United States
Environmental Protection
Agency
Office of
Pesticide Programs (TS-757)
Washington, DC 20460
April 1980
Administration
of the
Pesticide Programs
iscal-Year 1979
.
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Note: This report is for informational
purposes only. Data contained in this
report must be considered provisional
and current as of the date of the report.
Mention of trade names or commercial
products in this publication does not
constitute endorsement or recommen-
dation for use by the Environmental
Protection Agency.
OPP acknowledges the assistance of
the Graphics and Photographic
Services of EPA, especially that of
Virginia Pulley.
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Foreword
I oday the U.S. Environmental
Protection Agency's Office of Pesticide
Programs is making tougher, more
consistently reliable and comprehensive
pesticide decisions than ever before in the
thirty years of Federal pesticide
regulation. Our progress has resulted
largely from internal administrative and
organizational improvements designed to
improve the coordination and
management of pesticide activities.
Since the enactment of the 1978
amended FIFRA, the Office of Pesticide
Programs has streamlined and further
strengthened the review and registration
processes of pesticide chemicals. Two of
the more important changes have involved
registration standards and the conditional
registration processes, both of which were
initiated and tested in Fiscal Year (FY)
1979.
The registration standards process,
which was formerly in the procedure
development mode, is now about to enter
the production mode. Under this new
approach to registration, the Agency will
issue a comprehensive regulatory position
for all products containing the same active
ingredient. This means that the Agency
will replace the traditional product-by-
product review with a chemical-by-
chemical review.
Because full data under today's require-
ments are not available for many
chemicals entering the review process
now and noting that all currently
registered chemicals will take a decade or
more to review, the Agency has
implemented an interim process of
conditional registration authorized by
recent Congressional amendments. Under
this system, the Office of Pesticide
Programs (OPP) is able to process
applications of new products which are
identical or similar to previously registered
products, thereby permitting new products
to enter the market on an equal footing.
Conditional registration may also be
granted for new uses of old chemicals and
for new chemicals if it is in the public
interest.
In addition to implementing these two
major initiatives, OPP has taken steps to
strengthen its existing programs. After
examining the processes and
management systems in OPP, the Office
has installed several formalized planning,
management and information systems to
coordinate the broad range of pesticide
activities. Not only will these systems
support OPP managers and decision-
makers, but they will also provide outside
individuals and groups with more accurate
and timely information concerning the
activities of this organization.
As you will see from reading this
annual report, the Office of Pesticide
Programs has made many significant
advances and accomplishments in Fiscal
Year 1979. These accomplishments, of
course, represent the dedicated efforts
of all the Office's employees and outside
supporters who have contributed towards
building a strong program. The continued
success of this program will largely
depend upon these talents and resources
committed to the most important mission
of safeguarding the health and the
environment and upon the continued
active interest, support and constructive
criticism of user and environmental
groups and the pesticide industry.
Edwin L Johnson
Deputy Assistant Administrator
Office of Pesticide Programs
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Executive Summary
ith conditional registration
authorized by the Federal Pesticide Act of
1978, the Office of Pesticide Programs
has dramatically increased the processing
and approval rate for new pesticide
applications in FY 1979. Receipt and
approval rates for emergency exemptions
also increased substantially (over 50%) in
FY 1979 compared to FY 1978. During
this fiscal year, the registration and
special registration programs continued to
give top priority to applications for
environmentally safe and innovative
compounds, such as new selective and
safer chemicals, biologicals, and third-
generation pesticides suited to integrated
pest management programs. In
conjunction with the newly authorized
registration changes, OPP has
implemented a more flexible approach to
minor use tolerance data review and
decision making.
Other significant gains of the fiscal year
have occurred in the Rebuttable
Presumption Against Registration (RPAR)
Program which involves an intensive
risk/benefit review of pesticide chemicals
suspected of causing unreasonable
adverse health or environmental impact.
In FY 1979, the emphasis in the RPAR
process shifted from the pre-RPAR phase
(PD 1) to the post-RPAR phase (PD 2/3
and PD 4). Because of this policy shift,
OPP completed proposed decisions for 7
RPAR chemicals, proceedings for 3 RPAR
chemicals, and resolutions for 2 RPAR
chemicals.
In FY 1979, the Agency issued its first
emergency suspension action for major
uses of two RPAR chemicals—2,4,5-T and
Silvex. After this suspension action, the
Agency reached agreements with major
registrants to voluntarily cancel Silvex
home and garden products. EPA is now
arranging for appropriate and safe disposal
of these pesticide products.
In the registration standards program,
efforts were largely concentrated on the
development and modification of
registration standards procedures and on
the data gathering and preparation phase
(Phase 1) for 15 registration standards.
During Fiscal Year 1979 a prototype
standard for metolachlor was designed to
provide industry and the public with an
example of a standard and to solicit their
comments concerning it.
OPP continued to actively participate in
regional and international programs in FY
1979, by responding to more than 10,000
external requests for pesticide related
information from the regions and by
attending international pesticide meetings.
In addition OPP formally answered 700
Congressional inquiries, 100 inquiries
from the Administrator's Office (including
White House inquiries), over 400 general
public inquiries, and 700 Freedom of
Information requests. The Agency also
analyzed 15,500 public comments on the
registration guidelines.
Recognizing the need for improved
planning, management, and control of its
diverse activities, OPP initiated the
development of the first large-scale Time
Accounting Information System (TAIS) in
EPA, a comprehensive Planning and
Management System (PMS), and a
registration tracking system. Both the
TAIS and the PMS were implemented in
the first half of FY 1980.
OPP has also initiated special projects
and programs, including integrated pest
management, farm and farmworker
safety, classification by regulation, label
improvement, advisory opinions, and other
regulatory restrictions to deal with
concerns about human exposure to off-
target spray residues and drift. Through
these special projects, OPP has continued
to advance the development of innovative
approaches for the regulation of
pesticides.
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Contents
Foreword 1
Executive Summary 3
Introduction
Organization 7
Functions and Goals 7
Principal Regulatory Programs
Registration 9
Special Registration 10
Tolerances 12
Enforcement 12
RPAR 13
Scientific Advisory Panel 14
Laboratory Audits 15
Registration Standards 15
Epidemiology Programs and Laboratory Support
Epldemiologic Studies Program 17
OPP Laboratory Support 17
Regional and International Programs
Pesticide Use Management 20
International Programs 20
Program and Management Support
Management and Information Systems 23
Registration Guidelines 24
External Affairs 24
Special Projects and Programs
Integrated Pest Management (IPM) 26
Classification by Regulation 26
Advisory Opinions 26
Label Improvement Program 27
Farm and Farmworker Safety Program 28
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Introduction
OPP FY 1979 Organizational Chart
Office of Pesticide
Programs
Deputy Assistant
Administrator
Mr. Edwin L. Johnson
Associate Deputy
Assistant
Administrator
Mr. James M. Conlon
Program Support
Division
Mr. Louis P. True
• Program Develop-
ment and
Evaluation Branch
Mr. Richard Longmire
• Administration &
Personnel Services
Branch
Mr. Karson Kosowski
• Information
Services Branch
Mr. William Grosse
• Systems Support
Branch
Mr. Elgin Fry
Special Pesticide
Review Division
Ms. Marcia Williams
• Regulatory Analysis
and Lab Audits Branch
Ms. Jan Auerbach
• Chemical Review
Branch No. 1
Mr. Homer Hall
• Chemical Review
Branch No. 2
Mr. Frank Parsons
• Chemical Review
Branch No. 3
Mr. Robert Brown
• Chemical Review
Branch No. 4
Dr. Geri Werdig
• Chemical Review
Branch No. 5
Mr. Kevin Keaney
Registration Division
Mr. Douglas Campt
• Insecticide/
Rodenticide Branch
Mr. Herbert Harrison
• Fungicide/
Herbicide Branch
Mr. James Akerman
• Disinfectants
Branch
Dr. Reto Engler
• Process Coordina-
tion Branch
Ms. Ferial Bishop
Benefits & Field
Studies Division
Mr. James Touhey
• Chemical and
Biological Investiga-
tion Branch
Mr. Warren Bontoyan
• Economic Analysis
Branch
Dr. Arnold Aspelin
• Plant Sciences
Branch
Mr. Donald Marlow
• Animal Sciences
Branch
Dr. William Phillips
Hazard Evaluation
Division
Dr. Peter McGrath
• Toxicology Branch
Dr. Adrian Gross
• Environmental
Fate Branch
Dr. Gunther Zweig
• Ecological Effects
Branch
Mr. Clayton Bushong
• Residue Chemistry
Branch
Dr. Richard Schmitt (Acting)
• Health Effects
Branch
Dr. Dale Parrish (Acting)
•Operations Division
Mr. Phil Gray (Acting)
•In Fiscal Year 1980 the Operations Division was renamed the Regional Support Branch and transferred to the Program Support Division.
