a party can show
that the cost is unduly burdensome.
Any person not a party to the proceed-
ing may receive a copy of the tran-
script upon payment of the reproduc-
tion fee. except for those parts of the
transcript order to be kept confiden-
tial by the Presiding Officer.
922.26 Proposed
and order.
findings, conclusions,
Within twenty (20) days after the
parties are notified of the availability
of the transcript, or within such
longer time as may be fixed by the
Presiding Officer, any party may
submit for the consideration of the
Presiding Officer, proposed findings of
fact, conclusions of law, and a pro-
posed order, together with briefs in
support thereof. The Presiding Officer
shall set a time by which reply briefs
must be submitted. All submissions
shall be in writing, shall be served
upon all parties, and shall contain ade-
quate references to the record and au-
thorities relied on.
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Subport EInitial Decision and
Motion To Roopon a Hearing
922.27 IniUal decision.
(a) Filing and contents. The Presid-
ing Officer shall issue and file with
the Regional Hearing Clerk his initial
decision as soon as practicable after
the period for filing reply briefs under
§ 22.26 has expired. The Presiding Of-
ficer shall retain a copy of the com-
plaint in the duplicate file. The initial
decision shall contain his findings of
fact, conclusions regarding all material
issues of law or discretion, as well as
reasons therefor, a recommended dvfl
penalty assessment, if appropriate,
and a proposed final order. Upon re-
ceipt of an initial decision, the Region-
al Hearing Clerk shall forward a copy
to all parties, and shall send the origi-
nal, along with the record of the pro-
ceeding, to the Hearing Clerk. The
Hearing Clerk shall forward a copy of
the initial decision to the Administra-
tor.
(c) Effect of initial decision. The ini-
tial decision of the Presiding Officer
shall become the final order of the Ad-
ministrator within forty-five (45) days
after its service upon the parties and
without further proceedings unless (1)
an appeal to the Administrator is
taken from it by a party to the pro-
ceedings, or (2) the Administrator
elects, sua sponte, to review the initial
decision.
(b) Amount of civil penalty. If the
Presiding Officer determines that a
violation has occurred, the Presiding
Officer shall determine the dollar
amount of the recommended civil pen-
alty to be assessed in the initial deci-
sion in accordance with any criteria
set forth in the Act relating to the
proper amount of a civil penalty, and
must consider any civil penalty guide-
lines Issued under the Act. If the Pre-
siding Officer decides to assess a pen-
alty different in amount from the pen--
alty recommended to be assessed in
the complaint, the Presiding Officer
shall set forth in the initial decision
the specific reasons for the increase or
decrease. The Presiding Officer shall
not raise a penalty from that recom-
mended to be assessed in the com-
plaint if the respondent has defaulted.
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0 22J8 Motion to reopen a hearing.
(a) Filing and content A motion to
reopen a hearing to take further evi-
dence must be made no later than
twenty (20) days after service of the
initial decision on the parties and shall
(1) state the specific grounds upon
which relief is sought, (2) state briefly
the nature and purpose of the evi-
dence to be adduced, (3) show that
such evidence is not cumulative, and
(4) show good cause why such evi-
dence was not adduced at the hearing.
The motion shall be made to the Pre-
siding Officer and filed with the Re-
gional Hearing Clerk.
(b) Disposition of motion to reopen
a hearing. Within ten (10) days follow-
ing the service of a motion to reopen a
hearing, any other party to the pro-
ceeding may file with the Regional
Hearing Clerk and serve on all other
parties an answer thereto. The Presid-
ing Officer shall announce his intent
to grant or deny such motion as soon
as practicable thereafter. The conduct
of any proceeding which may be re-
quired as a result of the granting of
any motion allowed in this section
shall be governed by the provisions of
the applicable sections of these rules.
The filing of a motion to reopen a
hearing shall automatically stay the
running of all time periods specified
under these Rules until such time as
the motion is denied or the reopened
hearing is concluded.
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Subport FAppeals and
Administrative Review
6 22.29 Appeal from or review of interloc-
utory orders or rulings.
(a) Request for interlocutory appeal
Except as provided in this section, ap-
peals to the Administrator shall obtain
as a matter of right only from a de-
fault order, an accelerated decision or
decision to dismiss issued ' under
ft 22.20(b)(l), or an initial decision ren-
dered after an evidentiary hearing.
Appeals from other orders or rulings
shall lie only if the Presiding Officer
or Regional Administrator, as appro-
priate, upon motion of a party, certi-
fies such orders or rulings to the Ad-
ministrator on appeal Requests for
such certification shall be filed in writ-
ing within six (6) days of notice of the
ruling or service of the order, and
shall state briefly the grounds to be
relied upon on appeal.
(b) Availability of interlocutory
appeal The Presiding Officer may cer-
tify any ruling for appeal to the Ad-.
ministrator when (1) the order or
ruling involves an important question
of law or policy concerning which
there is substantial grounds for differ-
ence of opinion, and (2) either (i) an
immediate appeal from the order or
ruling will materially advance the ulti-
mate termination of the proceeding, or
(11) review after the final order is
issued will be inadequate or ineffec-
tive.
(c) Decision. If the Administrator
determines that certification was im-
providently granted, or if he takes no
action within thirty (30) days of the
certification, the appeal is dismissed.
When the Presiding Officer declines
to certify an order or ruling to the Ad-
ministrator on interlocutory appeal, it
may be reviewed by the Administrator
only upon appeal from the initial deci-
sion, except when the Administrator
determines, upon motion of a party
and in exceptional circumstances, that
to delay review would be contrary to
the public interest. Such motion shall
be made within six (6) days of service
of an order of the Presiding Officer re-
fusing to certify a ruling for interlocu-
tory appeal to the Administrator. Or-
dinarily, the interlocutory appeal will
be decided on the basis of the submis-
sions made by the Presiding Officer.
The Administrator may, however.
allow further briefs and oral argu-
ment.
(d) Stay of proceedings. The Presid-
ing Officer may stay the proceedings
pending a decision by the Administra-
tor upon an order or ruling certified
by the Presiding Officer for an inter-
locutory appeal. Proceedings will not
be stayed except in extraordinary cir-
cumstances. Where the Presiding Offi-
cer grants a stay of more than thirty
(30) days, such stay must be separate-
ly approved by the Administrator.
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B22JO Appeal from or rerlew of initial
decision.
(a) Notice of appeal (1) Any party
may appeal any adverse ruling or
order of the Presiding Officer by filing
a notice of appeal and an accompany-
ing appeUate brief with the Hearing
Clerk and upon all other parties and
amicus curiae within twenty (20) days
after the initial decision is served upon
the parties. The notice of appeal shall
set forth alternative findings of fact,
alternative conclusions regarding
issues of law or discretion, and a pro-
posed order together with relevant ref-
erences to the record and the initial
decision. The appellant's brief shall
contain a statement of the issues pre-
sented for review, a statement of the
nature of the case and the facts rele-
vant to the issues presented for
review, argument on the issues pre-
sented, and a short conclusion stating
the precise relief sought, together
with appropriate references to the
record.
(2) Within fifteen (15) days of the
service of notices of appeal and briefs
under paragraph (a)(l) of this section,
any other party or amicus curiae may
file and serve with the Hearing Clerk a
reply brief responding to argument
raised by the appellant, together with
references to the relevant portions of
the record, initial decision, or opposing
brief. Reply briefs shall be limited to
the scope of the appeal brief. Further
briefs shall be filed only with the per-
mission of the Administrator.
(b) Sua sponte review by the Admin-
istrator. Whenever-the Administrator
determines sua sponte to review an ini-
tial decision, the Hearing Clerk shall
serve notice of such intention on the
parties within forty-five (45) days
after the initial decision is served upon
the parties. The notice shall include a
statement of issues to be briefed by
the parties and a time schedule for the
service and filing of briefs.
(c) Scope of appeal or review. The
appeal of the initial decision shall be
limited to those issues raised by the
parties during the course of the pro-
ceeding. If the Administrator deter-
mines that issues raised, but not ap-
pealed by the parties, should be
argued, he shall give counsel for the
parties reasonable written notice of
such determination to permit prepara-
tion of adequate argument. Nothing
herein shall prohibit the Administra-
tor from remanding the case to the
Presiding Officer for further proceed-
ings.
(d) Argument before the Administra*
tor. The Administrator may. upon re-
quest of a party or sua sponte, assign a
time and place for oral argument after
giving consideration to the conven-
ience of the parties.
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Subport GFinal Order en Appeal
0 22J1 Final order on appeal.
(a) Contents of the final order. When
an appeal has been taken or the Ad-
ministrator issues a notice of intent to
conduct review sua sponte, the Admin-
Istrator shall issue a final order as
soon as practicable after the filing of
all appellate briefs or oral argument,
whichever is later. The Administrator
shall adopt, modify or set aside the
findings and conclusions contained in
the decision or order being reviewed,
and shall set forth in the final order
the reasons for his actions. The Ad-
ministrator may, in his discretion, in-
crease or decrease the assessed penalty
from the amount recommended to be
assessed in the decision or order being
reviewed, except that if the order
being reviewed is a default order, the
Administrator may not increase the
amount of the penalty.
(b) Payment of a civil penalty. The
respondent shall pay the full amount
of the civil penalty assessed in the
final order within sixty (60) days after
receipt of the final order unless other-
wise agreed by the parties. Payment
shall be made by forwarding to the
Regional Hearing Clerk a cashier's
check or certified check in the amount
of the penalty assessed in the final
order, payable to the Treasurer,
United States of America.
0 2&32 Motion to reconsider a final order.
Motions to reconsider a final order
shall be filed within ten (10) days
after service of the final order. Every
such motion must set forth the mat-
ters claimed to have been erroneously
decided and the nature of the alleged
errors. Such motion shall not stay the
effective date of the final order unless
specifically so ordered by the Adminis-
trator.
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Subparf HSupplemental Rules
922.33 Supplemental rules of practice
governing the administrative assess*
ment of civil penalties under the Toxic
Substances Control Act
(a) Scope of these Supplemental
rules. These Supplemental rules of
practice shall govern. In conjunction
with the preceding consolidated rules
of practice (40 CFR Part 22). all
formal adjudications for the assess-
ment of any civil penalty conducted
under section 16(a) of the Toxic Sub-
stances Control Act (15 U.S.C.
2615(a)). Where inconsistencies exist
between these Supplemental rules and
the Consolidated rules, (§{22.01
through 22.32), these Supplemental
rules shall apply.
(b) Subpoenas. (1) The attendance of
witnesses or the production of docu-
mentary evidence may be required by
subpoena. The Presiding Officer may
grant a request for a subpoena upon a
showing of (i) the grounds and necessi-
ty therefor, and (11) the materiality
and relevancy of the evidence to be ad-
duced. Requests for the production of
documents shall describe the evidence
sought as specifically as practicable.
(2) Subpoenas shall be served in ac-
cordance with S 22.05(b)(l) of the Con-
solidated Rules of Practice.
(3) Witnesses summoned before the
Presiding Officer shall be paid the
same fees and mileage that are paid
witnesses in the courts of the United
States. Fees shall be paid by the party
at whose instance the witness appears.
Where a witness appears pursuant to a
request initiated by the Presiding Offi-
cer, fees shall be paid by the agency.
-------
§22.34 Supplemental rules of practice
governing the administrative assess*
ment of civil penalties under Title II of
the Clean Air Act
(a) -Scope of these Supplemental
rules. These Supplemental rules of
practice shall govern, in conjunction
with the preceding Consolidated Rules
of Practice (40 CFR Part 22), all
formal adjudications for the assess-
ment of any civil penalty conducted
under section 211 of the Clean Air Act
as amended (42 U.S.C. 7445). Where
Inconsistencies exist between these
Supplemental rules and the Consoli-
dated Rules, (§5 22.01 through 22.32).
these Supplemental rules shall apply.
(b) Headquarters enforcement
Where the complainant is the Assist-
ant Administrator for Enforcement or
his delegate, the prehearing confer-
ence and hearing shall be held in
Washington, DC, unless the Presiding
Officer determines that there is good
cause for it to be held at another loca-
tion.
(c) "Presiding Officer". For purposes
of hearings conducted pursuant to sec-
tion 211 of the Clean Air Act, "Presid-
ing Officer" means the Administrative
Law Judge appointed under 5 U.S.C.
3105 (see also Pub. L. 95-251, 92 Stat
183) or an attorney who is an employ-
ee or authorized representative of the
Agency.
(d) Assignment of a Presiding Offi-
cer. Upon the filing of an answer, the
Regional Hearing Clerk or Hearing
Clerk, as appropriate, shall forward
the complaint, answer, and any other
documents filed thus far in the pro-
ceeding to the Regional Administrator
or Administrator, respectively, who
shall assign the Presiding Officer. The
Regional Administrator or Administra-
tor may, however, forward the case
file to the Chief Administrative Law
Judge and request that he assign an
Administrative Law Judge as Presiding
Officer. If the Chief Administrative
Law Judge finds that such an assign-
ment can be made without impairing
the ability of his office to timely dis-
charge its other responsibilities, he
shall make the assignment. Otherwise,
he shan notify the Regional Adminis-
trator or Administrator that he is
unable to make such an assignment.
The Presiding Officer assigned to the
proceeding shall obtain the case ffle
from the Chief Administrative Law
Judge, Regional Administrator, or Ad-
ministrator, as appropriate, and notify
the parties of his assignment.
(e) Evaluation of proposed civil pen-
alty. In determining the dollar amount
of the recommended civil penalty as-
sessed in the initial decision, the Pre-
siding Officer shall consider (1) the
gravity of the violation. (2) the size of
respondent's business, (3) the respond-
ent's history of compliance with the
Act, (4) the action taken by respond-
ent to remedy the specific violation.
and (5) the effect of such proposed
penalty on respondent's ability to con-
tinue in business. The Presiding Offi-
cer must also consider any guidelines
for the Assessment of Civil Penalties
issued under the Act
-------
122.35 Supplemental rules of practice
governing the administrative assess*
ment of civil penalties under the Feder-
al Insecticide, Fungicide, and Rodenti-
cideAct
(a) Scope of these Supplemental
rules. These Supplemental rules of
practice shall govern, in conjunction
with the preceding Consolidated Rules
of Practice (40 CFR Part 22). all
formal adjudications for the assess-
ment of any civil penalty conducted
under Section 14(a) of the Federal In-
secticide, Fungicide, and Rodenticide
Act as amended (7 U.S.C. 1261(a)).
Where inconsistencies exist between
these Supplemental rules and the
Consolidated rules, (§5 22.01 through
22.32), these Supplemental rules shall
apply.
(b) Venue. The prehearing confer-
ence and the hearing shall be held In
the county, parish, or incorporated
city of the residence of the person
charged, unless otherwise agreed in
writing by all parties.
(c) Evaluation of proposed civil pen-
alty. In determining the dollar amount
of the recommended civil penalty as-
sessed in the initial decision, the Pre-
siding Officer shall consider, in addi-
tion to the criteria listed in section
14(a)(3) of the Act, (1) respondent's
history of compliance with the Act or
its predecessor statute and (2) any evi-
dence of good faith or lack thereof.
The Presiding Officer must also con-
sider the guidelines for the Assess-
ment of Civil Penalties published in
the FEDERAL REGISTER (39 FR 2.7711).
and any amendments or supplements
thereto.
-------
022J6 Supplemental rulei of practice
governing the administrative assess-
ment of civil penalties and the revoca-
tion or suspension of permits under the
Marine Protection, Research, and
Sanctuaries Act
(a) Scope of these ^Supplemental
rules. These Supplemental rules shall
govern, in conjunction with the pre-
ceding Consolidated Rules of Practice
(40 CFR Part 22), all formal adjudica-
tions conducted under section 105(a)
or (f) of the Marine Protection, Re-
search, and Sanctuaries Act as amend-
ed (33 U.S.C. 1415(a) and (f)). Where
inconsistencies exist between these
Supplemental rules and the Consoli-
dated Rules, (55 22.01 through 22.32),
these Supplemental rules shall apply.
(b) Additional criterion for the issu-
ance of a complaint for the revocation
or suspension of a permit. In addition
to the three criteria listed In 40 CFR
22.13 for issuing a complaint for the
revocation or suspension of a permit,
complaints may be issued on the basis
of a person's failure to keep records
and notify appropriate officials of
dumping activities, as required by 40
CFR 224.1 and 223.2.
-------
Monday
July 28, 1980
Part VI
Environmental
Protection Agency
Statement of Policy on the Labeling
Requirements for Exported Pesticides,
Devices, and Pesticide Active Ingredients
and the Procedures for Exporting
Unregistered Pesticides
-------
50274
Federal Register / Vol. 45. No. 146 / Monday, July 28.1900 / Rules end Regulations
NVIROMMEfJTAL PROTECTION
"ENCY
.0 CFR Parts 152, 163,164.165,166,
167, 1G8. 169, 170. 171. 172.173, 174,
175, 176.177.178, 179. and 180
IFRL 1546-51
Statement of Policy on the Labeling
Requirements for Exported Pesticides,
Devices, and Pesticide Active
Ingredients and the Procedures for
Exporting Unregistered Pesticides
AGENCY: Office of Enforcement.
Environmental Protection Agency (EPA
or the Agency).
ACTION: Notice of policy statement.
SUMMARY: The Federal Insecticide.
"'Fungicide, and Rodenticide Act (FIFRA'
or the Act) was amended by the Federal
Pesticide Act of 1978 on September 30.
1978. Section 17(a) of the Act was
modified so that pesticides, devices, and
active ingredients used in producing
pesticides which are manufactured for
export must now bear certain minimal
labeling, and ths producers of such
products are now subject to the
requirements of both FIFRA sections 7
(establishment registration) and 8
(books and records). In addition, unless
r pesticide is registered under section 3
r is being sold under section 6(a){l] it
jnnot be lawfully exported unless.
prior to export. (1) the foreign purchaser
has signed a statement acknowledging
that the purchaser understands that the
pesticide is unregistered and therefore
cannot be sold in the United States, and
(2) a copy of that statement has been
transmit'.ed to EPA for transmittal to the
appropriate officials of the importing
country. This foreign purchaser
acknowledgement statement must be
acquired by the exporter and
transmitted to EPA for the first shipment
of each unregistered pesticide to a
particular purchaser for each importing
country, anr.ually.
This notice informs the public of the
scope of the.new labeling requirements
and of the procedures that an exporter
of unregistered pesticides must follow to
acquire acknowledgement statements
which will be transmitted by the U.S.
Government to the government of the
importing country.
EFFECTIVE DATES": Labeling. Labeling
requirements for exported pesticides.
devices, and pesticide active ingredients
became effective March 29.1979.
(Federal Pesticide Act of 1978, Pub. L.
95-396. 92 Stat. 833). Therefore, exported
products which fall v/ithin the purview
of this notice must now bear.labels
,-hich comply with the statutory
.equircments of FIFRA section 17(a)(l).
Purchaser Acknowledgement
Statements. After thirty day* from the
date of this notice, exporters of
unregistered pesticides will be in
violation of FIFRA if the foreign
purchaser acknowledgement statements
have not been acquired before shipment
and transmitted to EPA in accordance
with this policy.
FOR FURTHER INFORMATION CONTACT:
John ]. Neylan III. Office of Enforcement,
Pesticides and Toxic Substances
Enforcement Division (EN-342), EPA.
401 M Street. S.W., Washington. D.C.
20450 (202) 755-1212.
SUPPLEMENTARY INFORMATION: On
Wednesday. July 18.1979. EPA's Office
of Enforcement published a proposed
statement of policy on the labeling
Tequirements iorexported-pestlcides, -.«
devices, and pesticide active ingredients
and the procedures for exporting
unregistered pesticides, [44 FR 41955].
That proposed policy statement
explained in some uetail what
information would be required to appear
on the labels or labeling of pesticides,
devices, or pesticide active ingredients
destined for export in order to be
considered in compliance with the law.
It also described the procedures for
acquiring from a foreign purchaser of
unregistered pesticides a statement in
which the purchaser acknowledges the
registration status of the pesticide. Both
of these requirements became effective
180 days after the date of enactment of
the Federal Pesticide Act of 1978 [March
29,1979).'
The July 18 notice invited the public to
comment on the proposed policy before
September 17,1979. Twenty-three
comments were received. Following is a
summary of the major modifications to
the policy statement made as a result of
the comments.
(1) A more detailed explanation was
included of which products will be
considered as not registered for use in
the United States, for purposes of this
policy statement.
(2) The policy statement explains in
greater detail what labeling is expected
to appear on exported pesticides,
devices, and pesticide active
ingredients.
Appendix A contains summaries of
the comments made to the July 18,1979
policy statement and the Agency's
response to them.
Accordingly, the Office of
Enforcement's general statement of
policy on the labeling requirements for
exported pesticides, devices, and
pesticide active ingredients and the
1 P-jb. L 35-306,9Q S'.at. 819. September 30.1978.
Section IB(b).
procedures for exporting unregistered
pesticide are set forth below.
Dated: )u!y 10.1980.
Jeffrey C. Miller.
Acting Assistant Administrator for
Enforcement. . .
L Summary of Policy
Pesticides, devices, and active
ingredients used in producing pesticides
which are manufactured for export must
now bear labeling which will serve to '
both identify the product and the
producer and to protect persons who
come in contact with the product.
Certain of the label items must be
written in both the English language and
in the language of the importing country.
These bilingual labeling requirements
.* apply to. the_pwduct'3 ingredient.
statement and its warning and
precautionary statements. Exporters of
pesticides which are not registered for
use in the United States (in accordance
with this policy) must obtain a
statement from the foreign purchaser of
the pesticide in which the purchaser
acknowledges the registration status of
the product. The pesticide must also
bear labeling to indicate that it. is not
registered in the United States. For
purposes of this policy an unregistered
pesticide is one which (l) contains an
active ingredient not found in a
federally registered product; or (2) bears
labeling for a use which is currently
subject to denial or cancellation of
registration: or (3) is not similar in
composition and use pattern to a
.federally registered product
The acknowledgement statement must
(1) identify the purchaser, the exporter,
the product's identity and the product's
destination; (2) be obtained for the first
shipment of a particular pesticide to a
particular purchaser for each importing
country, annually: (3) be obtained before
exportation takes place: and (4) be
transmitted to EPA within seven (7)
days of receipt by the exporter.
II. Labeling Requirements
Section 17(a) of FIFRA has been
amended to provide as follows:
(a) Pesticides and Devices Intended for
Export.notwithstanding any other provision
of this Act. no pesticide or device or active
ingredient used in producing a pesticide
intended solely for expert to any foreign'
country shall be deemed in violation of this
Act-
Ill when prepared or packaged according
to the specifications or directions of the
foreign purchaser, except that producers of
such pesticides and devices and active
ingredients used in producing pesticides shall
be subject to sections 2(p|. 2lq;(l)!A), (C), (D),
(El, (C). and (H), 2(q)C)(A). (D). (C)(i) and
(iii). and (0), 7. and 8 of this Act;
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Federal Register / Vol. 45. No. 146 / Monday, July 28. 1980 / Rules and Regulations 50275
Every exported pesticide, device, and
active ingredient used in producing a
pesticide must bear a label or labeling,
in English or in the language of the
importing country, which meets the
requirements of F1FRA section 17(a)(l).
In addition, certain information which
will satisfy F1FRA sections 2(q)(l)(E).
(C). and (H) and 2 (q)(2)(A) and (D) must
also appear on the label or labeling so
as to provide bilingual (in other words,
in English and in the language of the
importing country) information to
anyone who handles or comes in contact
with these products. Any language in
which official government business is
conducted in the country or which is the
predominately spoken language of the
country, is acceptable as the second
language on the label.
Pursuant to Section 17(a)(l), all
"exported pesticides,' devices'.'and active '
ingredients used in producing pesticides
must bear labels or labeling which:
(a) bear EPA Establishment Numbers;
(b) have ingredient statements:
(c) have the name and address of the
producer or registrant;
(d) have statements of net weight or
measure;
(ej if highly toxic, bear skull and
crossbones and statements of practical
treatment in case of poisoning:
(f) include warning and caution
statements;
(g) do not make false representations;
(h) are not in imitation of other
products: and
(i) in the case of unregistered
pesticides, bear the statement "Not
Registered for Use in the United States
of America." All such required
statements must be conspicuous and
readable.
To satisfy FIFRA section 2(q)(l)(E),
the labeling provisions set forth below
must appear in the English language and
in the language of the importing country.
This section specifies that required
statements must be represented ". . , in
such terms as to render it likely to be
read and understood by the ordinary
ir.divitiual . . ." Therefore, the following
information must appear bilingually on
exported product labeling:
'(a) the warning and caution
statements:
(bj the ingredient statement;
(c) where required, the word "poison"
and the statement of practical treatment;
and
. (d) the statement "Not Registered for
Use in the United States of America."
The following may provide more
specific guidance on particular elements
which must appear on the label or
labeling of each exported product:
a. EPA Establishment Number. The
Establishment \umbcr may appear
anywhere on the label or immediate
container in accordance with the
establishment registration labeling
requirements set forth in 40 CFR
fi 162.10(f].
b. Precautionary Statements. Warning
or caution statements must be biligual
and must be adequate for the protection
of persons handling the pesticide,
particularly with respect to general
lexicological hazards and
environmental, physical, or chemical
hazards. Where.the bilingual translation
is obviously inappropriate to protect
residents of the importing country, (for
example, where a label calls for a gas
mask meeting the specification of the
U.S. Bureau of Mines) an equivalent
caution may be substituted.
c. Unregistered Products. Labels of
pesticides which are not registered
under TWRA'C&ve Products* Subjettto*
the Requirement for an
Acknowledgement Statement below)
must prominently display the following
statement: "Not Registered for Use in
the United States of America." This
statement must appear bilingually.
d. Ingredient Statement. The
ingredient statement must appear
bilingually unless the ingredients are
easily identifiable despite their being
listed in a foreign language.
e. Use Classification Statement. The
statement of use classification
(Restricted Use Pesticide or General Use
Pesticide) must appear on the labeling of
the pesticide; however, summary
statements regarding the terms of the
restriction, e.g., "For retail sale to and
application only by Certified
Applicators . . ." are not required.
f. Identity of Parties. Name and
address of the producer, registrant, or
person produced for must appear in the
labeling.
g. Net Weight. The net weight must
appear on the labeling in either
conventional English units or metric
units.
h. Highly Toxic Pesticides. If the
pesticide is highly toxic, the skull and
crossbones, the word "Poison", and a
statement of practical treatment must
appear on the labeling. The word
"Poison" and the statement of practical
treatment shall be bilingual. The skull
and crossbones may be in red or black.
For guidance on what pesticides are
highly toxic, see 40 CFR § 162.10 (h).
The Agency is concerned that labeling
required by FIFRA not conflict with
labeling requirements of the importing
country. Such a situation might arise, for
example, where pesticides are being
exported to a foreign country with strict
labeling and registration laws such as
this country has. To avoid such potential
conflicts, yet still meet the statutory
requirements of FIFRA. exporters may
use supplemental labeling. Pesticides.
devices, and active ingredients used in
producing pesticides may, therefore,
bear a label with the appropriate
information required by FIFRA section
17(a)(l) or may be accompanied by
supplemental labeling in instances
where FIFRA required labeling is in
contravention of foreign labeling
requirements. Supplemental labeling
may be attached to or accompany the
product container or shipping container.
III. Foreign Purchaser Acknowledgment
Statement
Section 17 of FIFRA has been further
amended to provide as follows:
(a) Pesticides and Devices Intended for
Export. Notwithstanding any other
provision of this Act. no pesticide or device
pesticide intended solely for export to any
foreign country shall be deemed in violation
of this Act
(2) In the case of any pesticide other than a
pesticide registered under section 3 or sold
under section 6(a)(l) of this Act. If, prior to
export, the foreign purchaser has signed a
statement acknowledging that the purchaser.
understands that such pesticide is not
registered for use in the United States and
cannot be sold in the United States under the
Act. A copy of that statement shall be
transmitted to an appropriate official of the
government of the importing country.
This notice also delineates what
pesticide products are affected by this
provision and procedures EPA believes
would satisfy the purposes of section
IV. Products Subject to the
Requirements for an Acknowledgment
Statement
Many pesticides which are produced
in the United States solely for export
contain active ingredients that are also
registered as components of pesticides
used within the United States. However,
the export formulations in many cases
contain slightly different percentages of
active ingredients and are labeled
differently. Several factors dictate these
minor modifications in formulation end
labeling, such as different systems of
measurement, pests to be controlled
which are different from those for which
the same or a similar pesticide product
is used in the United States, and
requirements for labeling in a language
other than English.
The Agency believes that Congress
did not intend the requirement for
obtaining an acknowledgement
statement which is applicable to
"unregistered" pesticides to apply to
products which are minor variations on
formulations registered in the United
Slates and which contain only active
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50276
Federal Register / Vol. 45, No. 146 / Monday, July 28, 1980 / Rules and Regulations
ingredients *l ' -.! - ' »
United §ia!rs ' - ' \:*- \ s
view lhat the c»p...: o <;.:ier.!s v\cte
meant to apply in cases in which either
(1) an adverse decision concerning the
use of the pesticide.in the United States
has been made, or (2) no decision has
been made concerning use of the
pesticide. The requirement for obtaining
an acknowledgement statement from a
foreign purchaser will apply to pesticide
products in which:
(aj'The pesticide active ingredient baa
been judged to posa "unreasonable
adverse effects" to man or the
environment, and the registrations of
products with that active ingredient
have been cancelled or denied: or
(b) Either, (1] no assessment or no
conclusive assessment of the hazard
.. resulting frorause of the pesticide has
been made by EPA (while the pesticide
may have been used under limited
experimental or emergency conditions).
(2) the pesticide has never been
registered under section 3 because
registration for the pesticide active
ingredient has not been sought or has
not yet been granted, or (3) the pesticide
is being exported for a use which is
substantially different from any
currently registered use of that pesticide
(e.g., a pesticide which is registered in
this cour.try for use as a termiticide is
exported bearing directions for use on
food crops).
Consequently, the Agency interprets
section l"(aj(2) to apply to:
(a) All pesticide products which
contain an active ingredient that is not
found in a federally registered product;
(b) All pesticide products bearing
labeling for a use which is currently
subject to denial or cancellation of
registration (section 17(a)(2) will also
apply to uses not considered by the
Administrator during a cancellation or
denial determination); and
(c) All pesticide products which are
not similar in composition and use
pattern to a federally registered product.
To be considered similar in
composition and use pattern, a pesticide
product must contain only the same
ingredient or combination of active
ingredients and must have the same
category of toxicity as a federally
registered product. Also, the use pattern
must be similar to the use pattern of the
federally registered pesticide to which it
is being compared. Registrations
involving changes in use patterns such
as changes from non-food to food use,
outdoor to indoor use, terrestrial to
aquatic use, or non-domestic to
domestic use, are not considered to
qualify as similar use patterns. Pesticide
uses which were never reviewed during
e cancellation or denial of registration
(such as a pesticide use
>n a i rop which is not grown in the
L'n.'ed Stales) also do not qualify as a
similar use.
Pesticide products which are subject
to the requirements of section 17(a)(2)
must also bear the label atatement, "Not
Registered for Use in the United States
of America" stipulated by section
2(g)(l)(H)ofthisAct
A pesticide product which has been
registered under Section 24(c) of FIFRA
will be considered as registered for
purposes of this policy. A pesticide
product which may be legally used only
under an experimental use permit
(Section 5) or an emergency exemption
(Section 18) will not be considered as
federally registered. Nor will a pesticide
product whose distribution and use are
legal in intrastate commerce because the
producer has filed an application for
federal registration in accordance with
the procedures found in 40 CFR § 162.17.
Technical grade and manufacturing use
pesticides which are net federally
registered will be considered as
registered for purposes of this policy, if
they qualify as being similar in
composition to a registered formulation.
use pesticide, (i.e., if the products Rave
the same active ingredients and
category of acute toxicity).
V. Procedures
Section ir(a)(2) requires that before a
pesticide which is not registered for use
in the United States can be exported, the
foreign purchaser of the pesticide must
acknowledge in writing that he
understands the registration status of
the pesticide and that the pesticide
cannot be sold in the United States. An
exporter of unregistered pesticides must
have received the required
acknowledgement statement before the
product is released for shipment. The
Agency feels that requiring exporters to
have in hand the purchaser
acknowledgement statement before
exportation takes place is the only way
to assure that foreign purchasers comply
with these new FTFRA export
requirements. The Agency recognizes
that this requirement may cause some
disruption in the export of pesticides.
However, any such delays will be
visited only upon exporters of
unregistered pesticides, and then only
for the first shipment to a foreign
purchaser, in a particular country,
annually. The information required on
the acknowledgement statement, along
with a certification signed by the
exporter, must be transmitted to the
Environmental Protection Agency within
sever, days of receipt by the exporter, or
by the date of export, whichever occurs
first. The certification must state that
the shipment did not take place before
the exporter had the signed
acknowledgement statement in hand.
The Agency will consider the receipt
of purchaser acknowledgement
statements by. local company
representatives in foreign countries to
be receipt by the exporter. Nevertheless,
the information required by the
acknowledgement statement must still
be transmitted to EPA within seven
days of receipt, or by the date of export.
whichever occurs first
Acknowledgement statements nay be
acquired at any time in advance of
shipment. For example, an exporter that
ships to the same foreign purchasers
year after year may acquire at the
beginning of a year all of the
acknowledgement statements which are
anticipated to be needed.
The Agency will transmit the'
acknowledgement statements to
appropriate foreign officials through the
Department of State. Statements will be
transmitted promptly after receipt.
The Agency believes that the purpose
of the purchaser acknowledgement
statement is to advise foreign
governments that pesticides which have
been judged by the United States to be
hazardous to human heafth or the
environment, or pesticides for which no
hazard assessment has been made, are
being exported by U.S. producers to
their country. Foreign governments may
then use such information as they
desire, perhaps, for example, in
evaluating the risk of continued use of
the pesticide in that country versus the
benefits that pesticide provides. The
Agency does not consider that the
acknowledgement statement is primarily
intended to serve as preshipment
notification to foreign governments in
order that they may intercept shipments
of such pesticides. Nevertheless.
because of the Agency's concern that
acknowledgement statements reach
foreign governments in a timely manner.
the information contained in the
acknowledgement statement will be
forwarded to foreign governments
promptly upon receipt by EPA.
As an information mechanism, the
purchaser acknowledgement statement
serves the purpose of alerting the foreign
government that a certain pesticide is
entering its country. The Agency
believes that the first notice fulfills this
purpose: repetitive notices would be of
only marginal value, and in cases of a
high volume of exports to a foreign
country, might result in a flood of paper.
After considering the administrative
burdens placed on exporters. EPA. and
foreign governments and the value of
repetitive notices, the Agency has
concluded that each exporter should
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Federal Register / Vol. 45. No. 146 / Monday. July 28. 1980 / Rules and Regulations 50277
complete and have signed a purchaser
acknowledgement statement, for the
first shipment of a particular product to
a particular purchaser for each
importing country, annually. A shipment
of the same product to a different
purchaser or to the same purchaser for
disposition to a different importing
country would also trigger the
requirement for obtaining a signed
acknowledgement statement from the
foreign purchaser. A second shipment
during tie same calendar year, involving
the same product, purchaser, and
importing country would not trigger this
requirement Any change in the
variablesdifferent purchaser, different
product, different importing country-
will result in the need for obtaining a
new purchaser acknowledgement
statement _
in summary, the procedures that an
exporter of unregistered pesticides must
follow in obtaining and transmitting
foreign purchaser acknowledgement
statements are:
(a) The exporter must provide the
foreign purchaser with instructions
about the required information on en
acknowledgement statement and inform
the foreign purchaser that shipment of
the pesticide cannot be undertaken
unless the exporter has received from
the foreign purchaser a properly
completed, signed, and dated
acknowledgement statement;
(b) The exporter must secure, prior to
shipment, on acknowledgement
statement which contains the
in/crmation outlined in the Required
Information section of this notice. Such
a statement must be secured for the first
purchase each year of a particular
pesticide product by a foreign purchaser
destined for a particular country;
(c) The exporter must forward the
information required on the
acknowledgement statement, along with
the certification that exportation did not
take place until a signed
acknowledgement statement was
received, within seven (7) days of
receipt, or by the date of exportation,
whichever occurs first, to the following
address: Environmental Protection
Agency. Pesticides and Toxic
Substances, Enforcement Division (EN-
342). 401 M Street SW.. Washington.
D.C. 20460.
Attention: Export Acknowledgement
Statement
VI. Required Information
As previously stated, a foreign
purchaser of a pesticide which is not
registered for use in the United States
must sign a statement acknowledging
his understanding that the product is
unregistered and cannot be sold in this
country. The Agency does not intend to
prescribe a format for this
acknowledgement statement However,
the statement must include the following
information:
(a) Name and address of the exporter;
(b) Name and address of the foreign
purchaser,
(c) Name of the product and the active
Ingredient and an indication that the
purchaser understands that the product
is not registered for use in the United
States:
(d) Destination of the export shipment,
if different than purchaser's address;
(e) Signature of the foreign purchaser
and
(f) Date of the foreign purchaser's
signature.
VU. Confidentiality
" Persons submitting the information" ~
specified in Part VI may assert a claim
of business confidentiality by marking
this information as "FIFRA Confidential
Business Information." Information so
marked will not be disclosed, with the
exception of disclosure to the foreign
government except in accordance with
the procedures set forth in 40 CFR Part
2. 7 USC 136h, and this policy statement
If such claim is not asserted, EPA may
disclose the information to the public
without providing notice of disclosure or
an opportunity to object.
Notwithstanding any claim of
confidentiality, the acknowledgement
statement will be forwarded to the
appropriate foreign government in its
entirety as required by section 17.
VIII. Relationship to Other Statutory
Requirements
Producers of pesn'cides.-devices. and
active ingredients used in producing
pesticides which are intended for export
are subject to the establishment
registration procedures, including the ..
report requirements, as well as the
record keeping requirements of FIFRA.
The Agency has proposed amendments
to the regulations which are
promulgated under the authority of
those parts of the Act (sections 7 and 8)
to bring them into conformity with the
newly amended FIFRA. These
regulations are found at 40 CFR Part 167
and Part 169, respectively.
Pesticides, devices, and pesticide
active ingredients for export are not
considered to be in violation of FIFRA
when produced according to the
directions of the foreign purchaser.
when properly labeled and, in the case
of unregistered pesticides, when the
foreign purchaser has signed a
statement in which he acknowledges
that he understands the registration
status of the pesticide and the exporter
has forwarded the statement to EPA.
Exported pesticides, devices, and active
ingredients used in producing pesticides
which do not bear labels or labeling in
compliance with FIFRA section 17{aJ(l)
will be considered to be misbranded."
Exporters of such products will be
subject to civil or criminal liabilities for
violation of FIFRA sections 12(a)(l) (DJ
or (E)misbranding. Exporters of
unregistered pesticides will be subject to
civil or criminal liabilities for violation
of FIFRA section 12(a)(lJ(A)selling or
distributing a pesticide which is not
registeredif they fail to secure, prior to
export a properly completed, signed,
and dated acknowledgement statement
from the foreign purchaser of the
pesticide. Falsification of the required
certification may subject an exporter to
-sanctions-under 18-U;&C.-ianr'
Appendix A.Significant Comments
and Responses
General Comments
Comment No. 1. Applicability of ^
Rulemaking Procedures. Two
commenters stated that the Agency*
should have implemented the export
provisions of FIFRA through the
procedures established by the
Administrative Procedures Act for the
promulgation of "substantive" rules. The
Agency disagrees. As mentioned
previously, these requirements for
export labeling and purchaser
acknowledgement statements were
statutorily effective March 29.1979.180
days from enactment of the Federal
Pesticide Act of 1978. The law lists the
type of information required on an
exported pesticide's labeling and the
legislative history makes it dear that
purchaser acknowledgement statements
ere to be transferred to foreign
governments in the same manner that
cancellation notices are furnished. The
Agency's position, therefore, ij that
there is no need for rulemaking but
rather there is a need for a general
statement of policy on such matters as:
(a) what would constitute minimally
acceptable labeling, (b) how such
labeling could be attached or
accompany shipments, and [c] how .
foreign purchaser acknowledgement
statements are to be transmitted to
foreign governments.
Comment No. 2. Use of Suspended
and Cancelled Pesticides List. Another
commenter suggested that foreign
countries can be adequately informed of
the hazards of U.S. manufactured
pesticides through'an expansion of the
Suspended and Cancelled Pesticides
List. This is not the intended function of
the Suspended and Cancelled Pesticides
List. That list constitutes only a guide
-------
50270 Federal Register / Vol. 45, No. 146 / Monday, July 28. 1980 / Rules and Regulations
for Government officials: it is not the
final Authority on the status of a given
pesticide. It is the intent of Congress
that the procedures that are followed for
notifying foreign governments of the
suspension or cancellation of pesticides
be those which are also used to inform
them that an unregistered pesticide will
be entering their country. Therefore, the
channel of communication described in
this policy is derived from the
procedures already used to notify
foreign governments of major
suspension or cancellation actions.
Comment No. 3. Scope of the FIFRA
Section 17 Requirements. A number of
comrnenters addressed the definition
contained in this policy statement of an
unregistered pesticide. The Agency
agrees that clarification on this point is
i>ece«5fr?\!-l4-i9-Bot-EPA'fl-mt«nt-to limit
export of a chemical if it is properly
labeled and the exporter complies with
the procedures for obtaining and
transmitting to EPA a properly executed
acknowledgement staterr.ent. A more
detailed explanation cf which products
will be regarded as unregistered for the
purposes cf this policy has been given.
One commenter objected to including
products with denied or cancelled uses
and products with different composition
or use patterns with products xvhich
contained no registered active
ingredient. In drafting this policy
statement, E?A adopted a bread
interpretation of the registration status
of a pesticide.
The Agency could have required
exporters of ail pesticide products that
were not registered under secticn 3 to
acquire an acknowledgement statement
from the foreign purchaser. The effect of
this would be that an acknowledgement
statement would have been required for
the overwhelming rr.jjority of exported
.pesticides since most exports differ
slightly in formulation or directions for
use from the U.S. registered product, or
the labels are written in a foreign
language. The EPA clearly stated in the
proposed policy statement that in its
view Congress did not intend that
exportsJ products with minor variations
from £PA registered pesticides be
subject to the export notification
procedures. However, products \vith
cancelled uses or with substantial
differences in composition or use
patterns car.not be considered products
with minor variations. The Agency must.
therefore, reject this comment.
Comment N'o. 4. Status of Certain
Unre;:£!orcd Pesticides. Cns ccmrnenier
S'jzici'.sd that experimental use
pr-.-diJCts be Ireuted as rcpistcred
prcducis: anc:hcr commenter thought
th.-i! products with temporary tolerances
should be considered as if they were
registered. Since registration data for
such products are not complete, it has
consistently been Agency policy to treat
experimental use products and products
with temporary tolerances as
unregistered products. Products which
bear registrations under section 24(c) of
FIFRA will, however, be treated as
registered products. Products undergoing
Rebuttable Presumption Against
Registration will be considered in
accordance with their registration status
at the time of export. It was suggested
by one commenter that those pesticides
which were registered by a foreign
country should not be subject to the
requirement for an acknowledgement
statement. In order to adequately
enforce a policy which took this
.»pproach,-the~ERA..woulri hnvp to. -. ....
evaluate the internal registration .
procedures conducted by other countries
and to regulate exports based upon the
policies of the importing country. Thus,
EPA policy would be different for
similar shipments going to different
countries. The Agency rejects this
comment. Not only would it be
administratively difficult to operate such
an export program, but such a policy
fails to recognize the point of having the
acknowledgement statement: To inform
foreign governments of the U.S.
registration status.of a pesticide
Comment No. 5. Non-Commercial
Exportation. Another commenter
requested clarification on the
application of the notice provision to
pesticides which are exported without a
commercial transaction. There are two
possible categories of products to which
this comment might apply: the first
would be small amounts of pesticide
exported for research purposes only; the
second would be large shipments
exported to a foreign establishment of
the domestic company which
manufactures it. Research quantities are
subject to the labeling rules of this
policy but not to the acknowledgement
statement requirement. Large shipments
transferred from a domestic facility to a
foreign facility of the same company will
be treated in accordance with their U.S.
registration status. That is.' if the product
is registered (in accordance with the use
of that term in this policy), no
acknowledgement statement is required:
if the product is not registered, an
acknoxviedgement statement will be
required.
Comment No. 6. Technical and
Multiple Use Chemicals. Some
comrnenters asked for clarification of
the impact of this policy upon
formulated and technical grade products
and multi-use products. Formulated and
technical grade products which are
subject to FIFRA are subject to this
policy. The label on the exported
product must comply with section 17 of
FIFRA. A multi-use product for which no
pesticide claims are made and which is -
not an active ingredient in any pesticide
product in the United States is not
subject to this policy, even if it is
subsequently processed into a pesticide
in another country.
Labeling Comments
Comment No. 7. Use of Bilingual
Labeling. A number of commenters
stated that the law did not require
bilingual labeling. The law states that an
exported pesticides, device, or pesticide
active ingredient must bear labeling in
conformance with FIFRA section
J2fq)(l)(E). The FIFRA states in section
"2[q)tl){E) tfiat'a pesticide is misbranded
if:
Any word, statement, or other Information
required by or under authority of this Act to
appear on the label or labeling is not
prominently placed thereon ... in such
terms as to render it likely to be read and
understood by the ordinary individual und_er
customary conditions of purchase and use;'
(Emphasis added.)
The EPA interprets this passage to
apply to ordinary individuals in the
importing country as well as in the
United States. Thus, the bilingual
requirements are meant to communicai
some basic information about the
product to as many handlers of the
pesticide as possible. International
symbols, suggested by one commenter,
could not adequately communicate all
the required label elements, although
they may be used in addition to the
required wording. Commenters asked .
for guidance regarding EPA's
enforcement of the bilingual requirement
in two specific instances: when the
importing country has several official
dialects, or when English is an official
government language. Any language in
which official government business is
commonly conducted in the country, or
which is the predominately spoken
language of the country, is acceptable as
the second language on the label. If
English is one of these languages, then a
bilingual label is optional, except as
may be required by the importing
country. One commenter asked if a
translation of the U.S. label would be
satisfactory. Such a label would be
acceptable if the necessary elements
appeared both in English and in the
foreign language.
Comment No. 8. Foreign Labeling
Requirements. Several commenters
asked about the application of this
policy to labels which comply with the
laws of the importing country. It is not
-------
Federal Register / Vol. 45. No. 146 / Monday. July 28. 1080 / Rules and Regulations 50279
the intention of this policy to supersede
the,labeling requirements of foreign
governments. However. FIFRA now
requires that exported pesticides,
devices, and pesticide active ingredients
bear certain minimal labeling. If the
labeling which currently appears on
exported pesticides does not meet the
minimum FIFRA requirements, even
though it may meet the foreign country's
requirements, additional labeling must
be added to satisfy U.S. law.
Comment No. 9. Supplemental
Labeling. Several commenters suggested
that supplemental labeling be liberally
allowed. The Agency intends to be as
flexible as possible in this respect.
Exporters will be permitted to use a
variety of types of labeling to comply
with the FIFRA export requirements.
The Agency's principal interest will be
to ascertain that products to which this
policy applies bear labels or labeling
which, taken together, conform to the
FIFRA section 17(a)(l) requirements.
Comment No. 10. Establishment
Numbers. One commenter requested the
option of substituting another code for
the EPA Establishment Number on the
label. The Act clearly requires that an
Establishment Number appear on the
label. The Agency must reject this
suggestion since permitting other means
of identifying the production .
establishment would negate the
usefulness cf such numbers.
Comment *+o. 11. Restricted Use
Pesticides. Several commenters
requested guidance on label
requirements for exported restricted use
pesticides. If the product is a restricted
use pesticide, then the statement
"Restricted Use Pesticide" must appear
on the label or labeling. The
supplementary statement of the terms
and conditions of restriction is not
required.
Acknowledgment Statement
Comment No. 12. Prior Possession of
Acknowledgement Statements. A
number of commenters questioned the
require.Tient that the acknowledgement
statements be in the exporter's
possession before shipment of the
pesticide can take place. Other
ccmmenters stated that in their opinion
foreign importers, through oversight or
bureaucratic inefficiency, will not
comply with the acknowledgement
statement requirement. In the proposed
policy statement, the Agency clearly
recognized the problem of r.on-
compliance by foreign importers. For
this precise reason. EPA must reject the
contention that acknowledgement
statements should not be required to be
in the exporter's control before shipment
can take place. A more liberal
interpretation of what constitutes
receipt of the acknowledgement
statements has been provided in the
final policy statement to facilitate
compliance. One commenter suggested
that a signed acknowledgement in the
hands of a local company representative
be considered a receipt by the exporter.
