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- Permanent Link:
- https://ufdc.ufl.edu/UF00008521/00001
Material Information
- Title:
- Legal aspects of pesticide use and impact assessment reports the regulatory process in review
- Series Title:
- Bulletin ;
- Creator:
- Daniels, Alan H
Olexa, Michael T ( Michael Theodore ), 1947-
- Place of Publication:
- Gainesville, Fla
- Publisher:
- Food and Resource Economics Dept., Institute of Food and Agricultural Sciences, University of Florida
- Publication Date:
- 1982
- Language:
- English
- Physical Description:
- iv, 43 p. : ; 28 cm.
Subjects
- Subjects / Keywords:
- Pesticides -- Law and legislation -- United States ( lcsh )
- Genre:
- bibliography ( marcgt )
non-fiction ( marcgt )
Notes
- Bibliography:
- Includes footnotes.
- General Note:
- Identified by IFAS Editorial as Florida Cooperative Extension Service Bulletin 211.
- General Note:
- Bulletin - University of Florida Food and Resource Economics Department ; F636b
- Statement of Responsibility:
- A.H. Daniels and M.T. Olexa.
Record Information
- Source Institution:
- University of Florida
- Holding Location:
- University of Florida
- Rights Management:
- All applicable rights reserved by the source institution and holding location.
- Resource Identifier:
- AAA6783 ( LTQF )
AEP2740 ( LTUF )
16569093 ( OCLC )
030251061 ( AlephBibNum )
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DOCUMENT
LEGAL ASPECTS OF PESTICIDE USE AND
IMPACT ASSESSMENT REPORTS:
The Regulatory Process in Review
Central Science
Library
JUL 13 1987
University of Florida
_Food and Resource Economics Department
Institute of Food and Agricultural Sciences
University of Florida
Gainesville, Florida 32611
fcl-'~
LEGAL ASPECTS OF PESTICIDE USE AND
IMPACT ASSESSMENT REPORTS:
The RegrFlatory Process in Review
A.H. Daniels and M.T. Olexa
Co-Principal Investigators:
Professor James S. Wershow
Agricultural Law
Department of Food and Resource Economics
Professor Grover C. Smart, Jr.
Nematologist
Department of Entomology and Nematology
Supported by Grant 12-05-300-495 from the Extension Service, USDA
Food and Resource Economics Department
Institute of Food and Agricultural Sciences
University of Florida
Gainesville, Florida 32611
1982
The materials contained herein are current as of the date of publication.
However, since the administrative rulings, court decisions and laws on which they
are based are subject to constant revision, portions of this publication could
become outdated at any time.
PREFACE
This manual is part of an overall review of current issues in agricultural law
and an effort to expand extension education on legal topics of importance to
farmers, agricultural scientists and people in farm related businesses. This phase
of the program in agricultural law was supported in part by Special Need Project
Funds from the Extension Service, U.S. Department of Agriculture. The main
purpose of the grant was to develop educational materials for agricultural
scientists on the legal aspects of Pesticide Impact and Assessment Reports. This
document is one of three in preparation dealing with impact and assessment
reports and pesticide user liability.
Principal Investigators on the grant project are James S. Wershow, J.D.,
L.L.M. Professor of Agricultural Law, Food and Resource Economics Department,
University of Florida; and Grover C. Smart, Ph. D., Professor of Nematology,
Department of Entomology and Nematology, University of Florida.
The authors are indebted to them, to Melvin L. Upchurch, Ph. D.,
Consultant, for review and consultation on this paper, and to Ronald L. Perry, J.D.
and W.C. Price HI for providing research, legal review and consultation.
Gratitude is expressed to Margaret Breinholt, J.D., Office of General
Counsel, USDA, for suggestions and guidance in reviewing project drafts.
Appreciation is extended especially to Paul W. Bergman, Ph. D., Extension
Service USDA for making the grant available and reviewing the work; and John T.
Woeste, Ph. D., Dean for Extension, for constructive input and support.
TABLE OF CONTENTS
Page
PREFACE........................................ ........... . iii
CHAPTER 1. INTRODUCTION ...............................1
CHAPTER 2. REGISTRATION OF PESTICIDES .................. 4
Section 1. Requirements for Registration ................... 5
Section 2. Amended, Supplemental and Reregistration ..........6
Section 3. Exemptions to Registration ....................7
Section 4. State Authority ................................8
Footnotes ................................................9
CHAPTER 3. RPAR-REBUTTABLE PRESUMPTION AGAINST
REGISTRATION (SPECIAL REVIEW) ................11
Section 1. RPAR: Triggering the RPAR ....................11
Section 2. RPAR: Formal Review .... ...............12
Section 3. Regulatory Options: Risk/Benefit Analysis .........12
Section 4. Final Regulatory Decision ........................14
Section 5. Special Review: Proposed Revisions to the
RPAR process .................................14
Section 6. Revisions in the Risk Criteria .....................14
Section 7. Initiation of Special Review....................... 14
Footnotes ................ .............................17
CHAPTER 4. THE ADMINISTRATIVE HEARING .................19
Section 1. The Proceedings: Obtaining the Hearing............ 19
Section 2. Parties to the Proceedings (Hearing) ...............20
Section 3. The Administrative Law Judge .................. 20
Section 4. Disqualification of the Administrative
Law Judge .................. ....... ....... 20
Section 5. Prehearing Procedures: Discovery.................21
A. Burden of Proof........................... 22
B. Presenting Evidence/Witnesses...............22
Section 6. The Accelerated Decision .......................23
Section 7. The Initial Decision.............................23
Section 8. The Administrator's Decision: Appeal from
or Review of the Initial Decision .............. 24
Footnotes ............................ ...... .... ... 26
CHAPTER 5. FINAL AGENCY ORDERS: REVIEWABILITY ........31
Section 1. Scope of Judicial Review, Standards and
Effect of Review............................31
Section 2. Standing: Who May Initiate Judicial
Review ................. ...... ............ 32
Section 3. Suspension Orders: Reviewability ..............32
Section 4. Scope of Review, Standard and Effect of:
Review ................................ 33
Section 5. Standing....................................33
Footnotes...................... .................. ... .... 35
ABBREVIATIONS AND ACRONYMS.............................40
CHAPTER ONE
INTRODUCTION
Historically, government control of pesticides began with the Insecticide
Act of 1910 in which Congress attempted to protect farmers from adulterated or
misbranded products. Subsequent amendments gave government greater control,
but the 1910 Act was repealed and a new approach was taken in the Federal
Insecticide, Fungicide and Rodenticide Act (hereinafter referred to as FIFRA or
the Act) as amended. In it, Congress charged the Department of Agriculture with
the promulgation of regulations for the registering and labeling of pesticides prior
to their introduction into interstate commerce. A 1967 amendment authorized
the Secretary of Agriculture to refuse to register a new pesticide or to remove
from the market pesticides that were unsafe or ineffective.
The administration of FIFRA was transferred to the Environmental
Protection Agency (hereinafter referred to as EPA or the Agency). This marked a
shift in policy from control of pesticides for reasonably safe use in agricultural
production to control of pesticides for reducing the risks to man or the environ-
ment. This policy shift was strengthened by the Federal Environmental Pesticide
Control Act (FEPCA) of 1972 which required EPA to promulgate regulations and
to have the administration fully effective by August 1975. The Act was further
amended in 1978 and 1980.
As it now stands, FIFRA states that no one may sell, distribute, offer to sell,
hold for sale, ship, deliver for shipment or receive and (having so received) deliver
or offer to deliver a pesticide unless it is registered by the Administrator of EPA
(exceptions are explained in this text). Additionally, the Administrator must
approve the pesticide label and labeling on which the use recommendations and
limitations of the material are specified. The Act further states that the
-2-
Administrator must classify pesticides for restricted or general use and that only
certified applicators may use restricted materials. The law, supplemented by EPA
regulations, specifies how to register a pesticide and the steps to be taken if the
Administrator decides not to register a material. It also empowers the
Administrator to withdraw registration from any pesticide which in his judgment
is likely to cause unreasonable risk to man or the environment. The Act specifies
penalties for violations and goes into many more details which will be covered
later. The law, the regulations promulgated under the law, the guiding
administrative practices and policies, and the relevant court decisions constitute
an imposing mass of legal machinery. The Act and the mass of other laws, rules
and court decisions relevant to governmental control of pesticides often are
confusing and frustrating to people in agriculture, and may even perplex attorneys
who encounter them for the first time.
One purpose of this paper is to describe the legal machinery relating to
pesticides so that people in agriculture may better understand the rules,
regulations and processes in control. Another purpose is to help people in
agriculture and the pesticide industry prepare information that will be useful in
the decision making required for registration of a pesticide.
This paper deals with the laws and regulations governing the registration of
pesticides and with the administrative and legal steps that are brought into play if
the Administrator decides to deny an application for registration or decides to
withdraw or alter the registration of an existing pesticide.
Legal remedies, available in courts of law for persons concerned with
registration or denial of registration of pesticides are discussed. Throughout, the
paper focuses on the kinds and quality of information required and how
information is used in the decision making processes, from initial administrative
consideration of an application to register, through the administrative hearing
and, finally, in courts of law.
-3-
In the footnotes, additional details are given when needed, relevant statutes
and regulations are cited, and references are made to court cases and other
information deemed to be useful. A glossary is included which defines both legal
and scientific terms to aid scientists, farmers and others in their understanding of
the pesticide regulatory process.
-4-
CHAPTER TWO
REGISTRATION OF PESTICIDES
Generally, in order to sell, offer for sale, hold for sale, distribute, ship,
deliver for shipment, or receive and (having so received) deliver or offer to deliver
a pesticide to any person, the pesticide material must be registered with EPA.
The Act and the regulations issued by EPA set out the requirements and
procedures for registration1. The registration process includes submission of an
application by the producer of a pesticide, admission of specified information in
support of the application, and the consideration and disposal of the application by
EPA. If, after reviewing the application and its supporting data, the
Administrator of EPA decides that the pesticide meets the criteria outlined in
FIFRA, he approves the application and the pesticide product is "registered".2 If
he does not approve, he may issue a "conditional registration" pending admission
of additional data or pending further consideration by EPA.3 Disapproval may
initiate a process known as RPAR (Rebuttable Presumption Against Registration)4
which will be discussed in Chapter 3.*
An application for registration may be for a new material-one not
previously registered with EPA-or for an amended, supplemental or reregistration
of a registered material 5
*The RPAR process is now also referred to as Special Review. The terms RPAR
and Special Review are used synonymously throughout this manual.
-5-
Section 1. Requirements for Registration
Briefly, an application for a registration must contain the name and address
of the applicant, a proposed label for the product, composition of the material,
proposed classification (for general or restricted use), and supporting data.6 Title
40 of the Code of Federal Regulations which includes "Guidelines for Registering
Pesticides: Registration Procedures" provides details on the requirements for
applications.7
The EPA requires substantial supporting data. The applicant must
substantiate all claims for the pesticide including proof that the material will
perform its intended function without causing unreasonable adverse effects on
man or the environment.8 The applicant must furnish or refer to data sufficient
to demonstrate that the pesticide meets the criteria specified in FIFRA.9 The
supporting data must include any factual information regarding adverse effects of
the pesticide on the environment or man which the applicant has obtained or is
aware of and which, insofar as the applicant knows, has not previously been
submitted to EPA.10 This includes, but is not limited to, published or unpublished
laboratory studies or accident experience. The applicant must comply with any
requests for information which EPA deems to be needed for proper consideration
of the application.11
Supporting data is a prerequisite to approval of any application for registra-
tion.12 Normally, data submitted in support of registration must be disclosed
publicly within 30 days of registration.13 However, the Administrator generally
can not make public information which in his or her judgment consists of trade
secrets; but even a trade secret (information relating to formulas of products),
when necessary for the purposes of FIFRA, may be subject to limited
disclosure.14 The Administrator must give 30 days notice before disclosing any
-6-
submitted data. Within that time, the producer of the data may file suit to
determine whether such information is protected from disclosure.
When the submitted data are not produced by the applicant, the applicant
must offer to pay reasonable compensation to the producer of such data.15
Section 2. Amended, Supplemental and Reregistration
Normally, data requirements for applications to amend or supplement
existing registrations or for reregistrations are somewhat less stringent than for
new registrations. An amended registration is required when an applicant
proposes changes on the label, minor changes in the composition, or marketing of
a pesticide under different brand names.16 A supplemental registration allows a
pesticide producer to market a registered pesticide under a distributor's brand
name.17 These applications deal with an already registered pesticide and the data
to support such applications need not be as elaborate as for registering a new
pesticide.
All pesticide registrations are subject to automatic cancellation at the end
of five years from the date of registration.18
The Administrator must publish a notice in the Federal Register, at least 30
days before the registration's expiration date, that registration will be cancelled
unless the registrant or other interested person with the registrant's concurrence,
before the expiration date, requests that the registration be continued for another
5 year period.19 The request for continued registration must be made in
accordance with regulations prescribed by the Administrator.20
If the EPA needs additional data to continue an existing pesticide
registration, the Administrator must so notify all registrants of the pesticide to
which the determination relates and provide a list of such registrants to any
interested person.21 Each registrant must provide within 90 days of being so
notified, evidence that it is taking appropriate steps to secure the additional
-7-
required data.22 Two or more of such registrants may share the cost for providing
this additional information or may develop such data jointly.23
Section 3. Exemptions to Registration
The regular registration procedures are not required for:
-Pesticides being transferred from one establishment to another of the
same producer solely for packaging or for use as a part of another
formulation.24
-Pesticides transferred under experimental use permits.25
-Pesticides transferred for purposes of disposal.26
-Pesticides intended for export.27
-Pesticides granted emergency exemption.28
-Pesticide products that may come under the Federal Food, Drug and
Cosmetic Act.29
-Pesticides exempt by virtue of their being adequately controlled by
another federal agency.30
-Any other pesticide the Administrator may choose to exempt while still
carrying out the intent of FIFRA.31
While pesticides being transferred from one registered establishment to
another (both operated by the same producer) for packaging or for use as a
component in another formulation need not be registered, they are, however,
subject to the provisions of FIFRA and the regulation regarding misbranding.32
Any person may apply for an experimental use permit. If the Administrator
grants such a permit, the pesticide in question is exempt from the usual
registration requirements. A permit is granted only if the applicant needs it to
develop information necessary for an application for registration.33 In granting
the permit, the Administrator may place time limits and other restrictions on the
use of the material.34 The Act provides also that the Administrator may issue
-8-
experimental use permits for unregistered pesticides to public and private agricul-
tural agencies for use in experimentation.35
Pesticides being transferred for disposal are exempt from registration, but
they must meet the requirements concerning misbranding and the containers must
be marked clearly "for disposal only."36
Pesticides produced and transferred for export are exempt from registration
when they are prepared and packed according to specifications of a foreign
purchaser.37
The Act further provides that the Administrator may permit the use of an
unregistered pesticide upon application by a federal or state agency (usually a
State Commissioner of Agriculture). Such use is permitted only when a serious
pest outbreak occurs or is threatened, when no registered pesticide adequate for
control is available, when time does not permit registering the needed pesticide in
the usual manner, and when significant economic or health damage may occur.
The Administrator may specify the conditions under which an unregistered
pesticide is to be used in an emergency.38
Section 4. State Authority
A state may regulate, within its borders, the sale or use of any federally
registered pesticide. However, the state regulations cannot permit any sale or use
which is prohibited by FIFRA or the EPA.39 States cannot impose any labeling or
packaging requirements in addition to or different from those required by FIFRA
or the EPA.40
-9-
FOOTNOTES
17 U.S.C. #136 a: 40 CFR162.2(b).
27 U.S.C. 9136 a (c)(5); 40 CFR 162.11(a).
340 CFR 0162.18-1 162.18-5.
4See 40 CFR 162.11(a). Amended and supplemental registrations need not neces-
sarily go through RPAR, "Exemptions for Registration", this chapter.
57 U.S.C. s136a; 40 CFR 162.6-162.9, 162.43(f)(1)-(5).
67 U.S.C. ~136a.
740 CFR 0162.5-162.6,162.41-47.
87 U.S.C. *136a(c)(Amended 1978).
9Id.
