office pf
pesticide
programs
STATUS REPORT
AND
ACTION GUIDE
CRAFT
ctecember 31 1976
-------
NOTE TO THE READER:
The attached document was intended for distribution for
December 1976. Late in that month, two developments occurred
which may prove to impact on program operations in ways not fore-
seen when the paper was originally prepared. First, the Senate
Subcommittee on Administrative Practice and Procedure of the
Committee on the Judiciary issued a draft report critical of the
depth of data review undertaken by the Agency prior to reregistration,
The report now before you has been rewritten since its previous draft
to reflect the Agency's commitment to the Senate committee regarding
data review. Secondly, a preliminary injunction recently issued
by a United States District Court has required the Agency to consider
basic modifications to its reregistration data requirements.
The Agency is now reviewing resources, adjusting program plans,
and preparing to go before Congress for the FIFRA reauthorization
hearings with these new developments in mind. The public will be
kept informed throughout the next few months as events unfold
through prepared statements, reports, and Federal Register notices.
Since a new Administrator will soon assume leadership of the
Agency, this document may be a logical starting point to discussion
of the operation of Pesticide Programs in the future. We would,
therefore, welcome your comments and suggestions.
Although this is a draft document and the new Administrator
has not had an opportunity to review it, the Office of Pesticide
Programs intends to begin implementing the policy decisions and
changes discussed herein except in those instances where they
may conflict with existing formal policy statements or legal
constraints.
-------
PESTICIDE PROGRAMS
A STATUS REPORT AND GUIDE FOR ACTION
DECEMBER 1976
TABLE OF CONTENTS
I BACKGROUND
A. Purpose p. 1
B. Program Objectives p. 2
C. Historical Perspective p. 3
D. Accomplishments p. 4
E. Problems p. 6
II. PREMARKET REVIEW
A. Background p. 6
B. Priorities p. 8
C. Data Requirements
1. Background p. 8
2. Problems p. 10
a) Section 3 modifications p. 10
b) Minimum standards p. 10
c) Nonconforming tests p. 11
d) Conveying data requirements p. 12
D. Data Availability, Validity, and Applicability
1. Background p. 13
2. Problems p. 17
a) Cataloging p. 17
b) Reliability p. 17
c) Depth of review p. 19
d) Compensation/trade secrets p. 21
E. Transition Impacts p. 24
1. Background p. 24
2. Problems p. 24
a) Registration p. 24
b) Status of Guidance Packages p. 26
c) Labeling p. 27
d) Use Inconsistent with Labeling p. 29
e) RPAR p. 30
f) Petroleum Distillates p. 33
g) Minor Uses p. 34
h) Intrastate Pesticides p. 36
F. Tolerances p. 37
-------
-2-
III. USE REGULATION
A. Background p. 38
B. Classification p. 39
C. Certification p. 40
D. Problems p. 41
1. Restricted Use List p. 41
2. Contingency plans p. 42
3. States without plans 10/77 p. 43
4. Federal applicators p. 43
5. Indian reservations p. 44
6. Quality assurance p. 44
7. Costs p. 45
IV. ORGANIZATION p. 45
V. ATTACHMENTS
-------
PESTICIDE PROGRAMS
A STATUS REPORT AND GUIDE FOR ACTION
DECEMBER 1976
I. BACKGROUND
A. Purpose. The deadline for full implementation of the 1972 amendments
to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
was originally. set for October 1976, later extended until October 1977.
Since the deadline is approximately one year away, this is an annro-
priate. tjime -to review what has been accomplished and what remains in
be done. Significant progress has been made, but frustrating delavp
have also occurred. There is some confusion about just where we
stand -in- implementing the Act, particularly in the effort to reregister
'ami classify, all the pesticides presently marketed in this country.
These have been active and controversial years. Although it
may appear that progress has been tortuously slow, much forward
movement has been made, despite unforeseen delays due to lengthv
public debate, on rulemaking, an in-depth Congressional oversieht
'pe'riod during,which the future of some major program elements were
tih'ce'rtain, and some unexpected discoveries affecting our fundamental
assumptions for reregistration purposes.
Pesticide regulation affects many interests: the Congress,
the regulate^ industry, farm groups, professional applicators,
ot'hei: pesticide users, our State and Federal colleagues, environ-
mental groups, consumer groups, acaderaia, and the general public.
All these, groups are the audience for this paper and we thus include
basic background for those less familiar with the Agency's develop-
ment of pe,st,i,c'idei .regulatory policy, while also providing specific
discussions of, problem1 areas and solutions. This paper is intended
to' provide a description of our goals, an historical per-sufect ive
of pesticide regulation, a status report on some of the major areas
of 'difficulty, and our proposed, solutions to the problems.
We dan"ri6t provide all the answers now. Where we cannot,
we can nevertheless propose pathways to decisions. We need your
constructive thoughts on these issues. The challenges posed by
this' transit ion time between the "old" and "new" FIFRA must be
met wil.h patience and careful thought, and above all with a co-
operat'ive spirit between the regulators, the regulated, and the
many interests'-affected by EPA's, decision making.
-------
-2-
This document is not a replacement for the long-range Pesticides
Strategy paper. The Strategy, now being developed, will address in
detail the Agency's objectives and plans for the entire regulatory
program through 1981. This paper addresses immediate concerns and
issues. It is a discussion of short-term problems (although some
of the solutions may be extended over a period of time) to deal
with the major current dilemmas which need prompt attention.
ฎ* Program Objectives. The primary mandate of the Office of Pesticide
Programs is to protect human health and the environment from unreason-
able adverse effects of pesticide use. Pesticides are deliberately
introduced into the environment to achieve a distinct benefit.
Decisions on pesticides must thus consider not only the possible
adverse effects from pesticide use, but also the potential effects
on food production and health of the absence of these pest control
tools. It would not serve this nation to restrict the use of pesticides
to the point that an adequate supply of food and fiber could not
be produced or protected, or that disease vectors or structural
pests could not be adequately controlled. Nor would it be a service
to permit the continued use of pesticides to the detriment of the
health of our citizens. The heart of the regulatory objective,
then, is to assess and determine the acceptability of risks as
balanced against the benefits.
Social policy in this context requires that the benefits,
or social utility, afforded by a pesticide be weighed aeainst its
undesirable consequences. The standard guiding all pesticide regulatory
decisions is "unreasonable adverse effects on the environment." This
is defined by law as "... any unreasonable risk to man or the environment,
taking into account the economic, social, and environmental costs
and benefits of the use of any pesticide." Risk/benefit decision-making
is not easy; there are no magic formulas for achieving the absolutely
right answer. Neither side of the equation is known with certainty,
since each involves some non-quantifiable inputs. The key question
is simply, "What is an acceptable level of risk?" That determination
is not based on science, economics, or social factors alone; all
components and their interrelationships must be considered in the
regulatory decision-making process. It is, in short, decision-
making which most typically involves extrapolation beyond the strict
bounds of scientific measurement: the very subjective area of
trans-science.
-------
-3-
Thus, in fulfilling our objective to protect the public from
unreasonable adverse effects of pesticide use, we turn to three
crucial elements: 1) obtaining the most up-to-date, complete,
and accurate information available, 2) conducting a thorough
assessment of risks and benefits and 3) making decisions in the
open, with as much public participation as possible.
C. Historical Perspective. EPA assumed pesticide regulation responsi-
bilities from the Department of Agriculture and the Federal Food
and Drug Administration in 1970. All pesticides Federally registered
before 1972 were subject to the 1947 FIFRA, an Act passed when the
great benefits of pesticide use were first being recognized. It took
many years to realize that some of these products, although efficient
in pest control, could cause subtle long term adverse effects in
man, wildlife, and the environment. In addition, overuse of certain
chemicals was creating a resistance in some pests.
Congress responded to the need for a more comprehensive regulatory
scheme with the passage of the Federal Environmental Pesticide Control
Act to amend FIFRA in 1972. The amendments transformed FIFRA from a label in;
Act to a comprehensive regulatory Act, affecting all aspects of pesticide
use. EPA assumed responsibility for regulating pesticides from the early
experimental stages, through premarket data review, to use in the
environment. The Agency was assigned responsibility to monitor
for long term effects and to respond to accumulated scientific
knowledge. And we were to get underway with two giant tasks: the
registration, reregistration, and classification of all pesticides
marketed in the country; and the establishment with the States of
programs to train and certify applicators who would need to use
restricted pesticide products.
Several important factors were at work at the time the 1972
amended FIFRA was passed. They are still of critical importance:
o Rapidly advancing scientific knowledge and public interest
which escalates the serious question of long-term effects
cancer, mutagenesis, birth defects, and nervous system,
blood and organ dysfunctions.
o Advancing monitoring technology that increased our
ability to detect pesticides first in parts per
million, then parts per billion, and now parts
per trillion, beyond our ability to estimate significance;
-------
o Tliซ' results of monitoring studies usinp. such technology
showing that, pesticide residues are found in soil, water.
air, and can accumulate in wildlife and man;
o Increasingly complicated legal issues that are slow
and costly to resolve;
o Increasingly complicated economic and political factors
that must be considered.
The Congress further amended the FIFRA in 1975 after a lengthy
oversight process. The latest amendments are intended to ensure
that all agricultural and scientific ramifications of proposed
rulemaking or cancellation actions are explored. They require EPA
to submit copies of proposed regulations or notices of intent to
cancel to the Secretary of USDA and to a Scientific Advisory Panel
60 days before public notification. Final notices and rulemaking
are to be submitted 30 days prior to public notification. EPA
must also submit to USDA an assessment of the agricultural impact
of proposed cancellation actions. The Senate and House Agricultural
Committees are also informed in advance of our significant actions.
D. Accomplishments. Despite the complexities, progress has been slow
but steady. Regulations began appearing in 1973 and most major
rulemaking followed over the subsequent three years:
July 1973: Section 6, Administrative Review (cancellation
and suspension procedures);
November 1973: Section 7, Registration of Establishments;
December 1973: Section 18, Emergency Exemptions;
May 1974: Section 19, Disposal and Storage;
May 1974: Farm Worker Protection Standards;
July 1974: Section 14(a) , Assessment of Civil Penalties;
September 1974: Section 8, Books and Records;
October 1974: Section 4, Standards for Certification of
Applicators;
March 1975: Section 4, State Plans for Certification of
Applicators;
-------
-5-
Harch 1975: Subpart D, Section 6, Reconsideration of Previous
Cancellation Decisions;
April 1975: Section 5, Experimental Use Permits;
June 1975: Proposed Registration Guidelines;
May 1975: Section 17, Notice to Foreign Governments;
July 1975: Section 3, Registration, Reregistration, and
Classification; and
September 1975: Proposed 24(c), Special Local Needs.
In addition, some significant policy statements have been
issued under the new Act: two papers on the compensation for
data provisions of the Act, Section 3(c)(l)(D) (November 1973
and January 1976); the categorization and call-in scheme for
reregistration (February 1976); the procedures for handling
problem chemicals through the Office of Special Pesticide Review
(December 1975); the procedures for handling new registrations
identical or substantially similar to already registered products
(May 1976); and five Pesticide Enforcement Policy Statements
regarding how the Agency will enforce "use inconsistent with
the label" under Section 12(a)(2)(G):
#1, less than label dosage May 1975,
#2, unnamed structural pests September 1975,
#3, State registered products April 1976,
#4, preventive treatments July 1976, and
#5, unnamed agricultural pests September 1976.
#6, use and labeling of service containers December 1976.
Twenty-nine Pesticide Regulation (PR) notices have been issued to
registrants on a variety of policy issues. In addition, the Agency
proposed an EPA-wide policy on addressing chemical carcinogens,
including potential pesticide carcinogens, in May of 1976.
During this time, too, we have been processing the applications
which come in daily. In the past 4 years, we have issued more
than 145,000 supplemental registrations; 16,930 amended regis-
trations, and 11,140 new registrations. More than 500 experimental
permits, and more than 110 emergency exemptions have been processed.
In addition, great progress has been made by joint effort with USDA
Extension Service (ES), EPA Regions, and the States in starting
applicator certification. As of this writing, 47 State Plans have
been submitted for approval, and more than 225,000 applicators
have gone through training programs.
-------
-6-
K. IV obi t'.mn. Although wu are pleased with these accomplishments,
major proj',r/im decisions must be made to complete the task of imple-
menting FIKkA. Many of our problems are caused by the dynamics
of the transition from the old law to the new law. Registrants
knew where they stood under the old Act. They know where they will
stand when the 1972 FIFRA is implemented. But they are confused
and impatient about their status during this important in-between
period. Industry, users, and environmentalists alike are equally
concerned as we try to sort out an avalanche of complex and new
variables.
To explain our policies and problems, this paper will systematically
address two of the primary functions of the Office of Pesticide Programs
in achieving program objectives: premarket review of pesticide products,
and use regulations.
Part II will describe the foundation of the regulatory process
and will discuss data requirements, the status of the data, the
problems concerning the data, ways to convey requirements to
registrants and the public, registration and reregistration proce-
dures, and the problems being experienced during the transition
between the old and new Acts. Part III will discuss the use aspects
of the regulatory process, specifically applicator certification
and training. Part IV will discuss the Office of Pesticide Programs
staffing and organization to carry out program functions.
II. PREMARKET REVIEW
A. Background. Before a pesticide can be registered by EPA,
the applicant must demonstrate to the Agency that the product will
perform as claimed on the label, and that its use will not cause
unreasonable adverse effects on man or the environment. A registration
application, then, must be supported by data on efficacy, human
safety, chemistry, fish and wildlife, and environmental effects.
We are presently engaged in two simultaneous processes under
the new statute:
. registering pesticides not previously on the market, and
. reregistering those products already registered under the
1947 Act.
-------
-7-
A system Lo reregister the more than 35,000 products which
arts already Federally registered was developed in 1973. Products
will be grouped into "batches"; all products in a batch will be
"called in" for reregistration according to chemical similarities
in their active ingredients.
In ta*ing this approach, the Agency is attempting to minimize
potential confusion during the reregistration process, and to
facilitate the submission of reregistration applications by clarifying
what information is or will be expected for the applicant to achieve
full registration. The entire onus for submitting a full and complete
application with supporting data could have been placed squarely
on the industry. The Agency chose the task sharing approach, however,
which we believed would be the most equitable and orderly option.
Applications will be called in through the Guidance Package,
a document which:
. informs the registrant of the proposed classification of
his product (either general or restricted use),
. cites pertinent data already on file,
. provides label information, and
. specifies any additional data requirements to be filled.
When long-term data must be accumulated, presuming there are no
data indicating adverse effects in our files, the registrant will
receive a conditional registration for the specified period of
time necessary to conduct the additional tests.
The primary purposes of reregistration are to:
. classify products,
. update labeling,
. identify and fill data gaps, and
. review data on hand to ensure that the problem pesticides
will be identified and subjected to in-depth scrutiny.
The in-depth risk/benefit review procedure is triggered when
the risk criteria enumerated in the Section 3 regulations are met
or exceeded. The Agency then "presumes" that a reregistration will
not be issued. The registrant, users and the public may "rebut"
this presumption by submitting information showing that there
is no risk, that the hazard can be reduced by special use directions,
packaging, or other means, or that the benefits of the pesticide's
use outweigh the risks.
-------
-8-
This information-gathering and decision-making process, which
will be discussed in greater detail later, is known as "rebuttable
presumption against registration" (RPAR).
B. Priorities. The Agency has set registration/ reregistration
priorities to provide the greatest public protection and best use
of limited resources:
1. Classification and reregistration of those product uses
most likely to be restricted.
2. Basic registration/cancellation decisions on those products
triggering presumptions against registration on the basis
of potential adverse health effects.
3. Making the basic registration process more workable by
such efforts as improving data cataloging, data valida-
tion and regional support to help firms properly make
application.
4. Reregistration of products destined for general use.
While we will not meet the statutory deadline of October 1977,
devoting top resources to classification of restricted uses, reviewing
pesticides which potentially cause unreasonable adverse effects,
and smoothing the registration mechanisms, will be responsive to
essential goals of the statute. An important point to note is that
products will remain on the market regardless of the October 1977
date until action on reregistration is taken.
C. Data Requirements;
1. Background. There are three places where data requirements
are articulated:
The Law: The statute requires under Section 3(c)(5) that the
Administrator make a finding prior to registration that a product,
among other things, will perform its intended function without
unreasonable adverse effects on the environment. To make this
finding the Act authorizes the Administrator to request test data
in support of the application for registration.
-------
-9-
The Regulations: To write regulations implementing that
standard has been one of the biggest challenges before the Office
of Pesticide Programs. Efforts to include the public in the
decision making process for devising the registration, reregis-
tration, and classification regulations were unprecedented. In
July of 1974, a public meeting was held in Washington in which
the first draft of the regulations which had previously been
mailed to over 200 interested parties was openly discussed.
That meeting was followed by the formally proposed regulations
in October of that year. Because of the tremendous impact these
regulations were to have, and the intense public interest, there
was an extensive comment period on the proposals. Final regulations
were not issued until July 1975, and were effective in August.
The regulations enumerate the basic registration requirements
(ง162.8) and establish criteria for identifying those products
with potential for an "unreasonable adverse effect1' (ง162.11).
The regulations reflect the Agency's concern about the potential
chronic effects of pesticides on human health. They include
requirements for oncogenic, mutagenic, teratogenic, and
reproductive testing where appropriate to adequately assess
health effects in addition to environmental chemistry, wildlife,
phototoxicity, chemistry, and efficacy data.
The Guidelines: To more clearly define specific data recuirenents
to support registration, Section 3(c)(2) of the Act instructs the
Agency to issue Guidelines. The Guidelines will specify, among
other things:
.data requirements for registration,
.characteristics of acceptable testing,
.examples of acceptable test methods, and
.the information required in test reports.
Proposed Guidelines were published in the Federal Register on
June 25, 1975. The Agency is revising this document after careful
review of the large number of comments received.
The Guidelines represent a difficult concept: the regulatory
articulation of scientific requirements. In science, practically
nothing is absolute. In regulatory affairs, clear-cut answers
are required. In science, the search for knowledge never ends.
In regulatory affairs, decisions must be made on the basis of
the knowledge available. In science, the freedom to experiment
and innovate is cherished. In regulatory affairs, a definitive
method of measuring and judging must be established.
-------
-10-
Cotnpetent regulatory decisions must, of course, be made
largely on the basis of scientific information. EPA, therefore,
must find a way to reconcile these differences. In the final
Registration Guidelines, EPA will provide minimum standards for
acceptable testing. Thus, with respect to many types of toxicity
testing, the Registration Guidelines will not only indicate when
the testing is required, but also specify such factors as relia-
bility, preferred species of test animals and routes of adminis-
tration, numbers of dose levels to be tested, reporting requirements
and so on. In practically all instances, these specifications
have been derived from, or are consistent with, test protocols
already published in the scientific literature.
2. Data Requirements; PROBLEMS
PROBLEM ffl; Should the Section 3 regulations be modified?
Discussion. The State-Federal FIFRA Implementation Advisory
Committee (SFFIAC) has suggested several changes in the registration/
reregistration/classification regulations. SFFIAC"s major recommendations
are to:
.better define "use inconsistent with the label,"
.increase flexibility in efficacy and hazard data requirements,
.re-establish negligible residue concept,
.clarify precautionary statement requirements, and
.increase flexibility of the numerical toxicity indicators
used to trigger an in-depth risk/benefit review or classify
products.
Agency commitment. Amendments to the Section 3 regulations
will be prepared for transmittal to USDA, Congress, and the Scientific
Advisory Panel in early 1977 as the Agency deems appropriate.
PROBLEM #2:Will EPA insist that new testing conform without
' exception to the minimum standards specified in the Guidelines?
Discussion. Testing that meets the standards in all respects
may not always be accepted without question, but testing that does
not meet the standards is much more likely to run into problems.
-------
-11-
When a prospective registration applicant believes that a
particular testing standard is inapplicable or impractical in a
particular case, or when the applicant wishes to deviate from the
standards in any significant respect, consultation with EPA before
testing begins will be strongly advised. Alternatively, the
applicant can proceed with testing and take a chance that it may
be accepted. In either case, it will be up to the applicant to
spell out reasons why non-conforming tests should be accepted.
Such reasoning will have to include a persuasive argument showing
that the non-conforming testing will not (or did not) significantly
reduce the likelihood of discovering any adverse effects that a
pesticide may be capable of producing. In short, insofar as new
testing is concerned, applicants will have to take the initiative
in persuading EPA to accept testing that will not (or did not)
meet the minimum standards.
Agency commitment. Taking into account the intricacies of
toxicological testing and the diversity of scientific opinion on
many aspects of such testing, EPA's position must be that while
the minimum standards are designed to facilitate decision-making,
testing that does not conform in all respects does not necessarily
preclude decision-making. To the extent that EPA's scientists can
reach reasoned conclusions from test results (even though the testing
fell somewhat short of EPA's standards) without making extrapolations
or assumptions that have no foundation in the test results or in
other pertinent data, such test results will not be rejected. In
such cases, of course, the EPA scientists performing the evaluation
will thoroughly document their reasoning so that the public may
be fully informed.
PROBLEM #3: How will the Registration Guidelines be applied to data
submitted in years past?
Discussion. Thousands of tests performed over the past 25
years will be examined during reregistration. Many of them, however,
do not satisfy the specific criteria of new testing standards in
many respects. EPA could, of course, reject all such nonconforming
tests. The testing standards set forth in the Registration Guidelines,
however, are not an absolute prerequisite for decision-making.