The Agency agrees that this would be
acceptable so long as the information
required on the acknowledgement
statement is sent to EPA within the
stated time period. If a company
anticipates several orders in a year, the
acknowledgement statements may be
obtained in advance of the actual order.
One commenter stated that the
requirement that acknowledgement
statements be sent to EPA within seven
days of receipt by the exporter was too
restrictive. This commenter suggested
that transmittal of the acknowledgement
statement should be tied to the date cf
shipment. The Agency disagrees. Where
possible, acknowledgement statements
will be sent to foreign governments as
far in advance of shipment as possible.
This will provide the government some
time to review the information received.
The Agency feels more timely
notification will occur if transmittal of
the acknowledgement statement is tied
to date of receipt.
Comment No. 13. Certifications. Some
.commenters objected to filing, along
with the acknowledgement statement, a
certification that the order was not
shipped before the acknowledgement
statement was received. The Agency
believes that a certification statement is
necessary. While some monitoring of
compliance will .be through inspection of
required books and records, a
certification requirement will serve to
remind exporters that shipment must
wait until the acknowledgement
statement has been received.
Comment No. 14. Destination of
Shipment. One commenter suggested
that there was no need to include in the
acknowledgement statement the
destination of the export shipment, if
different than the purchaser's address.
This comment is rejected because
without this information the Agency
would be unable to determine if the
labeling complied with the bilingual
requirements nor would it know the
proper place to send the
acknowledgement statement.
Comment No. 15. Annual Reporting.
Several commenters stated that the
requirement that a new
acknowledgement statement be
acquired each year that a particular
product is exported is overly
burdensome. They point out that the law
requires an acknowledgement statement
only once per country, not once per
country, per year. The Agency must
reject this comment. Although FIFRA is
not clear on this point, the law sccmi to
indicate that an acknowledgement
statement.should be acquired for each
export shipment of an unregistered
pesticide. It is the Agency's position that
imposing such a requirement would be a
burden for all parties concerned-
exporters, importers, and the U.S.
Covemment, as well as foreign
governmentsbeyond any regulatory
purpose it may serve. The requirement
to send an acknowledgement statement
once per year, which is similar to that
being considered under the Toxic
Substances Control Act, is not overly
burdensome, and yet accomplishes the
purpose of regular notification to foreign
..governments-. . _
Comment No. 16. Notification of
Foreign Governments. Several
commenters questioned the procedure
for notifying foreign governments. It was
suggested that either the foreign
purchaser or the exporter should
directly notify the foreign government.
The EPA rejects this proposal. First, it
would be difficult, if not impossible, for
the Agency to monitor compliance under
such a procedure. Second, as previously
explained, the procedure for
transmitting acknowledgement
statements parallels that of the
notification of foreign governments cf
suspended or canceled registratior.s. It
is the understanding of the Agency that
such a procedure, namelygovernmer.:-
to-govemment contact, was the intent of
Congress.
Comment No. 17. Problems with
Importing Countries. Two commenters
suggested that the policy be different for
socialist or communist countries. Ths*e
corr..T.enters cited their experience
exportir.7 pesticides to these countries
. where the "i.T-portsr" is an agency of the
government. Thijse import agencies are
said by the commsntsrs to be stalled by
very conservative bureaucrats who are
reluctant !o sign unusual requests. As
has beer, discussed earlier, it is r.ct the
irrtent of '.his Agencv to write a different
export policy fnr dilferent countries.
However, should r.uT.erous problems
arise with any particular count.-y. the
Agency will work u:th industry ap.d the
Depart.Tiem cf State to solve thcrr..
|F3 Doc. nO-HUSS f .led r-:v-80: 4:45 ;»1
BILLING CODE 6560-01-M
-------
7- 30-
0?FiCE OF cNFOrCSMENT
MEMORANDUM
SUBJECT:
PROM:
TO:
Request Procedures for Pesticide Samples
and Followup on Pesticide Complaints
John S. Seitz, Chief
Compliance..-Monitoring -Branch
PTSED Staff
Recent confusion regarding requests fot pesticide samples or
investigations has resulted in a need to formalize procedures for
making such requests. This memorandum and attachments describe
the new procedures.
Situations which are referred to the regions can be divided
into three major categories: 1) pesticide sample or label required,
2) complaint followup. required, and.3) requests for large numbers
of any type of sample or investigation. 'Attachment 1 outlines
subcategories and appropriate responses for each.
1. Pesticide Sample or Label Required
Initiator of the request should complete EPA Form
8500-1 "Special Request for Sample" (attachment 2)
according to directions in attachment 3. This
form should be given to the Chief, Compliance
Monitoring Branch. The request will be reviewed,
authorized, and transmitted to the region
by the compliance monitoring coordinator for that
region.
2-' Complaint Followup Required
Initiator should write down all pertinent information
including who made the complaint, whert and where he/
she can be reached, complete description of the problem,
and any memos, labels, advertising, references, etc. that
are pertinent. This information (which can be hand-
written if it's readable) should be given to the Chief,
Compliance Monitoring Branch. The compliance monitoring
coordinator will forward the information to the region.
-------
Large Numbers of Samples or Investigations
Initiator should provide all pertinent information to
the Chief/ Compliance Monitoring Branch. Mike Wood
will act as coordinator for all large requests.
Mr. Conroy will authorize the forwarding of these
requests to the regions.
-------
Attachment I
PROCEDURES
PESTICIDE SAMPLE REQUESTS AND REFERRALS
SITUATION
Pesticide Sample Required
Physical sample
required for
chemical or
efficacy testing
Documentary sample
required: label,
pamphlets or
advertising to
be- reviewed
ilaint:
v .egistered
product, mis-
branding,
claims differ
Complaint Followup Required
Marketplace
investigation:
suspended/can-
celled, health
hazard
Complaint:
advertising
followup
, Incident report:
soning, ill-
jS, crop damage,
isuse
PAPER WORK
Sample request
form (8500-1)
-need registration
number
check ERSS for
establishment
address and
recent production
-health hazards
are "urgent"
Sample request
form as above
except note:
Documentary
sample per
manual
Sample request
form, documentary
sample (see
above)
Buck slip for-
warding informa-
tion for
investigation;
phone call to
notify
Buckslip or memo
forwarding com-
plaint: please
investigate and
document as
necessary
Msno forwarding
information, and/o:
phone call,
depending on
severity or
public
interest *
APPROVING
OFFICIAL
CMS STAFF
SENT TO
Regional contact*
CMS STAFF
Regional contact
CMB STAFF
Regional contact
Chief, CMB
CMB STAFF
Pesticides Branch
Chief
Regional contact
Regional contact
AS
NECESSARY
AS NECESSARY
-------
SITUATION PAPER WORK APPROVING SENT TO
OFFICIAL
3. Large Numbers of Samples or Investigations Required
m
i. Large number of Contact Mike Director, PTSED Enforcement Division
samples required Wood (472-3701) Director
for instructions Pesticide Branch Chief
>. Large numbers of Contact Mike Director, PTSED Enforcement Division
investigations/ Wood (472-3701) Director
inspections . for instructions Pesticide Branch Chiei
required
:. Multi-region Contact Mike Director, PTSED Enforcement. Division .....
-- request"for " "' '" " " Wood (472-3701) ..... ~ ...... "" Director
samples, for instructions Pesticide Branch Chief
inspections
REGIONAL CONTACTS
SGION CONTACT PESTICIDES BRANCH CHIEF
I .. . .... . ...c. Lincoln . . . . C. Lincoln . . . :: ......
II S. Fenichel S. Fenichel
EC III J. Smith N. Davis
IV R. Clark R. Clark
.* V G. Marsh M. Wrich
2GION VI A. Anderson N. Dyer
3GICN VII J. wicklund J. Wicklund
iGION viil B. Harding L. Johnson
3GION IX R. Mandel R. M. Stenburg
3GION X . D. Donaldson . R, Poss
3LLOWUP
riginals of sample request form and copies of referrals will be kept in a regional
asticide sample/referral file.
:en a sample is picked up, the region will return the acknowledgement copy to the
riginator. This will contain ID number and date of inspection. This copy will
: filed with original.
: a physical sample is analyzed by a laboratory, one copy of the results of analysis
irm should be sent to the originator of. the sample request. This will be filed with
jnple request copy. ' ' -.--. ..--> .--.-; /.w -. ; - =. -::..- '. -. ..... «c .-.->-
^SS followup should be made periodically to determine status of sample.
.c alls to .regional contact should be made when PENS followup is not possible or
.c o action.
-------
Block 1:
Block 2:
Block 3:
3lock 6:
Jlock 7:
Jlock 8:
(lock 9:
Attachment 3
Directions For Completing Form 8500-1 Special Request For Sample-
DATE OF REQUEST
From: Compliance Monitoring Branch
Pesticides & Toxic Substances
Enforcement Division EN-342
Washington, D.C.
NAME OF ECONOMIC POISON
This name and address should be the site at which the pesticide is
actually manufactured, formulated or distributed. It should include
a street address which the inspector can use to locate the company
and the establishment number if available. Please check with
Carol Buckingham/ Establishment Registration Support System coordi-
nator (755-2047), to make sure of the address, establishment number,
and to verify that the product was actually produced recently, at
that site. This is to save state and regional inspectors unneces-
sary trips- to sites"that do not produce the pesticide requested. ' '
LAB TO RECEIVE SAMPLE .
If a physical sample is requested for chemical or efficacy testing,
a laboratory address should be specified. This laboratory may be
a state pesticide lab, NEIC, Beltsville or a contractor.
SPECIFIC SAMPLE SIZE REQUESTED
Unless there is a specific reason for a large sample, "MINIMUM"
should be specified in this block. If documentary samples are
requested, this block should read "DOCUMENTARY.11
DATS SAMPLE REQUIRED -
Samples needed in less than 60 days should be marked "URGENT" and
justification given in Block 9. All others will be collected when
the region or state can reasonably collect them. In this case,
this block should remain blank.
REGISTRATION NUMBER
This number should be obtained from label, fiche or Registration
Division. ' ' ' '
REASON FOR COLLECTION
This block should contain all relevant information which resulted
in the request for collection of a sample. The phrases "complaint",
"unregistered product" "misleading advertising" are not adequate.
Reference to letters or memos should be included as needed. This
block should also contain the name, organization and phone number
of the requestor in case questions or problems arise.
-------
Block 10-15: Should remain blank. The region or state will complete
Block 16: SIGtfATUBE OF APPBD7ING OFFICIAL
Ihis block will be completed by the Compliance Monitoring Branch
regional liaison, Branch Chief or the PTSED Director, as appropria
v »
-------
O. . OOVUHMUMT MNNTIM4
ATTAC.HMTHT Z.
1971-721-700
SPECIAL REQUEST FOR SAMPLE
NOTE: Ui« a Mparat* fern (or
aek product
DATE OF REQUEST
TOi
FROMi
Director, Pesticide Enforcement Division
Environmental Protection Agency
Washington, D.C. 20250
Attn: National Sampling and Recall Section
NAME Or ECONOMIC POISON (Mu»l 6e ««n« product t>n lfti*l-:"''-/T
SAMPLE IDENTIFICATION
PREVIOUS
NAME OF INSPECTOR
/C
1
10 NO.
;/
ILOCATION of COLLECTION
...., .,-.-.;,:.. ^.- -.V; : '.W, ^ ;"
SIGNATURE OF
APPROVING OFFICIAL
'..15 . .-'
DATE . . ....... . _. ...
NEW
Any correspondence should refer to the Registration Mo. j
above and the ID No. below. i
IO NO. DATE
-a,.'- ' ' ''. ' / Cl --' :'.'.---:..
:- : ..-. T'3 ;' - ' " '' / "'. : . .- ' . '
NAME Of INSPECTOR . ' .
'''.-'-. ''"'..'. ":!!.'..-.-. - '- .-...-..--,<.-
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
17 880
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: Routine Use of SEC "10-K" Statements in TSCA and FIFRA
Civil Penalty Actions T
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: (l) 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 basis.
-------
-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
of 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.
-------
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
-------
parent company, it is sometimes difficult to identify past
violations.
The 10-K statement should "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 ertremely 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, itiven-
""""' 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 in business 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, B.C. 20549- Regions must specify the name of
t,T)*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.
Conroy II,
Pesticides and ToxicM3ubstances
Enforcement Division
-------
Sample Extracted Filings
COMPANY PROFILE
0592799 PROFILE LAST FILED: 79/07/31 CO MO: C321300000
CENESCO "iNC ' " ' '
CENESCO PARK
BASHVILLE TN 37202
. WCDRPORATED IN:'TN' . . .
EXCHANGE: NYS TICKER SYMBOL: CCO ' ": '".": . ' " ,' V -.'"..
SEC FILE NO: 1-3083 IRS MO: 62-0211340 CUSIP: 3715323
SIC CODES: 2311 2331 3143 3144 5661
DESCRIPTION OF BUSINESS: MANUFACTURES AND RETAILS CLOTHING. OPERATIONS ARE
DIVIDED INTO FOUR SEGMENTS: FOOTWEAR, MEN'S APPAREL, SPECIALTY RETAILING AND
VARIETY RETAILING. OPERATES 61 MANUFACTURING PLANTS ACT WAREHOUSES AND
APPROXIMATELY 1,400 RETAIL STORES AND LEASE DEPARTMENTS THROUGHOUT THE U.S. AND
CANADA. .
FISCAL YEAR'END: 07/31 ' .. \ . ; . ' ... .;.'.. . .
10-K 79/07/31 ' ' '
AHS . 79/07/31 . .
I0-q 79/04/30
EECST SOB 78/05/01
^^^^^
10-K EXTRACT
'0592791 10-K .. : >V.WIZ: 79/07/31, .00 »:.C321300000.
v cEHEsco-we '" ."-"' :'"'' ."*..' >.:'.-'. .:'..-':'"'";
' : '.SHARES OP COMMON STOCK: .12,620,920:' -T';. . :"':-'. ' v
' NUMBFR OF SHAREHOLDERS: 32,403 '" '' ' ' ' ..'-"' ';''
NUMBER OF EMPLOYEES: 26,500
?ARENTS:
H/A - **" .
SUBSIDIARIES: ' ' '
BBC, WC.; "v
COLLEGE CROVE TRUCK COMPANY:
TLAGC BROS. OF PUERTO RICQ, WC..I -,. - . .
..CEVERXL^AETAll CORPORATION; '. ' '. '::' '.'. .;.'.. '-:' '''
CENESCO APPAREL AND FOOTWEAR. (FAR EAST)' LIMITED; ' '
CENLEATHER INCORPORATED;
S. R. KRESS OF LOUISIANA, WC.;
CENESCO ITALIA S.P.A.;
TENNESSEE RAVENWOOD PROPERTIES, WC".; " ' ' .
.CCO PROPERTIES, WC.;.... . . . . .
CENESCO CROOP INC.;'" : : " '".'' "'": '.-':'"^:'!>v. . . \..; x.-?ro-
UNIVERSAL SHOE "AND APPAREL EXPORT, WC.;
HENRI BENDEL, INC.;
I. MILLER & SONS, INC.:
S. R. KRESS AND COMPANY;
7. J. ELMDRE AND COMPANY;
BENESOO MERCER COMPANY, INC.;
oCO STOPS INCORPORATED;
EOEEN RESTAUTUNT'CORPORATIW; ,.-...-.-. . . '. .
..CENESCO APPAREL LIMITED; . .'"'.'
ACKEW-SURPASS SHOE. STORES, LIMITED; '' ' ' '-..' ' '.
-------
10-K Extract cont.
LIABILITIES
ACCOUKTS PAYABLE 75,3*7,000 87.035.000
NOTES PAYABLE ' -27,365,000 78.365,000 .
TAXES DUE M/A W/A '.
. TOTAL CURRENT LIAB. 117,174,000 187,078,000 ' : ' I
LONG TERM DEBT. .-...< 129,928,000 . 126>662:,000 . !
SHAREHOLDERS EQUITY ">"- .. '90.698,000 86,104^000 . ";'* - . ' .' ' ' !
INCOME STATEMENT !
WET REVENUE 992,925,000 1,048,351,000
COST OF COODS 672,812,000 705,740,000
CROSS PROFIT . . 320,113,000 . .342,.61l,000 . - -.. . -, :.-..>..'
SELL, 'CEN.'i A0MIH'. EX?.': ' 292,157;000 ' " 302,960,000 ' "' .,-'. ^ " :,-<
INCOME BEFORE TAX (1,045,000) 19,364,000
EXTRAORDINARY ITEM K/A M/A
NTT INCOME *,332,000 14,936,000 . v '
'.COMMENTS: '.'-.' . .. ' .'...' :-.. . . . .'" .-.
EXTRAORDINARY ITEM IS OPERATING LOSS CARRYFORWARD ' '
FOOTNOTES: .
. ACCOUNTING PRINCIPLES: ACCOUNTING CHANCE.FOR .COMPUTING THE U.S. TAX . .
PROVISION . . : .--.'. '.'":. .'.''. ' -' .' ' - . .'. ..-;' ' "-; ' .'.' ." ;' : ' '.' * . '
MERCER AND/OR ACQUISITION: PURCHASE, TENNESSEE RAVENWOOD PROPERTIES, INC., ' . ..'.''
PAYMENT IN CASH ' . . .
PRINCIPLES OF CONSOLIDATION: CENESCO FINANCIAL CORP. CARRIED ON EQUITY .....' . '
:^^V^-4f^>>^v4?^.^^*vfV:-*%:^
DEPRECIATION: SUM Of fftCnSj COUBLI DEaiNTKC BALANCE': PRINCIPAL METHOD" IS '" .-.':*>*"? .::*:% r«,-. ......;-.*r.-.--. .
STRAIGHT LINE . .
INVENTORIES: FIFO; RETAIL METHOD USED FOR RETAIL COMPANIES
SHORT TERM DEBT: LINE OF CREDIT: COMPENSATING BALANCE: RESTRICTING .
LONG TERM DEBT: COLLATERALIZED: CONVERTIBLE: RESTRICTING: AMENDED;
SUBORDINATED NOTE, SENIOR SINKING FUND NOTE, SUBORDINATED DEBENTURES, FIRST
MORTGAGE NOTES
' TAXES r. NET OPERATING LOSS CARRYFORWARD, $66,433,000, EXPIRES 'IN 1985 -I- -. ! .: .'.'.; : .'..'; >v '-.
; STOCK OPTION: .ONQUALIFIED: KEY.-EMPLOYEES STOCK OPTION PLAN; EMPLOYEE'. .. ..-: .':/.^ '.' '^--' v.' "\ v .'.'.>. :.s'\.." ' i
.INCENTIVE P1ANS A 4 B ...-.'.' .." ..' ' ' ' ' ' - - v - . '. » ... "..;... .-.-..;',. -V :.-."... ' .'..'
FOREIGN OPERATIONS: TRANSLATION CAINS OR LOSSES . ' . . ' . .' V-
LEASES:. .CAPITALIZED: EXPENSED: .PASB 13; SUBLEASES. .. ......:-.. . ...-,;'..-.. ...:'
:-:-..PENSION-PLANS:: "FUNDED":.^COST ACCRU?D;: VESTED BENEFITS EXCEEDED-ASSETS' , .:.v:v '%:':;-r: ''\^
:.; COMMrrMENTS/CONTINCENCIES: -..LEASES.; LTriCATIONS ... .:..:'. ...... ..-.'...,...., = .-..; ".,'.."..!".-.. . ..." .,'...'
..SUBSEQUENT -EVENTS: '»/>''.'.:-.. ''-.. .'.;:>*''."'*.>': ' ": :," '' ;'". -' '..-''A-..-. ':'.'"' .-'....";. ..":.'. ;. ' ''''
OTHER FOOTNOTES: REPLACEMENT COSTS: QUARTERLY FINANCIAL DATA: SEGMENT
INFORMATION: COMMON STOCK: SUPPLEMENTARY INCOME STATEMENT INFORMATION: CAPITAL
STOCK, PREFERRED STOCK: RECEIVABLES; CURRENT ASSETS OF OPERATIONS BEING
DIVESTED: INVESTMENTS AND LONG TERM RECEIVABLES: FIXED ASSETS OF OPERATIONS '
BEING DIVESTED: SUBORDINATED COMMITMENT TO FOREIGN FINANCE SUBSIDIARY;
PROVISION FOROPERATIONS BEING DIVESTED ANT RETAIL STORE CLOSINGS
The cost for retrieval and display of the above information (all
3 reports) is in the approximate range of S6.00 to S 12.00 de-
pending on search complexity and system vendor used.
9
-------
10-K Extract cont. .. .'... ' ... ' .... :... :;
s . * . '".'*'*,'' ' " "
DISCO SHOES LIMITED;
CENESCO OF CANADA CO. LTD. I '
CONTINENTAL SHOE SALES CORPORATION LTD.; . ' '
SHOE VILLA LIMITED; .
J. A. JOHNSTON COMPANY OF CANADA LIMTTED; . ..--....
. '..1EWARD SHOE STORES OF CANADA LIMITED; ' . !" .'.'...- v . .''''.: '..' ,. - '' - -.-.«' '
''DEXTER SHOES,'LIMITED; ' ' ..; . .
CENESCO WORLD APPAREL, LTD.|
PINEBROOK REALTY CORP.; , . ;:. ....
CENESOO INTERNATIONAL CORP.f ° ' ' .
-. -FULTON-PROCESS « CHEMICAL CORPORATION .-.'- ' ". :'., ' : ' ' ' ' % V-/
LEGAL PROCEEDINGS:
VIOLATION OF SECURITIES, IMPROPER SUSPENSION OF EXCHANGE RIGHTS OF HOLDERS OF ' , ..;>*«>
SERIES C STOCK AND SERIES B STOCK, CLASS ACTION, DENCO AND MICHAEL W. CRAMER r
V. CENESCQ, INC., DISPOSITION ADVERSE, APPEAL PENDING; ... '. , ... ,--. ..;.
VIOLATION OF SECURITIES, IMPROPER SUSPENSION OP THE RIGHT TO EXCHANGE SERIES B ...
STOCK, FALSE AND MISLEADING STATEMENTS, ERVIN CAMP, ET AL. V. CENESCO, INC.,
DISPOSITION ADVERSE SUMMARY JUDGEMENT, OTHER ISSUES PENDING:
. .VIOLATION OF SECURITIES, WRONGFUL .REFUSAL TO MAKE DEPOSITS TO SINKING FUND, . ' . .
. CEORCE THOMAS, ET AL. Vl'cENESCO, VHC'.', DISPOSITION PENDING; "
VIOLATION OF ANTITRUST, RETAIL PRICE FIXING, VARIOUS CLASSES OF CHARGE ACCOUNT .
CUSTOMERS V. CENESCO, INC. AND CERTAIN RETAILERS, DEFENDANTS IN SEVERAL
r COMMON-
STOCK PRICES, CLASS ACTION, LILA ZIPKIN V. CENESCO, INC., DISPOSITION PENDING;
VIOLATION OF SECURITIES. CLASS ACTION, CENESCO, INC., CENESCO FINANCIAL CORP.,
LEEDS SHOES, INC. .ET AL. DEFENDANTS, DISPOSITION PENDING:
.VIOLATION OF SECURITIES, FALSE 'AND MISLEADING STATEMENTS, INFLATING COMMON
STOCK PRICES, FORMER OWNERS OF AN ACQUIRED CORPORATION V. CENESCO, INC.,
DISPOSITION PENDING " ' '
DIRECTORS AND. OFFICERS: ... ..'.".. : - ;.. . .
' JtANlCAN, JOHN L.V CHAIRHAN-,:>RESIDENr AND 'CHIEF' 'EXECUTIVE OFF.ICER '. :' .' '."
J-vibwLES-,-RALPH >.V EXECUTIVE VICE PRESIDEWTV- GENERAL MANAGER OF RETAILING ''.'
LANCSTAFF, CEORCE Q.; EXECUTIVE VICE PRESIDENT, GENERAL MANAGER OF FOOTWEAR
SHELTON, LARRY'S.; EXECUTIVE VICE PRESIDENT, GENERAL MANAGER OF MEN'S APPAREL
.-. WIRE, WILLIAM S. M;: VICT -PRESIDENT .-'FINANCE AND -TREASURER CHIEF .FINANCIAL .
".OFFICER -.' '. Vv.-r r- -.':'"-:-' ...-;..-: ...-.;;.:....
. .CLARK, THOMAS -'B.|'-VICE FRESn»ENT',.;CENERAL WUNSEL .. ... ' " -.'. ': , . --'.-'.
O'CONNOR, WILLIAM C.: SECRETARY, ASSISTANT GENERAL COUNSEL
WHITE, JIMMIE D.; VICE PRESIDENT, CHIEF ACCOUNTING OFFICER
EXHIBITS: COMPUTATION EARNINGS PER SHARE; REVOLVING CREDIT AGREEMENT,
. 3/13/79, JJRO.UP OF 14 BANKS AND CENESCO FINANCIAL CORPORATION; EMPLOYMENT
AGREEMENT, AMENDED, 9/26/79, CENESCO AND JOHN L. HANICAN: STOCKHOLDERS'
PROPOSAL,^FUTURE STOCK OPTION PLANS, ANNUAL MEETING L2/4/78; CENESCO
RETIREMENT "SAVINGS FLAN, 1/1/79; HIGHLIGHTS OF THE CENESCO RETIREMENT SAVINGS
,.FLAN; CENESCO. RETIREMENT. FLAN r 1/1/79, .SUMMARY PLAN D.ESCRIFTION .... .. '. :.
''-AUDITOR:.-1«RICE WAlZRHOUSE**'-«>i: '.''" >-''-r- -' ..--. :.-''. .-''-..
' AUDITOR'S -REPORT: UNQUALIFIED " ''' - ' "
FISCAL YEAR OF REPORT ! -.1979 1978
. . .<:"**:&&&. t. ASSETS .5
'CASH - . .-;;;,. li,37i,ooo 20,576,000
, . MARKETABLE SECURmjM ,. ;.X -^-,,- -yl',.- .»/A,..,. ., , , . .:.-.. JI/A - .. '
"" ''RECEIVAiLES " '"' ''rf'"':..' J-- *^M't&1,000 ' ' ' 27,574,000
INVENTORIES : - 197,687,000 213,471,000
CURRENT ASSETS . - 242,226,000 294,419,000
PROP, PLANT AND EQUIP. '^:* 98,350,000 102,451,000
DEPRECIATION »/A N/A
TOTAL ASSETS 360,127,000 . 426,953,000
-------
Federal Resistor / Vol. A(>. No. 2LM / Thursday. October 22. TJ1U / Rules atul Ruyulaliuns 51745
40 CFR Part 162
IOPP 00149; PH-FRL-1964-8J
Advocacy of Pesticide Uses Which Oo
Not Appear on Registered Pesticide
Label; Statement of Policy
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Rule related notice.
SUMMARY: The Office of Pesticides and
Toxic Substances Enforcement has
reconsidered its position that the
advocacy of section 2(ee) of the Federal
Insecticide. Fungicide, and Rodenticide
Act uses be limited to user/applicators.
This notice informs the public that since
sec. 2(ce)'uses are no longer misuse, any
person may legally recommend or
advertise such uses.
DATE: This policy statement is effective
October 22.1981.
FOR FURTHER INFORMATION CONTACT:
l D. Selmaru Office of Pesticides
Toxic Substances Enforcement (EN-
342). Environmental Protection Agency.
401 M St.. SW.. Washington. D.C. 20460
(202-755-9404).
SUPPLEMENTARY INFORMATION: The
Federal Insecticide. Fungicide, and
Rodenticide Act (F1FRA) was amended
by the Federal Pesticide Act of 1978
(FPA) on September 30,1978. The FPA
broadened the construction of section
12(a)(2)(C) of FIFRA which provides
that it shall be unlawful "to use any
registered pesticide in a manner
inconsistent with its labeling." The new
suction 2(ee) defines the phrase "to use
tiny registered pesticide In a manner
inconsistent with its labeling."
According to the language of this new
section, it is a violation of section
12(a)(2)(C) to use a registered pesticide
"in a manner not permitted by the
labeling" with the exception of four
specific areas. Under section 2(ee) it is
not misuse to:
1. Apply a pesticide at any dosage.
concentration, or frequency less than
(hat specified on the labeling.
2. Apply a pesticide against any
target pest not specified on the labeling
if the application Is 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).
3. Employ any method of application
not prohibited by the labeling..
4. Mix a pesticide or pesticides with a
fertilizer when such mixture is not
prohibited by the labeling.
This notice informs the public that
since section 2(ee) uses are no longer
misuse, any claims made.regarding
these uses are not unlawful unless the
registered pesticide label specifically
prohibits the use. Thus, to the extent
that section 2(ee) allows particular uses.
any person may legally recommend or
advertise such uses provided that
recommendations made under section
2(ee)(l) pertaining to the amount of
diluent used in applying pesticides for
forestry or agricultural purposes must be
made in accordance with the Advisory
Opinion published In the Federal
Register of March 3,1981 (40 FR14965).
This Policy does not prospectlvely
.mend any existing pesticide labeling;
all changes in a registered pesticide
label must still be approved by the
Agency. This Notice supersedes the
Federal Register notice of June 8.1979.
(44 FR 33151] which limited section 2(ee)
recommendations to user/applicators.
Civil Liability
This new policy not only implements
the Congressional intent of section 2(ee)
to allow beneficial nonlabel pesticide
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 dvil liability of
persons who recommend pesticide uses.
It should be noted that the FPA only
amends Federal pesticide law and does
not purport to affect Slate pesticide laws
or possible private civil liability. The
only change is that the Agency 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)(l](B) against any person with a
financial Interest who makes pesticide
use recommendations which exceed the
limits of section 2(ee). Additionally, any
^crson who recommends section 2(ee)
scs. of course, remains lioblo for
(Sees. 2 and 12. ai amended. 82 Stal. 019 17
U.S.C 136))
Dated: October 14. 1981.
Edwin H. Clark,
Acting Atsistont Administrator. Office of
Pcstitidet and Toxic Substances.
(FS Dec «-»«? Rl«l lO-H-W: C45 .m|
BIUJNO COOt U40-3I-44
-------
53112.
TITLE 40--PROTECTION. OF ENVIRONMENT
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
SUBCHAPTER E--PESTICIDE PROGRAMS
[OPP 40010A]
PART HICERTIFICATION OF PESTICIDE APPLICATORS
RECORDKEEPING AND REPORTING REQUIREMENTS
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final Rule.
SUMMARY: EPA by this rule will amend the existing regulations
at 40 CFR Part 171 by imposing certain recordkeeping and
reporting requirements upon pesticide dealers.in States or
on Indian Reservations where the Administrator conducts the
applicator certification and training program, as authorized
by section 4(a)(l) of the Federal Insecticide, Fungicide, and
Rodenticide Act, as amended (FIFRA or the Act). This rule
will require persons who make restricted use pesticides available
to users to provide a one-time written report to the Agency,
certifying that they are maintaining records of the sale or
distribution of restricted use pesticides. The rule wi 1-1 also
prescribe conditions under which pesticide dealers can make
restricted use pesticides available to uncertified persons for
use by a certified applicator, and describe more precisely the
location where records concerning application of restricted use
pesticides must be maintained.
83P-917
-------
-2-
EFFECTIVE DATE: This rule will not take effect before the end
of 60 calendar days of continuous session of Congress after
the date of publication. EPA will issue the effective date of
this rule in the FEDERAL REGISTER. See Supplementary Information
for further details.
FOR FURTHER INFORMATION CONTACT:
David Hannemann,
Compliance Monitoring Staff (EN-342),
Office of Pesticides and Toxic Substances,
Environmental Protection Agency,
Rm. 2624-D,
401 M St., SW.,
Washington, D.C. 20460,
(202-382-7849).
SUPPLEMENTARY INFORMATION: Approval by OMB is pending.
BACKGROUND
Section 4(a)(l) of FIFRA, as amended by the Federal Insecticide,
Fungicide, and Rodenticide Act (Pub. L. 96-539, 92 Stat. 819,
7 U.S.C. 136b(a)(l)), provides that the Administrator may
prescribe by regulation the maintenance of records and submission
of reports concerning the commercial application, sale or
distribution of restricted use pesticides in States or on
Indian Reservations where the Administrator conducts a pesticide
applicator certification program. Recordkeeping requirements
for commercial applicators in such States were promulgated and
may be found at 40 CFR 171.11(c)(7).
-------
-3-
DISCUSS10N
Tne «G..V! n i st rator proposed a 'rule which was published in
the FEDERAL REGISTER of July 28, 1982, (47 FR 32551), requiring
that persons who sell or distribute restricted use pesticides in
States or on Indian Reservations where the Administrator conducts
a certification program must: (1) submit a one-time report
certifying that the records required by the final rule are being
kept, and (2) maintain records of all transactions in which
restricted use pesticides are made available for use. At the
present time, persons to whom such restricted use pesticides
are made available for use must be certified. Commercial
certified aplicators must keep records of their use of restricted
use pesticides in accordance with regulations at 40 CFR Part 171.
This rule does not apply to transactions .between pesticide
producers, registrants, wholesalers, and retail sellers which
do not involve the sale or distribution to persons who will
actually use or supervise the use of the restricted use pesticides
Prior to the 1978 amendments to FIFRA, there were no
requirements that records be kept and reports be made concerning
the sale and distribution of restricted use pesticides. As a
«i
result, the Agency has no comprehensive inventory of dealers
who sell or distribute restricted use pesticides.
This rule adds a new paragraph (b) to 40 CFR 171.2 defining
/'
the terms "restricted use pesticide retail dealer," "make avail-
able for use," "dealership," "uncertified person," and "principal
place of business." It also adds a new paragraph (g) to 40 CFR
171.11 which requires dealer reporting, recordkeeping, and
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-4-
avallability of records regarding making restricted use pesti.cides
available to certified applicators and uncertified persons and
lists potential remedies for failure to comply.
The one-time reporting requirements contained in this
rule will identify all dealers of restricted use pesticides in
States or on Indian Reservations where the Administrator conducts
the applicator certification and training program. The Agency
will then be able to use this information to establish a neutral
administrative inspection scheme to monitor compliance by both
certified applicators and uncertified persons obtaining restricted
use pesticides for use by certified applicators.
COMMENTS RECEIVED
During the public comment period on the proposed rule, which
was published in the FEDERAL REGISTER of July 28, 1982 (47 FR 32551)
five comments were received. Several of the commenters supported
the proposed rule in general but recommended changes to particular
sections. Minor changes were made to the regulation in response
to the comments received. No major changes were required.
One commenter indicated that the commercial certified applicator
recordkeeping requirements at 40 CFR 171.11(c)(7) should be
clarified to make both the individual applicator and the firm by
which he is employed responsible for assuring that the records
regarding the use of restricted use pesticides will be maintained.
The Agency does not wish to impose a duplicative recordkeeping
requirement on certified commercial applicators and the firms
which employ them. The Agency's expectation in making the certified/
commercial applicators responsible for maintaining records of
-------
-5-
Fheir use of restricted use pesticides and making the records.
readily available to EPA inspectors was that such records would
be kept at the principal place of business of the person or firn
that makes the arrangement with a property owner to have the
pesticide applied to the property.
Because of the many different types of relationships that
exist between certified commercial applicators and the firms
that utilize their services, many readers were unclear as to
their particular recordkeeping responsibilities. Accordingly,
the Agency has amended §171.11(c)(7) to require that records
regarding the use of restricted use pesticides by a certified
commercial applicator must be maintained at a self-employed
Commercial applicator's principal place of business and at the
principal place of business of a firm that employs a certified
commercial applicator or that contracts to have such an applicator
apply a restricted use pesticide on the property of another.
The Agency finds that this amendment is appropriate because
it will allow EPA to examine records at the place of business
of the person or firm with whom the property owner dealt in
arranging to have a pesticide applied. This will facilitate
investigation of improprieties alleged to have occurred in
particular applications of restricted use pesticides. Moreover,
the record of a use of a restricted use pesticide is usually an
invoice prepared by the certified commercial applicator or his
employing firm when a commitment or contract for application is
kiade prior to the actual application. The employer's principal
place of business is generally the central repository for such
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-6-
application records. Requiring the records to be kept at thi-s
location should not add a separate recordkeeping burden.
One commenter suggested that the term "make available for
use" appeared to include the activities of common carriers trans-
porting restricted use pesticides, thus making common carriers
subject to the requirements of this section. The Agency disagrees
with this comment. Restricted use pesticides are not "made
available for use" by common carriers. Common carriers simply
transport material between pesticide producers, registrants,
wholesalers or retailers. Common carriers are not subject to
the requirements of this section. No changes were made in the
definition of the term "make available for use."
One commenter indicated that requiring the dealer to record
information outlined in §171.11(g) will require additional work
since much of the information is already on the delivery record
or billing invoice. The rule does not require the dealer to
record separately on the delivery receipt or billing invoice any
of the required information which appears on the delivery record
or billing invoice as a routine record of the commercial trans-
action. If the information is already present on the delivery
receipt or the billing invoice, the dealer need not duplicate
such information. Indeed, the Agency feels that most of the
information required to be maintained under this rule is already
routinely kept as a part of the commercial sales records.
Several commenters indicated that it would be difficult for
the dealers to provide the name and address of the person(s)
to whom the restricted use pesticide is made available for use
-------
-7-
i f 111 c dfrcier delivers _t h e restricted use pesticide to a field
or an airstrip. The rule has been clarified to indicate that in
such instances, the address which the dealer must keep on
record is the address of the certified applicator's principal
place of business, and not the delivery address.
Several commenters indicated that recording the name and
EPA registration number (or the special local needs registration
number) would impose an unwarranted burden, and that when pre-
paring a delivery record or invoice, firms would be required to
go into the warehouse to search out the appropriate registration
number. The Agency believes that both the dealer and EPA need
to know exactly which restricted use pesticides are being made
available for use to individual users. Because substantially
different restricted use pesticides have similar names, pesticide
dealers cannot simply use a generic reference, such as parathion
8 lb., to identify the product made available for use. Only the
registration number will identify a restricted use pesticide
exactly. Furthermore, commercial applicator certifications are
issued for specific limited use categories. It is essential
that the dealer document that the certification of the applicator
is appropriate for each specific restricted use pesticide
product made available for use. This link between a specific
product and a specific applicator can be made only with a
reference to a registration number. This requirement has been
retained.
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-8-
Several commenters indicated that it is meaningless to
require a record of the expiration date of an applicator's
certification since the applicator's certification could expire
after the restricted use pesticide was purchased, but before
the product was used. An applicator who uses a restricted use
pesticide after his certification has expired would be in
violation of FIFRA. To eliminate the further availability of
restricted use pesticides to applicators whose certifications
have expired and to minimize the opportunity that such a
violation could occur, the requirement has been retained.
Several commenters indicated that many restricted use
pesticide dealers maintain files with the names, addresses,
certification numbers, and certification expiration dates of
applicators who purchase restricted use pesticides. They argue
that requiring this information, particularly information
regarding the certified applicator, on the sales record would
unnecessarily dictate one method of recordkeeping for all dealers
subject to this rule. The Agency disagrees. While the restricted
use pesticide dealer is responsible for maintaining the information
required by this rule, the Agency does not prescribe any particular
method for keeping these records. The dealer may elect to maintain
the required information regarding the certified commercial
applicator in a file containing the name, address, certification
number, certification category (if applicable) and expiration
date of certified applicators who regularly purchase restricted
use pesticides from them. The dealer may reference these records
to verify the information presented at the time of each trans-
action and to update his own files.
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-9-
The Agency believes that the best source of data regarding
the name, address, certification number, certification category
(if applicable) and expiration date of the certified applicator
who purchases the restricted use pesticides is the applicator's
current certification document or a facsimile of that document.
The Agency has no preference, however, regarding the system used
by the dealers to catalogue or maintain the information required
by this rule. This requirement has been retained.
One commenter pointed out that restricted use pesticides,
when delivered to an applicator's residence, business or
application site, are frequently received by an individual who
is not certified. In other circumstances, a certified applicator
may send an associate, employee or spouse to obtain a restricted
use pesticide for use by the certified applicator. In response
to this comment, the Agency has divided the recordkeeping section
of the rule into two parts. The first set of recordkeeping
requirements applies to persons making restricted use pesticides
available to certified applicators. The second set of recordkeeping
requirements applies to the special situation when a dealer makes
restricted use pesticides available to an uncertified person
for use by a certified applicator.
FIFRA 12(a)(2) states that it is unlawful for any person
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-10-
"{}') lo male available (or use. or to use, any registered pesticide
classified lor restricted use (or some 01 all purposes other than in ac-
cordance with section 3(d) and am regulations thereunder;
Provided. That it shall not be unlawful to sell, under regulations
issued by the Administrator, a restricted use pesticide to a person
uho is not a certified applicator for application by a certified ap-
plicator;
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-11-
. .. (^cognizes the' need to ensure that restricted use pesticides
are made available only to persons who are qualified to use them
safely, without making it unduly burdensome for certified
applicators to obtain restricted use pesticides. Therefore, the
Agency has amended the rule to permit pesticide dealers to make
restricted use pesticides available to uncertified persons for
use by certified applicators only under the circumstances set
forth therein.
This rule affects only pesticide dealers making restricted
use pesticides available to uncertified persons in States or on
Indian Reservations where the Administrator conducts the pesticide
applicator certification and training program. States having
State Plans approved under FIFRA section 4 and wishing to adopt
a similar procedure of making restricted use pesticides available
to uncertified persons shall submit to the Administrator a Plan
containing the minimum standards outlined in 40 CFR Part 171.
Such a Plan should contain the information as outlined in Unit
IX, (entitled "Purchase By Uncertified Persons For Use By Certified
Applicators") of the preamble to the rule entitled "Optional
Procedures for Classification of Pesticide Uses by Regulation;
Pesticide Use Restrictions" published in the FEDERAL REGISTER of
February 9, 1978 (43 FR 5783).
FURTHER INFORMATION ON EFFECTIVE DATE OF THIS RULE
On December 17, 1980, an Act to extend the Federal Insecticide,
Fungicide, and Rodenticide Act (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
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-12-
paragraph, section 25(e), to FIFRA which requires EPA to submit
final rules to Congress for review before the rule becomes
effective. Copies of this rule have been transmitted to the
appropriate committees 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 con-
tinuous 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 the date on which this rule will become effective.
Therefore, at the appropriate time, EPA will announce in the
FEDERAL REGISTER expiration of the legislative review period and
the effective date of this rule.
COMPLIANCE WITH THE REGULATORY FLEXIBILITY ACT
AND EXECUTIVE ORDER 12291
I hereby certify that this rule will not have a significant
economic impact on small business entities. This rule affects
only a small number of businesses in States where the Administrator
conducts the pesticide applicator certification and training
program.
This rule was submitted to the Office of Management and
Budget (OMB) for review as required by Executive Order 12291.
COMPLIANCE WITH THE PAPERWORK REDUCTION ACT
< , Under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501
et seq., the information provisions in this rule have been
submitted for approval to the Office of Management and Budget
(OMB) and have been assigned OMB Control Number 2000 - 0355.
-------
-13-
3(d), 4(a)(l), and 25(a)(l), Pub. L. 95-396, 92 Stat
b. r.C. 136a, 136b, 136w))
LIST OF SUBJECTS IN 40 CFR PART 171
Pesticides and pests
Intergovernmental relations
Indian lands
Recordkeeping and reporting requirements
n _, KOV 17 1383
Dated:
/S/ WILLIAM 0. RUCKELSHAUS
William D. Ruckelshaus,
Admi nistrator.
Therefore, Part 171, Subchapter E, Chapter I of 40 CFR is
amended as follows:
1. In §171.2, by redesignating paragraphs (a) through
(bb) as paragraph (a)(l) through (28); by revising the
introductory text of §171.2 and designating it as the
introductory text of paragraph (a) as set forth below; and
by adding a new paragraph (b) as set forth below:
§171.2 Definitions.
(a) General. Terms used in this subpart shall have the
meanings set forth for such terms in the Act. In addition,
the following definitions are applicable to all aspects of
the certification of pesticide applicator program in this part:
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-14-
\. ' ml t e d . The following definitions apply only to
dealers, dealerships and transactions in States or on Indian
Reservations where EPA conducts a Federal Pesticide Applicator
Certification Program.
(1) The term "restricted use pesticide retail dealer" means
any person who makes available for use any restricted use
pesticide, or who offers to make available for use any such
pesti cide.
(2) The term "make available for use" means to distribute,
sell, ship, deliver for shipment, or receive and (having so
received) deliver, to any person. However, the term excludes
transactions solely between persons who are pesticide producers,
registrants, wholesalers, or retail sellers, acting only in
those capacities.
(3) The term "dealership" means any site owned or operated
by a restricted use pesticide retail dealer where any restricted
use pesticide is made available for use, or where the dealer
offers to make available for use any such pesticide.
(4) The term "uncertified person" means any person who is
not holding a currently valid certification document indicating
that he is certified under section 4 of FIFRA in the category
of the restricted use pesticide made available for use.
(5) The term "principal place of business" means the
principal location, either residence or office, in the State
in which an individual, partnership, or corporation applies
pesticides.
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-15-
2. In §171.11 paragraph (c)(7)(i) is revised and paragraph
(g) is added to read as follows:
§171.11 Federal certification of pesticide applicators in
States or on Indian Reservations where there is no approved
State or Tribe certification plan in effect.
* * * * *
(c) . * * *
(7) Recordkeeping requirements, (i ) Each self-employed
certified commercial applicator, each firm employing a certified
commercial applicator, and each person who contracts with a
certified commercial applicator (or his or her employer) to have
a restricted use pesticide applied on property owned or operated
by another person shall keep and maintain at their principal
place of business true and accurate records of the use of
restricted use pesticides, providing the following information:
* * * * *
(g) Pesticide dealer reporting and recordkeeping
requirements, availability of records, and failure to comply--(1)
Reporting requirements. Each person who is a restricted use
pesticide retail dealer in a State or on an Indian Reservation
c
where the Administrator conducts the applicator certification
and training program shall:
(i) Report to the Environmental Protection Agency (EPA)
the business name by which the restricted use pesticide retail
dealer operates, and the name and business address of each of
his dealerships. For dealers or dealerships in Nebraska this
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-16-
initial report must be submitted to EPA, Region Vll, 324 E. llth
Street, Kansas City, MO 64106. For dealers or dealerships in
Colorado this initial report nust be submitted to EPA, Region
VIII, 1860 Lincoln Street, Denver, Colorado 80295. This report
shall be submitted to the appropriate EPA regional office no
later than 60 days after the date the person first becomes a
restricted use pesticide retail dealer, or within 60 days
after the publication of the effective date of this final rule,
whichever date is later.
(ii) Submit revisions to the initial report to the
appropriate EPA regional office listed above reflecting any
name changes, additions or deletions of dealerships. Revisions
shall be submitted to EPA within 1.0 days of the occurrence of
such change, addition or deletion.
(2) Recordkeeping requirement. Recordkeeping is required
when making restricted use pesticides available to:
(i) Certified applicators. Each restricted use pesticide
retail dealer shall maintain at each individual dealership
records of each transaction where a restricted use pesticide 1s
/'
made available for use by that dealership to a certified applicator.
Record of each such transaction shall be maintained for a period
of 24 months after the date of the transaction, and shall
include the following information:
(A) Name and address of the residence or principal place of
business of each person to whom the pesticide was made available
for use.
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-17-
(B) The certification number on the document evidencing
that person's certification, the State (or other governmental
unit) that issued the document, the expiration date of the
certification, and the categories in which the applicator
is certified, if appropriate.
(C) The product name, EPA registration number, and the
State special local need registration number, granted under
section 24(c) of the FIFRA (if any) on the label of the pesticide.
(D) The quantity of the pesticide made available for
use in the transaction.
(E) The date of the transaction.
(ii) Uncertified persons. No dealer or dealership may make
a restricted use pesticide available to an uncertified person
unless he can document that the restricted use pesticide will
be used by a certified applicator, and he maintains the
records required in this subsection. Each restricted use pesticide
retail dealer shall maintain records at each individual dealership
of each transaction where a restricted use pesticide was made
available to an uncertified person for use by a certified applicator,
Records of each such transaction shall be maintained for a period
of 24 months after the rfate of the transaction, and shall include
the following information:
(A) The name and address of the residence or principal place
of business of the uncertified person to whom the restricted use
pesticide is made available for use by a certified applicator.
