8/2/84
Draft
ENVIRONMENTAL PROTECTION AGENCY
40 CFR 162
(Docket No. OPP-30057)
CRITERIA AND PROCEDURES FOR SPECIAL REVIEWS OF
PESTICIDES
AGENCY: Environmental Protection Agency (EPA or the Agency)
ACTION: Notice of Proposed Rulemaking
SUMMARY: The EPA proposes to revoke 40 CFR §162.11 (a) and
(b) and to issue a new 40 CFR Part 154 in its place. Section
162.11 contains rules governing what is known as the "Rebut-
table Presumption Against Registration" or RPAR process.
These proposed amendments would revise both the substantive
criteria under which EPA initiates review of pesticide products
(leading to an ultimate determination of whether their use or
uses pose unreasonable adverse effects to humans or the
environment) and the procedures for the process. The proposed
amendments are based primarily on changes made to the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136
£t seq., by Congress in 1978 and on the experience acquired by
EPA in regulating pesticides pursuant to the present section
162.11.
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DATES: Comments should be received on or before (insert
date 90 days after date of publication in the Federal Register).
ADDRESSES: Comments should be addressed to the Document
Control Officer (TS-793), Office of Pesticides and Toxic
Substances, U.S. Environmental Protection Agency, Rm. E409,
401 M Street, SW., Washington, D.C. 20460. All comments
should bear the identifying notation "OPP-30057." All comments
will be available for public inspection from 8:30 a.m. to
4:00 p.m., Monday through Friday at EPA's Office of Document
Control, Room E-409, 401 M Street, SW., Washington, D.C. 20460.
FOR FURTHER INFORMATION, CONTACT:
Joanna J. Dizikes,
U.S. Environmental Protection Agency
Office of Pesticide Programs
1921 Jefferson Davis Highway
Crystal Mall 12 Rn. 711
Arlington, VA 22202,
(703) 5*7-7400
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This notice consists of six sections:
I. .Overview
II. Historical Background
A. The 1972 PIFRA
B. The 1975 Amendments to the FIPRA
C. The 1978 Amendments to the FIFRA
1. Section 3(c)(2)(B)
2. Section 3(c)(8)
D. The RPAR Process
1. Risk Criteria of the Current RPAR Process
2. Stages of the Current RPAR Process
III. The Change of the Name
IV. Proposed Changes to the Risk Criteria
A. Introduction
B. Exposure Information
C. Exposure as a Basis for Assessing Risk
D. Risk Assessment
E. The Proposed Criteria Revisions
1. Acute Toxicity to Humans or Domestic Animals
2. Oncogenic, Teratogenic, Fetotoxic, Reproductive,
and Other Chronic or Delayed Toxic Effects
3. Nutagenic Effects
4. Hazard to Wildlife
5. Hazard to Threatened or Endangered Species
6. Other Adverse Effects
7. Lack of Emergency Treatments
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V. Proposed Procedural Changes to the RPAR Process
A. Registrant Notification
B. Current Benefits Review (CBR)
C. Significance of Risk - Decision Whether to Initiate
a Special Review
D. Administrative Record
E. The Special Review Process
1. Public Discussions
2. Preliminary Determination
3. Review and Comment on Preliminary Determination
4. Final Determination
VI. Request for Comments
VII. Statutory Review
VIII. Regulatory Review Requirements
A. Executive Order 12291
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
IX. List of Subjects in 40 CFR Part 162
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I. Overview.
This proposed rulemaking is issued pursuant to sections
3, 6, and 25 of the Federal Insecticide, Fungicide and Rodenti-
cide Act, as amended ("FIFRA" or "the Act") (7 U.S.C. 136 et
seq.). The preamble consists of five major parts. This
first part is the Overview. The second part gives an histo-
rical background. The third part describes the change of
the name from "RPAR" to "Special Review". The fourth part
describes the proposed revisions to the risk criteria presently
found in section 162.11. The fifth part describes the
proposed revisions to the procedures of the Rebuttable Presumption
Against Registration process. The preamble concludes with a
request for comments.
Section 162.11 is entitled: "Criteria for determinations
of unreasonable adverse effects" and is commonly known as EPA's
Rebuttable Presumption Against Registration ("RPAR") process.
Section 162.11 includes both the substantive criteria for
initiating, and the procedures for conducting the public
administrative reviews leading to determinations by EPA as
to whether unreasonable adverse effects to humans or the
environment exist or will be created as the result of some
or all uses or prospective uses of a pesticide.
This document proposes to revise both fhe substantive
criteria and the procedures of section 162^11. Furthermore,
this document proposes to change the name of the RPAR process
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to revise the criteria and procedures in response to (a) the
requirements and legislative intent of Congress as expressed
in the 1975 and 1978 revisions to FIFRA and (b) the Agency's
own experiences gained after more than eight years of dealing
with pesticide regulation under the present section 162.11.