For instance, the results of a test performed with only 40 animals
per dose level, when considered in light of both the remainder
of the test protocol and other available information about the
pesticide, may very well enable a scientist to reach sound conclusions
regarding the pesticide's chronic toxicity.
-------
-12-
Agency commitment. In the reregistration process, EPA will
necessarily take the initiative in evaluating nonconforminp, test inc.
EPA will determine whether tests performed before the issuance of
the Registration Guidelines if they do not meet the new minimum
standards can be considered scientifically valid and provide
the information needed for decision-making. Again, the EPA
scientists who make such judgments will document their reasoning.
The key issue to consider in reviewing non-conforming tests
is validity can the Agency have confidence in the results? In
each case, EPA must assess the information present and determine
if 1) the data are reliable and meet or exceed the "unreasonable
adverse effects" criteria enumerated in the Section 3 regulations,
and thus that an RPAR is triggered, 2) the data are reliable and
show a negative effect, thus supporting registration or reregis-
tration, or 3) the test was so poorly conducted that the results
are meaningless, and thus that a data gap exists.
PROBLEM #4 How can the Agency successfully convey data requirements?
Discussion. It is not a simple matter to convey a complex set
of data requirements to an applicant or any other interested party for
the first Lime. But it is important to do so. It wastes company
resources to submit and resubmit incomplete applications for
registration. This is most important to the small manufacturer or
formulator and to potential minor use registrants. And it wastes
Agency resources to deal with procedural matters, when there are
so many substantive issues which demand attention.
After the Section 3 regulations were published last year, the
Agency sent a team across the nation to explain the new requirements
and to assist registrants in understanding and preparing for reregis-
tration. Nine workshops in 10 cities were attended by approximately
2000 registrants. The Agency found that it is very helpful to discuss
requirements face to face with registrants, and we should thus not
only be able to express data requirements in written form, but also
be available for personal explanations. Because of the changes
in the registration process since those workshops, further personal
guidance should be available to registrants at the local level.
-------
-13-
Agency commitment. To convey data requirements, the Agency
will:
. issue the Guidelines. The schedule is as follows:
Hazard Evaluation and Chemistry Sections: first quarter
1977: through internal EPA review groups; second quarter
1977: to USDA, Congress, and the Scientific Advisory
Panel; third quarter 1977: publish in Federal Register.
A document with which the EPA staff can work will be
complete by the first of March and will be available
to registrants and the public and will be used while
the Guidelines are under review by the rest of the Agency.
Notice of availability will be published in the Federal
Register after EPA working group approval, but before
interagency review.
. train Regional personnel to assist registrants at the local
level. The initial phase of this training program is near
completion, and additional programs and instructions will
follow.
. invite registrants to use the Regional expertise. PR
Notice 76-2 was issued on June 21, 1976, notifying all
manufacturers and formulators of the availability of
Regional assistance.
D. Data Availability, Validity, and Applicability
1. Background
a) Company data files.
What data do we have, and how good is it? The data required
by the Agency is received from individual manufacturers in support
of product registrations. Most of the data on hand, therefore, is
in data files submitted by companies. When the 1972 Act was passed,
none of the data was cataloged. It was in different formats, and
reflected the various regulatory standards acceptable at the time
of submission. Data files thus go back many years and range widely
in terms of quantity, quality, and organization.
-------
-14-
Under the old FIFRA, products could be registered in accordance
with "accepted patterns of use." In other words, a reviewer could
issue a registration based on the fact that a similar product was already
registered. An application did not have to be linked to specific
data. Now, in accordance with Section 3 of the amended Act, the
Agency must be able to identify specific data in support of any
registered product. This does not mean that reams of duplicate
data must be submitted nor that duplicate testing would be required;
it does mean, however, that specific data references must be associated
with each registration.
b) Data Validation.
This is an area of particular concern to the Agency. To
discuss it properly, we must first establish the historical per-
spective for data examination for the reregistration process. In
1973, during the planning stages for the new registration/reregis-
tration program, we were operating on the basis of certain important
precepts and constraints:
o first, there would be no significant increase in
resources, particularly manpower;
o there was a Congressional deadline to reregister some
35,000 Federally registered products and register for
the first time an estimated 15,000 intrastate products
by October 1976, now, of course, by October 1977;
o the Agency had to maintain a reasonable response
capability to continue handling applications for new
registration, tolerance, and experimental use permits;
o the Agency anticipated that data gaps would exist because
of new data requirements. However, we made three very
important assumptions about the data already on file;
data results were derived from testing which generally
was properly performed and fully reported;
they were initially reviewed in accordance with
scientific standards appropriate for today's
decision-making; and
data problems were generally identified by prior reviewers
and followed up in terms of resolving questions or obtaining
additional studies as needed.
-------
-15-
It was recognized that these assumptions would not hold for
every case. However, it was anticipated that in those few instances
when imperfect decisions had been drawn, the potential errors would
appear when registrations had to be renewed (the law requires renewal
every 5 years) and could be addressed then. All in all, we believed
that our suppositions were sound, and our resources could be focused
on the obvious problem products, label improvements, and the collection
of additional data where gaps were discovered.
Our assumptions, as will be discussed in the problem section
below, did not prove to be viable. Increased emphasis has been
placed on validation during the past year. Data validation will
consist of three primary elements in the regulatory context:
1. First, the data must be evaluated on a purely scientific
basis to establish the scientific soundness of the
conclusions.
2. If these studies are found to be scientifically sound,
their applicability to the regulatory decision must be
determined, after consideration of other supplementary
data and the Guidelines.
3. Finally, validation consists of a statement of the
scientific decision on the adequacy of the data to
fulfill the standard and a summation of the basis for
the decision.
One difficult concept relates to the absence of data as related
to the presence of risk. Bad data or missing data, unless falsified
to show opposite conclusions, does not equal a potential human
or environmental risk. The presence or absence of a certain type
of study reduces the certainty of making a proper finding of un-
reasonable adverse effect but does nevertheless not show a risk
to be present. Data validity shows hopefully first, that studies
are not fraudulently conceived or reported; second, that they are
relevant or not; and, third, identifies where data gaps exist which
must be filled in order to reduce the potential for a regulatory
misjudgment.
-------
-16-
c) Data Accessibility.
Company data files are accessible to the public and the industry
to varying degrees. Section 3(c)(2) provides that the Administrator
of EPA "shall make available to the public the data called for in the
registration statement together with such other scientific information
as he deems relevant to his decision." However, the Agency is speci-
fically prohibited in Section 10 from releasing "trade secrets ,or
commercial or financial information" pertaining to registration
applications.
Congress in deliberating on the 1972 FIFRA amendments grappled
with the issue of whether companies who do not develop their own
data should get a "free ride" by relying on data already submitted
by another registrant. To equalize the costs of data development ,
a Section was incorporated into FIFRA which prohibits the Administrator
from considering data submitted by one applicant in support of another
application unless the originator of the data has given permission or
the applicant has offered to pay reasonable compensation for use of
the data. That is, of course Section 3(c)(l)(D). In part, this
Section became effective with the issuance in the Federal Register of
the Interim Policy Statement (IPS) of November 1973. According to
the IPS, data first submitted on or after October 21, 1972, were
eligible for compensation under 3(c)(l)(D). This policy pertained to
all applications for registration submitted after November 19, 1973.
However, in 1975 Congress further amended the FIFRA to specify that
data submitted on or after January 1, 1970, were eligible for compensation
and that the compensation provisions applied to all applications for
registration submitted on or after October 21, 1972, and not approved
before November 28, 1975, the effective date of the amendment.
The issue is further complicated because various segments of
the pesticide industry are disagreeing as to what data are covered by
Section 10, Trade Secrets. Data covered by Section 10 cannot be
relied upon by the Administrator or released to the public without
consent of the owner. In addition, small formulators are concerned
about signing an offer to pay statement, or "blank check," which
commits them to paying an unspecified sum in the future. Congress
is concerned that the data compensation provisions may be encouraging
a monopoly within the industry to the detriment of the small businessman.
Many of these issues are now being considered in the courts, which
will ultimately resolve some of the fundamental problems.
We have issued a second Federal Register notice (January 1976)
stating our current policy with regard to data compensation and describ-
ing the changes to this Section brought about by the 1975 amendment.
This amendment further provided that registration not be delayed
pending the determination of reasonable compensation in the courts.
-------
-17-
It has been EPA's position that the Agency should proceed with
registration if an applicant either has permission to use data
submitted by a previous registrant or has signed an offer to pay
reasonable compensation for the use of the data, unless the Agency
is specifically prohibited from utilizing the supporting data by
court order.
2. Data Availability, Validity, and Applicability: PROBLEMS
PROBLEM #1: How and when will the Agency organize the data on
file in suppport of registrations?
Discussion. As stated in the background section, company
data have never been completely sorted or organized. This creates
a problem for the industry in referencing data to support registrations
and for the Agency in locating specific files.
Agency Commitment. EPA is now in the progess of cataloging all
company data in the files.
The first step was to index the volumes of data currently in
our data library. We have now identified 50,000 volumes of company
data, i.e., we have an index of the physical description of each
volume on hand.
The second major step in the cataloging process will be to
identify the tests within each volume (each volume averages 20-22
tests). An OPP contractor is cataloging these tests at a steadily
increasing rate. We have twice accelerated the contractor's schedule
to obtain maximum speed: for the priority chemicals (those which
may be subject to RPAR and the restricted classification), the job
will be complete in January of 1977, the entire file to be completed
by April 1977.
?ROBLEM ^2; Are data in EPA files reliable and properly reported?
Discussion. Based on the precepts developed when the new
registration, reregistration, and classification regulations were
written (see page 14), the Agency began sorting pesticides into
three categories in 1974/75: those for which the rebuttable presump-
tion against registration would likely be triggered; those potentially
restricted to use by certified applicators; and those for general
use candidacy. In looking into past files, the Agency sought what
was missing, i.e., what now-required studies had not been
completed, rather than what was on hand. Our primary purpose
was to identify data gaps which could then be filled during the
rerergistration process.
-------
-18-
Then in 1976, new information came to light which questioned
the assumptions of the registration and reregistration process.
In January, it was disclosed in discussion with FDA and CAO
officials and during Senate hearings that some toxicological
data provided to FDA were of questionable reliability. An
independent toxicologist was contracted to look into a sample
of pesticide data. Based on his preliminary findings, the Office
of Pesticide Programs established its own review force. In
April 1976 we developed, in cooperation with FDA., a thorough
auditing program to examine laboratory data validity. Serious
questions were raised about the adequacy of the testing in
EPA files, and the completeness of the Agency's own review and
followup.
As a result of these efforts, we now know that it is not enough
to determine whether a study is present. Preregistration review
must go beyond that to determine what the study showed and whether
proper follow-up was taken. Grossly inadequate and misreported
previous testing will hopefully not be widespread; however, the
problem cases already identified require us to go to the extra
effort.
Agency Commitment. To resolve the reliability of data question,
several important steps are to be taken:
First the Agency is initiating an auditing program in conjunction
with FDA to determine if:
1. The testing in audited files was performed in accordance
with the test protocol selected by the sponsor (i.e., pesticide
company) or testing laboratory.
2. Any errors were made that may have materially affected
the test results.
3. Any practices were followed that may have biased the test
results or obscured the biological effect of the chemical.
4. Test procedures or results or any relevant data were
materially altered during or after testing.
5. Test reports submitted to EPA (or predecessor agencies)
fully and accurately reflected all material facts regarding
the actual test procedures and results.
-------
-19-
Seconcl KPA published an ndvnnce notice of proposed rnlos on
October 5, 1976, which would require toxicology tost
reports to include certain information to provide the
Agency with a greater degree of confidence that the work
has been properly conducted. Public comment has been
solicited.
PROBLEM: T3: How deeply should data in EPA files be reviewed
prior to reregistration?
Discussion: Just what "review of data" means has recently
become a matter of some considerable concern. A Senate sub-
committee report has stated that the Agency has misled the public
as to the depth of review of data on file prior to reregistration.
Obviously, there are several levels of data review each with
specific implications regarding resources, timeliness, and public
impact which are possible. The following logical review stages
could be applied:
1) identify all the acute, subacute, and chronic toxicity
data on hazard to humans, domestic animals, fish and wildlife and
all environmental chemistry data currently in our files;
2) review any existing Agency summary and analyses of these data;
3) review summaries of use history, if any, including any
accident reports;
4) review the full test report which was submitted by the
applicant and validate the data in accordance with present day
standards. The test report is the narrative and graphic description
of the test method and results;
5) compile and review any articles and monographs readily
available in the open literature and any Agency working documents
which bear on the effects of the compound;
6) review the raw data and slides which were the bases for
the test report which was submitted to the Agency. Raw data
includes the laboratory workbooks and any other recorded material;
7) perform an extensive literature search and review any
articles which bear on the effects of the compound.
When the Agency planned its original strategy for reregistration
in 1973, it was decided -that the best utilization of public resources
in the alloted time would be to basically divide pesticides into
two primary categories: suspected problems and those which the
use history and the literature implied were not posing unreasonable
adverse effects. Those suspected problem pesticides (those which
had greatest potential for causing an unreasonable adverse effect)
-------
-20-
wpuld undergo a thorough data validation and risk/benefit review
through the RPAR process. The other pesticides would be classified,
their labeling upgraded, and data gaps identified and new testing
required in accordance with the regulations implementing Section 3
of the amended Act. Our approach, then, was to screen out the "bad
actors" to which our resources could be immediately devoted while
further testing was being conducted on the other pesticides which
could be more thoroughly reviewed after the new test results were
received.
However, due to the discoveries made earlier in the year as
discussed above regarding data on hand, our original approach was
not affording adequate examination of data in our files for non-
RPAR products.
A full review, including examination of every piece of paper
in each file, data validation including recourse to tissue slides
and raw data where needed, literature search and outside consul-
tation on risk data as well as an assessment of economic and social
importance of the compound's uses, alternatives, and use history
would at best require about two man-years of effort per chemical.
A basic de novo review of all the data on hand, then, could take
between 10 - 20 years to accomplish at our current resource level,
especially considering the scarcity of hazard evaluation scientists.
At the other extreme, we could simply look at the first level of
review and give primary priority to identifying data gaps. That
kind of job could be accomplished in one or two years even with
current resources. And in between those two options are various
levels of review depth and resource commitments which could affect
the thoroughness and timeliness of the task.
The more in-depth the data review prior to reregistration, the
greater is the eventual certainty that the public will not be exposed
to an unreasonable adverse effect based on all available knowledge.
But on the other hand, the longer the Agency spends on reviewing data
on hand, the longer it will be until Guidance Packages identifying
da'ta gaps and requiring additional testing are issued, and thus the
longer it will be until the review of each product takes place. In
actuality, there is no alternative but to sacrifice some degree of
either certainty or timeliness. The policy question is then: is
the public best protected by a thorough in-house review of those
data in our files which delays filling data gaps, or is the public
interest best served by a screening process which seeks to identify
the "bad actors" and while these compounds are going through the
RPAR process increase the data base from which a more complete
assessment can be made? Clearly, this question comes down to how
the public will be best protected.
-------
-21-
Agency Commitment. The Agency will conduct a review on bioeffects
and environmental chemistry data through level five as explained above.
As far as efficacy data are concerned, we are considering relying on a
certification either by the applicant or USDA that the pesticide will
perform per label claims, provided that any new use will require
efficacy data, and all efficacy data on disinfectants or other products
related to public health will be reviewed and validated. General
chemistry data will be required with each application.
The general reregistration strategy will remain the same,
that is, products will be called in by batches and Guidance
Packages will be issued. However, the internal review before
the development of the Guidance Package will be substantially
amended. The Agency will:
1. look at the files through level 5, and determine whether
studies are valid and proper follow-up on reviewers'
questions has occurred in the past;
2. develop standard procedure for our own reviewers to use
in documenting their findings, so that the basis for the
decision is clear;
3. consult with other Agencies in addition to looking
to primary literature sources;
4. present all pertinent findings to an internal review
panel before the issuance of the Specific Guidance
Package to assure scientific, legal, and policy
consistency and credibility.
The heart of the new procedures will be a chemical review
file (CRF). The CRF will contain a summation of all supporting
data, the use history of the pesticide, literature citations, and
all other pertinent information. The review panel will examine
the CRF for content and completeness, concur in the classification
conclusions, the RPAR conclusions, and the action recommendations.
PROBLEM #4:What data are eligible for compensation, and can the
Agency register in cases where a compensation dispute is outstanding?
Discussion. While 3(c)(l)(D) now provides clear direction as to
what data are compensable, if used by another registrant in support
of a subsequent registration, it is not certain what data are available
-------
-22-
for use in this way. The trade secret provisions of Section 10 of
the Act significantly affect the availability of data. Specifically,
test data submitted before January 1970 may be relied on without
consent of the owner firm, without an offer to pay compensation, and
without regard to Section 10. (This does not mean such data may be
released, but rather may be considered internally for purposes of .
reviewing registration applications). However, the right to rely
on test data submitted on or after January 1, 1970, depends upon
the applicability of Section 10. If the data are not confidential,
the data may be relied upon by other applicants with or without
the consent of the owner (although in this case the applicant must
offer to pay reasonable compensation). If the data are confidential
they may be relied upon only with the consent of the owner so long
as the provisions of 3(c)(l)(D) are observed. There is thus a
reciprocal relationship between 3(c)(l)(D) and Section 10. It is
the Agency's position that data submitted by companies in support
of registration (e.g., toxicity data, feeding studies, environmental
chemistry data, etc.) may be compensable, and are not trade secrete.
It is our view that upon a showing that the information has been
maintained in confidence and that its public disclosure would likely
cause substantial harm to the data submitter's competitive position,
the confidential formula, financial information and data in support of
an application not yet approved, should be accorded confidential
treatment.
Ten cases involving data compensation/trade secret disputes
are currently at issue in the courts. Pending any final decision
on these trade secret issues, we have been enjoined from considering
any of the data in question in support of other registrants' applications
or have entered into stipulations to that effect. This is a significant
problem, as it potentially can affect approximately 12,000 products
on which no registration or reregistration actions may be taken until
the courts make a final ruling. In the meantime the current registrations
continue on the market and applications for new registrations cannot
rely on that data without the consent of the owner.
An even more crucial trade secret problem concerns use of
confidential formulas. The relevance of data in support of an
application is generally determined by comparing one registrant's
product with another. Product B cannot rely on Product A's data
-------
-23-
unless the two products are the same. Some segments of industry
claim that EPA cannot compare any application to a previously
registered product without considering the formula of the two
products in question, and thus all data are protected under Section
10. Litigation is also pending on this issue, which will have
a major impact on the whole reregistration process.
Agency Commitment. EPA is taking several steps to help resolve
data compensation complexities:
o a Federal Register notice was issued on October 18 relating
to the determination of data compensation claims. In that notice,
the Administrator authorizes the Chief Administrative Law Judge
to hold hearings and issue Initial Decisions as to claims under
Section 3(c)(l)(D).
o the proposed Section 3(c)(l)(D) regulations have been written
and were transmitted to the USDA and the Agriculture Committees of
Congress in November 1976. They were presented to the Scientific
Advisory Panel when it convened in early December.
o a solution to the identicality question in some
cases is the submission of complete chemical analyses on the two
products showing practical identicality, thus demonstrating the
relevancy of prior data to the current action without use of trade
secret materials. Some applicants have requested that we accept
these reports as evidence of identicality. Where such comparative
analyses are not adequate to show relevance of prior testing, the
problem remains.
o a paper is being prepared for the House Agriculture Committee
which addresses the competitive aspects of FIFRA implementation,
including the data compensation and trade secret issues. During
the next oversight hearings early next year, we will discuss with the
Committee the possibility of amending the Act to clearly define
what information falls under the trade secret provisions of Section
10, and how the Agency can use this information during the registration
and reregistration process.
-------
-24-
E. TRANSITION IMPACTS
1 ..'.: '
1. Background. Many of the problems now being-faced by the
Ofefice of Pesticide Programs are attributable to the dynamics of
changing from the 1947 statute to the new Section 3 regulations
under the 1972 amendments. It has been obvious from the beginning
that a certain amount of confusion and inconvenience would be ex- <
perienced in this transition period; however, when it was anticipated
that the transition would be but a year or two, the associated
problems appeared to be tolerable. Now because of the data validity
question the transition period will be considerably lengthened,
and it is imperative that additional thought be given to the transition
impacts, especially as they affect applications for new registration.
2. Transition Impacts; PROBLEMS
a) Registration
PROBLEM: How will the Agency treat registrations and conditional
registrations now that all chemicals are back in Category V for
purposes of data validation? ;
Discussion: It has been the Agency position that data requirements
for registration and reregistration should be separate, and that
applications for new registrations should for the most part fully
comply with all the requirements of the Section 3 regulations prior
to registration. On February 17, 1976, the Agency published in the
Federal Register a description of the reregistration process, and
placed all pesticides in five categories according to data status:
I) compounds for which all supporting data were present, II) compounds
for which long-term data were missing, III) compounds for which short-
term data were missing, IV) compounds in the RPAR category, and V)
compounds unreviewed. Data policy was further described in the
May 1976 statement on conditional registration which allowed regis-
trations of products identical or substantially similar to those
already registered while long term data gaps were being filled
so long as the parent compounds were placed in Categories I or II.
With the data validity problem, however, all products are back
in Category V (unreviewed) and thus the May statement is virtually
inoperative.