1040 CFR 162.8(a-c).
117 U.S.C. 136a(c)(2)(a). The Administrator shall publish guidelines specifying the
kinds of information which will be required to support the registration of a
pesticide and shall revise the guidelines from time to time. 40 CFR 1 162.41 et.
seq.
1240 CFR 162.7(d)(1).
137 U.S.C. s136a(c)(2).
14The information which relates to formulas of products may be revealed:
1) to any federal agency consulted,
2) at a public hearing,
3) in findings of fact issued by the Administrator.
7 U.S.C. S136h(b)
15There are regulations covering the payment of reasonable compensation for
data use. 40 CFR s162.9 (1-9).
1640 CFR162.6(b)(3-5).
17Id., at 162.6(b)(4).
187 U.S.C. s136(a)(1), and 40 CFR 162.6(c).
19Id.
2040 CFR S162.6(c)(1)(2), 162.43(a)(c).
217 U.S.C. 136a(c)(2)(B)(i).
22Id., at s36a(c)(2)(B)(ii).
- 10 -
23I., at 136a(c)(2)(B)(i-v).
2440 CFR 162.5(b)(1).
25Id., at 6162.5(b)(2).
26Id., k162.5(b)(3).
271d., at i162.5(b)(4).
28Id., at s162.5(b)(5).
29Id., at 9162.5(b)(6).
301d., at 162.5(b)(7)(i).
31Id., at k162.5(b)(7)(ii).
327 U.S.C. 136a(b) 40 CFR 162.5(b)(1).
337 U.S.C. l36c(a).
34Id., at 136c(b, c).
35Id., at 9136c(g).
3640 CFR 162.5(b)(3). See also 7 U.S.C. S136q.
37Id., at 0162.5(b)(4). See 7 U.S.C. #136o.
38Id., at l62.5(b)(5). See 40 CFR k166 in general.
397 U.S.C. 136v(a)(c). A use is prohibited by FIFRA or the EPA if registration for
such use has been previously denied, disapproved or cancelled by the EPA
Administrator.
40Id., at s 36v(b).
- 11 -
CHAPTER THREE
RPAR REBUTTABLE PRESUMPTION AGAINST
REGISTRATION (SPECIAL REVIEW)
The process known as the Rebuttable Presumption Against Registration
(RPAR), created by EPA regulations in 19751 to intensely study pesticides
suspected of causing unreasonable effects to man or the environment, is currently
under revision.2 The name RPAR is being changed to Special Review.3 Many
aspects of the RPAR process are being dramatically revised.4. Due to the current
state of change, we cannot detail precisely what the review process for
potentially harmful pesticides will be.
What follows is an outline of the RPAR process, pre-revisions, and an outline
of the proposed major revisions to this process.
Section 1. RPAR: Triggering the RPAR
If there is a suspicion that a pesticide may cause an unreasonable risk to
man or to the environment, based upon a study or other significant evidence, a
pesticide is nominated as a RPAR candi ate.5
Once nominated, the EPA staff or its contractors review all readily
available literature on the pesticide's toxicology and exposure patterns.6 The
trigger studies or other evidence are also examined to see if they are valid. There
is only nominal participation in the pre-RPAR evaluation by the
registrant/applicant, public or other government agencies.
Based on this survey, if the EPA determines that the pesticide meets or
exceeds one or more of the RPAR risk criteria7, a notice of RPAR is prepared and
published in the Federal Register.
- 12 -
Section 2. RPAR: Formal Review
Formal review begins with the publication of the "Notice of RPAR" in the
Federal Register. Agency review encompasses all of the major and minor uses of
the RPAR'd pesticide.
Upon the publication of the Notice of RPAR, all interested persons
(including other federal agencies) may submit evidence rebutting (or supporting)
the presumption against registration. The initial rebuttal period is 45 days8;
however, this period can be extended by 60 days if it can be shown that additional
time is necessary.9
There are two ways to rebut a presumption against registration.10 It must
be demonstrated that:
1 The study or studies (or other evidence) on which the presumption was
based are not scientifically valid, or
2 Exposure to the RPAR'd pesticide will not cause an unreasonable adverse
effect to man or to the environment.
Information on the pesticide's benefits can also be submitted during the
rebuttal period.11
At the end of the rebuttal period, the EPA staff reviews all comments,
information and responses received. They also review additional risk data or risk
analysis provided by divisions within the EPA, such as the Carcinogen Assessment
Group (CAG).
Section 3. Regulatory Options: Risk/Benefit Analysis
If after the rebuttal period, the agency determines that the presumption
against registration has not been rebutted, the agency intensifies the risk and
benefit assessment to determine what type of regulatory action is appropriate.12
Input from internal EPA divisions, such as the CAG, intensifies, and a joint
EPA-USDA-State team conducts a benefits analysis.13 It is at this point that
- 13 -
"pesticide use and assessment reports" are formulated and submitted. The EPA on
its own also conducts a benefits analysis. Initially, the risk analysisl4 is
conducted separately from the benefits analysis.
A risk/benefit synthesis is then conducted for each regulatory option. Based
on the risk/benefit balance, a use-by-use regulatory position is proposed by the
EPA.
A Preliminary Notice of Determination, announcing the proposed use-by-use
regulatory actions, is published in the Federal Register.15 This notice requests
comments from interested persons on the proposed regulatory actions.16 Usually
30 days are given for submitting responses. FIFRA17 requires that the EPA give
the Secretary of Agriculture and the Scientific Advisory Panel (SAP) 60 days
notice before formally denying or cancelling registration for a particular use.18
The publication of the Notice of Determination starts this 60 day period.19
The SAP holds a public session to consider the relevant risk issues and,
sometimes, the benefits information. The Secretary of Agriculture confers with a
staff technical advisory group and usually comments upon the impact that the
proposed actions will have on the 'agricultural community'. Sometimes, the EPA
conducts informal field hearings with farmers or other pesticide users to elicit
their comments.20
The EPA, usually after publication of the Notice of Determination and
before issuing its final proposal, attempts to negotiate with the principal
registrants/applicants. The agency tries to reach an agreement on the final
regulatory actions so as to minimize the chances that the final proposed actions
will be challenged.
- 14 -
Section 4. Final Regulatory Decision
After the EPA receives and evaluates all comments, and following
completion of any negotiations, the EPA staff prepares a final regulatory decision
and forwards it to the EPA Administrator for approval.21 If approved, a Final
Notice of Determination, announcing the end of RPAR and the EPA's regulatory
decision, is published in the Federal Register.22
Section 5. Special Review:23 Proposed Revisions to the RPAR Process
The proposed revisions are designed to 1) assure a reasonable level of
concern before the review process is initiated; 2) expedite the review process;24
3) reduce the resource burden imposed on the EPA staff; 4) promote better
quality scientific review in the early stages of the review; and 5) increase the
likelihood that restrictions placed on registration are endorsed, voluntarily, by the
registrants/ applicants.
Section 6. Revision In the Risk Criteria
Currently, exposure estimates are not considered by the EPA prior to initia-
tion of the formal RPAR process. Also, it appears that present EPA regulations
require RPAR to be initiated on the basis of one positive study (reflecting health
risks) regardless of whether the weight of evidence justifies initiating the RPAR
process. Revisions are being made to provide a stronger assurance of a potential
risk before Special Review will be initiated.25
Section 7. Initiation of Special Review
Registrants/Applicants will be involved from the outset. They will be
informed when a potential 'trigger' study is received and again when the study is
- 15 -
reviewed. If Special Review is necessary, the Office of Pesticide Programs (OPP)
will meet with the registrant/applicant to explain the risk concerns. The
registrant/applicant will help the agency decide what use sites should be reviewed
or cancelled. The registrant/applicant will be given the opportunity to develop
exposure data.
Following completion of exposure data, the OPP may be able to identify
what restrictions would be necessary to reduce risks to acceptable levels. If so,
these restrictions will be discussed with the registrants/applicants and if voluntary
compliance can be achieved, the registrations) would be amended and Special
Review would be terminated.26
If Special Review does not end as above, the EPA staff would assemble the
risk data, along with preliminary usage/exposure data. EPA management would
then review this information. If they agree that a risk problem exists, the SAP
would review and comment on the agency's risk case.27 While EPA's management
reviews the risk case, the registrant/applicant would be allowed to submit a
benefits analysis. This analysis would be forwarded to the USDA for review and
comment.28
Depending on the comments received, Special Review may be terminated,
suspended29 or continued. If continued, OPP would attempt to develop,
informally, risk/benefit information so as to help identify appropriate registration
restrictions. Once developed, the agency would attempt to negotiate a settlement
with the registrant/applicants.
If successful, registrants/applicants would agree to restrictions and the
registrations/applications would be amended. If these negotiations fail, a more
formal review would be initiated. The USDA would be requested to supply
information necessary to generate a benefits analysis. If cancellation or denial is
not contemplated, a brief benefit's analysis will be compiled, but if cancellation or
- 16 -
denial of registration is contemplated, a fuller, more precise analysis will be
made. The EPA staff would then conduct a new risk/benefit synthesis and prepare
a document consisting of proposed regulatory options. If the document is
approved by the EPA, its availability would be announced in the Federal Register
and formal comments would be solicited from the public, USDA and SAP.
After comments have been received and analyzed, settlement negotiations
would be tried again. If this fails, a final action document would be prepared, and
if approved by the EPA Administrator, a notice of the proposed final agency
regulatory action (and of the availability of the final action document) would be
published in the Federal Register.
- 17 -
FOOTNOTES
1The RPAR process was created by EPA regulations. These regulations can be
found in 40 CFR #162.11.
2See 'Implementation of Bush Task Force Initiatives on RPAR', Pesticide and
Toxic Chemical News, Vol. 10, #24, April 28, 1982, page 9.
3Id.
41d.
57 U.S.C. s136a(c)(8).
6When a pesticide is nominated, it is assigned to a project manager within the
Special Pesticide Review Division (SPRD) of the EPA. An RPAR support team is
formed. The team is composed of scientific personnel from the EPA's Office of
Pesticide Programs (OPP) and an attorney representing the EPA's office of
General Counsel. Validation studies can be contracted to scientists outside the
EPA.
740 CFR 162.11(a)(3).
840 CFR s62.11(a)(i).
91d.
10Id. at s62.11(a)(4)(i)-(iii).
11The EPA has indicated that benefit evidence can rebut the presumptions too.
Risks may not be unreasonable in light of certain benefits derived from using the
pesticide. See 45 Fed. Reg. 52,637.
12If the presumption against registration has been rebutted, the RPAR process is
terminated.
13The OPP's Hazard Evaluation Division (HED) is responsible for assessing acute
and chronic hazards. Investigation and analysis of cancer hazard lies with the
CAG.
14The regulatory options range from registering the pesticide for all uses
requested, to denying the registration for all such uses.
15The average time elapsing from the Notice of RPAR to this publication is over
two years. See, "The RPAR and Label Improvement Programs and Cancellation
and Suspension Proceedings Under FIFRA" Ebner, page 17.
16A position document, supporting the agency's position, is available upon request.
177 U.S.C. 136d(b).
18If no comments are submitted in writing to the Administrator within 30 days of
such notice, the Administrator may issue a notice of intent to deny or cancel
registration at anytime after such 30 day period rather than after 60 days.
- 18 -
19The position document, discussing the agency's position, is available for their
review.
20 Supra note 15, at page 21.
2141 Fed. Reg. 21404.
227 U.S.C. #136d(b). A final position document is also prepared. This document
contains the agency's responses to the comments received and explains the basis
for the final regulatory decision.
23The following revisions can be found in a paper prepared by the EPA's OPP. The
draft paper is titled "Implementation of Bush Task Force Initiatives on RPAR."
24It is established that current RPAR review takes between 2-3 years from start
to finish.
25See note 23, at page 2.
261d., at page 3. If registrants use the opportunity to interact with the agency to
delay final action, the OPP could initiate more formal review.
27At the time of referral to the SAP, a notice of such referral would be published
in the Fed. Reg., and a summary of the risk case would be made available. The
public would then have the opportunity to submit information or comments.
28The USDA comments would be received at about the same time the SAP files
comments on the risk case.
29Suspension of Special Review would be appropriate if additional data were
necessary to resolve uncertainty.
- 19 -
CHAPTER FOUR
THE ADMINISTRATIVE HEARING
Section 1. The Proceedings: Obtaining the Hearing
At the conclusion of the RPAR process, (or in the future, Special Review),
the Administrator may issue a notice of intent to hold a hearing to determine
whether the registration for some or all uses should be cancelled or denied, or may
issue a notice of an intent to deny or cancel registration for some or all uses.1
In the latter case, any person adversely affected by such notice may request
an administrative hearing to determine the issue of registration.2 This request
must be made within 30 days of publication or receipt by the registrant/applicant,
whichever is later, of the notice of such intent.3 This request must be filed with
the EPA hearing clerk.4
The person requesting the hearing must file, concurrently with the hearing
request, a document stating objections to the proposed regulation.5 If a notice of
intent to hold a hearing is filed by the Administrator, the Administrator must, at
the same time, file a statement of issues (to be addressed at the hearing).6 Any
person wishing to participate in a hearing commenced pursuant to such a notice,
must file a written response to the statement of issues.7
The hearing is conducted in accordance with section 556 and 557 of the
Administrative Procedure Act (APA).8 The procedures employed are set out in
the regulations promulgated under FIFRA.9
- 20 -
Section 2. Parties to the Proceedings (Hearing)10
If a hearing is held pursuant to the Administrator's request, the initial
parties to the proceedings are the EPA and any person responding to the
Administrator's statement of issues. If the hearing was initiated on the request of
a person adversely affected by the notice of intent to deny or cancel registration,
the parties are the individual requesting the hearing and the EPA. Alternatively,
any person11 may request, by filing a motion, to become a party to the
proceedings.12 If the request is granted, such persons) become a party to the
proceedings with the full status of original parties.13
Persons not parties to the proceedings, on approval by the Administrative
Law Judge, may file briefs.14
Section 3. The Administrative Law Judge (ALJ)
An Administrative Law Judge is appointed by the EPA's Chief
Administrative Law Judge to oversee the hearing process. 15 The ALJ must
conduct the proceedings fairly and impartially. The ALJ's conduct is subject to
the precepts of the Canons of Judicial Ethics of the American Bar Association.16
The ALJ cannot decide any matter in which he has a financial interest, or a
relationship with a party that would make it inappropriate for him to act.17
Section 4. Disqualification of the Administrative Law Judge
The Administrative Law Judge may, at any time, withdraw from the
proceedings.18 Additionally, any party may request the ALJ to disqualify himself,
if the party feels the ALJ has pre-judged the facts or may be biased.19
Due to the ALJ's wide discretion in conducting all phases of the proceedings,
it requires a substantial showing of bias to disqualify him/her.20 If the ALJ is
removed or withdraws voluntarily, a new ALJ is appointed.21
- 21 -
Section 5. Prehearing Procedures: Discovery
Unless unnecessary or impracticable, the Administrative Law Judge must
order at least one prehearing conference.22 The conference is designed to
streamline and simplify the (actual) hearing.23
No transcript of the prehearing conferences) is made, unless a party
requests one and such request is approved.24 However, the ALJ must prepare a
written report of the actions taken, stipulations, or agreements made by the
parties, all rulings upon matters considered and appropriate orders. This report
becomes part of the record.