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Organization
The Office of Pesticide Programs
(OPP) consists of the immediate
Office of the Deputy Assistant
Administrator, three staff units (External
Affairs Staff, Executive Support to the
Scientific Advisory Panel, and Special
Projects Staff), and the following six
divisions: (1) Registration Division, (2)
Special Pesticide Review Division, (3)
Hazard Evaluation Division, (4) Benefits &
Field Studies Division, (5) Program
Support Division, and (6) Operations
Division. To perform pesticide related
functions in the field, the Office also
maintains a staff complement of scientists
at EPA laboratories in Beltsville, Maryland
and in Corvallis, Oregon.
Because of the complexity of pesticide
decision making, OPP has designed a
management system which divides
activities among regulatory teams (those
processing registration or reregistration
actions) and those teams providing
scientific and technical support which are
critical elements in making the regulatory
decisions. The Registration Division and
.the Special Pesticide Review Division, as
lead divisions, coordinate the complete
review and evaluation processes for
pesticide chemicals, while the Hazard
Evaluation Division, the Benefits and Field
Studies Division, and the Program Support
Division provide technical and scientific
suport to the two lead divisions. This
system requires a great deal of interaction
and cooperation among the lead and
support divisions; all are interdependent
and share the program's objectives
equally.
As one of the lead divisions in OPP, the
Registration Division focuses on the
registration of pesticides and the
establishment of tolerance levels for
pesticide residues on food and feed crops.
The second lead division, the Special
Pesticide Review Division, focuses on the
review of pesticide chemicals which
exceed specific risk criteria and on
developing standards for active
ingredients for registration and
reregistration of pesticide products. Both
processes involve an intensive and open
risk and benefit review and may result in
continued registration, suspension,
cancellation, or restrictions on uses of
pesticides containing the chemical under
review.
Both of the lead divisions use a project
mode'of operation to coordinate and
expedite the review of pesticide
chemicals. In support of these lead
divisions, the Hazard Evaluation Division
supplies the scientific and technical
expertise for review of the risk data, while
the Benefits and Field Studies Division
supplies the technical and economic
expertise for review of the benefit data
associated with the use(s) of a particular
pesticide. The Program Support Division
supports all the divisions in OPP by
providing technical information, literature
and computer services, personnel and
administrative assistance, as well as
overall program, policy, planning,
evaluation and budget guidance.
(Appendix 1 lists the 1979 Appropriation
for OPP).
Function
and Goals
The EPA Pesticides Program has been
established to regulate pesticides under
the authority of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and Cosmetic
Act (FFDCA). The FIFRA, as amended,
requires that EPA regulate pesticide
compounds to ensure that they do not
cause "any unreasonable risk to man or
the environment, taking into account the
economic, social, and environmental cost
and benefits of the use of any pesticide."
Under the FFDCA, EPA is required to
establish tolerance levels for pesticide
residues on food and animal feed crops.
All pesticides marketed in the United
States must be registered by the EPA
prior to their sale or use. Pesticide
producers are obligated to supply basic
health and safety data on their products
on a continuing basis as needed to
support registrations. After the registrant
submits safety data and in some cases
efficacy data, the Office of Pesticide
Programs analyzes the data and
recommends that the Agency either
register a particular pesticide for general
or restricted use or deny registration.
The amended FIFRA allows the Agency
to grant specific exemptions from
registration requirements for emergency
pest control, to issue experimental use
permit programs for generating data to
support registration, and to supervise
State registration for special local needs.
Under the legislation, the Agency has
been mandated to review the registrability
of all pesticide products on the market
against more stringent and current
scientific standards. Whenever data
indicate that a pesticide chemical meets
or exceeds certain measures of potential
risk, EPA undertakes detailed risk/benefit
decision-making through a process called
"Rebuttable Presumption Against
Registration" (RPAR). This process may
result in continued registration,
suspension and/or cancellation and
removal from the market, and use
restrictions. The other program for review
of currently registered pesticides is the
development of registration standards.
Instead of examining each pesticide
product on an individual basis, OPP, under
the registration standard system, is
evaluating each active ingredient chemical
common to numerous products.
The basic goals of the pesticides
program are to (1) protect the public
health and the environment from potential
unreasonable adverse effects from
pesticide exposure, (2) contribute to
environmental protection by facilitating
the entry of new and environmentally safe
pesticide products into the market, and (3)
contribute to agricultural productivity by
permitting the use of a range of effective
pest management methods and
chemicals.
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Principal
Regulatory
Programs
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Registration
Registration or pre-market clearance of
pesticides involves a comprehensive
review of human and environmental risks
and a limited review of benefits data
submitted by industry. Risk is often
quantified in terms of the number of or
probability of certain health and
environmental effects, while benefits are
usually expressed in dollar valuations of
such effects as increased crop yields,
lower food costs, reduced chance of
disease or the cost savings with respect to
the use of alternative control measures.
Data requirements for applicants seeking
registration of pesticide products are
outlined in the registration guidelines.
The Federal Pesticide Act of 1978,
which amended FIFRA, authorized EPA to
grant conditional registrations. Conditional
registration is a necessary transition
between old and new data requirements—
it places registrants of similar products on
an equal footing as far as data
requirements are concerned. Before
conditional registration was authorized,
OPP routinely rejected new appli-
cations of products similar to those
already on the market because the new
data requirements had not been satisfied.
Congress believed this put manufacturers
of products already on the market at an
unfair competitive advantage and
authorized EPA to grant registrations to
new producers, primarily on the
"condition" that missing data would be
provided by all registrants of like products
at some future time to be specified by
EPA.
Under this program, EPA is able to
process applications of new products
which are similar to ones already
registered and new uses of old chemicals
if sufficient information is available to
evaluate the unique hazards posed by the
new uses. New chemicals are also eligible
Microscopic Examination of Pathology Slide
Submitted by Industry in Support of
Registration
for conditional registration if EPA
determines that the public interest would
be served by registration, and if
unreasonable risks will not be incurred
during the period required to complete
and submit additional studies.
Central to the conditional registration
program is "incremental risk
assessment." The amended FIFRA
requires the Agency to focus its attention
only on the increased risks or incremental
risks resulting from the registration of old
pesticides and new uses of old pesticides.
Specifically, conditional registration of
both identical and substantially similar
products and uses and new uses is
authorized only if the new use or product
will not significantly increase the risk of
unreasonable adverse effects on the
environment.
Litigation challenging the
constitutionality of trade secret and use of
data provisions of the new amendments
and the Agency's authority to consider all
data for conditional registrations has been
initiated by 17 pesticide manufacturers.
Unless these lawsuits are resolved in
favor of the amendments and EPA's
implementation, they could have the
effect of halting the conditional
registration program and the registration
standards development program.
In FY 1979 the registration program
continued to give top priority to
environmentally safe and innovative
compounds and technologies, such as
biorational compounds and other
alternative means of pest management,
and to substitute for cancelled or suspect
chemicals. Out of the 59 new chemical
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registration requests received in FY 1979,
23, or approximately 40% were approved.
This represents a 100% increase over FY
1978 in the rate of approval of new
chemicals received. During FY 1979, OPP
experienced a two and a half-fold increase
in the number of new chemicals received
compared to FY 1978. In response to this
increase, the registration program not
only maintained an equivalent processing
rate1 but increased the quantity of new
chemicals processed by 100% and the
number of amendments by 30%. (See
Table 1).