The Agency must therefore come to grips with the question of
processing new applications while the data validation efforts are
underway. It is clear that all new chemicals must meet the new
Section 3 requirements fully prior to registration. If the Agency
were to insist that every data requirement of Section 3 be met
-------
-25-
and validated prior to any new registration of old chemicals,
however, (given the fact that data validation will take many years),
we could virtually bring new registrations of old chemicals to
a standstill. (The Administrator's Pesticide Policy Advisory Committee
has passed the following resolution: "Old chemicals now registered
will be treated alike regardless of whether they are now registered
or will be conditionally registered in the future, while data are
being gathered; the definition of old chemicals to include existing
products with new formulations.") On the other hand, if we permit
any registration of any old chemical without data validation, we
would not be protecting the public health. Clearly, to best serve
the public interest (which demands a balancing of pest control
needs with potential adverse effects impacts), we must take a position
intermediate to either extreme.
Several important factors must be noted in this regard:
o the Section 3 regulations require some chronic data which
take years to accumulate; thus, while the regulations
became effective overnight, the ability of registrants
to comply with new data requirements did not;
o during a transition period, it is more logical and less
economically and socially disruptive to get from point
x to point y gradually rather than abrubtly the important
thing is to get to point y, and to get there
without creating havoc along the way;
o the absence of data does not preclude our ability to make
an "unreasonable adverse effects" decision if, for
example, the Agency has 95% of the studies on a certain
pesticide but one long term study is missing, that final
study will serve to only incrementally add to our know-
ledge about the product and our confidence that the
product will not pose an unreasonable adverse effect.
But that one increment may not prevent the Agency from
making a Section 3 finding based on all the information
which is available;
o any new uses of old chemicals during the transition period
must be supported by validated data pertaining to the new
use;
o our primary mandate is to protect public health and the
environment; however, we should strive to assure that
our registration policies do not disrupt pest control
producers and particularly users without achieving
environmental protection.
-------
-26-
Agency Commitment. The Agency will develop a new registration policy
which treats like chemicals in a like manner during the transition
period. We plan basically to remove the distinction between
registration and reregistration as far as data requirements are
concerned. Any application involving a change in use pattern
will be treated as a new chemical with respect to the new use,
i.e., the full complement of data necessary to judge the environ-
mental impact will be required prior to registration.
A policy statement implementing the new approach to registration
and its implications for tolerance setting is being prepared, and
will appear in the Federal Register in February 1977. A general
description of the process is in Attachment II. Additionally, the
Agency plans to exercise an open-minded policy with regard to Section
18 requests for use of new chemicals during the transition period
in cases where there is an urgent need for pest control and,most of
the information needed for registration is developed and looks
promising.
b) Status of Guidance Packages
PROBLEM; What is happening to the 72 Guidance Packages previously
issued by the Agency?
Discussion. After the need to better review data on hand was
discovered, a moratorium was declared on registration. At that time,
72 Specific Guidance Packages covering 2,527 pesticide products had
been mailed. The following actions have since been taken with regard
to these 72 packages:
an acute hazard profile has been built for the
Chemical Review File. Most of the earlier packages
were built from abbreviated chemical worksheets which
are now considered inadequate;
external reviews have been added to a substantial number
of CRF's;
a summary of chemical use history is being added;
documentation of the original classification decision
has been added to each package.
Agency Commitment. The following actions require completion
for the CRF covering the 72 Specific Guidance Packages:
use pattern summaries;,
environmental chemistry summary;
-------
-28-
o antidote statements which need to be reviewed and improved.
These problems complicate the following broader issues
dealing with the Act, and/or Agency policy:
o current strict interpretation of 12(a)(2)(g), which according
to many user groups gives rise to unnecessary problems of
misuse;
o possible inadequacy of PEPS to meet long-term interpretations
and/or specific cases on a broad policy basis;
o transition from old labels to reregistered labels;
o coordination of certified applicator training program with
label classification changes.
Agency Commitment. To resolve these issues, we will:
1. Initiate improvement of use directions in the reregis-
tration process as follows:
A. develop a format for the elements found in use
directions and the order in which they should appear.
B. develop an internal training program to alert
EPA reviewers to inconsistencies in labeling
so that such problems can be addressed in future
Guidance Packages.
2. Ask a special Chemical Specialities Manufacturers Association
(CSMA) committee to help us develop a new class of labels for
home products. A proposal from CSMA is expected within the
next few months. Such labels would bear simplified, less techni-
cal use directions and general pest descriptions. The Agency
could then consider whether or not home labels may serve
as a prototype for similar approaches for agricultural labels.
3. Adopt the transitional scheme included as Attachment III
for conversion of old labels to reregistered labels.
-------
-27-
-*- literature search;
completion of the use history summaries; ;
annotations of data bibliographies with abstracts of
prior reviews.
Following the completion of the CRF's for the 72 packages these
files will be reviewed for:
validation of the data
RPAR criteria ;
Recommendations for action will then be prepared and the CRF's
will be submitted to the internal review panel.
v
Depending upon the changes indicated (if any), either a
revision letter or a new package will be issued for each of the
Guidance Packages.
c) Labeling
PROBLEM: What actions to improve the pesticide label
will be taken during reregistration?
Discussion. While existing pesticide labels are undergoing
considerable upgrading as a result of regulatory changes during
the reregistration process, these, improvements are largely confined
to the warning and precautionary statements concerned with the safety
aspects of the label. The label format has been standardized to
make labels more uniform and easier to read.
Because of time and resource constraints, very little has
been done to improve the use directions portion of the pesticide
label. A number of problems exist with use directions:
o inconsistency between directions for the same use on
different product name labels of identical formulation;
o lack of a standard format and nomenclature for presenting
a given use direction to insure uniformity and inclusion
of all the necessary elements such as method of applica-
tion, site, timing, etc;
o a high degree of specificity with regard to pests, which in
some cases is considered too rigid;
6 extensive technical language which is too sophisticated for
certain user audiences;
-------
-29-
(d) Use Inconsistent With the Label
PROBLEM: Are all deviations from the label directions illegal?
Discussion: Part of the labeling problem is the issue of "use
inconsistent with the label" as incorporated in Section 12(a)(2)(G)
of the Act. The Agency has interpreted 12(a)(2)(G) in a "strict"
manner, i.e., it is Agency position that any deviation from the
label is at least technically a violation of the law. In a series
of Pesticide Enforcement Policy Statements (PEPS), the Agency has
exercised its prosecutorial discretion by defining those kinds of
label deviations against which enforcement action will not be taken.
The PEPS are meant to be an intermediary tool during the
transition period between the 1947 Act and the fully implemented
1972 amendments. As the transition period is extended, so is the
question of PEPS viability.
Agency Commitment. To help alleviate this problem, registrants
will be encouraged rather than discouraged to broaden label directions
during registration and reregistration, e.g., the phrase "... and
similar corn root pests" and "similar broadleaf weeds in the home '
lawn." This policy has been used in the herbicide area, and should
be expanded to other areas where applicable. The basic difficulty
to this approach is the reluctance of some registrants to broaden
labels because of potential liability problems.
A more fundamental approach to the problem would be to develop
a more flexible interpretation of "use inconsistent with the label."
The Report of the House Agriculture Committee issued after the 1975
oversight hearings specified that not all deviations from the label
should be considered a misuse, although the Report did not provide
any definitive guidance in this regard. During the first half of the
year, the Agency will give priority to reviewing the various views
on use inconsistent with the label. PEPS were designed primarily
with a relabeling completed in 10/76 or 10/77. If the process is
to run on longer we now expect to 1979-80 then other longer
term alternatives must be considered including a process of before-use
definition of what our reviewers have in mind when looking at label
directions, and giving advisory guidance to growers before the use as
to whether we consider it inconsistent or not.
-------
-3 fl-
it is likely that further Congressional direction will be
forthcoming this Spring in the absence of a finite solution
before that time.
e) Rebuttable Presumption Against Registration (RPAR)
Background
One of the most significant processes of registration/reregis-
trat ion, which is particularly intensive during the transition period,
is the screening of already registered products to determine if they
meet the "unreasonable adverse effects" standard of amended FIFRA.
Products which meet or exceed the risk criteria enumerated in the
Section 3 regulations undergo an intense risk/benefit analysis under
the auspices of the Office of Special Pesticides Review. If any of the
risk criteria have been triggered, the Agency may "presume" that the
product will pose unreasonable adverse effects on man or the environ-
ment. The registrant can rebut that presumption by demonstrating
that the risk is not present or that the risk, while valid, can be
mitigated so as to reduce actual hazard. Failing to establish that
the risk is invalid or can be acceptably mitigated, the registrant
also has the option of demonstrating that the benefits exceed the
risks of the product's use.
A notice of rebuttable presumption is not tantamount to
a notice of intent to cancel. It is rather a statement of the reasons
why the Agency presumes against registration, and an invitation
for the industry, other Government agencies, users, environmental
groups, and the public to provide benefit and risk data. The
process may last up to 180 days, during which time the pesticide
in question may continue to be sold.
Basically, RPAR is a five-step process:
1. Preliminary review of EPA data files and the relevant
literature to determine candidates;
2. Validation of the data to establish the trigger of the
unreasonable adverse effects criteria;
3. Notification of the registrant and the public of the
RPAR, via the Federal Register and solicitation of input;
4. Submission of rebuttal and/or supporting information by
the registrant and interested parties regarding risks and
and benefits; and
-------
-31-
Determination as to whether to register or deny registration,
or to initiate cancellation. If the decision is to proceed
with a notice of intent to cancel, the Agency must submit
the proposed notice to USDA and the Scientific Advisory
I'anel as mandated by tho 1975 FIFRA .imciulnuMit s. If tin-
decision is to proceed with reregistration, the public is
notified of the decision and the reasons therefore in the
Federal Register.
Seven RPAR's have been issued: Kepone, Chloroform, Chlorobenzilate ,
Endrin, BHC, 1080 and strychnine. Two chemicals (picloram and sperm
whale oil) have been cleared and referred to the reregistration
process.
RPAR Problem yl;_ What is an RPAR candidate & what is its status?
Discussion. RPAR candidates are those compounds which "appear" to
meet or exceed the "unreasonable adverse effects" criteria enumerated
in Section 3 regulations. They remain candidates until we examine
the data which we feel may trigger the criteria. If that examination
confirms that the data are good and do meet or exceed the criteria, an
RPAR is issued. If, on the other hand, we find that the data are not
good or do not meet the criteria, the product is returned to the
registration process.
Candidates were identified from three primary sources:
1. the Mrak report ("Report of the [HEW's] Secretary's Commission
on Pesticides and Their Relationship to Environmental Health",
1969);
2. "Bioassy of Pesticides & Industrial Chemicals for Tumorigenicity
in Mice: A Preliminary Note" done in 1969 for the National
Cancer Institute.
3. Referrals from chemical screening by the Registration
and Criteria and Evaulation Division in preparation for
reregistration.
Registrants have inquired as to the status of their products which are
on the candidate list as far as registration and reregistration purposes
are concerned.
-------
-32-
Agency Commitment. The following policy applies to candidates on
the RPAR list:
no RPAR candidate will be reregistered until it receives
clearance from the Office of Special Pesticide Review.
no new registrations involving an ingredient on the RPAR
candidate list will be issued unless the registrant can
demonstrate that there would be a positive environmental
or health benefit from the new registration.
RPAR PROBLEM # 2: Are too many candidates being identified
through the acute triggers?
Discussion. The Section 3 regulations at ง162.ll(a)(3) set out
three acute toxicity criteria which if met or exceeded, trigger the
RPAR procedure. However, it has been discovered that the criteria
are not serving their intended function as a screening mechanism
to select out those pesticides which should be subjected to an
intensive review. For example, one-third of the insecticides
have triggered at least one of the criteria.
Agency commitment. We are presently preparing a proposed regulation
change to modify the acute trigger criteria, which we plan to present
to USDA and the Scientific Advisory Panel in early 1977.
RPAR PROBLEM #3: How will benefits data be collected and
incorporated into the procedures?
Discussion. One important concern to the user community
is that EPA receive proper information regarding benefits of a
pesticide during the RPAR process. One of the primary purposes
of the RPAR review is, in fact, the consideration of benefits data
outside the adjudicatory process.
The Agency has been working with USDA to develop a system
which will facilitate the collection of benefits data from the
field. USDA recently announced the establishment of a national
pesticide assessment program to provide input to pesticide decision
making. This effort includes participation by seven USDA agencies,
land grant colleges, and agricultural components of state governments
-------
-33-
and other concerned organizations. Questionnaires will be sent
to participators requesting information on the benefits and risk
of RPAR candidates. The flow of information should also be augmented
by a data use system, which USDA predicts will be operational by
July 1977, and will be accessible through existing computer networks.
This system will advise participators of the current registration
status of pesticide products.
Agency Commitment. EPA has just completed a formal memorandum
of understanding with USDA. The memorandum outlines the specific
procedures for:
.exchanging existing benefits information,
.gathering new information where appropriate including
that for minor uses,
.introducing this information into the RPAR process.
A copy of the memorandum of understanding is Attachment IV.
RPAR PROBLEM #4: Why is the process behind the original schedule
and what does this mean in terms of the October 1977 date?
Discussion. According to the original schedule, 21 compounds
were to have been reviewed by October to determine whether or not
RPAR's should be issued. Unfortunately, the establishment and
staffing of the Office of Special Pesticide Reviews took longer
than anticipated. The Agency also found that the validation review
was more complex than originally thought and that grouping of compounds
on the list by major use patterns, e.g., fumigants, wood treatments,
cotton insecticides, would provide for more efficient and logical
decision making.
Agency Commitment. EPA has just published a new OSPR schedule.
Decisions on whether or not to issue RPAR's on that list will be
made by October 1977. A copy of the schedule is Attachment V.
f) Petroleum Distillates
PROBLEM: What will the Agency do in the reregistration of pesticides
containing petroleum distillates given potential of risk from PNA's?
Discussion. Petroleum distillates are contained in thousands
of pesticide products both as inert and active ingredients. Poly-
nuclear aromatic hydrocarbons (PNA) can be found in petroleum
distillates. Since some PNA's are carcinogens, the Agency is concerned
about the PNA content in pesticide products, and the associated potential
hazard.
-------
-34-
On September 21, EPA published a proposed method for detecting
PNA's through ultraviolet (UV) absorption. Each applicant for
registration and reiregistration of any product containing a petroleum
distillate would be required to provide the Agency with information
regarding the -PNA content of the distillate as indicated by the
UV absorption method. Registrants would also be required to keep
records of the UV absorbance of subsequent batches, which shall
be made available to EPA upon request. Public input to the proposed
action was solicited in the Register notice.
The Agency is evaluating: (1) the risks which petroleum
distillates may pose for man and the environment, (2) the type
and amount of exposure to petroleum distillates which the public
experiences as a result of pesticide products, and (3) the benefits
accruing from use of petroleum distillates in pesticides.
Agency Commitment. Because more than 20,000 products are
affected by the petroleum distillate question, it would unduly
interfere with the production of food and fiber to deny registrations
while the' risk is being assessed. Therefore, the Agency is preparing
a notice to appear in the Federal Register which in effect rebuts
the presumption against registration for cetain products and outlines
the data requirements which will be attached to conditional registrations
The petroleum distillate question is but an example of an
environmental problem which includes pesticides only marginally
(less than 1% of petroleum distillates manufactured are used in
pesticides). In all such cases, the Agency should have an overall
policy to resolve the entire problem. This dilemma will be further
explored as the Agency implements the new Toxic Substances legislation.
Petroleum distillates are also but an example of the general
issue of inerts-contaminants (e.g., HCB, dioxin, nitrosamine) which
fundamentally affects the registration/reregistration process. The
Agency's general approach in this area will be consistent with the
PNA situation, i.e., we will attempt to limit exposure while taking
appropriate steps to assess the risk.
g) Minor Uses
PROBLEM: How can the Federal Government assist in the registration
of needed products which are too minor to justify industry expense?
Discussion: The availability of pesticides for so-called "minor
uses" has long been a topic of concern to growers. In general, a
pesticide use is considered minor if its market potential is insufficient
to economically justify the development of needed data required for
registration by the manufacturer. Apart from data development,
industry is also concerned about high liability risk in cases where
damage may be great even though pesticide use is small.
-------
-35-
Before 1972, FIFRA did not require all uses to be Federally
registered and did not include penalties if label directions
were not followed. Section 12(a)(2)(G) of the amended Act now
makes it unlawful "to use any registered pesticide in a manner
inconsistent with its labeling." Under the earlier Act, too,
intrastate products were not regulated by the FIFRA, and many
minor use needs were registered by States. The problem is, then,
that it is now a violation of the law to approve minor uses via
many of the former techniques and the industry cannot justify
the expense of gathering necessary data to achieve Federal
registration. It is also anticipated that registrants will drop
some minor uses during the reregistration process rather than
meet new data requirements. While Section 24(c) of the Act
permits the States to register products for special local needs,
which include minor uses, such registrations cannot be granted
unless a tolerance for the food crop in question already exists.
24(c) thus is not a complete solution.
A cooperative effort to facilitate Federal registration of minor
uses has been underway for several years through the Interregional
Research Project group (IR-4) at Rutgers, sponsored by USDA and EPA.
Just a few years ago thousands of minor use pesticide products needed
to be registered. IR-4 liaisons at the various State Agricultural
Experiment Stations analyzed and prioritized these needs, and now
the current list for agricultural uses, which constitutes the major
part of minor use requirements, includes about 700 requests.
Agency Commitment. As a regulatory agency, EPA does not have
lead responsibility in obtaining the data needed to support regis-
tration; because of the difficulties in the minor use area, however,
we will facilitate the resolution of the problems as best we are
able. Toward this end, we will take several steps:
1. The Registration Division of OPP is assigning a
special manager to "shepherd" minor uses exclusively and to
address industry and user group concerns. The possibility of
grower organizations becoming registrants will be explored.
Instructional material to guide EPA reviewers will also be made
available to industry and other interested parties outlining how
minor use registrations will be handled.
2. A full time professional from the Registration Division
has been assigned to work in IR-4 for the next year to assist in
developing complete submissions to the Agency.
3. The 700 requests referred to above will, with the assistance
of EPA Regions and the States, be prioritized by the end of January
1977. The prioritized list will be sent to industry representatives
to determine their willingness to cooperate in registering/reregistering
the proposed uses. Attempts will then be made to identify adequate
-------
-36-
substitutes that will not be encumbered by minor use considerations.
These combined efforts will permit USDA, EPA, IR-4 and the industry
to focus their efforts in dealing with minor uses that are of priority
importance.
4. A similar prioritized list will also be developed in January
in cooperation with user groups for non-agricultural applications.
Since tolerances are not involved, the difficulties in registering
these uses are considerably less, although the liability issue
remains.
5. EPA is working with USDA to accelerate the cataloging
and release of registration use data. The data on registered uses
via microfiche is the current mechanism used to convey this use
information to the States and to user groups. The use computer
system described on page 28 could assist in collecting efficacy
and phytotoxicity data from the States. This combined system could
well ease the minor use and 24(c) problem by ensuring that users
have easy access to needed data on currently registered uses.
6. EPA will encourage Directors of State Experiment Stations
to apply for and employ broad, one-year experimental use permits
for uses related to those cited on the EPA, IR-4, USDA priority list.
7. Beginning in January 1977, EPA will begin providing brief
quarterly progress reports in the minor use area for Congress and
other interested parties.
8. EPA will discuss with the House Agriculture Committee
the possibility of creating a liability fund for minor use
pesticides and exploring such options as user group/non-EPA
Federal Agency registration during the next oversight session in
early 1977. This might be a means of relieving industry's concern
about liability from expanding current labels.
h) Intrastate Pesticides.
PROBLEM: How will EPA register the products currently being
marketed solely within a State without a Federal registration?
Discussion. On September 17, 1975, the Agency published a notice
in the Federal Register advising all manufacturers of intrastate pesti-
cides of the impending promulgation of new final regulations for the
registration and classification of pesticides. To provide for an orderly
transition from State to Federal regulation. The Agency has permitted
a manufacturers of valid State registrations to continue marketing
intrastate so long as they submitted a notice (within 60 days of the
effective date of the Section 3 regulations) of this intent to apply
for Federal registration. We would notify such registrants, at a later
date, when to submit a full application for registration.
-------
-37-
Agency Commitment. EPA will issue a Federal Register notice in
April 1977 requesting manufacturers of intrastate products to submit
an application for Federal registration.
F. Tolerances
Background. Section 408 of the Federal Food, Drug, and Cosmetic
Act (FFDCA) requires that a tolerance (allowable residue level) or
tolerance exemption be established for a pesticide that is added to
a raw agricultural commodity. A petitioner for such a tolerance must
submit to the Agency data on the pesticide's toxicology, residue, and
analysis. Toxicological data are also required by the Agency in
evaluating whether a pesticide meets the standards for registration as
set out in Section 3 of the FIFRA. Hazard evaluation performed to
meet the standards of the FFDCA cannot be inconsistent with hazard
evaluation performed to meet the standards of FIFRA. Thus, require-
ments for toxicological tests for pesticides which may result in
residues in food or feed, as articulated in the Section 3 regula-
tions and the Registration Guidelines, are equally applicable to
registration and tolerance setting activities. Similarly, the data
validation program which is aimed at reviewing the validity of data
for purposes of reregistration will also pass comment on the validity
of data for purposes of tolerance setting. The net result is that
the enactment of the '72 FIFRA and the promulgation of Section 3
regulations have blurred the sharp distinctions between regulation
and tolerance matters. FIFRA and FFDCA are intrinsically related and
the Agency must act accordingly.