Each party must make available to the other parties, at the conference or
otherwise before the hearing, the names of all witnesses expected to be called,
together with a brief summary of the expected testimony and a list of all
documents and exhibits the party expects to introduce.25
Further prehearing discovery shall also be permitted if such discovery 1) will
not unreasonably delay the proceedings, 2) the information sought is not
otherwise obtainable, and 3) such information has significant probative value.26
At the prehearing conferencess, parties may request to have questions of
scientific fact submitted to a committee formed by the National
Academy of Sciences (NAS).27 If the ALJ decides that this referral (submission)
is necessary or desirable, the ALJ will submit appropriate questions.28
The committee's response must be made public and the response becomes
part of the record as well.29
When motions are required, except those made orally during the hearing,
they must be submitted in writing, and state with particularity the grounds and
the relief order sought.30
- 22 -
A. Burden of Proof
On all issues arising in connection with the hearing, the ultimate burden of
persuasion lies with the party seeking registration.31
When a hearing is requested to contest an order cancelling registration, the
agency must first present an affirmative case for cancelling the registration.32
When a hearing is requested to contest an order denying registration, the party
seeking registration must first present an affirmative case. When the agency calls
for the hearing, the agency must first present an affirmative case as to the
statement of issues.33
B. Presenting Evidence/Witnesses
Evidence (including pesticide assessment documents and other material
developed and submitted during the RPAR phase) which is relevant and material
to the issues raised in the objections filed by the party or parties, or to the state-
ment of issues if the Administrator called for the hearing, is admissible.34
The parties to the proceeding may call their own witnesses and cross
examine adverse witnesses. Upon a showing of relevance and materiality, any
party may request the ALJ to subpoena any person to compel testimony or to
produce documents.35
At any time during the hearing, a party may request that relevant questions
of scientific fact be submitted to a committee of the NAS.36 If the ALJ finds
such submittal is necessary or desirable, the questions will be referred. The
committee's response becomes part of the evidence on the record. Objections to
these responses also become part of the record.37
The ALJ may take official notice of some facts not disputed by the parties.38
Parties must be given an opportunity to show that officially noticed facts are
erroneous by presenting evidence to the contrary.39
- 23 -
Section 6. The Accelerated Decision
The ALJ may at any time during the proceedings render a decision in favor
of the Agency as to all or any portion of the proceedings, including dismissal of
the action supporting registration or opposing cancellation for any of the following
reasons:
(1) Untimely or insufficient objections filed pursuant to 164.20;
(2) Failure to comply with discovery orders;
(3) Failure to comply with prehearing orders;
(4) Failure to appear or to proceed at prehearing conferences;
(5) Failure to appear at the hearing;
(6) Failure to state a claim upon which relief can be granted;
(7) That there is no genuine issue of any material fact;
(8) Such other and further reasons as are just.40
This decision will become the final agency order with respect to registration or
cancellation unless it is appealed to the Administrator, or unless the
Administrator orders its review.41
Section 7. The Initial Decision
The ALJ makes an initial (recommended) decision with respect to
registration within 25 days after the close of the hearing.42
The initial decision must be based on the substantial weight of the evidence
on the record as a whole.43 The hearing record includes: all pleadings, all written
motions, intermediate rulings, all evidence received-including all exhibits and
documents introduced as well as all (written and oral) testimony; all objections
and rulings thereon, a statement of matters officially noticed, and each party's, if
they so file, proposed orders, findings of facts, conclusions of law and briefs in
support of their positions.44
- 24 -
The initial decision will become the final agency order unless it is
appealed,45 or unless the Administrator orders its review.
Section 8. The Administrator's Decision: Appeal From or Review of the Initial
Decision
Within 20 days after the ALJ's initial decision is filed, any party may take
exception to any matter set forth in the decision, 47 or to any adverse ruling or
order to which they objected during the hearing, and appeal these exceptions to
the Administrator.48
If no exceptions are timely filed the hearing clerk must notify the
administrator, 30 days from the date the ALJ filed an initial decision, of this
fact.49 Within 10 days of such notice, the Administrator must issue an order
either declining to review, or expressing an intent to review, the ALJ's initial
decision.50 If the ALJ's initial decision is reviewed by the Administrator, a party
who filed exceptions and briefs may make oral argument before the
Administrator.51 During review, the Administrator may determine that additional
exceptions should be argued. In such cases, the Administrator must give counsel
for the parties written notice of this determination.
At any time before the Administrator issues the final order, any party may
move to re-open the hearing so that further evidence may be introduced.52 This
motion must state briefly the nature and purpose of the evidence to be adduced,
show that such evidence is not repetitive and set forth reasons why the evidence
was not offered at the hearing. If the motion is granted, the hearing is re-opened
for this limited purpose. If it is denied, the motion and the ruling thereon become
part of the record for purposes of judicial review.53
If the initial or accelerated decision is reviewed, the Administrator must
render a final decision, unless otherwise agreed to by the parties, within 90 days
- 25 -
after the close of the hearing or from the filing of an accelerated decision.54
This decision must be based on the substantial weight of the evidence on the
record as a whole.55 In rendering this final decision, the Administrator may
accept or reject all or part of the ALJ's initial (or accelerated) decision.56
Within 10 days of service of the final order, a party may move to re-hear,
re-argue the proceedings, or to reconsider the final order. These motions must
briefly and specifically state the matters claimed to have been erroneously
decided. If the motion is granted, the final decision is set aside pending the
rehearing or re-argument of the proceedings, or reconsideration of the final
decision. If the motion is denied, the motion and the resulting ruling are placed on
the record for purposes of judicial review.57
Any party to the proceedings adversely affected by the final order may seek
judicial review of that order.58 If judicial review is granted, the order is not put
into effect until judicial review is completed.
- 26 -
FOOTNOTES
17 U.S.C. 9136d(b). The notice of intent to hold a hearing may be issued without
RPAR being invoked. See Procedural Requirements for Registraton, Chapter II.
2Id.
3Id.
440 CFR 164.20(a).
5Id. at s164.20(b). The document stating the objections to the Administrator's
decision "shall clearly and concisely set forth...the basis for each objection,
including relevant allegations of fact concerning the pesticide under
consideration. The document shall indicate the registration number of the
pesticide, a copy of the currently accepted and/or proposed labeling and a list of
the currently registered or proposed uses of the pesticide..." See 40
CFRI164.22(a).
61d. at 164.20(b) and 164.23(a).
740 CFR S164.24. Such response must include the position and interest of such
person.
85 U.S.C. s551 et. seq. The language of FIFRA in 136d(d) triggers the applica-
bility of the APA. The decision is required to be determined on the record after
opportunity for a hearing.
940 CFR 164.20-164.111.
10"The proceedings" refer to all phases from prehearing to the final decision.
"Party to the proceeding" is used as a legal term of art. Status as a party to the
proceeding is important in several respects:
1) Standing for judicial review (See Chapter V Judicial Review -
Standing).
2) Rights/obligations during the course of the hearing: right to cross-
examine, file motions, introduce evidence, compel testimony or
production of documents, object to offers of or rejection of
evidence, right to notice on rulings or officially noticed materials,
right to contest official notice, right to appeal ALJ decision to
Administrator, and obligation to appear at the prehearing
conference. See the CFR and this chapter for further rights and
obligations.
11See 40 CFR 164.2(m) for definition of "person".
1240 CFR 164.31. The motion must set forth the reasons why the person wishes
to be a party and their position and interests in the proceeding. They must file
the document of objection to the decision, if the decision was to deny or cancel
the registration, or file a response to the Administrator's statement of issues, if
the Administrator ordered the hearing. The motion ordinarily must be filed before
the start of the first prehearing conference. If not, a statement of good cause for
not filing earlier must be included in the motion.
- 27 -
1340 CFR 164.31(c). These persons have full status of original parties except
possibly for purposes of a settlement.
14Id. at 64.31(d). A person not a party to the proceeding wishing to file a brief
must file a motion with the ALJ. The motion must state the interests of such
applicant and the reasons why filing the brief is desirable. Unless the parties to
the hearing otherwise agree, this brief must be filed within the time allowed to
the party whose position the brief will support. A late filing may be granted if
good cause is shown.
1540 CFR ~64.20(c).
16Id. at 164.40(c).
17Id. at 164.40(a).
181d. at 164.40(b)(2).
19The party must file a motion asking for disqualification. If the ALJ rules
against disqualification, he must certify the ruling for appeal. 40 CFR 164.40(b).
20U.S. ex rel De Luce v. O'Rourke, 213 F. 2d 759 (1954).
2140 CFR 164.40(e).
22Id. at 164.50(a). The ALJ has discretion to order more than one conference.
23The following may be considered at this conference:
1) The simplification of issues including listing of specific uses to be
considered;
2) The necessity or desirability of amendments to the objections or
statement of issues, or any document filed in response thereto;
3) The possibility of obtaining stipulations of fact and documents which
will avoid unnecessary delay;
4) Matters of which official notice may be taken;
5) The limitation of the number of expert and other witnesses;
6) Procedure at the hearing except as so provided in 164.80(a);
7) The use of verified written statements in lieu of oral direct
testimony;
8) The intent of any party to request a scientific advisory committee as
defined in 0164.2(f);
9) The issuance of subpoenas and subpoenas duces tecum for discovery
and hearing purposes;
10) A setting of a time and place for the public hearing, after giving
careful consideration to the convenience of all the parties, the
- 28 -
witnesses, the public interest and the necessity for notice in the
Federal Register as provided by #164.8; and
11) Any other matter that may expedite the hearing or aid in the
disposition of the proceeding. 40 CFR 064.50(a)(1-11).
2440 CFR 164.50(c).
25Id. at *64.50(b).
26Id. at 164.51(a). Upon a showing of good cause, and when necessary to preserve
evidence for presentation at the hearing, or when the information sought cannot
be obtained otherwise, the ALJ shall order depositions to be taken. s164.51(b).
27Id. at 164.50(e)(1).
28Id. at 64.50(e)(2). The ALJ prepares these questions. If the questions
submitted are not in substance based on the submission of the parties, the parties
have 10 days to respond to the proposed submission. The ALJ makes the final
determination on the questions to be referred to the committee. These questions
cannot be referred until at least 30 days after the ALJ notifies the NAS that
questions will be referred to them.
2940 CFR 164.50(e)(3).
30Id. at 164.60(a). Procedures for disposition of motions made before the ALJ's
initial decision are found in 9164.60(b)(c). See also #164.111 and 164.110 for
procedures for certain motions made after the ALJ's initial decision. See section
4.8 on Administrator's Review of Initial Decision.
310nce an affirmative case for denying registration is made, unless the party
seeking registration demonstrates by substantial evidence otherwise, registration
will be denied.
321f another person becomes a party by motion, on the agency's side, this person
rather than the agency may present the affirmative case for cancellation. See 40
CFR 164.80(a).
33The agency must demonstrate that these really are controverted issues.
34Evidence which is unduly repetitious is not admissible. Strict common law rules
of evidence do not apply, Calhoun v. Bailor, 626 F. 2d 145 (1980), nor do the
Federal Rules of Evidence. The ALJ rules on the admissability of evidence. If he
deems evidence inadmissible, the party seeking admission may offer proof with
respect to the relevance and materiality of the evidence. This offer becomes part
of the record. 40 CFR s164.8(f). If a party objects to the admission of evidence,
the party may state its grounds for objection. The ALJ's ruling and reasons given
on the objection become part of the record. The party adversely affected by the
ALJ's ruling cannot appeal this objection to the Administrator unless the ALJ
certifies the ruling for appeal. *164.81(c) and ?164.100. See, 164.100, this section
for conditions for the ALJ to certify rulings for appeal.
357 U.S.C ?136d(d). The ALJ may limit the scope of any examination or cross-
examination of witnesses. If a party objects to the limit, or objects to no limit
- 29
being set, they may file an objection. This objection and the ALJ's response
becomes part of the record. 40 CFRs164.82(c).
367 U.S.C. 9136d(d).
370bjections to these responses are dealt with as in footnote 34.
38These facts are matters which are commonly noticed judicially by the federal
courts, plus other facts specific to the knowledge and expertise of the agency. 40
CFR 9164.8(e).
391d.
401d. at 164.91(a).
41Id. at S164.91(b). The accelerated decision has the same effect as an ordinary
initial decision, and becomes the final decision and order unless appealed from by
a party.
4240 CFR 164.90(b).
437 U.S.C. 163d(d).
44Within 20 days after the last evidence is taken, each party may file findings of
fact and conclusions of law based solely on the record. Each party then is given
the opportunity to file a reply brief. An extension of up to 30 days for filing these
findings and briefs may be granted by the ALJ. 40 CFR s164.90(a). The ALJ's
initial decision, findings of fact and conclusions of law, plus any briefs or
exceptions to the initial decision, filed by any party, become part of the record
for purposes of further review.
4540 CFR s164.100. This appeal to the Administrator is a matter of right.
4640 CFR 164.90(b).
4740 CFR 164.101(a)(1).
48This is the same procedure for appealing an accelerated decision. 40
CFR 164.102. In this same time period, each party appealing exceptions must file
a brief concerning each of the exceptions being appealed with the hearing clerk.
Within 7 days of service (transmission) of the exceptions and briefs, any other
party or Amicus Curiae may file and serve a brief responding to exceptions or
arguments raised by any other party. These briefs may not raise additional (not
previously asserted) exceptions. 40 CFR s164.101(a)(2).
4940 CFR 9164.101(b).
501d.
511f a party desires to offer oral argument, a written statement to this effect is
required. If the party fails to so state, the party is deemed to have waived such
oral argument. 40 CFRs164.101(c)(l).
5240 CFR 164.110(b).
30 -
53See f164.111 for disposition of motions. See also Chapter V, Judicial Review.
5440 CFR 164.103.
557 U.S.C. 136d(d). See footnote 45 and accompanying text for hearing record's
content.
5640 CFR 164.103.
57See Id. at s64.111 for procedures for disposition of these motions.
587 U.S.C. S136d(f); also 136n(b). See Chapter V on Judicial Review.
- 31 -
CHAPTER FIVE
FINAL AGENCY ORDERS: REVIEWABILITY
Final agency orders seeking 1 to deny or to cancel registration of a pesticide
are subject to judicial review.2 Preliminary, procedural or intermediate agency
actions not otherwise reviewable, are reviewable during the review of the final
agency action.3
Final agency orders4 granting, or refusing to cancel or suspend registration
are also subject to judicial review.5 Additionally, preliminary, procedural or
intermediate agency actions or orders not otherwise reviewable are subject to
review during the review of this final agency action.6
The above final orders are reviewable by district courts, if issued before or
without a public hearing.7 If the final orders are issued following a public hearing,
the court of appeals handles the review.8 The judgment of either reviewing court
is subject to further review.9
Section 1. Scope of Judicial Review, Standards and Effect of Review
In reviewing agency actions-orders denying, cancelling, granting, or
refusing to cancel or suspend, registration; courts examine the whole record of the
"proceedings." The content of the 'record' will vary depending on which stage of
the registration process the order became final.10
Generally, if the substantial weight of the evidence on the record as a whole
supports the agency's decision, the court must sustain the decision.11 When
questions of law are implicated on judicial review, courts, independent of the
agency, decide them.12
- 32 -
Agency actions can be invalidated in whole or in part if the court determines
the decision is not supported by the substantial weight of the evidence on the
record, the agency exceeded it statutory authority, abused its discretion or failed
to provide procedures required by law or due process.13
Section 2. Standing: Who May Initiate Judicial Review
In the case of an order denying, cancelling, granting, or refusing to cancel
registration, issued after a public hearing, only those persons adversely affected
by the order and who were a party14 to the proceedings may initiate judicial
review.15
When such final orders are issued without holding a public hearing, any
person whose interests are protected or regulated by FIFRA and had those
interests harmed, can initiate judicial review.16
Section 3. Suspension Orders:17 Reviewability
With one exception, final suspension orders18 are subject to judicial
review.19 When a registrant fails to request a hearing within 5 days from notifi-
cation of a proposed suspension order, or in the case of an emergency suspension
order, fails to request a hearing within 5 days from notification of such order's
issuance, the suspension order issued is not reviewable by a court.20 For
reviewable suspension orders, court review may commence even if related cancel-
lation or other administrative procedures have not been completed.21
Suspension orders issued following a hearing are reviewable exclusively by
courts of appeals.22 Emergency suspension orders, effective when issued pending
completion of a timely requested expedited public hearing,23 are reviewable by
district courts.24 The judgment of either reviewing court is subject to further
review.25
- 33 -
Section 4. Scope of Review, Standard and Effect of Review
In reviewing suspension orders issued following an expedited hearing, the
courts will examine the whole record of the suspension hearing.26 Generally, if
the substantial weight of the evidence on record supports the suspension order,
courts will uphold the order.2 7
In reviewing emergency suspension orders-orders issued prior to an
expedited hearing, effective pending the hearing's outcome;28 courts will review
the information the Administrator relied upon in determining that an emergency
exists. Such emergency orders will be upheld unless, in issuing such orders, the
Administrator is found to have acted arbitrarily, capriciously or in abuse of
discretion.29 Courts may review, independently, to see whether the procedures
required to be followed, by law or due process, were indeed followed.30 If an
expedited hearing is timely requested, the order issued following the expedited
hearing is reviewable, regardless of whether there was judicial review of the
initial emergency order, and is reviewable in the manner as described above (first
paragraph).