(B) The name and address of the residence or principal place
of business of the certified applicator who will use the restricted
use pesticide.
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-18-
(C) The certified applicator's certification number, the
State (or other governmental unit) that issued his certification
document, the expiration date of the certification, and the
categories in which the applicator is certified, if appropriate.
(D) The product name, EPA registration number, and the
State special local need registration number, granted under
section 24(c) of the F1FRA (if any) on the label of the pesticide,
(E) The quantity of the pesticide made available for
use in the transaction.
(F) The date of the transaction.
(G) At the time of each transaction, EPA recommends that
the dealer obtain the information required in paragraph (g)(2)
(ii)(A) through (C) of this section and assure himself that
the restricted use pesticide is made available for use by a
certified applicator by examining one of the following sets of
documents:
(I) The original of the certified applicator's certification
document, and a driver's license or other State, county, or
Tribal identification document issued to the uncertified
person to whom the restricted use pesticide is made available.
(2) A photocopy or facsimile of the certified applicator's
certification document, together with a statement signed by
the certified applicator authorizing the uncertified person to
purchase the restricted use pesticide on his behalf, and a
driver's license or other State, county, or Tribal identification
document issued to the uncertified person to whom the restricted
use pesticide is made available.
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-19-
(2.) A phot.ocopy or facsimile of the certified applicator's
certification document, together with a copy of a signed contract
or agreement, between the uncertified person to whom the restricted
use pesticide is being made available for use and the identified
certified applicator, which provides for the use of the restricted
use pesticide by the identified certified applicator, and a
driver's license or other State, County, or Tribal identification
document issued to the uncertified person to whom the restricted
use pesticide is made available.
(3) Availability of required records. Each pesticide
dealer shall, upon request of any officer or employee of EPA
duly designated by the Administrator, furnish or permit such
person at all reasonable times to have access to and copy all
records required to be maintained under this section.
(4) Failure to comply. Any person who fails to comply with
the provisions of thi's rule may be subject to civil or criminal
sanctions, under section 14 of the Act, or 18 U.S.C. 1001.
Violations include failure to submit or falsification of any
report required under this paragraph, failure to maintain or
falsification of records as required under this section, and
making available for use any pesticide classified for restricted
use to a person who is not a certified commercial applicator
other than in accordance with these regulations and section
3(d) of the amended FIFRA or rules promulgated thereunder.
-------
tl / Wcdr.
PSM.IV. A
1!>M-' / Rul
..ud posts, A^j.iiniiv'.i.itivi1 p'.'( !'
P.i1' i: A|iri! 10. 1'JW.
!')!m A. Mu;>ro.
A::si.'.';:nt Administrator for Pus'.it.:*:"
(t-T.I)ii»*-IO«0« Tiled «-:<-M 0«Sci.i|
CiLUMO CODE O^GC-IO-U
40 CFR Pert 171
(OPP-25CQS4; PH-FRL 2565-7)
Certification of Pesticide Applicators
Effective Date for Rccordkecplng and
Reporting Requirements
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final Rule: Effective Date.
SUMMARY: As required by section
25(a)(4) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA),
EPA submitted a final regulation
establishing certain recordkecping end
reporting requirements for pesticide
dealers in States or on Indian
Reservations where the Administrator
conducts the applicator certification and
training program under FIFRA to both
Houses of Congress for review prior to
the regulation taking effect. This
regulation was published in the Federal
Register cf November 23, 1333 (-:0 FR
53972]. The minimum 60-day period for
Congressional review ended or. April 2.
1964. Also during thin period, the Office
cf Mar.crcrrier.t and Budget (OMB)
assigned control number 2GCO-C352 to
the information collection requirements
cf this rule.
EFf^CTiVc DATE; The regulation is
effective Apr:! 25, 1S3-J. '
FOR rUiTTHEH If.TOKr.'.ATIOf: CONTACT:
David Hanr.err.ar.n, Ccmpliance
Monitoring Staff (EN-342). Office of
Pesticides and Toxic Substances,
Er.vironmental Protection Agency. P-m.
262-ID. 101 M St.. SW.. Washington. D.C.
20-ieO. (2C2-332-7&49).
SUPPLEMENTARY ircrorr.iATicu: ON'B
control number: 2000-0352. EPA issued c
fir.i:! regulation, which was published in
the Fodor.-.l Register of Ncvcrrbcr C^.
19S3 (4G FR 53972), under section 4 cf
F!FRA. cs amended (7 U.S.C. 130 et
sen.). The regulation prescribed the
maintenance of rcccrds end submission
cf reports concerning the sale cr
distribution cf restricted use pcstid'Jns
in States or on Indian Reservations
where the Administrator conducts u
certification program. However, ns
required by section 25(a)(4) of FIFRA,
the regulation could not take effect until
it had been submitted to both Houses of
Congress for o period of GO days of
( .:.'i::;in'!!i Con ;r,.",',iu!i:n v, :' 'ii-.:. ;::
,!"fif'i'. >.y Mvlinn j.-if,.](.!). f-ir,.." il \\..
i-ii! |v.. iiili; to preilicl n;i ( x.ii.t d.il-: i-.,
ulii .!i the Ciinjjri:r,Mon..l irvicw j.-iriod
w.-.-iild end. tho prcv.:iihl-.: to lh:: fin..i
rr; uh'.lio.i ttiitcs that F.i!A would is..uj u
scpai j'.u Federal Register notice after
the r.ivicw period was over announcing
the effective date of the regulation. On
April 2,1QIA4, GO days of continuous
Congressional snsr.ion elnpsed.
During the period of Congressional
review, the information collection
requirements contained in this rub were
approved by OMB under the provisions
of Ihc Paperwork Reduction Act of 19EO, '
44 U.S.C. 3501 et seq. and were assigned v
OMB control number 2000-0352. ':
List of Subjects in 40 CFR Part 171
Rccordkeeping and reporting
requirements, Intergovernmental
relations, Indian lands, Pesticides and
pests. v.
PAST 171 [AMENDED]
Accordingly, the final regulation
promulgated on November 29.1933, is
effective April 25,1934. The OM3 '
control number 2000-0352 is added to
the end of 49 CFR 171.11 to read as
fellows: ;
V
§ 171.11 Fec'srsl certification of pesticide
cppllcators In States cr en Indlsn
ncscrvctlsp.3 Where there is no spprovcd
Sta'.a cr Tdisl ccrtlftcctlcn plan In cffcc!.
(Approved by the Office cf Mcr.agc-ment
and Budget under ccr.L-ol number 2003-0352.)
(Sec. 25. as amended, Pub. L. S6-539, 94
Slnt. 3103 (U.S.C. 136))
D^tcd: April 1G, i'J3i.
Ji;hn A. Mcsrc,
A:s::tcrtAJ:r.!:'.:;:K:;rfc.*Pcs!:c::d!SZ.-:C'
Toxi; S-bs'.cr.zts.
rnic;: tv-icsc; ni=-J t-:-i-o>; c«;c^;
c:ujr:3 cos; C3oc:-u
i
by the dc.icr.;ni:nt control nuniliur jixXJCj,'
R06C). may he submitted to t'si:: Huarir;;
Clerk (A-110), Eiu-ironnenlal Proter.'.iun
Agency, Rm. 3708, 401 M St., SW..
Washington. D.C. 204CO.
FOn FURTHER INFORMATION CCUTAC7: !
i
By mail: 1 Icr.ry !.l. Jacoby, Product I
Manager (PM) 21, Registration i
Division (TS-767C), Office of Peslicid; !
Programs, Environmental Protection
Agency. 401 M St., SW.. Washington. |
D.C. 20400. ;
Office location and telephone number:
Rm. 229. CM No. 2.1S21 Jefferson j
Davis Highway, Arlington, VA 22102. ]
(703-557-1900).
SUFPLEUZMTARY INFOnrOATlCN: EPA
" issued Q proposed rule, published in the
Federal Register of March 20,1964 (-:3
FR 11055), which announced that th-:-
Agency proposed to amend
-------
United States
Environmental Protection
Agency
Office of Pesticides
and Toxic Substances
4>EPA Suspended, Cancelled, and
Restricted Pesticides
Office of Compliance
Monitoring
Washington DC 20460
-------
Suspended, Cancelled, and Restricted (SCR) PestJddes
Prepared by the Office of Compliance Monitoring,
Office of Pesticides and Toxic Substance*,
U.S. Environmental Protection Agency (EPA)
This booklet has been compiled for the purpose of summarizing and clarifying
actions taken by EPA for pesticides that the Agency has suspended, cancelled, or
otherwise restricted because of concern for potentially adverse effects.'
The following have been excluded from this booklet:
a) Pesticide registrations that have been cancelled for failure to pay the annual
registration maintenance fee required by the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended in 1988;
b) Cancellations on pesticide use patterns that were cancelled by Pesticide
Regulation Notices based on "residue," "no residues," and "zero tolerances";
c) Pesticides that have been cancelled by some, but not all, registrants; and
d) Pesticides that have been suspended as the result of Stop, Sale, Use, or
Removal Orders as defined under Section 3(C)(2)(B) of FIFRA.
This listing identifies the current status and references the regulatory history of each
pesticide, as well as the criteria of concern for which the chemical was reviewed by the
Agency. This booklet was designed to provide EPA inspectors with a quick reference
guide, as well as to provide other government agencies, both domestic and foreign, with
current information on these pesticides. This guide should aiso prove useful to anyone
interested in pesticides or involved in pesticide regulatory work.
This publication was compiled in conjuction with technical, legal, and scientific
divisions within the Office of Pesticides and Toxic Substances. It represents the fifth
edition of the Suspended, Cancelled, and Restricted Pesticides booklet and replaces the
previous edition published in January 1985. The material in this edition was compiled as
of February 1990. Future Agency actions will necessitate updating this publication, and
inserts will be published periodically.
* The term restricted applies to pesticide uses that have been limited, revised, or restricted to
comply with specific label changes mandated by the Agency and does not include ail restricted-use
pesticides, which require application by or under the direct supervision of a certified applicator as
defined under Section 3(d) of tho Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). To obtain
a separate list of these restricted-use pesticides, please contact the EPA Registration Support Branch,
Registration Division, Office of Pesticide Programs (703) 557*7700.
SCR Pesticides List February 1990
-------
Comments on the accuracy and completeness of this list should be addressed to:
Office of Compliance Monitoring (EN-342)
Office of Pesticides and Toxic Substances
Environmental Protection Agency
Washington, D.C. 20460
SCR Pesticides List " February 1990
-------
INDEX
Alar
Aldrin
Amitraz
Arsenic Trioxide
Benomyl
BHC
Bithionol
Bromoxynil
Bromoxynil Butyrate
Cadmium
Calcium Arsenate
Captafol
Captan
Carbon Tetrachloride
Chloranil
Chlordane
See Oaminozide
Hexachlorohexahydro-endo, exo-dimethanonaphthaJene
95 percent, nnd related compounds 5 percent (CAS No.
309-00-2)
N'-(2,4-Dimethylphenyl)-N-[((2,4-dimethylpheny1) imino]
methyl] N-methyl-methaneimidamide (CAS No. 33089-
61-1)
Arseneous oxide (CAS No. 1327-53-3)
Methyl 1 (butylcarbamoyl)-2-benzimidazo!ecarbamate
(CAS No. 17804-35-2)
Benzene hexachloride, other isomer of (CAS No. 608-73-
1)
2,2'-Thiobis(4,6-dichlorophenoJ) (CAS No. 97-18-7)
Benzonrtrile, 3,4-dibromo-4-hydroxy (CAS No. 1689-84-5)
(CAS No. 3861-41-4)
(CAS No. 7440-43-9)
See Wood Preservatives
Cis-N-((1,1,2,2-tetrachloroethyl)thio)-4-cyclohexene-1,2-
dicarboximide (CAS No. 2939-80-2)
N-Trichloromethylthio-4-cyclohexene-1,2-dicarboximide
(CAS No. 133-06-2)
(CAS No. 56-23-5)
Tetrachloro-p-benzoquinone (CAS No. 116-29-0)
Octachloro-4,7-methanotetrahydroindane (CAS No. 57-
74-9)
SCR Pesticides List
February 1990
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Index
Chlordimeform
Chlorobenzilate
Copper Arsenate
Creosote
Cyanazine
Cyhexatin
Oaminozide
DBCP
ODD (TDE)
DDT
2,4-D
Diallate
Dicofol
Dieldrin
Dimethoate
Dinocap
Dinoseb
Disinfectants
EBDCs
EDB
N,N-Dimethylformamidine, N'-(4-chloro-o-totyl) (CAS No.
6164-98-3)
Ethyl 4,4'-dichlorobenzflate (CAS No. 510-15-6)
(CAS No. 10103-61-4)
See Wood Preservatives
Propaneitrile, 2-((4-chloro-6-(ethyiamino) 1,3,5-triazin-2-y-
1)amino)-2-methyl (CAS No. 21725-46-2)
Tricyclohexylhydroxystannane (CAS No. 13121-70-5)
Butanedioic acid, mono(2,2-dimethylhydrazide) (SCI)
(CAS No. 1596-84-5)
1,2-Dibromo-3-chloropropane (CAS No. 96-12-8)
Dichloro diphenyl dichloroethane (CAS No. 72-54-8)
Dichloro diphenyl trichloroethane (CAS No. 50-29-3)
2,4-Dichlorophenoxyacetic acid (CAS No. 94-75-7)
S-(2,3-Dichloroallyl) diisopropylthiocarbamate (CAS No.
2303-16-4)
Benzenemethanol, 4-chloro-,alpi ir,-(v-c,' i.'orophoiiy»;- .
,alpha,-(trichloromethyl) (CAS No. 115-32-2)
See Aldrin
0,0-Dimethy1S-((methylcarbamoyl)methyl)
phosphorodithioate (CAS No. 60*51-5)
Dinrtro (l-methylheptyl)phenyl crotonate (CAS No. 39300-
45-3)
Phenol,2-(1-methyfpropy1)-4,6-dinitro (CAS No. 4097-36-
3)
Ethyfene bisthiocarbamates
Ethylene dibromide (CAS No. 106-93-4)
SCR Pesticides List
February 1990
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Index
Electromagnetic Pest
Control Devices
Electronic Mosquito
Repelling Devices
Endrin
EPN
Fluoroacetamide
Heptachlor
Kepone
Lead Arsenate
Lindane
Mercury
Metaldehyde
Mirex
Monocrotophos
OMPA
10,10'-
Oxybisphenoxarsine
Oxyfluorfen
Parathion
PCNB
Hexachloroepoxyoctahydro-endo-demethanonaphthalene
(CAS No. 72-20-8)
0-Ethyl 0-(p-nitrophenyl)phenylphosphonothioate (CAS
No. 2104-64-5)
1081 (CAS No. 640-19-7)
See Chlordane
Decachlorooctahydro-1,3,4-metheno-2H-
cyclobuta[cd]pentalen-2-one (CAS No. 143-50-0)
(CAS No. 7784-40-9) See Wood Preservatives
1,2,3,4,5,6-Hexachlorocyclohexane, gamma isomer of
benzene hexachloride (CAS No. 58-89-9)
(CAS No. 7439-97-6)
2,4,6,8-Tetramethyl-1,3,5,7-tetroxcane (CAS No. 108-62-
3)
Dodecachlorooctahydro-1,3,4-methano-1 HCyclobuta[cdJ
pentalene (CAS No. 2385-85-5)
3-(dimethoxyphosphinyloxy-N-methyl-cis-crotonamide
(CAS No. 6923-22-4)
Octamethylpyrophosphoramide (CAS No. 152-16-9)
(CAS No. 58-36-6)
2-Chloro-1 (e-ethoxy-4-nrtrophenoxy)-4-
(trofluoromethyl)benzene (CAS No. 42874-03-3)
0-Ethyl 0-(p-nitropheny1)phenyfphosphonothioate (CAS
No. 56-38-2)
Pentachloronrtrobenzene (CAS No. 82-68-8)
SCR Pesticides List
February 1990
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Index
Pentachlorophenol
Phenarsazine Chloride
PCBs
Polychlorinated
Terphenyls
Pronamide
Quaternary Ammonium
Compounds
Safrole
Seed Treatments
Silvex
Sodium Arsenate
Sodium Arsenite
Sodium Cyanide
Sodium Fluoride
Sodium
Monofluoroacetate
Strobane
Strychnine
2,4,5-T
2,4,5-TCP
Thallium Sulfate
TOK
(CAS No. 87-86-5) See Wood Preservatives
(CAS No. 578-94-9)
Polychlorinated biphenyls
Arochlor
N-(1,1-Dimethylpropynyl) 3,5-dichlorobenzamide (CAS
No. 23950-58-5)
4-AllyM,2-(methyfenedioxy)benzene (CAS No. 94-59-7)
2-(2,4,5-Trichlorophenoxy) propionic acid (CAS No. 93-
72-1)
(CAS No. 13464-38-5) See Wood Preservatives
(CAS No. 7784-46-5) See Wood Preservatives
(CAS No. 143-339)
i
(CAS No. 7681-49-4)
Compound 1080 (CAS No. 62-74-8)
Terpene polychlorinates (65% or 66% chlorine) consists
of chlorinated camphene, pinene, and rented
polychlorinates (CAS No. 8001-50-1)
(CAS No. 57-24-9)
See Silvex
Phenol, 2,4,5,-trichloro-(8CI)(9CI)
(CAS No. 7446-18-6)
2,4,-Dichlorophenyl p-nitrophenyl ether (CAS No. 1836-
75-5)
February 1990
SCR Pesticides List
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Index
Toxaphene
Tributyltin
Trifluralin
Vinyl Chloride
Wood Preservatives
(Calcium Arsenate)
Wood Preservatives
(Creosote)
Wood Preservatives
(Phenol, pentachloro-
(8CI)(9CI))
Wood Preservatives
(Sodium Arsenate)
Wood Preservatives
(Sodium Arsenite)
Technical Chlorinated Camphene (67-69% chlorine) (CAS
No. 8001-35-2)
Distannoxane, hexabutyi (CAS No. 56-35-9)
a,a,a-Trifluoro-2,6-dinitro-N,N-dipropy1-p-toluidine (CAS
No. 1582-09-8)
Chloroethylene (CAS No. 75-01-4)
February 1990
SCR Pesticides List
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Suspended, Cancelled, and Restricted Pesticides List
-------
ALAR
See Daminozide.
Reference 54 FR 47492 November 14,1989.
SCR Pesticides List February 1990
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ALDRIN
Criteria of Concern Carcinogenicfty
Bioaccumulation
Hazard to wildlife
Other chronic effects
Action /Use Affected Cancelled, all products.
Reference PR Notice 71-4 March 18,1971; Accelerated Decision by
the Chief Administrative Law Judge May 27,1975; Order
declining Review of the Accelerated Decision of the
Administrative Law Judge issued by the Chief Judicial
Officer June 30,1975; 37 FR 37246 October 18, 1974.
Letter to EPA from the Manufacturer requesting voluntary
cancellation of termrticide uses, May 15,1987.
SCR Pesticides List February 1990
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AMITHAZ
Criteria of Concern
Action/Use Affected
Oncogenicity
All products containing amrtraz as a sole active ingredient
may continue to be registered for sale, distribution,
reformulation, and use on pears, and on pears used as
feed for cattle and hogs, subject to the terms and
conditions specified in the EPA publication "Guidance for
the Registration of Pesticide Products Containing
Amrtraz as the Active Ingredient." Registrants must
provide, or agree to develop, additional data, specified in
the aforementioned publication in order to maintain
existing registrations or to permit new registrations.
In order to avoid cancellation, registrants must make the
following labeling amendments:
1.) The following revised environmental hazard
statement must appear on all manufacturing-use
product labels:
This pesticide is toxic to fish. Do not
discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or
public water unless this is specifically identified
in an NPOES permit. Do not discharge
effluent containing this product into sewer
systems without previously notifying the
sewage treatment plant authority. For
guidance, contact your State Water Board or
Regional Office of EPA.
2.) The reentry statement below must appear in the
use directions of labels with the directions for use
on pears:
Do not reenter treated areas for 24 hours
without protective clothing.
3.) The worker protection statements listed below
must appear as part of the precautionary
statements for all end-use amitraz products:
During mixing/loading or application, wear a
protective suit which has long sleeves and
long pants. Wear chemical resistant gloves, a
hat, boots, and goggles or face shield. A
helmet with visor may be substituted for th«
hat and goggles during aerial application.
Mixer/loaders should also wear a chemical
resistant apron when handling the
concentrated product Wash thoroughly with
SCR Pesticides List
February 1990
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AMITRAZ
soap and water after handling and before
eating, urinating, or smoking. Remove and
wash clothing before reuse. Clothing should
be laundered separately from household
articles. Replace gloves frequently. Clothing
which has been drenched and used gloves
should be disposed of in accordance with
state and local regulations. Instead of clothing
specified above, the applicator can use an
enclosed tractor cab or cockpit with properly
filtered air supply.
4.) The following environmental hazards statement
listed below must appear on the end-use label in
the Environmental Hazards section:
This product is toxic to fish. Do not apply
directly to water. Drift and runoff from treated
areas may be hazardous to fish in adjacent.
sites. Do not contaminate water by cleaning
of equipment or disposal of wastes.
Reference 44 FR 32736 June 7,1979; 44 FR 59938 October 17,
1979. EPA Document: Guidance for the Reregistration
of Pesticide Products Containing Amitraz as the Active
Ingredient, October 1987.
SCR Pesticides List February 1990
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ARSENIC TOIOXIDE
See Wood Preservatives, nonwood uses.
Reference PR Notice 67-2 August 1,1967; Interpretation No. 25
August 1968; 53 FR 5524 February 24, 1988; 53 FR
24787 June 30, 1988.
SCR Pesticides List February 1990
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BENOMYL
Criteria of Concern Reduction in nontarget organisms
Mutagenicity
Teratogenicfty
Reproductive effects
Hazard to wildlife
Action/Use Affected In order to avoid cancellation of benpmyf products for
aerial application uses, registrants with products
packaged in 5-pound or larger containers must include
the following labeling statement:
Harmful if inhaled. Wear a clotf or disposable paper
dust mask during handling and mixing.
Reference 47 FR 46747 October 20,1982.
SCR Pesticides List ~"February 1990
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BHC
Criteria of Concern Oncogenicrty
Action/Use Affected Voluntary cancellation, all products.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of BHC nongamma isomers is prohibited in the
U.S.
Reference 43 FR 31432 July 21,1978.
SCR Pesticides List February 1990
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BITHfONOL
Action/Use Affected
Reference
Cancelled, products intended for
1.
2.
Direct contact with the skin or expected direct or
continuous contact with the skin.
Use in textiles or other materials likely to come in
contact with the skin.
3. Household use.
PR Notice 68-13 August 14, 1968.
SCR Pesticides List
February 1990
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BROMOXYNIL
Criteria of Concern
Action/Use Affected
Mutagenicrty
In order to avoid cancellation, the sole registrant, Rhone-
Poulenc, was required to amend the registrations for its
two bromoxynil products, buctril and bronate. These
products can no longer be used for turf and noncrop
areas.
These amendments include adding warning statements
to the product labels stating that exposure during
pregnancy causes birth defects in laboratory animals,
restricting its use to certified applicators, and requiring
additional protective clothing for mixers, loaders, and
applicators.
Rhone-Poulenc is also required to conduct an extensive
notification and educational program for bromoxynil users
to inform them of the potential birth defect risks for
mixing, loading, and applying bromoxynil, as well as the
importance of following the new risk reduction measures.
Rhone-Poulenc was also required to adhere to the
following shipment provisions:
1.) By May 6,1989, the registrant was required to halt
shipment of all bromoxynil products until approved
amended stickers are affixed to each container
within the company's possession.
2.) By May 15,1989, the registrant was required to'
provide each distributor holding inventory of
bromoxynil products sufficient stickers for such
inventory.
3.) By May 25,1989, the registrant was required to
provide each reseller and retailer holding inventory
of bromoxynil products suffhient stickers for such
inventory.
4.) The registrant was also required to provide each
distributor, reseller, and retailer with instructions
concerning the manner in which the sticker must
be affixed to each container, and to implement the
attached labeling communication plan by the dates
described therein.
February 1990
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BROMOXYNIL
5.) The registrant is also required to assume
responsibility for ensuring that each distributor,
reseller, or retailer attaches the sticker to each
container that is sold or distributed by the
distributor, reseller, or retailer after the date the
stickers are received.
6.) After October 1,1989, the registrant was required
to ensure that all bulk containers released for
shipment include a mechanical transfer
mechanism which terminates in a drip-free hard
coupling that may be used only with a spray or
mix tank that has been fitted with a compatible
coupling.
7.) By October 1,1989, the registrant was required to
establish a program to provide assistance to users
who do not own a mechanical transfer system
which terminates in a drop-free hard coupling and
who wish to obtain such a system or to modify
their present system.
Existing Stocks Provisions
The shipment of bromoxynl products by the registrant
that do not include the amended labeling and restrictions
listed above was prohibited in the U.S. as of October 1,
1989.
Reference 54 FR 24949 June 12,1989.
$CR Pesticides List February 1990
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BROMOXYNIL BLTTYRATE
Criteria of Concern
Action/Use Affected
Reference
Mirtagenicrty
Voluntary cancellation, all products.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks by bromoxynfl butyrate is prohibited in the U.S. as
of June 13, 1989.
54 FR 24950 June 12, 1989.
SCR Pesticides List
February 1990
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CADMIUM
Criteria of Concern Oncogeniclty
Mutagenicity
Teratogenicity
Fetotoxicrty
Action/Use Affected Cancellation and denial of registrations of products that
contain cadmium for use on golf course fairways and
home lawns.
In order to avoid cancellations of cadmium products
labeled for use on golf course greens and tees,
registrants must make the label modifications specified
below:
RESTRICTED USE PESTICIDE for retail sale to and use only
by certified applicators or persons under the direct
supervision of a certified applicator and only for those uses
covered by the certified applicators' certification.
Cadmium has been shown to produce kidney toxicrty in
humans, and tumors in laboratory animals.
This product is only to be applied by power boom spraying
equipment to golf course greens and tee areas only. Do not
apply through portable, manned, or hand-held pump
sprayers.
Wear chemical resistant gloves, long-sleeved shirts, and
long-legged pants. In addition, wear a chemical resistant
apron during mixing and loading.
Wash gloves with «oap and water before removing. Launder
all clothing worn during use before reusing and launder
separately from household articles.
Existing Stocks Provisions
1.) No manufacturer may release for shipment after
January 31,1988, existing stocks of any cadmium
product unless the product bears the required
amended label.
2.) The sale or distribution of any cadmium product
by a retailer or other person was prohibited after
April 30,1988, unless the product bears the
required amended label.
Reference 52 FR 31076 August 19,1987.
SCR Pesticides List February 1990
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CALCIUM ARSENATE
See Wood Preservatives, non-wood uses.
Reference 53 FR 5524 February 24, 1988; 53 FR 24787 June 30,
1988.
SCR Pesticides List February 1990
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CAPTAFOL
Criteria of Concern
Act/on/Use Affected
Oncogenicity
Acute and chronic wildlife effects
Voluntary cancellation, ail products.
Reference
foisting Stocks Provision?
The sale, distribution, shipment, and use of existing
stocks of captafol products is prohibited in the U.S.
52 FR 27576 July 22, 1987; 51 FR 11341 April 2, 1986.
February 1990
SCR Pesticides List
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CAPTAN
Criteria of Concern
Action/Use Affected
Oncogenicrty
Cancellation and denial of registrations for products
containing captan as an active ingredient, except for the
following uses':
1.) All nonfood uses, including technical captan.
2.) Seed treatments.
3.) The following food uses:
Almonds, apples (pre- and post-harvest), apricots,
blackberries, blueberries, celery (plant-bed),
cherries (pre- and post-harvest), dewberries,
eggplant (plant-bed), grapes, green onions,
lettuce, mangoes, nectarines, peaches, pears
(post-harvest only), peppers (plant-bed), pimentos
(plant-bed), plums/prunes, raspberries, spinach
(plant-bed), strawberries, taro, tomatoes (plant-
bed).
All captan uses other than those listed above are
cancelled.
Reference
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of cancelled captan products is prohibited in the
U.S. after February 24,1990.
54 FR 8116 February 24,1989.
* Captan is still being reviewed by EPA. Current requirements and restrictions are available from trie
EPA Registration Division.
SCR Pesticides List
February 1990
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CARBON
Criterfa of Concern
Action/Use Affected
Reference
Oncogenicrty
Toxic effect on liver and kidneys
Cancelled, all products.
51 FR 4104 November 12,1986. FIFRA Sec. 3
registration cancelled for nonpayment of 1989
maintenance fee, October 12,1989.
eoruary 1990
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CHLORANIL
Criteria of Concern Oncogenicrty
Action/Use Affected Voluntary cancellation, all products.
Reference 42 FR 3702 January 19, 1977.
SCR Pesticides List " February 1990
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CHLORDANE
Criteria of Concern
Action/Use Affected
Oncogenicity
Voluntary cancellation of all chlordane/heptachlor
products by the registrant, Velsicol. All other
chlordane/heptachlor products are either voluntarily
cancelled, or suspended for failure to meet EPA data
requirements.
The only commercial use of chlordane/heptachlor
products still permitted is for fire ant control in power
transformers.
Reference
Existing Stocks Provisions
1.) The sale, distribution, and shipment of existing
stocks of all cancelled chlordane/heptachlor
products is prohibited in the U.S. as of April 15,
1988.
2.) Commercial use of existing stocks of these
products is also prohibited, except for fire ant
control in power transformers.
3.) Use of existing stocks of termrticide products in
the possession of homeowners is also permitted.
PR Notice 74-11 December 2,1974; 41 FR 7552
February 19, 1976; FIFRA Docket No. 336 et al. March 6,
1978; PR Notice 78-2 March 28,1978; ruling of D.C.
Judge February 23,1988; 53 FR 11798 April 8,1988; 54
FR 20194 May 10,1989.
February 1990
SCR Pesticides List
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CHLORDIMEFORM
Criteria of Concern
Action/Use Affected
Oncogenictty
Cancelled, all products.
Reference
Existing Stocks Provisions
1.) The sale and distribution of existing stocks of
chlordimeform in the possession of registrants,
retailers, and distributors was prohibited after
February 19,1989.
2.) The use of existing stocks of chlordimeform in the
possession of end users was prohibited after
October 1,1989.
3.) Registrants are required to recall those stocks that
are in the hands of retailers and distributors.
53 PR 36422 September 19,1988; 54 FR 6242 February
8, 1989.
February 1990
SCR Pesticides List
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CHLOROBENZILATE
Criteria of Concern
Action/Use Affected
Oncogenicrty
Testicular effects
Cancellation and denial of registrations of chlorobenzilate
products for uses other than citrus in Florida, Texas,
California, and Arizona.
In order to avoid cancellation for citrus uses in these four
states, registrants must make the following labeling
modifications:
1.) Restricted Use Pesticides
For retail sale to and use only by certified applicators or
persons under their direct supervision and only for those
uses covered by the certified applicator's certification.
2.) General Precautions
Take special care to avoid getting chlorobenzilate in eyes,
on skin, or on clothing.
Avoid breathing in vapors or spray mist.
In case of contact with skin, wash as soon as possible with
soap and plenty of water.
If chlorobenzilate gets on clothing, remove contaminated
clothing and wash affected parts of body with soap and
water. If the extent of the contamination is unknown, bathe
entire body thoroughly. Change to clean clothing.
Wash hands with soap and water each time before eating,
drinking, or smoking.
At the end of the workday, bathe entire body with soap and
plenty of water.
Wear clean clothes each day and launder before reusing.
3.) Required Clothing and Equipment for Application
One-piece overalls that have long sleeves and long pants
constructed of finely woven fabric as specified in the
USD A/EPA Guide for Commercial Applicators.
Wide-brimmed hat
Heavy duty fabric work gloves.
SCR Pesticides List
February 1990
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CHLOROBENZILATE
Any article of clothing that has been worn while applying
chlorobenzilate must be cleaned before reusing. Clothing
that has been drenched or has otherwise absorbed
concentrated pesticide must be buried or burned.
Face piece respirator of the type approved for pesticide
spray applications by the National Institute for Occupational
Safety and Health.
Instead of the equipment and clothing specified above, the
applicator can use an enclosed tractor cab that provides a
filtered air supply. Aerial application may be conducted
without the specified clothing and equipment.
4.) Handling Precautions
Heavy duty rubber or neoprene gloves and apron must be
worn during loading, unloading, and equipment clean up.
Reference 44 FR 9548 February 13, 1979.
SCR Pesticides List ~~~ February 1990
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COPPER ARSENATE (BASIC)
Criteria of Concern Oncogenicrty
Action/Use Affected Voluntary cancellation of the only product containing
copper arsenate (basic).
Reference 42 FR 18422 April 7,1977; PR Notice 83-1 February 17,
1983.
SCR Pesticides List " ~ February 1990
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CREOSOTE
See Wood Preservatives, wood uses and nonwood
uses.
Reference 49 FR 28666 July 13, 1984; 51 FR 1334 January 10,
1986; 53 FR 5524 February 24,1988; 53 FR 24787 June
30, 1988.
SCR Pesticides List '. February 1990
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CYANAZINE
Criteria of Concern Teratogenicrty
Action/Use Affected In order to avoid cancellation of their cyanazine products,
registrants must submit an application to amend the
registration of their product. The application must
propose to amend the registration of the product to
include the following conditions and labeling
modifications:
1.} Require the use of protective gloves when mixing
or loading cyanazine or when adjusting, repairing,
or cleaning equipment.
2.) Require the following precaution concerning the
washing of protective gloves:
Protective gloves must be washed with soap
and water after use and before removing
from the hands.
3.) Require the use of closed systems in connection
with aerial use and chemigation (product
formulations that cannot be used in a closed
loading system must prohibit aerial use and
chemigation).
4.) Require use of a chemical resistant apron when
mixing or loading.
5.) Tic. ^ j!,% ttat all "Restricted Use" statements
include a statement that cyanazine products have
been classified for restricted use because
cyanazine has caused birth defects in laboratory
animals.
6.) Include the following precaution concerning the
washing of contaminated clothing:
Cyanazine-contaminated clothing should be
laundered separately from household laundry
to prevent cross-contamination of the
laundry. Heavily contaminated or drenched
clothing and protective equipment must be
discarded or destroyed in accordance with
state and local regulations.
SCR Pesticides List February 1990
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CYANAZINE
Existing Stocks Provisions
1.) EPA will allow use of existing stocks of cyanazine
products for up to 6 months after final
cancellation or approval of an amendment to the
registration. Existing stocks may be used after
this 6-month period only in accordance with the
modifications identified above.
2.) Existing stocks of cyanazine products not
relabeled as specified above must be disposed of
in accordance with the Research Conservation
and Recovery Act.
3.) Existing stocks of cyanazine products voluntarily
cancelled prior to January 13,1988, are not
affected by these provisions.
Reference 53 PR 795 January 13,1988.
SdR Pesticides List February 1990
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CYHEXATIN
Criteria of Concern Teratogenicfty
Action/Use Affected Voluntary cancellation, all products.
Reference EPA's Environmental News November 1,1987.
SCR Pesticides List February 1990
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DAMINOZIDE
Criteria of Concern Oncogenicrty
Action/Use Affected Cancelled, all daminozide products, for food uses.
Remaining registrations for nonfood uses include cut
chrysanthemums and bedding plants.
Special review of nonfood uses continued, pending an
evaluation of the cancer studies in rats and mice with
unsymmetrical dimethyl hydrazine, a degradate and
metabolite of daminozide. Final study results to be
submitted to EPA in January 1990.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of daminozide for food uses is prohibited in the
U.S.
Reference 54 FR 47492 November 14,1989.
SCR Pesticides List February 1990
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OBCP
Criteria of Concern Oncogenicity
Mutagenicity
Reproductive effects
Ground water contamination
Action/Use Affected Cancelled, all products.
Existing Stocks Provisions,
1.) The sale, distribution, shipment, and use of
existing stocks of OBCP for Hawaiian pineapple
culture is prohibited in the U.S.
2.) Existing stocks that are not exported must be
disposed of in accordance with the Resource
Conservation and Recovery Act.
Reference FIFRA Docket Nos. 398, 399, and 400 October 27,1977;
42 FR 57543 November 3, 1977; FIFRA Docket No. 435
October 29, 1979; 46 FR 19592 March 31, 1981; 50 FR
1122 January 9,1985; 50 FR 46512 November 8,1985.
SCR Pesticides List February 1990
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DDDfTPE)
Criteria of Concern
Action/Use Affected
Reference
Carcinogenicrty
Bioaccumulation
Hazard to wildlife and other chronic effects
Cancelled, all products containing ODD, a metabolite of
DDT.
PR Notice 71-5 March 18,1971.
February 1990
SCR Pesticides List
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DDT
Criteria of Concern Carcinogenicfty
Bioaccumulation
Hazard to wildlife and other chronic effects
Action/Use Affected Cancelled, all products.
Reference PR Notice 71 -1 January 15,1971; 37 FR 13369 July 7,
1972.
SCR Pesticides List February 1990
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2,4-D
Criteria of Concern Carcinogenicity
Action/Use Affected In order to avoid cancellation, registrants with 2,4-0
products must make the following labeling revisions:
1.) Use Pattern Statements
All manufacturing-use products must state
that they are intended for formulation into
end-use products for acceptable use
patterns.
2.) Disposal Statements
Certain unused stocks are listed as toxic
hazardous waste under the Resource
Conservation and Recovery Act (RCRA); others
may be hazardous waste because of their
chemical physical characteristics. The following
is the appropriate pesticide disposal statement for
all 2,4-D products, except those labeled for
household use only:
Pesticide wastes are toxic. Improper
disposal of excess pesticide, spray mixture,
or rinsate is a violation of federal law and
may contaminate ground water. If these
wastes cannot be disposed of by use
according to label instructions, contact your
state pesticide or environmental control
aQsncy or the hazardous waste
representative at the nearest EPA Regional
Office for guidance.
Products labeled for household use only must
bear the following disposal statement:
Securely wrap original contain* r in several
layers of newspaper and discard in trash.
3.) Use Directions. End-Use Products
The following statements are required in the use
directions for all end-use products:
SCR Pesticides List February 1990
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2,4-D
a.) Liquid products.
This product can reach ground water as a
result of mixing and loading. To minimize
ground water contamination from spills
during mixing, loading and cleaning of
equipment, take the following steps:
Mixing and Loading. When mixing, loading,
or applying this product, wear chemical-
resistant gloves. Wash nondisposable gloves
thoroughly with soap and water before
removing.
The mixing and loading of spray
mixtures into the spray equipment must be
carried out on an impervious pad (i.e.,
concrete slab or plastic sheeting) large
enough to catch any spilled material. If spills
occur, contain the spill by using an
absorbent material (e.g., sand, earth, or
synthetic absorbent). Dispose of the
contaminated absorbent material by placing
in a plastic bag and following disposal
instructions on this label.
Triple rinse empty containers and add
the rinsate to the mixing tank.
Cleaning of Equipment When cleaning
equipment, do not pour the washwater on
the ground - spray or drain over a large area
away from wells and other water sources.
o.) Granular products.
This product can reach ground water from
improper handling. To minimize ground
water contamination from spills during
loading and cleaning of equipment, take the
following steps:
Handling. When handling this product, wear
chemical-resistant gloves. Wash
nondisposable gloves thoroughly with soap
and water before removing. If spills occur,
collect the material and dispose of by
following disposal instructions on this label.
Cleaning of Equipment When cleaning
equipment, do not pour the washwater on
the ground - spray or drain over a large area
away from wells and other water sources.
SCR Pesticides List "" February 1990
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2,4-D
c.) Products for use on pastures and rangeland
grasses.
Labels for products registered for use on
pastures and rangeland grasses must be
revised to reflect the following intervals, if
such intervals are not currently on the label:
i.) A 7-day pregrazing interval for dairy
cattle;
ii.) A 30-day preharvest interval for grass
cut for hay; and
iii.) A 3-day preslaughter interval for meat
animals.
d.) Products for certain food and feed uses.
Label use directions for products registered
for the following uses must be revised:
potatoes, apples, pears, grapes,
strawberries, barley and barley forage, corn
and corn forage and fodder, millet, oats, rice
and rice straw, rye, sorghum and sorghum
forage and fodder, wheat, rangeland and
pasture grass, asparagus, and sugarcane.
The revisions pertain to preharvest intervals,
.anges of diluent, and maximum seasonal
application rates and/or specific
requirements for each commodity. The
registrants must propose the specific
language.
Existing Stocks Provisions
1.) The shipment of existing stocks of 2,4-0 products
by registrants without the amended labeling
specified above and in the September 1988
Registration Guidance Package was prohibited
as of October 1,1989.
2.) The sale, distribution, and shipment of existing
stocks of 2,4-0 products by persons other than
the registrant without the required amended
labeling will be prohibited in the U.S. as of
October 1,1990.
SCR Pesticides List February 1990
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2,4-D
Reference PR Notice 67-7 October 12,1967. Reregistration
Guidance Package 23-4; PR Notice 83-2; PR Notice 83-
3; Reregistration Guidance Package September 1988.
SCR Pesticides List February 1990
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DIALLATE
Criteria of Concern Oncogenicrty
Mutagenicfty
Action/Use Affected In order to avoid cancellation of their diallate products,
registrants must modify the terms of registration to
include .the following labeling provisions:
1.) Restricted-Use Pesticide
For retail sale to and use only by certified applicators or
persons under their direct supervision and only for those
uses covered by the applicator's certification. See FIFRA
Section 3(d).
2.) Protective Clothing Required
The following items of clothing must be worn
when mixing, loading, or applying Avadex:
Long trousers and long-sleeved shirt or
jacket of close-knit material.
Gloves made of rubber or other similar
impermeable material.
Leather or rubber boots high enough to
cover the ankle.
Reference 47 PR 27109 June 23,1982.
SCR Pesticides List February 1990
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DICOFOL
Criteria of Concern Ecological effects
Action/Use Affected Cancelled, all products containing greater than 0.1
percent DDTr.
Existing Stocks Provisions
The sale, distribution, and shipment of existing stocks of
dicofol products greater than O.T percent DDTr is
prohibited in the U.S.
Reference 51 FR 1950S May 29, 1986.
SCR Pesticides List ' February 1990
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DIELDRIN
See Aldrin.
Reference PR Notice 71-4 March 18,1971. Accelerated decision by
the Chief Administrative Law Judge May 27,1975. Order
declining review of the accelerated decision of the
Administrative Law Judge issued by the Chief Judicial
Officer June 30, 1975. 37 FR 37246 October 18, 1974.
SCR Pesticides List February 1990
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DIMETHOATE
Criteria of Concern
Action/Use Affected
Reference
Oncogenicrty
Mutagenicrty
Cancelled, all dimethoate products for use in dust
formation.
In order to avoid cancellation for all other uses of
dimethoate products, registrants must include the
following labeling provisions:
1.) Required Clothing and Equipment for Application
All applicato.'S, including homeowners and
flaggers and personnel involved with the mixing,
loading, and transferring operations, must wear
the protective clothing and equipment
enumerated below. Pilots are exempt from this
requirement. The protective clothing and
equipment to be worn is as follows:
a.) Impermeable gloves (for example, rubber or
plastic-covered gloves).
b.) Rubber or synthetic rubber boots or boot
covers.
c.) Long-sleeved shirt and long pants, made of
closely woven fabric.
d.) Wide-brimmed hat.
e.) Respirators must be worn by flaggers and
mixer/loaders.
2.) Dimethoate Products for Aerial Application
These products must include the following
statements:
AUTOMATIC FLAGGING DEVICES SHOULD
BE USED WHENEVER FEASIBLE.
IF HUMAN FLAGGERS ARE EMPLOYED,
THEY MUST WEAR THE PROTECTIVE
CLOTHING AND RESPIRATOR SPECIFIED
ON THIS LABEL
46 FR 5334 January 19,1981.
SCR Pesticides List
February 1990
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OINOCAP
Criteria of Concern Teratogenicity
Action/Use Affected In order to avoid cancellation of their dinocap products,
registrants must include the following developmental
toxicity warning statement on their product label:
1.) Use of this product may be hazardous to your
health. This product has been determined to
cause birth defects in laboratory'animals. The
following products do not require any label
changes, except No. 1 above:
a.) Liquid and wettable powder formulations
used on peaches/apricots, and field roses.
b.) Liquid formulations used on pears, apples,
and in greenhouses.
c.) All home and garden uses.
2.) All liquid formulation products that bear uses for
pears must limit the maximum application rate to
0.47 pounds/acre.
3.) All wettable powder formulation products that
bear uses for apples must bear the following label
statement for use on apples:
a.) During the mixing and loading of
concentrated dinocap, wear a protective suit
of one or two pieces that covers all parts of
the body except the head, hands, and feet.
Wear chemical resistant gloves, apron, and
shoes, and shoe coverings or boots. Wear
goggles or a face shield. A hood or hat may
also be worn.
b.) Whenever possible, it is rec >mmended that
application be made from a vehicle with a
completely enclosed cab. All vents and
windows of the cab should remain closed
during application. During application from a
completely enclosed cab, wear a long-
sleeved shirt and long pants. A clean sat of
protective clothing and equipment, as defined
here, must be available in case you must exit
the cab in treated areas. Always wear
protective gloves upon exiting the cab.
Remove protective clothing and equipment
before reentering the cab to prevent cab
contamination.
Jcides List February 1990
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DINOCAP
c.) If application from a vehicle with a completely
enclosed cab is not possible and during
repair and clean-up of equipment for reentry
into treated areas prior to drying of the spray,
wear a protective suit of one or two pieces
that covers all parts of the body except the
hands, feet, and head. Wear chemical
resistant gloves and chemical resistant
shoes, shoe coverings or boots. A hood or
hat may also be worn. During air blast or
mist blower application a protective hood or
wide-brim hat must be worn.
d.) Warning: Wearing the protective suit for the
prolonged periods required for application
may produce heat stress at temperatures
above 85° F. on a cloudy day or 80s F. on a
sunny day. Application of this product must
be conducted from enclosed cab vehicles
when the temperature exceeds 85° F. (80° F.
on sunny days) or delayed until the
temperature drops.
e.) After application of the pesticide is
completed, remove all clothes and shoes.
Shower using soap and water. Redress only
in clean clothes. Oo not use contaminated
clothing. Wash nondisposable protective
equipment with soap or detergent and water
after each use. Personal and nondisposable
protective clothing worn during use must be
laundered separately from household articles.
Clothing or protective equipment heavily
contaminated or drenched with dinocap must
be destroyed according to state or local
regulations. Heavily contaminated or
drenched clothing cannot be adequately
decontaminated.
4.) All liquid and wettable powder formulations that
bear uses for grapes and field cucurbits and all
wettable powder formulations that bear uses for
pears must bear the following label statement for
use on these commodities:
a.) See 3.a. above.
b.) This product must be applied from a vehicle
with an enclosed cab. See 3.b. for required
protection.
c.) See 3.c.
d.) See 3.e.
SCR Pesticides List
Februa/y 1990
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DINOCAP
Existing Stocks Provisions
The sale, distribution, and shipment of dinocap products
that do not bear the amended labeling as specified
above was prohibited in the U.S. as of August 6,1989.
Reference 54 FR 5908 February 6,1989.
SCR Pesticides List : " February 1990
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DINOSEB
Criteria of Concern
Action /Use Affected
Teratogenicrty
Reproductive effects
Acute effects
Cancelled, all products.
Reference
Existing Stocks Provisions
1.) The sale, distribution, and shipment of existing
stocks of dinoseb for use on caneberries in
Washington and Oregon was prohibited after the
1989 use season.
2.) The sale, distribution, and shipment of existing
stocks of dinoseb for all other uses is prohibited
in the U.S.
51 FR 36634 October 14, 1986; IF&R Docket No. 590
June 10, 1988. U.S. Court of Appeals March 20, 1989.
February 1990
SCR Pesticides List
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DISINFECTANTS
Action/Use Affected Cancelled, products bearing labeling claims involving the
terms germ proofing, gem proofs, and germ proof.
Reference PR Notice 69-13 August 8,1969.
SCR Pesticides List February 1990
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EBDCS
Criteria of Concern
Action/Use Affected
Oncogenictty
Teratogenicity
Ail zineb products registered for agricultural food uses
are either suspended for failure to submit data to the
Agency, or cancelled.