The revisions to FIFRA in 1972, 1975, and 1978 will be
discussed, by year, in the following section. However, the
changes to the criteria and procedures which are proposed in
this document are based especially on: (a) section 3(c)(8)
of the 1978 revisions to FIFRA and (b) section 3(c)2(B) of
the 1978 revisions to FIFRA. Regarding FIFRA section 3(c)(8),
the 1978 Conference Report of the House and Senate directs
the EPA to consider exposure to a pesticide before initiating
the RPAR process (Conf. Rp. p. 21). Under this proposal,
before -a Special Review is initiated on a pesticide use the
EPA would take into account actual or projected human or
environmental exposures from that use. In effect, these
proposed amendments would change several of the present
initiating criteria from reliance primarily upon toxic effects
foun/3 under laboratory conditions to criteria based on the
assessment of actual or estimated risk in the environment.
Furthermore, the 1978 revisions to the FIFRA include
section 3(c)(2){B) which allows the Agency to require the
registrants to generate and submit additional data to support
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an existing registration. Prior to section 3(c)(2)(B) the
Agency could obtain additional data only through its cancel-
lation authority. Submission of data under section 3(c)(2)(B)
can be enforced by suspension.
Since the inception of the RPAR review program in 1975,
the Agency has accumulated experience in regulating pesticides
suspected of causing health or environmental problems. The
Agency's experience has led to concern over the amount of
time and resources required to review each chemical and
achieve a regulatory solution; the result has been a limited
number of chemicals that could be processed each year. The
length of time involved in the review of RPAR chemicals has
been considerable. Review times have generally ranged from
two to six years before a final resolution has been achieved.
The process needs to be made more efficient so that
risk concerns from problem chemicals can be thoroughly reviewed
and quickly resolved. The process must allow the Agency to
respond more quickly to referral requests and, therefore,
implement health and environmental protection measures sooner.
The Agency believes that the proposed changes to the RPAR
criteria and procedures will achieve this goal by integrating
legislative revisions with Agency experience. The legislative
history of section 3
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luate risk and to make a decision, section 3(c)(2)(B) allows
the Agency to require the registrant to submit additional data.
Furthermore, the proposed revisions would insure that Agency
resources are spent on the most significant chemicals, and
assure public involvement in the Agency's decision-making
and provide for peer review of data and issues when needed.
Peer review would help to insure that: (a) action is taken
on valid data or evidence; (b) the Agency knows whether the
risks to health or the environment are significant; and (c)
the Agency is provided with the most current thought and
information in the field.
In summary,|this document proposes certain changes to
update and facilitate EPA's public interim administrative
review process initiated when the Agency believes there are
data or other significant evidence which raise prudent concerns
that a use, or uses, of a pesticide cause or will cause an
unreasonable risk to humans or to the environment*/ as defined
and required by section 3(c)(8) of FIFRA. The sometimes
rigid requirements of section 162.11 have not achieved the
goal of speedy resolution of risk concerns. The EPA believes
that these proposed amendments will aid the Agency in the
future regulation of pesticides that may pose unreasonable
adverse effects to humans or the environment and will -implement
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both the letter and the spirit of the statutory changes made
by the Congress.
EPA believes that the goals of openness/ speed, scientific
accuracy/ and candor will be achieved by the new procedures.
This notice requests the submission of written comments, data
and other evidence or argument from all interested persons
concerning all issues raised by this rulemaking. By this
notice, EPA intends to provide the public with full opportunity
for discussion of all these issues and participation in the
development of the final rule.
II. Historical Background.
A. The 1972 FIFRA (7 U.S>C. 136 et seq.).
In 1972f the FIFRA was significantly amended in scope and
procedure with respect to the federal regulation of pesticides.
Section 3(c)(5) of the FIFRA provides that the Administrator
shall register a pesticide only if he determines that, among
other things, "when used in accordance with widespread and
commonly accepted practice it will not cause unreasonable
adverse effects on the environment" (section 3(c)(5)(D)).
Likewise, section 6(b) of the 1972 FIFRA authorizes the
Administrator to cancel the registration of a pesticide if
he determines that use of a product causes unreasonable
adverse effects on the environment. "Unreasonable adverse
effects on the environment," as used in both the registration
and cancellation contexts, is defined by section 2(bb)
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to mean "any unreasonable risk to man or the environment,
taking into account the economic, social and environmental
cost and benefits of the use of any pesticide." Furthermore,
the 1972 legislation required that all previously registered
pesticides be reviewed in light of possible adverse effects
to health or the environment (FIPRA section 3(g)).