The commencement of judicial review does not delay the suspension order's
effect, unless ordered by the court. 31 A court ruling, which invalidates a
suspension order issued after a hearing,32 is only effective until the
Administrator's final decision with respect to cancellation.33 If an emergency
suspension order, effective pending an expedited hearing's outcome, is invalidated,
such ruling is effective until the decision following the expedited hearing is issued.
Section 5. Standing
In the case of a suspension order issued following a hearing, generally only
those persons adversely affected by the order and who were a party34 to the
34 -
suspension hearing may initiate judicial review.35 However, standing has been
granted to consumers of a suspended pesticide who were not parties to the
hearing.36
In the case of an emergency order, effective pending completion of an
expedited hearing, judicial review may be initiated only by the registrant or "other
interested person with the concurrence of the registrant."37
- 35 -
FOOTNOTES
1Agency orders are final when 1) no further administrative review is available, or
2) further administrative review is available, but such review is not timely
requested.
An order denying or cancelling registration is final and effective at the end of 30
days from receipt by the applicant, or publication of a notice of intent to deny or
cancel, whichever is later, unless a request for a public hearing is made within 30
days by a person adversely affected by such decision. If the request for the
hearing is made timely, the decision issued after the public hearing's completion is
the final agency order. 7 U.S.C. sl36d(b).
27 U.S.C. s136d(f). The Administrative Procedure Act (APA), 5 U.S.C. 551 et
seq.; s704 states "agency actions made reviewable by statute...are subject to
judicial review." FIFRA expressly provides for judicial review of final agency
orders: denying, cancelling, suspending, granting, or refusing to cancel or suspend,
registration. See footnote 1, 4, 17, 18 and 19.
Generally, judicial review is not available until the administrative process has
been exhausted, and the issue is ripe, i.e. the order reflects final agency action.
However, there exist three exceptions to this general rule. Judicial review,
before a final order is issued, is allowed:
1) When an agency acts in excess of its delegated powers or contrary to
a specific statutory mandate, Leedom v. Kyne 358 U.S. 184
(1958).
2) When the proceedings involve questions of high national interest
because of their international complexion, McCulloch v. Sociedad
Nacionel de Marineris de Honduras, 372 U.S. 10 (1963).
3) When agency action has clearly violated the constitutional rights of
the party seeking injunctive relief against the agency proceedings.
Fay v. Daud, 172 F. 2d 720 (1949). Fairchild, Arabatzis and Smith
v. Sackhern, 451 F. Supp. 1181 (1978) .
Under the last exception, if the necessary constitutional protection
initially lacking is provided to the party in a later stage, it could
not reasonably be said the agency clearly violated the party's
constitutional rights. See e.g. Coastal States Gas Corp. v. Doe, 495
F. Supp. 1300, 1309 (1980).
35 U.S.C. sT04. When a public hearing is held to determine the issue of
registration, agency actions occurring before the public hearing process are not
directly reviewable. See footnote 2 for exception. Such actions can include the
agency's use of the pesticide assessment documents during the RPAR process, and
the ruling issued after the RPAR process. The APA allows for court review of
these actions at this time.
4Agency orders granting registration, or refusing to cancel or suspend
registration, are final on the effective date the 'Notice of Registration' or letter
of approval is issued. 40 CFR #162.47(d)(3).
- 36 -
57 U.S.C. Y136n(a)(b). See footnote 2, this chapter, for the exceptions to the
general rule that only final agency orders are reviewable. FIFRA s136n(a)
expressly provides for judicial review of final agency orders refusing to cancel or
suspend registrations issued before a public hearing. Section 136n(b) provides for
judicial review of any agency order issued following a public hearing. This would
include final agency orders granting registration issued after a public hearing.
Final orders granting registration issued before a public hearing, are made review-
able by 0163n(a). This section provides judicial review for "other final agency
actions not committed to agency discretion by law." The decision to register a
pesticide or not is not committed to agency discretion by law. FIFRA sets out
standards which must be met for a pesticide to be registered. If the standards are
met the agency must register the pesticide. See 7 U.S.C. #136a(c)(5)(A)(B)(C)(D).
6See footnote 3, this chapter.
77 U.S.C. s136n(a).
81d., at s36n(b). Persons seeking judicial review must file with a court of appeals
for the circuit wherein the individual seeking review resides or has a place of
business. Such person must file within 60 days from the date the final order
became effective.
97 U.S.C. s136n(b).
10The record, for orders made final without a public hearing, can include:
registration application and data in support thereof and position documents if
RPAR was invoked. If the order is issued following a public hearing, the full
course of that hearing-pleadings, motions, intermediate rulings, evidence
received, considered or rejected, statement of matters officially noticed, offers
of proof, objections and rulings thereon, proposed findings, and the Administrative
Law Judge's decision-constitutes the record. See footnote 45, Chapter 4, and
accompanying text.
117 U.S.C. 163n(b), and 5 U.S.C. 8706(2)(E).
125 U.S.C. s706. Questions of law arise when the party seeking review alleges
that the agency: 1) acted outside the scope of their authority or 2) failed to
provide procedures) required by statute or due process. Questions of fact can be
distinct from questions of law. Questions of fact arise when the party seeking
review alleges the agency reached an improper decision, based solely on the
evidence. Agency finding on questions of fact must be sustained if they are
supported by the substantial weight of the evidence on the record. Mixed
questions of law and fact arise when there is a dispute both as to the propriety of
inferences drawn by the agency from the evidence and as to the meaning of a
statutory or regulatory term. NLRB v.Marcus Trucking Co., 286 F. 2d 583, 590-91
(1961). In such mixed question cases, the standards-statutory or regulatory
terms-are not of a nature as to be appropriate for independent judicial review, as
are questions of law. O'Leary v. Brown-Pacific-Mason, Inc. 340 U.S. 504 (1951).
The agency findings on these mixed questions must be upheld if supported by'the
substantial weight on the record. Id.
- 37
13Constitutional due process requires a minimum of procedural protection. The
procedures established by the APA, 5 U.S.C. 9556 and 557, followed by the EPA
during the public hearing, provide applicants their due process. The public's
ability to provide input plus the right to invoke judicial review if adversely
affected by an agency order or rule, see standing, this chapter provides the
general public with sufficient constitutional protection.
Unless another statute imposes more specific standards than those found in the
APA, or a fundamental constitutional right requires greater protection, courts
cannot require the EPA to provide further procedural protection. See Vermont
Yankee, 435 U.S. 519 (1978). FIFRA tracks the APA language which triggers
APA's 556, 557 applicability. See 7 U.S.C. 9136d and 5 U.S.C. s554(a).
If a violation of procedural due process is found, courts will remand the case back
to the agency. The agency must re-hear the issue, employing the necessary
procedures.
14See Chapter 4, Section2. For emergency suspension order hearings, no one
other than the original parties-agency, registrant-may participate. However,
persons adversely affected by the suspension may file briefs. Any person so filing
is considered a party for purposes of judicial review. Id.
157 U.S.C. s136n(b).
16See Id. at 136n(a). Unlike standing to seek judicial review of final orders issued
following a public hearing, no specific grant of standing for these orders is found
in FIFRA. Standing must be determined according to APA, 5 U.S.C. :702 and
court imposed standards.
Basically, standing depends on whether the party has alleged such a "personal
stake in the outcome of the controversy," Baker v. Carr, 369 U.S. 186, 204, (1961),
so as to insure "the dispute will be presented in an adversary context and in a form
historically viewed as capable of judicial resolution." Flast v. Cohen, 392 U.S. 83,
101 (1967).
The U.S. Supreme Court, in Association of Data Processing Service Organization,
Inc., v. Camp 397 U.S. 250 (1969) established the two-tier test for standing. 1)
Injury-in-fact-includes economic injury see Sierra Club v. Morton, 405 U.S. 727
(1973) for example and 2) injury is to an interest "arguably within the zone of
interest to be protected or regulated by the statute (FIFRA here) the agency is
claimed to have violated."
For final orders denying or cancelling registration, those having standing can
include users of the banned pesticide and consumers of the user's products.
For final orders granting or refusing to cancel or suspend registration, those
having standing can include environmental protection organizations. See Sierra
Club and E.D.F. v. Ruckelshaus, 439 F. 2d. 584 (1974).
17The Administrator can suspend the registration of a pesticide upon
determination that such action is necessary to prevent an imminent hazard during
the time required for cancellation of registration or change in classification
proceedings. 7 U.S.C. 136d(c)(1).
- 38 -
A suspension order technically can only be issued if a notice of intent to cancel
the registration or change the pesticide's classification has been, or is
simultaneously, issued. Id.
Non-Emergency Suspension Orders: Such an order can be issued anytime after 5
days from the registrant's receipt of a notice of intent to suspend, unless within
those five days the registrant requests an expedited hearing. In this case, such
order can only be issued following the expedited hearing if the substantial weight
or preponderance of the evidence warrants it.
Emergency Suspenson Orders: When the Administrator determines that an
emergency exists that does not permit a hearing to be held before suspending a
pesticide's use, the Administrator may issue a suspension order in advance of
notification. If a request for the expedited hearing is timely made, such order
remains effective pending the hearing outcome. If no request is timely made, the
suspension order is final and not reviewable by the courts.
18Suspension orders, for purposes of judicial review, are "final" when issued. See
footnote 17 and section 5.4 this chapter.
197 U.S.C.A. 136d(c)(4)(1982).
207 U.S.C. 136d(c)(2). Only the registrant may request such a hearing. See Id.,
at 0136(d)(c)(1).
21Id., also see footnote 17 and 19 at emergency orders.
227 U.S.C.A. s136d(c)(4)(1980).
23See footnote 19 on emergency orders. This expedited hearing is not the same
as the public hearing conducted to determine the issue of registration or
cancellation. For General Rules of Practice for Expedited Hearings see 40
CFR 164.120-164.123 (1980).
247 U.S.C.A. 136d(c)(4)(1980).
251d. at s9136n(b).
26See footnote 10 for general content of 'the record'. See footnote 23.
27See footnotes 11, 12, 13 and accompanying text.
28See footnote 17.
297. U.S.C.A. s136d(c)(4)(1980), to invalidate the emergency suspension order,
the aggrieved party must show the Administrator made an error of judgment so
clear as to deprive the decision of a rational basis. Dow Chemical v. Blum, 469
F. Supp. 892.
307 U.S.C.A. s136d(c)(4)(1980).
317 U.S.C.A. 9136d(c)(4)(1980).
- 39 -
32See the text accompanying footnote 13. The text is applicable for court
rulings on these suspension orders.
337 U.S.C.A. #136d(c)(4)(1980).
34See footnote 14.
357 U.S.C.A. 136d(c)(4)(1980). This section triggers the standing requirement
found in s136n(b).
361n State of Wyoming v Hathaway, 525 F. 2d 66, cert. denied, 426 U.S. 906,
the court held that while consumers of economic poisons are so remotely
involved as not to be entitled to notice and hearing concerning EPA's proposal
to suspend registration of chemical toxicants, consumers do have right to seek
judicial review of the EPA's order in the court of appeals.
37U.S.C.A. k136d(c)(4)(1980).
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ABBREVIATIONS AND ACRONYMS
ALJ Administrative Law Judge
APA Administrative Procedure Act
CAG Carcinogen Assessment Group
CFR Code of Federal Regulations
EPA Environmental Protection Agency
FEPCA Federal Environmental Pesticide Control Act
FIFRA Federal Insecticide, Fungicide and Rodenticide Act
HED Hazard Evaluation Division
NAS National Academy of Sciences
OPP Office of Pesticide Programs
RPAR Rebuttable Presumption Against Registration
SAP Scientific Advisory Panel
USC United States Code
USCA United States Code Annotated
USDA United States Department of Agriculture
- 41 -
GLOSSARY
1. Amicus Curiae Latin. "A friend of the court". A by-stander (usually a
counselor) who interposes and volunteers information upon some matter
of law in regard to which the judge is doubtful or mistaken, or upon a
matter of which the court may take judicial cognizance. Implies friendly
intervention of counsel to remind the court of legal matters which has
escaped its notice, and regarding which it appears to be in danger of going
wrong.
Also a person who has no right to appear in a suit but is allowed to
introduce argument, authority, or evidence to protect his interest.
Black's Law Dictionary, 4th ed. (1968).
2. Briefs a written or printed document used as a basis for an argument
upon a cause on appeal. It is usually filed for the court's information. It
conveys the essential facts of a party's case-embodies points of law,
together with the arguments and authorities on which a party rests their
contentions. Black's Law Dictionary, 4th ed. (1968).
3. Discovery the disclosure by one party to another of facts, titles,
documents or other things which are in their exclusive knowledge or
possession, and which are necessary to the party seeking the discovery for
purposes of the action pending. Black's Law Dictionary, 4th ed. (1968).
4. Foreign purchaser as used in the Act, a person who purchases a pesticide
product solely for use outside the United States.
5 Formal adjudication a hearing by the agency of evidence on the factual
issues involved, in which procedures similar to those used by courts of law
are employed. Black's Law Dictionary, 4th ed. (1968).
6. Injunction a court order determining rights of parties directing or
forbidding one party to do a certain act. As used in this Act, a court may
enjoin (issue an injunction) to suspend registration proceedings until a
matter has been determined at the federal court level.
7. Motion an application for a rule or order made to a court or judge. A
motion may be written or oral. Black's Law Dictionary, 4th ed. (1968).
8. Mutagenic the property of a substance or mixture of substances to
induce changes in the genetic complement of either somatic or germinal
tissue in subsequent generations. 40 CFR 162.3(bb).
9. Official (judicial) notice the act by which a court, in conducting a trial
or framing its decision, will, of its own motion and without the production
of evidence, recognize the existence and truth of certain facts having a
bearing on the issues at bar. To be a proper fact for judicial notice, the
fact must be universally regarded as established by common notoriety or
fact which, from its nature, is not properly the subject of testimony.
Black's Law Dictionary, 4th ed. (1968).
- 42 -
10. Oncogenic the property of a substance or a mixture of substances to
produce benign or malignant tumor formations in living animals. 40
CFR s162.3(bb).
11. Pesticide any substance or mixture of substances intended for preventing,
destroying, repelling, or mitigating any pest, and any substance or mixture
of substances intended for use as a plant regulator, defoliant, or desiccant.
The term "pesticide" when not specifically modified or delimited by other
words, shall include any one or combination of the following aspects of the
term: The active ingredient (chemical or biological); the pesticide formula-
tion; and the pesticide product. The following are examples of classes of
pesticides:
Amphibian and reptile poisons and repellents
Antimicrobial agents
Attractants
Bird poisons and repellents
Defoliants
Desiccants
Fish poisons and repellents
Fungicides
Herbicides
Insecticides
Invertebrate animal poisons and repellents
Mammal poisons and repellents
Nematicides
Plant regulators
Rodenticides
Slimicides
40 CFR 62.3(ff).
12.Pleadings that process performed by the parties to the action, in
alternatively presenting written statements of their contentions, each responsive
to preceding statements. From this process, issues (points affirmed by one side
and denied by the other) evolve. Balck's Law Dictionary, 4th ed. (1968).
13.Probative value in the law of evidence, a fact, document, testimony, or other
evidentiary material has probative value if it has the effect of proof, tends to
prove, or actually proves something related to a relevant issue. Black's Law
Dictionary (1968).
14.Rebuttal the introduction of evidence tending to show that prior evidence
admitted is not true or accurate.
15.Rebuttable presumption a species of legal presumption which holds good until
disapproved. Black's Law Dictionary, 4th ed. (1968).
16.Regulation a rule or order prescribed for agency conduct and for those under
agency control. Agencies are delegated the authority to promulgate these 'rules
or orders'. Black's Law Dictionary, 4th ed. (1968).
17.Standing as used in the term "standing to sue" or bring action, in federal
courts a person has no right to go to court complaining against another's (generally
- 43 -
official) conduct unless such conduct invades or will invade a legally protected
interest of the complaining party. Black's Law Dictionary, 4th ed.(1968).