All nabam products registered for agricultural food uses
are either suspended for failure to submit data to the
Agency or have had their registrations amended to delete
agricultural food uses from the product labels.
The following crop uses are retained:
Maneb Almonds, bananas, potatoes, sugar
beets, and sweet corn.
Metiram Potatoes.
Mancozeb Asparagus, bananas, cranberries, figs,
grapes, onions, peanuts, potatoes,
sugar beets, sweet corn, tomatoes, and
wheat.
The following crop uses are deleted:
Maneb
Metiram
Mancozeb
Peppers, tomatoes, onions, beans,
broccoli, cabbage, cantaloupes,
watermelon, other melons, cucumbers,
squash, apples, spinach, stone fruits,
carrots, celery, turnips, cauliflower,
brussels sprouts, collards, mustard
greens, kale, rhubarb, lettuce, Chinese
cabbage, eggplant, endive, grapes, and
pumpkins.
Apples.
DuPont Corporation has deleted:
apples, crab apples, quince, pears,
papayas, pineapples, carrots, celery,
fennel, cucumbers, melons, squash
(summer and winter), tobacco (plant
bed arid field), cotton (foliar), field corn,
oats, barley, and rye.
SCR Pesticides List
February 1990
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EBDCs
Rohm and Haas Company has deleted:
apples, barley, cantaloupes, carrots,
celery, corn (field and hybrid seed
corn), crab apples, cucumbers, fennel,
melons, muskmelons, oats, papaya,
pears, pineapples, quince rye, squash,
and watermelons.
Pennwaft Corporation has deleted:
cucumbers, melons, summer squash,
field corn, celery, carrots, apples, pears,
crab apples, and quince.
Existing Stocks Provisions
1.) ZiDfifc
a.) The sale and distribution of existing stocks of
zineb products labeled for agricultural food
uses by registrants and supplemental
distributors are prohibited.
b.) Persons other than zineb registrants and
supplemental distributors with these products
in their possession may sell or distribute
existing stocks of these zineb products until
these stocks are exhausted.
2.) Nabam
a.) The sale and distribution of existing stocks of
nabam labeled for agricultural use by
registrants and supplemental distributors are
prohibited.
b.) Persons other than nabam registrants or
distributors with these products in their
possession may sell or distribute existing
stocks of these nabam products until these
stocks are exhausted.
3.) Maneb. Metiram. Mancozeb
a.) Rohm and Haas, OuPont, and BASF are
responsible for ensuring that all of their
maneb, metiram, and mancozeb products
SCR Pesticides List February 1990
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EBOCs
released for shipment or in the channels of
trade after January 1,1990, bear the
amended labeling specified above.
b.) PennwaJt is responsible for ensuring that all
of its maneb and mancozeb products bear
the amended labeling specified above, by the
date listed in the February FR Notice.
c.) Products already in the possession of
growers are not required to be relabeled.
d.) Formulators of end-use products may not
use any relabeled maneb, metiram, or
macozeb technical registered by Rohm and
Haas, DuPont, PennwaJt, or BASF to
formulate any end-use products that are
labeled for a deleted use.
Reference 47 FR 47669 October 27,1982; 54 FR 50020 December
4, 1989; 55 FR? February ?, 1990.'
* At this writing, the Federal Register notice, including the latest restrictions for EDBCs, had not yet
been published. Please contact the Agency's Registration Division for further information regarding this
reference.
SCR Pesticides List February 1990
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EDB
Criteria of Concern Oncogenicity
Mutagenictty
Reproductive effects
Action/Use Affected Cancelled, ail products.
Existing Stocks Provisions
The use of existing stocks of EDB for beehive supers and
honeycombs is permitted.
Reference 48 FR 46228 October 11,1983; 49 FR 4452 February 6,
1984; 49 FR 14182 April 10,1984; 50 FR 12072 March
27, 1985; FIFRA Sec. 3 registration cancelled for
nonpayment of 1989 maintenance fee, October 12, 1989.
SCR Pesticides List February 1990
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ELECTROMAGNETIC PEST CONTROL DEVICES
Action/Use Affected Products ineffective in controlling rodents and insects.
Regulatory actions have been taken to remove them from
the marketplace.
Reference EPA Publication No. EPA 340102-80-001, October 1980,
Investigation of Efficacy and Enforcement Activities
Relating to Electromagnetic Pesticide Control Devices.
SCR Pesticides List February 1990
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ELECTRONIC (SONIC) MOSQUITO REPELLING DEVICES
Action/Use Affected Products ineffective in repelling mosquitoes. Regulatory
actions have been taken to remove them from the
marketplace.
Reference EPA's Environmental News October 13,1976.
SCR Pesticides List February 1990
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ENORIN
Criteria of Concern Oncogenicity
Teratogenictty
Reduction in endangered and nontarget species
Action /Use Affected Voluntary cancellation, all products.
Reference Unnumbered PR Notice May 20,1964; 44 FR 43632 July
25, 1979; 49 FR 42792 October 24,1984; voluntary
cancellations 1984-85.
SCR Pesticides List February 1990
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EPN
Criteria of Concern Neurotoxicrty
Hazard to aquatic organisms
Action/Use Affected Voluntary cancellation, all products.
Reference 48 FR 39494 August 31,1983; 52 FR 27453 July 21,
1987.
SCR Pesticides List February 1990
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FLUOROACETAMIDE
Criteria of Concern Acute toxicrty to mammalian and avian species
Reduction in endangered and nontarget species
Acute toxicrty without antidote
Action/Use Affected Cancelled, all products.
Reference Label amendment accepted by OPP November 2,1979;
45 PR 13189 February 28, 1980; FIPRA Sec. 3 cancelled
registration for nonpayment of 1989 registration
maintenance fee, October 12,1989.
SCR Pesticides List February 1990
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HEPTACHLOR
See Chlordane.
Reference PR Notice 74-1 December 2,1974; 41 FR 7552 February
19,1976; FIFRA Docket No. 336, et al., March 6,1978;
PR Notice 78-2 March 28,1978.
SCR Pesticides List February 1990
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KEPONE
Criteria of Concern Oncogenicrty
Action /Use Affected Cancelled, ail products.
A summary of kepone products follows:
1.) Inaccessible Products
a.) Antrol Ant Trap (Reg. No. 475-11), Black Rag
Ant Trap (Reg. No. 475-82), Grant's Roach
Trap (Reg. No. 1663-22), Grant's Ant Control
(Reg. No. 1663-24), and Dead Shot Ant Killer
(Reg. No. 274-23) were cancelled as of May
11,1977.
Inaccessible products includes those enclosed
kepone traps made from metal or plastic, as well
as metal stakes containing enclosed kepone bait
that are hammered into the ground.
b.) Black Leaf Ant Trap (Reg. No. 5887-63), Hide
Roach and Ant Trap (Reg. No. 3325-4), Lily's
Ant Trap with Kepone (Reg. No. 460-17),
T.N.T. Roach and Ant Killer (Reg. No. 2095-
2), Johnston's No-Roach Traps (Reg. No.
2019-19), Mysterious Ant Trap with Kepone
(Reg. No. 395-19), Magikil Ant Trap with
Kepone (Reg. No. 395-21), Magikil Roach
Trap with Kepone (Reg. No. 395-25), Ant-
No! Ant Trap (Reg. No. 358-20), Nott Roaoh
Trapp (Reg. No. 358-129), E-Z Ant Trap
Contains Kepone (Reg. No. 506-109), Tat Ant
Trap (Reg. No. 506-126), and Ant Check Ant
Trap (Reg. No. 506-129) were effectively
cancelled on May 1,1978.
2.) Accessible Products
All of these products were cancelled as of
December 13,1977.
Accessible products includes those that, in
normal use, would be removed from their
containers, as well as foil or cardboard-covered
traps.
SCR Pesticides List February 1990
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KEPONE
Existing Stocks Provisions
1.) The sale, distribution, and shipment of existing
stocks of inaccessible products formulated prior
to May 11,1977, is permitted until such stocks
are exhausted.
2.) The sale, distribution, and shipment of existing
stocks of accessible products is prohibited in the
U.S.
Reference 41 FR 24624 June 17,1976; 42 FR 18885 April 11,1977;
42 FR 38205 July 27,1977; FIFRA Docket Nos. 392 et al.
October 27,1977, and the affirmation of FIFRA Docket
Nos. 392 et al. by the Judicial Officer December 13,
1977.
SCR Pesticides List February 1990
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LEAD ARSENATE
See Wood Preservatives, nonwood uses.
Reference 53 FR 5524 February 24,1988; 53 FR 24787 June 30,
1988.
SCR Pesticides List February 1990
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LJNDANE
Criteria of Concern Oncogenicity
Teratogenicfty
Reproductive effects
Other chronic effects
Acute toxicity
Action/Use Affected Cancellation of lindane products for use in vaporizers.
Cancellation of lindane products used for direct
application to aquatic environments.
In order to avoid cancellation, registrants of lindane
products for all other uses must make the following
amendments to their registration:
1.) Commercial Ornamentals. Avocados. Pecans.
Livestock Sprays. Forestry. Christmas Trees,
Structural Treatments. Dog Shampoos, and Dog
Dusts
a.) These products must be classified for
restricted use, and their labels must include
the following statements:
Restricted Use Pesticide.
For application only by or under
the direct supervision of a
certified applicator.
b.) Products for the above uses (except dog
shampoos) must also include the following
labeling statement:
Applicators must wear the
following protective clothing
during the application process: a
light-weight protec. ve suit or
coveralls; water-resistant hat;
unlined, waterproof gloves; and
unlined, light-weight boots.
Mixers and loaders must also
wear goggles or face shield,
waterproof gloves, and a
waterproof apron.
2.) Additional Requirements for Dog Dust Use
Labels of lindane products for dog dust use must
include the following statement:
SCR Pesticides List February 1990
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LJNDANE
This product should be applied in a well-
ventilated area.
3.) Additional Requirements for Structural Treatment
Labels of lindane products for structural treatment
use must contain the following statement:
Applicators working in enclosed areas, such
as crawl spaces must wear a respirator
approved by OSHA. (29 CFR 1910.134)
4.) Protective Clothing Requirements for Dog
Shampoos
Applicators of lindane-containing dog shampoos
must wear waterproof, elbow-length gloves; a
waterproof apron; and unlined, waterproof boots.
5.) Homeowner Ornamentals
Lindane products for use on homeowner
ornamentals must include the following labeling
statement:
Applicators must wear the following
protective clothing during the application
process: long-sleeved shirt, long pants,
waterproof gloves, full foot covering, and a
head covering.
6.) Hardwood Logs and Lumber
Lindane-containing products for use on
hardwood logs must include the following labeling
statement:
Applicators must wear the following
protective clothing during the application
process: light-weight protective suit or
coveralls, unlined waterproof gloves, and
unlined, lightweight boots.
SCR Pesticides List
February 1990
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LJNDANE
7.) Dog
Lindane products for use in dog dips must be
labeled as follows*:
a.) The following statement must appear on the
product label beneath the Mix as Directed
statement under Caution:
AN INDIVIDUAL APPLICATOR
MUST NOT APPLY THIS
PRODUCT MORE THAN TWELVE
TIMES PER YEAR
b.) The following statement shall be located on
the front panel of the label, beneath the
product name and in the same size type as
the signal word:
FOR KENNEL, COMMERCIAL,
FARM, AND SPORT DOG USES
ONLY.
c.) The last two sentences under Directions for
Use shall state the following:
An individual applicator must not
use this product more than
twelve times per year. Each
treatment of three dogs or fewer
sho'.ild be considered one use.
d.) Applicators must wear the following
protective clothing during the treatment
process: elbow-length, waterproof gloves; a
waterproof apron; and unlined, waterproof
boots.
e.) The label shall state that "improper dilution
could cause serious injury to your dog."
f.) The label shall state that children under the
age of 13 should not be allowed to handle or
apply this product.
* One registrant contested the initial cancellation of all lindane dog dip products to control pests other
than mites. Consequently, on June 27, 1984, the Agency agreed to continue registration of lindane dog
dips to control fleas, ticks, lice, sarcoptic mange, and scabies provided certain additional protective
measures were instituted.
SCR Pesticides List February 1990
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LJNDANE
g.) The label shall be revised in accordance with
the provisions of the Notice of Intent to
Cancel dated September 30,1983, regarding
disposal of dips.
8.) Moth Sprays
Lindane products for use in moth sprays must
include the following label statements:
Applicators must wear MSHA/OSHA
approved cartridge respirators when applying
this product.
9.) Seed Treatment
Lindane-containing products for use in seed
treatments must be labeled as follows:
Applicators who apply this product manually
or without the use of a closed-system
treatment procedure must wear the following
protective clothing during the application
process: long-sleeved shirt, long pants,
gloves, and a disposable, paper dust mask
that covers at least one-third of the face.
This product should be applied in a well*
ventilated area.
Protective clothing for airfomated or closed-
system treatment is not required.
10.) Other Household Uses (Rea Collars. Shelf Paper.
and Household Sprays)
Lindane products for these uses must be labeled
with the following warnings:
Do not allow children to handle or apply this
product.
Children and pets should not be allowed in
treated areas until spray surfaces are dry.
11.) Smoke Fumigation
Lindane smoke fumigation products for outdoor
use must include the following label statement:
SCR Pesticides List February 1990
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UNDANE
Not for indoor
Labels for all lindane products must be modified
to meet the standards of 40 CFR 156.10. Labels
must describe symptoms and proper practical
treatment for poisoning, proper handling and
disposal, and warnings appropriate for the
product's toxicrty category. Where applicable,
labels must include the following statement:
Aerial application of lindane is prohibited.
Lindane products for residential use that contain
more than 6.5 percent active ingredient must
comply with the child-resistant packaging
regulations described in 40 CFR 157, Subpart B.
12.) Disposal of Dips
Lindane products for dip uses (other than
household uses) must be labeled with the
following provisions:
Used dip solutions must be disposed of in
accordance with the Resource Conservation
and Recovery Act (RCRA). If the applicator
generates more than 1,000 kg 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 treat, store,
or dispose of hazardous waste must obtain a
permit to serve as a hazardous waste facility
pursuant to RCRA.
Existing Stocks Provisions
1.) The use of existing stocks of lindane products by
end users is permitted until the supply is
exhausted.
2.) Any existing stocks of products within the
possession of the registrant and within the
possession of distributors other than the
registrant, including retailers, must be disposed of
in accordance with the Resource Conservation
and Recovery Act.
SCR Pesticides List
February 1990
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UNDANE
Reference PR Notice 69-9 April 28,1969; IF&R Docket No. 19
December 2,1974; 48 FR 48512 October 19,1983; 49
FR 26282 June 27,1984; 50 FR 5424 February 8,1985.
Illinois District Court Memorandum Opinion and Order
February 9,1987.
SCR Pesticides List February 1990
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MERCURY
Criteria of Concern
Action /Use Affected
Reference
Hazard to aquatic organisms
Acute toxicrty
Cancelled, all products, except for the following uses:
1.) As a fungicide in the treatment of textiles and
fabrics intended for continuous outdoor use;
2.) As a fungicide to control brown mold on freshly
sawn lumber;
3.) As a fungicide treatment to control Dutch elm
disease;
4.) As an irvcan preservative in water-based paints
and coatings;
5.) As a fungicide in water-based paints and coatings
used for exterior application;
6.) As a fungicide to control winter turf diseases*,
such as Sclerotinia boreales, and gray and pink
snow mold subject to the following:
a.) The use of these products shall be prohibited
within 25 feet of any water body where fish
are taken for human consumption.
b.) Theso ?r?^:t3 c&n-be applied only by or
under the direct supervision of golf course
superintendents.
c.) The products are classified as restricted-use
pesticides when they are reregistered and
classified in accordance with Section 3(d) of
FIFRA.
PR Notice 72-5 March 22,1972; FIFRA Docket No. 246
et al. December 22, 1975; 41 FR 16497 Apry 19,1976; 41
FR 26742 June 29, 1976; 41 FR 36068 August 26,1976.
* The term winter turf diseases refers to the forms of snow mold that can attack and damage the fine
tun* of greens, tees, and aprons.
SCR Pesticides List
February 1990
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METALDEHYDE
Criteria of Concern Acute and chronic wildlife effects
Action/Use Affected Registrants must include the following statement on the
front panel of the product label:
This pesticide may be fetal to dogs or other pets if
eaten. Keep pets out of treated area.
Reference. PR Notice 74-7 July 1,1974.
SCR Pesticides List February 1990
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MIREX
Criteria of Concern
Action/Use Affected
Carcinogenicrty
Bioaccumulation
Hazard to wildlife and other chronic effects
Cancelled, ail products.
Although all products are cancelled, existing stocks of
Harvester Bart 300, Reg. No. 38962-5, may only be sold
and used for the control of the pheidole ant, Argentine
ant, and fire ant on pineapples in Hawaii.
The application of Harvester Bait 300 is subject to the
following restrictions:
1.) Aerial Application
No longer permitted.
2.) Ground Application
a.) Permissible in all areas of infestation provided
that there is no ground application to aquatic
and heavily forested areas or areas where
run-off or flooding will contaminate such
areas.*
b.) Treatment shall be confined to areas where
the imported fire ants are causing significant
prob'°ms.
Existing Stocks Provisions
The sale, distribution, and use of Mirex products (with the
exception of Harvest Bart 300) is prohibited in the U.S.
Reference
FIFRA Docket No. 293 October 26,1976; 41 FR 56694
December 29, 1976.
* Aquatic areas encompasses, without limitation, estuaries, rivers, streams, wetlands (those land and
water areas subject to inundation by tidal, riverine, or lacustrine flowage), takes, ponds, and other bodies
of water.
SCR Pesticides List
February 1990
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MONOCROTOPHOS
Criteria of Concern
Action/Use Affected
Avian effects
Voluntary cancellation, all products.
July 30,1989, was the last date for use of the product for
manufacturing purposes, and the last date for sale and
distribution by the registrant, DuPont.
Reference
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of monocrotophos products is prohibited in the
U.S.
Letter from registrant to EPA, June 13,1988.
SCR Pesticides List
February 1990
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OMPA
Criteria of Concern Oncogenicrty
Action/Use Affected Voluntary cancellation, all products.
Reference 41 FR 21859 May 28,1976.
SCR Pesticides List February 1990
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10,10'-OXYBf SPHENOXARSINE
Criteria of Concern Oncogenicity
Mutagenicity
Teratogeniclty
Action/Use Affected In order to avoid cancellation, registrants must amend
product labels to eliminate use in wind breakers and
baby pants.
Reference Special Pesticide Review Division's position document on
10,10'-oxybisphenoxarsine approved April 20,1979.
SCR Pesticides List February 1990
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OXYFLUORFEN
Criteria of Concern Oncogenictty
Action /Use Affected Cancelled, all oxyfluorfen products (Goal) for use on
nonbearing and bearing fruits and nuts, conifer
seedbeds, transplant and out-plantings, soybeans, and
field corn (in conjunction with the USDA Witchweed
Eradication Program), unless registrants modify the
conditions of registration as follows:
The perchloroethylene (PCE) contamination of
oxyfluorfen products (Goal) must not exceed 200 ppm.
This must be stated in the confidential statement of
formula foi each registered oxyfluorfen product.
Reference 47 FR 27118 June 23,1982.
SCR Pesticides List February 1990
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PARATHION (ETHYL)
Criteria of Concern Acute toxicrty
Toxic to aquatic organisms
Action/Use Affected Registration of ethyl parathion limited to those products
packed in one gallon containers or larger.
Manufacturers and formulators of registered ethyl
parathion should be in compliance with the standardized
safety label that was enclosed with PR 71-2.
Registrants must include the following label statement on
the front panel of their parathion products:
RESTRICTED USE PESTICIDE due to very high
acute toxicity to humans and birds. For retail sale
to and use only by certified applicators or persons
under their direct supervision and only for those
uses covered by the certified applicator's
certification. Direct supervision for this product is
defined as the application, mixing, loading, repair,
and cleaning of application equipment.
Commercial certified applicators must also ensure
that all persons involved in these activities are
informed of the precautionary statements.
Reference PR Notice 71 -2 April 5,1971; 40 CFR 152.175.
SCR Pesticides List February 1990
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PCNB
Criteria of Concern
Action/Use Affected
Reference
Onocogenicity
Voluntary cancellation of ail dust-based formulations
except those used in planter box seed treatment.
Registrants of PCNB products must make the following
amendments:
1.) Reduction of the hexachlorobenzene (HCB) level
in technical PCNB products to 0.1 percent or less
because of risks associated with the oncogenic
effects of HCB.
2.) Granular Formulations Used in Parks and Golf
Courses
These products must include on their labels the
following precautionary statement:
Do not apply directly adjacent to potable
water supplies.
3.) Homeowner Products
These products must include on their labels the
following precautionary statement:
Avoid contact with skin by wearing the
following protective clothing: long-sleeved
shirt, long pants, socks, and shoes. Wash
hands thoroughly after using.
4.) Professional Applicator Products
These products must include the following
protective clothing requirements on their labels
during mixing/loading procedures:
Granular formulations: gloves, long-sleeved
shirt, long pants, socks, and shoes.
Emulsifiable concentrate and liquid
formulations: respirator, gloves, long-sleeved
shirt, long pants, socks, and shoes.
47 FR 18177 April 28, 1982.
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February 1990
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PENTACHLOROPHENOL
See Wood Preservatives, wood and nonwood uses.
Reference 49 PR 28666 July 13,1984; 51 PR 1334 January 10,
1986; 53 PR 5524 February 24,1988.
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PHENARSAZINE CHLORIDE
Action/Use Affected Voluntary cancellation, all products.
Reference 42 FR 59776 November 21,1977.
SCR Pesticides List February 1990
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POLYCHLORINATED BIPHENYLS
Criteria of Concern Oncogeniclty
Action/Use Affected Cancelled, all products.
Reference PR Notice 70-25 October 29,1970.
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POLYCHLORINATED TERPHENYLS
Criteria of Concern Chronic toxicity to aquatic organisms
Action /Use Affected Cancelled, all products.
Reference PR Notice 70-25 October 29,1970.
SCR Pesticides List February 1990
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PRONAMIDE
Criteria of Concern Oncogenicity
Action/Use Affected Cancelled, all pronamide products for hand spray
application, except those used on ornamentals and
nursery stock.
In order to avoid cancellation and denial of registrations
of all pronamide products registered for use on lettuce,
alfalfa, forage legumes, and other uses, registrants must
make the following amendments:
1.) Wettable Powder Products
Pronamide labels for wettable powder products
must include the following statement:
RESTRICTED-USE PESTICIDE. For retail
sate to and use only by certified applicators
or persons under their direct supervision and
only for those uses covered by the
applicator's certification.
Because pronamide has produced tumors in
laboratory animals, this product is for use
only by certified applicators or persons under
their direct supervision and only for uses
covered by the certified applicator's
certification.
2.) General Precautions,
Under general precautions, the labels must
include the following statements:
Take special care to avoid contact with eyes,
skin, or clothing.
Wash clothing and gloves after use.
3.) » Protective Clothing
The following items of clothing are required when
mixing or applying pronamide:
a.) Long-sleeved shirts and long pants,
preferably one piece (overalls).
b.) Hat with brim.
c.) Heavy duty fabric or rubber work gloves.
SCR Pesticides List February 1990
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PRONAMIDE
d.) Hand-spray applications of pronamide will
require the use of heavy duty leather or
rubber boots.
4.) Water-Soluble Packaging
For all wettable powder products introduced in
commerce, the label must include the following
statement:
Qilution Instruction^
The enclosed pouches of this product are
water-soluble. Do not allow pouches to
become wet prior to adding to the spray
tank. Do not handle the pouches with wet
hands or gloves. Always reseal overwrap
bag to protect remaining unused pouches.
Do not remove except to add directly to the
spray tank.
Add the required number of unopened
pouches as determined by the dosage
recommendations into the spray tank with
agitation. Depending on the water
temperature and degree of agitation, the
pouches should dissolve completely within
approximately five minutes from the time they
are added to the water.
5.) Granular Formulation for Turf Use
tun use of granular formulation pronamide,
the label must include the statement:
This product should be watered in within 24
hours.
Reference 44 FR 61640 October 26, 1979; Registration Standard
issued May 15, 1987.
SCR Pesticides List February 1990
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QUATERNARY AMMONIUM COMPOUNDS
Criteria of Concern Other chronic effects
Action/Use Affected Cancelled, for use as a sanrtizer in poultry drinking water.
Reference PR Notice 73-5 August 29,1973.
SCR Pesticides List February 1990
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SAFROLE
Criteria of Concern Oncogenicity
Mutagenicity
Action/Use Affected Voluntary cancellation, all products.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of Surf-Kote Pet Repellent, Reg. No. 1811-8, and
Scram Dog Repellent Spray, Reg. No. 239-2057, are
permitted only be persons other than the registrants.
Reference 42 FR 11039 February 25,1977; 42 FR 16844 March 30,
1977; 42 FR 29957 June 10,1977.
SCR Pesticides List February 1990
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SEED TREATMENTS
Criteria of Concern Other chronic effects
Action/Use Affected Cancelled, all products not containing a dye or
discoloring agent that will impart an unnatural color to the
seed, unless labeling includes directions for adding a dye
at the time of treatment. Exceptions to this are products
bearing directions for use solely as planter box
treatments.
Reference PR Notice 70-17 June 26,1970; PR Notice 70-24 October
28, 1970.
SCR Pesticides List February 1990
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SILVEX/2.4.5-T
Criteria of Concern Oncogenicity
Mutagenictty
Fetotoxiclty
Action/Use Affected Cancelled, all products.
Reference PR Notice 70-22 September 28,1970; 44 FR 15917
March 15,1979; 44 FR 41536 July 17,1979; 48 FR
48434 October 18,1983. Ruling by an Administrative
Law Judge, January 2,1985.
SCR Pesticides List February 1990
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SODIUM ARSENATE
See Wood Preservatives, nonwood uses.
Reference 53 FR 5524 February 24,1988; 53 FR 24787 June 30,
1988.
SCR Pesticides List February 1990
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SODIUM ARSENITE
See Wood Preservatives, nonwood uses.
Reference PR Notice 67-2 August 1,1967; Interpretation No. 25
August 1968; 53 FR 5524 February 24,1988; 53 FR
24787 June 30, 1988.
SCR Pesticides List February 1990
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SODIUM CYANIDE
Criteria of Concern Toxicity to wildlife and endangered species
Acute toxicrty
Action/Use Affected Cancelled and suspended, all products for mammalian
predator control except the registration of sodium
cyanide capsules for use in the M-44 device is allowed
for the purpose of controlling certain wild canid predators
subject to the following 26 restrictions:
1.) Use of the M-44 device shall conform to all
applicable Federal, state, and local laws and
regulations.
2.) Applicators shall be subject to such other
regulations and restrictions as may be prescribed
from time to time by the EPA.
3.) Each applicator of the M-44 device shall be
trained in (1) safe handling of the capsules and
device, (2) proper use of the antidote kit, (3)
proper placement of the device, and (4)
necessary recordkeeping.
4.) The M-44 devices and sodium cyanide capsules
shall not be sold or transferred to, or entrusted to
the care of, any person not supervised or
monitored by the registrant.
5.) The M-44 device shall only be used to take wild
canids suspected of preying on livestock, ooultry,
or federally designated threatened or endangered
species.
6.) The M-44 device shall not be used solely to take
animals for the value of their fur.
7.) The M-44 device shall only be used on or within 7
miles of a ranch unit jr allotment where losses
due to canid predation are occurring or where
losses can be reasonably expected to occur
based on recurrent prior experience of predation
on the ranch unit or allotment. Full
documentation of livestock depredation, including
evidence that such losses were caused by wild
canids, will be required before applications of the
M-44 are undertaken.
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SODIUM CYANIDE
8.) The M-44 device shall not be used in (1) national
or state parks, (2) national or state monuments,
(3) Federally designated wilderness areas, (4)
wildlife refuge areas, (5) prairie dog towns, and
(6) areas where exposure to the public and family
pets is probable.
9.) The M-44 shall not be used in areas where
threatened or endangered species might be
adversely affected. Each applicator shall be
issued a map, prepared by or with the
consultation of the U.S. Rsh and Wildlife Service,
which clearly indicates such areas.
10.) One person other than the individual applicator
shall have knowledge of the exact placement
location of all M-44 devices in the field.
11.) In areas where more than one government
agency is authorized to place M-44 devices, the
agencies shall exchange placement information
and other relevant facts to ensure the maximum
number of M-44s allowed is not exceeded.
12.) The M-44 devise shall not be placed within 200
feet of any lake, stream, or other body of water.
Natural depression areas that catch and hold
rainfall only for short periods of time shall not be
considered bodies of water for purposes of this
restriction.
13.) The M-44 device shall not be placed in areas
where food crops are planted.
14.) M-44 devices shall be placed at least 50 feet or
more from any public road or pathway as may be
necessary to remove it from the sight of persons
and domestic animals using any such public road
or pathway.
15.) The maximum density of M-44s placed in any
100-acre pastureland area shall not exceed 10,
and the density in any one square mile of open
range shall not exceed 12.
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February 1990
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SODIUM CYANIDE
16.) No M-44 device may be placed within 30 feet of
draw stations (livestock carcasses). No more
than four M-44 devices shall be placed per draw
station; and no more than five stations shall be
operated per square mile.
17.) Supervisors of applicators shall check the
records, warning signs, and M-44 devices of
each applicator at least once a year to verify that
all applicable restrictions, laws, and regulations
are being strictly followed.
18.) M-44 devices shall be inspected by the applicator
at least once a week, weather permitting access,
to check for interference or unusual conditions
and shall be serviced as required.
19.) Damaged or nonfunctional M-44 devices shall be
removed from the field.
20.) An M-44 device shall be removed from an area if,
after 30 days, there is no sign that a target
predator has visited the site.
21.) All persons authorized to possess and use M-44
capsules and devices shall store said devices
under lock and key.
22.) Used sodium cyanide capsules shall be disposed
of by deep burial or at a proper landfill site.
23.) Bilingual warning signs in English and Spanish
shall be used in all areas containing M-44
devices. All such signs shall be removed when
M-44 devices are removed.
a.) Main entrances or commonly used access
points to areas in which M-44 devices are set
shall be posted with warning signs to alert
the public to the toxic nature of the cyanide
and to the danger to pets. Signs shall be
inspected weekly to ensure their continued
presence and ensure that they are
conspicuous and legible.
b.) An elevated sign shall be placed within 6 feet
of each individual M-44 device warning
persons not to handle the device.
SCR Pesticides List
February 1990
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SODIUM CYANIDE
24.) Each authorized or licensed applicator shall carry
an antidote kit on his person when placing
and/or inspecting M-44 devices. The kit shall
contain at least six pearls of amyf nitrate and
instructions on their use. Each authorized or
licensed applicator shall also carry on his person
instructions for obtaining medical assistance in
the event of accidental exposure to sodium
cyanide.
25.) In all areas where the use of the M-44 device is
anticipated, local hospitals, doctors, and clinics
shall be notified of the intended use and informed
of the antidotal and first-aid measures required
for treatment of cyanide poisoning. It is the
responsibility of the supervisor to perform this
function.
26.) Each authorized M-44 applicator shall keep
records dealing with the placement of the device
and results of each placement. Said records
shall include, but need not be limited to:
a.) The number of devices placed.
b.) The location of each device placed.
c.) The date of each placement, as well as the
date of each inspection.
d.) *i ne number and location of devices that
have been discharged and the apparent
reason for each discharge.
e.) The species of animal taken.
f.) All accidents or injuries to humans or
domestic animals.
Reference PR Notice 72-2 March 9,1972. 10th Circuit Court's
Vacation of the Wyoming District Court's Predicide
Injunction, December 2,1975. 40 FR 44726 September
29, 1975; 41 FR 21690 May 27, 1976; 42 FR 8406
February 10,1977; 53 FR 9515 March 19,1988.
SCR Pesticides List February 1990
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SODIUM FLUORIDE
Action/Use Affected Cancelled for home use, if the product contains more
than 40 percent of this compound.
Reference PR Notice 70-14 June 1,1970.
SCR Pesticides List February 1990
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SODIUM MONOFLUOROACETATE (1080)
Criteria of Concern Reduction in nontarget and endangered species
Action /Use Affected Cancelled, all products except those used for the
following:
a.) Livestock collars for predicide use, provided label
requirements established by EPA are followed.
Exact label requirements can be obtained from
the EPA Registration Division.
b.) Control of certain rodents in California and
Colorado, provided requirements established by
EPA are followed. These uses are currently
under review by the Registration Division of EPA.
Exact requirements and restrictions can be
obtained by contacting the EPA Registration
Division.
Reference PR Notice 72-2 March 9, 1972. 10th Circuit Court's
Vacation of the Wyoming District Court's Predicide
Injunction, December 2,1975. 49 FR 4830 February 5,
1984; 50 FR 31012 July 31, 1985.
SCR Pesticides List February 1990
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STROBANE
Criteria of Concern . Oncogenicity
Action/Use Affected Voluntary cancellation, all products.
Reference 41 FR 26607 June 28,1976.
SCR Pesticides List February 1990
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STRYCHNINE
Criteria of Concern Reduction in nontarget and endangered species
Action/Use Affected 1.) Cancellation and suspension of products used for
mammalian predator control. Label should have
instructions for predator use blocked out.
Agency may consider registration of strychnine to
control rabid skunks.
2.) Cancellation of registrations and denial of future
registrations for strychnine-containing products
for the following uses:
a.) Control of deer mice, and chipmunks on
rangeland, pasture, cropland, and
nonagricultural sites; marmots/woodchucks
on rangeland, cropland, and pasture; and
cotton rats, kangaroo rats, mountain
beavers, opossums, rabbits, and jackrabbits
(except around airports) on nonagricultural
sites.
3.) Cancellation of registrations and denial of future
applications for registration for strychnine-
containing products for control of the following
rodents, unless certain specifications and label
amendments are made:
a.) Ground squirrels, prairie dogs, and meadow
mice on rangeland, cropland, and
nonagr!cultur?J sites.
b.) Cotton rats, kangaroo rats, and jackrabbrts
on rangeland, pastures, and cropland.
c.) Marmots/woodchucks on nonagricultural
sites.
d.) Birds on croplands. :
e.) Birds on nonagricultural sites.
The use of strychnine varies among states according to
the geographic location of certain endangered species
and the evidence of one or more black-footed ferrets in a
survey of land in which strychnine is to be applied. Other
restrictions include placement of baits and disposal of
carcasses. Each state may designate an appropriate
SCR Pesticides List February 1990
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STRYCHNINE
Reference
agency to conduct its strychnine program. Consult with
the state or with the U.S. Fish & Wildlife Service prior to
use.
At this writing, the United States District Court for the
District of Minnesota has issued an order requiring the
temporary cancellation of all registrations of pesticides
containing strychnine for above-ground use. The
temporary cancellation does not affect registrations
limited to below-ground use. If a registrant uses a
product that permits both above- and below-ground use,
a label permitting below-ground use only may be
requested from the EPA. This cancellation will remain in
effect until either the conditions established in the court's
order are fulfilled or the order is overturned on appeal.
PR Notice 72-2 March 9, 1972. 10th Circuit Court's
Vacation of the Wyoming District Court's Predicide
Injunction, December 2,1975. 48 FR 48522 October 19,
1983; 51 FR 28623 August 8, 1986; 52 FR 6762 March 4,
1987; 53 FR 18952 May 25,1988.
SCR Pesticides List
February 1990
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2.4.5-T
See Silvex
Reference PR Notice 70-22 September 28,1970; 44 FR 15917
March 15,1979; 44 FR 41536 July 17,1979; 48 FR
48434 October 18,1983. Ruling by an Administrative
Law Judge, January 2,1985.
SCR Pesticides List February 1990
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2,4,5-TCP AND ITS SALTS
Criteria of Concern Oncogenicrty
Fetotoxicity
Action/Use Affected Cancelled, all products.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of 2,4,5-TCP and its salts is prohibited in the U.S.
and must be disposed of in accordance with the
Resource Conservation and Recovery Act.
Reference PR Notice 70-22 September 28,1970; PR Notice 70-13
May 1,1970; 44 FR 15874 March 15, 1979; 44 FR 41531
July 17,1979; 48 FR 48434 October 18, 1983; 52 FR
15549 April 29, 1987.
SCR Pesticides List February 1990
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THALLIUM SULFATE
Criteria of Concern Chronic and acute toxicity
Reduction in endangered and nontarget species
Action/Use Affected Cancelled and suspended, all products.
Reference PR Notice 72-3 March 9,1972.
SCR Pesticides List February 1990
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TOK
Criteria of Concern Other chronic effects
Action/Use Affected Voluntary cancellation, all products.
Reference 49 FR 2151 January 19,1984.
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TOXAPHENE
Criteria of Concern
Action/Use Affected
Oncogenicfty
Population reduction in nontarget species
Acute toxicrty to aquatic organisms
Chronic effects to wildlife
Cancelled, all products.
Reference
Existing Stocks Provisions
1.) The sale, distribution, shipment, and use of
existing stocks of toxaphene products is
prohibited in the U.S., except for the following
uses:
a.) Cattle dip for scabies control.
b.) Pineapples in Puerto Rico.
c.) Bananas in the Virgin Islands.
d.) Emergency treatment of cotton, corn, and
small grains.
2.) All other stocks must be disposed of in
accordance with the Resource Conservation and
Recovery Act.
PR Notice 69-5 February 14, 1969; 47 FR 53784
November 29, 1982.
SCR Pesticides List
February 1990
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TOBU7YLT1N
Criteria of Concern Acute and chronic toxicrty to nontarget organisms
Action/Use Affected In order to avoid cancellation of their TBT paint products,
registrants must:
1.) Comply with the Organotin Antifouling Paint
Control Act (OAPCA) of 1988 average daily
release rate limit of 4.0 ug organotin/cmVday.
2.) Comply with OAPCA's prohibition on the use of
TBT antifouling paints on all nonaluminum vessels
under 82 feet (25 meters) in length (on deck).
3.) Are classified as restricted-use pesticides,
restricting their sale to certified commercial
applicators and their use to persons under the
direct supervision of an on-srte certified
commercial applicator (except for products
packaged in 16 ounce or less spray-can
containers that are labeled for use only on
outboard motors, propellers, and other nonhull
underwater aluminum components). This
restricted-use classification of TBT begins March
1,1990.
4.) Do not have labeling that requires compliance
with applicable OSHA regulations and with the
following directions for use:
During and after paint removal and or
application of new TBT paint, employ
methods designed to prevent introduction of
TBT paints into aquatic environments.
Following removal of TBT paint and/or
application of new TBT paint, all paint chips
and spent abrasives, paint containers,
unused paint, and any other waste products
from paint removal or application must be
disposed of in a.sanitary landfill.
5.) Limit certain uses for some types of products, as
specified herein.
The Agency is requiring that the registrants develop and
submit a prototype training program for the use,
disposal, and removal of TBT paints and paint wastes
within 180 days from the date of application for
conditional registration.
SCR Pesticides List February 1990
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TRIBUTYLTIN (TBT)
Existing Stocks Provisions
The sale, distribution, and use of existing stocks of
cancelled tributyltin products is prohibited in the U.S.
Reference 53 FR 39022 October 4,1988; 50 FR 778 January 8,
1986; 52 FR 37510 October 7,1987.
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VINYL CHLORIDE
Criteria of Concern Oncogenicity
Action/Use Affected Cancelled and suspended, all pesticide products
containing this compound, whether as an active or inert
ingredient, for uses in the home, food-handling
establishments, hospitals, or in enclosed areas.
Reference PR Notice 74-5 April 30,1974; 40 FR 3494 January 22,
1975.
SCR Pesticides List February 1990
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TRIFLURALJN
Criteria of Concern Oncogenicity
Mutagenicity
Action/Use Affected In order to avoid cancellation of all trifluraJin products,
registrants must amend the terms of registration as
follows:
1.) Confidential Statement of Formula
a.) Registrants must amend the inert ingredients
statement of formula for each technical
registered product to read as follows:
Total N-nitrosamin«
contamination: no greater than
0.5 ppm.
b.) Registrations for formulated registered
products must be amended to include the
following statement in the confidential
statement of formula:
Total N-nitrosamine
contamination: no greater than
(number to be calculated as
follows: 0.5 ppm total N-
nitrosamine contamination
allowed in technical trifluralin x
X% technical trifluralin in the end-
use product x 2 to allow for
possible generation of
nitrosamines during formulation).
2.) Quality and Records
Registrants of trifluralin pesticides products must
maintain accurate records of their quality control
efforts, which will be subject to EPA review and
must inform EPA of the quality control
procedures that they will adopt to ensure that the
N-nitrosamine contamination limit listed in the
confidential statement of formula will not be
exceeded.
Reference 47 FR 33777 August 4,1982.
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WOOD PRESERVATIVES
INORGANIC ARSENICALS, PENTACHLOROPHENOU CREOSOTE
(WOOD USES ONLY) _^
Criteria of Concern
Action/Use Affected
Reference
Oncogenicrty
Mutagenictty
Teratogenicrty
In order to avoid cancellation, registrants must adhere to
the terms and conditions of the Federal Register notices
cited for creosote, pentachlorophenol, and inorganic
arsenicals - wood uses only.
49 FR 28666 July 13,1984; 51 FR 1334 January 10,
1986.
SCR Pesticides List
February 1990
-------
WOOD PRESERVATIVES
INORGANIC ARSENICALS, PENTACHLOROPHENOL, CREOSOTE
(NONWOOD USES ONLY)
2.) Existing stocks of calcium arsenate for turf
fungicide use may continue to be sold,
distributed, shipped, and used until all remaining
stocks are exhausted.
3.) The sale, distribution, shipment, and use of all
other cancelled inorganic arsenical products is
prohibited after August 1,1988.
B. Pentachlorophenol
Cancelled, all products for pentachlorophenol products
used in paper mills in the wet end of the paper making
process. These uses were previously included among
the retained registrations.
Cancelled, any of the retained registrations for
pentachlorophenol uses in cooling towers, pulp paper
mills, and oil wells unless the'registrations are amended
to comply with the following terms and conditions:
1.) HxCDD Contaminant Limitations
After February 2,1989, each batch of
pentachlorophenol manufacturing-use product or
portion thereof released for shipment will contain
no more than 4 parts per million (ppm) HxCDD,
and the average of all batches released in any
calendar month will not exceed 2 ppm HxCDD.
This reduction in content must be achieved
without increasing the amount of HCB beyond 75
ppm. The manufacturing-use pentachlorophenol
products will not contain any 2,3,7,8-TCDD higher
than 1 part per billion (ppb).
2.) End-Use Products
Registrants must include labeling provisions on all
end-use products to require use of either single,
treatment-sized water-soluble bags or closed-
system metering devices.
SCR Pesticides List February 1990
-------
WOOD PRESERVATIVES
INORGANIC ARSENICALS, PENTACHLOROPHENOL, CREOSOTE
(NONWOOD USES ONLY)
Criteria of Concern
Action/Use Affected
Oncogenicity
Mutagenicity
Teratogenicity
A. Inorganic Arsenicals
All registered products, for nonwood use that contain the
inorganic arsenicals lead arsenate, calcium arsenate,
sodium arsenate, and sodium arsenite are cancelled and
applications denied, with the exception of the following:
1.) Arsenic trioxide insecticide use (solid formulation
manufactured in a sealed metal container only)
for:
Domestic outdoor-domestic dwellings
Domestic indoor-domestic dwellings
2.) Arsenic trioxide, mole, gopher, and pocket
gopher killer use (solid formulation only) for:
Domestic outdoor-domestic dwellings
TerrestiaJ nonfood crops-golf courses
Ornamental plants, lawns, and noncrop areas
The following uses have been voluntarily cancelled:
1.) Lead arsenate. Plant growth regulator MCO op
grapefruit.
2.) Calcium arsenate. Turf fungicide use.
The sodium arsenite fungicide use on grapes and the
desiccant uses of arsenic acid on okra (grown for seed)
and cotton are still under special review by the Agency.
After reviewing data, a final decision will be made
regarding these uses.
Existing Stocks Provisions
1.) Existing stocks of lead arsenate for plant growth
regulator use on grapefruit may continue to be
sold, distributed, shipped, and used until all
remaining stocks are exhausted.
SCR Pesticides List
February 1990
-------
WOOD PRESERVATIVES
INORGANIC ARSENICALS, PENTACHLOROPHENOU CREOSOTE
(NONWOOD USES ONLY) __^__
3.) Cautionary Statements
These labels must include the following
cautionary statement:
The U.S. EPA has determined that
pentachlorophenoi can produce defects in
the offspring of laboratory animals. Exposure
to pentachlorophenoi during pregnancy
should be avoided.
The Agency is continuing fts review of the
retained nonwood uses (cooling water, paper mill,
and oil well operations) of pentachlorophenoi.
After receiving and reviewing data, a final decision
will be made.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of cancelled pentachlorophenoi products was
prohibited in the U.S. after February 24,1989.
C. Creosote
All nonwood creosote and coal tar products ha^«
cancelled, excluding those products for use on gypsy
moth egg masses.
Existing Stocks Provisions
The sale, distribution, shipment, and use of existing
stocks of cancelled creosote products are prohibited in
the U.S. Disposal of creosote products must be in
accordance with the Resource Conservation and
Recovery Act.
Reference 50 FR 41943 October 16,1985; 53 FR 5524 February 24,
1988; 53 FR 24787 June 30,1988.
SCR Pesticides List February 1990
-------
19174 Federal Register / Vol 51. No. 102 / Wednesday, May 28. 1986 / Rules and Regulations
PART 230ASBESTOS DETECTION
AND CONTROL LOCAL
EDUCATIONAL AGENCIES [REMOVED]
1. 34 CFR Part 230 ia removed.
PART 231ASBESTOS DETECTION
AND STATE PLAN: STATE
EDUCATIONAL AGENCIES [REMOVED]
2. 34 CFR Part 231 ia removed. -
[FR Doc. 80-11793 Filed 5-27-86; 8:45 am)
BILUNQ COOt 4000-01-tf
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 162
[OPP-00149A; FRL 3021-5]
Advocacy of Pesticide Uses Which Do
Not Appear on Registered Pesticide
Labels; Amendment to the Statement
of Policy
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice of amendment to policy.
SUMMARY: This notice amends a policy
statement published in the Federal
Register or October 22,1981 (46 FR
51745) (October 1981 policy) and affects.
persons who distribute, sell, offer for
sale, hold for sale. ship, deliver for
shipment, or receive and (having so
received] deliver or offer to deliver any
antimicrobial pesticide. If any such
person makes any claims for an
antimicrobial pesticide product targeted
against microbial human pathogens,
which differ from those made in
conjunction with that product's
registration, the EPA will regard that
person as having violated section
12(a)(l)(B) of the Federal Insecticide.
Fungicide, and Rodenticide Act (FIFRA).
even when such claims are for uses
allowed by FIFRA section 2(ee).
DATE This policy is effective June 27,
1988.
FOR FURTHER INFORMATION CONTACT:
Daniel A. Helfgott (enforcement
information). Office of Compliance
Monitoring (EN-342). Office of
Pesticides and Toxic Substances,
Environmental Protection Agency, 401
M St., SW., Washington. D.C, 20460,
(202-382-7847).
D. lean Jenkins (technical information).
Registration Division (TS-767C),
Office of Pesticide Programs. 401 M
St.. SW.. Washington. D.C. 20460.
Office location and telephone number
Rm. 246. CM #2.1921 Jefferson Davis
Highway, Arlington, Virginia, (703-
557-7443).
SUPPLEMENTARY INFORMATION:
I. Policy
FIFRA section 12(a)(l)(B) states that it
is unlawful for a person who distributes,
sells, offers for sale, holds for sale.
ships, delivers for shipment, or receives
and (having so received) delivers or
offers to deliver a registered pesticide.
to make any claims for that product
which differ substantially from those
claims made in conjunction with that
product's registration. The term "claims"
includes, but is not limited to. claims
appearing in advertising, literature,
letters, or other documents, as well as
oral statements.
Under section 2(ee) of FIFRA it is not
a misuse to:
1. Apply a pesticide at any dosage,
concentration, or frequency less than
that specified on the labeling.
2. Apply a pesticide against any target
pest not specified on the labeling if the
application is 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).
3. Employ any method of application
not prohibited by the labeling.