Special
Registration
OPP Meeting with Industry Representatives to Discuss the Registration of a Specific Pesticide
Table
Registration Program2
New Active Ingredients
Received Processed Approved Disapproved
593 42 23 19
Previously Registered Active Ingredients
Amended Registrations
Supplemental Registrations
1772
8835
17,836
867
6475
16,503
378
5349
16,073
489
1126
430
The processing rate indicates the percentage of units received which are processed In FY 1979 59 new
chemicals were received and 42 were processed, while in FY 1978 24 new chemicals were received and 21
were processed The rates of processing for these two years (42 '59 versus 21 24) did not change significantly
This indicates that the same percentage of demand was satisfied and the amount of output doubled, using the
same level of resources
!For a more detailed breakdown, see Appendix 2
lumber includes total work units, including resubmissions
The Special Registration Program was
established to respond promptly and
effectively to unexpected and temporary
health and agricultural exigencies and to
support state and local governments in
registering pesticides for local or state
use. Under the Special Registration
Program, OPP issues emergency
exemptions under Section 18 of the
FIFRA, Experimental Use Permits under
Section 5, and temporary tolerances to
establish safe levels of pesticide residues
in food and feed from pesticide use for
experimental purposes.* Minor use
registrations or minor use/specialty crop
petitions for tolerance submitted by public
interest user-oriented groups, such as the
Inter-Regional Project No. 4 (IR-4) based
at Rutgers University, are a high priority.
Under the Special Registration Program,
OPP also monitors Section 24(c)
registrations by states.
Experimental Use Permits (EUP's) allow
registrants to perform large-scale
experimentation needed for the
development of data for new pesticides or
new uses of currently registered
pesticides. In cases where crops will not
be destroyed after the experimental
program is ended, a temporary tolerance
for a safe residue level on the food or feed
commodity must be established by the
Agency before the EUP is issued. The
Office of Pesticide Programs issues EUP's
and establishes temporary tolerances
based upon a case-by-case scientific
determination of the human and
environmental risks and benefits
associated with the use of a particular
pesticide.
Under the Special Registration Program,
emergency exemptions may be granted to
State or Federal agencies, authorizing
pesticides to be used for purposes not
included on registered labeling.
Emergency situations which are deemed
to justify granting of an emergency
exemption must meet the following
requirements: (1) A pest outbreak has or
is about to occur and no pesticide
registered for the particular use, or
alternative method of control, is available
to eradicate or control the pest, (2)
significant economic or health problems
will occur without the use of the
pesticide, and (3) the time available from
discovery or prediction of the pest
'Temporary tolerances submitted in support of EUP's
allow for continuing pesticide research on agricultural
crops used for feed or food.
1
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Table 2
Special Registration Program
Emergency Exemptions
Experimental Use Permits
Temporary Tolerances
State Registrations
Received Processed Approved Disapproved
282 *285 201 36
120 *176 143 33
36 32 27 5
1,086 1,080 1,069 17
•These numbers include carryover from FY 1978
See Appendix 3 for a detailed breakdown
outbreak is insufficient for a pesticide to
be registered for the particular use. In
determining whether an emergency
condition exists, OPP scientists and
product managers carefully evaluate the
benefits as well as the human and
environmental risks associated with the
use of such pesticides.
Because of the extremely broad
authority provided under Section 18 of
FIFRA regarding emergencies, these
exemptions may include use of pesticides
on crops for which no tolerances have
been established (approximately 95% fall
into this category) and, in some cases,
pesticides which have been cancelled for
the proposed use. Granting of emergency
exemptions results in reduced annual crop
losses amounting to millions of dollars
each year. The exemptions have spared
growers catastrophic economic losses and
have prevented the loss of millions of
pounds of valuable food commodities.
Emergency exemptions also have been
granted for various public health
emergencies, such as rabies and plague,
quarantine situations, such as witchweed
and citrus black fly, and for protection of
endangered species.
The Special Registration Program also
includes approval or disapproval of state
registrations of pesticides that are
distributed and used only within a
particular registering state. In conjunction
with the state registration overview
authority, OPP monitors the issuance of
experimental use permits that are needed
to support subsequent state registrations.
During Fiscal Year 1979, the Special
Registration Program received 282
emergency exemption requests, 120 EUP
applications, and 1086 Section 24(c) state
registrations. This represents a substantial
increase of approximately 50% in the
receipt and approval rates of emergency
exemptions compared to FY 1978. The
approval rate for the total special
registration requests averaged 90%. Table
2 summarizes the outputs for this
program.
Information Retrieval System for Registration Documents
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Tolerances
Under the Federal Food, Drug, and
Cosmetic Act (FFDCA), as amended, the
Agency is required to establish tolerance
levels and exemptions from the
requirements for a tolerance. These
tolerance levels protect the public health
while giving appropriate consideration to
the production of an adequate,
wholesome, and economic food supply.
Determination of tolerances involves
careful review and evaluation of residue
chemistry and toxicology safety data to
ensure that maximum residue levels likely
to be found in food or feed are acceptable
for human consumption. Included in this
consideration is the cumulative effect of
the respective pesticide and related
substances with the same physiological
activity.
In FY 1978, OPP initiated a review of
the tolerance setting system by the
Science Advisory Board (SAB) of EPA.
The Science Advisory Board's Study
Group on Pesticide Tolerances released a
preliminary draft or working paper which
has been reviewed by OPP and revised
during FY 1979. The SAB will release
their final report recommending changes
in EPA's tolerance setting system in FY
1980.
In conjunction with conditional
registration and other newly authorized
registration program changes, OPP is
implementing a more flexible approach to
minor use tolerance data review and
decision making. "Minor uses" are those
Table 3
uses that are so small that the pesticide
companies would spend more money in
developing registration data and would
incur more prospective liability claims
than are warranted by sales for that use.
However, these uses are of substantial
economic significance to many growers.
Thus, EPA and USDA through the IR-4
program have attempted to facilitate
minor use tolerances and registrations.
During Fiscal Year 1979, OPP processed
247 tolerance petitions, 110 tolerance
amendments, and 9 inert ingredient
requests. Out of the total tolerance
petitions processed, 30% of the total or 88
tolerance levels were established for
pesticide residues on food and feed crops.
(See Table 3)
Enforcement
Scientist Reviewing Registration Data
Tolerance Decision Unit
Received Processed Established Disapproved
E Petitions (Government-Initiated 50
Requests)
F Petitions (Raw Agricultural Commodities) 58
H Petitions (Processed Foods) 44
Amendments to Petitions 121
Inert Ingredient Requests 16
61
133
53
110
9
22
53
13
—
5
39
80
40
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•i
The pesticides enforcement program is
designed to insure user compliance with
label directions and industry compliance
with registrations, classification, and
labeling requirements. Consistent with the
1978 amendments to FIFRA, most States
have primary responsibility for enforcing
the misuse provisions of FIFRA. During
Fiscal Year 1979, the program has
enhanced State involvement through
Federal/State cooperative enforcement
grants. Although most of these functions
are located within the Enforcement Office
of the Environmental Protection Agency,
OPP maintains a small cadre of technical
personnel who review enforcement
pesticide referral cases. Table 4 illustrates
the number of enforcement activities
funded by OPP for Fiscal Year 1979.
Table 4
Activity
Establishment
Inspections
Use/Reentry & Exp.
Use Observations
Market Place
Investigations
Import Investigations
Enforcement Case
Reviews
Number of Cases
3910
7588
9635
215
801 Completed
81 6 Received
Enforcement Invei
12
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Rebuttable
Presumption
Against
Registration
(RPAR)
The RPAR process is an intensive risk/
benefit review of pesticide chemicals
suspected of causing unreasonable
adverse health or environmental impact.
OPP employees, with the support of other
EPA offices and Federal agencies, develop
recommendations for a regulatory position
with regard to the registration,
suspension, cancellation, or restriction on
uses of pesticides containing the chemical
under review.
The RPAR process begins when a
suspected pesticide chemical is identified
as posing a potential significant risk and
is referred to the Special Pesticide Review
Division for consideration. Before this
chemical is accepted as an RPAR
candidate, data supporting the statement
of risk must be scientifically validated. If
accepted as an RPAR candidate, a project
team is named and a comprehensive
literature search is initiated for the pre-
RPAR chemical. The first part of the RPAR
process focuses on the development of a
risk assessment, followed by a publication
of the Agency's position on the pesticide
chemical in the Federal Register. During
the comment period, the public,
manufacturers, and users are given an
opportunity to offer evidence in rebuttal or
in support of the presumption against
registration.