B. The 1975 Amendments to the FIFRA.
In 1975, Congress amended the FIFRA in two relevant res-
pects. These changes required the Administrator to submit
proposed cancellation actions or proposed changes in classi-
fication, under the FIFRA section 6, to the United States
Department of Agriculture (USDA) and the Scientific Advisory Panel
(SAP) for review prior to the initiation of hearings. These
procedures were added to assure that the Agency complied
with the section 6(b) cancellation criteria by looking at
both risks and benefits prior to formal cancellation hearings.
First, the Administrator is required to submit a proposed
action, along with an analysis of its impact on the agricul-
tural economy, to the Secretary of Agriculture for review.
This submission must occur at least 60 days prior to issuing
the notice of final action. If the Secretary of Agriculture
comments in writing on the proposed action and analysis
within 30 days after receipt, the Administrator is required
to publish both the Secretary's comments and the Administrator's
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responses to these comments in the Federal Register, along
with the notice activating the hearings rights of registrants
and other adversely affected persons.
Second, the Administrator is required to submit certain
proposed actions to the SAP for peer review. The Administrator
is required to establish this review, pursuant to detailed
procedures specified in the PIFRA section 25(d). Proposed
cancellation actions are referred to the SAP for comment on
"the impact on health and the environment of the action
proposed..." (section 25(d)) . The procedures governing the
timing of submissions to the SAP and response to any comments
received from the SAP are identical to the procedures governing
review by the Secretary of Agriculture.
C. The 1978 Amendments to the FIFRA.
1. Section 3(c)(2)(B).
The Federal Pesticide Act of 1978 substantively amended
the FIFRA. One significant 1978 addition that is relevant
to this proposal is section 3(c)(2)(B). As previously mentioned,
this section allows the Agency to require the registrants
to submit additional data in support of an existing registration;
prior to section 3(c)(2)(B) if the Agency needed more data in
order to assess a possible hazard from a registered pesticide
it had no express authority to do so.
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2. Section 3(c)(8) .
Another significant 1978 addition is FIFRA section 3(c)(8).
The current oncogenicity and mutagenicity criteria for
initiating RPAR reviews do not take exposure into account.
Thus, section 162.11 technically requires the initiation of
the RPAR process in some cases when the Agency may be convinced
that exposures off risks are insignificant. Because of this
perceived rigidity, Congress added section 3(c)(8). It
provides:
Interim Administrative Review. Notwithstanding any
other provision of this Act, the Administrator may not
initiate a public interim administrative review process
to develop a risk-benefit evaluation of the ingredients
of a pesticide or any of its uses prior to initiating
a formal action to cancel, suspend, or deny registration
of such pesticide, required under this Act, unless
such interim administrative process is based on a
validated test or other significant evidence raising
prudent concerns of unreasonable adverse risk to man
or the environment. Notice of the definition of the
terms 'validated test1 and 'other significant evidence1
as used herein shall be published by the Administrator
in the Federal Register.
The requirement that the Agency publish a notice in the
Federal Register defining the terms "validated tests" and "other
significant evidence" was satisfied on February 14, 1979, by the
publication of a notice titled "Proposed Definitions of 'Validated
Tests' and 'Other Significant Evidence.'" (44 FR 9626 February 14,
1979.) This document provided that the definition of these terms
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shall be the definitions given to them in the Conference Report on
the Federal Pesticide Act of 1978 (S. Rep. No. 94-1188, 95th Cong.,
2d Sess. 35 (1978).V
The legislative history of section 3(c)(8) makes it
clear that Congress wanted the EPA to have some solid evidence
of risk to humans or the environment in hand before initiating
the lengthy and time-consuming RPAR process, and that the
extent of human or environmental exposure to a pesticide
should be considered when evaluating risk. The Conference
Report of the House and Senate stated in pertinent parti
Human exposure to pesticides through any medium or
pathway is a central issue in evaluating the unreasonable
adverse effects of pesticide products. Where this issue
can be resolved without an RPAR being initiated, it shall
be (Conf. Rp. p. 21).
Also, the Conference Report states that "[tjhe Administrator
should notify in writing the registrant of a pesticide product
under special Review of the exact scope and nature of any
alleged unreasonable adverse effect on human health or the
I/ Those definitions are as follows: "The Administrator shall
Tnsure that the pesticide shall be subject to the RPAR process
only on the basis of a validated test or other significant evidence
(and not on the basis of unsubstantiated claims,) and that the term
'validated test1 be defined as a test conducted and evaluated in a
manner consistent with accepted scientific procedures, and that the
term 'other scientific evidence,' be defined as evidence that relates
to the uses of a pesticide and their adverse risk to man or to the
environment. It is the intent of the conferees that 'other
significant evidence1 of adverse risk means factually significant
information and is not to include evidence based only on misuse
of the pesticide" (Conf. Rp. p. 20).