In the October 1981 policy. EPA stated
its policy that, since a FIFRA section
2(ee) use is not a misuse, any claim
made regarding FIFRA section 2(ee)
uses would not be treated as a violation
of FIFRA section 12(a)(l)(B) unless the
registered pesticide's labeling
specifically prohibits that use.
EPA has reconsidered its policy on
FIFRA section 12(a)(l](B) with respect to
certain claims made for nses not on the
labeling. This notice informs the public
that a person with financial interest in
the use of an antimicrobial pesticide
product, targeted against human
pathogens, may not make any claims for
the product which differ from those on
the product's approved labeling. This
policy does not affect the applicability
of the October 1081 policy to any
pesticides other than those specified in
this notice.
The Agency believes that efficacy
claims for antimicrobial products that
are not supported by efficacy data
submitted in conjunction with that
pesticide's registration may foster a
false sense of security among health
care professionals relying on that
product. Additionally, since the
presence of the target microorganism
cannot be readily discerned by users,
the users cannot easily judge for
themselves the effectiveness of that
product (see 40 CFR 162,163). Therefore,
claims made for antimicrobial products
which substantially differ from those
made in conjunction with registration
could pose a serious public health
threat.
Since pesticides intended for use
against microorganisms are now
excluded from the October 1981 policy,
the Agency will take appropriate
enforcement action, pursuant to FIFRA.
against any person who distributes,
sells, offers for sale, holds for sale.
ships, delivers for shipment or receives
and (having so received) delivers or
offers to deliver any antimicrobial
pesticide if any claims made for it as
part of its distribution or sale,
substantially differ from those made in
conjunction with its' registration.
Additionally, any person who
recommends a FIFRA section 2(ee] use
for an antimicrobial pesticide remains
liable for possible civil damages arising
out of his own negligence.
EL Background
EPA is currently concerned about
unwarranted claims for antimicrobial
pesticides used against human
pathogens, especially against hepatitis-B
virus (HBV), the causative agent of
serum hepatitis, and human T-
lymphotropic virus type III/
lymphadenopathy-associated virus
(HTLV-m/LAV), the apparent etiologic
agent for acquired immune deficiency
syndrome (AIDS). Most of the inquiries
EPA has received concerning control of
HBV and HTLV-UI/LAV pertain to
sterilizer and disinfectant products.
Sterilizers are antimicrobial products
". . . intended to destroy viruses and all
living bacteria, fungi and their spores,
on inanimate surfaces" (40 CFR
162.3(ff)(2)(i)(D)). Sterilization is an
absolute term and denotes killing of all
microorganisms, including the most
resistant spore forms, against which
these products are tested. Disinfectants
are antimicrobial products
". . . intended to destroy or irreversibly
inactivate infectious or other
undesirable bacteria, pathogenic fungi.
or viruses on surfaces or inanimate
objects" (40 CFR 162,3 (fr)(2)(i)(A)). In
contrast to sterilizers, disinfectants are
intended for effectiveness only against
representative groups of vegetative
bacteria and pathogenic fungi, and
against specifically tested viruses. Some
antimicrobial products are registered
with label directions allowing use as a
sterilizer if one treatment regimen is
used (e.g., immersion for 10 hours) or as
a disinfectant if a less stringent regimen
is used (e.g., immersion for 10 minutes).
FIFRA section 3(c)(5)(A] states that
the Administrator shall register a
pesticide if he determines that". . . its
composition is such as to warrant the
proposed claims for it." In addition. 40
CFR 158.160(b)(l), published-in the
Federal Register of November 13.1985
-------
Federal Register / Vol. 51, No. 102 / Wednesday. May 28. 1986 / Rules and Regulations 19175
(50 FR 46765). states that efficacy data
are required to support all claims ". . .
to control pest microorganisms that pose
a threat to human health and whose
presence cannot be readily observed by
the user, including but not limited to,
microorganisms infectious to man in any
area of the inanimate environment."
EPA requires the following data prior to
registering a product with a virucidal
label claim: (1) Demonstrated recovery
of the infective form of the particular
virus dried on an inanimate surface, and
(2) availability and use of suitable assay
methods to demonstrate absence of the
dried virus after treatment of the surface
with the antimicrobial product (Pesticide
Assessment Guidelines, Subdivision G
Product Performance, Section 91-30
(d](5), National Technical Information
Service Order Number PB 83-153924).
To register a product with a label
claim that the product can be used as a
sterilizer, EPA requires data showing
that the product is sporicidal. (Pesticide
Assessment Guidelines, as above.
Section 91-30(a)(l).) Since spores are the
most resistant form of microorganism,
no additional data are needed to support
virucidal claims for products that are
already registered as sterilizers. While
HBV is a relatively well understood
human pathogen, there are only limited
experimental data concerning viral
recovery and inactivation by
disinfectants on hard surfaces. This is
due to lack of a suitable assay method
for determining whether the infective
virus remains on hard surfaces after
disinfection. To determine this, the
experimenter must attempt to grow the
virus in a host system.
The only known nonhuman host
system is the chimpanzee, and
chimpanzees are practically unavailable
for such experiments. In 1983 the
Centers for Disease Control (CDC]
published findings of a clinical study In
which five chimpanzees were injected
with dried HBV-infected plasma treated
with each of five different germicides (J.
Clinical Microbiology, 18(3): 535-538,
1983). Though the chimpanzees did not
show evidence of HBV infection after 9
months, these data an too limited to be
conclusive. Therefore, the data an
inadequate to demonstrate that
disinfection provides adequate control
against HBV contamination when
sterilization may be the only effective
control measure. This discrepancy in
control procedures (Le. disinfection
rather than sterilization) could result in
failure to reduce HBV contamination,
thereby increasing public health risk*.
The only known routes of
transmission for AIDS virus, which was
isolated and identified in 1984, are
through sexual contact, blood products.
or from mother to newborn.
Transmission of AIDS via casual
contact has not been demonstrated
(New England Journal of Medicine.
314(6):344-349,1986). Recently, data
have become available which indicate
that HTLV-III/LAV may be recovered
after drying on inanimate surfaces for
extended periods (Journal of the
American Medical Association.
255:1887-1891.1986). These findings
advance the possibility that the virus
may be transmitted via such surfaces.
Given the insidious and fatal nature of
AIDS, hospitals and other health-care
facilities are seeking guidance on the
effectiveness of antimicrobial chemicals
in controlling the spread of HTLV-in/
LAV. Researchers at both CDC Q.
Infectious Diseases, 152(2):4OM03,1985)
and the Pasteur Institute (Lancet. 2:899-
901.1984) have conducted studies
demonstrating that certain chemicals
effectively kill HTLV-m/LAV in liquid
suspensions. The CDC issued a report to
advise interested parties of their
recommendations for preventing
transmission of HTLV-III/LAV in the
workplace (Morbidity and Mortality
Weekly Report 34(45):681-«95,
November 15,1985). The report
emphasizes that the recommendations
for preventing transmission of AIDS are
directed towards people who may be
exposed to blood or body fluids from
persons who may be infected with
HTLV-m/LAV. The report provides
certain broad recommendations fo?
sterilizing or disinfecting inanimate
surfaces or objects that have been in
contact with blood or other body fluids
of an AIDS patient
If HTLV-in/LAV can be recovered
from inanimate surfaces, it appears that
an acceptable protocol can be
developed to test the efficacy of
antimicrobial products (Journal of
Immunological Methods 76.171-183,
1985). However, since no acceptable
protocol has been developed, and no.
data submitted, no claims have been
accepted against AIDS virus for any
product
in. Summary
Given the available evidence and
methodology concerning these viruses,
EPA lacks sufficient basis to approve
HBV or HTLV-m/LAV virucidal claims
for any disinfectiant product This
situation may change as research on the
AIDS and HBV viruses continues and
registrants develop acceptable protocols
to demonstrate virus isolation and
disinfectant product efficacy.
EPA will allow registrants to make
HBV and HTLV-III/LAV virucidal
claims for sterilizer products when used
in accordance with label directions '
the sterilization procedure, and wher
approved in connection with the specific
product registration.
Dated: May 18.1986:
John A. Moore,
Assistant Administrator for Pesticides and
Toxic Substances.
[FR Doc. 80-11785 Filed 5-27-86:8:45 am)
8ILLJNO CODE &MO-40-y
40 CFR Part 180
[PP 6F3335/RS40; FRL-3019-6]
Pesticide Tolerance for Dlctofop-
Methyl
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: This rule establishes a
tolerance for the combined residues of
the herbicide diclofop-methyl and its
metabolites in or on the raw agricultural
commodity pea seeds (dry). This
regulation to establish a maximum
permissible level for residues of the
herbicide in or on the commodity was
requested in a petition submitted I
American Hoechst Corp.
EFFECnvi OATH: Effective on Ma>
1988.
ADDRESS: Written objections, identified
by the document control number [PP
6F3335/R840], may be submitted to:
Hearing Clerk (A-110), Environmental
Protection Agency, room 3708,401 M St
SW., Washington. DC 20460.
FOR FURTHER INFORMATION CONTACT.
By mail; Richard Mountfort, Product
Manager (PM) 23, Registration
Division (TS-787C), Environmental
Protection Agency 401M St SW..
Washington. DC 20460.
Office location and telephone number:
Rm. 237, CM No. 2.1921 Jefferson
Davis Highway Arlington. VA. (703-
557-1830).
SUPPUUCNTARY INFORMATION: EPA
issued a notice, published in the Federal
Register of Febraury 19.1988 (51 FR
6034), which announced that American .
Hoechst Corp., Agricultural Division.
Rte. 202-208, North Somerville, NJ 08878.
had filed pesticide petition 6F3335 to
EPA proposing to amend 40 CFR 180.385
by establishing a tolerance for the
combined residues of the herbicide
diclofop-methyl (methyl 2-[4-(2.4-
dichlorophenoxyfrhenoxyjpropagaile)
and its metabolites 2-[4-(2,4-
dichlorophenoxy)phenoxy]prof
acid and 2-[4-{2.4-
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
FEB I 1988
MEMORANDUM
SUBJECT: Endangered Species Enforcement Strategy
FROM: John J. Neylan III, Director
Policy and Grants Division (EN-S^Z)
Office of Compliance Monitoring
TO: Addressees
On January 26, 1988, the Office of Pesticide Programs
signed the attached PR Notice 88-1 which rescinded PR Notices
87-4 and 87-5 dated May 1, 1987. Therefore, there is no longer a
requirement that registrants make label changes by February 1988.
If a registrant has already made such changes, he may: (a) use
that labeling until the existing supply is exhausted; (b)
sticker over the language required by PR Notices 87-4 and 87-5;
or (c) use labeling approved prior to issuance of PR Notices 87-4
and 87-5 provided all other labeling requirements implemented
since May 1, 1987 are included on that labeling. For products in
the market with the endangered species label changes based on PR
Notices 87-4 and 87-5, bulletins will be available explaining the
deferral. However, if the user fails to obtain the bulletin, no
action is warranted.
Prior to the cancellation of PR Notices 87-4 and 87-5, the
Office of Compliance Monitoring sent a draft Endangered Species
Enforcement Strategy to all Regional Directors for review and
comment. However, as indicated in PR Notice 88-1, it is unlikely
that a program for the protection of endangered species will be
in place bafore September 1988. Therefore, OCM is rescinding
the draft Enforcement Strategy for Endangered Species until
further notice. A revised version of the strategy will be sent
to you at a later date for comments.
-------
-2-
Attached for your information is a copy of the Pesticide
Use Bulletin for the Protection of Endangered Species and the
Endangered Species Program deferral letter from Anne L. Barton of
the Hazard Evaluation Division.
As a reminder, please note that although PR Notices 87-4 and
87-5 have been rescinded, endangered species are still protected
under the Endangered Species Act of 1973.
If you have any questions concerning this memorandum please
feel free to call me at 382-7825.
Attachments
-------
Addressees
Douglas Campt
'Edwin F. Tinsworth
Frederick F. Stiehl
Stanley Abramson
Connie Musgrove
Ken Shiroishi
Phyllis Flaherty
John J. Neylan III
Mike Wood
Jerry Stubbs
Dexter Goldman
(TS-792)
(TS-792)
(LE-134A)
(LE-132A)
(EN-342)
II
III
IV
VI
VII
VIII
IX
cc:
Jake Mackenzie
Western Regional Compliance Director
A. Charles Lincoln
Eastern Regional Compliance Director
Louis F. Gitto, Director
Air Management Division
Barbara Metzger, Director
Environmental Services Div
Stephen R. Wassersug, Director
Hazardous Waste Management Div
Winston A. Smith, Director
Air, Pest. & Toxics Magnt. Div
William H. Sanders III, Dir
Environmental Services Div
William B. Hathaway, Dir
Air, Pesticides & toxic Div
William A. Spratlin, Director
Air and Toxics Division
Irwin L. Dickstein, Director
Air and Toxics Division
Jeffrey Zelickson, Director
Marvin Rosenstine, Chief
Pesticides & Toxic Substances Br
Ernest Regna, Chief
Pesticides & Toxic Substances
Larry Miller, Chief
Toxic & Pesticides Branch
Richard DuBose, Chief
Pesticides & Toxic Substances Br
Phyllis Reed, Chief
Pesticides & Toxic Substances Br
Robert Murphy, Acting Chief
Pesticides & Toxic Substances Br
Leo Alderman, Chief
Pesticides & Toxic Substances Br
Alvin Yorke, Chief
Toxic Substances Branch
Richard Vaille, Chief
Toxics and Waste Management Div Pesticides & Toxics Branch
Gary O'Neal, Director
Air and Toxics Division
Anita Frankel, Chief
Pesticides & Toxic Substances Br
Michael Walker
Jane Hopkins
Margaret Rostker
(LE-134P)
(TS-788)
(TS-788)
-------
(
8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f~ WASHINGTON. D.C. 20460
' JAN 2 6 1S88
PR NOTICE 88-1
NOTICE TO MANUFACTURERS, FORMTJLATORS,
3 AND REGISTRANTS OF PESTICIDES
4
ATTENTION: Persons Responsible for Federal Registrations of Pesticides Registered for
FOREST USES, MOSQUITO LARVAE CONTROL, RANGE AND/OR PASTURELAND USES, and
uses on C0&V, COTTON, SOYBEANS, WHEAT, SORGHUM, OATS, BARLEY, or RYE.
SUBJECT: Withdrawal of PR Notices 87-4 and 87-5
PR Notices 87-4 and 87-5 were issued as pan of a program to protect endangered species determined by
the U.S. Fish and Wildlife Service to be jeopardized by exposure to certain pesticides. These PR Notices
directed registrants to add labeling to their products which referred users to additional information that, in
rum, explained limitations on use of the pesticide within the range of jeopardized endangered species.
While the Agency believes this approach would serve to protect endangered species from pesticide
- .- exposure, the information to which,users were referred may be inaccurate and thus, may limit the use of
I pesticides beyond what is necessary to ensure protection of the species.
] .
j The Federal Government, in partnership with the states and with public input, is working to refine and
] tailor the limitations in order to minimire the impact while continuing to fulfill our obligations under
I section 7 of the Endangered Species ACL This process may result in limitations in fewer locations than
I currently indicated or limitations less severe than prohibition of use within a species' range. A recer.;
I Congressional action mandates that EPA not enforce against pesticide users, die labeling program a£
i presented in PR Notices 87-4 and 87-5, before September 15,1988. Given the level of state a^fcjblic
I participation being sought by the Federal Government, and the possibility of resultant changeWo the
j program, it is unlikely that a program will be ready to implement in September 1988.
i
I ": y:. PR Notices 87-4 and 87-5 are, therefore, being withdrawn pending development of a more focusec
i '' program to protect endangered species from exposure to pesticides. If you have already made labeling
i changes indicated in PR Notices 87-4 and 87-5 you may: a) use thai labeling until your existing supply i;
. . exhausted, b) sticker over the language required by PR Notices 87-4 and 87-5, or c) use labeling approvec
! ' prior to issuance of PR Notices 87-4 and 87-5 provided all other labeling requirements implemented since
j May 1,19 87 are included on that labeling.
; Because some products are already in the marketplace with labeling changes indicated in PR Notices 87-'
j ' and 87-5, EPA will publish Pesticide Use Bulletins for Protection of Endangered Species. Rather thai
contain ^formation on limitations of use, these bulletins will explain the program deferral Pesticide user.
who phone the U.S. Fish and Wildlife Service as indicated on some pesticide labeling will be informed b;
the U.S. FWS that the program is deferred.
Finally, PR Notices 87-4 and 87-5 directed registrants of affected products to respond to EPA by sendir.;
; :. EPA a certification which indicated that after a certain date, products would not be released for shipmer.
"'"" unless the product had revised labeling which complied with PR Notices 87-4 and 87-5, as appropriate
This Notice also serves to eliminate the direction that registrants provide such a certification to EPA
Because that direction is eliminated, certifications already submitted to EPA in response to PR Notices 87
~ 4 and 87-5 are not valid. If future PR Notices require the submission of a certification of compliance,
new certification must be submitted. - - -- - -
Edwin F. Tinsworth, Director
Registration Division (TS-767C)
-------
&EPA
Pesticide Use Bulletin For
Protection Of Endangered Species
THIS PESTICIDE USE BULLETIN FOR PROTECTION OF ENDANGERED
SPECIES EXPIRES ON FEBRUARY 1, 1989.
The labeling of certain pesticide products contains statements
requiring users of those products to obtain a bulletin. The bulle-
tin was intended to identify the range(s) of endangered species
and use limitations for pesticides which may jeopardize those
species. However, the U.S. Environmental Protection Agency
(EPA) is not imposing, through Pesticide Use Bulletins to Protect
Endangered Species, cny use restrictions to protect endangered
species in 1988. The U.S. EPA has become aware of a number of
difficulties in implementing restrictions at this time. These prob-
lems are being resolved by the Federal Government with public
and state participation in order to implement a sound and effec-
tive program to protect endangered species from pesticides in
the future.
To assist pesticide users in protecting endangered species on a
voluntary basis in 1988, endangered species information may be
available for your county later in the year. Protecting endangered
species is a responsibility we ell share.
-------
(»
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
PCtTICIOCS ANobc SU1»TANCE«
Dear Pesticide Dealer:
Enclosed are Pesticide Use Bulletins for Protection of Endangered
Species that you ordered. If you ordered more than 25,
additional bulletins will be sent when the printing backlog
has been cleared.
As you may know, implementation of the U.S. EPA's Endangered
Species Labeling Program has been deferred. This deferral is
explained in the enclosed bulletins. To ensure that your
customers are aware of the program deferral please post and/or
provide them with a copy of the bulletin when they purchase
their pesticide product. We hope this will prevent any
misunderstanding or inconvenience that may result from
pesticide labeling that requires them to obtain a bulletin.
While the U.S. EPA is not implementing limitations on pesticide
use through Pesticide Use Bulletins for Protection of Endangered
Species at this time, please be aware that endangered-species
are still protected under the Endangered Species Act of 1973.
I appreciate your cooperation in informing your customers of
the EPA's program deferral and the continuing need to conserve
endangered species.
enclosure
Sincerely,
Anne L. Barton, Acting Director
Hazard Evaluation Division
-------
Thursday
August 17, 1989
Part IV
Environmental
Protection Agency
40 CFR Part 160
Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA); Good
Laboratory Practice Standards; Final Rule
-------
34052
Federal Register / Vol. 54. No. 158 / Thursday. August 17, 1909 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 160
[OPP-3001S5A; FP.L-3518-2]
R!N 2070-AB63
Federal Insecticide, Fungicide and
Rodenticlde Act (FIFRA); Good
Laboratory Practice Standards
AGENCY: Environmental Protection
Agency (EPA). '
ACTION: Final rule.
SUMMARY: EPA is issuing this final rule
that expands the regulations to require
compliance with Good Laboratory
Practice.(GLP) standards for testing
conducted in the field and for such
disciplines of testing as ecological
effects, chemical fate, residue chemistry,
and, as required to be submitted by 40
CFR 158.640, product performance
(efficacy testing). EPA is amending these
regulations to ensure the quality and
integrity of all data submitted to EPA in
conjunction with pesticide product
registration, or othe* marketing and
research permits. EPA is also amending
the FIFRA GLP standards to incorporate
many of the changes made by the Food
and'Drug Administration (FDA) to its
GLP regulations (52 FR 33768, September
4,1987; 21 CFR Part 5&>
DATE: Effective: This rale becomes
effective on October 16,1989.
Compliance All studies conducted,
initiated, at supported after tfte effective
Uvtc vi un9 Fttiv slfUfc DC" SUOjCCl CO* crtCoc
regulations.
FOR FURTHER INFORMATION CONTACT:
Stephen Howie, Office of Compliance
Monitoring (EN-342X Rm E-7D7R.41HIM
St., SW., Washington, DC 20460.
Telephone: (202] 362-7825.
SUPPLEMENTARY INFORMATION:
. Following is an index to the remainder
of this preamble:
I. Introduction
A. Legal Authority.
B. Background.
C. Consistency With FDA GLP Regulations.
D. Publication of the Complete Rule.
LL Summary -of Comments and Responses
A. General Provisions.
B. Organization and Personnel.
C. Facilities.
D. Equipment.
E. Testing Facilities Operation.
F. Test and Control Substances. *
G. Protocol For and Conduct of A Study.
H. Records and Reports.
III. Regulatory Requirements
A. Executive Order 12291.
B. Regulatory Flexibility Act.
C. Paperwork Reduction Act.
I. Introduction.
EPA is. amending the FIFRA GLP
standards (40 CFR Part 160) to
incorporate many of the changes, made
by the Food and Drug Administration to
ks GLP regulations.
A. Legal Authority
These standards are promulgated
under the authority of sections 3.4,5,6V
8,18, 24(c), and 25(a) of FIFRA. 7U^C
136 et seq., as amended, sections 408.,
409, and 701 of the Federal Food. Drug
and Cosmetic Act (FFDCA), 21 P.S.C,
301 et seq., and the Reorganizetioa Plan
No. 3 of 1970.
B. Background
EPA originally published FIFRA GIF
standards in the Federal Register of
November 29,1983 (48 FR 53946J; winch
were codified as 40 CFR pel 1601 At the
same time, EPA published GLP
standards applicable to testing required
under the Toxic Substances Control Act
(TSCA, 48 FR 53922,40 CFR part 792).
These regulations were promulgated in
response to investigations by EPA and
FDA during the mid-1970s which
te.vpalpd thnt gome studies submitted to
the Agencies had not been conducted ta
accordance with acceptable laboratory
practices. Some studies had been
conducted so poorly that the resulting
data could not be relied upon in EPA's
regulatory decision-making process. For
instance. »me studies had been
submitted1 which did not adhere to
specified pcotacob, were conducted by
undennialiSed personnel and
supervisors, or were not adequately
monitored by study sponsors. In some
caves refute were selectively repotted,
undeneportedv or fraudulently reported.
In addition, ft was discovered that some
testing facilities d&played poor animal
are procedures and inadequate record-
keeping techniques. The FIFRA GLP
standards specify minimum practices
and procedures which must be foQrmed
in order to ensure the quality and
Integrity of data submitted to EPA in
support of a research or marketing
permit for a pesticide product. .
When EPA published its final FIFRA
and TSCA GLP standards in the Federal
Register of November 29,1983, EPA
sought to harmonize the requirements -
and language with those regulations
promulgated by the FDA in the Fedctaf
Register of December 22,1978 (43 FR
60013), and codified as 21 CFR part 58.
Differences between the two Agencies'
current GLP regulations exist only to the
extent necessary to reflect the Agencies''
different statutory responsibilities under
TSCA, FIFRA, and the Federal Food,
Drug and Cosmetic Act (FFDCAJ,
Similar to the FDA GLP regulations, tha
FIFRA and TSCA GLP standards
delineate standards for studies designed
to determine the health effects of a test
substance; however, the TSCA GLP
standards also contain provisions
related to environmental testing (i.e.,
ecological effects and chemical fate).
Compliance with EPA's FIFRA and
TSCA GLP standards has been
monitored through a program of
laboratory inspections and study audits
coordinated between EPA and FDA.
Under an Interagency Agreement
originated in 1978, FDA carries out GLP
inspections at laboratories which
conduct health effects testing. EPA
primarily performs GLP inspections for
environmental laboratories and
conducts data audits for health effects
sod environmental studies.
After a thorough review of its GLP
regulations and compliance program,
FDA concluded that some of the
provisions of the GLP regulations
needed to be clarified, amended, or
deleted to reduce the regulatory burden
en testing facilities. Accordingly, FDA
revised its GLP regulations in the .
Federal Register of September 4,1987
£52 FR 33768). These GLP revisions are
intended to simplify the regulations
without compromising study integrity.
EPA agrees with FDA that many
provisions of the GLP regulations can be
streamlined without compromising the
goals of tie GLP standards. Therefore,
EPA w amending the FIFRA GLP
standards to incorporate many of the
dianges made by FDA to its revised
GLP regulations. In addition, EPA is
expanding the scope of the FIFRA GLP
standards to include the environmental
testing provisions currently found in the
TSCA GLP standards. EPA's revision to
the FIFRA GLP standards also extends
tfeeir scope to include product
performance data (efficacy testing) as
currently required to be submitted by 40
CFH 158.640. In summary, the FIFRA
GIF standards will allow EPA to ensure
tbe quality and integrity of all data
submitted in support of pesticide
product research or marketing permits.
Elsewhere in this Federal Register, EPA
fs making similar changes to the TSCA
GLP standards.
C Consistency With FDA GLP
Regulations
Ik is EPA's policy to minimize the
regalatory burden on the public which
aright arise from conflicting
requirements promulgated under
diSerent regulatory authorities. In
keeping with this policy, the final FIFRA
1S83 GLP standards, 40 CFR part 160,
followed the format and, with few
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Federal Register / Vol. 54. No. 158 / Thursday, August 17. 1989 / Rules and Regulations 34053
exceptions, the wording of FDA's final
GLP regulations, 21 CFR part 58.
Differences between the EPA and FDA
GLP regulations were based upon
varying needs and responsibilities under
each Agency's regulatory statutes. This
revision to the FIFRA GLP standards .
follows this same policy by conforming
to many of the changes FDA made to its
GLP regulations, published in the
Federal Register of September 4.1987
(52 FR 33768). EPA has varied from
FDA's revised GLP regulations only
when necessary due to EPA's statutory
responsibilities. The most significant
differences between the EPA and the
FDA revised GLP regulations are the
scope of the testing and test systems
affected.
More specifically, EPA is requiring
compliance with the FIFRA GLP
standards for all studies submitted to
EPA which are intended to support
pesticide product research or marketing
permits. Under the 1983 FIFRA GLP
regulations EPA only required GLP
compliance under FIFRA for health
effects testing. However, unlike FDA,
testing required oy EPA in support of
research or marketing permits may
include ecological effects,
environmental and chemical fate, and
efficacy (as stipulated by 40 CFR 158.840
Product performance data
requirements), as well as health effects
testing. Therefore, in an effort to attain
consistency in the quality and the
integrity of all data submitted to the
Agency, EPA has determined thai it is
necessary to expand the scope of the _
FIFRA GLP standards to require that all
types of testing which are used to obtain
data in support of research or marketing
permits be conducted in accordance
with the amended GLP standards that
are required to be submitted under 40
CFR 158.640. .
EPA's amended FIFRA GLP standards
also vary from FDA's in their coverage
of testing conducted in the field-To
ensure the quality and integrity of all
data submitted in support of research or
marketing permits, EPA believes that
GLP standards musi apply whenever
data collection occurs. Because many of
the test data required by EPA under
FIFRA are developed in the field, or
more accurately in outdoor laboratories
(i.e.. ground water studies, air
monitoring studies, degradation in soil,
etc.). EPA is including field testing
within the scope of the standards.
EPA's FIFRA GLP standards also
differ from FDA's in the scope of the
requirements provided for test system
care facilities, test system supply
facilities, and test system care. Because
testing required by FDA is focused on
health testing, in which animals are the
central test system, it is appropriate for
FDA's GLP regulations to focus on
requirements for appropriate animal
care facilities (21 CFR 58.43), adequate
animal supply facilities (21 CFR 58.45),
and proper animal care (21 CFR 58.90).
However, the broad range of testing
required by EPA may involve plants,
soils, and microorganisms, as well as
animals, for the primary test systems. To
ensure the quality and integrity of all
data submitted to EPA, 5160.43 Animal
care facilities. § 160.45 Animal supply
facilities, and § 180.90 Animal care are
being expanded to cover facilities,
handling, and care of all test systems.
Accordingly, EPA is retitling these
sections as follows: 5160.43 Test system
care facilities, 8 160.45 Test system
supply facilities, and $ 160.90 Animal
and other test system care. Further, in
most instances, EPA is replacing the
term "animal," which is currently used
in the FIFRA GLP standards, with the
broader term "test system." Specifically,
this change occurs in $$ 160.43,160.45.
160.81.160.90 and 160.120. These
changes are further discussed in Unit Q.
of this preamble.
The remaining difference* between
the EPA and FDA GLP regulations are
described in the preamble to this final
rule and the preamble to the FIFRA GLP
standards, published in the Federal'
Register of November 29,1983 (48 FR
53946). EPA has coordinated this final
rule with FDA and has considered
public comments on the December 28,
1987 EPA proposal (52 FR 48920).
D. Publication of the Complete Rule
The entire FIFRA GLP rule (40 CFR
part 160) is published in this notice to
simplify interpretation and facilitate the
use of this notice by the regulated
community. The following lists the
sections of 40 CFR part 180 that were
changed from the 1983 rale:
Sections
affected
Sections
affected
160.3
160.28
160.31
160.35
160.41
160.43
16CU5
160.47
160.49
160.53
ChMQM
"Batch." -Control substance," "Study."
and Test system." revise* "Test
f*h^*E«*ft^ or mbluTB," fWMMctr
-Center.- "Experimental start date,"
"Experimental termination: dale,"
"Reference substance," "Study com-
pMbn date," "Study Initiation date."
Teat substance," and "vehicle,"
(d). (el and (f) revised
(b) and (d). revised
(a), (b) (1). and (3). revised: (e), re-
Revised
Revised
Revised
Revised.
Revised
Removed
160.61
160.63
160.81
160.90
SubpartF
160.105
160.107
160.113
160.120
160.130
160.135
160.165
160.190
160.195
Changes
Revised
(b). revised.
(b) (1). (2), (3). (5). (6). (7), and (12) and
(c). revised.
Revised
Heading revised
Revised
Heading and introductory text, revised
Revised
(a), revised
(d) and (e). revised
Added
(a) (4) and (5). and (0. revised.
(a) and (e), revised
(c), revised; (i) added
II. Summary of Comments and
Responses
EPA received 43 comment letters: 24
from manufacturers of pesticide
products regulated by EPA, 8 from
associations, 10 from testing or
consulting laboratories, and 1 from
another government agency; The
majority of the comments supported the
proposed changes, although numerous
suggestions were made for additional
revisions to parts of the 1983 FIFRA GLP
regulations not subject to this
rulemaking or modifications to
proposed changes. Comments
raised important policy questio
suggested modification to the essence of
the proposed regulation, or required an
individual response, are discussed
below. Comments addressing changes to
the GLP standards that were not
proposed are not the subject of this
rulemaking. However, all comments
made have been placed in the public
record.
A. General Provisions
1. ScopeComment EPA. should
specify exactly what categories of
studies (especially efficacy) are covered
under the revised GLP regulations since
they are discussed hi the preamble and
will not appear at 40 CFR part 180 when
the final rule is published.
Response: EPA intends GLP standards
to cover all types of studies required to
be submitted and does not feel it
necessary to list each type.
Please note that EPA is developing
additional product performance
regulations. EPA plans to consider the
impact that GLP standards will have on
these new product performance
requirements to determine if the full
scope of the GLP standards should
apply to studies performed to
these requirements. Unless the
is modified to specifically exclude:
certain parts of product performance
regulations, the full GLP rule will apply
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34054 Federal Register / Vol. 54, No. 158 / Thursday, August 17, 1989 / Rules and Regulations
existing and prospective product
formance studies required under 40
158.640.
2. Definitions-a. Batch. The
definition of "batch" is expanded to -
include reference substances. This was
an omission in the proposed rule that is
corrected in the final rule to maintain
consistency with the use of the term in
§ 160.105(a).
b. Carriep-i. Comment: The word
"systems" should replace the word
"organisms" in the definition of
"carrier," to be consistent with the term
"test system."
Response: EPA concurs with the
suggestion. To be consistent with the
definition of "test systems," the word is
changed accordingly.
ii. Comment: EPA should revise the
list in parentheses that follows the word
"material" in-the definition of "carrier"
to make it all-inclusive.
Response: EPA has decided to add the
phrase "including but not limited to
.to indicate that the list provides-
examples and is not meant to be all
inclusive.
c. Control substanceL Comment-
Since "material" conveys a broader
description than "substance" and is
already used in definitions for "carrier,"
ontrol substance," and "reference
bstance," "chemical substance"
Eiould be changed to "chemical
material" in the definition of "control
substance."
Response: EPA does not believe that a
change in terminology is needed to
broaden the definition since the term
"material" is already included in the
present definition. The term "substance"
must also be retained to maintain
consistency with TSCA and the TSCA
GLP standards.
ii. Comment- EPA should delete the
phrase "for no-effect levels" in the
definition of control substance. The
definition as written is too narrow and
excludes analytical chemistry (e.g.,
chemical fate, residue chemistry)
operations where the term "control" has
a meaning distinctly different from
biological effects.
Response: Since the purpose of the
analytical control is to establish '
eventually that none of the materials
administered to the test system interfere
with identification of the test substance
and its degradate(s) and metabolite(s),
EPA agrees that the terminology is too
limiting and is replacing the phrase "for
no-effect levels" with the phrase "for
known chemical or biological
Measurements." The definition now
Bads: "Control substance means any
chemical substance or mixture, or any
other material other than a test
substance, feed, or water, that is
administered to the test system in the
course of a study for the purpose of
establishing a basis for comparison with
the test substance for known chemical
or biological measurements."
d. Experimental start and termination
datesComment- These dates would be
difficult to predict especially for field
studies, because they would be subject
to natural or man-made conditions that
cannot be controlled or anticipated.
Since the dates would be subject to
change, many protocol amendments
would be required, thereby creating an
undue administrative burden.
Response: The experimental start and
termination dates specified in the
protocol are merely proposed dates.
Therefore if the actual experimental
start or termination date is different
from the proposed dates no protocol
amendment shall be required.
e. Reference substanceComment: If
EPA intended the term "reference
substance" to include analytical and
calibration standards, then several other
sections of the proposed rule which
mention "reference substance," would
also require the same types of records to
be kept for analytical standards. This
would constitute an excessive burden
oh management which would require
maintaining various records that do not
add any value to the study.
Response: The definition of reference
substance is intended to include
analytical reference standards.
Therefore, EPA has modified the
definition of "reference substance," as
follows: "Reference substance means
any chemical substance or mixture,
analytical reference standard, or
material, other than a test substance,
feed, or water, that is administered to, or
. used, in analyzing the test system in the.
course of a study for purposes of
establishing a basis for comparison with
the test substance for known chemical
or biological measurements." EPA
believes this change eliminates any
ambiguity in the definition.
EPA disagrees that inclusion of
analytical reference standards in this
part constitutes an excessive
documentation burden or adds no value
to the study. Documentation which
supports defining analytical reference
standards should not require excess
paperwork since common laboratory
practices already require assurance of
the validity of standards in order to
make certain that the measurements are
accurate.
f. Studyi. Comment- "Basic -'
exploratory studies" are excluded from
GLP standards, but the results of such
'studies may be required to meet GLP
standards, if included in support of
research or marketing permits.
Response: EPA does not wish to
discourage basic exploratory testing and
does not explicitly require GLP
standards for such tests even if the data
are later submitted to EPA. However, if
the data are to be used in sole support of
a marketing permit such non-GLP
studies may not be accepted. GLP
standards are required when data is
developed in the context of a study that
is required to be submitted to EPA in
support of a research or marketing
permit. Where GLP standards were not
followed in the case of a study
performed with the original intent of
exploratory testing, a GLP compliance
statement should be included in the
study report to indicate this.
ii. Comment: It is not clear what
constitutes separate studies and what
studies could be included under a single
protocol. Specifically, is a test system
located in several different geographical
locations a single study or would each
location by means of its particular
requirements need to be a separate
study?
Response: The protocol defines what
the study entails. Therefore, if the test
system for a specific study is located in
different geographical locations, the
protocol will describe the study as being
located at the different sites. EPA is
adding the phrase "at one or more test
sites" to the definition of "study" to-
clarify the intent that more than one
field site may be included in one study.
iii. Comment- The proposed definition
of study would imply that each
determination such as stability,
solubility, octanol water partition
coefficient, volatility, persistence, and
other data point determinations would
be separate studies with concomitant
requirements such as protocols and
quality assurance unit (QAU)
inspections.
Response: EPA intends that QAU
inspections as listed in § 160.35 be
conducted at intervals adequate to
ensure the integrity of the study for each
determination such as stability,
solubility, octanol water partition
coefficient, volatility, persistence, and
other data point determinations.
However, if done as part of a larger
study, then these determinations are
covered under the larger study's
protocol or standard operating
procedure (SOP). If they are submitted
to EPA as studies unto themselves, then
they db require their own protocols.
iv. Comment- An experiment such as
product chemistry which does not
involve a test system cannot be
considered a "study" and therefore
would not be covered by GLP standards.
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Federal Register / Vol. 54, No.' 15B / Thnrsday, August 17. 1989 / Rales and Regulations' 34055
Response: Studies designed to
determine the physical or chemical
characteristics o£ a teat substance are
included within the scope of these
regulations. Therefore, EPA intends to
include product chemistry experiments
in the definition of "study." this change
is consistent with the definition of the
term "study" as.it now appears, and as
it appears in the TSCA GLP standards at
40 CFR Part 792. In the case of product
chemistry experiments, the test
substance itself may be the test system.
y. Comment: The addition of the term
"or in the environment" to the definition
of "study" indicates that the change
extends the proposed regulations to field
studies. While it is necessary to ensure
the validity of all data collected, the
variety and special requirements of field
research have not been addressed in the
new roles.
flesponser These regulations are
intended to apply to aU studies required
to be submitted under FIFRA. including
those conducted in the field. EPA
recognizes that-field studies vary and
have special requirements, but believes
that the development of protocols and
SOPs by the testing facility provides
adequate flexibility in this respect
. vi. Comment Why are metabolism.
product performance, environmental.
and chemical fate, persistence and .
residue listed in the definition of
"study", but not toxicology data or data
to assess hazards and product
chemistry.
Response: The list is not meant to be
limiting in any way. Data to assess
toxicology, hazards and product : .
chemistry are included under "effects"
and "other characteristics" under the
new definition of "study".
viL Comment: "Prospectively" should
not be deleted from the definition of
study. If the essence of GLPs requires a
carefully planned study and the
proposed rule is very strict about
documentation that must be completed
prior to the experimental start date, how
can the GLP standards also apply to
studies that were generated without a
protocol or advance planning, such as
epidemiology.
Response: EPA disagrees with the
comment. The term prospectively is
deleted because EPA wishes all studies,
including epidemiological studies where
past exposure to a study population is
determined or estimated retrospectively.
to be performed under GLP standards.
EPA recognizes that in such studies data
used may nottavebeen geHeretea'ih" "'
conformanoe with FIFRA GLP
standards. However; it is EPA's position
that the epidemiological study itself can
be conducted and submitted to EPA in .
accordance with the GLP standards.
Retrospective aspects of such studies -
that are not performed according to GLP
standards, for example, test system ^
treatment, should be identified in the
compliance statement submitted with
the study report
In addition, the types of studies
potentially not covered by these
regulations were expanded in the
definition of "study" to include
experiments involving test methods.
g. Study initiation and completion
dateComment EPA should delete the
definition of "study initiation date" and
"study completion date," since these
terms were notdefined in the 1983 GLP
standards. The dates will be included in
the protocol and final report and do not
need further emphasis*.
Response: EPA believes that it is
necessary to define me terms to
differentiate them from "experimental
start and termination" dates. These
terms indicate the dates on which
specific milestones occur during a study.
The definition is necessary to clarify
EPA's requirements, and to ensure
consistency with FDA's GLP regulations
(52 FR 33780).
The phrase "dose of the study" as
used in § 16033(0. and the phrase
"study is completed" as used in
§ 160.195(bH3 j both refer ta the "study
completion date." Therefore, as of the
study completion date: (1) Under
§ 160.33(f). the study director must
ensure-that all raw data, documentation,
protocols, specimens, and final reports
are transferred to the archives; (2) after
this date under § 160.185{c), corrections
or additions to the final report must be
in the form of an amendment by the
study director under the procedures
specified in that section; and (3) in the
applicable situation* described in
§ 160.195(b)(3), records must be
maintained for a period of at least 2
years following the study completion
date. -
Furthermore, the phrase, "study is
initiated" as used in } 16O31(a), and the
phrase "study was initiated" as need in
§ 160.35(b)(l) would refer to the "study
initiation date." Therefore, as of the
study initiation date: (1) Under
§ 160.31(a), the testing facility
management would designate a study
director; (2) under § 180.35fb)(l}, the
study would be entered on the master
schedule sheet by the QAU; and (3)
under § 160.120(b). after this date all
changes or revisions in the protocol
would be documented, signed by the
study director, and dated. EPA also
expects that as of the study initiation
date, under §160.31(6), the testing
facility management would have
ensured that personnel, resources,
facilities, equipment material; and-
methodologies are available a
scheduled.
. h. Test systemComment: WnTTt
constitutes the "test system" in tests of
pre-emergent herbicides, soil pesticides.
and product chemistry studies? '
Response: The definition of "test
system" includes the statement that it is
"* * * any * * * chemical or physical
matrix * * *", including subparts thereof
that are treated with the test, control, or
reference substance and also
appropriate components of the system
that are not treated. Therefore, test
systems may include the soils that
pesticides are applied to, and in the case
of product chemistry, the test system
may be the test substance itself.
EPA is including the term "reference,''
which was inadvertently omitted from
the definition as it appeared in the
proposed rule. In addition, EPA is
replacing "e.g." in the parenthetical with
"including but not limited to" in order to
clarify that it is not our intent for the list
to be all encompassing.
i. VehicleComment The definition
of "vehicle" serves to clarify the GLP
standards, but there has been no
confusion based on the current
standards and this change is contrary to
EPA's stated objective of being ^^k
consistent with FDA's GLP regiflHs.
Response: EPA believes that
clarification is needed. The EPA GLP
standards cover a larger number of
types of studies and the need for
clarification of the meaning of
potentially ambiguous terms is greater.
B. Organization and Personnel
1. Testing Facility Management
Comment The specific requirement to
document the replacement of the study
director as raw data should be retained.
The "master schedule" should not be
considered "raw data" as was indicated
in the preamble (52 FR 48923) to the
proposed rule.
Response: EPA deleted the
requirement thai the replacement of a
study director must be documented as
"raw data" to conform to the revised
FDA GLP regulations. This is because
replacement of the study director must
be reflected on the master schedule
sheet which is a study record that must
be retained.
In addition, the term "reference,"
which was inadvertently omitted in the
proposed rule, has been added to
§ 160.31(d).
2. Study Director-Comment:
Archiving the study records wit
"reasonable period" after the stud.
completion date-, instead of at the dose
of the study as required by 5160.33(0.
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34056 Federal Register /Vol. 54, No. 158 / Thursday, August 17, 1989 / Rules and Regulations
ftould not impact on the integrity of the
Hcords.
Response: EPA believes that the
requirement that all raw data, ;'
documentation, protocols, specimens,
and final reports be transferred to the
archives at a definitive time, i.e. the
study completion date, is necessary.
This assures an intact audit trail for the
study.
3. Quality assurance uniti.
Comment: A QAU that is entirely
separate from and independent of the
personnel engaged in the conduct of the
study creates an unjustified financial
burden on some facilities. In some cases
it would be impossible to establish a
completely independent QAU with
qualified personnel - :
Response.1 As stated in the: proposed
rule (5ZFR 48920), EPA does not require
the QAU to be a fixed, permanently
staffed unit whose only functions are to
monitor the quality of a- study. EPA is
only concerned that there be a distinct
separation of duties between those
personnel involved with the conduct or
direction of a study and. those personnel
performing quality assurance on the
same study. Therefore, § 160.35(a)
prohibits personnel from performing
"ty assurance activities on their own
r. The regulations allow a study
tor for a particular study to serve-
as a part of the QAU or as the QAU for
a different study. FDA noted (52 FR .
33771) that it was aware that many
small laboratories could-not afford the
operation of a permanently staffed
QAU. EPA would like to point out that
in those situations where there are
different individuals performing the
quality assurance functions for different
studies, each individual is required to
maintain that portion of the master. .,.
schedule sheet which relates to the
study being monitored. For this reason,
EPA agrees with FDA's conclusion that
the separation of functions oh a study-
by-study basis, as permitted in the
existing and revised regulations, would
provide effective quality assurance. In
view of the potential gain to
management to sponsors, and to EPA,
through the 'added assurance of'well-
conducted studies, the increased costs
are thereby justified. EPA believes that
its intent is more dearly indicated by.
the changes how being made.
ii; Comment: EPA-should delete the
requirement to index the master
schedule by test substance, and the
QAU should only be required to index
the master schedule to facilitate
Hrieval'of the information monitored. .
m Response: EPA acknowledges that a
test facility may have several studies in .
progress on each test substance .that is
listed on the master schedule'sheet
However, EPA concludes that deleting
the requirement to index by test
substance would be inappropriate, since
the master schedule sheet is the
mechanism through which the QAU can
assure management that the facilities
are satisfactory and there are adequate
numbers of competent personnel
available to perform the scheduled
tasks. Furthermore, § 160.31(e) requires
that management assure.-that study
materials (e.g., test substances) are . .
available as planned. Therefore,1 -
elimination of this requirement would
hinder a major function of the master
schedule sheet and hamper the conduct
of a critical management role.
iii. Comment Laboratory management
should have the discretion to determine
who enters the1 data into the master
schedule, as long, as the required ?.
information is listed. , .
Response: EPA believes that :
management retains such discretion
since it is involved in determining the
composition of the QAU and it provides
an adequate number of such personnel
(§ § 160.31(c) and (e)). The QAU is
distinguished by training that ensures
that QAU functions are properly
conducted. As stated above, study
personnel may belong to the QAU as -
long as they, are not performing the QAU
functions associated with studies they
are involved in. -.;.-. .
iv. Comment- Do all studies conducted .
by ail analytical laboratory have to be
listed on a master schedule, or just those
studies that will be, or likely be,
submitted to EPA? . ;
Response: The GLP standards ..
specifically exempt many product -
chemistry, studies as described in
§ 160.135. The master schedule need
only list those analytical chemistry
studies that will be or will likely, be
submitted to EP/L ..'..
v. Comment The requirement for
inspection of each study under
$ 16O35(b)(3) regardless of duration is
excessive for the quality assurance
needed to address study integrity, :
especially where studies are performed
by highly standardized procedures. The
repetitive inspection of these types of
studies would consume large amounts of
time for both the study personnel and
QAU staff. Auditing each study is not
necessary to ensure the work is
conducted in compliance with the
regulations. Random sampling ,;
procedures should be allowed in
selecting studies and phases of studies .
to inspect to decrease the work load and
resource requirements of the QAU.
Response: EPA does not believe that a
random inspection program would be an
appropriate method of evaluating a ,
study. Generally, random sampling
provides an adequate means of quality
control where analysis involves
repetition or identical procedures.
However, any assumption that the
conduct of one phase of one study
would be representative of another
would be invalidated by the differences
among study personnel and the
operations they conduct-Furthermore.
this requirement is not intended for all
routine studies. Section 160.35(b) is
among the exclusions for chemical and
physical characterization studies as
listed in § 180.135(b).
In conformance with the revised FDA
GLP regulations (52 FR 33780). EPA
modified the requirements of
§ 160.35(b)(3) to provide for inspections
of a study on a schedule adequate to
ensure the integrity of the study. The
changes to this section will allow the
QAU the necessary latitude to adjust its
monitoring activities to meet the
individual heeds of each study.
However, each study, no matter how
short must be inspected at least once
while in progress. EPA expects that by
allowing the QAU flexibility in '-
designing a reasonable inspection
schedule, the goal of ensuring the
quality of the study can be best
achieved.
vi. Comment: EPA indicates in the
preamble to the proposed rule
(§16035(6), (52 FR 48923)) that all QAU
records will now be routinely available
to inspectors. Existing GLP standards
treat certain QAU records as
confidential, and explicitly state that the
only QAU records to be reviewed by
EPA auditors would be the master
schedule (e.g., the inspection dates.
study inspected, the phase or segment of
the study inspected and the name of the
individual performing the inspection): If
QAU records for findings and corrective
action are available on an auditor's
request QAUs would lose their ,
effectiveness.