If the comments do not rebut the risk
presumption, the project team develops a
risk/benefit analysis for each significant
use of the RPAR chemical and for each of
several regulatory actions which may be
taken by the Agency. Representing the
proposed Agency decision, the second
Position Document (PD 2/3) is published
in the Federal Register followed by a
second public comment period. The
tentative Agency decision and supporting
data are reviewed by USDA and the EPA
Scientific Advisory Panel (SAP). Their
recommendations and appropriate public
comments are incorporated into the final
regulatory document and forwarded to the
Assistant Administrator for the Office of
Pesticides and Toxic Substances for
approval. After this comprehensive review
and sign-off process is completed, EPA
publishes the final decision in the Federal
Register. The Agency may decide to
register or reregister or restrict all or
some of the uses of the pesticide.
In FY 1979, OPP initiated proceedings
for three RPAR chemicals and completed
proposed decisions (PD 2/3) for seven
RPAR chemicals and final resolutions or
decisions (PD 4) for two RPAR chemicals.
Because the emphasis in FY 1979 shifted
from the pre-RPAR phase to the post-
RPAR phase, the number of proposed
decisions and proceedings increased
dramatically in comparison to FY 1978.
Some of the more important RPAR
decisions included the following
chemicals:
• Chlorobenzilate. In February 1979,
EPA announced the intent to cancel all
non-citrus uses of the miticide
Chlorobenzilate. The cancelled sites
included primarily cotton, fruits, nuts,
RPAR Project Team Meeting
13
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melons, and turf grass, while non-
cancelled uses included citrus crops in
Florida, California, Texas, and Arizona. All
cancelled uses of chlorobenzilate have
registered available alternative chemical
controls that will keep mite control at
current levels. The Agency's decision is
currently in appellate proceedings.
• Endrin. In July 1979, EPA announced
the intent to cancel registrations for all
uses of the insecticide endrin west of
U.S. Route #35. Because endrin exhibited
acute wildlife toxicity, labeling was
amended to include warning statements
and uses were restricted in areas where
run-off and water contamination would be
a problem. This decision was not appealed
and is final.
• DBCP. Based upon carcinogenicity and
reproductive effects in animals and man,
several notices of intent and orders of
cancellation and suspension have been
issued concerning the nematocide, DBCP.
These notices and orders culminated in
Fiscal Year 1978 and continued into FY
1979 when EPA suspended all uses of
DBCP except for pineapples in Hawaii.
The notice of intent to cancel DBCP was
reached in the early part of FY 80,
followed by several requests for hearings.
Cancellation hearings are expected to
begin in the middle of FY 80 and continue
into FY 81. After the completion of these
hearings, the Administrator will issue a
final decision for the cancellation and/or
registration of specific uses for DBCP.
• Trifluralin. Two years ago, EPA was
petitioned to suspend the registration of a
herbicide trifluralin after findings
indicated nitrosamine contamination in
the product. Informal hearings were held,
and the suspension petition was denied. A
comprehensive risk/benefit analysis for
trifluralin indicated that the negative
impact or loss of $300 million/yr to
agricultural producers exceeded the low
long-term risks. In FY 1979 the Agency
issued a proposed decision which would
allow continued registration if the
registrant amended the product's
composition to include less than 1 ppm
nitrosamine contamination.
• Dimilin. After an RPAR was issued
because of potential oncogenicity, dimilin,
an insect growth regulator, was subjected
to a rigorous risk/benefit analysis. The
results of this analysis showed that the
overall risks posed by the use of dimilin
were less than the risks for existing
alternative chemicals. Furthermore,
dimilin has been a favorble control in
Integrated Pest Management Programs. In
April 1979, the Agency issued a
conditional registration for the use of
dimilin on cotton only. During this five-
year period of conditional registration, the
registrants will be repeating a battery of
chronic toxicity tests in animals and
wildlife.
• Pronamide. After an extensive risk/
benefit analysis, the Agency
recommended the continued registration
of the herbicide pronamide. In the final
decision published in FY 1979, EPA
required the registrants to amend the
product labeling and to repackage the
product in water-soluble bags. This
innovative measure will protect the
highest exposed group—the applicators—
from dermal contact with the herbicide
product.
• BAAM (Amitraz). Because of potential
oncogenic effects in mice, the first of the
unregistered pesticides, BAAM, was
referred to the RPAR program in 1977. In
Fiscal Year 1979, EPA published a
preliminary notice of determination and a
final notice which granted conditional
registration for BAAM and set a tolerance
of 3 ppm on pears. BAAM was found to
be the only pesticide effective against the
fungus, Psylla, on pears. Registration of
BAAM for apples, however, was not
granted because of the availability of safer
effective, registered alternative chemicals.
• 2,4,5-T and Silvex. For the first time in
Agency history, on February 28, 1979, the
Administrator issued an emergency order
to suspend registrations for major uses of
two toxic chemicals. The chemicals involved
were 2,4,5-T and Silvex. This action was
based upon evidence indicating a possible
correlation between human miscarriages
and the uses of these products as well as
extensive animal data showing adverse
reproductive effects, particularly with a
dioxin contaminant of the products, TCDD,
and positive oncogenicity results. After
this suspension action, the Agency
reached agreements with major
registrants to voluntarily cancel Silvex
home and garden products. The Agency is
currently arranging for their safe disposal.
The major manufacturer for 2,4,5-T is
appealing the cancellation in ongoing
hearings before an Administrative Law
Judge.
FIFRA Scientific Advisory Panel
The Scientific Advisory Panel (SAP) was
created by Section 25(d) of FIFRA, added in
Scientific Advisiory Panel Meeting
' -
-------
1975. The SAP consists of seven expert
scientists representing various fields and
recommended by the National Institutes of
Health and the National Science
Foundation. (See Appendix 4 for a list of
SAP members, disciplines and affiliations)
The SAP members comment and advise
OPP on the scientific validity of the data
base used for regulatory decisions
proposed in notices of intent issued under
Section 6(b) (cancellations and changes in
classification) and Section 25(a) (proposed
and final regulations). The Agency also
refers RPAR actions to the Panel for
review, as well as special scientific issues
as the need arises.
During 1979 the Panel held a total of
twelve meetings where they discussed
and made recommendations concerning
the following pesticide regulatory
initiatives:
• Interim—Final Regulations for
Conditional Registration of Pesticides.
• Section 24(c) Proposed Regulations—
State Registrations.
• Final Rulemaking for Classification of
Pesticides—Group I.
• Proposed Rulemaking for Classification
of Pesticides—Group II.
• Proposed Guidelines for Registering
Pesticides, Subparts F, G, I, and J.
• Proposed Regulatory Actions for
Amitraz (BAAM), Endrin, Benomyl,
Treflan, Dimilin, Pronamide, DBCP, 2,4,5-
T, and Silvex.
The Panel also assisted in the voluntary
cancellation of a potent rodenticide
(Vacor) which posed an acute poisoning
threat to the public.
Laboratory Audit Program
The Office of Pesticide Programs
established a Laboratory Audit Program
because of evidence that there were
defects in basic industry submitted studies
used to support pesticide registrations.
The reliability of the data base is critical to
all the basic regulatory programs in OPP,
including removal or restriction of
hazardous pesticides and development of
registration standards.
In cooperation with the Food and Drug
Administration and EPA's Office of
Enforcement, OPP personnel have been
managing systematic audits of
independent testing laboratories which
generate toxicology data in support of the
registration of pesticides. After conducting
laboratory audits, OPP audit personnel
recommend appropriate regulatory and/or
judicial action.
During Fiscal Year 1979, OPP personnel
conducted 33 on-site data audits and 190
reviews of registrant validations of
possibly faulty lab data. The lab audit
process identified several new suspect
chemicals and four labs which had
significant problems.
An early laboratory audit identified
significant problems with data generated
from Industrial Biotest Laboratory (IBT), a
large independent laboratory which has
generated data in support of registration
of over 100 pesticide chemicals. In FY
1979, EPA launched an intensive
investigation of all pivotal registration
data generated by IBT. Registrants were
required to submit validated and raw data
on over 600 studies. Receipt and review
of validated reports and raw data has
continued through FY 1979. The IBT
review program is being conducted jointly
with the Government of Canada.
Registration
(Generic)
Standards
The Registration Standards System, a
new approach to registration and re-
registration sanctioned by the 1978
amendments, will streamline these
processes. Instead of reviewing for
reregistration each of the 41,000
currently registered products on a case-
by-case basis, the Agency is developing
comprehensive registration standards for
each active ingredient common to
numerous pesticide products. Out of the
41,000 registered pesticide products, EPA
will be concentrating its effort on the
review of approximately 500 chemicals
(active ingredients) representing the major
pesticide chemicals produced. Overall, the
registration standards system has been
designed to create an open and well-
documented decision-making process
resulting in effective, efficient, and fair
regulation of pesticides.