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environment prior to initiating an interim public review"
(Conf. Rp. p. 145). In the view of the Conferees, this
notification should be a written, private communication
between the Agency and the registrant (Conf. Rp. p. 71).
Such notification is intended to give the registrants an
opportunity to refute the Agency's findings in order to
"... furnish a greater degree of protection for the
property rights of pesticide registrants and ameliorate the
indictment-like characteristics of the interim public review
process" (Conf. Rp. p. 145).
Therefore, the Agency has followed a practice of notifying
registrants by letters when it believes a pesticide will
become the subject of a Notice of Rebuttable Presumption
Against Registration. Typically, such letters have informed
the registrant in general terms of the bases for the Agency's
tentative conclusions.
The Agency's practice regarding such early notification
has been consistent with Senator Leahy's statement on the
Senate floor debate on consideration of the Conference, Report
regarding the 1978 revisions to the FIFRA:
I wish to stress that this provision is not meant
to permit extended private or closed negotiations. We
want to protect rights of producers, but not circumvent
established case law in regard to substantial questions
of unreasonable adverse effects.
Pesticide regulation is not the private business of
the pesticide industry and the EPA. The conference report
language affording affected pesticide producers an
opportunity to respond to a "private communication" about
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an impending RPAR is not intended to afford the registrant
a protracted and secret discussion of risks and benefits
with EPA. If the registrant discovers egregious errors
in the studies to be cited by EPA in an RPAR, all parties
are served by having this brought to EPA's attention. When,
however, the registrant disputes the conclusions EPA may
choose to draw from these experimental results, his views
are of no greater relevance than those of any other person,
and, indeed, because of his vested interest in the regulatory
outcome, should be subject, along with the EPA interpretation,
to public scrutiny. Therefore, "reasonable" time to respond
to a private communication on an impending RPAR must take
into account the interest of the public in participating in
any risk-benefit evaluation that affects their health, and
the need to consider that the public may remain exposed to
the hazard the pesticide poses while the RPAR process is
underway (cite to be provided).
D. The RPAR Process.
In its 1975 regulations implementing the registration
provisions of the 1972 amendments, the Agency created a public
administrative review process which has become known as the
"Rebuttable Presumption Against Registration" or "RPAR" process.
As mentioned previously, this process and the criteria that trigger
it are found in 40 CFR 162.11. The process (a) was intended to
provide an administrative mechanism for identifying pesticide uses
which might pose substantial questions of safety, (b) was expected
to provide an exchange of information between the Agency and
interested persons on the question of whether a substantial question
of safety in fact existed, (c) attempted to provide a forum for
broad public participation during those steps, and (d) required
initiation of formal adjudicatory proceedings under the FIFRA if
the risk criteria were not rebutted.
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Some of these criteria do not require the Agency to
consider whether significant adverse effects result from the
use of the pesticide; rather, they require the Agency to
initiate the RPAR review on any pesticide that demonstrates
the effect in animal studies. The regulations have not been
amended since 1975.
1. Risk Criteria of the Current RPAR Process.
Presently, section 162.11 requires the Agency to initiate
the RPAR process for a pesticide if it meets or exceeds any of
the following criteria when used according to label directions:
(i) "Acute toxicity
(A) Hazard to Humans and Domestic Animals.
(1) Has an acute dermal LD50 of 40 rag/kg
or less as formulated; or
(2) Has an acute dermal LD50 of 6 g/kg
or less as diluted for use in the
form o'f a mist or spray;
(3) Has an inhalation LC50 of 0.04
rag/liter or less as formulated.
(B) Hazard to Wildlife
(1) Occurs as a residue immediately
following application in or on the
feed of a mammalian species represen-
tative of the species likely to be
exposed to such feed in amounts
equivalent to the average daily
intake of such representative species,
at levels equal to or greater than
the acute oral 1*050 measured in
mammalian test animals as specified
in the Registration Guidelines.
(2) Occurs as a residue immediately
following application in or on avian
feed of an avian species, representative
of the species likely to be exposed
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to such feed in amounts equivalent to
the average daily intake of such
representative species, at levels
equal to or greater than the subacute
dietary LC$Q measured in avian test
animals as specified in the Registration
Guidelines.
(3) Results in a maximum calculated
concentration following direct
application to a 6-inch layer of water
more than 1/2 the acute LCso for
aquatic organisms representative of the
organisms likely to be exposed as
measured on test animals specified in
the Registration Guidelines.
(ii) Chronic Toxicity
(A) Induces oncogenic effects in experimental
mammalian species or in man as a result of
oral, inhalation or dermal exposure; or
induces mutagenic effects, as determined by
multitest evidence.