Response: EPA shares the concerns of
the commenters that access to all parts
of a QAU inspection would weaken the
inspection system, .and recognizes the
need to maintain a degree of
confidentiality. Therefore, records of
findings and problems, as well as
records of corrective action
recommended and taken, are exempt
from routine EPA inspections, except
under special circumstances as
indicated in § 160.15. However, EPA -
maintains that all other reports and
records must be easily accessible and.
made available to EPA and FDA - .
inspectors when requested as indicated
in 9 160.35(c).
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Federal Register / Vol .54, No. 158 / Thursday, August 17. 1989 / Rules and Regulations . 34057
C. Facilities
1. Generalri. Comment: Outdoor
testing facilities should not be under
CLP standards since: (a) Outdoor test. ,
facilities will be conducting studies
according to approved protocols; (b)
ensuring suitability is highly subjective
based on the diverse number of possible
locations; (c) there is a concomitant lack
of clear standards for determining
suitability of locations. Procedures must
be specified by EPA regarding the
determination of suitability for ' '
locations, testing facilities, etc.
Despite best efforts, the choice could
always be subject to criticism and even
criminal liability based on a good faith
Compliance Statement indicating GLP
standards hacTbeen followed. Most
outdoor testing is done to mimic normal
agricultural conditions which are
specific for the test substance and use
being proposed. Therefore, the
determination of whether the size,
construction or location of a facility is
suitable fora study is a technical issue,
and is not within the scope of the GLP
regulation and would be considered in
the experimental design of the protocol!
Response: In cases where an EPA-
approved protocol establishes test
locations, that protocol would satisfy
GLP requirements. EPA considers any
site to be the testing facility wherever
testing is undertaken to generate data
required to be submitted to EPA. The
conditions required by. the protocol are
not necessarily conducive to artificial
manipulation in the field, or to other
outdoor testing facilities. Therefore,
ensuring the suitability of the location of
these types of testing facilities is both a
valid and necessary part of protocols
approved by EPA. V
ii. Comment: The designof the
individual scientist could be dictated by
§ 160.41 since, a "testing facility"
(definition from § 160.3) means "a
person who actually conducts a study
The term "test site" should be
defined to refer to the actual location of
a given "study system." 'Testing
facility" could then be used as currently
defined and refer to an individual
(mobile development scientist or
scientist working from a testing farm
facility). :'''
Response: The definition of "person"
in this Part refers to the legal entity :
responsible for testing, including
organizational units; Consequently, it
does not specifically indicate an
individual gdieM'st. '"" * r" f>«.r«-^~
2. Test system care facilities\; : .
Comment Instead' of expanding the
original document to fit all test systems.
the old rales should be left as is, and ;a:
statement added to cover non-animal
test systems.
Response: EPA disagrees with the '
comment and believes that specific
changes of the old rule are necessary to
avoid ambiguity concerning the meaning
of non-animal test systems.
ii. Comment: Section 160.43(a)(2) and
(b). (e), (f), (g), and (h) should be deleted
because EPA has already stated that
these GLP requirements will be
applicable to all types of testing. It is not
necessary to add the four new
paragraphs detailing specific
requirements of environmental
conditions for aquatic organisms and
plants.
Response; EPA believes that some test
systems, e.g. aquatic, are unique, and for
the sake of clarity, they require special
treatment in the regulations.
iii. Comment Field studies should be
exempted because isolation is not
possible in these types of studies.
Response: EPA disagrees and believes
that inclusion of field studies poses no
unusual burden, since the separation is
only required to be "as heeded" to
ensure "proper separation." If the '
procedures used are justifiable based on
experimental design and documented
then this requirement is met "Proper
separation" in a field study may mean
simply that only one crop is planted in
the same subplot. ' :
iv. Comment: The change in
} 160.43(c) is appropriate but the current
wording, does hot require separate
disease handling facilities in every case.
The proposed change has merit in
clarifying the options available to
laboratories and the change promotes
harmony between EPA and FDA GLP
regulations.
Response: EPA agrees with the
comment In 5 160.43(c), EPA is deleting
the requirement that separate areas be
provided hi all cases for the diagnosis,
treatment and control of test system
diseases. Instead, a change is made so
that separate areas are provided "as
appropriate." This change is consistent
with the September 4.1987, revised FDA
GLP regulations and the revised TSCA
GLP regulations. '
EPA has made this change to allow
laboratories the option of disposing of
diseased^ test systems without also
bearing the expense of maintaining
separate areas in testing facilities for
diagnosis, treatment and control of
disease. Additionally, EPA recognizes
that the diagnosis and treatment
requirements of § 160.43(c) may not be ;
appropriate when dealing with such test
systems as .soil, plants, or
microorganisms. However, if the
decision is made not to dispose of the " ''
test system^ test system care faciUfies, \.
as specified in § 160.43(c], i
provided.
3. Test system supply facilfi
Comment- The first sentence in
§ 160.45(a] should be changed so that
plants and plant materials are covered
in this section. . : .
Response: EPA believes that since
plants and plant materials are covered
in 5 160.45(b), Including them in
S 160.45(a) is unnecessary.
ii. Comment Change § 160.45(b) by
deleting it or expanding it to include
tests not confined to the indoor
laboratory or greenhouse.
Response: EPA agrees with .the
comment and is expanding the wording
of S 160.45 to emphasize that this section
is not intended to be confining..
Therefore, 9160.45(a) is changed to read
"* * * areas where the test systems are
located * * V and § 160.45(b) is
changed to read "* * * (.included but
not limited to fields,
greenhouses, * * *)."
iii. Comment: The addition of the two
new paragraphs outlining plant and
aquatic facilities to 9 160.45(b) is
unnecessary. These considerations are
addressed in 5 160.41 with the
requirement that testing facilities be of
suitable construction "to facilitate
proper conduct of studies."
Response: EPA maintains tha"
facilities as mentioned in { 160.4rand
test system supply facilities as
mentioned in § 160.45, are not the same
and must be addressed separately.
iv. Comment- EPA should delete
§ 160:45(b) introductory text (b)(l).
(b)(2), and (c) because this information
was adequately covered in 9 160.45(a)
and in 5160.43. and the facilities they
refer to will be addressed in study
protocol
Response: EPA maintains that § 160.43
(test system care) is different from
§ 160.45 (test system supply facilities)
and must therefore be treated
separately.
4. Facilities for handling test, control,
and reference substancesi. Comment-
These requirements would severely
restrict the ability of efficacy
investigators to test their product since
S 160.47 would require separation of
facilities for test animals and testing.
material The real issue for efficacy
testing is test substance accountability,
which should be a vital part of the
efficacy testing protocol, and
appropriate records maintained to verify
test substance accountability.
Response: EPA notes that simij/
concerns were raised by comme
regarding the 1983 rule. The we
necessary" was included then to allow.,
latitude in facility design and operation.
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34058 Federal Register / VoL 54, No. 158 / Thursday, August-17, 1989-/ Rules -and-Regulations
EPA agrees that other measures, i.e.
protocol, SOPs, and appropriate records,
lust be adequate to demonstrate the
pitegrity of test control, and reference
substances during handling.
li. Comment: Would it be necessary to
provide separate sink facilities or .
separate rooms for mixing of the test,
control, and reference substances or for
adding water to tank sprayers?
Response: Separate areas are required
for receipt, mixing and storage of test,
control, and reference substances and
their mixtures as necessary, to prevent
contamination or mixups. The same sink
could be used for all work involving
mixing provided that the procedures
(SOPs) used are adequate to prevent
contamination and mixups. Separate
areas for receipt and storage and for
mixing and storage of test control, and
reference substances as required in.
§ 160.47(a)(l), (2), and (3) does not
mandate the use of separate rooms. The
areas could be in the same room
provided there is adequate space and
equipment to provide that
contamination and mixup do not occur.
This determination should be made on a
case-by-case basis.
D. Equipment .
Maintenance and calibration of
^equipmentL Comment: The entire
kection, j 160.63(b), requires
Unnecessary documentation and/or is
vague about what is required, especially
for field portions of residue 'studies.
Equipment used in these studies may
only be used on an occasional basis,
and routine inspection should only be
"before use." Requiring calibration and
maintenance logs for all equipment
involved in generating a residue sample
would be prohibitive, would often be
forgotten or overlooked and would then
be a cause for not meeting audits..
Response: The requirement states that
equipment shall be "adequately
inspected, cleaned and maintained" and
"adequately tested, calibrated and/or
standardized." This requirement is not
changed from the old rule. The
laboratory has latitude in defining in its
SOPs what is "adequate" unless given
specific guidance otherwise (i.e. in test
rides or testing guidelines). However,
EPA recommends mat calibration and
maintenance records be available for all
equipment used hi field studies. This
includes equipment used only rarely and
rental equipment.
ii. Comment It is better to designate
in § 160.63(b) that repair and
maintenance will be performed by :
''qualified personnel." than to require
hat a person be designated in the
nwritten SOP. The requirement for
written SOPs in § 160.63(b) causes
problems since at many laboratories the
equipment used in conducting a study is.
shared by a number of individuals and
the care and maintenance of the
equipment is also shared. In the event of
equipment failure,: a number of
laboratory personnel may be capable of
repairing or correcting a problem, or in '
more serious equipment failures, a
service representative of the
manufacturer may be called. It is
therefore difficult and very inefficient to
designate specific people to perform
each specific maintenance and repair
operation.
Response: The definition of "person"
as it appears in § 160.3(h) is not limited
to an individual scientist or technician,
but includes an organizational subunit.,
Consequently, the SOP that designates
the '.'person responsible" will be
designating a subunit of the testing
facility, which could be one or several
individuals. This view is consistent with
FDA's (52 PR 33774) interpretation and
definition of "person." Where duties are
delegated in the SOPs, all contingencies-
may be addressed, including the
contracting of service personnel.. . v..........
iii. Comment Certain pieces of
equipment such as tractors, land
preparation and land measuring devices
should be exempt from the calibration
requirement as should standard
commercially available laboratory ware,
such as graduated cylinders, beakers,
flasks, etc. Only equipment directly.
related to application of the test
substance, such as sprayers or granular
applicators should be listed as requiring
calibration. Therefore, 9 180.63(cJ.is not
appropriate for field studies.
Response: EPA believes that
calibration should be required for the
application phase of field studies.
However, the method of calibration, and
hence the exact equipment to be
calibrated, are not specified in GLP .
standards, as long as the methods and
records ensure the quality and integrity
of the study. Some equipment, such as
graduated cylinders and volumetric
flasks are pre-calibrated and do not
need to be recalibrated. Equipment
directly related to the application of the
test substance may require calibration,
but application rates may include other
parameters. The methods used to
measure all parameters inherent in the
determination of application rates
would have to be adequately calibrated
in order-to ensure the quality and
integrity of the study.
E*' Testing Facilities Operation r r ~
1. Standard operating procedures-r-l.
Comment There are few standardized
tests available to researchers related to
novel microbial pesticides. An :.
experimental use permit is required for
the evaluation of certain microbials at
an earlier stage of research than is
required for chemical evaluations.
Therefore, it would be very cumbersome
to require written SOPs for microbial
pesticides, since the methodology may
be in a state of flux. It may only be
possible to develop SOPs following the
completion of a study. If methods of
application and assessment need to be
modified for each microbial developed,
it would be best to affirm that methods
development could be performed in
accordance with accepted scientific
standards without having SOPs as
described in § 160.81. EPA is encouraged
to take a flexible, case-by-case
approach to establishing appropriate
GLP standards for a given set of
experiments concerning development of
microbial pesticides Allowances could
be made for situations in which SOPs
are inappropriate, .such as in the early
stages of field work. These allowances,
made in advance of the work, could then
be positively affirmed as good
laboratory practice, rather than as
tolerated; 7ion
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Federal Register / VoL 54; No; 15fr :fr Thursday. August 17, 1989 / Rules and Regulations 34059
make decisions if necessary to deviate
from the SOPs; (d) in field studies, :
deviations from SOPs will occur before
the researcher is able to consult with the
study director (e) decisions about
deviations from SOPs that are made by
field personnel would be based on
standard agricultural practices.
Response: EPA disagrees with the
suggestion that some deviations do not
require authorization by the study
director. It is necessary for the study
director to authorize deviations from
SOPs to ensure that these deviations do
not have an adverse impact on the
study. SOPs should be written with
sufficient flexibility to accommodate
field studies by anticipating conditions '
under which appropriate action? must
be taken without the need for '
authorization by the study-director.
Standard agricultural practices cao.be
referenced in SOPs as long as this does
not lead to ambiguity concerning the
appropriate action to' be taken in a given
situation. If SOPs state the constraints
on action and a decision is made within
these limits, there is no deviation. This.
is in concert with FDA's.GLP-regulations
(52 FR 33774) which require that the
study director make certain that
specified procedures are followed and
that all modifications to the procedures
in the approved study plan are
documented and approved.
iii. Comment: Some of the examples of
required SOPs provided in § 160.81(b) .
are not applicable to all test systems or
study types. For example, "test room
preparation" would not be appropriate
when conducting field residue studies.
and "necropsy of test system or post-
mortem examination of test systems,"
would not apply to studies using a
chemical or physical matrix as the test-
system (sterile water, soil, agricultural
fields). Furthermore, § 160.81(c) states
that, "Each laboratory or other study
area shall have immediately available
manuals and SOPs relative to the
laboratory or field procedures being
performed."
Response: EPA agrees that the term
"room" in § 160.81(b)(l) is inappropriate
to many studies and is changing the
word to "area" in order to clarify that
field studies are included. EPA believes
that § l60.81(b) should apply in all cases
since the purpose of SOPs is to insure
the quality and integrity of the data
generated in the course .of a study as
stated in § 160.81(a). However,
procedures that are not necessary to be
performed',' siich1 as necropsy in1 tite-caSe1
of field studies, do not require SOPs.
iv. Comment: The term "test systems"
should not replace "animals" in :
5 I60.81(b) (6) and (7). Although this
requirement is useful for preventing or
slowing autolysis for toxicology studies,
for other studies, such as metabolism, :
addressing the handling of moribund or
dead test systems is not appropriate. In
these types of studies, if a test system
were moribund or dead, the testing
guidelines require the part of the study
that was impacted to be repeated, and
this requirement is only applicable to
animals. .
Response: EPA disagrees with the
comment This rule applies to plants as
well as animals.
v. Comment: Published literature (e.g.,
ASTM methods) should be acceptable in
§ 160.81(c) as an appropriate part of an
SOP and hot just as a supplement to a
written SOP. The written SOP could
incorporate the published literature by
reference, without having to rewrite the
entire procedure. -
Response: EPA agrees that it would
not be appropriate to rewrite published
literature, hence the allowance for SOPs
to use it as supplements. The SOPs are
still needed to establish the relationship
of the method to data collection
procedures and needs in the laboratory.
While the-resulting SOP would still have
to be written, it would in effect be
abbreviated in that all of the
methodology referenced would not need
to be rewritten.
2. Animal and other test system
care4. Comment Section 160.90(a]
should be deleted since the subject is
covered in § 160.81(b).
Response: EPA recognizes that
§ 160.81(b) requires testing facilities to
establish SOPs for animal or other test
system care. Section 160.90(a), however,
expressly specifies that SOPs shall also
cover test system housing, feeding and
handling. This section is consistent with
FDA's GLP regulations and is not an
additional requirement
ii. Comment: Section 160.90(b) should
be simplified to provide that test
systems be evaluated prior to use but :
not necessarily isolated. For some
studies, such as plant metabolism,
isolating the plants or soil is not
appropriate.
Response: EPA disagrees. Isolation is
necessary to insure that a test system is
free from disease or other conditions .
that may impact the study. Further, the
inclusion of this is consistent with
FDA's GLP regulations.
iii. Comment: The evaluation of
certain test systems according to
"acceptable * * * scientific practice"
creates some difficulty, particularly for
plants, microorganisms, soil and water,
since such practices are not defined.
"Acceptable" should be deleted
regarding scientific practice and the
requirement be only that a scientific
basis be used in determining
appropriateness for testing, h^^ way,
testing facilities would not nj
justify or prove their basis to 1
"acceptable" in ill-defined areas or
those in flux.
Response: EPA agrees that the term
"acceptable scientific practice" may not
be definable when method
developments are in flux The term
"acceptable" is retained, but the term
"scientific practice" is changed to
"scientific methods." This change
preserves EPA's intent that rigorous
scientific methodology be used without
implying that rigid practices be adhered
to where they may not appropriately
exist
Iv. Comment: The requirement under
§ 160.90(c] that the test area be disease-
free prior to study initiation is
inappropriate for field studies since it
would be impossible to declare areas
totally disease free under field
conditions. Also, one of the objectives of
performing studies in the field is to
conduct the studies under representative
environmental conditions which
includes encountered disease and insect
pressures, making this part in direct
conflict with the study objective.
Response: The requirement is for the
test system to be "free of diseg
condition that interfere with I
or conduct of the study." The cTPBht
wording therefore provides sufficient
latitude for field studies. Furthermore,
EPA does not intend compliance with
this provision to require deviation from
accepted agricultural practices. If
disease and insect pressures are
considered to be an integral part of a .
study, they clearly do not interfere:with
the. purpose and conduct of that study.
The test system would therefore not
need to be free of them.
v. Comment- Section 160.90(c) should
be deleted since the effect of corrective
treatment cannot be accounted for in
test results.
Response: EPA believes that while the
effects of corrective actions taken to
isolate and treat disease or signs of
disease may complicate interpretation of
test results, so might the effects of the
disease itself. This requirement for field
studies is not inconsistent withJts
inclusion for laboratory, i.e., toxicology,
studies.
vi. Comment: Markings which identify
animals individually, rather than the
group as required by § 160.90(d), are
needed in many studies with warm-
blooded vertebrates in pens, or i
field. For example, precocial;
avian species should be marked
individually.
Response: Specific criteria for
marking of individuals to meet study
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34060 Federal Register / Vol. 54. No. 158 /Thursday. August 17. 1989 / Rules and Regulations
requirements should be addressed
Separately in the protocol of the study.
nhe requirement in § 160.90(d)
addresses the need that test systems be
adequately identified to prevent
confounding with other test systems.
Identification of precocial birds, for
example, may be outlined in the study
protocol.
viL Comment- The proposed
multispecies housing under
§ 160.90(e)(l) is redundant to proposed
§ 160.43(a)(l) and is inconsistent with
EPA's desire to streamline GLP
standards.
Response: EPA disagrees with the
conclusion that these sections are
redundant. While § 160.43(a)(l) states
that the facilities shall be sufficient to
allow proper'separation of species,
1 160.90{eJ(l) refers specifically to test
system care within the facilities.
viii. Comment: Field studies should be
exempt from the periodic testing
requirement of § 160.90(g). A bioassay or
chemical analysis prior to study
initiation should suffice to show that
contaminants are not present at levels
capable of interfering with the study.
The need for prior analysis may even be
obviated by documentation of the
previous history of pesticide use in the
^soil according to Standard Evaluation
procedures to ensure that no interfering
'contaminants are present
Response: The regulations as written
do not require that periodic tests be
performed during a study unless there
are "contaminants known to be capable
of interfering with the study and
reasonably expected to be present at
levels above those specified in the
protocol." If there is no reasonable
expectation that a problem exists,
periodic testing is not needed. An
acceptable method to determine this,
such as evaluation of the history of
pesticide use, should be defined in the
protocol or SOPs.
ix. Comment: The requirement in
9 16(L90(j) for acclimatization of plants
and animals should be deleted, since it
is not defined and promotes-confusion.
Animal toxicology tests would be
subject to isolation and separately to
acclimatization. Organisms in
environmental studies will have been
isolated with their health status being
evaluated per § 160.90(b) and
acclimatization would have already
been performed as part of the process.
This part should be amended to indicate
that test organisms be acclimatized to
all experimental conditions except the
test substance.
Response: EPA believes that the term
acclimatization has common meaning
that is clear in the context of its usage in
the regulation. Acclimatization implies
accustoming to experimental, i.e.,
environmental, conditions other than the
actual introduction of the effect (e.g.,
test substance) to be measured in the
experiment If acclimatization is
achieved during the process of isolation,
it should be so stated in the protocol and
does not require additional technical
effort
In addition, the term "organisms" in
§ 160.90(j) has been changed to
"systems," This change is consistent
with the intended expansion of GLP
standards and was an inadvertent
omission in the proposed rule.
F. Test and Control Substances
1. Test, control, and reference "
substance characterizationi.
Comment Requiring stability and
solubility before testing would result in
a costly burden to the efficacy testing
sponsor; The solubility testing portion of
this requirement would not cause
significant problems, but requiring
stability testing to be completed before
study initiation could result in
significant time and cost burdens.
Response: It is more costly to have to
repeat a study because of inadequate
solubility or stability in respect to
experimental needs. EPA agrees,
however, that requiring stability testing
to be completed before the study may
result in unnecessary delays and is
allowing concurrent stability testing.
Therefore, EPA has changed the
requirement to allow stability testing
concurrently with the study. Solubility,
where this is relevant to a study, must
still be known before the experimental
start date. Please note that the 1983 GLP
standards require determination of
characteristics which will appropriately
define the test or control article before
study initiation. Thus solubility
determination before a study, where it is
relevant to the study and hence an
appropriate characteristic, is not a new
requirement
ii. Comment The term "purity" should
be expanded to include-radiochemical
purity since further-definition is needed
to encompass metabolism/
environmental fate studies conducted
with radioactive materials.
Response: Radiochemical purity is
covered under "other characteristics
which appropriately define the test,
control, or reference substance." It is not
necessary to specifically list this
characteristic.
iii. Comment: What level of analysis
constitutes "appropriate"
characterization? Is quality control
batch analysis sufficient? Is it necessary
to fully characterize technical materiala
to 0.1 percent?
Response: TJw aetails of what
"approDriate>y" defines the test
substance is a guideline or protocol
issue that cannot be specified in a
generic document such as GLP
standards. The appropriate level of
characterization is largely dependent on
the nature of the study that the
substance is to be used for.
iv. Comment: What needs to be
characterized, the technical grade active
ingredient or the end product?
Response: The test substance needs to
be characterized. If the test substance is
the end product the end product needs
to be characterized.
v. Comment: The characterization
requirement is inappropriate since it
conflicts with management
responsibilities, is costly, and adds
unnecessary delays to the development
process. It removes a necessary option
of planning by objectives that
responsible business management must
retain. Delays and rescheduling, which
may result if inadequate work is
permitted by management are real
consequences that must be accepted by
management and management must
decide whether or not to risk beginning
an experiment prior to doing
characterization studies. Since the
ultimate validity of a study will require
that such data be obtained before the
study is completed and as long as the
sponsor can demonstrate that a study
was conducted with authentic material,
it is irrelevant when the characterization
is completed. This-proposal is not in
concert with FDA GLP regulations.
Many times prospective products fail to
reach the marketplace due to unusual or
insurmountable problems.Therefore,
eliminating the need for characterization
of product will reduce the costs of
products that "fall out of developmental
process.
Response: Characterization is
necessary to ensure integrity of studies.
It is also necessary for EPA to have
characterization data available for
inspections! purposes during ongoing
studies, and thus to have this
information complete at the beginning of
the study. Without characterization, it is
not possible to know whether test,
control, or reference substances from
different batches that are used in a
single study are in fact identical.
Adequate testing for characterization
normally occurs during the synthesis or
production of test control, and reference
substances, and thus should already be
available before the test begins.
Consequently, having characterization
data available should not impose an
additional burden in most cases.
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34061
EPA does agree, however, that
stability testing should be allowed to be
performed concurrently, to prevent
unreasonable delays. The-sponsor will
bear the burden of a repeated test in the
case that concurrent stability testing
suggests that the study is not valid. For
that reason, EPA is revising §,ieo.!05{b)
to allow for concomitant determination
of stability.
vi. Comment: The last sentence of
§ 160.105(a), relating to methods and
fabrication, should be deleted since
these may contain CBI.
Response: This is not a new
requirement and has not posed any
problems. Inspectors are cleared to
handle GBI material; any sensitive
information can be declared CBI and
treated as such.
. vii. Comment Some EPA .auditors are
interpreting this section to require that
the testing facility not only archive
certification jecords concerning the
purity or assay .of an analytical standard
(reference substance), but to also
archive copies of the raw data and
records generated during the
certification process. The sponsor or
chemical supplier should only be
required to archive the raw data .
supporting the certification of an
analytical standard. The testing facility
need only archive a copy of the
certification of the standard.
Response: ERA agrees with the
comment and is modifying f 160.105(a)
to allow for-specification of the
availability of the documentation
supporting the characterization if it is
not available at the testing facility. The
phrase "and .such documentation
availability shall be specified"'is added
to the end of the first sentence in
§ 180.10S(a). following the-word *~ * *
experiment.''
viiL Comment Many of the tests -
coming under the scope of the proposed
GLP standards .are in themselves
stability studies. Soil dissipation tests
are stability determinations of '
herbicides, as are tests of mfcrofaial
genetic markers for measuring
persistence of recombinantiy derived
organisms. The proposal places industry
in the quandary of conducting stability
studies priorto a stability study.
Response: The performance tests cited
cannot be considered to be stability
tests- under the GLP standards. In the
context described above, the persistence
of the substance hi the environment is a
separately measured parameter.
However, when performing such tests, it
is still important to know the stability of
the substance to ensure that the
measured effect was due to the effect of
the test-system.
ix. Comment: Would it be acceptable
to EPA if the stability knowledge is
based on the extrapolation of the results
of a short-terra stability study under
extreme conditions carried out before
the experimental starting date?
Response: Such an accelerated study
would not demonstrate stability under
test conditions, and could not be part of
the concurrent stability testing
performed in conjunction with a larger
study. It would be a separate study with
its own protocol.
x. Comment: The proposed rule does
not address whether quality control
activities fall under the GLP standards.
Response: Not all quality control
activities are GLP issues. Quality control
work that is integral to the laboratory
performing the study would be under
GLP standards, but not that performed
during manufacturing. Studies as
defined in this part are subject to GLP
standards only when required to be
submitted to fulfill data requirements.
xi. Comment: The part related to
"storage container assignment for the
duration of a study" in J 16Q.105[c)
would be unrealistic for field studies,
especially where storage containers may
be large tanks, or delivery systems
which are possibly not even owned by
the sponsor or testing facility.
Response: The delivery systems and
tanks that are par! of delivery systems
are not ""storage containers." Test,
control, and reference substance will,
however, be stored before use in some
containerlhat is unique to that
substance during die test. This may be
the container that it comes in or that is
assigned to it by the testing facility.
xiL Comment: Liquids from large
containers are often placed into smaller
containers^ for use during the study.
Consolidation of the test substance into
smeller containers as the supply is
depleted should be allowed. These
containers need not be retained after
they are empty, since their retention
does not enhance the quality or integrity
of the data collected.
Response: EPA disagrees with the
suggestion, The retention of containers
is necessary to ensure the integrity of
the study. This includes empty
containers, which must be kept to verify
the disposition of the test, control, and
reference substance. Disposal of
containers adversely affects
accountability. This provision of the rule
is not changed from the 1983 rule, but
was commented on by the public
. because it may affect types-ef studies,
such as field studies, that will now fall
under the provisions of the rule as a
result of these amendments.
xtti.Comment: How are "studies of
more than 4 weeks duration" specified
in § 160.105(d) defined? They she
defined as studies having an "
phase" of more than 4 weeks.
Response: The term "4 weeks
duration" is meant to apply to the
experimental start and experimental
termination dates. The suggestion of
using.the term "in-life phase" is not
accepted since this introduces new .
terminology, that is not adequately
defined. The term "4 weeks
experimental duration" replaces "4
weeks duration" in S 160.105(d) to
clarify that the study initiation and
study completion dates are not implied.
xiv. Comment: Section IfiOJOSJbljmd
(e) do not provide necessary discretion
to testing personnel to determine what
data are needed to characterize stability
for a substance, and how the
determination is made. The phrase
"under test conditions" needs additional
clarification, since a variety of
temperature, humidity, moisture, and
other test conditions may be
encountered across the United States..
Routine product chemistry testing for
emulsion stability, hydrolysis,
photostability, eta, should satisfy this
Response: The terminology "under
test conditions" is ambiguous and may
be misinterpreted..so EPA has dej
to delete "under test conditions"
§ 160.105(6) and replace it with "urRTer
storage conditions at the test site." This
may be adequately addressed by routine'
product chemistry testing as long a«
storage of the substance at die test site
is in known, acceptable conditions.
xv. Comment Section 160.105(e) -
should be deleted since it was
redundant with § 160.113(a)(2).
Response: EPA disagrees that these
sections are redundant Section
160.105(e) refers to the test, control, and
reference substance, while § 160.113
jefera to mixtures. --- .
xvi. Comment: Knowledge of stability
makes sense for long-term, but not short
term studies because if stability is
suspect then doses are made up each
day and given or sprayed immediately.
Adequate knowledge of stability may
exist from chemical information about
the test substance.
Response: If a substance is known to
be stable for a few days, then its
stability is known in terms of the test
requirements. If the stability is not
known, it must be determined, even for
short-term studies. Storage stability
needs to be known even if the material
is used "immediately". If enough
information is known,about the i
to support its stability from other
testing, its stability is known and the
requirement is met. However,
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34062 Federal Register / Vol. 54, No. 158 / Thursday, August 17, 1989 / Rules and Regulations
theoretical stability is not considered to
Ibe adequate. The method used to
ompensate for poor stability, such as
^aily mixing or immediate application,
is addressed in guidelines rather than in
GLP standards.
2. Test, control, and reference
substance handlingComment: If the
test, control, or reference substance is
inherently unstable, it may not be
possible to "preclude deterioration."
Therefore, the regulation should allow
for periodic evaluation of the purity of
the test substance during a study to
assure its integrity and replace it when
shown to be warranted.
Response: The intent is to prevent
deterioration due to handling. Periodic
testing is allowed under § 160.105(b) as
changed in the final rule.
3. Mixtures of substances with
carriersi. Comment: Does § 160.113
require determination of uniformity,
stability, and solubility during field
residue studies? If so, does it require
analyses for each tank preparation? This
requirement would impose a large
burden on testing facilities performing
these types of studies.
Response: The purpose of this section
is to assure that the methodology used
to prepare the mixture is valid. Once the
methodology has been proven for a
particular mixture, it need not be
Reconfirmed each time that mixture is
prepared. For field residue trials, there
will be data submitted to EPA that
support the uniformity, stability, and
solubility of a substance in the carrier
when prepared .by appropriate
methodology, i.e. according to the
proposed use or label. In such cases it
may not be necessary to test each batch
that is prepared for field application.
However, field residue trials do remain
subject to the requirements of this
section. Where available data are
inadequate to support uniformity,
stability, and solubility in a particular
case, then it is necessary for the data to
be generated under this section. Also,
there may be"protocol stipulations
applicable to a particular study that
require tank mixture analyses in
addition to any provisions of this
section.
ii. Comment: The range of
environmental conditions encountered.
in field trials are great and would
require extensive evaluations of
stability and solubility under numerous
environmental conditions. This amount
of data could not be evaluated prior to
study initiation.
Response: Section 160.113(a)(2) states
that the determination(s) shall te "* * *
under the environmental conditions
specified in the protocol and as required
by the conditions of the test." All
possible environmental conditions do
not have to be anticipated and tested
unless required in the protocol.
iii. Comment: Short-term toxicity and
field residue studies should be exempted
from this section since supplementary
analyses are performed for other studies
with the same test substance. The
analytical cost could equal or exceed
the cost of the remainder of the short-
term study.
Response: The GLP standards do not
require characterization for each study.
The characterization is required for each
test, control, and reference substance.
The same substance may need to be
characterized only once, even if used oh
multiple studies.
iv. Comment: The requirement for
stability and solubility should allow
flexibility for the sponsor to make the
determination either before, during, or
after the study. When to determine the
stability is a business decision based on
knowledge of the risk of having to
repeat a study, if the stability data
negatively impacts the integrity of the
study.
Response: EPA understands that
requiring stability testing to be
completed prior to a study may
introduce unreasonable delays. In
harmony with the modification of
§ 160.105(b) to allow concurrent stability
testing of test, control, and reference
substances, § 160.113(a)(2) is changed to
allow stability testing of mixtures to be :
performed concomitantly with the study.
This allows the necessary flexibility and
is also consistent with FDA's GLP
regulations.
-v. Comment: In the very early stages
of a compound's development there is a
need for basic acute toxicity tests. "
However, there are no analytical
methods and calibrated reference .
standards available to test the stability
of the test substances in the carrier
according to GLP standards. An
estimate of the stability of the
compound in-an inert carrier like starch;
oil, or polyethylene glycol is possible
and should be sufficient as a
preliminary approach; The stability test
will be carried out as early as the
analytical methods are available.
Response: If a carrier is used, the
mixture with the carrier must go through
the same test, i.e. stability, solubility,
etc. Instability of the mixture in a
specific carrier is important since it may
affect the apparent effects of the test
substance.
vi. Comment: The assurances called
for in § 160.113(c) are not well defined.
How would the addition of the vehicle
used to facilitate mixing of the test
substance with the carrier to the control
system affect this requirement? If the .
vehicle is identically mixed in control, is-
there a need to show noninterference?
Response: Any vehicle used to
facilitate mixing must be shown not to
interfere with the study. This includes a
vehicle control to determine interaction
effect.
vii. Comment: If a test substance is
applied to a soil, is the soil a carrier or.
test system?
Response: This section does not
generally consider "soil" to be a carrier;
it is considered to be part of the test
system.
G. Protocol for and Conduct of a Study
1. ProtocolGenerali. Comment:
The proposed regulations do not offer
sufficient latitude for the generation of
protocols. The regulations state that a
protocol must exist prior to study
conduct, yet it would be almost
impossible to specify the exact analyses
that would be performed on biological
samples collected in the field until the
samples were collected.
Response: The protocol requirement is
not too restrictive to allow for situations
where the exact analysis performed may
not be known in advance. The type or
nature of analysis still needs to be
' specified in the protocol. The protocol
should state what samples are intended
to be collected, how they are to be
collected, and how they are intended to
be analyzed. If there is a need for
latitude, (for instance it is not known
specifically how many samples will
result from a particular study) that
should be anticipated and stated in the
protocol.
ii. Comment: Section 160.120(a)(5), (7),
(10), and (11) should not apply to
product chemistry experiments.
Response: The term ."test system" is
redefined to include any physical
matrix, which may thus be applicable to
product chemistry studies. However,
note that a study designed solely for the
determination of certain chemical or
physical characteristics of a test
substance are exempted from
§ 160.120(a) (5), (7), (10), and (11) as
described in § 160.135.
In addition, the word "of prior to
"frequency" should be "and." This was
a typographical error noticed by one
commenter and has been corrected in
this final rule.
iii. Comment Guidance is needed in
the final preamble for presenting
addresses, as required by
§ 160.120(a)(3), of field and
environmental locations used to conduct
tests.
Response: The address of the testing
facility is the address of the "person"
(i.e. organizational unit or subunit) who
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Federal Register / VoL 54, No. 158 / Thursday. August 17, 1989 / Rules and Regulations 34SS3
actually conducts the study. Even if tins
organizational unit includes parts
situated in different locations it may still
be considered to have one address. The
address should be a permanent address "
and would probably be synonymous
with the address of the study director .
and/or testing facility's management
iv. Comment: "Address of sponsor"
should be removed from this Pact to
maintain consistency with FDA CLP
regulations.
Response: EPA maintains that the
address of the sponsor is essential to its
inspectorial process, which differs from
that of FDA
v. Comment: The requirement in
§ 160.120f a}[4) to state proposed
experimental start and termination
dates poses problems for Geld studies
where these dates cannot be predicted
with certainty. "Would this result in
protocol deviations whenever these
dates are not exactly met?
ResponsK'ttM requirement to
document the proposed experimental
start and termination dates in tke
protocol does not suggest that a protocol
deviation occurs when the date it not
met The tern "proposed?* signifies that
this date is estimated. However, gross
deviation from the proposed date may
be a violation of the protocol if there
are date-critical aspects of the study .
that are identified as such,
vi. Comment: Section J#L120(aX5} is
inappropriate because: (a) Justification
should be required only when more than
one test system can be used in a study..
and not. for example, in residue
chemistry studies where residue levels
in specific target crops are the subject of
a study; (b) Justification should only be
required for those that deviate from, or
fall flittyidf the normal EPA guidelines
and hot where standard test systems
(Pesticide Assessment Guidelines gpd
Standard Evaluation Procedures) are
used; (c)The retention of this
requirement does not promote harmony
between the EPA and FDA GLP
regulations.
Response: Environmental studies are
more diverse than health effects testing
and are subject to details relevant to
test system design thataremors
chemically dependent than is the case in
health effects studies. Furthermore, this
is not seen to ftapose a burden in the
cases described in this comment. In the
case where-only one test system can be
used, that is the justification that should
be stated. The targeting^a specific
crop may be part of the justification and
so stated; it is still necessary to state
that the test system (e.g* strain of crop,
soil location) used is justified forthe
purpose of the study, if a standard test *
system is used because it is the '"
referenced system in EPA or
Organization for Economic Cooperation
and Development (OECD) guidelines,
citing the use of such guidelines is
sufficient justification. Thus, detailed
discussions are required only in the
relatively few cases where the study
design requires deviation or special *
choices to be made in selection of the
test system.
vii. Comment: EPA should add
"range" to § I60.120(a)(6) so it reads
"* * * body weight range," since
without specifying range, the protocol
requirement could be misinterpreted to
mean that all individual body weights of
the test .system should be included. This
would not be possible since exact
weights of test systems would not be
known when the protocol is prepared.
Response: EPA did not intend a
change here and retains the term "body
weight range" as used in the 1983 rule.
viii. Comment Section 160.120(a){7)
should be deleted since the test system
win be identified and justification for. its
selection win be in the protocol
Response* Identification of the test
system is not covered Jo any of the other
parts of § 160.ua Identification is the
specific description of which individual
test system is used, not a general
description of the kind of test system.
ix. Comment: The method for
controlling bias is nsnally in the SOP.
therefore inclusion of a reference in the
protocol-to the SOP should suffice.
Response: EPA. agrees that this is
allowed The .SOP may be referred to in
the protocol in such cases.
x. Comotent: The terra "nutrients"
should be added to the list for the
description .of the diet used in the study
to cover the use of fertilizer in plant
studies. . .
Response: EPA has incorporated this
suggestion into the final rate.
xi. Ounreanfr Section l£)0.12n(a)(10)
should be deleted, or amended with "if
appropriate" because: (a) The reason for
selecting the route of administration is
the objective of the study; (b) route of
administration and reason for its choice
is not applicable to studies soch as
aqueous hydrolysis and anaerobic
aquatic (c) EPA Pesticide Assessment
Guidelines require the use of certain
routes.
Response: Unlike FDA, EPA requires
many tests -whets a predefined route of
exposure is not available. Multiple
exposure routes may be possible-for
many test substances. It is appropriate
to state that the route is mandated by
guidelines or by the purpose of the study
if either of these are the case;
xii. Comment Section 160.120(aHlO)
should be modified to-read "*:» * route
of administration and/or exposvj
to encompass other types.c
Response: EPA disagrees ivithj
suggestion since the experimenter
controls administration but does not
have control of the route of exposure.
Administration routes cover the
potential of all exposure routes and
hence is a more general, all-inclusive
term in this case.
\iii-Comment: Section 160.120(a)
should be reworded so that it reads:
'The route or method of administration/
application and the reason for choice, if
appropriate."
Response: EPA disagrees with the
suggestion. The route of administration
is not the same concept as method of
application or administration. It would
not be appropriate to introduce
statements concerning methodology to
this section.
xiv. Comment: In the case where the
study director is part of a contract
laboratory engaged for the study by the
sponsor, it should be clarified that such
signature as required under
§ 160.120(a)(14) does not constitute
review and approval of those parts of
the protocol not related to the work
done by the contract lab. For example.
the study director for the chemical
analysis of pesticide residues in ]
may not be trained in the i
design of the sponsor's overall study,
although he or she may be qualified to
conduct the subpart of the study
contracted to the laboratory. Such a
dilemma may similarly arise in
§ 160.120(a)(5), (7), (10), and (IS].
Response: EPA believes that the study
director cannot, by definition, be an
individual who is not trained or
cognizant of the overall study. A study
is not subdivided into multiple studies
with multiple study directors. The
definitions of "study" and "study
director" preclude such a separation of
responsibility.
xv. Comment; "Where applicable"
should be added to § 160.120{a){15) since
statistical methods are not used in field
studies.
Response: Statistical methods are and
should be used in field studies.
However, where the use of statistics is
limited this can be so stated.
The phrase "to be used" should
modify theterm "statistical method" as
in 5 160.120(a)(16) of the 1963 rule. This
was a typographical error noted by one
commenter and has been corrected.
xvi. Comment Section 160.120(a
is redundant since all of S 160.1851
requires statistical methods empic
for analyzing the data,
/ZesponserSectiorrt60.18S describes.
reporting requirements after the study,
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34064 Federal Register / Vol. 54. No. 158. / Thursday^ August 17. 1989;./ Rules and Regulations
while § 160.120 describes protocol ..
requirements,before the study. .
" 2. Physical andchemical ' " _.'".'
characterization studies i'. Comment:
Section 160.135 is confusing and heeds
to be read several times iii order to
understand it EPA should clarify its
intent by specifying those studies to be
conducted under GLP standards, and by,'_
removing the double negatives currently
presented in 1160.135(a) and (b);
Response: EPA agrees with the "
comment. The section-is changed to
eliminate the double negative and
reworded for clarity while retaining the
intent of the proposed changes.
ii. Comment Should exemptions alsc
apply to "assembly line" biological
studies, such as the Ames test, acute
lethality, eye irritation, etc?
Response: EPA does not intend to
expand exemptions to biological tests
previously covered by GLP standards,
even when repetitive in nature. Section
160.135 applies only to physical and ~-
chemical characterization studies and is
intended to ease the burden on many .
studies that will now come under GLP
standards.
iii. Comment The concept of what
constitutes a study is blurred by this . .
section. Partial deletion of protocol
requirements implies that a protocol is -
mtill required for these "exempted
"measurements." : .
Response:. EPA intends that a protocol
still be required for the partially . : .
exempted studies. Some, but not all, of
the full protocol requirements are
eliminated. .. '.* -. : :
iv. Comment Areas forreceipt and \
storage of test substances have been,- :
deleted in §160.47(a)(l), but,: .
corresponding SOPs are still required by
5 160.81(b)(3).
Response: EPA maintains that .SOPs.,
for test control and reference^ubstance
handling are still important if not more.
important when facilities for their
handling are not specified. .. . . :
v. Co/zunentrStabUity is to be known
under conditions of the test under .-
S 160.105(e), but the requirement to
report that information is deleted in ;.
S 160.185(a](5)) and the requirement to :
determine stability is removed by
deleting S 160.105(b). . -
Response: EPA agrees, but there is no
contradiction. The requirements for ..
determination and reporting of stability-V
are relaxed although stability, still needs.
to be known. . . ..... > - ^
vi. Comment A protocol is required . -
even though certain specific elements. . -
thave been defeted (§ 160.120(a)(5) . ,
through {12) and (15)), but the . , ; ; "
^requirenientfor the quality assurance.'..,,
unit to retain the protocol is deleted:"'.'.;
r ^MM m^^f jv»- ; : *.-'* '- -*- =-- ,f * v >--.
Response: EPA agrees that this is true.
The QAU recbrdkeeping requirements .
are relaxed although the protocol still . .
needs to be written. .
vii. Cbm/ne^fr A.quality assurance. . .
unit is required by § 160,35(a), but by .
deleting 5 160.31(c) management will not
have to assure the existence of a QAU.
Response: EPA eliminated 5 180.31(c)
because ft requires management to ,
"assure that there is a quality ..assurance
unit as described in S 160.35." This
would have contradicted the exclusion
of certain portions of S 160.35 as
specified (i.e. S 160.35(b) and (c)). That
which is hot excluded under § 160.35
must comply with S 160.35(a).
viii. Comment- A study director is
required according to §5 160.12 and
160.33, but does not have to be shown in.
the final report by the deletion of .. . : '
§ 160.185(a)(lO);
Response: The study director iff still
required to sign the compliance
statement submitted with the final
report as required in § 160.12 and is thus
required to be named in the final report.
A number of individuals are listed in
§ 160.185(a)(10) in addition to the study .
director. This section was exempted to
reduce reporting requirements.. _
ix Comment Studies designed to
determine stability, octanol water
partition coefficient, volatility, and
environmental persistence
(biodegradatioit photodegradation, or
chemical degradation studies) should.
exclude 5 160.43(a)(l) through (c) and (f)
through (h). 160.45,160.81(b)(l). (2), (6),
(7). and (9), and 160.90. Only the
physical and chemical properties that
are used to. predict the environmental
fate of a test substance should be
developed in compliance with these
regulations. Those properties which are.
not clearly used for this purpose should
be excluded. ".'. ' . . .
Response: EPA does not agree that the
listed sections are irrelevant in their
entirety to the listed studies. Those
portions of the sections which are
plainly not applicable to these studies.
(e.g. animal care facilities) do not place
any burden on these studies.
x. Comment-The removal of physical.
and chemical characterization from the
responsibilities .of the QAU should not.
be accepted because it presents a major .
problem for the QAU personnel. The .
QAU should be responsible for.every ..
study wifetn the laboratory with no
exception. ' ',... . ":. ? .
Response: EPA;disagrees with the ...-.'
conclusion that the QAU has no . ... r .
responsibilities in physical and chemical
characterization studies. The exclusions.
reduce, the responsibilities of the^QAU^ :
i.e. mas|ejr schfidule requirement^ etc., -_.-
but do notefiminate them. '..--,.-'., lts.?.
xi. Comment The.QAU should be -.-.-. .
responsible for looking at the functional
components of the laboratory (e.g._all
melting points, all GC/MS analyses,
etc.] rather than focusing on a particular
study, such as with toxicology studies..
Response: EPA agrees and is
modifying the inspectional requirements
of the QAU under § 160.35. This change
specifies that the QAU conduct
inspections and maintain records that
are appropriate to particular studies.
This gives latitude to the QAU with
respect to how the information is
gathered; i.e., as part of the standard
review procedures of the laboratory, or
as needed for the test This change
should reduce the burden in cases
where it is appropriate to maintain
central records regarding functional
components'that affect several studies
rather than requiring such records to be
maintained separately.
xii. Comment: If physical and
chemical characteristics are to be
covered by GLP standards, they should
not be referred to as separate
"characterization studies." These tests
are listed in 40 CFR part 158 as physical
and chemical characteristics and
properties and are submitted to EPA in
studies by Guideline series numbers, not
- necessarily as individual
"characterization studies." Additionally,
in product chemistry many of the
characteristics listed in proposed
§ 160.135(b) are part of Series 63 (i.e.
stability, solubility, etc.), which is
submitted as a single study. If these
characteristics are to be covered by GLP
standards, it should only be to the
extent of the data requirements in 40
CFR 158, because it is not the purpose of
the GLP standards to define studies for
registration. :
Response: EPA disagrees with this
comment GLP standards do not expand
data requirements. The regulations only
specify how the data are to be
generated.
xiii. Comment All product chemistry
should be exempted from these
regulations, except for those studies .
specifically noted in the preamble (l.e.
stability, solubility, octanol water
partition coefficient, volatility and
persistence), which also affect the .
environmental hazard assessment and/ .
or are required by other sections, of the
guidelines. . , .,.. -., ,v:;« ...'...-._..- ; -:
Response:. EPA maintain? that all data ;
that are required to be submitted to EPA .
be collected according to GLPL , ;;-.'
standards. WhUe^A^ beiieyeff that a
poctionof thejrequirement»of,the,
previous GLP standard^ can-be, reduced
for some studies, the, standarda-are still,v
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Federal Register / VoL 54. No. 158 / Thursday. August 17, 19897 Ruiea and Regulations 7 34065
important to assure the quality and
Integrity of the data generated.
yav. Comment: The series 60, 61,62,
and 63 requirements are mainly process
and method development type
experiments, and are developed over a
period of time with portions sometimes*
contributed from laboratories in plant
locations, making it prohibitively
expensive and unrealistic to have these
portions under a GLP program.