Although it would be most desirable to review tolerances for a
chemical at the same time that its Chemical Review File is being
prepared, two factors argue against doing so: lack of resources to
perform both reviews simultaneously and the existence of uncertainties
surrounding the tolerance question. Rather than beginning a tolerance
review without full resolution of these uncertainties, it would be
better to delay the review until a comprehensive set of procedures
and policies is developed. Thus, we propose first to study the
current procedures and if necessary to amend them; and also develop
policies on how to handle interim tolerances, zero tolerances,
temporary tolerances, and existing uses which result in residues
on food or feed but for which no tolerances exist.
Agency Commitment. EPA intends to:
1. Complete a detailed description of present tolerance
setting procedures by January 1977.
2. Perform a comprehensive evaluation of the principles
underlying tolerance setting. The Environmental Health
Advisory Committee of EPA's Science Advisory Board will
be asked to undertake this task.
-------
-38-
3. Issue new procedural tolerance regulations taking into
account the Advisory Committee's findings by January 1978.
4. Systematically review tolerances chemical-by-chemical after
January 1978 independent of the reregistration process.
As part of the reregistration process, however, some steps can
be taken to improve the tolerance situation:
1. Labels will be reviewed to identify those uses which can
be expected to result in food or feed residues and for which no
tolerances exist. We will impose animal feeding or other restrictions
on the label where corrective action is found to be appropriate.
2. Toxicology data will be reviewed in-depth as part of the
data validation program for reregistration. If long-term data gaps
are discovered and if the pesticide does not exceed any RPAR criteria,
the pesticide will be conditionally registered for the length of time
necessary to perform and report additional testing. During this
period, the pesticide tolerances will remain in effect. They will
be reviewed again after the missing data are submitted to the Agency.
III. USE REGULATION
A. Background
Congress, in passing the 1972 Act, recognized that pesticide use
presented both benefits and risks to human health and the environment.
One of the major additions to pesticide legislation was the strengthening
of regulatory controls over the uses and users of pesticides.
The new Act accepts the premise that most pesticides, if
correctly registered and properly labeled, can be used by the
general public with the assurance that human health and the
environment would be adequately protected. These are general
use pesticides.
The Congress also recognized that there would be certain
pesticides and certain uses of pesticides which, because of their
potential hazard, should not be used by an applicator who does
not have the needed level of skill or awareness. They determined,
therefore, that such a use would be classified as a restricted use
pesticide. Under the Act, a person applying restricted use pesticides
would need to become a certified applicator or would have to use
restricted use pesticides under the supervision of a certified applicator,
or be subject to any other restriction deemed appropriate by the
Administrator.
-------
-39-
The Act provides that EPA shall establish standards for
certification, and that States shall conduct certification programs.
EPA published standards in October 1974 that must be met by private
applicators (farmers) and 10 categories of commercial applicators:
(1) agricultural pest control; (2) forest pest control; (3) ornamen-
tal and turf pest control; (4) seed treatment; (5) aquatic pest control;
(6) right-of-way pest control; (7) industrial, institutional, structural
and health-related pest control; (8) public health pest control; (9)
regulatory pest control; and (10) demonstration and research pest
control.
EPA published guidelines for use in developing State Certification
Plans in March 1975. After considerable controversy over methods for
certifying fanners, an amendment to the FIFRA was passed in 1975
authorizing training as an acceptable certification method. The
program is now generally well received and commendable progress is
being made.
A major advantage of certification is that it eliminates the
"all or nothing" approach to registration and cancellation decisions.
Rather than removing a pesticide from the market, or denying its
access to the market, the Administrator can restrict the uses of the
pesticide and be assured that the product will be used only by skilled
applicators. This in turn provides the degree of human health and
environmental safety needed to authorize the use of the pesticide.
B. Classification
The key to implementation of the State Certification Plans is the
classification of pesticide uses. In the future, all new products will
be classified restricted or general during the registration process.
The reregistration and classification of the more than 33,000 pesticide
products currently registered and on the market is underway.
Classification involves:
.establishing criteria for identification of restricted uses;
.evaluating the toxicity and the exposure from use patterns
against these criteria;
.considering the use history in terms of reports of adverse
effects involving the product;
.making an initial EPA determination;
.allowing registrants to consider this determination;
.discussing any disagreements; and
.making a final EPA determination.
-------
-40-
Thia process will continually change the number of restricted uses.
Uses will be added and removed as the registration and reregistration
proceM moves forward.
Several issues discussed earlier have caused serious delays
in registration. Consequently, classification, which is integral
to the reregistration/registration process, is about to get underway.
C. Certification
As indicated above, the amended FIFRA, Section 4, calls for
a cooperative Federal/State program to provide for the certification
of applicators of restricted use pesticides. Through concerted
technical and funding assistance from EPA to all States over the
past 2 years, major progress has been made toward the goal of
fully operational State plans nationwide by the October 21, 1977,
deadline established by Congress. To date, 47 States have formally
submitted plans to EPA for approval. Nine more States are expected
to submit plans during the next several months. Applicator training
programs have been established in all States and have achieved a
generally high level of acceptance among private and commercial
applicators alike.
Over the past two years, and in cooperation with the States and
the USDA Extension Service, EPA has developed and published a host
of training materials which can be used by the State Cooperative
Extension Services which have the major responsibility for training
applicators. The basic concept of this cooperative approach is that
EPA would sponsor the development of training materials which would
be an extension of our standards for certified applicators. These
materials would, therefore, of necessity be minimal in terms of
all the complex material that might be made available for presen-
tation. The States would then add their more specific requirements
to this "core" material. This concept has worked well and has
led to reasonable and well developed training programs in almost
all States.
It should be pointed out that training is not mandatory under
the Act. All States, however, have recognized the value of
training, education, and voluntary compliance, and have made
training a major component of their certification program.
-------
D. Use Regulation: PROBLEMS
PROBLEM t 1: How can the States certify applicators in the
absence of a definitive list of restricted uses?
Discussion. Training and certification of applicators are intended
to be directed at the proper and safe use of pesticides classified
for restricted use. It can be assumed that for-hire commercial
applicators will need to use one or more restricted use pesticides
in the course of their normal operations. The same assumption
cannot be made with respect to the so-called "non-commercial" and
private applicators. The result is that for-hire applicators are
participating in training and certification programs, while many
non-commercial and private applicators are not, deferring parti-
cipation until pesticides are classified and a determination can
be made as to the necessity of becoming certified. EPA long
ago recognized this likelihood, and in 1975 prepared and
distributed a list of active ingredients which presumably would
have one or more restricted uses. EPA intended that the list
would provide information, pending actual product classification,
sufficient to enable States to develop and implement programs
which would reach maximum numbers of potential users of restricted
use pesticides prior to October 21, 1977. However, there is
still uncertainty among States and applicators as to the final
result of classification, leaving training and certification
programs in many States short of the necessary momentum.
Agency Commitment. In conjunction with States, industry, and user
groups, EPA has for the past month been developing a more compre-
hensive listing of active ingredients likely to have one or more
restricted uses. The list was completed and distributed in
early December. It should provide greater certainty of classifi-
cation and thereby increase the impetus of State training and
certification programs.
It is important to note that a good "rule of thumb" to apply is
that an applicator using pesticides with "danger"and skull and crossbones
on the current label, labeled for use in aquatic environment or in
forests, or registered as fumigants, should plan to be certified since
these types of uses are most likely to be restricted.
-------
-42-
EPA recognizes the difficulty in frequent changes in the number
of uses that are restricted. Such changes create problems for the
Extension Service training the applicators, for the State Lead Agency
administering the program, and for the farmer who may or may not
require certification, depending on which uses are restricted. To
compensate for these difficulties, we have taken three steps:
1) ensured that certification of farmers is an uncomplicated adminis-
trative process with many options available to the States;
2) authorized an emergency program to allow an uncertified farmer to
purchase a restricted use pesticide under circumstances beyond
his control, and; 3) established a phasing concept in terms of
label changes to reflect the restricted use determinations, and
in terms of the date by which the purchaser must either be certi-
fied or be the agent of a certified applicator. It is the Agency's
intent not to require a label change in the middle of a growing
season which could disrupt or inconvenience applicators.
PROBLEM #2: What is the relevance of the October 21, 1977, date
to those States whose plans have been approved on a contingency basis?
Discussion. Of the forty-six plans formally submitted to date,
all but five have been or will be approved contingent upon passage
of legislation and/or promulgation of regulations. Most of the
remaining eight States will receive approval of their plans also
on a contingency basis. In order to have a fully approved and
therefore fully operational plan, a State must satisfy all contin-
gencies; that is, it must enact any necessary legislation and
promulgate all necessary regulations. Failure of any State to
accomplish these actions by October 21, 1977, will leave such a
State deficient in requisite legal authorities, thereby preventing
EPA from granting full approval to that State's plan. The effect
of this situation, in terms of law, may be the termination of that
State's authority to carry out Section 4 of amended FIFRA.
Agency Commitment. EPA will continue to review and provide comments
on all proposed legislation and regulations, testify at legislative
and public hearings when requested by a State, and take other
appropriate actions to ensure that all States have received infor-
mation and assistance necessary to achieve full approval status.
-------
-43-
PROBLEM #3:What will happen in a State without an approved
plan by October 1977?
Discussion. Despite the best efforts of this Agency and the States,
circumstances may arise in one or more States to prevent compliance
with all requirements necessary for full plan approval by the
October 21, 1977, implementation deadline for certification. It is
EPA's legal opinion that in such a situation EPA has two available
options: (1) to defer enforcement against use of restricted use
pesticides by uncertified applicators in States without fully approved
plans until such time as those States satisfy the requirements of,
and are granted full plan approval; or (2) to make certification
available through some other mechanism or combination of mechanisms
such as:
developing a Federal certification program
relying on the certification apparatus of a neighboring State.
Agency Commitment. EPA is fully cognizant of the ramifications of
these options. Decisions are being made, and policies developed,
to structure programs necessary to take action under both. Cir-
cumstances will dictate whether one or both options will be
exercised, but regardless of the course taken, the actions will
be based not only in law, but also in equity. Restricted use
pesticides will not be denied to those needing and qualified to
use them.
PROBLEM M; How will Federal employees be certified?
Discussion. In the State Plan Regulations published March 12, 1975,
provision was made for the Government Agency Plan (GAP), through
which Federal employees could become qualified for certification.
The act of certifying Federal employees would be carried out by
the individual States. The failure of GAP to generate much interest
among Federal agencies, and recent Supreme Court decisions rendering
tenuous the concepts underlying GAP, have caused EPA to consider
other approaches. The most viable approach is to treat Federal
agencies as States for purposes of certification. A Federal agency
would thus certify its employees under a plan developed in accordance
with the State Plan regulations and approved by EPA. Federal agencies
not desiring to develop a plan would have the option to voluntarily
submit to State jurisdiction for certification.
-------
-44-
Agency Commitment. EPA will prepare amendments to the State Plan
regulations to provide for Federal agency certification, and will
work with agencies wishing to follow this course in the development
of necessary programs and plans. These efforts arc underway.
PROBLEM #5: How will applicators on Federal Indian
reservations be certified?
Discussion. State jurisdiction on Federal Indian reservations
varies widely. The State Plan Regulations take note of this fact
and make provision for Indian governing bodies to develop their
own'certification plans or to enter into cooperative agreements
with States for the purposes of carrying out certification under
those States' plans. To date few Indian governing bodies have
exercised either option or made their desires known. At the same
time, little effort has been made by States or the Federal government
to inform Indian governing bodies of the requirements of Section 4
and the available courses of action.
Agency; Commitment. EPA will increase its efforts in working with
the Bureau of Indian. Affairs to contact Indian governing bodies
and to ensure the development of appropriate certication programs
on all1 Federal Indian reservations.
PROBLEM #6: How will EPA ensure that State certification and training
programs are being carried out in accordance with approved plans, and
that the purposes of FIFRA are being achieved?
Discussion. The submission and approval of State plans is only the
first step in implementing Section 4. The heart of implementation
lies in the conduct and quality of State certification and related
training programs. To ensure attainment of the goals of certification,
a system must be established not only to measure State adherence to
the provision of approved plans, but also to evaluate the qualitative
effectiveness of certification and training.
Agency Commitment. A guidance document is being developed to provide
the basic structure for Regional Office evaluation of State certification
and training programs. The evaluation will begin this winter. In
addition, a Request for Proposal (RFP) will be issued for a major
contract to provide base line data on quality of current pesticide use,
and to evaluate the overall impact of certification and training.
This second element of the contract will involve not only an evaluation
of the relative improvement in the quality of pesticide use, but also
an effort to determine the adequacy of various EPA and State
certification requirements in achieving the purposes of FIFRA.
-------
-45-
PROBLEM #7:Can States be expected to assume the full cost
burden of certification and training programs?
Discussion. Prior to the passage of amended FIFRA in 1972, few
States had in place or intended to establish comprehensive pesti-
cide use control programs. It can be fairly said that many, if
not a majority, of the States would not now be constructing such
programs in the absence of the FIFRA requirement that they do so.
The reasons are both political and economic. The Federal Government
proceeded to urge States to participate on a cost sharing basis
for start up costs, presuming that the States would then continue
the program on a maintenance basis solely with State funds. The
exact point of the termination of Federal assistance is difficult
to determine precisely, but it appears that continued assistance
at a reduced level is appropriate for FY '78 and perhaps FY "79.
Agency Commitment. EPA has received an appropriation of $4.6 million
in FY '77 for certification and training assistance, and will request
additional funds in FY '78 and consult with the States on FY '79.
The amount of funds to be requested for the latter two fiscal years
will be determined on the basis of joint EPA/States assessment
of need.
IV. ORGANIZATION
It is clear from the preceding sections that there are two
vital but nonetheless separate processes in pesticide regulation:
the scientific evaluation and the regulatory decision. Scientific
expertise is necessary to validate and interpret data; regulatory
judgment is necessary to apply the scientific evaluation to risk/
benefit decision making in which social and economic as well as
scientific factors must be weighed to reach final conclusions.
The scientist must be free to make scientific judgments and the
regulator must be able to apply the findings of scientific reviews
to the requirements of the law and regulations in drawing conclusions.
The most important tasks within OPP all require scientific
support. The reregistration process must look to scientists for
data validation and assessment of data gaps. The registration
and tolerance setting process for new applications and petitions de-
pends upon scientific evaluation of supporting data. The RPAR process
looks first for the scientific validation of the information
triggering the Section 3 162.11 criteria. In other words, there
are three major program elements responsible for regulatory decisions
which rely on scientific data validation and evaluation efforts:
1) registration/tolerances
2) reregistration;
3) OSPR
-------
-46-
Presently, primary scientific support is divided up among the
Criteria and Evaluation Division, the Registration Division, and
the Technical Services Division. Because of the priority need
for data validation and review which cuts across Division lines,
it is only logical to reassemble the bulk of scientific personnel
in a new Division which will be responsible for review of supporting
and hazard data. During the recent past, OPP has not had adequate
staff in certain critical skill pools to accomplish all of its
objectives in a timely fashion, a condition that has been worsened
by the fact that the program's human hazard and environmental effects
analytical talent is scattered across three Divisions.
For these reasons, OPP management has decided to seriously pursue
an.organizational regrouping of some critical functions and activities.
Principally involved are those scientists with the responsibility for
hazard evaluation and hazard data validation, and those scientists
involved in the aggregation of use data and the preparation of the
benefits cases under RPAR. However, to complete that effort most
responsibly, OPP must also look at the other segments of the
organization as well and take this particular opportunity to make
some necessary changes in location of some additional functions
which are supportive of hazard assessment and benefits case
preparation.
Accordingly, OPP has taken a first cut at some major changes
which appear not only desirable, but essential. Stated somewhat
simply, these changes would go generally as follows: The science
directorate in the Registration Division, (RD) with one exception,
along with the Metabolic Effects, and the Chemistry Branch, and a
portion of the Ecological Effects Branch in the Criteria and Evaluation
Division would be consolidated in a newly created Hazard Evaluation
Division (HED). A portion of the staff in RD's Efficacy and Ecological
Effects Branch would also be moved to HED. The Registration Division
would retain its Pesticides Registration Office structure largely
as is including the Special Registration directorate.
The pesticides use data expertise in the Technical Services
Division (TSD) would be combined with similar expertise and functions
now existing in the Plant Studies and Ecological Effects Branch
in C&E into a use data/efficacy - RPAR benefits program within
TSD. Just how that program would be actually organized is still
very much an open question. The Economics Analysis Branch would
be relocated to TSD, and would retain its Branch status.
-------
-47-
The Technical Services Division would retain the Health
Effects and Ecological Monitoring programs to which would be
added the Pesticides Episodes Reporting System now located in
the Operations Division. The laboratories now in TSD would
remain in that Division with the addition of the laboratories and
analytical reference program now run in the Registration Division.
The System Support Branch and portions of the Information Branch
would be transferred to a newly created Management Operations Division.
That portion of the Information Branch which would remain in TSD
are those functions with lead responsibility for use data collection
and analysis vis a vis RPAR benefits cases.
The newly created Management Operations Division would have
not only the responsibilities just mentioned but also those
functions presently vested in the Office of Program Planning,
Evaluation and Administration.
The Office of Special Pesticides Review would be given
Division Status, but would remain essentially unchanged. The
Operations Division would, except for the loss of the Pesticides
Episode Reporting Program to TSD, remain as it is now.
Separating the sciehtific from the regulatory functions
in each area will optimize the use of both scientific and
management skills. A proposed reorganization chart is
Attachment VI; OPP has asked for its employee's thoughts on
this proposal, and management in pursuing it with Agency and
Civil Service personnel experts.
-------
LIST OF ATTACHMENTS
I Summary of Problems and Commitments
II Summary of New Approach to Registration/Reregistration
III Label Conversion Schedule
IV USDA/EPA Memorandum of Understanding
V Revised RPAR Decision Schedule
-------
ATTACHMENT I
SUMMARY OF PROBLEMS AND COMMITMENTS
PROBLEM
PREMARKET REVIEW
COMMITMENT
DISCUSSION
PAGE #
A. Section 3 Modification
proposed by SSFIAC
Agency will make decision as to
what proposed changes are deemed
appropriate early '77
10
Tests which do not meet
minimum standards of
guidelines
Agency will encourage applicants
to consult before deviating from
Guidelines. Agency scientists will
judge on case-by-case basis and
document decisions
10
Applicability of Guide-
line stopastdata
Scientific assessment on
case-by-case basis
11
Making data requirements
widely understood
Issue Guidelines
Regional assistance to
registrants (PR Notice 26-2)
13
E. Organizing data for
reference
Catalogue data. Priority chemicals
by February 1977, entire file by
April 1977
17
F. Data validity
reliability
Auditing program
Proposed rules published
10/5/76
17
review depth
Chemical Review File
Level 5 Review
19
G. Data compensation
disputes
10/18/76 FR Notice assigning
ALJ authority to begin hearing
disputes.
Proposed 3(c)(l)(D) regulations
transmitted to Congress & USDA
11/76.
Assessing proposal to establish
identicality by sampling from
the marketplace.
Ask Congress to consider clari-
fying trade secret provision of
Act
23
Transition impacts on
registration, reregis-
tration, and tolerances
FR notice by February '77
stating new policy
24
-------
-2-
PROBLEM
I. PREMARKET REVIEW
COMMITMENT
DISCUSSIOTP
PAGE #
I. Status of previously
issued Guidance Packages
Agency will complete use
pattern summaries, data
summaries, literature
search, use history summaries,
data validation.
26
J. Labeling
format label
internal training
development of new home
use labels
27
Use inconsistent with
the label
Broaden label directions
where appropriate
reconsider "strict" interpre-
tation of 12(a)(2)(G)
29
Status of RPAR
candidates
No reregistrations until
fully processed in OSPR
No new registrations
containing candidate
compound unless clear health
or environmental advantage
31
M. Benefits data input
into RPAR process
Memorandum of understanding
with USDA signed 12/76
32
N. RPAR behind schedule
New schedule 12/76
Decisions on whether to
issue RPAR's by 10/77
33
0. Petroleum distillates
Method for detecting PNA's
outlined in 9/21/76 FR Notice
New FR Notice explaining policy
by February 1977
33
P. Minor Uses
Special contact for minor
uses in Registration Division
Full time professional from
Registration Division to IR-4
for 1 year
Prioritize needs of agricultural
uses
34
-------
-3-
PROBLEM
PREMARKT REVIEW
COMMITMENT
DISCUSSION
PAGE #
P. Minor uses (con't)
Encourage Experiment Stations
to apply for broad, one-year
experimental use permits
Issue quarterly reports be-
ginning 1/77 on minor use
situation
Discuss with Congress the
possibility of creating a
liability fund
34
Q. Intrastate pesticides
D. Federal applicators
needing certification
Will issue FR notice calling
for applications for Federal
registration 4/77
Treat Federal agencies
like States and develop
plans .
36
R.
II.
I.
B.
C.