For every pesticide chemical and its
formulations, safety criteria will be set, to
which registrants must adhere, in order to
register and reregister products. An
intensive risk/benefit review will be
conducted only for those chemicals which
meet the "unreasonable adverse effects"
criteria; all others will be based on a more
qualitative risk/benefit judgment. In
addition, standards for registration will
state acceptable levels of exposure for
food consumers, field workers,
applicators, and other persons and
organisms unintentionally exposed to
pesticides.
In Fiscal Year 1979, efforts were largely
concentrated on the development and
modification of procedures for the
registration standards process.
Uncertainties caused by litigation
challenging the constitutionality of basic
FIFRA data use and disclosure provisions
as well as the sheer magnitude,
complexity, and unfamiliarity of this
process have delayed progress in the
development and publication of standards.
However, the Agency is beginning to
review systematically the data base upon
which registration of current pesticides is
based. During Fiscal Year 1979, OPP
completed the data gathering and
preparation phase for 15 Registration
Standards.
In Fiscal Year 1979, OPP also developed
a prototype standard for the chemical
metolachlor which was designed to give
industry and the public an example of a
standard and to solicit their comments
concerning the standard. It should be
noted that this prototype standard is not
the Agency's final regulatory position on
metolachlor but rather a model that will
enable OPP to improve future standard
developments.
Other major accomplishments included
the completion of an Advanced Notice of
Proposed Rulemaking (ANPRM),
announcing the Agency's plans for
approaching registration standards
development as well as a number of
miscellaneous changes to the existing
registration regulations. The ANPRM
addresses the organization, preparation,
content, and maintenance of a standard
as well as the issue of its legal status and
the order of development of standards.
15
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Epidemiology
Programs and
Laboratory
Support
-------
Epidemiologic
Studies
Programs (ESP)
The Epidemiologic Studies Program
(ESP) determines on a national basis
the magnitude and the effect of human
exposure to pesticides by monitoring
residues and metabolites of pesticides in
the general population and/or in specific
populations. The Epidemologic Studies
Program is carried out by consultant
specialists in the fields of veterinary
medicine, toxicology, oncology, pathology,
and related scientific disciplines directed
from three Centers of Excellence. The
projects directed by the Centers are
located in twelve states and include eight
universities and four state health
departments, the ESP also provides
consulting services for RPAR data
validation, analytical methods
development, farmworker reentry studies,
and retrospective health effects studies.
Another part of the Epidemiologic
Studies Program includes the Pesticide
Incident Monitoring System (PIMS). The
PIMS is an information and reporting
system designed to provide accurate
information on the number of pesticide
incidents occurring nationally, the PIMS
data provide information on causal
relationships suitable for RPAR and
Registration actions and for trend
analysis. The PIMS also functions as an
early warning system for the pesticide
reregistration process.
In Fiscal Year 1979, 13,622 pesticide
incident reports were submitted to the
PIMS, of which 4,926 were submitted by
the Epidemiologic Studies Program
Projects itself. The Pesticide Incident
Response Office managed OPP's response
to approximately 1 50 reported pesticide
incidents..The National Pesticide
Telecommunications Network staff, using
a toll-free number, answered 2,384
requests from physicians and health
personnel.
Working through the Centers of
Excellence, OPP's Epidemiologic Studies
Program planned and coordinated several
major health effect projects, including
DBCP and EDP field studies, dimilin
experimental use permit study,
nitrosamine decomposition study,
household pesticide usage and poisoning
survey, 2,4,5-T study, and exposure of
golf course applicators to cadmium.
OPP Laboratory
Support
A Chemical and Biological Investigations
Laboratory is operated at Beltsville,
Maryland to conduct special pesticide
investigations and to provide technical
assistance in support of pesticide
regulatory programs. The laboratory
provides chemical, ecological, and
biological data in support of the RPAR and
registration processes and develops and
applies analytical methods for detecting
pesticides. Even though the burden of
proof is on industry to demonstrate the
safety of pesticides, the Beltsville
Laboratory performs an important function
in designing scientific methods when
none exist, in providing technical
assistance to the States, and in
responding to emergency situations. The
Laboratory also provides a quality control
check by validating and verifying certain
scientific methods used by industry in the
generation of safety data.
Presently, the laboratory at Beltsville is
divided into seven units: 1) Toxicology
Unit, 2) Microbiology Unit, 3} Terrestrial
and Aquatic Biology Unit, 4) Biology
Resource Unit, 5) Chemical Residue
Support Unit, 6) Petition Methods
Validation Unit, and 7) Special Projects
Unit.
Using mammalian systems, such as the
rat and the rabbit, the Toxicology Unit in
FY 1979 conducted numerous studies to
determine the relative toxicity of over 40
pesticides. These studies included eye and
skin irritation studies, acute oral toxicity
and acute dietary studies.
In Fiscal Year 1979, the Microbiology
Unit examined the effectiveness of over
150 health-related pesticide products
such as water filtration products,
disinfectants used as sterilizers,
tuberculocidal, sporocidal, and virocidal
Quamitarion of the Number of Microbial Mutations Produced by the Ames Test
17
-------
products. These examinations required
approximately 2,000 individual tests. In
addition, this unit worked on several
special efficacy projects and established
12 short-term cytogenetic methods for
analyzing the mutagenicity of chemicals in
microbial systems and in mammalian cell
culture systems.
In Fiscal Year 1979, the Terrestrial and
Aquatic Biology Unit developed seven
laboratory testing methods and validated
and reviewed several other bioassays for
measuring acute toxicity and
bioaccumulation of pesticides in estuarine
and terrestrial organisms. They conducted
and completed approximately 240 trout,
bluegill, and daphnia LC50 and EC50
studies, 12 daphnia life cycle tests on 52
pesticide chemicals, and more than 200
rodenticide bioassays.
Using controlled greenhouse and field
experiments the Biology Resource Unit
developed eight plant-testing methods
(bioassays) and conducted 16 special
projects in FY 1979. Some of the more
significant projects have included a five-
year rotational crop study of carbofuran
and its metabolites, a phytotoxicity study
of picloram and 2,4-D in potatoes, and a
study of the movement of encapsulated
pesticide products through bee colonies.
The three Chemistry Units at the
Laboratory provide a wide range of sup-
port to all the other Beltsville Units as well
as to the Epidemiology Studies Program.
Using the most sophisticated instrumentation
available, these units identify and
measure pesticides and their metabolites
in plant, animal, air, and soil samples. In
addition they develop and assess
analytical methods and procedures used
in support of regulatory actions.
During Fiscal Year 1979, the Chemistry
Section developed and reviewed six
testing methods, completed the second
edition of the EPA Manual of Chemical
Methods for Analysis of Pesticides and
Devices and reviewed the Pesticide
Formulation Section of the 1980
Association of Official Analytical Chemists
(AOAC) Manual. In response to
State/American Association of Pesticide
Control Officials (AAPCO) requests, they
distributed 539 pesticide standards and
78 analytical methods and provided
technical information for 102 requests. The
Chemistry Section also conducted several
special projects, including analyses of
dioxins, nitrosamines, creosote, penta-
chlorophenol, dibromochloropropane,
carbofuran, and aldicarb.
Another part of the Pesticide Research
Program includes the Northwest Biological
Investigations Station (NWBIS)
located on the campus of Oregon State
University at Corvallis. Originally the
NWBIS evaluated pesticides for
effectiveness and label compliance and
developed efficacy methodologies.
Because of the deemphasis of efficacy
data development and review in the
registration program, the laboratory
program will be transferred to USDA in
the near future where it can make
significant contributions to the minor use
program.
In Fiscal Year 1979, the NWBIS
evaluated 14 minor use pesticide projects
for efficacy and phytotoxicity on
ornamental crops. The NWBIS staff also
conducted special projects concerned with
methods for evaluating plant fungicides,
nematocides, and bacteriocides; methods
for evaluating pesticide hand devices, and
methods for estimating fungitoxicity and
barrier action of tree wound paint.