(B) Produces any other chronic or delayed toxic
effect in test animals at any dosage up to
a level, as determined by the Administrator,
which is substantially higher than that to
which humans can reasonably be anticipated
to be exposed, taking into account ample
margins of safety; or
(C) Can reasonably be anticipated to result in
significant local, regional, or national
population reductions in non-target
organisms, or fatality to members of
endangered species.
(iii) Lack of Emergency Treatments
Has no known antidotal, palliative, or first aid
treatments for amelioration of toxic effects in man
resulting from a single exposure.
2. Stages of the Current RPAR Process.
The current RPAR process consists of several stages.
First, the initial investigation phase involves a review of
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the scientific studies that suggest that one or more of the
RPAR criteria have been met or exceeded by the chemical in
question. A validation of these studies is conducted by
Agency scientists or by contractors. An extensive literature
search is initiated in an attempt to identify all available
health and environmental effects information. If health
effects studies are found to be valid, an effort is made to
gather and preliminarily assess readily available information
on the exposure to the pesticide in question. The applicants
or registrants of the pesticide are informed of the review and
are offered the opportunity to submit additional information
or comment.
The validated health effects studies, the literature
search and the combination of this hazard information with
information on use and routes of exposure produces the Agency's
preliminary position on the potential risk of the pesticide.
The document describing this position on risk is referred to
as position Document 1 (PD 1). A notice of the availability
of the PD 1 and a formal Notice of Rebuttable Presumption
Against Registration is published in the Federal Register.
After a PD 1 is published, the public process begins.
Risks can be rebutted at this point in the RPAR process
by interested parties submitting to the Agency; (1) proof
that the study or studies upon which the presumption is based
are not scientifically valid; or (2) proof that any actual
risk can be reduced to levels where "unreasonable adverse
effects" will not occur.
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This phase of the process focuses on the gathering of
additional information in the form of rebuttal comments,
additional information on risk, and input from other agencies.
For example, the United States Department of the Interior
(USDI) provides information on the effects of pesticide use
on endangered species.
In the event that the Agency concludes at this point
that none of the risk criteria have been met with respect to
one or more uses of the pesticide, the pesticide is returned
to the normal registration process and the RPAR is terminated
with regard to those uses. A second Position Document (PD
2) is drafted which describes the Agency's decision to support
its regulatory action. The PD 2 ends the RPAR process for
those uses.
When the rebuttal is not successful, a rebuttal assessment,
risk assessment, benefits asessment, risk/benefit analysis
and proposed regulatory position are presented in a document
termed Position Document 2/3 (PD 2/3).
In the PD 2/3, the Agency attempts to examine the full
range of regulatory options which are available under the
la*. These options range from full registration of specific
uses to full cancellation. Within this range, the Agency
has a variety of options involving labeling changes
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and restricted use. ^J Each option is examined in regard
to its impact on the risks and benefits of each pesticide
use. The recommended decision presents the best balance of
risks and benefits in the interest of public health and the
environment. A notice of the proposed determination and an
announcement of the document's availability is published in
the Federal Register.
As discussed earlier, the 1975 amendments to the
FIFRA require that if the proposed decision (PD 2/3) proposes
involuntary regulatory measures, it must be submitted to the
Scientific Advisory Panel for review of its scientific basis
and to the Secretary of Agriculture for comment. These
comments, plus any industry or public comments on the proposed
decision, are evaluated. The Agency's assessment of these
comments and the final decision on the regulatory action
are then announced in the Federal Register. The risk/benefit
evaluation supporting the final decision is contained in the
Position Document 4 (PD 4) which is available from the
Agency on request.
I/ Restricted use pesticides are those pesticides with uses
"that are limited to certified applicators or persons under
their supervision, or subject to other regulatory restrictions
which might be imposed by regulation. The term "certified
applicator" refers to an individual certified under section
4 of the FIFRA. Although the Agency was given the authority
in 1972 to have restricted use pesticides, the criteria
necessary to classify pesticides for restricted use was not
established until 1975.
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III. The Change of the Name.
Over a period of years, registrants have commented
that the term "Rebuttable Presumption Against Registration"
implies that the risks posed by a product subject to an RPAR
review are not justified by the benefits of the product's
use. These comments point out that/ at the time the Agency
determines that a risk criterion has been met or exceeded,
there had not been an assessment of the benefits of
the product under review. As a result, many registrants have
expressed concern that governments of foreign countries and
members of the public may misinterpret the meaning of an
"RPAR" notice.