Tolerances
USE AND CERTIFICATION
Restricted Use List
States which have
contingency Plans
as of 10/77
States which have no
plans as of 10/77
. New procedural regulations
by 1/78
. New list issued 12/77
Commit resources to help
States achieve fully
approval plans by 10/77
. Defer enforcement or
. Establish Federal plan
37
41
42
43
43
* E. Indian reservations
Increase efforts to
work with Bureau of
Indian Affairs
. P. Quality assurance
Regional training
Contract study
G. Colts
Assess needs with States
4r,
-------
12/10/76
HP ^ฃ'Y
Summary of New Approach dJ'a^jHki a
to Reg1strat1on/Rereg1station
1. Data requirements for new registrations and reregistrations
will be Identical. Since the same finding of absence of unreasonable
adverse effect must be made 1n each case, there really 1s no basis for
distinguishing between the two.
2. Pesticides considered for reregistration will require, at time
of application, general chemistry data and acute and subacute toxicity
data for mammals, fish, and birds. If other required data are not
available at time of application, the pesticide may be conditionally
reregistered for the length of time necessary to perform the requisite
testing 1f there 1s no Indication that the product may otherwise pose
an unreasonable adverse effect.
3. Old Chemical; Old use pattern: .New registrations of products
Identical to currently registered products will be treated in a similar
manner. The short term data described 1n 2 above will be required at
time of application. All other required data must be cited by the
applicant accompanied by a signed offer to pay statement. However, if
any data other than that described 1n 2 above are not available for
citation ~ I.e., the tests have not been performed then the
applicant will be granted a conditional registration allowing him
the time necessary to perform the required tests.
4. Old Chemical; New use: New registrations of products which
are not Identical to currently registered products but which contain
currently marketed active Ingredients will be treated as follows. If
the new pesticide 1s similar to a currently registered one i.e.,
-------
adds a new pest to the label or Involves a relatively minor change 1n
formulation then 1n addition to the short term data described 1n 2
above, data to support the efficacy of the new formulation against the
new pest will be required at time of application.
If the new pesticide Includes a new food or feed crop on its label,
the registration will be granted 1f the Agency determines that the
available data can support the safety of the additional use, and there
is enough data to support a tolerance under the FFDCA. Such factors
as the percentage of the diet contributed to by the new crop, the per-
centage of the Allowable Dally Intake already taken up by other food
uses of the chemical, and the results of recent Market Basket Surveys
will be taken Into consideration 1n making this determination.
Finally, if the new product Involves a changed use pattern, its
registration will be approved 1f data are available to evaluate the
safety of any additional human or environmental exposure caused by
the changed use.
In all cases, 1f data other than that necessary to make the above
determinations are not available at time of application, the applicant
will be given a conditional registration for a length of time necessary
to perform the missing tests.
5. New Chemicals: Pesticide products with new ingredients or
which otherwise do not fall into any of the above categories will
require the full range of data at time of application -- no conditional
-------
3
registrations will be approved.
6. Amendments will be treated according to the principles of 4
above for new registrations. That 1s, amendments Including formulation
changes of a minor nature, or additions of new pests or minor uses
will be approved conditionally 1f short-term data and additional
safety and efficacy data to support the amendment are available at
time of application.
If the amendment Involves a major crop or changed use pattern, a
scientific and regulatory judgment will be made as to whether the
additional risks Incurred by the amendment are offset by the benefits
for the period of time necessary for the applicant to fill data gaps.
-------
CONVERSION SCKEDULE FROM NON-CLASSIFIED TO CLASSIFIED LABELS
ATTACHMENT III
Classification Decision
Sent to Registrant
Reregistration
RESTRICTED USES
called in prior to May 21.
1977
May 21, 1977 - July 31, 1977
(assume all restricted
called-in by 7/21/77)
RD Label Approval
to Registrant
Label in Effect for
all Production
(60 days for submission
30 days for approval)
3 mo. after call-in
no later than Oct 21, 1977
GENERAL USES ' 3 mo. after call-in
called in after Jan. 21, 1977
., . . ! 3 mo. after call-in, no later
called in prior to Jan. 21, ! than April 21, 1977
New Registrations before
October 21, 1977
After October 21, 1977
Case-by-case extensions may
be granted upon submission erf
written justification to RD
(cans, labels molded into
plastics, etc.)
j
Upon completion of review
Upon completion of review
October 21, 1977
December 21, 1977
6 months after receipt
October 21, 1977
October 21, 1977
Effective Immediately
Label in Effect for
all Channels of Trade
December 21, 1977
February 21, 1978
Not Applicable
Not Applicable
October 21, 1977
Effectively Immediately
-------
ATTACHMENT IV
MEMORANDUM OF UNDERSTANDING
between
THE U.S. DEPARTMENT OF AGRICULTURE
and
THE U.S. ENVIRONMENTAL PROTECTION AGENCY
I. Purpose
The purpose of this Memorandum of Understanding is to formalize
the working relationship between the United States Department of
Agriculture (USDA) and the U. S. Environmental Protection Agency (EPA)
that provides for Improving the capability of both Agencies- to
conduct pesticide benefit/risk assessments. The Memorandum of
Understanding identifies, consistent with existing statutory
authority, the principles and policies of cooperation between
the two Agencies and describes the general management and
operational approaches that will govern the planning, approval,
underwriting and conduct of the cooperative effort to accomplish
mutually agreed upon objectives. This Memorandum is within the
context of the overall Memorandum of Understanding as signed by
the Secretary of Agriculture and the Administrator of EPA, July 31, 1974.
II. Background
The USDA is the prime Federal Agency with responsibility for assuring
an adequate supply and efficient production of food, fiber, forest
and other agriculturally-related products and improving the welfare
of rural people. EPA has lead Federal responsibility in regulatory
actions to protect the environment. The 1972 amendments to the Federal
-------
Infiecticide, Fungicide and Rodenticide Act provided EPA with the respon-
sibility for regulating the use of pesticides. Additionally, the legis-
lative amendments to the Act in 1975 (PL 94-140) provide that EPA must
notify the Secretary of Agriculture 60 days prior to publication in the
Federal Register of intent to cancel a pesticide product, except in cases
where the Administrator of EPA determines that there is an imminent
hazard to human health wherein notification is waived. USDA has 30 days
to respond. This response is to be published jointly with the EPA notice.
With those pesticides that are presumed to present an unreasonable
adverse effect on the environment, an accurate benefit/risk assessment
is required to determine whether or not the pesticides should be
registered. Such assessments are multi-disciplinary, involving input
from biological, physical and social sciences. In this Memorandum,
both Agencies recognize the importance of benefit/risk assessment, and
the desirability of a viable cooperative working relationship to
carry out designated responsibilities.
III. Policy
It is the policy of the two agencies that.they work together to develop
objective and accurate data and related information required for
benefit/risk assessments of pesticide uses and use patterns subject
to a presumption to refuse to register or to reregister. It is
agreed that this will be done in a manner which recognizes and utilizes
the capabilities of each agency to the greatest feasible extent in
either making resources available to the other agency or for the joint
-------
.3
planning and execution of activities. Consistent with its broad agricultural
responsibilities, USDA and States/universities are recognized as major sources
of information on pesticide uses, relative effectiveness of pesticides and the
importance of specific pesticide uses for agricultural arid forestry purposes.
When USDA notifies EPA that it is not able to" supply the necessary information
for uses such as industrial, home and garden, and agricultural, EPA may work
with any available data source. EPA is recognized as a basic source of
information on pesticide registration and environmental and health hazards
associated with pesticide use. Both agencies have important contributions to
provide on environmental aspects of pesticide use.
IJI Organization and Policy Management .
USDA will establish an appropriate mechanism to plan, manage, and conduct:
activities. This mechanism involves a Steering Committee composed of
Associate or Deputy Administrators of key Departmental agencies and
State/University representatives. This Committee will be chaired by
the Coordinator of Environmental Quality Activities, Office of the Secretary.
The Steering Committee will draw upon the technical expertise of key agencies
through a Technical Advisory Group. The Technical Advisory Group will be
chaired by the USDA Pesticide Coordinator. The Steering Committee will
establish Assessment Teams for pesticides or groups of pesticides requiring
* detailed assessments. The Assessment Teams will develop a plan of work.
The individual agencies, through membership on the Steering Committee,
will concur in plans of work and mutually approve the commitments required
to implement the plans of work.
-------
4
I
EPA will interface with the USDA Steering Committee in addressing policy
issues, delineating specific joint activities, and to assure that both
agencies are fully aware of ongoing efforts in the respective agencies.
Additionally, EPA will identify a contact person to interface with the
Technical Advisory Group and serve to facilitate information exchanges.
When Assessment Teams are in existence, EPA will also identify a person
at the technical level to interact with the Assessment Team Leader and
to assign EPA members to assure that all information relevant to the data
collection and assessment efforts are utilized.
It is understood that, as appropriate, individual sub-agreements to
this general agreement will be developed to identify individual
activities and resource commitments.'
*
V. General Guidelines and Provisions
It is agreed that:
a. EPA and USDA will share all available data and analyses
required for assessment work, but will be free to reach
independent interpretations of the information.
).
b. EPA will channel its requests for agriculture and forestry
related information and analyses initially through a central
office in USDA to be designated. Information in central data
banks will be made available. For other information needs
not in central banks, consideration will be given to formation
of assessment teams. Upon recommendation of the USDA/Universi-
ty Steering Committee, requests for information will be passed
to the States. Each state system will be free to clarify
the extent to which information is available and the ability
of their system to be responsive to requests from assessment
teams or EPA requests for other data. EPA will be advised
within 15 days if requested data cannot be made available
within the required time frame and/or when available data can
be delivered.
-------
c. USDA, States/Universities and EPA will continue joint efforts to
determine data requirements and availabilities in order to identify
data gaps and facilitate filling those gaps.
d. USDA and States/Universities will develop and provide to EPA new
data to the extent possible, given resources available in the program.
e. EPA will share on a continuing basis with USDA its timetable of
actions in the RPAR process and the bases for triggering RPARs.
f. EPA will inform USDA of decisions on pesticide uses which in turn
may be assessed by the States and USDA.
g. EPA will appoint a contact person to channel information requests
and exchange of information through the USDA Pesticide Coordinator
as Chairman of the Technical Advisory Group.
h. In cases where an Assessment Team is assembled by USDA, OSPR/OPP,
EPA will appoint an EPA technical person(s) to work with each
Assessment Team as deemed appropriate.
i. EPA will advise USDA of its intentions to secure needed data or
information in cases where an assessment team is not established by USDA.
Both agencies agree that;
*
1. Pesticide benefit/risk assessment is multi-disciplinary, in which
inputs from biological, physical and social sciences are desirable;
2. Accurate, objective benefit/risk assessments are desirable for
implementing certain provisions of FIFRA as amended;
3. The information flowing from the cooperative effort is subject
to jndependent agency assessment;
4. This Memorandum does not inhibit in any way the participation of
either agency in any hearing, litigation process or regulatory
action initiated under FIFRA as amended, or other State or Federal
statutes;
5. This Memorandum does not prohibit either Agency from obtaining
additional data that will be available to both parties;
6. This Memorandum doe's not alter or negate any existing agreements,
except as both agencies agree; and,
7. Working documents and/or clarifying statement:; regarding opera-
tional relationships will be developed, as appropriate, to
facilitate the cooperation agreed to in this Memorandum.
-------
6
VI. Funding
The specif ic .defcaJLls of the levels of support to be furnished one agency
by another with respect to funding will be developed in specific sub-agreements.
VII. Procurement Policies
Any program or project activities undertaken by USDA for EPA or vice versa
may involve contractual arrangements with non-governmental institutions.
When such arrangements are necessary, they will be conducted in a manner
consistent with policy, regulations and procedures of the contracting
agency.
VIII. Public Information and Coordination
Timely release of information to the public regarding activities
implemented under this Memorandum will be an objective of both agencies.
IX. Amendment and Termination
A. This Memorandum may be modified or amended by written agreement
between USDA and EPA.
3. This Memorandum may be terminated by mutual agreement between USDA
and EPA.
X. Effective Date
his Memorandum is in effect when signed by both agencies.
\
fa
Ub A Deputy Assistant Stfjretary for /EPA Assistant Administrator for
Conservation, Research and Education Water andHazardous Materials
November 26. 1976 December 2, 1976
Date Date
-------
ATTACHMENT V
IO1SED RPAR DECISION SCHEDULE
December 8, 1976
MAJOR USE CATEGORY
AMD CHEMICAL OR CHEMICAL CLASS
PLANNED RPAR
DECISION DATE
INSECTICIDES - CANINE
Lead Acetate
LINDAME
January 1, 1977
January 15, 1977
HERBICIDES - FOOD
Oiallate
Triallate
Pronamide
RODENTICIOE5
Arsenic Trioxide
INSECTICIDES - COTTON
Toxaphene
EPN
.-.'OOP PRESERVATIVES
Arsenic Pentoxide
Sodium Araenate
Ammonium Arsenite
Sodium Pyroarsenate
Pentachlorophenol and salts
Creosota and related compounds
HERBICIDES - COTTON DESSICANTS
Arsenic Acid
Paraquat
OEF
Merphos
FUNGICIDES - FOOD
EBOC
Benomyl
DISINFECTANTS - DEODORANTS
Safrole
February 15, 1977
March 15, 1977
March 15, 1977
March 15, 1977
March .15, 1977
March 15, 1977
March 15, 1977
-------
GRAIN FUHIGANTS
Ethylene Dibronide
Ethylene Oxide
Carbon Tetrachloride
HERBICIDES - WEED CONTROL
Monuron
Cacodylic Acid and its sodium salt
Oisodium Methanearsenate (OSMA)
Monosodium Methanearsenate (MSMA)
Calcium Acid ilethanearsonate
Monoammonium Methanearsonate (MAMA)
Amine Methanearsonate (AMA)
2,4,5-T and related compounds
FUNGICIDES - NONFOOD
Cadmium
2,4,5-Trichlorophenols
10,10'-Oxybisohenoxarsine
SOIL FIJMIGANTS
April 1, 1977
08CP
PCNB
INSECTICIDES - FOOD
Oimethoate
Carbaryl
Trichlorfon
ฐerthane
Rotenone
Calcium Arsenats
Copper Arsenate
Lead Arsenate (Standard)
Lead Arsenf.te (Basic)
INSECTICIDES - NONFOOD
Paris Green
Sodium Arsenite
Phenarsazine Chloride
INSECTICIDES - HOUSEHOLD
DDVP
Piperonyl Butoxide
April 15, 1977
April 15, 1977
April 15, 1977
May 1, 1977
May 1, 1977
June 1, 1977
-------
RPAR'S ISSUED
CHEMICAL DATE
Kepone VI9/76
Chloroform 3/24/76
Chlorobtnrilate 5/14/76
Endrin 7/19/76
BHC 10/12/76
Strychnine 11/22/76
Strychnine Sulfata 11/22/76
1080 11/22/76
1081 U/22/76
CHEMICALS RETURNED TO REGISTRATION DIVISION
CHEMICAL SATE
Picloram 3/21/76
Sperm Oil 11/15/76
VOLUNTARY CANCELLATION - SECTION 6(a)(l)
CHEMICAL ' DATE
OMPA 5/20/76
Strobane 6/18/76
Aramite Pending
Chlorvnil Pending
Capper Araenite Pending
-------
FIFRA
BE
office
pesticide
programs
march 7,1977
-------
FI.FKA: IMPACT ON THK INDUSTRY
TAI1LE OF CONTENTS
INTRODUCTION p. I
A. PART I
AVAILABILITY OF DATA FOR
USE AND DISCLOSURE p. 3
1. Background p. A
a) Patent law considerations p. 4
b) Patterns of pesticide
development & marketing p. 5
c) Early regulatory practices
and assumpt ions p. 6
d) Development of the present
statutory provisions p. 8
2. Issues Requiring Resolution p. 9
a) What safety, efficacy, and environmental
chemistry data should be available for
use by competitors under FIFRA? p. 9
b) What safety and efficacy data should
be available for examination by
the general public? p. 11
c) Should information concerning the
impurity content of technical-grade
pesticide chemicals be available for
use by prospective competitors and
disclosure to the public? p. 12
-------
B. PART II
DATA VALIDITY p. 15
1. Background p. 16
2. Pending Decision p. 18
3. Two Basic Options p. 18
4. Agency Pos it ion p. 20
5. Specific Treatment of
Classes of Applications p. 21
6. Potential Congressional Action p. 22
C. PART III
OTHER IMPACTS p. 23
1. New Product R&D p. 23
2. Integrated Pest Management p. 24
3. Application Technology p. 27
4. Child Protective Packaging p. 27
3. Users & Applications p. 28
D. APPENDIX
STUDIES p. 29
E. FOOTNOTES p. 32
-------
FIFRA: IMPACT ON THE INDUSTRY
INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticidi? Act (FIFRA)
regulates all pesticides marketed in the United Stntes. Statutory
and regulatory requirements of the law naturally affect the industry
which manufactures and distributes pesticide products. Congress has
expressed interest in just how the administration of the FIFRA
is impacting the industry as a whole, and particularly the small
businessmen involved in the pesticide distribution chain. This
paper addresses this Congressional concern, and will discuss the
major impacts of the legislation since the 1972 amendments to date,
especially those affecting the competitive atmosphere in the
pesticide industry.
PROFILE OF THE INDUSTRY
Over 1.4 billion Ibs. of pesticide are produced each year,
encompassing some 1400 active ingredients. These 1400 active
ingredients are contained in approximately 2500 technical products,
which are in turn formulated in approximately 40,000 end-use
products.
About 400 registrants produce technical material in a given
year which is purchased and formulated into end-use products
by about 4200 registrants. Some manufacturers of technical material
also formulate their own end-use products. Some ^0% of the active
pesticide producers depend upon the other 10% for supply
of the active ingredients.
The industry can be divided into two groups: those who gather
their own data, and those who rely on data developed by others.
Almost all data developers are large companies which can afford the
long-term testing required under the Act. The bulk of the long-term
data which form the basis for all these registrations is developed
by the approximately 30 companies which contribute to innovative
R&D in pesticides in the U.S. Most of these are large, multi-product
firms for which pesticides comprise less than 20%, and in some cases
less than 1%, of their total sales. Most formulators are small firms
which lack the resources necessary to perform the required tests.
-------
-2-
RELEVANT ISSUES
The registration regulations and guidelines impose costs throuch
testing requirements; this overall impact has been considered in the
preparation of the regulations implementing the reeistration, reregis-
trat ion, and classification regulations, and a cost impact estimate
of the proposed guidelines was published in the Federal Register
on August 22, 1975. This issue is discussed briefly in the Appendix.
However, the primary purpose of this paper is to address the two
major issues affecting the ability of firms to register products
and the amount of competition within the industry:
Availability of Data for Use and Disclosure to what extent
can and should data developed in support of registration be shared
among registrants and available to the public (this issue centers
on Sections 3(c)(l)(D), 3(c)(2) and 10 of the Act).
Data Validity what is the quality of the data on file with
the Agency, and can an applicant receive a registration for a
product identical or similar to one already on the market without a
validation of the entire data base.
These two issues are discussed at length in I'.-irts I and II of
the following paper. Other impacts of the F1FRA include areas
where competition could be either stimulated or impaired by EPA
actions: research and development, integrated pest management,
application equipment and techniques, packaging, and application
(commercial vs. private applicators). These are discussed in
Part III. Results of some recent and on-going studies are summarized
in the Appendix.
-------
PART I
AVAILABILITY OF DATA FOR USE AND DISCLOSURE
Formulators of end-use products desire to purchase Ingredients
at reasonable prices. So long as a patent covers an active
Ingredient pesticide chemical, the developer controls the market
and the price. Once the patent expires, however, the formulator
could expect that other firms would begin to produce the chemical
and thus the resulting competition would lower prices. For
several years this was the pattern in the industry; competitors
obtained "me-too" registration for technical-grade chemicals*
after the patents expired.
The trade secrecy allegations recently raised by the data-
developer firms have drastically changed this situation. Although
a formulator-applicant who plans to use the technical-grade
chemical sold by the data-developer can still obtain registration,
a formulator who wishes to obtain technical-grade material from a
different source will be stymied because his technical-grade source
will be unable to furnish him access to the necessary data and
he will not be able to obtain a registration. Thus, an essential
question is whether the data developer firm should be able to
control the market after his patent has expired by denying access
to the data he submitted.
Equally controversial Is the closely related issue of whether
this data should be available to interested members ot: the public
under FIFRA Section 3(c)(2) and the Freedom of Information Ar.t.
How these issues are resolved will, to a large extent, determine
how the pesticide industry in this country is to be structured, how
much the public will be allowed to know about the possible risks of
pesticides, and perhaps how much research will be carried out on
new pesticides.
EPA1s interest in a speedy resolution of the various sub-issues
that make up the uae-of-data controversy stems from a desire to be able
to conduct the registration and reregistration programs in an efficient
manner, and to shift Agency resources now occupied with use-of-data
matters to more environmentally-oriented tasks.
* The basic chemicals sold for manufacturing u.se nrr> offer referred
to as technical-grade chemicals, and normally contain some amount
of impurities, ranging from less than 1% to, on occasion, 207 or
more. The Impurities are present because of the high cost nm!
technical difficulty of producing commercial quantities of
active ingredient.
-------
-4-
This Agency believes that the issues should be resolved by
Congress. This discussion is Intended to describe how the controversy
arose, and to indicate likely outcomes in terms of the amount of
competition (and the range of public disclosure) with or without
legislative changes. '
i ,
BACKGROUND
The controversy has arisen because of the interaction between
the patent law, the patterns of development and marketing of pesticides,
the various provisions of FIFRA bearing on use and disclosure of data,
and the changes in data requirements that have occurred.