18.Subpoena duces tecum a process by which a court, at the demand of a party,
commands a witness who has possession of some document or other article to
produce it at a proceeding.
19.Substantial weight of evidence such relevant evidence as a reasonable mind
might accept as adequate to support a conclusion. Black's Law Dictionary, 4th ed.
(1968).
20.Teratogenic the property of a substance or mixture of substances to produce
or induce functional deviations or developmental anomalies not heritable, in or on
an animal embryo or fetus. 40 CFR 162.3(mm).
21.Toxicity:
Acute toxicity the property of a substance or mixture of substances to cause
adverse effects in an organism through a single short term exposure. 40
CFR s162.3(nn)(1).
Subacute toxicity the property of a substance or mixture of substances to cause
adverse effects in an organism upon repeated or continuous exposure within less
than 1/2 the lifetime of that organism. 40 CFR s162.3(nn)(2).
Chronic toxicity the property of a substance or mixture of substances to cause
adverse effects in an organism upon repeated exposure over a period of at least
1/2 the lifetime of that organism. 40 CFR 162.3(nn)(3).
22.Trade secret a plan or process or compound known only to its owner, and
those of his employees to whom it is necessary to confide it. Such secret process
or compound is not patented, but its use has a commercial value. Black's Law
Dictionary, 4th ed. (1968).
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16 denial of registration is contemplated, a fuller, more precise analysis will be made. The EPA staff would then conduct a new risk/benefit synthesis and prepare a document consisting of proposed regulatory options. If the document is approved by the EPA, its availability would be announced in the Federal Register and formal comments would be solicited from the public, USDA and SAP. After comments have been received and analyzed, settlement negotiations would be tried again. If this fails, a final action document would be prepared, and if approved by the EPA Administrator, a notice of the proposed final agency regulatory action (and of the availability of the final action document) would be published in the Federal Register.
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17 FOOTNOTES 1The RPAR process was created by EPA regulations. These regulations can be found in 40 CFR 162.11. 2 See 'Implementation of Bush Task Force Initiatives on RPAR', Pesticide and Toxic Chemical News, Vol. 10, #24, April 28, 1982, page 9. 3Id. 4Id. 4 1d. 57 U.S.C. s136a(c)(8). 6 When a pesticide is nominated, it is assigned to a project manager within the Special Pesticide Review Division (SPRD) of the EPA. An RPAR support team is formed. The team is composed of scientific personnel from the EPA's Office of Pesticide Programs (OPP) and an attorney representing the EPA's office of General Counsel. Validation studies can be contracted to scientists outside the EPA. 740 CFR 162.11(a)(3). 840 CFR 162.11(a)(i). 9Id. 10Id. at 162.11(a)(4)(i)-(iii). 11The EPA has indicated that benefit evidence can rebut the presumptions too. Risks may not be unreasonable in light of certain benefits derived from using the pesticide. See 45 Fed. Reg. 52,637. 1 2 If the presumption against registration has been rebutted, the RPAR process is terminated. 13The OPP's Hazard Evaluation Division (HED) is responsible for assessing acute and chronic hazards. Investigation and analysis of cancer hazard lies with the CAG. 14The regulatory options range from registering the pesticide for all uses requested, to denying the registration for all such uses. 15The average time elapsing from the Notice of RPAR to this publication is over two years. See, "The RPAR and Label Improvement Programs and Cancellation and Suspension Proceedings Under FIFRA" Ebner, page 17. 16A position document, supporting the agency's position, is available upon request. 177 U.S.C. §136d(b). 18If no comments are submitted in writing to the Administrator within 30 days of such notice, the Administrator may issue a notice of intent to deny or cancel registration at anytime after such 30 day period rather than after 60 days.
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14 Section 4. Final Regulatory Decision After the EPA receives and evaluates all comments, and following completion of any negotiations, the EPA staff prepares a final regulatory decision and forwards it to the EPA Administrator for approval. 2 1 If approved, a Final Notice of Determination, announcing the end of RPAR and the EPA's regulatory decision, is published in the Federal Register. 2 2 Section 5. Special Review: 2 3 Proposed Revisions to the RPAR Process The proposed revisions are designed to 1) assure a reasonable level of concern before the review process is initiated; 2) expedite the review process; 2 4 3) reduce the resource burden imposed on the EPA staff; 4) promote better quality scientific review in the early stages of the review; and 5) increase the likelihood that restrictions placed on registration are endorsed, voluntarily, by the registrants/ applicants. Section 6. Revision In the Risk Criteria Currently, exposure estimates are not considered by the EPA prior to initiation of the formal RPAR process. Also, it appears that present EPA regulations require RPAR to be initiated on the basis of one positive study (reflecting health risks) regardless of whether the weight of evidence justifies initiating the RPAR process. Revisions are being made to provide a stronger assurance of a potential risk before Special Review will be initiated. 2 5 Section 7. Initiation of Special Review Registrants/Applicants will be involved from the outset. They will be informed when a potential 'trigger' study is received and again when the study is
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19 CHAPTER FOUR THE ADMINISTRATIVE HEARING Section 1. The Proceedings: Obtaining the Hearing At the conclusion of the RPAR process, (or in the future, Special Review), the Administrator may issue a notice of intent to hold a hearing to determine whether the registration for some or all uses should be cancelled or denied, or may issue a notice of an intent to deny or cancel registration for some or all uses.l In the latter case, any person adversely affected by such notice may request an administrative hearing to determine the issue of registration. 2 This request must be made within 30 days of publication or receipt by the registrant/applicant, whichever is later, of the notice of such intent. 3 This request must be filed with the EPA hearing clerk. 4 The person requesting the hearing must file, concurrently with the hearing request, a document stating objections to the proposed regulation. 5 If a notice of intent to hold a hearing is filed by the Administrator, the Administrator must, at the same time, file a statement of issues (to be addressed at the hearing). 6 Any person wishing to participate in a hearing commenced pursuant to such a notice, must file a written response to the statement of issues. 7 The hearing is conducted in accordance with section 556 and 557 of the Administrative Procedure Act (APA). 8 The procedures employed are set out in the regulations promulgated under FIFRA. 9
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-7required data. 2 2 Two or more of such registrants may share the cost for providing this additional information or may develop such data jointly. 2 3 Section 3. Exemptions to Registration The regular registration procedures are not required for: -Pesticides being transferred from one establishment to another of the same producer solely for packaging or for use as a part of another formulation. 2 4 -Pesticides transferred under experimental use permits. 2 5 -Pesticides transferred for purposes of disposal. 2 6 -Pesticides intended for export. 2 7 -Pesticides granted emergency exemption. 2 8 -Pesticide products that may come under the Federal Food, Drug and Cosmetic Act. 2 9 -Pesticides exempt by virtue of their being adequately controlled by another federal agency. 3 0 -Any other pesticide the Administrator may choose to exempt while still carrying out the intent of FIFRA. 3 1 While pesticides being transferred from one registered establishment to another (both operated by the same producer) for packaging or for use as a component in another formulation need not be registered, they are, however, subject to the provisions of FIFRA and the regulation regarding misbranding. 3 2 Any person may apply for an experimental use permit. If the Administrator grants such a permit, the pesticide in question is exempt from the usual registration requirements. A permit is granted only if the applicant needs it to develop information necessary for an application for registration. 3 3 In granting the permit, the Administrator may place time limits and other restrictions on the use of the material. 3 4 The Act provides also that the Administrator may issue
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-3In the footnotes, additional details are given when needed, relevant statutes and regulations are cited, and references are made to court cases and other information deemed to be useful. A glossary is included which defines both legal and scientific terms to aid scientists, farmers and others in their understanding of the pesticide regulatory process.
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13 "pesticide use and assessment reports" are formulated and submitted. The EPA on its own also conducts a benefits analysis. Initially, the risk analysis 1 4 is conducted separately from the benefits analysis. A risk/benefit synthesis is then conducted for each regulatory option. Based on the risk/benefit balance, a use-by-use regulatory position is proposed by the EPA. A Preliminary Notice of Determination, announcing the proposed use-by-use regulatory actions, is published in the Federal Register. 1 5 This notice requests comments from interested persons on the proposed regulatory actions. 1 6 Usually 30 days are given for submitting responses. FIFRA 1 7 requires that the EPA give the Secretary of Agriculture and the Scientific Advisory Panel (SAP) 60 days 18 notice before formally denying or cancelling registration for a particular use.l The publication of the Notice of Determination starts this 60 day period. 1 9 The SAP holds a public session to consider the relevant risk issues and, sometimes, the benefits information. The Secretary of Agriculture confers with a staff technical advisory group and usually comments upon the impact that the proposed actions will have on the 'agricultural community'. Sometimes, the EPA conducts informal field hearings with farmers or other pesticide users to elicit their comments. 2 0 The EPA, usually after publication of the Notice of Determination and before issuing its final proposal, attempts to negotiate with the principal registrants/applicants. The agency tries to reach an agreement on the final regulatory actions so as to minimize the chances that the final proposed actions will be challenged.
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28 witnesses, the public interest and the necessity for notice in the Federal Register as provided by 164.8; and 11) Any other matter that may expedite the hearing or aid in the disposition of the proceeding. 40 CFR 164.50(a)(1-11). 2440 CFR 164.50(c). 2 5 1d. at 164.50(b). 2 6 Id. at s64.51(a). Upon a showing of good cause, and when necessary to preserve evidence for presentation at the hearing, or when the information sought cannot be obtained otherwise, the ALJ shall order depositions to be taken. s164.51(b). 2 7 Id. at 164.50(e)(1). 2 8 Id. at s164.50(e)(2). The ALJ prepares these questions. If the questions submitted are not in substance based on the submission of the parties, the parties have 10 days to respond to the proposed submission. The ALJ makes the final determination on the questions to be referred to the committee. These questions cannot be referred until at least 30 days after the ALJ notifies the NAS that questions will be referred to them. 2940 CFR 164.50(e)(3). 3 0 Id. at §164.60(a). Procedures for disposition of motions made before the ALJ's initial decision are found in s164.60(b)(c). See also s164.111 and §164.110 for procedures for certain motions made after the ALJ's initial decision. See section 4.8 on Administrator's Review of Initial Decision. 3 1 0nce an affirmative case for denying registration is made, unless the party seeking registration demonstrates by substantial evidence otherwise, registration will be denied. 3 2 If another person becomes a party by motion, on the agency's side, this person rather than the agency may present the affirmative case for cancellation. See 40 CFR 164.80(a). 3 3 The agency must demonstrate that these really are controverted issues. 3 4 Evidence which is unduly repetitious is not admissible. Strict common law rules of evidence do not apply, Calhoun v. Bailor 626 F. 2d 145 (1980), nor do the Federal Rules of Evidence. The ALJ rules on the admissability of evidence. If he deems evidence inadmissible, the party seeking admission may offer proof with respect to the relevance and materiality of the evidence. This offer becomes part of the record. 40 CFR 0164.8(f). If a party objects to the admission of evidence, the party may state its grounds for objection. The ALJ's ruling and reasons given on the objection become part of the record. The party adversely affected by the ALJ's ruling cannot appeal this objection to the Administrator unless the ALJ certifies the ruling for appeal. 0164.81(c) and ?164.100. See, 164.100, this section for conditions for the ALJ to certify rulings for appeal. 357 U.S.C . §136d(d). The ALJ may limit the scope of any examination or crossexamination of witnesses. If a party objects to the limit, or objects to no limit
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20 Section 2. Parties to the Proceedings (Hearing) 1 0 If a hearing is held pursuant to the Administrator's request, the initial parties to the proceedings are the EPA and any person responding to the Administrator's statement of issues. If the hearing was initiated on the request of a person adversely affected by the notice of intent to deny or cancel registration, the parties are the individual requesting the hearing and the EPA. Alternatively, any person a l may request, by filing a motion, to become a party to the proceedings. 1 2 If the request is granted, such persons) become a party to the proceedings with the full status of original parties. 1 3 Persons not parties to the proceedings, on approval by the Administrative Law Judge, may file briefs.' 4 Section 3. The Administrative Law Judge (AUJ) An Administrative Law Judge is appointed by the EPA's Chief Administrative Law Judge to oversee the hearing process. 15 The ALJ must conduct the proceedings fairly and impartially. The ALJ's conduct is subject to the precepts of the Canons of Judicial Ethics of the American Bar Association. 1 6 The ALJ cannot decide any matter in which he has a financial interest, or a relationship with a party that would make it inappropriate for him to act. 1 7 Section 4. Disqualification of the Administrative Law Judge The Administrative Law Judge may, at any time, withdraw from the proceedings. 1 8 Additionally, any party may request the ALJ to disqualify himself, if the party feels the ALJ has pre-judged the facts or may be biased. 1 9 Due to the ALJs wide discretion in conducting all phases of the proceedings, it requires a substantial showing of bias to disqualify him/her. 2 0 If the ALJ is removed or withdraws voluntarily, a new ALJ is appointed. 2 1
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43 official) conduct unless such conduct invades or will invade a legally protected interest of the complaining party. Black's Law Dictionary, 4th ed.(1968). 18.Subpoena duces tecum a process by which a court, at the demand of a party, commands a witness who has possession of some document or other article to produce it at a proceeding. 19.Substantial weight of evidence such relevant evidence as a reasonable mind might accept as adequate to support a conclusion. Black's Law Dictionary, 4th ed. (1968). 20.Teratogenic the property of a substance or mixture of substances to produce or induce functional deviations or developmental anomalies not heritable, in or on an animal embryo or fetus. 40 CFR s162.3(mm). 21.Toxicity: Acute toxicity the property of a substance or mixture of substances to cause adverse effects in an organism through a single short term exposure. 40 CFR s162.3(nn)(1). Subacute toxicity the property of a substance or mixture of substances to cause adverse effects in an organism upon repeated or continuous exposure within less than 1/2 the lifetime of that organism. 40 CFR s162.3(nn)(2). Chronic toxicity the property of a substance or mixture of substances to cause adverse effects in an organism upon repeated exposure over a period of at least 1/2 the lifetime of that organism. 40 CFRl162.3(nn)(3). 22.Trade secret a plan or process or compound known only to its owner, and those of his employees to whom it is necessary to confide it. Such secret process or compound is not patented, but its use has a commercial value. Black's Law Dictionary, 4th ed. (1968).
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-9FOOTNOTES 17 U.S.C. §136 a: 40 CFR162.2(b). 27 U.S.C. §136 a (c)(5); 40 CFR #62.11(a). 340 CFR §162.18-1 162.18-5. 4 See 40 CFR 162.11(a). Amended and supplemental registrations need not necessarily go through RPAR, "Exemptions for Registration", this chapter. 57 U.S.C. 136a; 40 CFR 162.6-162.9, 162.43(f)(1)-(5). 67 U.S.C. 0136a. 740 CFR s162.5-162.6,162.41-47. 87 U.S.C. 136a(c)(Amended 1978). 9Id. 1040 CFR§162.8(a-c). 117 U.S.C. s36a(c)(2)(a). The Administrator shall publish guidelines specifying the kinds of information which will be required to support the registration of a pesticide and shall revise the guidelines from time to time. 40 CFR *162.41 et. seq. 1240 CFR 62.7(d)(1). 137 U.S.C. s136a(c)(2). 1 4 The information which relates to formulas of products may be revealed: 1) to any federal agency consulted, 2) at a public hearing, 3) in findings of fact issued by the Administrator. 7 U.S.C. s136h(b) 15There are regulations covering the payment of reasonable compensation for data use. 40 CFR §162.9 (1-9). 1640 CFRf162.6(b)(3-5). 1 7 Id., at S62.6(b)(4). 187 U.S.C. 136(a)(1), and 40 CFR 162.6(c). 19Id. 2040 CFR 162.6(c)(1)(2), 162.43(a)(c). 217 U.S.C. 136a(c)(2)(B)(i). 22Id., at s36a(c)(2)(B)(ii).