Chemical Analysis of Pesticides Using a Gas Chromatograph/Mass Spectrometer
Beltsville Laboratones
est Biological Investigations Station at Oregon State University
'-
-------
Regional and
International
Programs
-------
Pesticide Use
Management
The Pesticide Use Management
Program has been established to assist
states in handling special pesticides
incidents (fatal accidents, fires, etc.) and
registration needs and to certify
applicators to purchase and use restricted
use pesticides. OPP's Pesticide Use
Management Program provides technical
assistance, guidance, and policy to the
Regions, States and local governments
concerning pesticide issues and Agency
programs and decisions. This program is
conducted through 10 Regional Offices
which oversee State pesticide programs,
assist State pesticide regulatory officials
in carrying out the aforementioned
programs, and respond to public inquiries
about EPA's pesticide programs.
As part of the Public Outreach Program,
the pesticide use management staff in
Fiscal Year 1979 responded to more than
10,000 external requests for pesticide
related information, such as training
materials, certified applicator standards,
registration and use of pesticide
information. In addition they issued 52
Weekly OPP Operational Reports to the
Regions.States, and other external groups,
developed three certification and training
manuals, planned and coordinated the
second National Certification and Training
Meeting held in FY 1979 in Dallas, Texas,
and provided the Regional Offices with
detailed information concerning pesticide
regulatory actions, such as RPAR's,
classification by regulations, and advisory
opinions.
International
Programs
Pesticide Use Management Handbooks
The Office of Pesticide Programs in
EPA believes that the most effective and
appropriate means of reducing the
adverse impact of pesticides on the global
environment is through the efforts of all
countries working together. For this
reason, OPP actively participates in
several international programs which
have as their collective goal the
harmonization of chemical testing
standards and regulatory practices
relating to pesticide use.
As part of the US-USSR Agreement on
Cooperation in the Field of Environmental
Protection, the Office of Pesticide
Programs hosted a USSR delegation of
scientists in Fiscal Year 1979. Scientists
from both countries exchanged
information about beneficial insect
organisms used for control of agricultural
pests, the regulatory and administrative
measures needed for protecting
environmental quality, and the genetic
and biological effects of environmental
pollution.
OPP also participates in the Codex
Committee on Pesticide Residues (CCPR),
one of the committees in the Codex
Alimentarius Commission. This Committee
develops and reviews international
pesticide maximum residue limits (MRL's)
or tolerances. During the eleventh annual
meeting of the CCPR in the Hague,
Netherlands, OPP representatives made
tolerance recommendations for about 50
pesticide chemicals. After the meeting,
together with USDA and FDA repre-
sentatives, pesticide representatives
drafted a U.S. response to over 400 Codex
recommendations. This response included
a discussion of various issues, such as
classification of foods, sampling methods,
methods of analysis, and methods of
expressing MRL's for fat soluble
pesticides, processed foods, and animal
feeds.
In FY 1979, OPP representatives
participated with other representatives
from the U.S., Canada, and the United
Kingdom in the Tripartite Conference on
Pesticides held in Ottawa, Canada. The
purpose of the meeting was to exchange
information both on pesticides that are of
20
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current interest and on subjects of more
general nature, such as spray drift,
pesticide disposal techniques, and
exposure field studies and modeling.
OPP also participated in several
subsidiary groups of the Environment
Committee of the Organization of
Economic Development, such as the
Chemical and Toxicology Expert Groups.
During Fiscal Year 1979, OPP
representatives attended three OECD
Meetings of the Expert Groups. The Short-
Term and Long-Term Toxicology Groups
discussed and drafted guidelines for
toxicity testing. The Physical-Chemical
Group drafted guidelines for 20 physical
and chemical methods used to predict the
behavior of a chemical in the
environment, e.g., volatility and melting
point.
In cooperation with the National
Committee for Man and the Biosphere
and the U.S. Department of State, OPP
participated in the U.S. Strategy
Conference on Pesticide Management
held in Washington, D.C. on June 7 and
8, 1979. The overall objectives of the
conference were to provide policy and
program guidance to the Department of
State and to other U.S. institutions in
their search for ways to reduce the
adverse impacts of pesticides on the
global environment. With respect to the
global impacts of U.S. pesticide
regulations, Edwin L. Johnson, the Deputy
Assistant Administrator for Pesticide
Programs, described the recent changes
in U.S. pesticide legislation and the
impact that these amendments and EPA
pesticide regulatory policies have on other
countries. For a more detailed explanation
of these international programs, see
Appendix 5.
OECD Environment Committee Meeting under the Chairmanship of EPA Administrator, Doug/as M. Costle
OPP Representatives Attending OECD Meeting
21
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Program and
Management
Support
-------
Management
and Information
Systems
As the largest headquarters office in
EPA, the Pesticides Program
recognized the need for improved
planning, management, and information
systems to coordinate and better manage
the great diversity of pesticide activities.
Several formal systems were designed to
provide support for OPP managers and
decision makers, and to provide EPA
management with more accurate and
timely information concerning the
activities of the organization. During Fiscal
Year 1979, OPP initiated the following
systems:
• With the assistance of the Employee's
Advisory Committee (a committee of 12
staff personnel representing each OPP
division) and OPP managers, OPP system
analysts and programmers designed a
computer-based information system which
records the time expenditure of personnel
resources on a number of OPP activities,
outputs, and chemicals. To date, this is
the first large-scale time accounting
information system installed in EPA's
Headquarters. The Time Accounting
Information System or TAIS (which is now
fully operative) provides improved unit
cost data to support OPP's external budget
requests as well as biweekly data which
enables OPP managers to better manage
workloads and the impact of special
projects on schedules and personnel
resource allocations.
• A comprehensive Planning and
Management System (PMS), now being
implemented, was developed to improve
the quality and timeliness of outputs
within the allotted OPP budget. The PMS
provides specific formats for assigning
tasks, allocating resources for intra- and
extramural projects and processes, and
procedures for tracking, reporting, and
reviewing their progress. The uniformity
provided in the system formats is intended
to facilitate timely and continuing OPP-
wide work coordination and adjustment,
while permitting enough flexibility to
allow appropriate treatment of the full
variety of OPP work, situations, and
management styles.
• The availability of real-time information
on the status of product registration
actions is essential for the timely
assessment of program accomplishments.
During FY 1979, an on-line computer
system was under development to track
the status and priority of registration
actions and to provide necessary
workload, time accounting, and activity
reports for product managers and top
management. This Registration Tracking
System, when completed in FY 1980, will
include the capability to accumulate
aggregated descriptive statistics on
registrations processed, completed, and
pending.
OPP Computer Facilities
23
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Registration
Guidelines
Under the authority of FIFRA, the Office
of Pesticide Programs develops
proposed and final rules regarding
guidelines for data and information to be
submitted by applicants seeking
registration of their pesticide products.
These guidelines advise the applicants of
what studies and tests are needed to
provide acceptable data for registration,
the standards for reporting the data and
information, and guidance as to when
such information and data are required or
are not required, along with suggestions
as to how to obtain or develop it. (See
Appendix 8 for description of guideline
subparts).
During Fiscal Year 1979, OPP received
and analyzed over 14,000 formal public
comments and 1,500 informal comments
on subparts B, D, E, and F of the proposed
guidelines. Subparts G, H, I, and J were
completely redrafted and will be published
in 1980 as proposed guidelines, as will
worker safety (Subpart K) and Hazard to
Non-Target Insects (Subpart L). Final
guidelines are expected for Fish and
Wildlife (Subpart E), Product Chemistry
(Subpart D), and part of Human Hazard
(Subpart F) in 1980.
External Affairs
Programs
A strong and effective program in OPP
has been established to review and
respond to Congressional and public
inquiries. This program was developed to
maintain intelligence on all Congressional
pesticide-related activities and to provide
comments on legislative proposals and
pending bills. In addition to maintaining a
liaison role with other offices in EPA and
other Agencies and outside groups, this
staff arranges for public appearances for
top management and other OPP staff and
prepares speeches, testimony, and
briefing materials for such appearances.
During Fiscal Year 1979, the External
Affairs Staff received and answered over
700 Congressional inquiries, 100 inquiries
from the Administrator's Office (including
White House inquiries), and over 400
general public inquiries concerning
pesticide related matters. They
coordinated and prepared over 20 public
speeches and presentations for the
Assistant Administrator and the Deputy
Assistant Administrator.
This small staff successfully planned
and coordinated the implementation of the
1978 FIFRA amendments. In addition,
they coordinated the issuance of a policy
statement regarding minor use pesticide
registrations and tolerances and a
proposed policy statement on labeling
requirements for export products and
notification procedures.