The Agency recognizes that the presumption that arises
upon initiation of an RPAR review or Special Review is
that one of three types of notices—a notice of denial of
registration under FIFRA section 3(c)(6), a notice of intention
to cancel a registration under section 6(b)(l), or a notice
of intent to hold a hearing under section 6(b)(2)—will be
issued for each pesticide or pesticide use under review,
unless specific information is eventually brought forward
to rebut the presumption. The procedural device of a rebuttable
presumption reflects that under the FIFRA it is the registrant
who must satisfy the ultimate burden of establishing that
the risks posed by his product are reasonable in light of the
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benefits it provides. It is hot intended as a statement of
an Agency conclusion that the pesticide poses an unreasonable
risk. However, the Agency agrees that the public and others
may misinterpret the ongoing review as indicating that the
Agency has determined that registration of a pesticide or
pesticide use should be cancelled or denied.
Accordingly, to avoid any misinterpretations resulting
from the term "Rebuttable Presumption Against Registration,"
the Agency proposes to refer to its in-depth review of the
risks and benefits posed by a pesticide use as a "Special
Review." This description distinguishes the process from the
routine reviews that the Agency conducts in making most
registration and reregistration determinations, but it does
not connote an Agency conclusion that a pesticide use presents
or will present an unreasonable risk to the environment. The
term "Special Review" is intended instead to indicate that
the use of a pesticide may pose a significant risk, and,
therefore, the Agency will perform an in-depth review of the
risks and benefits of the pesticide use before deciding what
regulatory action, if any, is appropriate.
IV. Proposed Changes to the Risk Criteria.
A. Introduction.
As discussed above, the risk criteria issued in 40 CFR
162.11 in 1975 were intended to identify pesticides which
might pose significant risks and, therefore, might require
regulatory action. When one or more of the risk criteria
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were met or exceeded, the RPAR process was intended to provide
a brief period for comments by interested parties, and to
propose and then finalize a regulatory decision within a
short period of time.
The Agency has encountered problems in attempting to apply
or interpret the criteria. These problems include criteria
based on toxicity without considering exposure and unclear
or impractical criteria.
First, the existing criteria are narrow or unrealistic
since several of the criteria are based on toxicity demonstrated
in laboratory tests (i.e., the acute oral, dermal and inhalation
criteria, and the oncogenicity and routagenicity criteria)
without considering whether exposure to humans or other
nontarget species is high enough to pose an unreasonable
risk* Illustratively, the criteria for acute effects to
wildlife focus on laboratory test results and a theoretical
concentration of a pesticide in food or water which might
exceed a defined toxicity level, rather than considering the
exposure of wildlife to a pesticide. As a result of initiating
the RPAR process on criteria based only on toxicological
effects, the Agency has discovered during RPAR reviews that
either these studies or the exposure data were inadequate
for estimating potential risks.
Second, some of the risk criteria are ui,clear or have been
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impractical to apply. For example, the criterion for mutagenic
effects requires "multi-test evidence." However, it has not
been clear as to what evidence of mutagenicity would raise a
concern.
The proposed changes to the risk criteria address these
two problems by'assuring the sufficiency of exposure, as well
as toxicity information, prior to evaluating the significance
of the risk posed by the use of a pesticide.
B. Exposure Information.
Many different types of exposure information may be taken
into consideration when determining the sufficiency of the
exposure information. Among these are:
1. chemical characteristics measured in the laboratory
or derived from other chemicals with similar structures;
2. predicted mobility in soil;
3. parameters used to predict absorption through the skin
or gastrointestinal tract;
4. production volume;
5. location of use (soil characteristics, etc.);
6. persistence;
7. actual or expected presence in the food chain of humans
or wildlife; and
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8. estimates of the number of people exposed through
occupation, diet, or water consumption.
In addition, the amount of exposure information which the
Agency determines to be sufficient to investigate risk may
depend upon the toxicity or uses of the chemical at issue.
The Conference Report of the House and Senate on the 1978
amendments to the FIFRA stated:
In determining whether there is more than minimal
exposure, the toxic properties of the chemical should
be considered. In some cases, low levels of exposure
in a purely quantitative sense will, nonetheless,
because of the serious toxicity of the chemical,
raise prudent concerns about the safety of the chemi-
cal (Conf. Rp. p. 71).
A very toxic chemical would be assessed differently than
a less toxic chemical; a chemical used on food crops would
be assessed differently than a chemical used only on non-crop
lands. Also, the the amount of data which is sufficient may
vary according to the volume of use or whether the uses are
minor or major.
Also, the Agency may have sufficient exposure information
as a result of using "surrogate" data. Surrogate exposure data
are data regarding similar chemicals from which the Agency may
extrapolate if data are not available for the chemical under
review (45 PR 42858) . In such cases, the Agency will proceed
without waiting for exposure data on the chemical under review.
The Agency may determine that additional exposure information
is necessary. In such cases, the Agency will require under FIFRA
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section 3(c)(2)(B) that the registrant submit this information.