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-2Administrator must classify pesticides for restricted or general use and that only certified applicators may use restricted materials. The law, supplemented by EPA regulations, specifies how to register a pesticide and the steps to be taken if the Administrator decides not to register a material. It also empowers the Administrator to withdraw registration from any pesticide which in his judgment is likely to cause unreasonable risk to man or the environment. The Act specifies penalties for violations and goes into many more details which will be covered later. The law, the regulations promulgated under the law, the guiding administrative practices and policies, and the relevant court decisions constitute an imposing mass of legal machinery. The Act and the mass of other laws, rules and court decisions relevant to governmental control of pesticides often are confusing and frustrating to people in agriculture, and may even perplex attorneys who encounter them for the first time. One purpose of this paper is to describe the legal machinery relating to pesticides so that people in agriculture may better understand the rules, regulations and processes in control. Another purpose is to help people in agriculture and the pesticide industry prepare information that will be useful in the decision making required for registration of a pesticide. This paper deals with the laws and regulations governing the registration of pesticides and with the administrative and legal steps that are brought into play if the Administrator decides to deny an application for registration or decides to withdraw or alter the registration of an existing pesticide. Legal remedies, available in courts of law for persons concerned with registration or denial of registration of pesticides are discussed. Throughout, the paper focuses on the kinds and quality of information required and how information is used in the decision making processes, from initial administrative consideration of an application to register, through the administrative hearing and, finally, in courts of law.
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31 CHAPTER FIVE FINAL AGENCY ORDERS: REVIEWABILITY Final agency orders seeking 1 to deny or to cancel registration of a pesticide are subject to judicial review. 2 Preliminary, procedural or intermediate agency actions not otherwise reviewable, are reviewable during the review of the final agency action. 3 Final agency orders 4 granting, or refusing to cancel or suspend registration are also subject to judicial review. 5 Additionally, preliminary, procedural or intermediate agency actions or orders not otherwise reviewable are subject to review during the review of this final agency action. 6 The above final orders are reviewable by district courts, if issued before or without a public hearing. 7 If the final orders are issued following a public hearing, the court of appeals handles the review. 8 The judgment of either reviewing court is subject to further review. 9 Section 1. Scope of Judicial Review, Standards and Effect of Review In reviewing agency actions-orders denying, cancelling, granting, or refusing to cancel or suspend, registration; courts examine the whole record of the "proceedings." The content of the 'record' will vary depending on which stage of the registration process the order became final. 1 0 Generally, if the substantial weight of the evidence on the record as a whole supports the agency's decision, the court must sustain the decision." When questions of law are implicated on judicial review, courts, independent of the agency, decide them.12
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-4CHAPTER TWO REGISTRATION OF PESTICIDES Generally, in order to sell, offer for sale, hold for sale, distribute, ship, deliver for shipment, or receive and (having so received) deliver or offer to deliver a pesticide to any person, the pesticide material must be registered with EPA. The Act and the regulations issued by EPA set out the requirements and procedures for registration 1 . The registration process includes submission of an application by the producer of a pesticide, admission of specified information in support of the application, and the consideration and disposal of the application by EPA. If, after reviewing the application and its supporting data, the Administrator of EPA decides that the pesticide meets the criteria outlined in FIFRA, he approves the application and the pesticide product is "registered". 2 If he does not approve, he may issue a "conditional registration" pending admission of additional data or pending further consideration by EPA. 3 Disapproval may initiate a process known as RPAR (Rebuttable Presumption Against Registration) 4 which will be discussed in Chapter 3.* An application for registration may be for a new material-one not previously registered with EPA-or for an amended, supplemental or reregistration of a registered material 5 *The RPAR process is now also referred to as Special Review. The terms RPAR and Special Review are used synonymously throughout this manual
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-5Section 1. Requirements for Registration Briefly, an application for a registration must contain the name and address of the applicant, a proposed label for the product, composition of the material, proposed classification (for general or restricted use), and supporting data. 6 Title 40 of the Code of Federal Regulations which includes "Guidelines for Registering Pesticides: Registration Procedures" provides details on the requirements for applications. 7 The EPA requires substantial supporting data. The applicant must substantiate all claims for the pesticide including proof that the material will perform its intended function without causing unreasonable adverse effects on man or the environment. 8 The applicant must furnish or refer to data sufficient to demonstrate that the pesticide meets the criteria specified in FIFRA. 9 The supporting data must include any factual information regarding adverse effects of the pesticide on the environment or man which the applicant has obtained or is aware of and which, insofar as the applicant knows, has not previously been submitted to EPA. 1 0 This includes, but is not limited to, published or unpublished laboratory studies or accident experience. The applicant must comply with any requests for information which EPA deems to be needed for proper consideration of the application.l 1 Supporting data is a prerequisite to approval of any application for registration. 1 2 Normally, data submitted in support of registration must be disclosed publicly within 30 days of registration. 1 3 However, the Administrator generally can not make public information which in his or her judgment consists of trade secrets; but even a trade secret (information relating to formulas of products), when necessary for the purposes of FIFRA, may be subject to limited disclosure. 1 4 The Administrator must give 30 days notice before disclosing any
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32 Agency actions can be invalidated in whole or in part if the court determines the decision is not supported by the substantial weight of the evidence on the record, the agency exceeded it statutory authority, abused its discretion or failed to provide procedures required by law or due process. 1 3 Section 2. Standing: Who May Initiate Judicial Review In the case of an order denying, cancelling, granting, or refusing to cancel registration, issued after a public hearing, only those persons adversely affected by the order and who were a party 1 4 to the proceedings may initiate judicial review. 1 5 When such final orders are issued without holding a public hearing, any person whose interests are protected or regulated by FIFRA and had those interests harmed, can initiate judicial review. 1 6 Section 3. Suspension Orders:7 Reviewability With one exception, final suspension orders 1 8 are subject to judicial review. 1 9 When a registrant fails to request a hearing within 5 days from notification of a proposed suspension order, or in the case of an emergency suspension order, fails to request a hearing within 5 days from notification of such order's issuance, the suspension order issued is not reviewable by a court. 2 0 For reviewable suspension orders, court review may commence even if related cancellation or other administrative procedures have not been completed. 2 1 Suspension orders issued following a hearing are reviewable exclusively by courts of appeals. 2 2 Emergency suspension orders, effective when issued pending completion of a timely requested expedited public hearing, 2 3 are reviewable by district courts. 2 4 The judgment of either reviewing court is subject to further review. 2 5
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40 ABBREVIATIONS AND ACRONYMS ALJ Administrative Law Judge APA Administrative Procedure Act CAG Carcinogen Assessment Group CFR Code of Federal Regulations EPA Environmental Protection Agency FEPCA Federal Environmental Pesticide Control Act FIFRA Federal Insecticide, Fungicide and Rodenticide Act HED Hazard Evaluation Division NAS National Academy of Sciences OPP Office of Pesticide Programs RPAR Rebuttable Presumption Against Registration SAP Scientific Advisory Panel USC United States Code USCA United States Code Annotated USDA United States Department of Agriculture
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LEGAL ASPECTS OF PESTICIDE USE AND IMPACT ASSESSMENT REPORTS: The Regrflatory Process in Review A.H. Daniels and M.T. Olexa Co-Principal Investigators: Professor James S. Wershow Agricultural Law Department of Food and Resource Economics Professor Grover C. Smart, Jr. Nematologist Department of Entomology and Nematology Supported by Grant 12-05-300-495 from the Extension Service, USDA Food and Resource Economics Department Institute of Food and Agricultural Sciences University of Florida Gainesville, Florida 32611 1982
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42 10. Oncogenic the property of a substance or a mixture of substances to produce benign or malignant tumor formations in living animals. 40 CFR s162.3(bb). 11. Pesticide any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant. The term "pesticide" when not specifically modified or delimited by other words, shall include any one or combination of the following aspects of the term: The active ingredient (chemical or biological); the pesticide formulation; and the pesticide product. The following are examples of classes of pesticides: Amphibian and reptile poisons and repellents Antimicrobial agents Attractants Bird poisons and repellents Defoliants Desiccants Fish poisons and repellents Fungicides Herbicides Insecticides Invertebrate animal poisons and repellents Mammal poisons and repellents Nematicides Plant regulators Rodenticides Slimicides 40 CFRs162.3(ff). 12.Pleadings that process performed by the parties to the action, in alternatively presenting written statements of their contentions, each responsive to preceding statements. From this process, issues (points affirmed by one side and denied by the other) evolve. Balck's Law Dictionary, 4th ed. (1968). 13.Probative value in the law of evidence, a fact, document, testimony, or other evidentiary material has probative value if it has the effect of proof, tends to prove, or actually proves something related to a relevant issue. Black's Law Dictionary (1968). 14.Rebuttal the introduction of evidence tending to show that prior evidence admitted is not true or accurate. 15.Rebuttable presumption a species of legal presumption which holds good until disapproved. Black's Law Dictionary, 4th ed. (1968). 16.Regulation a rule or order prescribed for agency conduct and for those under agency control. Agencies are delegated the authority to promulgate these 'rules or orders'. Black's Law Dictionary, 4th ed. (1968). 17.Standing as used in the term "standing to sue" or bring action, in federal courts a person has no right to go to court complaining against another's (generally
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21 Section 5. Prehearing Procedures: Discovery Unless unnecessary or impracticable, the Administrative Law Judge must order at least one prehearing conference. 2 2 The conference is designed to streamline and simplify the (actual) hearing. 2 3 No transcript of the prehearing conferences) is made, unless a party requests one and such request is approved. 2 4 However, the ALJ must prepare a written report of the actions taken, stipulations, or agreements made by the parties, all rulings upon matters considered and appropriate orders. This report becomes part of the record. Each party must make available to the other parties, at the conference or otherwise before the hearing, the names of all witnesses expected to be called, together with a brief summary of the expected testimony and a list of all documents and exhibits the party expects to introduce. 2 5 Further prehearing discovery shall also be permitted if such discovery 1) will not unreasonably delay the proceedings, 2) the information sought is not otherwise obtainable, and 3) such information has significant probative value. 2 6 At the prehearing conferencess, parties may request to have questions of scientific fact submitted to a committee formed by the National Academy of Sciences (NAS). 2 7 If the ALJ decides that this referral (submission) is necessary or desirable, the ALJ will submit appropriate questions. 2 8 The committee's response must be made public and the response becomes part of the record as well. 2 9 When motions are required, except those made orally during the hearing, they must be submitted in writing, and state with particularity the grounds and the relief order sought. 3 0
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38 A suspension order technically can only be issued if a notice of intent to cancel the registration or change the pesticide's classification has been, or is simultaneously, issued. Id. Non-Emergency Suspension Orders: Such an order can be issued anytime after 5 days from the registrant's receipt of a notice of intent to suspend, unless within those five days the registrant requests an expedited hearing. In this case, such order can only be issued following the expedited hearing if the substantial weight or preponderance of the evidence warrants it. Emergency Suspenson Orders: When the Administrator determines that an emergency exists that does not permit a hearing to be held before suspending a pesticide's use, the Administrator may issue a suspension order in advance of notification. If a request for the expedited hearing is timely made, such order remains effective pending the hearing outcome. If no request is timely made, the suspension order is final and not reviewable by the courts. 18Suspension orders, for purposes of judicial review, are "final" when issued. See footnote 17 and section 5.4 this chapter. 197 U.S.C.A. §136d(c)(4)(1982). 207 U.S.C. §136d(c)(2). Only the registrant may request such a hearing. See Id., at 2136(d)(c)(1). 21Id., also see footnote 17 and 19 at emergency orders. 227 U.S.C.A. §136d(c)(4)(1980). 2 3 See footnote 19 on emergency orders. This expedited hearing is not the same as the public hearing conducted to determine the issue of registration or cancellation. For General Rules of Practice for Expedited Hearings see 40 CFR §164.120-164.123 (1980). 247 U.S.C.A. §136d(c)(4)(1980). 2 5 Id. at s136n(b). 2 6 See footnote 10 for general content of 'the record'. See footnote 23. 2 7 See footnotes 11, 12, 13 and accompanying text. 2 8 See footnote 17. 297. U.S.C.A. s136d(c)(4)(1980), to invalidate the emergency suspension order, the aggrieved party must show the Administrator made an error of judgment so clear as to deprive the decision of a rational basis. Dow Chemical v. Blum, 469 F. Supp. 892. 307 U.S.C.A. s136d(c)(4)(1980). 317 U.S.C.A. §136d(c)(4)(1980).
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18 19The position document, discussing the agency's position, is available for their review. 20 Supra note 15, at page 21. 2141 Fed. Reg. 21404. 227 U.S.C. #136d(b). A final position document is also prepared. This document contains the agency's responses to the comments received and explains the basis for the final regulatory decision. 2 3 The following revisions can be found in a paper prepared by the EPA's OPP. The draft paper is titled "Implementation of Bush Task Force Initiatives on RPAR." 2 4 It is established that current RPAR review takes between 2-3 years from start to finish. 2 5 See note 23, at page 2. 2 6 Id., at page 3. If registrants use the opportunity to interact with the agency to delay final action, the OPP could initiate more formal review. 2 7 At the time of referral to the SAP, a notice of such referral would be published in the Fed. Reg., and a summary of the risk case would be made available. The public would then have the opportunity to submit information or comments. 2 8 The USDA comments would be received at about the same time the SAP files comments on the risk case. 2 9 Suspension of Special Review would be appropriate if additional data were necessary to resolve uncertainty.
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25 after the close of the hearing or from the filing of an accelerated decision. 5 4 This decision must be based on the substantial weight of the evidence on the record as a whole. 5 5 In rendering this final decision, the Administrator may accept or reject all or part of the ALJ's initial (or accelerated) decision. 5 6 Within 10 days of service of the final order, a party may move to re-hear, re-argue the proceedings, or to reconsider the final order. These motions must briefly and specifically state the matters claimed to have been erroneously decided. If the motion is granted, the final decision is set aside pending the rehearing or re-argument of the proceedings, or reconsideration of the final decision. If the motion is denied, the motion and the resulting ruling are placed on the record for purposes of judicial review. 5 7 Any party to the proceedings adversely affected by the final order may seek judicial review of that order. 5 8 If judicial review is granted, the order is not put into effect until judicial review is completed.
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35 FOOTNOTES 1 Agency orders are final when 1) no further administrative review is available, or 2) further administrative review is available, but such review is not timely requested. An order denying or cancelling registration is final and effective at the end of 30 days from receipt by the applicant, or publication of a notice of intent to deny or cancel, whichever is later, unless a request for a public hearing is made within 30 days by a person adversely affected by such decision. If the request for the hearing is made timely, the decision issued after the public hearing's completion is the final agency order. 7 U.S.C. s136d(b). 27 U.S.C. §136d(f). The Administrative Procedure Act (APA), 5 U.S.C. §551 et seq.; s704 states "agency actions made reviewable by statute...are subject to judicial review." FIFRA expressly provides for judicial review of final agency orders: denying, cancelling, suspending, granting, or refusing to cancel or suspend, registration. See footnote 1, 4, 17, 18 and 19. Generally, judicial review is not available until the administrative process has been exhausted, and the issue is ripe, i.e. the order reflects final agency action. However, there exist three exceptions to this general rule. Judicial review, before a final order is issued, is allowed: 1) When an agency acts in excess of its delegated powers or contrary to a specific statutory mandate, Leedom v. Kyne 358 U.S. 184 (1958). 2) When the proceedings involve questions of high national interest because of their international complexion, McCulloch v. Sociedad Nacionel de Marineris de Honduras, 372 U.S. 10 (1963). 3) When agency action has clearly violated the constitutional rights of the party seeking injunctive relief against the agency proceedings. Fay v. Daud, 172 F. 2d 720 (1949). Fairchild, Arabatzis and Smith v. Sackhern, 451 F. Supp. 1181 (1978). Under the last exception, if the necessary constitutional protection initially lacking is provided to the party in a later stage, it could not reasonably be said the agency clearly violated the party's constitutional rights. See e.g. Coastal States Gas Corp. v. Doe, 495 F. Supp. 1300, 1309 (1980). 35 U.S.C. s704. When a public hearing is held to determine the issue of registration, agency actions occurring before the public hearing process are not directly reviewable. See footnote 2 for exception. Such actions can include the agency's use of the pesticide assessment documents during the RPAR process, and the ruling issued after the RPAR process. The APA allows for court review of these actions at this time. 4 Agency orders granting registration, or refusing to cancel or suspend registration, are final on the effective date the 'Notice of Registration' or letter of approval is issued. 40 CFR 0162.47(d)(3).