Response: While there may be
additional cost, the need to have the
work performed under GLP standards .
overrides this concern. EPA does not
agree that GLP requirements in this -
section entail unrealistic requirements
on laboratories that perform these types.
of experiments.
xv. Comment The data quality from
the series 60,81,62 and 63 studies would.
not be compromised since the
companies that are generating these
data are usually doing so for their own
economic benefit as well as for :
registration purposes.
Response: Data developed under
manufacturer's demands for quality
control information do not reflect the
same constraints upon data integrity as
required by EPA. During the
manufacturing process, cost and time '
considerations may conflict with safety
assessment data quality needs.
xvi Comment EPA should revise PR
Notice 88-5 to ensure that the definition
of study corresponds with the definition
in the GLP regulations. " ';
Response.-TheCLP regulations -
address, the integrity of data generated;
during a study, PR Notice 86-5 :-
addresses the reporting of the data, ., ...-,:."
which i» a separate concern. , ..
xviLComme/?fcThe term "studies" in
the title of 5 160.135 should be-replaced
with another term, such as .-
"experiments." to avoid the
misconception: that; these experiments :
must be carried out as-separate ...
"studies." As separate studies, they ......
would require separate protocols, study -
directors, study reports. QAU audits,
etc., when in fact .these experiments are
part of a larger study, which already has
its own protocol covering all the various
experiments to be performed Jt may be :
that this part should be deleted because
these tests do not fit the basic definition
. of study and should not be included, in
any way, under the1 scope of the GLP
standards.- . ._
Response: EPA disagrees that these I
tests aremrt studies. The definition of I
stady includes the phrase "to determine/
or help predict [the test substance's]
effect* ^antffatei" Therefore the- {:
physical and chemical characterizatior
parameters are included. EPA agrees
that in some cases, the determination*
will have been performed as part of a
larger study (e.g. product chemistry) and
consequently will have been performed
under the protocol of the larger'study. In
other cases, however, each of these
studies will require a separate protocol.
xviii. Comment: Are GLP requirements
applicable when analyses are conducted
by an outside laboratory, or are they
exempted from the various sections
outlined in § 160.135(a)? ' . . .
Response: The location where the ;]
analyses are performed does not affect
the applicability of the GLP regulations.
xix. Comment- Section 160.135(a) in ~~
the proposed rule should be deleted
because the regulation is far too
complex to start applying parts of it to
one study, but not to another. It is a
major task to instruct personnel on the
requirements in the GLP standards; and
it would be an impossible task to
instruct them on multiple versions of
GLP standards. -
Response: There should not be many
cases where the same workers will need
to be trained in both levels of GLP
interpretation. There are not "multiple
versions" of GLP standards, only a
relaxation of some requirements for
some studies. EPA does not consider
this to be imposing ah additional
burden.
xx Comment- Under 5 160.135(b), an
unusual situation canWcur with quality
assurance because a QAU: is required to
exist'by retention of 5 160.35(a) and is
implied to have records of inspection by
retention of § i60.35(d}, but has no
duties by virtue of deleting 9 160.35 (b)
and (c). Both f 160.35 (a) and (d) should
be added to the list of excluded
provisions. -''"''' ' '
Response: EPA agrees that there/are
inconsistencies in eliminating § 160.35
(b) and (c) since there are no -
inspectional responsibilities included hi
8 160.35 (a) or (d): Consequently, EPA is
expanding 5 160.35(a) to include
inspectional responsibilities. *
xxt Comment: The repetitive :
inspection of the types of studies
required in proposed } 160.135(b) would
consume large amounts of time for both
study personnel and 1he QAU staff
without contributing to the quality and
integrity of the data. The periodic -
inspection of such operations would-
provide the necessary assurance that
the data were of sufficient quality and
integrity to meet all requirements under
GLP standards.
Response: EPA disagrees:with the-
comment and expects that each study be
inspected by the QAU at least once.
Where these types of tests are repetitive
or routine in nature it should be possible
for the QAU inspectional process to be
equally routine. ; - : .- _. .
xxii. Comment: EPA should ;
proposed § 160.135(b) to make it!
perfectly clear that stability/soluT
experiments carried out as part of a
study are not excluded from the
exemption provided by § 160.135(a).
When the sole purpose of a study is to
determine stability or solubility, GLP
standards should apply, but where
stability or solubility determinations are
being made prior to the initiation of the
actual experiment for which the study is
\ being conducted, there is no reason to
j treat those determinations as a separate
study. The study protocol will cover the
need for, and method of, determining
stability and solubility in situations
where it is necessary to make those
determinations in order to ensure the
success of the study.
Response: EPA. agrees that "sole
purpose" stability/ solubility studies are
under GLP standards, but disagrees that
these studies should be exempt when
they are part of another GLP study. If
they are a part of a larger study, they
are within its protocol, and hence under
GLP standards. If they are not within
that protocol, then they are "sole
studies" under GLP standards hi their
own right
H. Records and Reports
1. Reporting of study resultsif
Comment- Section 160.185 delineates the
information to be included in the final
report Since the Office of Pesticide
Programs (OPP) has already designed
Data Reporting Guidelines (DRGs) as
addenda to the Pesticide Assessment
Guidelines and these are being used by
applicants, this section appears to be
unnecessary.'Furthermore, there are a
few issues where the GLP standards and
DRGs are not compatible and illustrate
a possible conflict in EPA requirements:
(a) Section ieai85(a)(2>(protocol)
The reviewer at OPP needs to know the
study objectives, not necessarily what
the objectives were in the protocol and
what changes were made during the
course of the study; (b) Section
160.1B5(a)(6>(methodology}A
description of the methods used is :
required, but residue chemistry reports
require a separate report for <
methodology; (c) Section 160.185(c}
(report amendments)Information
Services Branch has specific
requirements in PR Notice 88-5 : .
regarding the submission of amended
reports. In cases such as these, which
document has the superseding
authority?^ ;; ;: .
Response: DRGs are designed fd
presentation of data to EPA after t
performance of the study, and GLP
standards are designed to ensure data '
rth^^
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34066 Federal Register / VoL 54. No, 158 / Thursday. August 17, 1989 / Rules and Regulations
^tegrity during, the performance of the ,
Rudy. GLP standards require additional
Information to be contained in the final
report that are .not required by the
DRGs. This should not result in any
issues of superseding authority.
ii. Comment: Section 160.1B5{aj(12)
should be modified to require reports
only when they are necessary to explain
results that are highly subject to
interpretation or critical to the final
evaluation of the study. Otherwise this
will result in an unusual reporting
burden with little benefit during field
residue studies.
Response: EPA does not agree that die
requirement is impractical or
unnecessary. This reporting requirement
cannot be left entirely-to the discretion
of the study director.
iii. Comment: At the EPA's second
data submitters'workshop on the
implementation of PR Notice 66-5 on
December 15,1986; EPA handed oat the
"Clarification of PR Notice «&-5 '
Requirements" pertaining to GLP '
considerations. EPA states in this
clarification that reformatting final
study reports to comply with the
submission requirements of PR Notice
88-5 does no* constitute a formal
"correction or addition" to a final report
that would otherwise require the
ignature of the study director under 40
CFR 160.l85(c).
/tesponsarEPAagreesandn : :
incorporating the suggestion; in the final
rule so that modification to comply with
EPA BiihmJOTiftn requirements, does not
constitute acorrection, addittoa* at
amendment However. EPA advi*» that
the process of refonuaUiug final study :
report* does not alleviate the stady-:
Hirprtny nf myjMintnraHty to gignmgtn»
final report or the compliance statement
2. Storage and rstnend of records and
dotoi. Continent: Tas pfaran "beyond
quality assurance" in $ 19X190(a) needs
clarification since it could be
ambiguously interpreted. Does it mean
the date of, the final approved report or
does it mean beyond initial evaluation.
of the specimens, since that was the
statement used in me corresponding..
preamble section? - . .. <
Response: EPA intends, mat the
specimens be retained until the quality .
assurance unit assures that their :
discarding does not negatively impact ..
the integrity of the study. The weeding is
being changed to "after quality ... .' V
assurance verification" to clarify tins.
ii. Comment;Tissues "and animal feeds
collected .from non-toxicology studies .
should also be discarded after quality
assurance verifies tun. If EPA does not
intend foe animal tissues to be retained'
from residue studies, "animal*' not .;"!!
appearing after "plants" is ah oversight.
Response: EPA. did not include, the : ...
term "animal" in the list since it would
potentially include tissues and feeds .
from toxicology studies which must be
kept. It is felt that the suggested wording
would norprovide sufficient breadth to
coyer non-residue samples. Therefore.
EPA will require mat all animal tissue
samples, even from non-toxicology -
studies, be included in this Part
iii. Comment: Retention time for 14C-
labelled specimens Tippd*? to be
addressed since a facility's license Urnit
could be exceeded for storing
radioactive material.
Response: The problem of licensing .
requirements is a facility responsibility
under GLP standards. EPA does not
agree mat special consideration be
given to sample storage based on the
above reasoning.
iv. Comment: This Part does not
clearly define who must archive raw
data or authenticated copies. If the test :
facility's portion of the study is small
compared to the entire project it does
not make sense to archive at die test
facility. Thesponsor should be required
to archive all raw data in support of a
submission BTVJ provide that data to the
test facility in the event of an audit
Archiving at the test facility wiR pat an
undue and unnecessary hardship on
small laboratory facilities. Another
problem to be considered is whether the
test facility is required to archive the .. :
final import submitted to EPA. It could
find itself archiving analytical data,. ...,
generated by another facility, ;-::.:
Furthermore, in the event that the .,.; ., ~
sponsor may be involved in a lawsuit .,,
concerning the study, the contingent,,. =
liability exposure for the test facility: ,,r;
should be clarified^ : -
Response: The test facility may :!
contract with a commercial archivec. . .
under § 160095 (b) and (g). This implies
flexibility in the physical bcation of the
archives..
3. Retention of recordsL Comment
The appropriate andpoint for specimen
retention in 5 160.195 should be based
on *^"* integrity of the specimens and
use by the study director, or other
technical personnel, not based on when
QAUpersonnel may .perform a review.. ,*
Responses .Quality assurance
evaluation is needed to assure that the ..
integrity of the data are not '". .,"',-
compromised by the decision to discard ~
specimens. For consistency, EPA is , ' ','.'.
changing the wording of § .16QJ95(c) \o I
concur with, the wording of 5160^90(a).
iL Comment: EPA should explicitly -
state in £ 180.1)95(0 that when exact ''
copies are substiuted for original-source
as raw Aa^ thq" th° nrig}rmt may be
discarded. In the past. EPA inspectors:
have required retention of original data ' 20 percent.
sources even if exact copies existed..;
The burden imposed by some EPA
auditors, that each copy must be signed
and dated, is unrealistic. Verification of
"batches" of reproduction copies is just
as meaningful and would eliminate most
of the unnecessary burden on personnel
and time resources.
Response- Specific wording advising
the discarding of raw data after copying
is not necessary or useful. 'True copies"
will be acceptable as raw data by EPA
inspectors under 5 160.190. Signing and
dating each copy may be impractical -
and an acceptable alternative method
may be devised and incorporated into
standard operating procedures to ensure
the integrity of the copies. Laboratories
are cautioned that discarding originals
places an additional burden on .
verification of the authenticity of the ;
copies. ' '
m. Regulatory Requirements '
A. Executive Order 12291
Under Executive Order 12291. EPA
must judge whether, a rule is "major"
and therefore subject to the requirement
of a Regulatory Impact Analysis. EPA
has determined that the amendments
are not a major rule because they do not
meet any of the criteria set forth and
defined in section l(b) of the Order.
Compliance costs wen estimated using
data from a survey of laboratories
potentially affected by the revised GLP
standards and from data on pesticides
testing demand, and costs taken from a
1980 study of the pesticides testing
industry. .
This rule was submitted to die Office.
of Management and Budget (OMB) for
review as required by Executive Order
12291. Any comments from OMB to EPA
and any EPA response to those ;
comments are available for public
inspection at Information Policy Branch.
PM-223, U.S. Environmental Protection
Agency. 401M SU SW., Washington. DC
20480; and at the Office of Management
and Budget. Washington, DC 20503, with
OMB requests marked "Attention: Desk
Officer for EPA." : :
B. Regulatory Flexibility Act :
This rule has been reviewed under the
Regulatory Flexibility Act of 19BO (Pub.
L 96-354; 94 Stat 1165 (5 U.S.C. B01 et
seq.)), and it has been determined that it
will nnt imi/tt aionifipan^ eirrinamle .-, .
impact on a supstantialnumber of small
btiBinrssofl, am^ll flovenunentsi.or small,
organization. It was found that the GLP :
revisions will not increase the costs of :
health effects testing and that nonhealth
-------
Federal Register / Vol. 54, No. 158 / Thursday. August 17, 1989 / Rules and Regulations 34067
C. Paperwork Reduction Act
The Information collection
requirements in this rule will be
submitted for approval to OMB under
the Paperwork Reduction Act 44 U.S.C.
3501 et seq. These requirements are not.
effective until OMB approves them and
a technical amendment to that effect is
published in the Federal Register.
Public reporting for this collection of
information is estimated to average 15
hours per response, including time for
reviewing instructions, searching
existing data sources, gathering and
maintaining the data needed, and
completing and reviewing the collection
of information. Send comments
regarding the burden estimate or any.
other aspect of this collection of
information, including suggestions for
reducing this burden, to Chief, ;
Information Policy Branch, PM-223, U.S.
Environmental Protection Agency, 401M
SL SW. Washington, DC 20503. . '
List of Subjects in 40 CFR Part 160
Environmental protection. Good'
laboratory practice, Hazardous
materials, Pesticides and pests,
Reporting and recordkeeping
requirements.
Dated-July 27.1989. .
William ICReilly.
Administrator.
Therefore. 40 CFR. chapter I, part 160"
is revised to read as follows: :.
PART 160-GOOD LABORATORY
PRACTICE STANDARDS :
Subpart AGeneral Provisions ;
Sec.' . : ,.',.'
160.1 Scope. ' . . '.'.'.;.
160.3 Definitions. .
160.10 Applicability to studies performed
under grants and contracts.
160.12" Statement of compliance or non-
- compliance.
160.15 Inspection of a testing facility.
160.17 Effects of non-compliance.
'Subpart BOrganization and Personnel
16029 Personnel.
160.31 Testing facility management
160.33 Study director.
160.35 Quality assurance unit'
Subpart CFaculties
160.41 General.
160.43 Test system care facilities.
160.45 Test system supply facilities.
160.47 Facilities for handling test control,
and reference substances.
160.49 Laboratory operation areas.
160-51. Specimen and data storage facilities.
Subpart Dtqufpmerrt
160.61 Equipment design. -
160.63 Maintenance and calibration of ..'.-.,
equipment.
Subpart ETesting Faculties Operation
160.81 Standard operating procedures.
160.83 Reagents and solutions.
160.90 Animal and other test system care.
Subpart FTest, Control, and Reference
Substances
160.105 Test, control, and reference
substance characterization. '
160.107 Test, control, and reference .
substance handling.
160.113 Mixtures of substances with
carriers.
i^T
ol tar and Conduct of a
Subpart 0-Fr
Study
160.120 Protocol.
160.130 Conduct of a study.
160.135 Physical and chemical
characterization studies.
Subparta H and I(Reserved]
Subpart JRecords and Reports
160.185 Reporting of study results.
160.190 Storage and retrieval of records and
data.
160.195 Retention of records.
Authority: 7 U.S.C. 136a, 136& 1384 136f,
138J. 136t 138v, 136W 21 U.S.C. 348a, 348,371,
Reorganization Plan No. 3 of 1970.
Subpart AGeneral Provisions
9160.1 .Scope.
(a) This part prescribes good
laboratory practices for conducting
studies that support or are intended to .
support applications for research or
marketing permits for pesticide products
regulated by the EPA. This part is
intended to assure the quality and
integrity of data submitted pursuant to
sections 3,4, 5,8,18 arid 24{c) of the
Federal Insecticide, Fungicide, and
Rodentidde Act (FIFRA), as amended (7
U.S.C. 136a, 136c, 136f, 136q and 136v(c))
and sections 408 and 409 of the Federal
Food, Drug and Cosmetic Act (FFDCA)
(21 U.S.C. 346a, 348).
(b) This part applies to any study
described by paragraph (a) of this
section which any person conducts,
initiates, or supports on or after October
16,1889.
{160J Definitions.
As used in this part the following
terms shall have the meanings specified:
Application for research or marketing
permit Includes:
(1) An application for registration,
amended registration, or reregistration
of a pesticide product under FIFRA
sections 3,4 or 24(c).
(2) An application for an experimental
use permit under FIFRA section 5.
(3) An application for an exemption
under FIFRA section 18.
(4) A petition or other request for
establishment or modification of a
tolerance, for an exemption for the need
for a tolerance, or for other clearj
under FFDCA section 408.
(5) A petition or. other request I
establishment or modification of a food
additive regulation or other clearance by
EPA under FFDCA section 409.
(6) A submission of data in response
to a notice issued by EPA under FIFRA
section 3(c)(2)(B).
(7) Any other application, petition, or
submission sent to EPA intended to
persuade EPA to grant modify, or leave
unmodified a registration or other
approval required as a condition of sale
or distribution of a pesticide.
Batch means a specific quantity or lot
of a test, control, or reference substance
that has been characterized according to
§ 180.105(a).
Carrier means any. material, Including
but not limited to feed,'water: soil,
nutrient media, with which the test
substance is combined for
administration to a test system.
Control substance means any
chemical substance or mixture, or any
other material other than a test
substance, feed, or water, that is
administered to the test system in the
course of a study for the purpose of.
establishing a basis for comparison with
the test substance for known che
or biological measurements.
EPA means the U.S, Environme
Protection Agency.
Experimental start date means the
first date the test substance is applied to
the test system. .
Experimental termination date means
the last date on which data are collected
directly from the study.
FDA means the U.S. Food and Drug
Administration.
FFDCA means the Federal Food, Drug
and Cosmetic Act, as amended (21
U^.C 321 et seq).
FIFRA means the Federal Insecticide,
Fungicide and Rodentidde Act as
amended (7 U.S.C. 136 et seq).
Person includes an individual,
partnership, corporation, association,
scientific or academic establishment
government agency, or organizational
unit thereof, and any other legal entity.
Quality assurance unit means any
person or organizational element except
the study director, designated by testing
facility management to perform the
duties relating to quality assurance of
the studies.
Raw data means any laboratory
.worksheets, records, memoranda, notes,
or exact copies thereof, that are the
result of original observations andj^^k
activities of a study and are neces^^V
for the reconstruction and evaluatiorrof:'
the report of that study. In the event that
exact transcripts of raw data have been
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34068 Federal Register / Vol 54, No. 158 / Thursday, August 17, 1989 / Rules and Regulations
veparcd {^g, tapes which have been
inscribed verbatim, dated, and
drifted accurate by signature); the
exact copy or exact transcript may be
substituted for the original source as
raw data. "Raw data" may include
photographs, microfilm or microfiche
copies, computer printouts, magnetic
media, including dictated observations,
and recorded data from automated
instruments.
Reference sabstanca means any
chemical substance or mixture, or
analytical standard, or material other
than a test substance, feed, or water.
that is administered to or used in
analyzing the test system in the course
of a study for the purposes of
establishing a basis for comparison with
the test substance for known ctiomipnl
or biological measurements.
Specimens means any material
derived from a test system for
examination or analysis.
Sponsor means:
(1) A person who initiates and
supports, by provision of financial or
other resources, a study;
(2) A person who submits a study to
the EPA in support of an application for
a research or marketing permit: or
(3) A testing facility, if it both initiates
kid actmuy*conducts the stndy.
m Study means any experiment at one or
more test sites, in which a test
substance is studied in a test system
under laboratory conditions or in the
environment to detenuine or help
predict its effects, metabolism, product
performance (efficacy studies only as
required by 40 CFR 156.640),
environmental and chemical fate,
persistence and residue, orother
characteristics in humans, other living
organisms, or media. The fenn "study"
does not include basic exploratory
studies carried out to determine whether
a test substance or a test method has
any potential utility.
Study completion dote means the date
the final report is signed by the stndy
director.
Study director tooaos the individual'
responsible for the overall conduct of a
study.
Study initiation date mean* the date
the protocol« signed by tile study
director.
Test substance means a substance or
mixture administered or added to a test
system in a study, which substance or
mixture:
(1) b the subject of an-appiication for
a research or marketing permit
kipported by the study, or i* die
Ibntempiated subject of such an .
application: or , - -
(2) Is an ingredient impurity.:
degradation product metabolite, or
radioactive isotope of a substance
described fay paragraph (1) of this
definition, or some other substance
related to a substance described by that
paragraph, which is used in the study-to
assist in characterizing the toxicity,
. metabolism, or other characteristics of a
substance described by that paragraph.
Test system means any animal, plant
microorganism, chemical or physical
matrix, including bat not limited to soil
or water, or subparts thereof, to which
the test, control, or reference substance
is administered or added for study.
'Test system" also includes appropriate
groups or components of the system not
treated with the test control, or
reference substance. -
Testing facility means a person who
actually conducts a study, i.e., actually
uses the test substance hi a test system.
'Testing facility" encompasses only
those operational units that are being or
have been used to conduct studies.
VeA/c/e means any agent which
facilitates the mixture, dispersion, or
sohibilizatfon of a test substance with a
carrier.
S 160.10 AppftcaMRr to studies
performed under grants and contracts. .
When a sponsor or other person
utilizes the services of a consulting
laboratory, contractor, or grantee to
perform all or a part of a study to which
this part applies, ft shall notify the
consulting laboratory, contractor, or
grantee that the service is, or is part of,
a study that must be conducted in
compliance with the provisions of this
part.
91C0.12
t of ooinpflnee or non-
Any person who submits to EPA an
application for a research or marketing
permit and who, in connection with the
application, submits data from a study
to which this pert applies shall Include
in the application a true and correct
statement, signed by the applicant, the
sponsor, and the study director, of one
of the following types:
(a) A statement that the study was
conducted in accordance with this part;
or
(b) A statement describing hi detail aD
differences between the practices used
in the study and uuHte required by this
part; or
(c) A statement that the person was
not a sponsor of the study, did not
conduct the study, and does not know
whether me study was conducted in
accordance with this part.
representative of EPA or FDA, at
reasonable times and in a reasonable
manner, to inspect the facility and to
inspect (and in the case of records also
to copy) all records and specimens
required to be maintained regarding
studies to which this part applies. The
records inspection and copying
requirements should not apply to quality
assurance unit records of findings and
problems, or to actions recommended
and taken, except that EPA may seek
production of these records in litigation
or formal adjudicatory hearings.
(b) EPA will not consider reliable for
purposes of supporting an application
for a research or marketing permit any
data developed by a testing facility or
sponsor that refuses to permit inspection
in accordance with this part. The
determination that a study will not be
considered in support of an application
for a research or marketing permit does
not however, relieve the applicant for
such a permit of any obligation under
any applicable statute or regulation to
submit the results of the study to EPA.
} 160.17 Effects of noivcompHanc*.
(a) EPA may refuse to consider
reliable for purposes of supporting an
application for a research or marketing
permit any data from a study which was
not conducted in accordance with this
part.
(b) Submission of a statement
required by 5 160.i2 which is false may
form the basis for cancellation.
suspension, or modification of the
research or marketing permit or denial
or disapproval of an application for such
a permit under FIFRA section 3, 5, 6, 18,
or 24 or FFDCA section 406 or 409. or for
criminal prosecution under 18 U.S.C. 2
or 1001 or FIFRA section 14. or for
imposition of civil penalties under
FIFRA section 14.
Subpart B Organization and
Personnel
§160.15
(a) A testing faculty shall permit «n
authorized employee or duly designated <
(a) Each individual engaged in the
conduct of or responsible for the
supervision of a study shall have'
education, training, and experience, or
combination thereof, to enable that
individual to perform the assigned
functions.
(b) Each testing facility shall maintain
a current summary of training and
experience and Job description for each
individual engaged in or supervising the
conduct of a study.
(c) There shall be a sufficient number
of personnel for the timely and proper
conduct of the study according to the
protocol;
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Federal Register / VoL 54, No. 158 / Thursday, August 17. 1989 / Rules and Regulations 34069
- ~
(d) Personnel shall Ulce necessary
personal sanitation and health
precautions designed to avoid
contamination of test control, and
reference substances and test systems.
(e) Personnel engaged in a .study shall
wear clothing appropriate for the duties
they perform. Such clothing shall be
changed as often as necessary to
prevent microbiological radiological, or
chemical rnn*aTTHTvatkm pf test systems
and test, control, and reference
substances.
(f) Any individual found at any time to
have an illness that may adversely
affect the quality and integrity of the
study shall be excluded from direct
contact with test systems, and test,
control, and ypfpragcfl gnhatanfpji, and
any other operation or function that may
adversely affect the study until the
condition is corrected. All personnel
shall be instructed to report to their
immediate supervisors any health ox
medical conditions that may reasonably
be considered to have an adverse effect
on a study.
§16031 Testing tactty mMgwMnt
For each sluuy, testing facility
management shall:-' .
(a) Designate a: stndy director as
described in f 160.33 before ft* study is
initiated.
(b}Replace the study director
promptly if H becomes necessary to do
so during the conduct of a study.
(c) Assure that there is » quality
assurance unit as described in fi 180.35.
(d) Assure that test.control..and ,.
reference sofas tancas or mixture* hava
been appropriately tested for identity,
strength, parity, stability, and
uniformity, as applicable. . . .
(e) Assure that petaooael. .resources,
facilities, equipment, materials and .
methodologies ere available as
scheduled,
(f) Assure that personnel deariy
understand the/unction* diey am to
perform.
(g) Assure that any deviations from
these regulations reported by the quality
assurance unit are communicated to the
study director and corrective actions an
taken and documented.
§160.33 Study director.
. For each study, a scientist or other
professional of appropriate education,
training, and experience, or combination
thereof, shall be identified as the study
director. The study director has overall
responsibility far toe tecbpy.gJ conduct
of the study, as well as lor the
interpretation, analysis, documentation,
and reporting of results, and represents
the single point of study control The .
study director shall assure that:
(a] The protocol, including any
change, is approved as provided by
§ 160.120 and is followed.
(b) Al! experimental data, including
observations of unanticipated responses
of the test system are accurately
recorded and verified.
(cj Un/orseeo circumstances that may
affect the quality and integrity of the
study are noted when they occur, and
corrective action is taken and
documented.
(d] Test systems are as specified in
the protocol.
(e) All applicable good laboratory
practice regulations are followed.
(f) AH raw data, documentation,
protocols, specimens, and final reports
are transferred to the archives dtzring or
at the close of the study.
§ 160.35 Quality assurance unit
(a) A testing facility shall have a
quality assurance unit which shall be
responsible for monitoring each study to
assure management that the facilities,
equipment, personnel, methods,
practices, records, and controls are in
conformance with the regulations in this
part For any given study, the quality
assurance unit shall be entirely separate
from and independent of the personnel.
engaged in the direction and conduct of
that study. The quality assurance unit
shall .conduct inspections and maintain
records appropriate to the study.
(b) The quality assurance untt shall:
(1) Maintain a copy of a master
schedule sheet of aQ studies conducted
at the testing farfiity indexed by test
substance. »n«j containing the test
system, nature of study, date study was
initiated, current status of each study,
identity of the sponsor, aad name of the
study director/
(2] Maintain copies of all protocols
pertaining to all studies for which the
unit is responsible.
(3) Inspect each study at intervals
adequate to ensure the integrity of the
study and maintain written and properly
signed records of each periodic
inspection showing the date of the
inspection, the study inspected, the
phase or segment of the study inspected,
the person performing the inspection,
findings end problems, action
recommended and taken to resolve
existing problems, and any scheduled
date forreinspection. Any problems
which are likely to affect study integrity
found daring the course of an inspection
shall be brought to the attention of the
study director and management
immediately.
(4) Periodically submit to .management
and the study director written status
reports on each study, noting any
problems and the corrective a
taken.
(5) Determine that no deviati
approved protocols or standard
operating procedures were made
without proper authorization and
documentation.
(6) Review the final study report to
assure that such report accurately
describes the methods and standard
operating procedures; and that the
reported results accurately reflect the
raw data of the study.
(7) Prepare and sign a statement to be
included with the final study report
which shall specify the dates
inspections were made and findings
reported to management and to the
study director.
(c) The responsibilities and
procedures applicable to the quality
assurance unit, the records maintained
by the quality assurance unit, and the
method of indexing such records shall
be in writing and shall be maintained.
These items including inspection dates,
the stndy inspected, the phase or
segment of the stndy inspected, and the
name of the individual performing the
inspection shall be made available for
inspection to authorized employees or
duly designated representatives^
or FDA.
(d) An authorized employee ormily
designated representative of EPA or
FDA shall have access to the written
procedures established for the
inspection and may request testing
facility management to certify that
inspections are being implemented,
performed, documented, and followed
up in accordance with this paragraph.
SubpartC-TatHIMes
§160.41 General.
Each testing facility shall be of
suitable size and construction to
facilitate the proper conduct of studies.
Testing facilities which are not located
within an indoor controlled environment
shall be of suitable location to facilitate
the proper conduct of studies. Testing .
facilities shall be designed so that there
is a degree of separation that will
prevent any function or activity from
having an advene effect on the study.
$160.43 Test system care fadtttes.
(a) A testing facility shall have a
sufficient number of animal rooms or
other test system areas, aa needed, to
ensure: proper separation of specieajor
test systems, isolation of indfo
projects, quarantine or isolation <
animals or other test systems, t
routine or specialized housing of
animals or other test systems.
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34070 Federal Register / Vol. 54, No. 158 / Thursday. August 17. 1989 / Rules and Regulations
. (1) In tests with plants or aquatic
limals, proper separation of species
"an be accomplished within a room or
area by housing them separately in
different chambers or aquaria.
Separation of species is unnecessary
where the protocol specifies the
simultaneous exposure of two or more
species in the same chamber, aquarium,
or housing unit.
(2) Aquatic toxicity tests for
individual projects shall be isolated to
the extent necessary to preventcross-
contamination of different chemicals
used in different tests.
(b) A testing facility shall have a
number of animal rooms or other test
system areas separate from those
described in paragraph (a) of this
section to ensure isolation of studies
being done with test systems or test,
control, and reference substances
known to be biohazardous, including
volatile substances, aerosols,
radioactive materials, and infectious
agents. .
(c) Separate areas shall be provided,
as appropriate, for the diagnosis,
treatment, and control of laboratory, test
system diseases. These areas shall
provide effective isolation for the
housing of test systems either known or
kfiuspected of being diseased, or of being
Pbarriers of disease, from other test
systems. :
(d) Facilities shall have proper
provisions for collection and disposal of
contaminated water, soil, or other spent
materials. When animals are-housed,
facilities shall exist for the collection
and disposal of all animal waste and
refuse or for safe sanitary storage of
waste before removal from the testing _
facility. Disposal facilities shall be so
provided and operated as to minimize
vermin infestation, odors, disease
hazards, and environmental
contamination. . .
(e) Facilities shall have provisions to
regulate environmental conditions. (e,g.,
temperature, humidity, photoperiod) as
specified in the protocol.
(f) For marine test organisms, an
adequate supply of clean sea water or.
artificial sea water (prepared from
deionized or distilled water and sea salt
mixture) shall be available; The ranges
of composition shall be as specified in
the protocol.
(g) For freshwater organisms, an
adequate supply of clean water of the
appropriate hardness, pH, and
temperature, and which is free of
contaminants capable of interfering with
the study, shall be available as specified
in the protocol,
(h) For plants, an adequate supply of
soil of the appropriate composition, as
specified in the protocol, shall be
available as needed.
§160.45 Test system supply facilities.
(a) There shall be storage areas, as
needed, for feed, nutrients, soils,
bedding, supplies, and equipment.
Storage areas for feed nutrients, soils,
and bedding shall be separated from
areas where the test systems are located
and shall be protected against ......
infestation or contamination. Perishable
supplies shall be preserved by
appropriate means.
(b) When appropriate, plant supply
facilities shall be provided. As specified
in the protocol, these include:
(1) Facilities for holding, culturing, and
maintaining algae and aquatic plants.
(2) facilities for plant growth,
including, but not limited to
greenhouses, growth chambers, light
banks, and fields.
(c) When appropriate, facilities for
aquatic animal tests shall be provided.
These include, but are not limited to,
aquaria, holding tanks, ponds, and
ancillary equipment, as specified in the
protocol. :
§160.47 Faculties for handling test
control, and reference substances.
(a) As necessary to prevent
contamination or mixups, there shall be
separate areas for
(1) Receipt and storage of the test,
control, and reference substances.
(2) Mixing of the test, control, and
reference substances with a carrier, e.g.,
feed. , . . !
(3) Storage of the test control, and
reference substance mixtures.
(b) Storage areas for test control,
and/or reference substance and for test
control, and/or reference mixtures shall
be separate from areas housing the test
systems and shall be adequate to
preserve the identity, strength, purity,
and stability of the substances and
mixtures.
S 160.49 Laboratory operation areas.
Separate laboratory, space and other
spate shall be provided, as needed, for
the performance of the routine and
specialized procedures required by
studies.
{160.51 Specimen and data storage
facilities.
Space shall be provided for archives,
limited to access by authorized
personnel only, for the storage and
retrieval of all raw data and specimens
from completed studies.
Subpart DEquipment
§ 160.61 Equipment design
Equipment used in the generation,
measurement, or assessment of data and
equipment used for facility
environmental control shall be of
appropriate design and adequate
capacity to function according to the
protocol and shall be suitably located
for operation, inspection, cleaning, and
maintenance.
§ 160.63 Maintenance and calibration of
equipment
(a) Equipment shall be adequately
inspected, cleaned, and maintained.
Equipment used for the generation,
measurement or assessment of data .
shall be adequately tested, calibrated.
and/or standardized.
(b) The written standard operating
procedures required under
§ 160.81(b)(ll) shall set forth in
sufficient detail the methods, materials,
and schedules to be used in the routine
inspection, cleaning, maintenance,
testing, calibration, and/ or
standardization of equipment and shall
specify, when appropriate, remedial
action to be taken 411 the event of failure
or malfunction of equipment The
written standard operating procedures
shall designate the person responsible
for the performance of each operation.
(c) Written records shall be
maintained of all inspection,
maintenance, testing, calibrating, and/or
standardizing operations. These records.
containing the dates of the operations,
shall describe whether the maintenance
operations were routine and followed
the written standard operating
procedures. Written records shall be
kept of nonroutine repairs performed on
equipment as a result of failure and
malfunction. Such'records shall
document the nature of the defect how
and when the defect was discovered.
and any remedial action taken in
response to thVdefect
Subpart ETesting Facilities
Operation
§160.81 Standard operating procedures.
(a) A testing facility shall have
standard operating procedures in
writing setting forth study methods that
management is satisfied are adequate to
insure the quality and integrity of the
data generated in the course of a study.
All deviations in a study from standard
operating procedures shall be
authorized by the study director and
shall be documented in the raw data.
. Significant changes in established
standard operating procedures shall be
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Federal Register / Vol. 54, No. 158 / Thursday. August 17, 1989 / Rules and Regulations 34071
properly authorized in writing by
management.
(b) Standard operating procedures
shall be established for, but not limited
to, the following:
(1) Test system area preparation.
.(2) Test system care.
(3) Receipt, identification, storage,
handling, mixing, and method of
sampling of the test control, and
reference substances.
(4) Test system observations.
(5) Laboratory or other tests.
(6) Handling of test systems found
moribund or dead during study.
(7) Necropsy of test systems or
postmortem examination of test
systems.
(flj Collection and identification of
specimens.
(9) HistopathoJogy.
(10) Data handling, storage and
retrieval; .
(11) Maintenance aid calibration of
equipment
(12) Transfer, proper placement, and
identification of teat systems.
(c) Each laboratory or other study
area shall have immpHiaiply available
manuals and standard operating
procedures relative to the laboratory or
Meld procedures being pprforfpflfi-
Published literature may be used as a
supplement to standard operating
procedures.
(d) A historical file of standard
operating procedures, and all revisions -
thereof, incmding the dates of such
revisions, shall be maintained.
All reagents and solutions in the
laboratory areas shall be labeled to .
indicate identity, titer or concurt*3tV»ii.
storage requirements, and expiration
date. Deteriorated or outdated reagents
and solutions shall not be used.
J16&90 Animal and other test system
(a) There shall be standard operating
procedures for the housing, feeding,
handling, and care of animals and other
test systems.
(b) AH newly received test systems
from outside sources shall be isolated
and their health stains or
appropriateness, for the study shall be
evaluated. This
accordance with acceptable veterinary
medical practice or scientific B»p*k"d»-
(cj At the initiation of a study, test
systems shall be free of any disease or
condition that might interfere with the
purpose or conduct of the study. If .
during the course of the study, the test
systems contract snch a disease or
condition, the diseased test systems
should be isolated, tf necessary. These
test systems may be treated for disease
or signs of disease provided that such
treatment does not interfere with the
study. The diagnosis, authorization of
treatment, description of treatment, and
each date of treatment shall be
documented and shall be retained.
(d) Warm-blooded animals, adult
reptiles, and adult terrestrial
amphibians used in laboratory
procedures that require manipulations
and observations over an extended
period of time or in studies that require
these test systems to be removed from
and returned to their test system-
housing units for any reason (e.g., cage
cleaning, treatment, etc.], shall receive
appropriate identification fag., tattoo,
color code, ear tag, ear punch, etc.). All
information needed to specrficalry
identify each test system within the test
system-housing unit shall appear on the
outside of that unit Sodding-mammals
and juvenile birds are excluded from the
requirement of individual identification
unless otherwise specified in the
protocol.
(e) Except as specified in paragraph
(e)(l) of this section, test systems of
different spedes shall be housed in
separate rooms when necessary. Test
systems of the sane species, but used in
differentatadies, should not ordinariry
- be hcrtsed hi the same roots when
inadvertent exposure to test, control, or
reference substances or test system
mixup could affect the outcome of either
study. If such mixed housing is
necessary, adequate differentiation by
space and identification shail-be made.
(1) Plants, invertebrate annuals,
aquaticvertebrate animals, and
organisms that may be used in
multfspecies tests need not 'be housed in
separate rooms, provided that they are
adequately segregated to avoid mixup
and cross contamination.
(2) [Reserved]
ff) Cages, racks, peas, enclosures,
aquaria, holding tank*, ponds, growth
chambers, and other holding, rearing
and breeding areas, and accessory
equipment, shall be cleaned and
sanitized at appropriate intervals.
(g) Feed, soil, and water used for ihe
test systems shall be analyzed
periodically to ensure that contaminants
known to be capable of interfering with
the study and reasonably expected to be
present in such feed, soil or water are
not present at levels above those
specified in the protocol. Documentation
of such analyses shall be maintained as
raw data.
(h) Bedding used in animal cages or
pens shall not interfere with the purpose
or conduct of the study and shall be
changed as often as necessary to keep
the animals dry and clean.
(i) If any pest control materiaj
used, the use shall be docume ^^^
Cleaning and pest control materHFthat
interfere with the study shall not be
used.
(j) All plant and animal test systems
shall be acclimatized to the
environmental conditions of the test.
prior to their use in a study.
Subpart FTest, Control, and
Reference Substances
§ 160.106 Test control, and reference
substance characterization.
(a) The identity, strength, purity, and
composition, or other characteristics
which will appropriately define the test,
control, or reference substance shall be
determined for each batch and shall be
documented before its use in a study.
Methods of synthesis, fabrication, or
derivation of the test, control, or
reference substance shall be
documented by the sponsor or the
testing faculty, and the location of such
documentation shall be specified. .
(b) When relevant to the conduct of
the study the solubility of each test,
control or reference substance shall be
determined by the testing facility or the
sponsor before the experimental start
date. The stability of the test, i
reference substance shall be i
before the experimental i
concoiffl'tantly according to written
standard operating procedures* wnich
provide for periodic analysis of each
batch.
(c) Bach storage container for a test
control, or reference substance shall be
labeled by name, chemical abstracts
service number (CAS) or code number,
batch Timnber, expiration date, if any,
and, where appropriate, storage
conditions necessary to maintain the
identity, strength, purity, and
composition of the test control, or
reference substance. Storage containers
shall be assigned to a particular test
substance for the duration of the study.
(dj For studies of more than 4 weeks
experimental duration, reserve samples
from each batch of test control, and
reference substances shall be retained
for the period of time provided by
§150.195.
(e) The stability of test control, and
reference substances under storage
conditions at the test site shall be
known for all studies.
§ 160.107 'Test control, and reference
substance handling.
Procedures shall be established
system for the handling of the test
control, and reference substances
ensure mat:
(a) There is proper storage..
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34072 Federal Register / Vol. 54. No. 158 / Thursday, August 17, 1989 / Rules and Regulations
(b) Distribution is made in a manner
designed to preclude the possibility of
^contamination, deterioration, or damage.
m (c) Proper identification is maintained
throughout the distribution-process.
(d) The receipt and distribution of
each batch is documented. Such
documentation shall include the date
and quantity of each batch distributed
or returned.
§160.113 Mixture* of substance* with
carriers* .
(a) For each test, control, or reference
substance that is mixed with a.carrier,
tests by appropriate analytical methods
shall be conducted: -
(1) To determine the uniformity of the
mixture.and.to determine, periodically,
the concentration.of the test, control, or
reference substance in the mixture.
(2) When relevant to the conduct of
the study, to determine the solubility of
each test, control, or reference
substance in the mixture by the testing ;
facility or the sponsor before the '. ..
experimental start date.
p (3) To determine the stability of the
/ test, control, or reference substance in ,
i the mixture before the experimental
start date or concomitantly according to
; written standard operating procedures,
which provide for periodic analysis pf
L-each batch. - " ..,-'..'-
(b) Where any of the components of
test, control, or reference substance .
carrier mixture has an expiration date,
that date shall be dearly shown on the
container. If more than one component ,.
has an expiration date, the earliest date
shall be shown. ....'. .-.. -,..... . ...
(c) If a vehicle is used to facilitate the ,
mixing of a test substance .with a. carrier,
assurance shall be provided that the .
vehicle does not interfere with the , '
integrity of the test . . ,' '.'.
Subpart GProtocol for and Conduct
of a Study
§160.120 Protocol.
(a) Each study shall have an approved
written protocol that clearly indicates
the objectives and alTmethods for the
conduct of the study,The protocol shall
contain but shall hot necessarily be :
limited to the following information: -
(1) A descriptive title and statement of
the purpose of the study. <. ;
(2) Identification of the test, control
and reference substartce-by name, *.v
chemical abstracts service (CAS) '' '
number oroods number. : - , .> :
(3) The name* and address of the
sponsor and the name and address of
the testing facility at which the study is
being conducted. '....
.(4) The proposed experimental start
and termination dates. . ;
(5) Justification for selection of the
test system. ;:-.:
(6) Where applicable, the number,
body weight range,, sex, source of'
supply, species, strain, substrain, and
age of the test system.
(7) The procedure for identification of
the test system. .
{8) A description of the experimental
design, including methods for the control
of bias.
(9) Where applicable, a description
and/or identification of the diet used in
the study as well as solvents,
emulsifiers and/or other materials used
to solubilize or suspend, the test control,
or reference substances before mixing
with .the carrier. The description shall
. include specifications for acceptable
levels of contaminants that are
reasonably expected to be present in the
dietary materials and are known to be
capable of interfering with the. purpose '
or conduct of the study if present at
levels greater than established by the
specifications.
(10) The route of administration and
the reason for its choice.
(11) Each dosage level expressed in
milligrams per kilogram of body or test
system weight or other appropriate
units, of the test, control or reference .
substance to be administered and the
method and frequency of administration.
- (12) The type and frequency, of tests,.
analyses, and measurements to be
made.
(13) The records to be maintained.
(14) The date of approval of the
protocol by the sponsor and the dated
signature of the study director.
(15) A statement of the proposed ,
statistical method to be used. '
(b) All changes, in or revisions of an .
approved protocol and the reasons
therefore shall be documented, jigned :
by the study director, dated, and
maintained with the protocol
S 160.130 Conduct of a study.
(a) The study shall be conducted in
accordance with the protocol
(b) The test systems shall be ...... .
monitored in conformity with the
protocol ','"'..
(c) Specimens shall be identified by
test system, study, nature, and date of
collection. This information shall be
located on the specimen container or
shall accompany die specimen in a ;
manner that precludes error in the .""
recording and storage of data. : " ' :
(dUn animal studies where '" :"
histopathologyifl required, records of ;
gross findings for a specimen from
postmortem observations shall be ~ ::-
available to a pathologist when
examining that specimen ;
histopathqlogically.
(e) All data generated during the
conduct of a study, except those that are
generated by automated data collection
systems, shall be recorded directly,
promptly, and legibly in ink. All data
entries shall be dated on the day of
entry and signed or initialed by the
person entering the data: Any change in
entries shall be made so as not to
obscure the original entry, shall indicate
the reason for such change, and shall be
dated and signed or identified at the
time of the change. In automated data '
collection systems, the individual
responsible for direct data input shall be
identified at the time of data input. Any
' change in automated data entries shall
be made so as not to obscure the
original entry, shall indicate the reason
for change, shall be dated, and the
responsible individual shall be
identified.
9160.135 Physical and chemical
characterization studies.
(a) AD provisions of the GIP
standards shall apply to physical and
chemical characterization studies
designed to determine stability,
solubility, octanol water partition
coefficient volatility, and persistence
(such as biodegradatiori, ...
photodegradation, and chemical
degradation studies) of test control or
reference substances.
(b) The following GLP standards shall
not apply to studies, other than those
designated in. paragraph (a) of this
section, designed to determine physical
and chemical characteristics of a test
control or reference substance:
8160.31 (c),(d), and (g) :
§ 180.35 (b) and (c)
S 160.43
8 160.45
S 160.47
8160.49
S 160.6l(b) (1). (2). (6) 'through (9), and (12)
S 160.90
8 160.105 (a) through (d)
8 leans
8 160.120(8) (5) through (12). and (15)
8 160.185(a) (5) through (8), (10), (12), and (14)
8 ieai95:(c) and (d) .
SubpartsHandJ-KReserved] ,
Subpart J-^Record*and Reports
S 160.185 Reporting of study rasutts. :
(a) Afinal.report shall be prepared for
each study and shall include, but not '
necessarily be limited to, the following:;
(1) Name and address of the facility
performing .the study and the dates on
which the study was initiated and was
completed, terminated, or discontinued.
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Federal Register / VoL 54. No. 158 / Thursday, August 17, 1989 / Rules and Regulations 34073
(2] Objectives and procedures stated'
in the approved protocol, including any
changes in the original protocol.
(3) Statistical methods employed for
analyzing the data.
(4) The test, control, and reference ,
substances identified by name, chemical
abstracts service (CAS) number or code
number, strength, purity, and
composition, or other appropriate
characteristics.
(5) Stability and, when relevant to the
conduct of the study the solubility of the
test, control, and reference substances
under the conditions of administration.
(6) A description of the methods used.
(7) A description of the test system
used. Where applicable, the final report
shall include the number of animals
used, sex. body weight range, source of
supply, species, strain and substrain,
age, and procedure used for
identification.
(8) A description of the dosage,
dosage regimen, route of administration,
and duration.
(9) A description of all circumstances
that may have affected the quality or
integrity of the data. "
(10) The name of the study director,
the names of other scientists or
professionals and the names of all .
supervisory personnel, involved in the
study.
(11) A description of the
transformations, calculations, or
operations performed on the data, a
summary and analysis of the data, and a
statement of the conclusions drawn :
from the analysis.
(12) The signed and dated reports of
each of the individual scientists or other
professionals involved in the study,
including each person who, at the
request or direction of the testing facility
or sponsor, conducted an analysis or
evaluation of data or specimens from
the study after data generation was
completed.
(13) The locations where all
specimens, raw data, and the final .;.
report are to be stored. , .
. (14) The statement prepared and
signed by the quality assurance unit as
described in 5160.35(b)(7).
(b) The final report shall be signed
and dated by the study director.
(c) Corrections or additions to a final
report shall be In the form of an .
amendment by the study director. The
amendment shall eleariy identify that
part of the final report: that is being
added to. or. corrected and the reasons -
for the correction or addition, and shall
be signed and dated by the person .
responsible. Modification of a final 9
report to compTy with the submission ",
requirements of EPA does not constitute
a correction, addition, or amendment to
a final report
(d) A copy of the final report and of
any amendment to it shall be
maintained by the sponsor and the test
facility.