Patent law considerations.
A patent may be Issued to cover a newly-discovered chemical,
a newly-discovered use for a previously-known chemical, or a new
nethod for producing the chemical. New chemicals and new pestlcidal
uses are the kinds of patents with which we are concerned here.
A patent provides that during the 17-year period commencing
with the issuance of the patent, no one other than the patent's owner
can "practice" the Invention without the owner's permission. The
owner nay license others to practice the invention.
After the 17-year period expires, the patent law provides no
further protection; any firm can practice the invention, without
needing the prior consent of the patent-holder. This does not
necessarily mean that the patent owner has no remaining advantages;
he may have acquired valuable "know-how" that he can still license,
and he may have acquired marketing advantages due to his long
association with the product. However, he can no longer prohibit
unconsented competition in the market.
Developers of new chemicals or new pesticidal uses normally
take prompt application for patents, to avoid the possibility of loss
of rights through publication or independent invention by another.
In the case of pesticide chemicals, the patent normally issues well
before the developer has established, through long-term testing, that
the chemical is safe and effective enough to be registered under FIFRA.
Thus, there may be only 12 or so years of patent protection remaining
when the initial FIFRA registration issues.
The great majority of the important agricultural pesticides
were patented between 1945 and 1965. (Many of the products were
developed as a result of military research begun during World War II.)
Patents on many of the major pesticides have thus already expired, and
ore will expire in the next few years.
-------
-5-
Patterns of pesticide development and marketing.
Development of new pesticides is not easy. Discovery of a
chemical which is both effective against pests and adequately safe
for use occurs only Infrequently. The research and development
costs are great, and must be absorbed by the sale of successful chemicals.
When a firm does develop a promising new chemical and obtains a
FIFRA registration, there is every reason for that firm to promote its
sale and use during the remaining period of patent protection. The
firm will In most cases aggressively seek to develop and have approved
new uses of the pesticide (on crops or pests not originally the subject
of registration). Extensive advertising of the product is common.
A technical-grade pesticide chemical normally cannot be applied
directly for pest control; it must be dissolved, diluted, or otherwise
formulated into a product which is safe to the applicator, effective
in pest control, and adapted to desired methods of application.
The pesticide's developer may choose to formulate the chemical into
end-use products hiaself; he may decide not to engage in formulation,
instead reaping his profit from sale of the technical-grade pesticide
to firms specializing in formulating end-use products; or he may
choose to do both. Likewise, the patent-owner may choose to license
other firms to manufacture and sell the technical-grade chemical.
Each of these decisions will be made on the basis of profit maximization.
However, each technical-grade product which is to be sold in
commerce (by the developer or his patent licensee), and each formulated
product, must be separately registered under FIFRA. Each person who
seeks registration must demonstrate that the product he will offer for
sale is safe and effective. Unless formulators and license-seekers
can obtain FIFRA registration for such products, neither patent
licensing nor sale of technical-grade product will be feasible.
Thus, the patent owner has a powerful incentive to encourage these other
firms to use whatever data is necessary for the registration of their
products.
Once the patent expires, however, everything changes. There are
any firiป which might find it economically attractive to commence
production of a technical-grade product on which the patent has lapsed,
and to sell it in competition with the original developer. Because
these firms often do not maintain research operations, or have other
cost advantages over the firms who do, they could in many cases under-
sell the original developer. And all things being equal, the formulators
would prefer to purchase the lower-priced technical-grade chemical.
-------
These potential competitors cannot enter the market until they
can obtain FIFRA registration for their proposed products. And there
is absolutely no incentive for the developer to consent to the use of
his data for supporting these competitive registrationsinstead,
the incentives poinฎ in the opposite direction. Indeed, after patent
expiration the chemical's developer may desire to curtail whatever
competition already exists in the technical-grade market (from those
firms which were the subject of patent licenses granted earlier);
.On the other hand, the developer has no reason to attempt to curtail
the number of registrations of formulated (end-use) products, for each
formulator represents an existing or potential customer. The developer
merely desires to have control over the supply of the technical-grade
chemical.
It is perfectly understandable that a developer firm would
desire to lengthen the period of exclusive control of production of
the chemical beyond the 17 years the patent law allows. This may be
especially true when it is remembered that a portion of the 17-year
period may have been lost to pre-registration testing.
One can equally easily understand the lack of enthusiasm over
this kind of behavior on the part of the developer's potential
competitors, those who desire to enter the technical-grade market.
From their standpoint, the developer has obtained his due reward under
the patent law; now he wants to start all over in reliance on a different
kind of protection, that which can be obtained by denying access to the
test data required for FIFRA registration. If a prospective competitor
can be required to perform duplicate tests as a condition of market
entry, in most cases the potential profits will not justify the expense
of this duplicative testing and the developer will retain control
over production and price levels.
Early regulatory practices and assumptions.
Some of today's problems concerning use of data can be traced to
the practices and attitudes developed by both industry and Government
during the period prior to the 1972 amendments.
The system of registering each product individually developed
under the 19A7 FIFRA, at a time when most of the important agricultural
pesticides were still protected by patents owned by the major producing
firms. For the reasons noted earlier, these firms were anxious to
maximize production and use of their patented technical-grade chemicals ,
and many registrations were issued for formulated end-use products
containing these chemicals. It became routine practice for developer
firms to allow formulator applicants to rely on the data already on
file concerning the composition of the technical-grnde chemical.
-------
(This composition data was not publicly disclosed by USDA, which
treated it as trade secret.) USDA officials also routinely
considered the other data (that pertaining to safety and efficacy) in
Support of formulator applications, without authorization of the
technical-grade chemical's developer. This is understandable in the
context of the times, because it normally would have been safe to
assume that the data developer was anxious to have the formulated
product registered, and to have the formulator as a customer. Moreover,
during the early years of administering the 1947 FIFRA, the testing
requirements were not nearly as stringent as they became starting in
the raid-1960's. Thus, the data barrier would not have been formidable,
even if the data developer objected to other firms' use of existing
data.
But as time went on, two things changed: long-term testing
requirements were Imposed, and the patents began to expire. By
the early 1970's, firms which had held the patents could see that
their control over production would soon expire. These firms
suddenly became very concerned about the use of their test data
and composition statements by EPA in support of other firms'
registrations.
EPA (like USDA before it) had continued to process registration
applications on the assumption that it was proper to rely on any
teat data in its files. (The 1947 FIFRA, after all, made no mention
of this practice, speaking only of the confidentiality of the formulas.)
In fact, under the 1947 FIFRA, products were routinely registered
without any scrutiny of the underlying data, if there already existed
a product registered for the same use patterns. Other prevalent
assumptions at the time were also involved. One was that the potential
hazard from a pesticide was associated only with the active Ingredient
of a product, not with the accompanying impurities. This led to the
Idea that if one firm's technical-grade product containing a particular
active ingredient was safe, so was another firm's technical-grade product
containing the same active ingredient.
Application of these various assumptions ultimately led to the
registration of various technical-grade products made by firms other
than the original developer, both those holding patent licenses and
those which entered the market after the patent had expired. Many
of these "me-too" reaistrations of technical-erade products now exist;
the registrants have never performed their own tests on these products.
All these products will be subject to fresh examination at reregis-
tratlon.
-------
Development of the present statutory provisions.
In 1971-1972, during the debate over the amendments to FIFRA
then under consideration by Congress, the National Agricultural
Chemicals Association (NACA) urged adoption of a provision that
would have required the data developer's consent before test data
could be used to support the registration of a pesticide product.
NACA argued that the then-current EPA practice of allowing applicants
to rely on data developed by the original registrant was causing
pesticide firms to abandon their research and development programs.
NACA argued that this trend would be accelerat ed by the public
disclosure provisions of the amendments (which ultimately were enacted
without change as$3(c)(2) ). NACA did not oppose the disclosure
requirements, but argued strongly for the "exclusive use of data"
approach. The bill which passed the House in late 1971 contained
an "exclusive use" provision, and the same approach was initially
favored by the Senate Committee on Agriculture and Forestry.
However, the Senate Committee on Commerce strongly opposed it,
arguing that "exclusive use" would grant the original data developer
a practical monopoly for a period extending well beyond the 17-year
patent term. The two Senate committees arrived at a compromise that
became law as ง3(c)(l)(D). It provided that test data was to be
available for use by all applicants (mandatory licensing) , but required
those applicants who had not obtained the data developer's consent to
offer to pay the developer reasonable compensation.
In 1975, $3(c)(l)(D) was amended to provide that the limitations
it placed on the Administrator's consideration of data did not apply
to data received by EPA (or its predecessors) before 1970.
The 1972 amendments made both the public disclosure provision,
ง3(c)(2), and the mandatory licensing provision,ง3(c)(1)(D), subject
to one crucial exception: EPA could neither disclose to the public,
nor consider in support of another firm's application, data which
"contains or relates to trade secrets or commercial or financial
information obtained from a person and privileged or confidential."
It is the meaning of this "trade secrecy" exception, and the
interaction of it with $3(c) (1) (D) and ง3(c)(2), which has served to
fraae the present controversy. Congress did not define what kinds of
data were to be treated as "trade secrets."
-------
-9-
The
FIFRA amendments also put an end to the practice of
sssr ฃ
relied on.
The large pesticide producers (the firms which generated most
z ฃE r ^ ssi !^ ^r^rt^
passes any and all test data which the firms have ปซ' voluntarily
snsi
the reasonable compensation plan of 53(c) CD (fl)
The data developers' primary concern appears toj>e control over
the domestic technical-grade market. However they have opposed not
only u7e of data by other firms, but also disclosure of the data to
tne p^lic. The sole argument against public disclosure of teat
data! insofar as EPA is aware, is the possible usefulness of such
data to firms seeking to register products in other countries.
(ToKicity data is apl to be most useful in foreign regl ^^
Data on efficacy and environmental chemistry may be of little use,
because of the different weather and soil conditions, pest strains,
crorvarieties , and application methods prevalent in other countries.)
ฃ2. ฃ value of tSs data for purposes of preserving market .shares
in foreign countries must be balanced against the right of th*8
country's citizens to critically examine the toxicity data and other
information concerning pesticides used here. The Toxic Substances Control
lit It ATT" * jjLtlfl. ^ซdLi!ซซ t**t health ซnd Safety data on marketed
^^Cfc 9 *ป -^^^^^^^"*
products must be publicly disclosed.
ISSUES REQUIRING RESOLUTION
1. What safety, efficacy, and environmental chemistry data
should be available for use by competitors under FIFRA?
The kinds of hazard- related data that must be submitted or cited by
an applicant for reregistration or new registration include short-term,
acute toxicity studies; 90-day subacute toxicity studies; and often
long-term (normally 2-year) feeding studies designed to show whether
prolonged dietary exposure to the product produces cancer or other
adverse health effects. Such studies are performed using rats, mice,
or other test animals. In some cases, depending on the proposed use
-------
10
patterns, studies must be done of the effect of the pesticide on fish
and wildlife, and on the "environmental chemistry" of the product (its
behavior in soil, degradation time, etc.). Efficacy studies, showing
that the pesticide is useful against pests but not unduly harmful to
'desirable life forms, must be furnished. Finally, in the case of
products for use on agricultural commodities, or to which livestock
or poultry will be exposed, studies must be performed dealing with
such things as how the chemical is metabolized (chemically changed)
by food plants or feed animals, studies of pesticide residues which
result from the product's use, and studies showing the waiting periods
which must be eaployed after use of the pesticide to avoid unacceptably
high pesticide residues in food plants, meat, poultry, milk, or eggs.
EPA has taken the position that it was Congress* Intent to
make this information subject to the mandatory licensing procedure
of$3(c)(l)(D), and that Congress did not therefore Intend that data
of these types should be regarded as trade secrets. I/* However, most
of the major pesticide firms have commenced litigation alleging that
this data is trade secret. If these firms are successful, and the
test data is held to be immune from the mandatory licensing provisions,
true competition in the technical-grade pesticide market in the future
will be greatly diminished. The expense and delay incident to duplica-
tlve testing may effectively preclude market entry; only those firms which
"own" the data, or are able to come to terms with the data owners and
obtain permission to rely on the data, will be able to either enter or
stay in the market.
If Congress desires not to promptly encourage competition,
it need do nothing; the present law will continue in effect, and the
cases will wend their way through the courts. During the year or more
that the litigation will require, EPA will be able to register only
those products which have the blessing of data developers. EPA anti-
cipates that it will prevail in the litigation, but this result cannot
be guaranteed.
On the other hand, if Congress desires to resolve the matter
promptly in favor of increased competition in the production and
sale of technical-grade pesticides on which the patents have expired,
it should amend FIFRA ง3(c)(1)(D) by deleting the prohibition on
the Administrator's consideration of trade secret data. This will
facilitate competitive registrations, whether or not the data may
be publicly disclosed. 2/
* Footnotes are found at the end -of the paper.
-------
-11-
2. What safety and efficacy data should be available for
examination by the general public?
This Agency firmly believes that Congress, in enacting
FTFRA ง3(c)(2) in 1972, intended to make it possible for interested
members of the public to examine the actual data which is submitted
in support of the safety and efficacy of registered pesticides, and
therefore to encourage public understanding and criticism of Agency
decision-making as well as to increase the knowledge of risks and
benefits of pesticide use.
Public disclosure to supporting test data is fully consistent
with the licensing-and-compensation scheme of ,ง3(c)(1)(D). Disclosure
of data does not in any way diminish the right of a data developer
to be paid reasonable compensation for the use of the data by another.
In fact, by allowing a prospective user of the data to examine itp
disclosure of the data would facilitate data-sharing and would make
more likely the negotiation of acceptable compensation terms.
Some have suggested that only summaries of this data should be
disclosed. This would not assist those Interested in assessing the
validity of the data; it is the detailed data which must be
examined if public scrutiny is to serve any useful purpose.
EPA1 s position is that trade secret status should be routinely
afforded only to truly secret information concerning manufacturing
processes (and, perhaps, to the list of deliberately-added inert
ingredients in formulated, end-use products). The remaining data
needed to support a registration, including the data describing
the toxlcity of a product, its environmental behavior,.and its
efficacy, should be routinely available to the public once registra-
tion has been granted. This approach would be consistent with that
recently adopted under the Toxic Substances Control Act.
The procedural aspects of data disclosure are nearly as
important as the substantive issue of which data may be disclosed.
The present law, which requires disclosure of all data except that
which is trade secret (but does not define what data is trade secret) ,
encourages Judicial review. At present, most of the large data-
developing firms are engaged in litigation seeking to enjoin
EPA from disclosures of data. Some of these firms are arguing
that they are entitled to a complete evidentiary trial in
court to establish the facts concerning the confidentiality uad the
val'ie of each item of data in question. It is EPA's position that
the data is publicly available as a matter of law, i.e., that the
statute, properly construed, requires disclosure of the data. However,
if EPA does not prevail on that issue, full evidentiary hearings will
be the result whenever EPA proposes to disclose any item of data against
the data developer's desires.
-------
-12-
If Congress desires to clarify the matter in favor of disclosure,
It should amend FTFRA 10(b) to state that all data pertaining to the
properties, safety, behavior, or efficacy of a registered pesticide
is publicly available, except for those specific portions of an item
of data identified by the submitter as information which, if disclosed,
would divulge details of secret manufacturing methods or quality con-
trol procedures having competitive value to the data developer.
3. Should information concerning the Impurity content of
technical-grade pesticide chemicals be available for use
by prospective competitors and disclosure to the public?
Some large data-developing firms have recently argued that
toxiclty test data pertaining to one firm's product (even if
it is not trade secret) is simply Irrelevant, in a scientific sense,
to the question of the safety of another firm's product containing
the same active ingredient, because of the possible presence in
the second product of toxic impurities. Thus, they allege,
Firm B should be required to perform a complete battery of toxicity
tests on its product, and should not be granted registration on the
basis of tests on Firm A's product. If accepted, this argument
would tend to severely limit competition in the technical-grade
pesticide market.
Traditionally, toxicity testing has focused on the possible
adverse effects of the pesticidally-active ingredient which composes
the bulk of a technical-grade chemical. (Most toxicity testing is
performed using technical-grade chemical as the substance fed to
test animals.) However, this Agency has become increasingly
concerned about the possible adverse health effects attributable to
the impurities that are present In technical-grade chemicals.
These toxic effects may be either of an acute or chronic nature.
Certain dloxln compounds (present as impurities in some herbicides
unless very careful manufacturing precautions are taken) are among
the most acutely toxic substances known, and also have chronic
adverse effects. Some nltrosamlne compounds, present as impurities
in various pesticide products, are highly potent carcinogens, and
there are other highly carcinogenic pesticidal impurities. It is
likely that this concern with Impurities' toxicity will continue to
grow as more becomes known about their presence in pesticides.
Because of this concern, EPA has concluded that in the future
its registration decisions must take into account the toxicity of
possible Impurities that may be present in marketed quantities of
pesticides. Applicants will be required to state the maximum
limits for the various impurities that they will allow to be
present in marketed products, and the Agency will, base its health
evaluations in part on the impurity limits the applicant furnishes.
Enforcement action will be taken against firms whose marketed
products are found to contain impurities in excess of the limits
the applicant prescribed in Its application.
-------
The various toxicity studies required for registration differ
in their ability to demonstrate the toxicity of impurities. A
highly acute toxic impurity may demonstrate its effects even
though It is present in a test substance at very low concentrations.
On the other hand, the long-term animal feeding studies (especially
studies designed to show the possible carcinogenicity of the
pesticide) probably are only marginally useful in demonstrating the
safety of impurities. For one thing, these tests are, for reasons
of economy, designed to produce evidence of possible toxicity by
use of relatively small "test populations" of animals; to do this,
It is necessary to provide the test animals very high daily
dosages of the technical-chemical test substance. But the test
substance Is, of course, mostly comprised of the active ingredient.
Impurities are often present In the test substance at very low
concentrations, and therefore a finding that tested animals showed
no chronic adverse effects may demonstrate very little about the
toxicity of the impurity even though it says a great deal about
the safety of the active ingredient. Higher dosages of the
Impurity might demonstrate that it is indeed chronically toxic.
Moreover, any given sample of a technical-grade chemical,
including the lot used as the test substance in long-term feeding
studies, may happen to be free of impurities that would be found
in other lots of the same firm's technical-grade product. In
short, a "negative" long-term feeding study Is much more persuasive
of the safety of the principal active ingredient than of the
innocuousness of the various possible impurities in the marketed
product.
Limitations on availability of test facilities, as well as
cost considerations, make impracticable the theoretically-desirable
requirement of complete testing of impurities. FPA's hazard
evaluations of impurities will sometimes have to be. made in the
absence of hard data, and will have to be based in some cases on
the presence or absence of chemical characteristics known to be
Indicators of hazard.
Assuming that, using modern hazard criteria and evaluation
methods, EPA has concluded that Firm A's technical-grade product
(with its certified impurity limits) is safe enough to warrant.
registration or reregistratlon, how should EPA respond when a
potential competitor, Firm B, requests registration for its own
technical-grade product containing the same active Ingredient?
As already noted, Firm A may argue that EPA should deny
registration until Firm B has thoroughly tested the new product.
There is some merit to this argument, if one assumes that Firm B's
product will contain more or different impurities than Firm A's.
A new battery of tests Just might demonstrate that Firm B's
product is more toxic, because of Impurity differences.
-------
-14-
There are, however, counter-arguments, aside from the obvious
limiting effect on competition that required new testing would have.
First of all, Firm A's own product may contain Impurities that were
not present In the test substance used for Firm A's tests; thus,
the logic of the alleged need for testing by Firm B would lead one
to conclude that Firm A must also perform a complete new set of
tests on his current product.
Second, it will be remembered that the safety decision
concerning Firm A's product was based on an EPA evaluation of the
likely hazard of all the Impurities that Firm A indicated might
be present in its product as marketed. If EPA could be assured by
Firm B that Its product's Impurity levels would fall within the
limits already found safe with respect to Firm A's registered
product, the hazard decision would be easy to make. However, Finn
B cannot easily make this certification unless it is able to
ascertain what those approved limits are and whether its quality
control methods allow it to conform to those limits.
Under the present law, EPA cannot routinely disclose
information on the formulas of products. Such formula Information
would be available to Firm B only in the event that Firm A, when
queried, is unable to demonstrate that the formula is In fact
"secret" or unable to show likely competitive harm in the event of
the formula's disclosure. Each such determination must be made
individually and can be appealed in court, where Firm A would
probably be entitled to a full evidentiary hearing. Because of
the startling advances in analytical methodology, most
commercially-useful formula information is probably not truly
"secret" anymore; but establishing this in court can be an arduous
process under present law.
Accordingly, If Congress desires to encourage competition in
the production of technical-grade pesticides, it should amend
FIFRA SlO(b) to make clear that, as a matter of law, EPA may
routinely disclose to the public the Impurity limits which a firm
has stated may be present In commercial quantities of Its
technical-grade product (or at least those that pertain to any
product no longer protected by a U.S. patent).
EPA believes that requiring disclosure of impurity content
would also serve the general public's interest in knowing which
chemicals reach the environment as a result of pesticide use.