C. Exposure as a Basis for Assessing Risk.
Usually, the Agency evaluates the sufficiency of exposure
information in order to determine significance of risk after
validated toxicity data indicate an effect to health or the
environment. However, in some cases, the Agency will further
investigate to determine the significance of risk from concerns
originally raised from exposure information. One such case
would be when groundwater is found to be contaminated by a
pesticide.
Groundwater provides 45% of the United States drinking
water supply. Therefore, contamination of groundwater by
pesticides could result in widespread exposure to large
populations. The ability for some pesticides to persist
without significant degradation in soil or groundwater, the
mobility of groundwater (and waterborne residues) throughout
an aquifer, and the extreme heterogeniety of soil and aquifer
characteristics in the United States, makes it difficult
to predict what level or duration of groundwater contamination
at a given site may result from use of a pesticide at the
same or a different site. Evidence of relatively localized
levels of pesticide contamination of groundwater should be
treated as warnings of more widespread, future contamination.
In addition, groundwater once contaminated cannot be easily
decontaminated; thus, there is a considerable potential that
groundwater contamination will continue long after actions
have been taken to restrict application of the pesticide.
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Therefore, if the Agency finds any pesticide in groundwater
or if the Agency has data indicating the presence of a pesticide
in groundwater, the Agency will investigate further to determine
if there is a significant risk. If essential toxicity or
environmental fate data are not available, registrants will
be required to submit the data under the FIFRA section 3(c)(2)(B)
The Agency will evaluate the available data in regard to
levels and extent of ground water contamination, the likelihood
of more extensive groundwater contamination (both present and
future), environmental fate and transport, and toxic effects
in order to determine whether a Special Review should be
initiated. The mere presence of a pesticide in groundwater
will not be a basis for initiating a Special Review, but the
Agency evaluation of known contamination together with es-
timated current and future contaminantion at toxicologically
significant levels may provide the basis for initiating a
Special Review.
The Agency's Office of Pesticide Programs (OPP) discussed
toxicity assessment for drinking water contamination in a
document prepared by OPP for the FIFRA Scientific Advisory
Panel (SAP) in June 1983. This document states the following:
Contamination of any drinking water by pesticides
is undesirable, but may be unavoidable. Depending on
the level found, however, regulatory action or a public
health concern may or may not be warranted. In order to
assess the significance of pesticides in ground water,
EPA proposes to extend the concept of the acceptable
daily intake (ADI), used in the establishment of food
tolerances, as a benchmark for the assessment of potential
hazard. The ADI has been defined as follows: "The
daily exposure level of a pesticide residue which, during
the entire lifetime of man, appears to be without appre-
ciable risk on the basis of all facts known at the time.
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The ADI is expressed in milligrams of the pesticide, as
it appears in the diet, per kilogram of body weight per
day (mg/kg bw/day). 'Without appreciable risk' is taken
to mean the practical certainty that injury will not
result even after a lifetime of exposure...The ADI is
based on a rigorous evaluation of animal studies and, in
rare cases, human data. Although in most cases the ADI
will be based on a chronic feeding study, other studies
such as a multigeneration reproduction study may also be
used to set an ADI."
In determining whether to initiate a Special Review, the
Agency will consider, among other things, the levels of con-
tamination found in groundwater relative to drinking water
standards and health advisories.
The presence of a pesticide in groundwater is one example
of an exposure concern that would cause the Agency to further
investigate to determine if there is a significant risk.
Other examples include the presence of unanticipated pesticide
residues in consumer products and the presence of indoor
pesticide residues from domestic uses.
D. Risk Assessment.
When the Agency determines that there is sufficient exposure
and effects information on a chemical, a risk assessment will be
performed for the appropriate route(s) of exposure. Risk assess-
ment has been defined as:
...the characterization of the potential adverse health
effects of human exposures to environmental hazards. Risk
assessments include several elements: description of the
potential adverse health effects based on an evaluation of
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results of epidemiologic, clinical, toxicologic, and
environmental research; extrapolation from those results to
predict the type and estimate the extent of health effects in
humans under given conditions of exposure; judgments as to
the number and characteristics of persons exposed at
various intensities and durations; and summary judgments
on the existence and overall magnitude of the characterization
of the uncertainties inherent in the process of inferring
risk. 3/
The possible components in risk assessment, have been
described as follows:
Risk assessment can be divided into four major steps:
hazard identification, dose-response assessment, exposure
assessment, and risk characterization. A risk assessment
might stop with the first step, hazard identification,
if no adverse effect is found or if an agency elects
to take regulatory action without further analysis, for
reasons of policy or statutory mandate.
