United States
Environmental Protection
Office of
Pesticide Programs (TS-757)
Washington, DC 20460
April 1980
of the
Pesticide Programs
 iscal-Year 1979


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.

  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)
  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
  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

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
  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


 Foreword                                                                    1
 Executive Summary                                                           3

 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

                                              OPP FY 1979 Organizational Chart
                                                    Office of Pesticide
                                                    Deputy Assistant

                                                    Mr. Edwin L. Johnson
                                                    Associate Deputy

                                                    Mr. James M. Conlon
Program Support

Mr. Louis P. True

• Program Develop-
ment  and
Evaluation Branch
Mr. Richard Longmire

• Administration &
Personnel Services
Mr. Karson Kosowski

• Information
Services Branch
Mr. William Grosse

• Systems Support
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
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
Dr. Arnold Aspelin

• Plant Sciences
Mr. Donald Marlow

• Animal Sciences
Dr. William Phillips
Hazard Evaluation

Dr. Peter McGrath

• Toxicology Branch
Dr. Adrian Gross

• Environmental
Fate Branch
Dr. Gunther Zweig

• Ecological Effects
Mr. Clayton  Bushong
•  Residue Chemistry
Dr. Richard Schmitt (Acting)

•  Health Effects
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.

    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
  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
  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).
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


    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
  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
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
  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

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).
OPP Meeting with Industry Representatives to Discuss the Registration of a Specific Pesticide
 Registration Program2
 New Active Ingredients
Received   Processed  Approved  Disapproved
  593       42         23        19
Previously Registered Active Ingredients
Amended Registrations
Supplemental Registrations
 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
  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.

 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
Information Retrieval System for Registration Documents

    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
  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
  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)
                                        Scientist Reviewing Registration Data
Tolerance Decision Unit
Received   Processed  Established Disapproved
E Petitions (Government-Initiated 50
F Petitions (Raw Agricultural Commodities) 58
H Petitions (Processed Foods) 44
Amendments to Petitions 121
Inert Ingredient Requests 16



    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

                                          Use/Reentry & Exp.
                                            Use Observations
                                          Market Place
                                          Import Investigations
                                          Enforcement Case
                      Number of Cases




                       801 Completed
                       81 6 Received
                                                                               Enforcement Invei

    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
  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

• 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

 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

•  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
•  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

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

•  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.
    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
  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
  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
  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.

Programs and

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
  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
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
  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

 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
  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

Pesticide  Use
    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
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
  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
  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

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
  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

Program and

and  Information
    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
• 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
OPP Computer Facilities

    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
  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
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

Projects and

Integrated   Pest      Classification
Management          by  Regulation
    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
  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
    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
  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.

   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




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.

                DMtCT SUPERVWON
                         UM Of   PWOALLON
                                                        WARRANTY STATEMEN'

Farmer  and
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
  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
  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
 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
 PTSED   Pesticide and Toxic Substances
         Enforcement Division
OPA     Office of Public Awareness



SP«EJ  SPECIAL PtsnciDl Rf VIIA uivino1. UF» QPIS










Appendix 1

Salaries and Expenses
Research and Development
Abatement, Control and Compliance
Permanent Work-years
Full-time Equivalency
Authorization levels
Actual 1979
Appendix 2
Registration Program
New Active Ingredients
New Products (Previously
Registered Active Ingredients)
Amended Registrations
Unconditional (Administrative)
Conditional (Technical)
Supplemental Registrations
•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))
Exemptions 254


Appendix 4
      FIFRA Scientific Advisory Panel


      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

              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

              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

                      Plant Pathology
                      and Chemistry
                      Epidemiology and Public Health

                      Animal Ecology

                      Pharmacology and Toxicology

                      Entomology and Biochemistry

                      Toxicology and Biochemistry

Appendix 5
US-USSR Environmental
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
  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

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