§160.190 Storage and retrieval of records
and data. . .
(a) All raw data, documentation,
records, protocols, specimens, and final
reports generated as a result of a study
shall be retained. Specimens obtained
from mutagenicity tests, specimens of
soil, water, and plants, and wet
specimens of blood, urine, feees, and
biological fluids, do not need to be
retained after quality assurance
verification. Correspondence and other
documents relating to interpretation and
evaluation of data, other than those
documents contained in the final report,
also shall be retained.
(b) There shall be archives for orderly
storage and expedient retrieval of all
raw data, documentation, protocols,
specimens, and interim and final
reports. Conditions of storage shall
minimize^deterioration of the documents
or specimens in accordance with the
requirements for the time period of their
retention and the nature of the
documents of specimens. A testing
facility may contract with commercial
archives to provide a repository for all
material to be retained: Raw data and
specimens may be retained elsewhere
provided that the archives have specific >
reference to those other locations.
(c) An individual shall be identified as
responsible for the archives. .
(d) Only authorized personnel shall
enter the archives. "
(e) Material retained or referred to in
the archives shall be indexed to permit
expedient retrieval. .
§160.195 Retention of records.
. (a) Record retention requirements set
forth in this section do not supersede the
record retention requirements of any
other regulations in this subchapter.
(b) Except as provided in paragraph
(c) of this section, documentation
records* raw data, and specimens
pertaining to a study and required to be
retained by this part shall be retained in
the archive(s) for whichever of the
following periods is longest
(1) In the case of any study used to
support an application for a i
marketing permit approved by 1
period during which the sponsor holds
any research or marketing permit-to
which the study is pertinent.
(2) A period of at least 5 years
following the date on which the results
of the study are submitted to the EPA in
support of an application for a research
or marketing permit.
(3) In other situations (e.g., where the
study does not result in the submission
of the study in support of an application
for a research or marketing permit), a
period of at least 2 years following the
date on which the study is completed,
terminated, or discontinued.
(c) Wet specimens, samples of test,
control, or reference substances, and
specially prepared material which are
relatively fragile and differ markedly in
stability and quality during storage,
shall be retained only as long as the
quality of the preparation affords
. evaluation. Specimens obtained from
mutagenicity tests, specimens of soil,
water, and plants, and wet specimens of
blood, urine, feces, and biological fluids,
do not need to be retained after quality
assurance verification. In no case shall
retention be required for longer per
than those set forth in paragraph '"
this section.
(d) The master schedule sheet, copies
of protocols, and records of quality
assurance inspections, as required by
9 160.35(c) shall be maintained by the
quality assurance unit as an easily
accessible system of records for the
period of time specified in paragraph (b)
of this section.
(e) Summaries of training and
experience and job descriptions
required to be maintained by 9 160.29(b)
may be retained along with all other
testing facility employment records for
the length of time specified in paragraph
(b) of this section.
(f) Records and reports of the
maintenance and calibration and
inspection of equipment, as required by
{ 160.63 (b) and (c), shall be retained for
the length of time specified in paragraph
(b) of this section.
- (g) If a facility conducting testing or
an archive contracting facility goes out
of business, all raw: data,
documentation, and other material
specified in this section shall be
transferred to the archives of the:
sponsor of the study. The EPA shall be
notified in writing of such a transfer.
(h) Specimens, samples; or other j
documentary materials need not I
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34074 Federal Register / VoL 54. No. 156 / Thursday. August 17. 1989 / Rules and Regulations
Detained after EPA has notified in
writing the sponsor or testing facility
folding the materials that retention is nn
longer required by EPA. Such
notification normally will be furnished
upon request after EPA or FDA has
completed an audit of the particular
study to which the materials relate and
EPA has concluded that the study was
conducted in accordance with this part
(i) Records required by this part may
be retained either as original records or
as true copies such as photocopies,
microfilm, microfiche, or other accurate
reproductions of the original records.
[PR Doc. 89-19087 Filed 8-1&-B9; 8:45 am]
BILUNO, CODE 6MO-N-W /
Jl i\-"-..: '_. "
O-r'S ~
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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
US. Environmental Protection Agency
May 12,1992
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FIFRA GLP Q's & A's
May 12, 1992
Page I of 14
INTRODUCTION
On August 17, 1989, EPA published in the Federal Register revisions to the
Federal Insecticide, Fungicide, and Rodemicide 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) and expanded
the scope of the regulations to include data submissions which had previously not been
under GLPS. The expansion of GLPS to include field studies has brought many facilities
under GLPS for the first time 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 applicability of the rule to
their activities. These questions have ranged from simply asking whether the work they
are doing is required 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 GLP 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.
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FIFRA GLt
May
Page
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.
protocol need only address those parts of the study performed on or after
effective date. Please note that if a study was subject to the 1984 GLPS, a
[ protocol was required for all parts of the study conducted after the effective date
of that rule. The compliance statement submitted with that study's report must
specify in detail those study activities which were not performed in accordance
with GLPS.
i
' 3. Current iciegisuation procedures involve submission of data that resulted from
studies performed prior to the effective date of GLPS. Do GLPS apply to such
data, and if so, how?
I
; 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 EP^ in
detail of all differences between the practices used in the study and those require
by GLPS. It is not unlawful to truthfully admit that studies supporting such
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FIFRA GLP Q's & A's
May 12, 1992
Page 3 of 14
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(k), require retention of raw data
generated in support of registered pesticides prior to the effective date of GLPS.
.Admitting to destruction of records would not exclude the Agency from taking
enforcement actions for the books and records violation.
4. Do GLPS apply to data used to support tolerance petitions?
Yes. The scope of the regulations as stated at 40 CFR 160.1 require that studies
conducted to develop data pursuant to sections 408 and 409 of the Federal Food,
Drug, and Cosmetic Act be performed in accordance with GLPS.
5. Are studies conducted under the Interregional Research Project Number 4 (IR-4)
program to support the registration of minor uses subject to the GLPS?
Yes.
6. Do GLPS apply to weather data and soil analysis data?
Any data which are collected as part of a study listed in 40 CFR 160.1 must be
collected according to GLPS. This includes weather data and soil analyses which
are collected as part of a larger study which must comply with GLPS. If non-study
data such as local weather data are cited in a study report, and the study report
clearly indicates that such data were not gathered as pan of the study, GLPS
would not apply to such data.
' 7. What applicability do GLPS have when State, Federal, or independent
laboratories are used to provide soil or weather data for GLP studies?
GLPS 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.
J
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FIFRA GLP L
May L
Page 4
DEFINITIONS
8. Wfll EPA issue separate GLP 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 the 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
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 stand
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 involved in the submission.
10. What it EPA's formal policy on certifying copies of raw data? Must each page be
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
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FIFRA GLP Q's & A's
May 12, 1992
i Page 5 of 14
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.
t
12. What type of sponsor-testing facility communication is considered to be raw data
I 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.en 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 GLPS as required at 40 CFR 160.10, and
records of facility documents such as standard operating procedures.
STUDY DIRECTOR
13. Many field studies involve more than one technical phase, each involving different
I and different methodologies, often by different contractors. Concern
has been raised over the difficulty 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^singlc
point of control is necessary to the integrity of the study and to avoid the potential
for conflicting instructions and confusion in study implementation.
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FIFRA G Li-
May
Page
14. If there can only be one study director assigned to a study, is 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
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 confonnance 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.
Qearhy, the QAU must conduct inspections adequate to provide the
required at 40 CFR 160J5(a) and, in the course of so doing, must inspect each
study at least once. All parameters must 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 is in progress to assure that methods, personnel, etc. at a particular site are
in confonnance 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 in 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 while the study is in progress.
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FIFRA GLP Q's & A's
May 12, 1992
Page 7 of u
16. What would constitute adequate inspection of the ongoing study? Would 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 GLPS state at 40 CFR 160.3S(b)(3) that
inspections must be done at intervals adequate to ensure the integrity of the study,
and further, at 40 CFR 160J35(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
t 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
!t, may occur after all experimental work is completed-in short, 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
such types of audits would not meet the GLP requirements as stated at 40 CFR
16035.
FACILITIES
17. Is it permissible to store m^wl 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.
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FIFRA GLP Q's &. A's
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Page 8 of 14
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.
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 must 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. What 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 the 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. b it necessary to retain test substance storage containers for the duration of a
field stndy?
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 the containers to assure that this standard is met.
However, requests for waivers involving large numbers of containers or safety
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FIFRA GLP Q's & A's
May 12, 1992
Page 9 of 14
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, Policy and
Grants Division (see question # 23). The written letter authorizing disposal of
containers will impose certain requirements that will ensure that the intent of the -
GLP standards are met
I*
[ 23. How does one obtain such permission?
I A request for permission must be submitted in writing to the Director, Policy and
Grants Division, Office of Compliance Monitoring (EN-342), U.S. Environmental
Protection Agency, 401 M 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. What types of conditions would be imposed by EPA in granting such permission?
['
EPA wfll 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 of the Laboratory Data Integrity Assurance
Division of OCM be notified of the location of such records in order that they be
available faf inspection.
25. Can "generic? rrrmhirrm be obtained to cover multiple studies and/or test
No. Each case wfll 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. .
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Page 10 of
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 elements. 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 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
DC
Where crops or plants are the test system or a component of the test system, all
GLP 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 16Q.185(a)(12) require that signed and dated reports of
. each nirnriit or other professional in the study be included in the fi*»i report.
Can these reports be combined into one report; with all of the scientists and
dating and signing that report?
This requirement is intended to ensure that all information related to the study is
I included in the final report Specifically, when individual scientists findings are
I pan of the study effort, they are required to be included separately. Combined
I 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.
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FIFRA GLP Q's & A's
May 12, 1992
Page 11 of 14
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 GUPS 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 160J3(f)). Thus, there is no
grace period. The study director 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 must 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 16Q.190(b), the GLPS state that retention of records at alternate locations
; 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
-------
FIFRA GLP Q s & A's
May 12, 1992
Page 12 of 14 ,
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 mutagenicity tests, specimens of soil,
i 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 does not believe that this is
the case for many types of frozen tissues. The reason that tissues are frozen is 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.
I ....
I 33. Most field notebooks be archived during or at the dose 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 soQ, water and plant specimens be retained?
I . These need only be retained until the QAU has verified that their disposa^ will nut
i 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
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FIFRA GLP Q's & A's
May 12, 1992
Page 13 of 14
requirements in addition to and independent of GLP requirements. Failure to
retain such samples may result in rejection cf data by EPA or enforcement actions
independently of whether a 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
37. What are the passible violations under the statute?
Violations of GLPS may constitute unlawful acts under FIFRA. Under section
12(a)(2)(M) it is unlawful to knowingly falsify all or part of any application for
registration, application for experimental use permit, any information submitted to
the 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)(Q) 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)(R) 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. What are die '""'"""" 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 I
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FIFRA GLP Q's &. A's
May 12,
Page 14 of
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. Wfll civfl 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 x
environment Finally, section 14(a)(2) of FIFRA provides that persons other than
registrants, commercial applicators, wholesalers, 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? ,
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.
-------
Volume 1
Appendix
APPENDIX A
Volume 1: Technical Guidance
Table of Contents
TITLE
Institution of Pesticide Enforcement Policy Statements
[40 FR 19526]
"Water Purifiers"
Guidance for Enforcement Actions Involving Water
Purifier Products
Certain Enforcement Policies to Be Followed During the
Phased Implementation of FIFRA Section 3 [PEPS #3]
[41 FR 13984]
Preventive Pest Control Treatments in the Absence of
Target Pests; [PEPS #4] [41 FR 28005]
Pest Control Devices and Device Producers: Consolidation
and Clarification of Requirements [41 FR 51065]
Enforcement Priorities in Structural Pest Control
a) Establishment Inspections of Pest Control Firms
b) Pesticides Use Inspections
c) Prosecutorial Discretion in Pesticide Use Enforcement
Enforcement Policy Applicable to Bulk Shipment of Pesticides
Pesticide Registrant Reporting Requirements: Agency
Interpretation of Requirement Imposed on Registrants
by §6(a)(2) of the Federal Insecticide, Fungicide, and
Rodenticide Act [43 FR 37611]
Notice of Rescission of Pesticide Enforcement Policy
Statements (PEPS) Nos. 1,2,5,6,7 [44 FR 33151]
Enforcement Policy Regarding Failures to Report
Information Under §6(a)(2) of the Federal Insecticide,
Fungicide, and Rodenticide [44 FR 40716]
DATE
05/05/75
08/30/75
03/15/76
04/01/76
07/08/76
11/19/76
01/24/77
07/11/77
08/23/78
06/08/79
07/12/79
FIFRA Compliance/Enforcement
Policy Compendium
A-l
Guidance Manual
September 1992
-------
Volume 1
Appendix
Volume 1: Technical Guidance (continued)
TITLE
Pesticide Use and Production by Veterinarians;
Statement of Policy on the Applicability of the Federal
Insecticide, Fungicide, and Rodenticide Act to
Veterinarians [44 FR 62940]
Enforcement Actions Concerning Nonhazardous Pesticide
Devices
Federal Facilities Compliance
Consolidated Rules of Practice Governing the
Administrative Assessment of Civil Penalties
and the Revocation or Suspension of Permits
[45 FR 24360]
Statement of Policy on the Labeling Requirements
for Exported Pesticides, Devices, and Pesticide
Active Ingredients and the Procedures for Exporting
Unregistered Pesticides [45 FR 50274]
Request Procedures for Pesticide Samples and
Followup on Pesticide Complaints
Memorandum: Routine Use of SEC "10-K" Statements
in TSCA and FIFRA Civil Penalty Actions
Advocacy of Pesticide Uses Which Do Not Appear on
Registered Pesticide Labels; Statement of Policy
Certification of Pesticide Applicators
Recordkeeping and Reporting Requirements [48 FR 53972]
Certification of Pesticide Applicators Effective
Date for Recordkeeping and Reporting Requirements
[49 FR 17759]
Suspended, Cancelled, and Restricted Pesticides
DATE
11/01/79
12/19/79
01/16/80
04/09/80
(amended 05/16/89)
07/28/80
07/30/80
10/17/80
10/22/81
(amended 05/28/86)
11/29/83
04/25/84
2/90
FIFRA Compliance/Enforcement
Policy Compendium
A-2
Guidance Manual
September 1992
-------
Volume 1
Volume 1: Technical Guidance (continued)
TITLE
Advocacy of Pesticide Uses Which Do Not Appear on
Registered Pesticide Labels; Amendment to the
Statement of Policy [51 FR 19174]
Memorandum: Endangered Species Enforcement Strategy
Federal Insecticide, Fungicide and Rodenticide Act;
Good Laboratory Practice Standards (GLPs);
Final Rule [54 FR 34052] (40 CFR Part 160)
GLP Question and Answer Document
Appendix
DATE
05/28/86
02/01/88
08/17/89
05/12/92
F1FRA Compliance/Enforcement
Policy Compendium
A-3
Guidance Manual
September 1992
-------
Volume 1
Appendix
APPENDIX B
Volume 2: State-Related Guidance
Table of Contents
TITLE
Memorandum: Appropriate Documents to Be Presented
by State Inspectors Conducting Pesticide Use
Inspections in States Having Primacy
Methyl Bromide Label Revision in Response To Health
Concerns of Structural Fumigants
Consolidated Pesticide Cooperative Agreement Guidance
for Current Fiscal Year
DATE
12/18/80
09/01/92
FIFRA Section 26 and 27
Procedures Governing the Rescission of State Primary
Enforcement Responsibility for Pesticide Use Violations
[46 FR 26058]
Federal Insecticide, Fungicide, and Rodenticide Act,
State Primary Enforcement Responsibilities (Final
Interpretive Rule for §§26 & 27) [48 FR 404]
Memorandum: "FIFRA §§26 and 27 and SPMS Measures"
05/11/81
01/05/83
10/02/85
FIFRA Compliance/Enforcement
Policy Compendium
A-4
Guidance Manual
September 1992
-------
Volume 1
Appendix
APPENDIX C
Volume 3: Enforcement Strategies
Table of Contents
TITLE
Enforcement Facts and Strategy; Compliance Monitoring
Procedures; Water Purification Devices
Strategy for the Enforcement of the Child Resistant
Packaging Regulation Under FIFRA
General Compliance Strategy for Products Subject
to the FIFRA Label Improvement Program
Compliance/Enforcement Strategy for the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
Strategy for the Enforcement of the Good Laboratory
Practice Regulations Under TSCA and FIFRA
Compliance Strategy for FIFRA §3(c)(2)(B) Suspensions
Compliance Monitoring Strategy for Enforcement of
Pesticide Registration Cancellations Due to Non-Payment
Fees
10/80
06/08/81
04/21/83
11/22/83
01/15/85
09/03/85
08/21/90
Aldicarb
Aldicarb Compliance Monitoring Strategy
04/30/90
Aldrin and Dieldrin
Continuing State Registration of Products Containing
Aldrin and Dieldrin for Which Uses Have Been Suspended
01/10/75
FIFRA Compliance/Enforcement
Policy Compendium
A-5
Guidance Manual
September 1992
-------
Volume 1
Appendix
Volume 3: Enforcement Strategies (continued)
TITLE
Arsenical s
Compliance Strategy for the Cancellation of Non-Wood
Uses of the Inorganic Arsenicals
Request (Hickerson) for Modification of the Consumer
Information Sheet for Inorganic Arsenicals
Bromoxynil
Compliance Strategy for the Conditional Registration
and Cancellation of Certain Bromoxynil
Products
DATE
06/06/89
03/01/90
07/06/89
Carbon Tetrachloride
Compliance Strategy for the Cancellation of Carbon
Tetrachloride
07/13/87
Chlordane-Heptachlor
Enforcement of Administrator's Decision and Order
Suspending Most Uses of Heptachlor and Chlordane
Clarification of Heptachlor/Chlordane Suspension Order
Status Report on the Heptachlor/Chlordane Suspension
Heptachlor/Chlordane Suspension Order Enforcement Strategy
Heptachlor/Chlordane Suspension Order Enforcement
Strategy-CORN USE
Continued Enforcement of the Suspension of Registration
for Certain Products Containing Chlordane and Heptachlor
Revised Compliance Strategy for the Cancellation
and Suspension of Chlordane and Heptachlor Termiticides
01/15/76
01/22/76
02/19/76
03/23/76
08/27/76
11/23/76
04/13/88
FIFRA Compliance/Enforcement
Policy Compendium
A-6
Guidance Manual
September 1992
-------
Volume 1
Volume 3: Enforcement Strategies (continued)
TITLE
Chlordimeform
Chlordimeform Strategy
Final Compliance Strategy for the Cancellation of
Chlordimeform
Appendix
DATE
02/09/89
06/19/89
Compound 1080
Compliance Monitoring Strategy for Compound 1080
Livestock Protection Collars
07/25/86
Daminozide (Alar)
Final Compliance Monitoring Strategy for Daminozide
(Alar)
Compliance Strategy for the Agreement to Voluntarily
Halt Sales of Food-use Pesticides Containing Daminozide
10/20/86
06/14/89
Dinoseb
Compliance Strategy for the Emergency Suspension of
Dinoseb
Amendment to the Compliance Strategy for the Emergency
Suspension of Dinoseb
OCM Memorandum: Dinoseb
OCM Memorandum: FIFRA Section 18 for Dinoseb
OCM Memorandum: Dinoseb Stipulated Order
10/07/86
04/02/87
04/17/87
03/14/88
03/28/88
FIFRA Compliance/Enforcement
Policy Compendium
A-7
Guidance Manual
September 1992
-------
Volume 1
TITLE
Dinoseb (continued)
Appendix
Volume 3: Enforcement Strategies
DATE
Compliance Monitoring Strategy for Final Cancellation
of Dinoseb
Compliance Monitoring Strategy of the June 9, 1988
Dinoseb Cancellation Order for the 1989 Growing Season
06/15/88
03/03/89
DBCP Suspension Order Enforcement Strategy
11/07/79
EBDC
EBDC Compliance Monitoring Strategy
Compliance Strategy for the Cancellation
and Registration Amendments for Pesticide Products
Containing Ethylene Bisdithiocarbamate (EBDC)
03/12/90(a)
03/12/90(b)
EDB
Memorandum: "Indemnification Claims for Suspended
EDB Products"
EDB Facts - EPA Decision
Memorandum: "Emergency Suspension of Products Registered
for Use as a Grain Fumigant or Spot Fumigant of Grain
Milling Machinery"
Strategy for Compliance/Enforcement of the Emergency
Suspension of Ethylene Dibromide (EDB)
10/06/83
02/03/84
02/06/84(a)
02/06/84(b)
F1FRA Compliance/Enforcement
Policy Compendium
A-8
Guidance Manual
September 1992
-------
Volume 1
Appendix
Volume 3: Enforcement Strategies (continued)
TITLE
Lindane
Compliance Monitoring Strategy for Cancelled Lindane
Products
Memorandum from A.E. Conroy to Region VII: "Lindane
Notice of Intent to Cancel vs. Registration Standard"
DATE
04/25/85
07/10/86
Mercury
Conclusion of Mercury Cancellation Proceeding
Enforcement of Mercury Settlement
Compliance Strategy for Conditional Registration and
Voluntary Cancellation of Certain Mercury Biocides
Compliance Strategy Addendum for the Cancellation of
Phenylmercuric Acetate Pesticides
10/28/76
01/06/77
09/12/90
12/20/91
2.4.5-T and Silvex
Enforcement of Administrator's Emergency Orders Suspending
2,4,5-T and Silvex Registrations
Further Guidance Concerning Enforcement of the Administator's
Emergency Orders Suspending 2,4,5-T and Silvex Registrations
Further Guidance on the Cancellation and Suspension of
2,4,5-T and Silvex
03/07/79
04/05/79
08/20/79
Toxaphene
Toxaphene Cancellation Compliance Strategy
01/01/83
FIFRA Compliance/Enforcement
Policy Compendium
A-9
Guidance Manual
September 1992
-------
Volume 1 Appendix
Volume 3: Enforcement Strategies (continued)
TITLE DATE
Wood Preservatives
Compliance Monitoring Strategy for the Wood Preservative 10/23/86
Uses of Creosote, Pentachlorophenol, Inorganic Arsenicals
Compliance Monitoring Strategy for Non-Wood Preservative 06/09/87
Uses of Creosote & Coal Tar
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium A-10 September 1992
-------
Volume 1 Appendix
APPENDIX D
Volume 4: Enforcement Response Policies1
Table of Contents
TITLE DATE
Memorandum: Status of a State or County Government Agency 02/24/81
Section 14(a)(2) of FIFRA
Enforcement Response Policy for FIFRA Section 7(c) 02/10/86
Pesticide Producing Establishment Reporting
Requirement
Enforcement Response Policy for the Federal Insecticide, 07/02/90
Fungicide, and Rodenticide Act (FIFRA ERP)
'Note: These documents may also be found in Appendix 6 of the FIFRA Compliance/Enforcement
Guidance Manual.
tlFRA Compliance/Enforcement Guidance Manual
Policy Compendium A-ll September 1992
-------
Volume 1
Appendix
APPENDIX E
Volume 5: FIFRA Compliance Progam Policy Compendium
Table of Contents
NUMBER TITLE
2.1: Use Recommendations
2.2: Label ing of Outer Containers
2.3: Under the Direct Supervision of a Certified Applicator
in EPA Administered Programs
3.1: Shipment Prior to Registration
3.2: Distributor Registration
3.3: Fumigation of Truck Vans on Flatbed Rail Cars
3.4: Custom Blenders
3.5: Production of Pesticides for Personal Use
3.7: Temporary Conversion of Cropland (Revised)
3.8: The Use of Products Labeled "For Manufacturing Use Only"
to Produce Pesticides for Personal Use
3.9: Status of Supplemental Registration
3.10: Use of California's Methyl Bromide Fact Sheet
4.1: Written Examinations for Private Applicators
7.1: Custom Blenders
10.1: Release of Pesticide Production Data
12.1: Using Registered or Experimental Use Permit Pesticides
in a Manner Not Included On the Label or Permit
12.2: Pesticides Closed Transfer, Mixing/Loading and
Application Equipment (Closed Systems) (Revised)
DATE
05/10/82
05/10/82
04/05/85
05/10/82
05/10/82
05/10/82
05/10/82
05/10/82
02/10/88
08/29/86
07/06/87
09/01/92
07/28/83
05/10/82
05/10/82
05/10/82
12/15/83
FIFRA Compliance/Enforcement
Policy Compendium
A-12
Guidance Manual
September 1992
-------
Volume 1
Appendix
FIFRA Compliance Progam Policy Compendium (continued)
NUMBER TITLE
12.3: Authority for Use Inspections
12.4: Making RUPs Available for Use Other than in Accordance
with Section 3(d) of FIFRA (Revised)
12.5: The Use of a Diluent Not Specified on the Product Label
12.6: Enclosed Cab Use for Pesticide Application
12.7: Enforcement of the Label Improvement Program for
Pesticides Applied Through Irrigation Systems (Chemigation)
17.1: Pesticide Processing in Foreign-Trade Zones
17.2: Waiver of Notice of Arrival Requirements
24.1: Special Local Needs Labeling
25.1: Child-Resistant Packaging
26.1: Transfer of Use Enforcement Primacy to the States
26.2: Referral of State Misuse Cases to EPA
DATE
05/10/82
07/22/86
02/27/84
08/08/90
06/20/90
05/10/82
05/10/82
05/10/82
09/01/82
05/10/82
05/10/82
FIFRA Compliance/Enforcement
Policy Compendium
A-13
Guidance Manual
September 1992
-------
Volume 1
Appendix
APPENDIX F
Additional Sources of FIFRA Compliance Enforcement Information
FIFRA Miscellaneous Sources2
TITLE DATE
Reassessment of the Federal Pesticides Enforcement Program 06/80
Pesticide Registration, Registration Classification 03/03/81
Procedure, Clarification of Policies on Special Packaging
[46 FR 15104]
State and Local Assistance [47 FR 44946] (40 CFR Part 35) 10/12/82
General Regulation for Assistance Programs [48 FR 45056] 09/30/83
(40 CFR Part 30)
Child Resistant Packages for Pesticides (Booklet) 02/85
EPA Policy on Performance-Based Monitoring Plan 05/31/85
National Pesticides Monitoring Plan 07/85
Regulation Interpretation for Pesticide Applicator; 07/22/85
Washing/Rinse Water
OECM Memorandum: Issuance of Enforcement Considerations 08/15/85
for Drafting and Reviewing Regulations and Guidelines
for Developing New or Revised Compliance and Enforcement
Strategies
OECM Memorandum: Policy on Publicizing Enforcement 11/21/85
Activities
FIFRA Data Self-Auditing Program Events 11/22/85
Pesticide Programs; Child Resistant Packaging; Final Rule 06/11/86
[51 FR 21276]
OCM Memorandum: FYI Letter - Criminal Prosecution for 10/15/87
Misuse of Pesticides
documents are not contained in the Compendium but may be obtained from Headquarters.
FIFRA Compliance/Enforcement
Policy Compendium
A-14
Guidance Manual
September 1992
-------
Volume 1 Appendix
FIFRA Miscellaneous Sources (continued)
Manuals
EPA Delegations of Authority Manual
EPA Manual of Pesticide Misuse Review Committee (PMRC) Policy, Procedures, Cases, and Advisory
Opinions
EPA Security Manual
Multi-Media Compliance Audit Inspections Procedures
NEIC Policies and Procedures Manual (Multi-Media)
Office of Pesticide Programs Policy and Criteria Notice Manual
Office of Pesticide Programs Standard Operating Procedures
(S.O.Ps) PR Notices
Pesticides Inspection Manual
SFIREG Charter
FIFRA Compliance/Enforcement . Guidance Manual
Policy Compendium A-15 September 1992
-------
Volume 1
Appendix
APPENDIX G
Obsolete Documents
TITLE
Memorandum: Interim Civil Penalties Under Section 14(a)
FIFRA, as amended (39 FR 27637)
Guidelines for Assessing Civil Penalties Under
Section 14(a) of FIFRA; As Amended [39 FR 27637]
Primary Use Enforcement Responsibility Sections 26 & 27
Review of State Certification Plans Pursuant to FIFRA
Section 26
Suspended and Cancelled Pesticides (Booklet)
Clarification of Primary Use Enforcement Responsibility
Guidance
Regulation of Public Health Related Disinfectants
Guidance for Enforcement of the Child-Resistant Packaging
Regulation
Memorandum: FIFRA Enforcement Policy; Interim Penalty
Guidelines
FIFRA Compliance Program Policy No. 12.2: Pesticides
Closed Transfer, Mixing/Loading and Application
Equipment (Closed Systems)
FIFRA Compliance Program Policy No. 3.6: Contract
Manufacturing
General Compliance Strategy for Products Suspended
Under §3(c)(2)(B) of FIFRA
FY84 Cooperative Agreement Program Guidance
FIFRA Compliance Program Policy No. 12.4: Making
Restricted Use Pesticides Available to Persons
Without Pesticide Applicator Certification
DATE
07/31/74
07/31/74
01/04/79
03/14/79
10/79
03/04/80
12/17/80
06/08/81
06/11/81
05/10/82
05/10/82
07/02/82
04/21/83
05/10/83
FIFRA Compliance/Enforcement
Policy Compendium
A-16
Guidance Manual
September 1992
-------
Volume 1
Appendix
Obsolete Documents (continued)
TITLE
Pesticide Programs - GLP Standards Final Rule
FIFRA Compliance Program Policy No. 2.3: Under the
Direct Supervision of a Certified Applicator in EPA
Administered Programs
Suspended, Cancelled and Restricted Pesticides (Booklet)
FY86 State Cooperative Agreement Program Guidance
Interim Enforcement Response Policy for FIFRA
§7(c) Pesticide Producing Establishment Reporting
Final FY87 FIFRA Cooperative Assistance Guidance
FIFRA Compliance Policy No. 3.7: Temporary Conversion
of Cropland
Final Compliance Strategy for the Cancellation of
Velsicols's Chlordane and Heptachlor Termiticides
Final Cancellation of Dinoseb
Compliance Monitoring Strategy for Final Cancellation
of Dinoseb
DATE
11/29/83
07/09/84
01/85
04/10/85
05/24/85
04/18/86
07/15/87
01/29/88
06/15/88
06/21/88
FIFRA Compliance/Enforcement
Policy Compendium
A-17
Guidance Manual
September 1992
-------
Index
This index references all the documents in each volume of the Compendium. The documents are
referenced by the Compendium subject/volume abbreviation and the date of the document. However,
FIFRA Compliance Program Policy Compendium documents are referenced by the subject/volume
abbreviation and the document number. The abbreviations for the subject/volumes in this index are as
follows:
o FGCE - FIFRA General Guidance on Compliance and Enforcement (Volume 1);
o SRG - State-Related Guidance (Volume 2);
o CMS - Compliance Monitoring Strategies (Volume 3);
o ERP - FIFRA Enforcement Response Policies (Volume 4); and
o FCPP - FIFRA Compliance Program Policy Compendium (Volume 5)
Aerial application, FGCE 06-08-79
Agricultural use only, FCPP 25.1
Alar. See Daminozide
Aldicarb
stop sale, CMS 04-30-90
Aldrin, FGCE 02-00-90
Aluminum Phosphide products, FCPP 3.3
Amitraz, FGCE 02-00-90
Antifouling paints, CMS 04-21-83
Antimicrobial pesticide, FGCE 05-28-86
Application review procedures, SRG 06-13-89
Arsenic Trioxide, CMS 06-06-89,
FGCE 02-00-90
Basic registrations, FCPP 3.9
Benomyl, FGCE 02-00-90
BHC, FGCE 02-00-90
Bithionol, FGCE 02-00-90
Books and records. See Recordkeeping and
reporting
Bromoxynil, FGCE 02-00-90
conditional registration and cancellation of
certain products, CMS 07-06-89
Bromoxynil Butyrate, FGCE 02-00-90
Bulk shipments, FGCE 07-11-77
Cadmium, FGCE 02-00-90
Calcium Arsenate. See Wood Preservatives
Cancellation order, CMS 08-21-90
Captafol, FGCE 02-00-90
Captan, FGCE 02-00-90
Carbon Tetrachloride, FGCE 02-00-90
cancellation, CMS 07-13-87
Cedar Chemical Company, CMS 06-15-88
Certification plan, FCPP 26.1
Certified applicators,
FGCE 11-29-83, FGCE 04-25-84,
FCPP 2.3, FCPP 12.4
Chemigation, FCPP 12.7
Child-resistant packaging,
CMS 06-08-81, FCPP 25.1
Chloranil, FGCE 02-00-90
Chlordane/heptachlor, FGCE 02-00-90
corn use, CMS 08-27-76
suspension, CMS 01-15-76, CMS 01-22-76,
FIFRA Compliance/Enforcement
Policy Compendium
1-1
Guidance Manual
November 1990
-------
Index
CMS 02-19-76, CMS 11-23-76
enforcement strategy, CMS 03-23-76
termiticides
cancellation and suspension,
CMS 04-13-88
Chlordimeform, FGCE 02-00-90
cancellation strategy, CMS 06-19-89
existing stocks, CMS 02-09-89,
CMS 06-19-89
recall, CMS 06-19-89
Chlorobenzilate, FGCE 02-00-90
Civil compliance, FGCE 01-16-80
Civil liability, FGCE 10-22-81
Civil penalties, FGCE 07-12-79
Civil penalty, ERP 02-24-81
administrative, ERP 07-02-90
assessment, FGCE 01-17-80
calculation, ERP 07-02-90
matrix, ERP 02-10-86
Closed system, FCPP 12.2
Commercial applicator, FCPP 2.3
Communications strategy
FIFRA and TSCA GLPs, CMS 04-25-90
Complaint followup, FGCE 07-30-80
Compliance monitoring inspection,
CMS 06-15-88
Compound 1080, CMS 07-25-86,
FGCE 02-00-90
Confidentiality, FCPP 10.1
Conservation Reserve Program (CRP),
FCPP 3.7
Contract manufacturing, FCPP 3.2
Cooperative agreement, SRG 07-31-89
application requirements, SRG 06-13-89
funds, SRG 06-13-89
implementation, CMS 11-22-83
Cooperative enforcement agreement,
FPCC 26.1
Copper Arsenate, FGCE 02-00-90
Credentials, SRG 12-18-80
Creosote, CMS 10-23-86, FGCE 02-00-90
Criminal penalties, FGCE 07-12-79
Criminal proceedings, ERP 07-02-90
Crop rotation restrictions, FCPP 3.7
Cropland, FCPP 3.7
Custom blenders, FCPP 3.4, FCPP 7.1
Cyanazine, FGCE 02-00-90
Cyhexatin, FGCE 02-00-90
Daminozide (Alar), FGCE 02-00-90
agreement to halt sales, CMS 06-14-89
final compliance monitoring strategy,
CMS 10-20-86
Data call-in requirements, CMS 09-03-85
DBCP, FGCE 02-00-90
suspension order, CMS 11-07-79
ODD (TDE), FGCE 02-00-90
Dealer, FCPP 12.4
Dealer/distributor, CMS 02-09-89
Diallate, FGCE 02-00-90
Dibromochloropropane. See DBCP
Dicofol, FGCE 02-00-90
Dieldrin. See Aldrin
Diluent, FCPP 12.5
Dimethoate, FGCE 02-00-90
Dinoseb, FGCE 02-00-90, CMS 04-17-87,
CMS 03-14-88,
CMS 06-15-88 amendment to suspension,
CMS 04-02-87
cancellation, CMS 03-28-88,
CMS 06-15-88, CMS 03-03-89
emergency suspension, CMS 10-07-86
exemption requirements, CMS 04-02-87
stipulated order, CMS 03-28-88
suspension order, CMS 04-17-87
Direct supervision, FCPP 2.3
Disinfectants, FGCE 02-00-90
Distributor registrations, FCPP 3.2
District court injunction, CMS 03-28-88
Drinking water, FGCE 08-30-75,
CMS 10-00-80
EBDC, FGCE 02-00-90
compliance strategy, CMS 03-12-90
FIFRA Compliance/Enforcement
Policy Compendium
1-2
Guidance Manual
November 1990
-------
Index
EDB, FGCE 02-00-90
grain uses, CMS 02-03-84,
CMS 02-06-84(a), CMS 02-06-84(b)
soil fumigation use, CMS 10-06-83
suspension, CMS 10-06-83, CMS 02-03-84,
CMS 02-06-84(b)
Electronic mosquito repelling devices,
FGCE 02-00-90
Emergency exemptions, CMS 03-14-88
Enclosed cabs, FGCE 02-00-90, FCPP 12.6
Endangered species, FGCE 02-01-88,
SRG 06-13-89, SRG 07-31-89
Endrin, FGCE 02-00-90
Enforcement, FCPP 12.7
Enforcement actions, FGCE 08-30-75,
FGCE 12-19-79, CMS 11-22-83
Enforcement responsibility, primary. See
Primacy
Engineering controls, FCPP 12.6
EPN, FGCE 02-00-90
Establish competency, FCPP 4.1
Establishment registration, ERP 02-10-86,
FCPP 3.5, FCPP 7.1, FCPP 10.1
Ethylene bisdithiocarbamate. See EBDC
Ethylene dibromide. See EDB
Evidence, FCPP 26.2
Executive agencies, FGCE 01-16-80
Exemptions, FCPP 3.1
Experimental use permit (EUP), FCPP 12.1
Exporting
unregistered pesticides, FGCE 07-28-80
Existing stocks, CMS 08-21-90
chlordimeform, CMS 02-09-89,
CMS 06-19-89
Exports. See Imports and exports
Federal facilities, FGCE 01-16-80
Fertilizer
pesticide mixture(s), FCPP 2.1, FCPP 3.4
Financial status, FGCE 10-17-80
Fish and Wildlife Service (FWS),
CMS 07-25-80
Fluoroacetamide, FGCE 02-00-90
Foreign trade zones, FCPP 17.1
Form 10-K. See 10-K Statements
Free ports, FCPP 17.1
Fumigants, CMS 04-21-83
Fumigation, FCPP 3.3
Good Laboratory Practices (GLPs)
and data audits, CMS 11-22-83,
CMS 01-15-85
notification plan, CMS 04-25-90
Good Laboratory Practice (GLP) Standards
interagency; Department of Health and
Human Services, National Toxicology
Program, CMS 01-15-85
memorandum of; for conduct of laboratory
inspections and data audits, CMS 01-15-85
equipment, CMS 01-15-85
inspections, CMS 01-15-85
organization and personnel, CMS 01-15-85
quality assurance unit, FGCE 08-17-89
records and reports, FGCE 08-17-89,
CMS 01-15-85
regulations, CMS 01-15-85
standard operating procedures,
FGCE 08-17-89
testing, CMS 01-15-85
testing facilities, FGCE 08-17-89,
CMS 01-15-85,
Government agency
state or local, ERP 02-24-81
Grain uses
EDB, CMS 02-03-84, CMS 02-06-84(a),
CMS 02-06-84(b)
Grant application forms, SRG 06-13-89
Gravity levels, ERP 07-02-90
Ground water, SRG 06-13-89, SRG 07-31-89
Heptachlor. See Chlordane/heptachlor
HTLV-m/LAV, FGCE 05-28-86
FIFRA Compliance/Enforcement
Policy Compendium
1-3
Guidance Manual
November 1990
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Index
Imports, FCPP 17.2
and exports, FGCE 11-19-76
Indemnification claims, CMS 10-06-83
Inorganic arsenicals, CMS 10-23-86,
CMS 06-06-89
Inspections, CMS 11-22-83, FCPP 12.3
establishment, FGCE 01-24-77
Good Laboratory Practice Standards,
CMS 01-15-85
labeling, CMS 04-21-83
pesticide use, FGCE 01-24-77,
SRG 12-18-80
Intrastate use, FCPP 24.1
Kepone, FGCE 02-00-90
Knowledge expert, FCPP 2.1
Label Improvement Program (LIP),
CMS 04-21-83
Labeling, FGCE 10-22-81, FGCE 05-28-86,
FGCE 02-00-90, FCPP 2.2, FCPP 3.3, FCPP
24.1, FCPP 25.1
changes, FGCE 02-01-88
requirements for exported pesticides,
devices, and pesticide active ingredients,
FGCE 07-28-80
Lead Arsenate. See Wood Preservatives
Level of action, ERP 07-02-90
Lindane, FGCE 02-00-90
compliance monitoring strategy,
CMS 04-25-85
notice of intent to cancel, CMS 07-10-86
LIP Notice. See Label Improvement Program
Livestock protection (LP) collars,
CMS 07-25-86
Love v. Thomas, CMS 03-28-88
Low volume applications, FCPP 12.5
Maintenance fees
registration, CMS 08-21-90
Make available for use, FCPP 12.4
Manufacturing use only, FCPP 3.8
Mercury, FGCE 02-00-90
cancellation, CMS 10-28-76
settlement, CMS 01-06-77
Metaldehyde, FGCE 02-00-90
Mirex, FGCE 02-00-90
Misbranding, CMS 10-00-80
Misuse, FCPP 2.1, FCPP 12.3, FCPP 26.2
Monocrotophos, FGCE 02-00-90
Multi-use products, FCPP 17.2
Neutral administrative inspection scheme,
CMS 09-03-85
NOIC, CMS 07-10-86, CMS 06-15-88
Noncertified applicator, FCPP 2.3
Noncropland, FCPP 3.7
Notice of arrival, FCPP 17.2
Notice of intent to suspend (NOTTS),
CMS 09-03-85
Notices of detention, ERP 07-02-90
Notices of warning, ERP 07-02-90
OMPA, FGCE 02-00-90
Outer containers, FCPP 2.2
Oxyfluorfen, FGCE 02-00-90
Parathion, FGCE 02-00-90
PCBs, FGCE 02-00-90
PCNB, FGCE 02-00-90
Penalties
civil. See Civil penalties
criminal. See Criminal penalties
Pentachlorophenol. (See also Wood
Preservatives), CMS 10-23-86
PEPS (Pesticide Enforcement Policy
Statements), FGCE 04-01-76,
FGCE 07-08-76, FGCE 06-08-79
institution of, FGCE 05-05-75
Permissible Exposure Limitation (PEL)
F1FRA Compliance/Enforcement
Policy Compendium
1-4
Guidance Manual
November 1990
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Index
Program, CMS 10-23-86
Personal protective equipment, FCPP 12.2,
FCPP 12.6
Personal use, FCPP 3.8
Pest control
devices, FGCE 11-19-76
electromagnetic, FGCE 02-00-90
nonhazardous, FGCE 12-19-79
nonstructural, FGCE 06-08-79
preventive, FGCE 07-08-76
structural, FGCE 06-08-79
Pesticide
cancellation, FGCE 02-00-90
dealer, FCPP 2.3 restricted use,
FGCE 02-00-90
suspension, FGCE 02-00-90
Pesticide Enforcement Policy Statements. See
PEPS
Pesticide use
at less than label dosage rate,
FGCE 06-08-79
by veterinarians, FGCE 11-01-79
control of pests not named on the label,
FGCE 06-08-79
control of unnamed target pests,
FGCE 06-08-79
enforcement, FGCE 01-24-77
advocacy of uses which do not appear on
label, FGCE 10-22-81, FGCE 05-28-86
Phenarsazine Chloride, FGCE 02-00-90
Phosphine gas, FCPP 3.3
Phostoxin, FCPP 3.3
Polychlorinated Biphenyls. See PCBs
Polychlorinated Terphenyls, FGCE 02-00-90
PR Notice 87-1, FCPP 12.7
Press releases, ERP 07-02-90
Primacy, SRG 05-11-81, SRG 01-05-83,
SRG 10-02-85, FCPP 26.1, FCPP 26.2
rescission of, CMS 11-22-83
Private applicator, ERP 02-24-81, FCPP 2.3
certification, FCPP 4.1
Procedures for requesting samples,
FGCE 07-30-80
Processing, FCPP 17.1
Producer, ERP 02-10-86
Product labeling, CMS 04-21-83
Product registration, CMS 10-00-80,
FCPP 3.5, FCPP 3.8
Production data, FCPP 10.1
Program oversight, SRG 06-13-89
Pronamide, FGCE 02-00-90
Purifiers. See Water purification devices
Quaternary Ammonium Compounds, FGCE
02-00-90
Rail cars, FCPP 3.3
Recall, ERP 07-02-90
chlordimeform, CMS 06-19-89
dinoseb, CMS 03-14-88
Recordkeeping and reporting, FGCE 11-19-76,
FGCE 11-29-83, FGCE 04-25-84
Referrals, SRG 10-02-85
Registered use pesticides, FGCE 11-01-79,
ERP 02-24-81
Registrant
reporting requirements, FGCE 08-23-78
Registrant/distributor liability, FCPP 3.9
Registration, FCPP 3.4, FCPP 17.1
of establishments, FGCE 11-19-76
Repackaging, FCPP 3.2, FCPP 17.1
Reporting. See also Recordkeeping and
reporting, ERP 02-10-86, FCPP 7.1
Reporting requirements
study and experimental data,
FGCE 07-12-79
Rescission proceedings, SRG 05-11-81
Respirators, FCPP 12.6
Restricted use pesticides (RUP),
FGCE 02-00-90, FCPP 12.4
Rhone-Poulenc, CMS 07-06-89,
CMS 04-30-90
FIFRA Compliance/Enforcement
Policy Compendium
1-5
Guidance Manual
November 1990
-------
Index
Safrole, FGCE 02-00-90
Salt water emesis, CMS 04-21-83
Seed treatments, FGCE 02-00-90
Seizures, ERP 07-02-90
Shipment, FCPP 3.1
Shipping containers, FCPP 2.2
Silvex. See 2,4,5-T and Silvex
Sodium Arsenate. See Wood Preservatives
Sodium Arsenite. See Wood Preservatives
Sodium Cyanide, FGCE 02-00-90
Sodium Fluoride, FGCE 02-00-90
Sodium Monofluoroacetate. See Compound
1080
Soil fumigation use
EDB, CMS 10-06-83
Special local need, FCPP 24.1
Special packaging. See Child-resistant
packaging
Special request for samples, FGCE 07-30-80
Spot fumigation, CMS 02-06-84(a),
CMS 02-06-84(b)
Spot treatment, FCPP 3.7
State authority, FCPP 26.1, FCPP 26.2
Stop Sale, Use, or Removal Order,
FGCE 12-19-79, CMS 09-03-85,
CMS 08-21-90, ERP 07-02-90
aldicarb, CMS 04-30-90
dinoseb, CMS 03-14-88, CMS 06-15-88
Strategic Planning and Measurement System
(SPMS), SRG 10-02-85
Strobane, FGCE 02-00-90
Strychnine, FGCE 02-00-90
Supplemental registrations, FCPP 3.2,
FCPP 3.9
Suspensions, CMS 09-03-85
Target pest, FCPP 2.1
10-K statements, FGCE 10-17-80
Termiticides, CMS 04-21-83
Thallium Sulfate, FGCE 02-00-90
TOK, FGCE 02-00-90
Toxaphene, FGCE 02-00-90
cancellation, CMS 01-01-83
Toxic collar. See Livestock Protection Collars
Training/guidance, CMS 11-22-83
Transfer, FGCE 07-11-77
Tributyltin, FGCE 02-00-90
Trifluralin, FGCE 02-00-90
Truck fumigation, FCPP 3.3
Truck vans, FCPP 3.3
2,4-D, FGCE 02-00-90
2,4,5-T and Silvex, FGCE 02-00-90
cancellation, CMS 03-07-79
suspension, CMS 04-05-79, CMS 08-20-79
2,4,5-TCP, FGCE 02-00-90
Ultra-low volume application, FCPP 12.5
Unregistred pesticides, FCPP 3.1
Use enforcement, FCPP 26.1
Use inconsistent with the labeling, FCPP 2.1
Use inspections, FCPP 12.3
Use recommendations, FCPP 2.1, FCPP 12.1
Vegetable oil diluent, FCPP 12.5
Velsicol Chemical Corporation, CMS 04-13-88
Vinyl Chloride, FGCE 02-00-90
Violation history, FGCE 10-17-80
Water purification devices, FGCE 08-30-75,
FGCE 03-15-76, CMS 10-00-80
Wood Preservatives, CMS 10-23-86,
FGCE 02-00-90
Worker protection program, SRG 06-13-89,
SRG 07-31-89
Worker protection statements, FGCE 02-00-90
Written examinations, FCPP 4.1
FIFRA Compliance/Enforcement
Policy Compendium
1-6
Guidance Manual
November 1990
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