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34 suspension hearing may initiate judicial review. 3 5 However, standing has been granted to consumers of a suspended pesticide who were not parties to the hearing. 3 6 In the case of an emergency order, effective pending completion of an expedited hearing, judicial review may be initiated only by the registrant or "other interested person with the concurrence of the registrant." 3 7
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-15reviewed. If Special Review is necessary, the Office of Pesticide Programs (OPP) will meet with the registrant/applicant to explain the risk concerns. The registrant/applicant will help the agency decide what use sites should be reviewed or cancelled. The registrant/applicant will be given the opportunity to develop exposure data. Following completion of exposure data, the OPP may be able to identify what restrictions would be necessary to reduce risks to acceptable levels. If so, these restrictions will be discussed with the registrants/applicants and if voluntary compliance can be achieved, the registrations) would be amended and Special Review would be terminated. 2 6 If Special Review does not end as above, the EPA staff would assemble the risk data, along with preliminary usage/exposure data. EPA management would then review this information. If they agree that a risk problem exists, the SAP would review and comment on the agency's risk case. 2 7 While EPA's management reviews the risk case, the registrant/applicant would be allowed to submit a benefits analysis. This analysis would be forwarded to the USDA for review and comment. 2 8 Depending on the comments received, Special Review may be terminated, suspended 2 9 or continued. If continued, OPP would attempt to develop, informally, risk/benefit information so as to help identify appropriate registration restrictions. Once developed, the agency would attempt to negotiate a settlement with the registrant/applicants. If successful, registrants/applicants would agree to restrictions and the registrations/applications would be amended. If these negotiations fail, a more formal review would be initiated. The USDA would be requested to supply information necessary to generate a benefits analysis. If cancellation or denial is not contemplated, a brief benefit's analysis will be compiled, but if cancellation or
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36 57 U.S.C. 136n(a)(b). See footnote 2, this chapter, for the exceptions to the general rule that only final agency orders are reviewable. FIFRA §136n(a) expressly provides for judicial review of final agency orders refusing to cancel or suspend registrations issued before a public hearing. Section 136n(b) provides for judicial review of any agency order issued following a public hearing. This would include final agency orders granting registration issued after a public hearing. Final orders granting registration issued before a public hearing, are made reviewable by 0163n(a). This section provides judicial review for "other final agency actions not committed to agency discretion by law." The decision to register a pesticide or not is not committed to agency discretion by law. FIFRA sets out standards which must be met for a pesticide to be registered. If the standards are met the agency must register the pesticide. See 7 U.S.C. s136a(c)(5)(A)(B)(C)(D). 6 See footnote 3, this chapter. 77 U.S.C. §136n(a). 8 1d., at l36n(b). Persons seeking judicial review must file with a court of appeals for the circuit wherein the individual seeking review resides or has a place of business. Such person must file within 60 days from the date the final order became effective. 97 U.S.C. s136n(b). 10The record, for orders made final without a public hearing, can include: registration application and data in support thereof and position documents if RPAR was invoked. If the order is issued following a public hearing, the full course of that hearing-pleadings, motions, intermediate rulings, evidence received, considered or rejected, statement of matters officially noticed, offers of proof, objections and rulings thereon, proposed findings, and the Administrative Law Judge's decision-constitutes the record. See footnote 45, Chapter 4, and accompanying text. 117 U.S.C. §163n(b), and 5 U.S.C. 706(2)(E). 125 U.S.C. §706. Questions of law arise when the party seeking review alleges that the agency: 1) acted outside the scope of their authority or 2) failed to provide procedures) required by statute or due process. Questions of fact can be distinct from questions of law. Questions of fact arise when the party seeking review alleges the agency reached an improper decision, based solely on the evidence. Agency finding on questions of fact must be sustained if they are supported by the substantial weight of the evidence on the record. Mixed questions of law and fact arise when there is a dispute both as to the propriety of inferences drawn by the agency from the evidence and as to the meaning of a statutory or regulatory term. NLRB v.Marcus Trucking Co., 286 F. 2d 583, 590-91 (1961). In such mixed question cases, the standards-statutory or regulatory terms-are not of a nature as to be appropriate for independent judicial review, as are questions of law. O'Leary v. Brown-Pacific-Mason, Inc. 340 U.S. 504 (1951). The agency findings on these mixed questions must be upheld if supported by'the substantial weight on the record. Id.
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27 1340 CFR §164.31(c). These persons have full status of original parties except possibly for purposes of a settlement. 1 4 Id. at 164.31(d). A person not a party to the proceeding wishing to file a brief must file a motion with the ALJ. The motion must state the interests of such applicant and the reasons why filing the brief is desirable. Unless the parties to the hearing otherwise agree, this brief must be filed within the time allowed to the party whose position the brief will support. A late filing may be granted if good cause is shown. 1540 CFR 164.20(c). 1 6 Id. at 164.40(c). 17Id. at 164.40(a). 18Id. at 164.40(b)(2). 19The party must file a motion asking for disqualification. If the ALJ rules against disqualification, he must certify the ruling for appeal. 40 CFR 164.40(b). 20U.S. ex rel De Luce v. O'Rourke, 213 F. 2d 759 (1954). 2140 CFR 164.40(e). 2 2 Id. at §164.50(a). The ALJ has discretion to order more than one conference. 2 3 The following may be considered at this conference: 1) The simplification of issues including listing of specific uses to be considered; 2) The necessity or desirability of amendments to the objections or statement of issues, or any document filed in response thereto; 3) The possibility of obtaining stipulations of fact and documents which will avoid unnecessary delay; 4) Matters of which official notice may be taken; 5) The limitation of the number of expert and other witnesses; 6) Procedure at the hearing except as so provided in §164.80(a); 7) The use of verified written statements in lieu of oral direct testimony; 8) The intent of any party to request a scientific advisory committee as defined in s164.2(f); 9) The issuance of subpoenas and subpoenas duces tecum for discovery and hearing purposes; 10) A setting of a time and place for the public hearing, after giving careful consideration to the convenience of all the parties, the
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CHAPTER ONE INTRODUCTION Historically, government control of pesticides began with the Insecticide Act of 1910 in which Congress attempted to protect farmers from adulterated or misbranded products. Subsequent amendments gave government greater control, but the 1910 Act was repealed and a new approach was taken in the Federal Insecticide, Fungicide and Rodenticide Act (hereinafter referred to as FIFRA or the Act) as amended. In it, Congress charged the Department of Agriculture with the promulgation of regulations for the registering and labeling of pesticides prior to their introduction into interstate commerce. A 1967 amendment authorized the Secretary of Agriculture to refuse to register a new pesticide or to remove from the market pesticides that were unsafe or ineffective. The administration of FIFRA was transferred to the Environmental Protection Agency (hereinafter referred to as EPA or the Agency). This marked a shift in policy from control of pesticides for reasonably safe use in agricultural production to control of pesticides for reducing the risks to man or the environment. This policy shift was strengthened by the Federal Environmental Pesticide Control Act (FEPCA) of 1972 which required EPA to promulgate regulations and to have the administration fully effective by August 1975. The Act was further amended in 1978 and 1980. As it now stands, FIFRA states that no one may sell, distribute, offer to sell, hold for sale, ship, deliver for shipment or receive and (having so received) deliver or offer to deliver a pesticide unless it is registered by the Administrator of EPA (exceptions are explained in this text). Additionally, the Administrator must approve the pesticide label and labeling on which the use recommendations and limitations of the material are specified. The Act further states that the
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PREFACE This manual is part of an overall review of current issues in agricultural law and an effort to expand extension education on legal topics of importance to farmers, agricultural scientists and people in farm related businesses. This phase of the program in agricultural law was supported in part by Special Need Project Funds from the Extension Service, U.S. Department of Agriculture. The main purpose of the grant was to develop educational materials for agricultural scientists on the legal aspects of Pesticide Impact and Assessment Reports. This document is one of three in preparation dealing with impact and assessment reports and pesticide user liability. Principal Investigators on the grant project are James S. Wershow, J.D., L.L.M. Professor of Agricultural Law, Food and Resource Economics Department, University of Florida; and Grover C. Smart, Ph. D., Professor of Nematology, Department of Entomology and Nematology, University of Florida. The authors are indebted to them, to Melvin L. Upchurch, Ph. D., Consultant, for review and consultation on this paper, and to Ronald L. Perry, J.D. and W.C. Price Im for providing research, legal review and consultation. Gratitude is expressed to Margaret Breinholt, J.D., Office of General Counsel, USDA, for suggestions and guidance in reviewing project drafts. Appreciation is extended especially to Paul W. Bergman, Ph. D., Extension Service USDA for making the grant available and reviewing the work; and John T. Woeste, Ph. D., Dean for Extension, for constructive input and support. iii
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26 FOOTNOTES 17 U.S.C. 9136d(b). The notice of intent to hold a hearing may be issued without RPAR being invoked. See Procedural Requirements for Registraton, Chapter II. 2Id. 3Id. 440 CFR#164.20(a). 5Id. at 164.20(b). The document stating the objections to the Administrator's decision "shall clearly and concisely set forth...the basis for each objection, including relevant allegations of fact concerning the pesticide under consideration. The document shall indicate the registration number of the pesticide, a copy of the currently accepted and/or proposed labeling and a list of the currently registered or proposed uses of the pesticide..." See 40 CFRs164.22(a). 6Id. atsl64.20(b) and 164.23(a). 740 CFR S164.24. Such response must include the position and interest of such person. 85 U.S.C. s551 et. seq. The language of FIFRA in s136d(d) triggers the applicability of the APA. The decision is required to be determined on the record after opportunity for a hearing. 940 CFR 164.20-164.111. 10"The proceedings" refer to all phases from prehearing to the final decision. "Party to the proceeding" is used as a legal term of art. Status as a party to the proceeding is important in several respects: 1) Standing for judicial review (See Chapter V Judicial Review Standing). 2) Rights/obligations during the course of the hearing: right to crossexamine, file motions, introduce evidence, compel testimony or production of documents, object to offers of or rejection of evidence, right to notice on rulings or officially noticed materials, right to contest official notice, right to appeal ALJ decision to Administrator, and obligation to appear at the prehearing conference. See the CFR and this chapter for further rights and obligations. 11See 40 CFR 164.2(m) for definition of "person". 1240 CFR l64.31. The motion must set forth the reasons why the person wishes to be a party and their position and interests in the proceeding. They must file the document of objection to the decision, if the decision was to deny or cancel the registration, or file a response to the Administrator's statement of issues, if the Administrator ordered the hearing. The motion ordinarily must be filed before the start of the first prehearing conference. If not, a statement of good cause for not filing earlier must be included in the motion.
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10 23Id., at 136a(c)(2)(B)(i-v). 2440 CFR*162.5(b)(1). 2 5 Id., at 0162.5(b)(2). 26Id., 162.5(b)(3). 2 7 Id., at ^162.5(b)(4). 28Id., at 162.5(b)(5). 29Id., at §162.5(b)(6). 30Id., at 162.5(b)(7)(i). 3 1 d., at 162.5(b)(7)(ii). 327 U.S.C. 136a(b) 40 CFR 162.5(b)(1). 337 U.S.C. l36c(a). 3 4 Id., at 136c(b, c). 35Id., at 9136c(g). 3640 CFR 162.5(b)(3). See also 7 U.S.C. S136q. 37Id., at 162.5(b)(4). See 7 U.S.C. #136o. 38Id., at l62.5(b)(5). See 40 CFR §166 in general. 397 U.S.C. §136v(a)(c). A use is prohibited by FIFRA or the EPA if registration for such use has been previously denied, disapproved or cancelled by the EPA Administrator. 4 0 Id., ats&36v(b).
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33 Section 4. Scope of Review, Standard and Effect of Review In reviewing suspension orders issued following an expedited hearing, the courts will examine the whole record of the suspension hearing. 2 6 Generally, if the substantial weight of the evidence on record supports the suspension order, courts will uphold the order. 2 7 In reviewing emergency suspension orders-orders issued prior to an expedited hearing, effective pending the hearing's outcome; 2 8 courts will review the information the Administrator relied upon in determining that an emergency exists. Such emergency orders will be upheld unless, in issuing such orders, the Administrator is found to have acted arbitrarily, capriciously or in abuse of discretion. 2 9 Courts may review, independently, to see whether the procedures required to be followed, by law or due process, were indeed followed. 3 0 If an expedited hearing is timely requested, the order issued following the expedited hearing is reviewable, regardless of whether there was judicial review of the initial emergency order, and is reviewable in the manner as described above (first paragraph). The commencement of judicial review does not delay the suspension order's effect, unless ordered by the court. 31 A court ruling, which invalidates a suspension order issued after a hearing, 3 2 is only effective until the Administrator's final decision with respect to cancellation. 3 3 If an emergency suspension order, effective pending an expedited hearing's outcome, is invalidated, such ruling is effective until the decision following the expedited hearing is issued. Section 5. Standing In the case of a suspension order issued following a hearing, generally only those persons adversely affected by the order and who were a party 3 4 to the
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11 CHAPTER THREE RPAR REBUTTABLE PRESUMPTION AGAINST REGISTRATION (SPECIAL REVIEW) The process known as the Rebuttable Presumption Against Registration (RPAR), created by EPA regulations in 19751 to intensely study pesticides suspected of causing unreasonable effects to man or the environment, is currently under revision. 2 The name RPAR is being changed to Special Review. 3 Many aspects of the RPAR process are being dramatically revised. 4 . Due to the current state of change, we cannot detail precisely what the review process for potentially harmful pesticides will be. What follows is an outline of the RPAR process, pre-revisions, and an outline of the proposed major revisions to this process. Section 1. RPAR: Triggering the RPAR If there is a suspicion that a pesticide may cause an unreasonable risk to man or to the environment, based upon a study or other significant evidence, a pesticide is nominated as a RPAR candi ate. 5 Once nominated, the EPA staff or its contractors review all readily available literature on the pesticide's toxicology and exposure patterns. 6 The trigger studies or other evidence are also examined to see if they are valid. There is only nominal participation in the pre-RPAR evaluation by the registrant/applicant, public or other government agencies. Based on this survey, if the EPA determines that the pesticide meets or exceeds one or more of the RPAR risk criteria 7 , a notice of RPAR is prepared and published in the Federal Register.
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30 5 3 See §164.111 for disposition of motions. See also Chapter V, Judicial Review. 5440 CFR 164.103. 557 U.S.C. s136d(d). See footnote 45 and accompanying text for hearing records content. 5640 CFR 164.103. 5 7 See Id. at s64.111 for procedures for disposition of these motions. 587 U.S.C. 9136d(f); also 136n(b). See Chapter V on Judicial Review.
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r-.6 uDOCUMENT LEGAL ASPECTS OF PESTICIDE USE AND IMPACT ASSESSMENT REPORTS: The Regulatory Process in Review Central Science Library JUL 13 1987 Univei sty of Florida 1_ _ BFood and Resource Economics Department Institute of Food and Agricultural Sciences University of Florida Gainesville, Florida 32611
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37 13Constitutional due process requires a minimum of procedural protection. The procedures established by the APA, 5 U.S.C. 9556 and 557, followed by the EPA during the public hearing, provide applicants their due process. The public's ability to provide input plus the right to invoke judicial review if adversely affected by an agency order or rule, see standing, this chapter provides the general public with sufficient constitutional protection. Unless another statute imposes more specific standards than those found in the APA, or a fundamental constitutional right requires greater protection, courts cannot require the EPA to provide furtherr procedural protection. See Vermont Yankee 435 U.S. 519 (1978). FIFRA tracks the APA language which triggers APA's 556, 557 applicability. See 7 U.S.C. §136d and 5 U.S.C. s554(a). If a violation of procedural due process is found, courts will remand the case back to the agency. The agency must re-hear the issue, employing the necessary procedures. 14See Chapter 4, Section2. For emergency suspension order hearings, no one other than the original parties-agency, registrant-may participate. However, persons adversely affected by the suspension may file briefs. Any person so filing is considered a party for purposes of judicial review. Id. 157 U.S.C. 136n(b). 16See Id. at 136n(a). Unlike standing to seek judicial review of final orders issued following a public hearing, no specific grant of standing for these orders is found in FIFRA. Standing must be determined according to APA, 5 U.S.C. s702 and court imposed standards. Basically, standing depends on whether the party has alleged such a "personal stake in the outcome of the controversy," Baker v. Carr, 369 U.S. 186, 204, (1961), so as to insure "the dispute will be presented in an adversary context and in a form historically viewed as capable of judicial resolution." Flast v. Cohen, 392 U.S. 83, 101 (1967). The U.S. Supreme Court, in Association of Data Processing Service Organization, Inc., v. Camp 397 U.S. 250 (1969) established the two-tier test for standing. 1) Injury-in-fact-includes economic injury see Sierra Club v. Morton, 405 U.S. 727 (1973) for example and 2) injury is to an interest "arguably within the zone of interest to be protected or regulated by the statute (FIFRA here) the agency is claimed to have violated." For final orders denying or cancelling registration, those having standing can include users of the banned pesticide and consumers of the user's products. For final orders granting or refusing to cancel or suspend registration, those having standing can include environmental protection organizations. See Sierra Club and E.D.F. v. Ruckelshaus, 439 F. 2d. 584 (1974). 17The Administrator can suspend the registration of a pesticide upon determination that such action is necessary to prevent an imminent hazard during the time required for cancellation of registration or change in classification proceedings. 7 U.S.C. §136d(c)(1).