-------
-1 5-
PART II
DATA VALIDITY
Before registering a pesticide, the Administrator is required under
J3(c)(5) of the Act to find, among other things, that the product will
not pose "unreasonable adverse effects" on man or the environment. In
order to apply this standard prior to registration or reregistration,
the Agency must determine:
how much data are required in order to make a S3(c)(5) finding;
to what depth should those data he reviewed prior to a
reregistration decision; and
in registering a product, is the Administrator making a
determination that the active ingredient is not posing an
unreasonable adverse effect, or that the individual
product considering that the environmental burden of that
active ingredient is actually posed by the aggregate of all
products on the market will pose an unreasonable adverse
effect. In other words, should the Agency consider the whole
hazard of the active ingredient, or consider the incremental
hazard of the product for which registration is pending.
All these considerations are important to the competitive situation
among pesticide registrants, and particularly to pesticide formulators
who do not submit their own data to support product registrations.
With full reregistration, and the accompanying data review, being
stretched years into the future, the Agency is at a critical juncture
in deciding how to treat applications for pesticides which utilize active
ingredients that are also found in products already on the market.
If, on the one hand, the Agency requires all the data on the active
ingredient, the formulator may find it impossible to comply, since some
of the data may never have been generated by any registrant. Meanwhile,
since the Act contemplates that registrants already on the market should
have time to gather missing data, they enjoy a distinct competitive
advantage. Even if a formulator can cite data submitted in the past,
it may be that EPA will be unable to validate the data for reregistration
purposes for three or more years. Because of the Agpncv workload, it
would not be reasonable to take the data in question out of its scheduled
review sequence; but neither is it desirable to inform an applicant
that his application cannot be processed for three years. From his
standpoint that would be unreasonable.
-------
- h-
On the other hand, the Agencv could permit new registrations of
products utilizing active ingredients already on the market until
such time as all products containing the active ingredient are
scrutinized during the reregistration process. This option would
favor a competitive situation within the industry; further, it can
be argued that this option would not jeopardize environmental quality
in that it is the active ingredient as a whole from all sources of
its use which is or is not posing an unreasonable adverse effect, and
thus all products containing that ingredient should be evaluated at
the same tine. The legality of the latter option has been questioned
by one Congressional Committee. The Agency is pursuing development of
an approach incorporating conditional registration. This consideration
is at the heart of the resolution of the so-called "double standard"
problem: should products registered under the 1947 Act have the advantage
of remaining on the market while their data base is being verified,
when identical or similar products are denied access to the market-
place until the 1972 FIFRA standards are fully met. Congressional
affirmation of the Agency position would help break the registration
logjam.
BACKGROUND
Why has data validation become an issue and what does it mean
in terras of competition?
The original reregistration program was based on the assumption
that data on file were accurate and reliable and had been reviewed
internally in a thorough manner according to still valid scientific
principles. The section 3 regulations thus made a distinction in
the data requirements for new registrations and reregistrations in
order to ease the administrative burden of reregistering 30,000+
pesticides (by October 1976). While a full range of data would be
necessary to support ah application for a new registration, a much
more limited range of data would be sufficient to support an
application for reregistration. It was felt that #ivpn a product's
prior registration and its use history, the ง3(c)(5) safety finding
would be adequately met until full compliance with the data
requirements could be achieved.
To ensure that reregistration would proceed in an orderly and
systematic manner, products were grouped into hatches on the basis
of similarity of formulation and broad use patterns. At a scheduled
time an entire batch would be called in for reregistration. In
addition, active ingredients were assigned to one of five categories
based, on a review of data to determine simply whether data existed to
meet the data requirements: Category I, all data requirements filled;
Category II, long-term data gaps; Category III, short-term data gaps;
Category IV, rebuttable presumption against registration (RPAR) (presume
not to reregister); Category V, unreviewed. Because of our assumption
that the data were generally reliable, the review did not actually
-------
-17-
exaraine the quality of the data on hand. A preliminary call-in schedule
for the batches and a list of active ingredients in the five categories
were published in the Federal Register on February 17, 1976. . '
1 ' :i N
However, as reregistration began, it became incrf.-isingly. apparent.
that the distinction between data requirements for new registrations
and reregistrations was creating serious inequities for producers of new
products. Registered products could be conditionally reregistered and
marketed pending the completion of long-term testing but identical new
products could not be registered without full submission of data, some
of which have not yet been developed. To alleviate this situation to
some extent, the Agency issued a General Statement of Policy - Data
Requirements for Registration in the Federal Register on May 27, 1976.
This notice provided for the conditional registration of new pesticide
products which were identical or substantially similar to currently
registered products which had been reviewed and found eligible for a
full or conditional reregistration (that is, products with no data gaps
or only long-term data gaps). Products not identical or substantially
similar to presently registered products still required the complete
submission of data prior to registration. Like full and conditional
reregistration, conditional new registration relied fundamentally on
the reliability of the data in Agency files.
However, early in 1976 new information came to light which
questioned the assumptions of the registration and rerogistration
process. Senate hearings, discussions with GAO and FDA concerning
the reliability of certain data submitted to FDA, and a subsequent
preliminary report of an independent toxicologist on a sample
of pesticide data raised serious doubts about 1) the adequacy
of the testing in EPA files, and 2) the completeness of the Agency's
own review and follow-up. Since then, in December 1976, the staff
of the Senate Subcommittee on Administrative Practice nnd Procedure
has issued a report stating that the Agency has, in fact, been
negligent in its public duty by not reviewing all data in depth
prior to reregistration.
In August 1976, reregistration was halted because the Agency
decided it was noto necessary to actually review the data in our
files. There are several important consequences of the Agency
commitment to this review.
. The May 27, 1976, policy statment is basically inoperable,
because all products are back in Category V (unreviewed). New
products utilizing chemicals already on the market are thus not
eligible for conditional registration, since the supporting data are
not reviewed.
. Reregistration will take far longer than was originally
anticipated. A recent zero-based program analysis indicates that,
at current resource levels, the task will take 10 years or more.
-------
. It is no longer reasonable to have different requirements for
registration and reregistration. Policies which would have worked
during a short transition period will not be equitable in a lengthy
transition. The removal of the distinction between registration and
reregistration requirements has also been recently required by a recent
Federal District Court injunction.
. Because of the large amounts of efficacy data which are on file,
considerable resources would have to be dedicated to complete validation
of those tests. EPA believes that except for public health and
disinfectant type products, the user community can best judge
a product's efficacy, based on local conditions and pest resistance.
Because of this and because a manufacturer would not find it in his best
interests to go to the expense of registering a product which did not work,
public resources can most effectively be put to use in hazard rather than
efficacy evaluation of products other than public health/disinfectant uses.
The length of time necessary for reregistration and the
complexities of handling individual registration actions resulting
from the trade secret disputes have led the Agency to the conclusion
that a new approach for regulating pesticides in this country is
in order. Specifically, Agency resources could best be utilized if
devoted to intensively reviewing technical products rather than
end-use products.
CURRENT PENDING DECISION
Currently registered products may remain registered ant! on
the market pending completion of data review and registration;
in this respect, they are not seriously affected by data validation
problems. Similar new products are in a much more difficult situation.
On the one hand, we could ask registrants of new products utilizing
old chemicals to provide all required data. On the-other hand, we
could just request data corresponding to the difference (e.g., new
target pest, new site, new method of application, new formula, etc.)
between the new products and those already on the market. The choice
of one of these two general options (or some combination of each) will
have a significant effect on the structure of the pesticide chemical
industry.
IMPACTS OF TWO BASIC OPTIONS
Option 1: Require full data submission or data citation for every
application for registration.
For individual pesticide producers, this means that where
long-term data gaps exist new applicants will not be able
to register products similar or even identical to those which
current registrants are selling for several years. While
current registrants are able to continue to market such
-------
-19-
products for up to three years while the data gaps are filled,
there will be no data for a "new registrant" to cite and it
will not be impossible for him to complete required tests
should he be willing and able to do so.
For the industry as a whole, the requirement of full data
submission will, to a large extent, preserve the status quo.
Those now marketing registered products will continue to do
so. But few new competitors, in particular small formulators,
will be able to enter the market for at least three years, and
probably much longer than that.
Registrations for minor uses will be impeded.
The total environmental burden of particular pesticide
chemicals may remain substantially the same until assessments
of their hazards can be completed. However, current registrants
are limited mainly by the elasticity of demand, and their own
capital formation abilities, from substantially increasing
production and sales. Thus, the environmental burden of a
particular pesticide may be more directly affected by marketing
strategies than regulatory controls.
On the other hand, the approach provides the greatest assurance
that each product will be assessed for safety thoroughly before
entering market.
Option 2: Generally require full data for new chemicals. However, for old
chemicals, require only the data pertinent to the incremental differences
between the new product registration and those already on the market to
achieve conditional registrations. Products thus conditionally registered
would have to meet the full requirements of the amended FIFRA when the
active ingredient as a whole is evaluated during reregistration.
. "Double standard" would be removed; all products containing
the same active ingredient would be treated fairly.
Competition would thus be served in that a barrier would be
removed for registrants of "me too" products and other new
products formulated with old active ingredients.
The interests of the environment can be served in that
a) the environmental burden of the chemical may not, it
can be argued, be appreciably increased by encouraging
competition for the existing market or by legalizing minor
uses; and b) the decision as to the environmental safety or
being posed can most efficiently and systematically be made
on the chemical as a whole.
The legality of such a conditional registration scheme
may be open to question. FIFRA does not specifically
provide for conditional registrations; its silence on
-------
-2 ri-
ch is subject could be interpreted to mean that the Agency
should not proceed in this direction.
AGENCY POSITION
The Agency believes It is in the best public interest to devote
its currently scarce resources to assessing the effects of pesticide
chemicals from a generic standpoint rather than laboriously processing
thousands of individual product actions. This approach, would
. focus attention on the broad risks and benefits of any
pesticide, encompassing all uses and all formulations;
. limit the primary data compensation arena to registrants
of technical, rather than end-use, products;
. provide a simple registration mechanism for formulators
who utilize an already-registered technical material,
in which only data pertinent to the individual product
which has not already been submitted to support the technical
registration would be required, which would thereby
. free EPA reviewers from complex paper work and record
keeping so that resources could be best utilized in
assessing the larger risk and benefits issues.
Regardless of whether the Agency maintains the current
product-by-product approach, or adopts the generic chemical approach,
there will be a transition period of many years before all data are
validated and reregistration is accomplished. What to do with new
applications during this time is crucial to the competitive situation
in the industry. Generally speaking, the Agency subscribes to the
philosophy articulated in the second option above, i.e., that it is
the incremental hazard which should be assessed during the transition
period, and that registrants of like products generally should be
treated alike. Our overriding-concern will be to answer several
fundamental questions:
. will the product pose a risk additional to that posed
by products already on the market?
. if so, are data available on the additional hazard?
. has an RPAR or intent to cancel notice been issued
on the active ingredient?
. is there a known inert or contaminant problem?
. will public health or the environment benefit by
denying the product access to the market place, or
would denial simply affect the structure of the industry?
-------
-21-
SPECIFIC TREATMENT OF_ CLASSES OF APPLICATIONS
Application For New Chemical
. Generally, all data required by Section 3 must be present.
For exceptional circumstances on a case by case basis --
in reliance on the chemical structure of the pesticide,
the exposure expected from use of the pesticide, and
short term indicator tests a conditional new registration
may be granted where one long term study has been completed
with negative results and the second is underway.
Application For Old Chemical, Old Use Pattern
("ME-TOO")
. Register product if all requisite data are submitted or cited
(with appropriate permission or offer to pay reasonable
compensation) for active ingredients not subject to an
RPAR or intent to cancel notice.
. Provide a conditional registration when long-term data are
missing, so long as registrant provides or cites short-term
data (and offers to pay reasonable compensation if applicable)
supporting registration of product already on the market
which is not subject to an RPAR or intent-to-cancel notice.
Full data requirements will have to be met by all like products
at the time of reregistration.
. Conditional registration may be granted if active ingredient
is an RPAR candidate, since the risk has not been validated
and in any event is not greater than that already being posed
by like products already on the market.
Application For Old Chemical, New Use Pattern
. Registration will be granted if all required datn ar<>
submitted or cited (along with permission or offer to pay
where applicable).
. Conditional registration will be granted if
long term data are missing but all short t'jrm data
are submitted or cited;
-------
_ '(X /
. data supporting tht efficacy anc safety of the new
use, i.e., the incremental difference between the
already registered uses and the proposed new use, ' '
can support a S3(c)(5) finding;
. if a food crop is added, pertinent data required to support
a tolerance under the Federal Food, Drug, and Cosmetic '
Act must be provided if a tolerance is not already
established; and '
. the active ingredient is not subject of an RPAR
notice or notice of intent to cancel.
. Products utilizing active ingredients which are in the RPAR
process will be eligible for conditional registration but
the burden of justification for the ง3(c)(5) finding for
the use will bear more heavily on the applicant.
The Agency believes that this approach would be conducive to
eliminating many of the current regulatory and statutory roadblocks
to registrations as formulators and other new registrants of products
utilizing chemicals already in use could enter the market on the
same footing as old registrants. This would eliminate the "double
standard" by equalizing registration requirements for products.
containing the same active ingredient. :
POTENTIAL CONGRESSIONAL ACTION , . ;
The Congress could either sanction or disagree with the Agency
position through a specific statement in the law or the Committee
Report regarding Congressional intent on conditional registrations.
The Agency would welcome discussion and instruction in this area.
-------
-2*3-
PART III
OTHER IMPACTS
The primary impacts on competition of FIFRA and it? administration
by EPA were dealt with in the previous two sections. Those were primarly
negative impacts, and ways to alleviate those negative effects were
described. This section describes five other areas where effects
can be identified on new product research and development, on inte-
grated pest management, on application technology, on child protective
packaging, and on users and applicators.
NEW PRODUCT R & D
How has FIFRA affected new product research and development? A
look at history shows that most new product research and development
has been done by larger firms. Therefore, although small businesses
are not presently a major factor in the innovation of new chemicals,
it does not appear that FIFRA has contributed significantly to this
situation. 3/
Although some firms have left the pesticide research and
development field in recent years, about an equal number have entered
the field. High profits and profit potential have kept the industry
interested. 4/ There has been some trend to consolidation of business
in the larger firms. Since few small firms have ever been in the field,
however, this trend is making very little change in the situation.
Chemical research and development, synthesis, screening, production, and
marketing have always required some substantial size for success.
As suggested by studies conducted by outside organizations for
EPA and the investment community, 5/ as well as by EPA's own contacts
with the regulated industry, the pesticides industry expects that
opportunities for innovators to be fewer in number than in the past,
but that a big success will be relatively more spectacular. In
addition, the industry will continue to build on its existing research
and development base with changes in use patterns and formulations of
previously-registered products, and new chemicals within already
successful classes of compounds.
One segment of the industry, however, is adversely affected by
increasingly stringent regulatory requirements thoso firms currently
or potentially pursuing products with inherent limitations on market
size. This applies to pesticides for minor crops, to biological controls
(predators and pathogens), and to such chemical agents as insect growth
regulators, pheremones, attractants, repellants, antimetabolites and
antifeeding agents. Many of these products are attractive from an
environmental point of view because of their low volume of use,
specificity of action to a small number of species, low toxicity to
humans and other non-target organisms, and lack of persistence. 6/.
-------
-2'*-
But to determine these desirable characteristics requires testing costs
of a magnitude similar to products with much larger production and
profit potential. The Agency is able to waive all or part of the 510,000
tolerance petition fee if the applicant can show financial hardship
or if waiving of the fee would be in the public interest. Considering
product development costs running into the millions of dollars, it
cannot be expected that waiving tolerance fees would be much of an
inducement to potential developers of such products.
INTEGRATED PEST MANAGEMENT
Integrated Pest Management (IPM) is ,in approach to pest
management that utilizes all suitable techniques and methods in
as compatible a manner as possible, to maintain pest population
at levels below those causing unacceptable economic or aesthetic
injury. It usually employs a means of scouting or monitoring; use
of "action thresholds" to trigger treatment; consideration of the
dynamic interactions among pests, weather, parasites or predators,
and costs of treatment; consideration of a series of strategies; and
selection of the most appropriate tools, with high priority given
to long-term human health and environmental concerns.
This is an area where opportunity exists for the entry, expansion
and prospering of small businesses. The primary responsibility for
.the development and promotion of IPM lies with USDA, but the Agency's
actions could encourage or discourage the growth of 1PM. Therefore,
it is worthwhile to examine the consequences for small businesses
and competition from a growth in IPM.
Characteristics of the IPM Industry
IPM is a knowledge industry. It operates bv col IfCf inyt and
analyzing information about crops, pests and their interactions, and
providing guidance for actions by the growers or managers of agricul-
tural crops, structures, parks, lawns, rights-of-way, etc. Practi-
tioners come by their knowledge via long experience in the field,
by formal training (associate degree to Ph.D.), informnl in-house
training courses or a combination of these.
There is a high degree of decentralization of the delivery
of services, since advice, to be useful, must be tailored to the
particular circumstances prevailing at the growers' sites. However,
some demonstration projects have utilized centralized data analysis,
in order to incorporate weather projections and other data more
amenable to a regional approach (eg., the Purdue system for alfalfa,
the Michigan State University system for apples, and a model for
cotton at the University of California.)
-------
-25-
IPM is currently fairly labor intensive because of the reliance
on scouts in the fields. Some technology is evolving to reduce this
reliance, such as satellite or airplane surveillance for presence of
plant pathogens or weed infestations, but there are limits on this
development there will probably always be a need for scouts in the
field, not only for the detailed information they can produce, but
to act as an effective human interface between the provider of the
information and the grower users. Likewise, there are opportunities
for more efficient means of information collection and processing,
but IPM represents a small move away from the current trend in capital
intensive farming.
In considering the potential acceptability of IPM, it should
be noted that the infrastructure and traditions exist in some areas
(eg., in California, where private farm advisors have become estab-
lished, consistent with the high degree of regulation of agricul-
tural activities), but IPM services delivered by private parties
would be seen as a new idea in other areas.
There is some set-up cost involved in developing and testing
out IPM techniques. This work has primarily been carried out by univer-
sity and USDA sponsored researchers, but some small firms have been
successful in developing their own techniques and adapting those
developed with public funds. In addition, some pesticide manu-
facturers have developed parts of IPM programs as vehicles for
the commercialization of their products (such as the information
provided by the Zoecon Corporation for effective use of their
insect lures.)
. These characteristics create an environment particularly
suited to small, localized firms, providing services via high-labor
and low-capital mechanisms, and dealing in information and innovation.
Experience to Date
Government sponsored or run programs have predominated,
reflecting the unique capabilities of the land prant system for
developing and proving out new ideas of use to the farmer. Among
the scouting and pest management projects examined by APHIS and
EPA, the program participants experienced a decline in pesticide
use and production costs, and increases in yield and profits, and
must therefore be deemed successes. 7/
-------
-26-
Studies conducted for EPA's Office of Research and Development
on farmers' considerations of risk have indicated the preferability
of information, as opposed to insurance or other mechanisms, as a
means for reducing growers' uncertainties. 8/ In this context,
pest infestation information and other components of IPM programs
can be cost effective means for maintaining profits and productivity,
while reducing environmental exposure to pesticides.
Results from a Ph.D dissertation from the University of
California suggest that the spread of IPM can best be promoted by
focusing support on the providers of information (as opposed to the
users of the information.) 9/ Governmental policies to encourage
an expanded supply of information services might include price
subsides to the information providers, training of potential IPM
practitioners, or cooperative development of pest management
techniques for particular crop/pest situations. Although the limited
crop and geographical bounds on that study restrict the ability to
generalize from it, it is worth noting, however, that this finding
is consistent with the long-established practice of USDA providing
area specialists to deal with particular crop production problems.
Over the past few years, numerous pest control advisors or
farm management firms have achieved recognized success. 10/
Success is measured not only in their own financial well-being,
but in their ability to improve their clients' profit situation.
EPA Mandate
Conduct of the pesticides registration scheme requires EPA to
understand IPM well enough to make intelligent regulatory decisions.
In addition, Section 20(a) directs EPA to conduct a research program,
giving "priority to research to develop biologically integrated
alternatives to pest control." Finally, Sec. 4(c) directs EPA
to provide information on IPM to those pesticide users requesting
it.
EPA Actions
EPA is evolving a statement on its stance and programs on
IPM, with particular attention to the research needs and where
the research should be conducted. EPA is looking into the develop-
ment of IPM in urban settings. EPA is also providing materials
potentially useful to persons interested in applying IPM to their
pest control problems to USDAjfor distribution through the Cooperative
State Extension Service. IPM will be considered among alternative
pest control practices in RPAR, cancellation and suspension decisions.
Through its research, information distribution and regulatory actions,
EPA intends to help create a climate that is conducive to the further
development of a healthy vigorous system of private providers of IPM
services.
-------
-27-
APPLICATION TECHNOLOGY
The Agency feels that its actions may also have an effect on
the portion of the pesticide industry which is concerned with
application technology. EPA regulations should stimulate changes
in methods of application, since more efficient application can
reduce the amount, and therefore the risks, of pesticides applied.
This is not a big push, but the pressure is there. The industry
seems aware of the need to refine application techniques, and users,
of course, are interested.