Another part of OPP's public affairs
program includes the Freedom of
Information (FOI) Program. All pesticide
FOI requests are coordinated and
processed within the Program Support
Division, while the other OPP divisions
supply input for the requests. In Fiscal
Year 1979, the Office of Pesticide
Programs processed approximately 700
Freedom of Information requests.
Deputy Assistant Administrator for Pesticides
Program, Edwin L. Johnson, Addressing the
Data Resources Agricultural Conference
Assistant Administrator for Pesticides and Toxic Substances, Steven Jellinek, Testifying before the House Subcommittee on
Oversight and Investigation
-------
Special
Projects and
Programs
-------
Integrated Pest Classification
Management by Regulation
(IPM)
Advisory
Opinions
The Integrated Pest Management
Program in OPP has been instrumental
in the development, integration, and
utilization of effective control techniques
for managing pests, including biological
and autocidal control agents, pest-
resistant plant varieties and animal
breeds, cultural practices, and improved
pesticide application technology. Through
the use of proper IPM strategies, OPP
anticipates that the need for chemical
pesticides will be reduced and pesticides
will be used in a more judicious manner,
resulting in sound environmental
management.
In cooperation with USDA during 1979,
OPP continued to support IPM research in
the Land-Grant University system, in the
initiation of demonstration pilot projects to
promote farmer acceptance of IPM and to
incorporate its approaches into applicator
training. Working with HUD, USDI, and
USDA, OPP developed and promoted
urban IPM programs and advanced
application technologies, such as the
electrostatic application of pesticides. OPP
played an active role in planning and
participating in numerous IPM meetings,
workshops, and demonstrations where
IPM technologies were presented to
farmers, industry. State and Federal
agencies and other groups. The pesticides
program also prepared IPM educational
packages which promoted the benefits of
pest management and detailed procedures
for implementing IPM techniques and
methods.
As required by Section 3(d) of FIFRA, the
Office of Pesticide Programs must
classify pesticides for both general and
restricted use. This classification process
will occur by regulation prior to the
completion of registration standards and
will emphasize classification of
uses/formulations for restricted use (to be
used primarily by certified applicators).
During Fiscal Year 1979, OPP published
a final rule classifying approximately 500
agricultural products for restricted use
and published a proposed rule classifying
the uses of an additional 400 products for
restricted use, including many of the
widely used granular insecticides. To date
2000 pesticide products have been
classified for restricted use.
Information gathering hearings were
held in Phoenix, Arizona as a result of
complaints by Scottsdale residents that
pesticides used on agricultural lands and
in communities were causing adverse
human health and environmental effects.
Prior to these hearings the National
Enforcement Investigations Center and the
Texas Epidemiologic Studies Center had
initiated an environmental monitoring and
exposure program in the Scottsdale and
Preescott areas of Arizona. The results of
the information gathering hearings and of
the monitoring program should help the
Agency in making more effective
regulatory decisions regarding pesticide
drift.
The Agency has issued an advisory
opinion outlining a series of
recommended application practices for
applying defoliants and desiccants in
Arizona to cotton fields located next to or
near sensitive areas. Following these
recommended practices is expected to
minimize pesticide drift into non-target
areas and should not present any
substantial countervailing costs or risks.
26
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Label
Improvement
Program
The FIFRA requires that pesticides be
registered and properly labeled prior to
their shipment in commerce. The 1975
Regulations and the proposed Labeling
Guidelines prescribe various labeling
requirements relating to product identity,
hazard, and use. When the regulations
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS
,4 DOMESTC ANMALS)
DANGER
ENVWONMENTAL HAZARDS
PHYSCAL ON CMEMCAL
HAZARD*
DflECTOMS «3H USE
RE-ENTRY STATEMENT
CATEGORY OF APPUCATOR
STORAGE AND
DISPOSAL
STORAGE
XOf
Recommended Format for Pesticide Labels
were promulgated in 1975, it was
anticipated that the reregistration process
would follow quickly and would provide
the proper framework to revise and
upgrade labels in a uniform fashion. Now
that the estimates for the reregistration
process have been extended to 10-15
years, the program needs to move more
quickly in a complementary effort to
upgrade labels.
During the interim period, there are
certain critical labeling improvements
which OPP plans to address. In an
attempt to meet the requirements of
FIFRA and the 1975 Regulations, OPP has
developed an action plan describing the
problems, factors, and issues to be
considered in a label improvement
program and several options for resolving
the problems. Under the work plan
schedule, the Registration Division in
conjunction with other OPP Divisions, will
evaluate various aspects of labeling which
are considered of immediate concern and
will initiate label revisions in those areas.
Through the preparation of Pesticide
Registration (PR) Notices or individual
letters, OPP will require registrants to
upgrade their labeling in a specified
manner. As the lead division, Registration
will also be responsible for'processing the
resulting labeling applications and for
cancelling those that do not submit
applications for upgrading labeling within
the specified time frames.
The label improvement program is an
interpretive program designed to help
users better understand EPA's intent in
permitting certain registered pesticide use
patterns, and to provide better and clearer
guidance to enforcers as to legal and
illegal use. Through the LIP, the Office of
Pesticide Programs hopes to make more
explicit, information that will allow safe,
lawful use of registered pesticides.
RESTRICTED USE
PESTICIDE
FOR RETAL SALE TO AND APPUCATON ONLY BY
CERHFCO APPLICATORS OR PERSONS UNDER THEM
DMtCT SUPERVWON
PRODUCT
NAME
ACTME
TOTAL
TMSPflOOUCTOONTl
10040%
UM Of PWOALLON
KEEP OUT OF REACH OF CHILDREN
DANGER
STATEMENT Of MUCTOAL TREATMENT
r SWALLOWED:
FMHALEO =
FMEYES
SEE 8DE PANEL FOR AOOmONAL PRECAUTIONARY STATEMENTS
CROP
CROP
CROP
CROP
WARRANTY STATEMEN'
27
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Farmer and
Farmworker
Safety Program
In April 1979, migrant farmworker
groups led by the Migrant Legal Action
Program (MLAP) and the National
Association of Farmworker Organizations
(NAFO) petitioned EPA to strengthen its
voluntary pesticide incident reporting
system and to promulgate rules requiring
pesticide users to promptly report
poisoning incidents. Spearheaded by this
petition, earlier Congressional and SAP
> —
hearings and data on hospitalized
pesticide poisonings of farmers and
farmworkers, the Office of Pesticide
Programs established a Working Group to
coordinate a program to protect farmers,
farmworkers, and their families from
unnecessary and unsafe exposure to
pesticides.
The farmworker problem, which is
perceived differently by the various
interest groups, is extremely complex with
on-the-farm pesticide exposure resulting
from direct application of the pesticide,
work-related contact from residues, and
off-the-job exposure from contamination
of dwellings and other areas. While EPA
has clear authority to regulate some of
these areas, it must rely upon the
authorities and enforcement mechanisms
of the Departments of Labor, Health and
Human Services, Agriculture, and State
organizations in other areas of pesticide
exposure. (See Table 5).
*: W]
In developing a farmer and farmworker
safety action plan, OPP personnel have
worked extensively with the
aforementioned Agencies, the Office of
Enforcement and the Office of Research
and Development, EPA, the Migrant Legal
Action Program, Rural America, and the
National Association of Farmworker
Organizations. The proposed farmer and
farmworker action plan includes short
term options, such as republishing worker
standards, providing guidance to DOL on
field reentry for pre-adolescents, and
providing worker information on poisoning
symptoms as well as long-term options for
improving the understanding of the
problem.
In order to define the risks associated
with field reentry situations, the
Epidemiologic Studies Program in OPP
has initiated and completed several
farmworker safety and health effects
projects. One of these projects, the
migrant worker study, was completed in
FY 1979 and describes the exposure
levels of migrant workers to pesticides
during nine months of work and travel in
the Atlantic Coast Migrant Stream. This is
the first well-documented record of
migrant workers' exposure to the use of
pesticides and the migrant workers'
dietary and social relationships which
affect their overall susceptibility to
pesticide illnesses.
Another major epidemiology study
measuring human exposure from ultra-
low-volume aerial pesticide applications
was completed in FY 1979. Cotton
applicators, flagmen, scouts, and local
residents were monitored, as well as field
foliage residues and pesticide drift. The
report detailing this study is currently
under Agency review.