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39 3 2 See the text accompanying footnote 13. The text is applicable for court rulings on these suspension orders. 337 U.S.C.A. §136d(c)(4)(1980). 3 4 See footnote 14. 357 U.S.C.A. s136d(c)(4)(1980). This section triggers the standing requirement found in s136n(b). 3 6 In State of Wyoming v Hathaway, 525 F. 2d 66, cert. denied, 426 U.S. 906, the court held that while consumers of economic poisons are so remotely involved as not to be entitled to notice and hearing concerning EPA's proposal to suspend registration of chemical toxicants, consumers do have right to seek judicial review of the EPA's order in the court of appeals. 3 7 U.S.C.A. §136d(c)(4)(1980).
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41 GLOSSARY 1. Amicus Curiae Latin. "A friend of the court". A by-stander (usually a counselor) who interposes and volunteers information upon some matter of law in regard to which the judge is doubtful or mistaken, or upon a matter of which the court may take judicial cognizance. Implies friendly intervention of counsel to remind the court of legal matters which has escaped its notice, and regarding which it appears to be in danger of going wrong. Also a person who has no right to appear in a suit but is allowed to introduce argument, authority, or evidence to protect his interest. Black's Law Dictionary, 4th ed. (1968). 2. Briefs a written or printed document used as a basis for an argument upon a cause on appeal. It is usually filed for the court's information. It conveys the essential facts of a party's case-embodies points of law, together with the arguments and authorities on which a party rests their contentions. Black's Law Dictionary, 4th ed. (1968). 3. Discovery the disclosure by one party to another of facts, titles, documents or other things which are in their exclusive knowledge or possession, and which are necessary to the party seeking the discovery for purposes of the action pending. Black's Law Dictionary, 4th ed. (1968). 4. Foreign purchaser as used in the Act, a person who purchases a pesticide product solely for use outside the United States. 5 Formal adjudication a hearing by the agency of evidence on the factual issues involved, in which procedures similar to those used by courts of law are employed. Black's Law Dictionary, 4th ed. (1968). 6. Injunction a court order determining rights of parties directing or forbidding one party to do a certain act. As used in this Act, a court may enjoin (issue an injunction) to suspend registration proceedings until a matter has been determined at the federal court level. 7. Motion an application for a rule or order made to a court or judge. A motion may be written or oral. Black's Law Dictionary, 4th ed. (1968). 8. Mutagenic the property of a substance or mixture of substances to induce changes in the genetic complement of either somatic or germinal tissue in subsequent generations. 40 CFR s62.3(bb). 9. Official (judicial) notice the act by which a court, in conducting a trial or framing its decision, will, of its own motion and without the production of evidence, recognize the existence and truth of certain facts having a bearing on the issues at bar. To be a proper fact for judicial notice, the fact must be universally regarded as established by common notoriety or fact which, from its nature, is not properly the subject of testimony. Black's Law Dictionary, 4th ed. (1968).
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24 The initial decision will become the final agency order unless it is appealed, 4 5 or unless the Administrator orders its review. Section 8. The Administrator's Decision: Appeal From or Review of the Initial Decision Within 20 days after the ALJ's initial decision is filed, any party may take exception to any matter set forth in the decision, 47 or to any adverse ruling or order to which they objected during the hearing, and appeal these exceptions to the Administrator. 4 8 If no exceptions are timely filed the hearing clerk must notify the administrator, 30 days from the date the ALJ filed an initial decision, of this fact. 4 9 Within 10 days of such notice, the Administrator must issue an order either declining to review, or expressing an intent to review, the ALJ's initial decision. 5 0 If the ALJ's initial decision is reviewed by the Administrator, a party who filed exceptions and briefs may make oral argument before the Administrator. 5 1 During review, the Administrator may determine that additional exceptions should be argued. In such cases, the Administrator must give counsel for the parties written notice of this determination. At any time before the Administrator issues the final order, any party may move to re-open the hearing so that further evidence may be introduced. 5 2 This motion must state briefly the nature and purpose of the evidence to be adduced, show that such evidence is not repetitive and set forth reasons why the evidence was not offered at the hearing. If the motion is granted, the hearing is re-opened for this limited purpose. If it is denied, the motion and the ruling thereon become part of the record for purposes of judicial review. 5 3 If the initial or accelerated decision is reviewed, the Administrator must render a final decision, unless otherwise agreed to by the parties, within 90 days
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-6submitted data. Within that time, the producer of the data may file suit to determine whether such information is protected from disclosure. When the submitted data are not produced by the applicant, the applicant must offer to pay reasonable compensation to the producer of such data. 1 5 Section 2. Amended, Supplemental and Reregistration Normally, data requirements for applications to amend or supplement existing registrations or for reregistrations are somewhat less stringent than for new registrations. An amended registration is required when an applicant proposes changes on the label, minor changes in the composition, or marketing of a pesticide under different brand names. 1 6 A supplemental registration allows a pesticide producer to market a registered pesticide under a distributor's brand name. 1 7 These applications deal with an already registered pesticide and the data to support such applications need not be as elaborate as for registering a new pesticide. All pesticide registrations are subject to automatic cancellation at the end of five years from the date of registration. 1 8 The Administrator must publish a notice in the Federal Register, at least 30 days before the registration's expiration date, that registration will be cancelled unless the registrant or other interested person with the registrant's concurrence, before the expiration date, requests that the registration be continued for another 5 year period. 1 9 The request for continued registration must be made in accordance with regulations prescribed by the Administrator. 2 0 If the EPA needs additional data to continue an existing pesticide registration, the Administrator must so notify all registrants of the pesticide to which the determination relates and provide a list of such registrants to any interested person. 2 1 Each registrant must provide within 90 days of being so notified, evidence that it is taking appropriate steps to secure the additional
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12 Section 2. RPAR: Formal Review Formal review begins with the publication of the "Notice of RPAR" in the Federal Register. Agency review encompasses all of the major and minor uses of the RPAR'd pesticide. Upon the publication of the Notice of RPAR, all interested persons (including other federal agencies) may submit evidence rebutting (or supporting) the presumption against registration. The initial rebuttal period is 45 days 8 ; however, this period can be extended by 60 days if it can be shown that additional time is necessary. 9 There are two ways to rebut a presumption against registration. 1 0 It must be demonstrated that: 1 The study or studies (or other evidence) on which the presumption was based are not scientifically valid, or 2 Exposure to the RPAR'd pesticide will not cause an unreasonable adverse effect to man or to the environment. Information on the pesticide's benefits can also be submitted during the rebuttal period. 1 l At the end of the rebuttal period, the EPA staff reviews all comments, information and responses received. They also review additional risk data or risk analysis provided by divisions within the EPA, such as the Carcinogen Assessment Group (CAG). Section 3. Regulatory Options: Risk/Benefit Analysis If after the rebuttal period, the agency determines that the presumption against registration has not been rebutted, the agency intensifies the risk and benefit assessment to determine what type of regulatory action is appropriate. 1 2 Input from internal EPA divisions, such as the CAG, intensifies, and a joint EPA-USDA-State team conducts a benefits analysis. 1 3 It is at this point that
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23 Section 6. The Accelerated Decision The ALJ may at any time during the proceedings render a decision in favor of the Agency as to all or any portion of the proceedings, including dismissal of the action supporting registration or opposing cancellation for any of the following reasons: (1) Untimely or insufficient objections filed pursuant to §164.20; (2) Failure to comply with discovery orders; (3) Failure to comply with prehearing orders; (4) Failure to appear or to proceed at prehearing conferences; (5) Failure to appear at the hearing; (6) Failure to state a claim upon which relief can be granted; (7) That there is no genuine issue of any material fact; (8) Such other and further reasons as are just. 4 0 This decision will become the final agency order with respect to registration or cancellation unless it is appealed to the Administrator, or unless the Administrator orders its review. 4 1 Section 7. The Initial Decision The ALJ makes an initial (recommended) decision with respect to registration within 25 days after the close of the hearing. 4 The initial decision must be based on the substantial weight of the evidence on the record as a whole. 4 3 The hearing record includes: all pleadings, all written motions, intermediate rulings, all evidence received-including all exhibits and documents introduced as well as all (written and oral) testimony; all objections and rulings thereon, a statement of matters officially noticed, and each party's, if they so file, proposed orders, findings of facts, conclusions of law and briefs in support of their positions. 4 4
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TABLE OF CONTENTS Page PREFACE ...... . .......................... ................... iii CHAPTER 1. INTRODUCTION .................................. CHAPTER 2. REGISTRATION OF PESTICIDES ,...................4 Section 1. Requirements for Registration .................... 5 Section 2. Amended, Supplemental and Reregistration .......... 6 Section 3. Exemptions to Registration ........................ 7 Section 4. State Authority .................................. 8 Footnotes ................................................. 9 CHAPTER 3. RPAR-REBUTTABLE PRESUMPTION AGAINST REGISTRATION (SPECIAL REVIEW) ................. 11 Section 1. RPAR: Triggering the RPAR ..................... 11 Section 2. RPAR: Formal Review .......................... 12 Section 3. Regulatory Options: Risk/Benefit Analysis ......... 12 Section 4. Final Regulatory Decision ....................... 14 Section 5. Special Review: Proposed Revisions to the RPAR process ................................ 14 Section 6. Revisions in the Risk Criteria ..................... 14 Section 7. Initiation of Special Review ....................... 14 Footnotes .. .... ..... ................... ......... 17 CHAPTER 4. THE ADMINISTRATIVE HEARING. ................. 19 Section 1. The Proceedings: Obtaining the Hearing ............ 19 Section 2. Parties to the Proceedings (Hearing) .... ........... 20 Section 3. The Administrative Law Judge . ................... 20 Section 4. Disqualification of the Administrative Law Judge ................................... 20 Section 5. Prehearing Procedures: Discovery ................. 21 A. Burden of Proof ............................ 22 B. Presenting Evidence/Witnesses ............... 22 Section 6. The Accelerated Decision ........................ 23 Section 7. The Initial Decision . ............................. 23 Section 8. The Administrator's Decision: Appeal from or Review of the Initial Decision ................ 24 Footnotes . .... .......... .......... 26 CHAPTER 5. FINAL AGENCY ORDERS: REVIEWABILITY ........ 31 Section 1. Scope of Judicial Review, Standards and Effect of Review .............................. 31 Section 2. Standing: Who May Initiate Judicial Review ........................ ............. 32 Section 3. Suspension Orders: Reviewability ................. 32 Section 4. Scope of Review, Standard and Effect of Review ....... ..... ................... 33 Section 5. Standing ................. ..................... 33 Footnotes. ............................................... 35 ABBREVIATIONS AND ACRONYMS ...... ....................... 40 iv
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-8experimental use permits for unregistered pesticides to public and private agricultural agencies for use in experimentation. 3 5 Pesticides being transferred for disposal are exempt from registration, but they must meet the requirements concerning misbranding and the containers must be marked clearly "for disposal only." 3 6 Pesticides produced and transferred for export are exempt from registration when they are prepared and packed according to specifications of a foreign purchaser. 3 7 The Act further provides that the Administrator may permit the use of an unregistered pesticide upon application by a federal or state agency (usually a State Commissioner of Agriculture). Such use is permitted only when a serious pest outbreak occurs or is threatened, when no registered pesticide adequate for control is available, when time does not permit registering the needed pesticide in the usual manner, and when significant economic or health damage may occur. The Administrator may specify the conditions under which an unregistered pesticide is to be used in an emergency. 3 8 Section 4. State Authority A state may regulate, within its borders, the sale or use of any federally registered pesticide. However, the state regulations cannot permit any sale or use which is prohibited by FIFRA or the EPA. 3 9 States cannot impose any labeling or packaging requirements in addition to or different from those required by FIFRA or the EPA. 4 0
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The materials contained herein are current as of the date of publication. However, since the administrative rulings, court decisions and laws on which they are based are subject to constant revision, portions of this publication could become outdated at any time. ii
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22 A. Burden of Proof On all issues arising in connection with the hearing, the ultimate burden of persuasion lies with the party seeking registration. 3 1 When a hearing is requested to contest an order cancelling registration, the agency must first present an affirmative case for cancelling the registration. 3 2 When a hearing is requested to contest an order denying registration, the party seeking registration must first present an affirmative case. When the agency calls for the hearing, the agency must first present an affirmative case as to the statement of issues. 3 3 B. Presenting Evidence/Witnesses Evidence (including pesticide assessment documents and other material developed and submitted during the RPAR phase) which is relevant and material to the issues raised in the objections filed by the party or parties, or to the statement of issues if the Administrator called for the hearing, is admissible. 3 4 The parties to the proceeding may call their own witnesses and cross examine adverse witnesses. Upon a showing of relevance and materiality, any party may request the ALJ to subpoena any person to compel testimony or to produce documents. 3 5 At any time during the hearing, a party may request that relevant questions of scientific fact be submitted to a committee of the NAS. 3 6 If the ALJ finds such submittal is necessary or desirable, the questions will be referred. The committee's response becomes part of the evidence on the record. Objections to these responses also become part of the record. 3 7 The ALJ may take official notice of some facts not disputed by the parties. 3 8 Parties must be given an opportunity to show that officially noticed facts are erroneous by presenting evidence to the contrary. 3 9
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29 being set, they may file an objection. This objection and the ALJ's response becomes part of the record. 40 CFRs164.82(c). 367 U.S.C. s136d(d). 3 7 Objections to these responses are dealt with as in footnote 34. 3 8 These facts are matters which are commonly noticed judicially by the federal courts, plus other facts specific to the knowledge and expertise of the agency. 40 CFR 9164.8(e). 3 9 Id. 40Id. at §64.91(a). 4 1 Id. at §164.91(b). The accelerated decision has the same effect as an ordinary initial decision, and becomes the final decision and order unless appealed from by a party. 4240 CFRs164.90(b). 437 U.S.C. s163d(d). 44Within 20 days after the last evidence is taken, each party may file findings of fact and conclusions of law based solely on the record. Each party then is given the opportunity to file a reply brief. An extension of up to 30 days for filing these findings and briefs may be granted by the ALJ. 40 CFR s164.90(a). The ALJ's initial decision, findings of fact and conclusions of law, plus any briefs or exceptions to the initial decision, filed by any party, become part of the record for purposes of further review. 4540 CFR s164.100. This appeal to the Administrator is a matter of right. 4640 CFR s64.90(b). 4740 CFR 164.101(a)(1). 4 8 This is the same procedure for appealing an accelerated decision. 40 CFR 164.102. In this same time period, each party appealing exceptions must file a brief concerning each of the exceptions being appealed with the hearing clerk. Within 7 days of service (transmission) of the exceptions and briefs, any other party or Amicus Curiae may file and serve a brief responding to exceptions or arguments raised by any other party. These briefs may not raise additional (not previously asserted) exceptions. 40 CFR§164.101(a)(2). 4940 CFR #164.101(b). 5 0 1d. 5 1 If a party desires to offer oral argument, a written statement to this effect is required. If the party fails to so state, the party is deemed to have waived such oral argument. 40 CFR 164.101(c)(l). 5240 CFR §164.110(b).
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