As an illustration of the potential savings involved, it has
been estimated that for a typical application of an agricultural
foliar insecticide, 40% of the quantity applied winds up away from
the target area through drift, misapplication, volatilization,
leaching and surface transport. Another 15%, although falling in
the target area, does not land on the target crop. Of the remaining
45%, only 4 % is typically applied near the target insect, and the
bulk of that makes no contact with the insect. Thus, less than 1% of
the amount applied is absorbed by the insect through contact, inhala-
tion and ingestion. The details are different for different crops
and pesticide types, but sizable opportunities exist for reducing
the quantity of pesticides applied without sacrificing any benefits
through the reduction of drift, improvement of placement within the
target area and attracting target pests to pesticide deposits. 11/
Innovations in recent years include ultra-low volume (ULV), micro-
encapsulation and time-release formulations and their attendant
application equipment; chemicals and devices for improved baits,
lures and traps; and other improvements stemming from an increased
understanding of the aeronautical and physical principles underlying
pesticide applications. 12/
Any market created for innovations in application methods need
not be restricted to large companies. Small firms are as viable
a source for new approaches to research, development and production
of application equipment as are larger firms.
CHILD PROTECTIVE PACKAGING
The Agency is planning to publish proposed child protective
packaging regulations early in 1977. Use of child protective
packaging will enable some products to be used in the home that
otherwise would not have been available. These are products with
an inherent toxicity making them candidates for restricted use.
-------
-28-
A recent study showed that the total annualized incremental cost of
child protective packaging will be less than $6 million, which is less
than 8 cents per container subject to the regulations. This cost should
not be a serious problem for manufacturers or formulators, particularly
since it means that these products can be kept in the home market. 13/
Developers and vendors of child protective packaging and
closures include a variety of large and small firms. The regulations
will expand the market for special packaging and both large and
small companies will be stimulated to compete.'on the basis of inno-
vative designs, price, and performance.
USERS AND APPLICATORS
Certification and training of applicators, as a condition on
the use of restricted use pesticides, is not expected to deny
agricultural users the benefits of such products, nor to make them
more dependent on commercial applicators than in the past. The
certification and training program has ample provision to allow
such agricultural users to qualify as private applicators.
Section 3(c)(5) provides that the Administrator "shall not make
any lack of essentiality a criterion for denying registration of any
pesticide." This allows multiple products to be introduced to compete
for the same use patterns. When considering products for cancellation
or suspension, EPA weighs the costs and benefits of the products' uses.,
particularly the effects on productivity in the affected agricultural
sector. A cancellation decision typically has different impacts on
agricultural users in different parts of the country, and some minor
uses may be adversely affected. Where cancellation occurred, the Agency's
judgment was, however, that these disadvantages were outweighed by
the advantages of the cancellation. 14/
Some products intended for home use will be available only as
restricted use products, although the exact numbers depend on re-
registration decisions between now and October 1977. This probably
will cause some increased reliance on professional applicators in
these instances, creating some benefit to that sector of the industry.
Contacts with the professional applicator industry show optimism
that classification of pesticides into restricted and general use
will be good for business.
-------
-29-
APPENDIX
STUDIES
Several studies done in recent months have given the Agency
a more accurate Idea of the side effects of our actions and some
suggestions for how the negative effects might be lessened.
ECONOMIC IMPACT.OF REGISTRATION DATA REQUIREMENTS
EPA is in the process of revising the Guidelines for Registering
Pesticides, proposed in June 1975. Concurrent with the development
of the Guidelines is an assessment of the cost impacts of the testing
requirements. EPA estimates on the Guidelines as proposed in 1975
amounted to an Incremental one-time cost of $68 million. 15/
Industry's own estimates have been much higher. A recurring problem
has been to Identify what Increased costs are due to data requirements
made progressively more stringent in the I960'8 and 1970's and
which are attributable to the Guidelines themselves. As the
Guidelines stood in mid-1976, the incremental one-time costs were
roughly estimated at $97 million or $29 million annualized over a
5 year period. As the Guidelines reach the point of re-proposal in
1977, the costs will be summed up and reported.
INCENTIVES AND DISCENTIVES
A study has recently been completed on incentives in the
pesticide industry. A working conference took place in October 1976
and EPA received the final report in January 1977. 16/ The study con-
cluded that although action by EPA, USDA, and the industry cannot
be expected to bring about a major change in pest control innovation,
EPA and others could take some incentive measures to improve the
likelihood of pest control research and development. Steps recommended
for inplementatlon as soon as possible Included specific actions to:
* Decrease regulatory hindrances to research and development
* Reduce the risk of product development by industry
* Increase the availability of minor use pesticides
* Lengthen patent life
* Advertise safety on product labels
* Increase use of integrated pest management
* Increase Information and training for pesticide users.
-------
- 30 -
A STUDY OF SMALL BUSIKES8E8
A study was conducted in 1975 for the Experimental Technology
Incentlvea Program and the Small Business Administration on "The
Impact oo Smll Business Concerns of Government Reguletione that
Force Technological Change." IT/ Although FIFRA and the FFDCA are
lave which bring about technological change, the effects of theae
atatutee vere not examined directly in thia study. The statute*
considered vere of the "minimal standard" or "allocation/distribution"
type, and not "pendeelos/probibitW variety which characterizes
PIFRA and FFDCA. In spit* of the lack of direct applicability of
the study to the specific* of the pesticide regulatory situation.
of the findings are worthy of mentions
Among the firms studied, the costo of compliance (per unit of
output) with the statutes under consideration roae es sise of the
firm decreased (reflecting economies of scale.) except for the very
smallest firms. Thia is related to exceptions that are made for
smaller firms (in the form of extension, modifications and exemptions),
and to flexibility of enforcement. In the opinion of the contractor,
flexible enforcement ie more common among the older, snore established
regulatory bodiea, but even the "younger, brasher outfits like SPA"
heve "confronted and accepted the impossibility of totsl enforcement."
Smaller firms face higher interest changes, less advantageous
terms of payment, end leee availability of money to finance spending
required by regulatory demands than larger firms. There is a tendency
to be able to pass through either nearly all or nearly nothing of the
costs incurred. The further down the production - distribution chain
a company la located, the less likelihood of cost pass-through.
The small fine studied alao had non-financial problems with
compliance which seem to be shared to some degree with pesticide
registrants time and paperwork burdens, confusion over regulatory
requirements, difficulties in dealing with agency personnel and in
the formulation of legislation and regulations.
The study notes the benefits partly off-setting the costs of
regulation, citing "a wide range of industries, including many small
businesses, (which) receive indirect benefits through sales of
materiala, equipment, supplies, and services to manufacturers of
pollution control equipment and the like."
The report recommends several kinds of action to the Small
Business Administration, including intervention and advocacy in the
federal legislative and regulatory process; financial assistance via
Regulatory Economic Injury Aasiatance Loans and the like; technical
assistance of aeveral types; and programs to foster cooperative
action among similarly-affected small businesses.
-------
- 31 -
HEW. PMOVATIVE PESTICIDES
A study on "New, Innovative Pesticides: An Evaluation of
Incentives and Disincentives of Commercial Development by Industry,"
is being conducted for QPP. Tentative findings include the expectation
that, over the next ten years, there will be a steady flow of products
from the chemical industry for pesticide uses, but that innovative
products (such as bacterial, pheromonal and viral pesticides) will
not be registered and available in sufficient quantities to dramatically
substitute for conventional chemical products, although some are expected
to complement the use of chemicals in selected markets. These conclusions
are based both on analysis of economic factors and on the views of
pesticide users.
By viewing profit as incentive for product development by
private industry and risk as disincentive, two limiting factors on
the development of innovative products are their generally narrow
spectrum (limiting the ultimate market size) and the lack of
proprietary protection. Therefore, the government should consider
thซ following changes to encourage develoment of innovative products.
* Moans to give some measure of proprietary protection to firms
seeking to market naturally-occurring agents.
* Maana to reduce risk to the developers, possibly through support
for R & D costs and modification of performance liability constraints .
These are preliminary conclusions, but it is worthwhile to
note that the measures seen as helpful in encouraging development of
innovative products are to some degree in conflict with the promotion
of an atmosphere of competition.
P10TBCTIVE
Another recent study looked at the cost of the child protective
packaging which will be required later in 1977. isy It showed that
the total annual ized cost will be less than $6 million and less than
8 cents for each container subject to the regulations. The effects
of the special packaging regulations were discussed further in the text.
-------
-32-
Footnotes
1. MeooranduB, March 5, 1976, to Deputy Assistant Administrator
for Pesticide Programs from EPA General Counsel.
2. The "data validation" problems will not be solved by this legis-
lative action.
3. Incentives for Research and Development in Pest Control,
Volume II, Appendices, 1976, EPA-540/9-77-009, pp. 1-12.
4. The Pesticide Industry An overview, William Blair and
Company, July 7, 1975, p. 15.
5. Ibid., and Incentives for Research and Development in
Pest Control,op. cit.
6. Conteaporary Pest Control Practices and Prospects, Vol.1
of Pest Control; An Assessment of Present and Alternative
Technologies, National Academy of Sciences, 1975, pp. 340-366.
7. An Evaluation of the Scouting Activities of Pest Management
Programs, 1974, EPA-540/9-75-014, pp. 34-38.
8. Crop Insurance and Information Services to Control the Use
of Pesticides, draft final report, 1974.
9. The Diffusion of Pest Management Information Technology,
Wayne Richard Willey, Ph.D. dissertation in economics,
University of California, Berkeley, 1973.
10. Contemporary Pest Control Practices and Prospects, op. cit.,
p. 397, and volume III, Cotton Pest Control.
11. Production, Distribution, Use and Environmental Impact Potential
of Selected Pesticides, 1974, EPA 540/1-74-001, pp. 106-108.
12. Incentives for Research and Development in Pest Control,Volume II,
op. cit., pp. 8-12, and Contemporary Pest Control Practices and
Prospects, op. cit., 365-380.
-------
-33-
13. Economic Impact of Child-Proof Packaging Regulations on the Cost
Of Pesticide Containers in the United States, draft screening
study, Office of Pesticide Programs, U.S. EPA, 1977.
.14. DPT; A Review of Scientific and Economic Aspects of the Decision
to Ban Its Use as a Pesticide, prepared for the Conndttee or.
Appropriations, D.S. House of Representatives, by the U.S. EPA,
July 1975.
15. Incremental Cost Impacts of the 1972 FIFRA, 1976, EPA-540/9-76-002,
p. 41.
16. Incentives for Research and Development in Pest Control, volumes
I and II, op. cit.
17. September 1975, CAI-800-F-2R.
18. Economic Impact of Child-Proof Packaging Regulations on the
Cost of Pesticide Containers in the U.S., op. cit.
-------
STATEMENT OF
. HONORABLE DOUGLAS M. COSTLE
ADMINISTRATOR
ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE
COMMITTEE ON AGRICULTURE AND FORESTRY
UNITED STATES SENATE
MARCH 11, 1977
Good morning, Mr. Chairman, and Committee members.
I am very pleased to be here with you this morning for
this hearing on the Federal Insecticide, Fungicide, and
Rodenticide Act.
As you know, the Senate voted my confirmation as
Administrator of the Environmental Protection Agency last
Friday. I am to be formally sworn into office by the
President this afternoon. I am present before your
Committee today to listen and learn, and Dr. Breidenbach,
who is serving as Assistant Administrator in charge of the
pesticide regulatory program, will present the Agency's
statement.
Although I had some involvement with pesticide regulation
as Deputy Commissioner and then Commissioner of the Connecticut
Department of Environmental Protection from 1972 to 1975, the
-------
issues which have arisen in the implementation of the 1972
Amendments to FIFRA are for the most part new to me. I
know that pesticide regulation is an extremely complex
and important area of EPA responsibility. I also know
that there are difficult problems which have to be solved.
I am pleased to be here today, to learn.directly from you
and from the discussion that will follow.
I would like to emphasize my desire to work closely
with this Committee. I regret that I have not yet had
the opportunity to meet with you, and hope that I can do
"so before too long.
With your permission, -.Mr. Chairman, I. will call on
Dr. Breidenbach to present the Agency.'s testimony.
-------
STATEMENT OF
HONORABLE ANDREW W. BREIDENBACH
ASSISTANT ADMINISTRATOR FOR WATER AND HAZARDOUS MATERIALS
ENVIRONMENTAL PROTECTION AGENCY
BEFORE THE
COMMITTEE ON AGRICULTURE AND FORESTRY
UNITED STATES SENATE
MARCH 11, 1977
Mr. Chairman, administration of the Federal Insecticide,
Fungicide, and Rodenticide Act is a tough job. The law
charges EPA with the responsibility .to protect health and
the environment from the adverse effects of toxic chemicals
manufactured.for the very purpose of adversely affecting
pests, while assuring that the great good they can perform
remains a productive part of the national economy. The
law provides us with the basic rationale and tools needed to
make decisions on pesticide use which strike the necessary
balance between environmental and economic concerns. As I
will describe, the job is made difficult by issues having
less to do with that balance than with rival economic
interests, paperwork, and problems inherited from the past.
We are making progress. Major rulemaking has been
conceived and promulgated with full participation from many
interested parties. Most of the States have done a magnificent
job in cooperating with EPA to establish workable and
sensible applicator training and certification programs; 49
State Plans have been submitted to EPA for approval, and
over 330,000 applicators have participated in training
programs. A system has been developed for intensely
-------
-2-
reviewing pesticides that may be posing an unacceptable
hazard to the environment or the public. The system includes
receiving and considering both benefit and risk information
received from the public. The new Scientific Advisory Panel
established by the 1975 FIFRA amendments has met three times
to consider proposed Agency rulemaking, and promises to be
active and informative. The Administrator's Pesticide
Policy Advisory Committee, established to provide input from
a wide spectrum of interested agricultural, industrial,
environmental and governmental vantage points, has been
extremely helpful in identifying and discussing significant
issues. Hundreds of thousands of individual actions,
including experimental use permits, emergency exemption
requests, tolerance petitions and requests for new, supplemental
and, amended registrations have been handled over the past
four years. It has been a busy and productive time.
But all is not well. The two major tasks assigned by
the 1972 amendments were, as you are certainly aware, the
reregistration and classification of all pesticides presently
marketed in the United States, and the certification of
applicators to use restricted pesticides. The former task
has encountered serious difficulties, and is still over
four years after the enactment of the 1972 law not close
to completion. In looking over those four years and the
chronology of events in the reregistration effort, several
impressions particularly strike me:
-------
the complexity of. the task was originally under-
estimated, and further complicated by a series of
new developments in 1976;
Agency resource needs were thus also underestimated,
another problem exacerbated by the 1976 developments;
the problems encountered have been patched by the
"bandaide" approach, and a thorough review of the
situation, with long term, thoughtful resolution,
is in order. '
There are two primary problems impeding reregistration:
data validity and trade secret litigation. I believe a
brief discussion of these issues would be helpful.
One major problem is that of data compensation and
trade secrets. It was always our belief that the mandatory
data licensing provision of the Act was intended to be a
mechanism to share costs of data development among all users
of- those data, and thus an incentive to research in the
producing industry. Section 3(c)(l)(D) prohibits the Administrator
from considering data developed by one manufacturer in
support of subsequent registrations without permission of
the data developer, or an offer to pay reasonable compensation
by the subsequent applicant for use of the data. Section
10 of the Act specifies that trade secret data cannot be
released nor, under 3(c)(1)(D), is it to be used in support
of subsequent registrations regardless of the willingness
-------
-4-
of an applicant to pay reasonable compensation. EPA's position
has been that trade secret information should be narrowly
defined, e.g.', the manufacturing process and confidential
formula. However, several registrants have asserted that all
data in support of registration such as toxicity, chemistry,
fish and wildlife, and efficacy are trade secrets, and
thus are not eligible for use by any other registrant without
express permission. This position,. if correct, would leave
little data subject to the compensation scheme under section
3(c)(l)(D). Ten cases are now pending in the courts, with
injunctions or stipulations preventing the Agency from using
the disputed data for registration or reregistration purposes
without consent of the data developer.
This issue has an especially profound impact on the small
formulator, who is generally incapable of developing data
and has historically relied on that already submitted by
another registrant. What this comes down to is a matter of
how many pesticide formulators will stay in business, and
who will control which formulators are in and which are out.
Also at issue -is the public's right to have access to data
supporting pesticide registrations.
The second major problem concerns reregistration and
classification. The original strategy for reregistration was
to screen and separate pesticides into two basic categories:
-------
-5-
(1) those suspected of posing an unreasonable risk to man or
the environment; (2) those for which no evidence of potential
unreasonable adverse1 effects was known. Pesticides falling
into the.first category were to be subjected to an intensive
review with full data validation (scientific review and
confirmation of results by EPA technical staff). Those in
the second category were to be classified, their labeling
updated, and examined for data gaps tests required to
meet today's standards which were not performed in the past.
The data supporting registrations of products in that category
were not to be individually evaluated and validated, the
assumption being that, for the most part, tests had been
performed properly, results had been honestly reported, and
testing deficiencies had been detected and resolved at the
time of registration. Utilizing this strategy, the Agency
believed the'job could be done by the October 1976 (not
October 1977) deadline.
Those underlying assumptions were proven invalid in
1976. Investigations by the Food and Drug Administration,
.the GAO, and a Senate Committee revealed questionable, even
fraudulent, practices in laboratories conducting animal
studies. In addition, an internal EPA review disclosed
problems with the data in Agency files. Reregistration was
halted in August of that year to consider the proper data
validation approach. In December, the Senate Subcommittee
on Administrative Practice and Procedure issued a draft
-------
-6-
report concluding that Agency review of data was insufficient,
and that the public was not being properly protected from
/
the hazards of pesticides. Former Administrator Train made
the commitment at that time to review test reports in Agency
files before reregistration.
Because we must undertake the immense job of validating
bio-effects data related to risks to health presented by
pesticides, our job is correspondingly greater. It is not
possible to accurately assess the amount of time this task
will add to our other jobs, but we estimate after a
thorough zero-based resource exercise that reregistration
including data validation for all products will take, at the
current resource level, 10-15 years.
This extended period forces us to readjust our thinking
about accomplishing program goals. Policies developed on
the assumption that reregistration would be accomplished
quickly must be reevaluated, and new strategies planned. We
are considering the following several ways to streamline our
program and deal with the longer reregistration period:
Separate Classification From Reregistration
Although reregistration will not be completed for many
ซ
years, most of the States are ready to begin implementing the
applicator certification provision of the Act. The Agency
-------
-7-
thus desires to classify products, apart from the reregistration
process/ by regulation. Classification could be accomplished
on or near the October 1977 deadline, and take effect during
the 1978 growing season. This approach would help minimize
the hazards associated with the restricted products, and put to
good use the hard work accomplished by the States, EPA Head-
i '
quarters and Regions, and the Extension Service in training
and certificationi .
Permit Conditional Registrations.
A problem corollary to the lengthier transition period
between old and new FIFPA is the matter of granting new
registrations. Where trade secrets and data compensation are
not at issue and applicants can submit or cite data to meet
current requirements, registrations can be granted. However,
there are certain data gaps which preclude a new registration
from either submitting or citing now-required information.
Many "new" products are actually just like products on the
market ("me too" registrations) or utilize an "old" active
ingredient in a different way than the products already
registered. The question is, is it fair to keep "new" products
utilizing old chemicals off the market until long-term data
requirements (which current registrants are being given time to
fill) are met? The Act clearly allows the current registrants
to remain registered until reregistration or an intent to
-------
-8-
cancel decision is made. I think it is important to establish
whether or not Congress wishes current registrants to enjoy
a competitive advantage over companies desiring to compete with
like products "grandfather^d" by the 1972 Act pending re-
registration. The law does not specifically permit or
specifically preclude conditional registrations, so Congressional
direction in this matter would be welcome.
Define "Trade Secret"
The trade secret dispute could be clarified if the
Congress specified which information should not be considered
trade secrets. Clarification as-to whether or not the Agency
can use trade secret information "in camera" for purposes of
comparing formulas of registered products and those of applicants
is also needed.
Diminish Efficacy Review -
it has become increasingly apparent that our scarce
resources should be applied where they can do the most public
good. One area in which we have devoted much time and
attention is the review of efficacy data. In practice,
especially for agricultural chemicals, efficacy is of limited
duration, affected by geography, climate and regionalized pest
resistance. Agencies such as the USDA Extension Service and
even farmers themselves are in a better position to assess
efficacy of particular products. With reregistration and
attendant data validation demanding priority, it seems an
-------
-9-
unwise use of our resources to spend the time to examine
efficacy data while more important issues and registration
/
activities suffer. EPA is therefore considering proposals which
would require examination of efficacy data only for certain
products or when required by special circumstance.
New Approach To Registration
Above all, I would like to broach for discussion the idea
of regulating pesticides by a generic rather than a product-
by-product approach. It became clear after grappling with the
complexities of FIFRA for over four years, that there was far
too much paperwork and attendant time devoted to individual
product registrations, without commensurate public advantage.
If the Agency were to adopt a technical-product-intensive
registration scheme (for example, X technical-grade product is
registered for A uses against B pests on C sites at D formulations),
and most data, including the expensive long term animal feeding
studies, were associated with the technical registration,
several important benefits would accrue:
the data compensation issues would be largely
confined to disputes between the hundred or so
producers of technical material;
formulators utilizing a registered technical product
in .a manner consistent with the registration would
have to cite much less data, and formulator
registrations could be issued quickly with minimum
review time;
-------
-10-
the public interest would he best served in that
Agency resources would be devoted to assessing the
risks and benefits of all uses of a chemical at
one time, more efficiently using scarce scientific
and technical talent.
These are all important broad issues I have raised, and
I urge the Committee to give them a thorough public airing to
develop sound and responsive legislative direction.
That concludes my prepared remarks, Mr. Chairman.
------- |