At the request of the Department of
Labor, OPP initiated an epidemiology
study in Florida to monitor the potential
exposure of pre-adolescents to pesticides
in an agricultural environment. Pesticide
residues are being monitored in air and
soil samples, in house dust, on clothing,
and in urine samples from 10-12 year-old
children who harvest the tomato crop.
Farmworker Safety Program
-------
In addition to the above studies, several
exposure studies are being conducted on
toxaphene, iso-cyanuric acid, 2,4,5-T,
carbaryl, EBDC, 2,4-D, lindane, DBCP,
EDB, and dimilin. A study to measure
occupational exposure to toxaphene was
completed in FY 1979 and is currently
under review.
Acting as the catalyst for the
farmworker safety program, OPP in
conjunction with other agencies and
offices in EPA will continue to emphasize
farm safety issues and to provide a focus
for interagency and public farmworker
activities in the 1980's. Under interagency
agreements with several agencies, EPA
will develop education, training, and
informational materials and conduct
training sessions and workshops
throughout the farmworker community.
Table 5
Farm Worker Program Coordination
Key to Abbreviations
OPTS Office of Pesticides and Toxic
Substances
OPP Office of Pesticide Programs
HED Hazard Evaluation Division
OPP OPTS
SPRD Special Pesticide Review Division
OPP OPTS
BFSD Benefits and Field Studies Division
OPP OPTS
RD Registration Division OPP OPTS
PSD Program Support Division
OPP OPTS
OE Office of Enforcement
OA Office of the Administrator
ORD Office of Research and
Development
PTSED Pesticide and Toxic Substances
Enforcement Division
OPA Office of Public Awareness
KEY TO ABBREVIATIONS
OPP Omci 0> PESTICIDE PROGRAMS
HtO HAZARD ( VALUATION DIVISION OPP OPTS
SP«EJ SPECIAL PtsnciDl Rf VIIA uivino1. UF» QPIS
BA'SU BENEFITS .••11) * l( LDSTUUlU 01 VISION OPP OPTS
HU HttlSlHAllUH OIVC.ICK. OPP OPTS
PSD PROGRAM SUPPORT Division QPP OPIS
01 Oftltt OF ENFORCEMENT
OA OFMCl 01 THI AOP.'IMSIHATOH
OGC Off ICE OF (,IM HAl COUNSEL
ORU OFFICE 01 Hi SEARCH iSO DEVELOPMENT
PI SID PfSTICIDE AND TOXIC SUBSTi'.CES ENFOflCtUENI G
OPA ofnct OF PUBLIC AWARJUESSOA
29
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Appendices
Appendix 1
Appropriation
Salaries and Expenses
Research and Development
Abatement, Control and Compliance
Total
Permanent Work-years
Full-time Equivalency
Outlays
Authorization levels
Actual 1979
(OOO)K
$32,369
7,401
30,469
$70,239
936
1,044
58,210
81,998
Appendix 2
Registration Program
New Active Ingredients
Unconditional
Conditional
New Products (Previously
Registered Active Ingredients)
Unconditional
Conditional
Amended Registrations
Unconditional (Administrative)
Conditional (Technical)
Supplemental Registrations
Received
41
18
187
1.585
5.613
3,222
17,836
Processed
33
9
245
622
4,594
1,881
16,503
Provisionally
Accepted
14
9
209
738
3,216
795
—
Approved
14*
9
166
212
3,995
1,354
16,073
Disapproved
19
0
79
410
599
527
430
•Note: Figures reflect number of products (technical, formulate). Total number of new active ingredients is 17. of which 13 are unconditional and 4 are conditional.
Appendix 3
Special Registration
Specific/Quarantine/Public Health
Crisis Exemptions
Experimental Use Permits
EUP Follow-up Reports
EUP Revised Labels
Temporary Tolerances
SLN State Registrations (§24(c))
Received
Exemptions 254
28
120
419
56
36
1,086
Processed
237
48
176
419
49
32
1,080
Approved
201
—
143
47
27
1,069
Disapproved
36
0
33
2
5
17
Withdrawn
10
0
4
0
—
30
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Appendix 4
FIFRA Scientific Advisory Panel
Member
Or. Dewayne C. Torgeson, Chairman
Dr. John E. Davies
Dr. David E. Davis
Dr. John Doull
Dr. Robert L. Metcalf
Dr. Robert A. Neal
Dr. Edward A. Smuckler
Affiliation
Program Director of Bioregulant
Chemicals, Boyce Thompson Institute
for Plant Research, Inc.
Cornell University
Chairman of the Department of
Epidemiology and Public Health
University of Miami School of
Medicine
Independent Consultant
Professor of Pharmacology and
Toxicology at the University of
Kansas Medical Center
Professor of Entomology, Biology
and Environmental Studies at
the University of Illinois
Director of the Center in Environ-
mental Toxicology at Vanderbilt
University School of Medicine
Chairman of the Department of
Pathology, School of Medicine,
University of California
Speciality
Plant Pathology
and Chemistry
Epidemiology and Public Health
Animal Ecology
Pharmacology and Toxicology
Entomology and Biochemistry
Toxicology and Biochemistry
Pathology
Appendix 5
US-USSR Environmental
Agreement
The US-USSR Agreement on
Cooperation in the Field of
Environmental Protection was
signed in Moscow on May 23,
1972 by President Nixon and
President Podgorny of the USSR.
The Agreement covers 11 problem
areas of environmental protection,
including pollution associated with
agricultural production.
As part of this agreement, a
delegation of OPP representatives
visited the USSR in 1976 to
discuss Integrated Pest
Management/crop loss determina-
tions in development of
alternatives to chemical pest
control and to explore the status of
chronic toxicological research. This
meeting was followed by a visit to
the United States by a USSR
delegation as described in the text
of the annual report.
Codex Alimentarius Commission
The Codex Alimentarius
Commission (CAC) was established
in 1962 as an international body
concerned with protecting the
health of consumers and ensuring
fair practices in food trade. The
CAC accomplishes these goals by
developing international food
standards under the joint Food
Standards Program of the
FOA/WHO. As a participating
member of the CAC, the Office of
Pesticide Programs is primarily
involved in activities of the Codex
Committee on Pesticide Residues
(CCPR). This Committee develops
and reviews international pesticide
maximum residue limits (MRL's) or
tolerances.
The procedure for the
elaboration or review of worldwide
Codex standards involves an 11 -
step process where international
governments and organizations
comment on each draft and
recommended standard for
tolerance. At step 9 in the
elaboration process, governments
are requested to accept a
recommended international
tolerance or to provide reasons for
non-acceptance. After the
Commission has determined that
the tolerance is appropriate, it will
publish the recommended
standard in the Codex
Alimentarius as a world-wide
Codex standard.
Organization for
Economic Cooperation
and Development (OECD)
The Organization for Economic
Cooperation and Development
(OECD) is the world's largest group
of industrialized market-economy
countries, comprising some 19
European nations, the U.S.A.,
Canada, Japan, Australia, and
New Zealand. The primary
objectives of the OECD are to
promote the economic growth of
member countries, to eliminate
barriers to trade, to aid developing
countries, and to use concerted
action in dealing with certain
environmental problems.
In 1970, the Council of the
OECD established the Environment
Committee to serve as a forum for
examining and discussing common
problems related to protection and
improvement of the natural and
urban environment. This
Committee also provides member
governments with policy options or
guidelines to prevent or minimize
conflicts arising from the use of
shared environmental resources.
A primary means by which the
Environment Committee ac-
complishes its mission is through
the efforts of subsidiary groups,
such as the Chemicals Group. The
Chemicals Group seeks to achieve
international cooperation in the
field of toxic substances
regulation. In September 1977, the
Chemicals Group of OECD
established several Expert Groups
which would prepare reports on
available test methods and provide
information concerning the
chemical characteristics and
effects of toxic substances. The
Office of Pesticide Programs
participates in the Physical
Chemical Expert Group, the Short-
Term Toxicology Expert Group, and
the Long-Term Toxicology Expert
Group.
31
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Appendix 6
Subparts of the Guidelines
Subpart A Introduction
Subpart B Applicability of Data Requirements and
Reader Guide
Subpart C Registration Procedures
Subpart D Chemistry Requirements
Subpart E Fish & Wildlife Requirements
Subpart F Human Hazard Requirements
Subpart G Product Development
Subpart H Label Development
Subpart I Experimental Use Permits
Subpart J Nontarget Plants
Subpart K Reentry Data Requirements
Subpart L Nontarget Insects
Subpart M Biorational Pesticides
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