Of the four steps, hazard identification is the
most easily recognized in the actions of regulatory
agencies. It is defined here as the process of
determining whether exposure to an agent can cause
an increase in the incidence of a health condition
(cancer, birth defect, etc). It involves characteriz-
ing the nature and strength of the evidence of causa-
tion. Although the question of whether a substance
causes cancer or other adverse health effects is
theoretically a yes-no question, there are few chemi-
cals on which the human data are definitive. Therefore,
the question is often restated in terms of effects
in laboratory animals or other test systems, e.g.,
"Does the agent induce cancer in test animals?11
Positive answers to such questions are typically
taken as evidence that an agent may pose a cancer
risk for any exposed humans. Information from short-
term in vitro tests and on structural similarity to
known chemical hazards may also be considered.
Dose-response assessment is the process of charac-
ter i¥Ing~THereTaTrorr^5etween the dos,* of an agent
administered or received and the incidence of an
37National Academy of Sciences. Committee on the Institutional
™ Means for Assessment of Risks to Public Health. Risk
Assessment in the Federal Government; Managing tHe"
Process.NAS-NRC, p.18, 1983
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adverse health effect in exposed populations and
estimating the incidence of the effect as a function
of human exposure to the agent. It takes account of
intensity of exposure, age pattern of exposure, and
possibly other variables that might affect response,
such as sex, lifestyle, and other modifying factors.
A dose-response assessment usually requires extrapo-
lation from high to low dose and extrapolation from
animals to humans. A dose-response assessment should
describe and justify the methods of extrapolation used
to predict incidence and should characterize the sta-
tistical and biologic uncertainties in these methods.
Exposure assessment is the process of measuring
or estimating the intensity, frequency, and duration
of human exposures to an agent currently present in
the environment or of estimating hypothetical expo-
sures that might arise from the release of new chemi-
cals into the environment. In its most complete
form, it describes the magnitude, duration, schedule,
and route of exposure; the size, nature, and classes
of the human populations exposed; and the uncertain-
ties in all estimates. Exposure assessment is often,
used to identify feasible prospective control options
and to predict the effects of available control
technologies on exposure.
Risk characterization is the process of estimat-
ing the incidence of a health effect under the various
conditions of human exposure described in exposure
assessment. It is performed by combining the exposure
and dose-response assessments. The summary effects
of the uncertainties in the preceding steps are
described in this step. 4/
Although scientific assumptions may be made in performing
risk assessments, when common parameters are applied to
many chemicals, the Agency can compare the potential risks
associated with the use of each of a number of chemicals.
Therefore, risk assssments can assist the Agency in ranking
or prioritizing chemicals for review. As a result, Agency
resources can be directed to those chemicals presenting the
greatest potential risk. The Agency will perform risk assess-
ments as expeditiously as possible so that any significant risk
4/ Ibid pp. 19-20
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to the public can be defined and announced quickly. Further,
in order to avoid replacement of one pesticide with another
whose risk may be equal or greater, the Agency will generally
attempt to review the risks and benefits of all alternative
pesticides in the same use category of a candidate for Special
Review.
E. The Proposed Criteria Revisions.
The following sets forth revisions in the risk criteria
(the standards for initiating a Special Review of pesticide
uses). Proposed §154.4 includes criteria for the initiation
of a Special Review based upon (1) acute toxicity to humans
or domestic animals (§154.4(a)); (2) the potential of adverse
chronic effects in humans (§154.4(b)); (3) mutagenicity
(§154.4(c)); (4) hazards to non-target wildlife (§154.4(d));
(5) separate criteria for hazards to threatened or endangered
species (§§154.4(e) and (f)); and (6) an "other adverse
effects" criterion which would permit the Agency to initiate
a Special Review in circumstances wherein the other criteria
have not been met (§154.4(g)). The revised criteria would
require the Agency to evaluate not only toxicity data, but also
actual and potential exposure information, prior to initiating
a Special Review.
1. Acute Toxicity to Humans or Domestic Animals.
Instead of the present numerical criteria that trigger the
RPAR process, EPA believes that the acute toxicity risk cri-
terion for initiating a Special Review [162.ll(a)(3)(i)(A)]
should be revised to read:
the use of a pesticide... may pose a risk of serious acute
injury to humans or domestic animals.
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This proposed change to the risk criterion for acute toxic
effects is intended to remedy the fact that the present criterion
does not consider exposure; the present criterion does not consider
whether humans or domestic animals will actually be exposed to
amounts of the pesticide high enough to induce the effect observed
in laboratory tests. The proposed criterion would consider exposure,
whether based on observed effects under conditions of use, simulated
field tests, or reliable estimates.
2. Oncogenic, Teratogenic, Fetotoxic, Reproductive, and
Other Chronic or Delayed Toxic Effects.
EPA believes the current risk criteria for initiating a
Special Review pertaining to oncogenicity [162.ll(a)(3)(ii)(A)]
or other chronic or delayed toxic effects [162.11(a)(3)(ii)(B)]
should be combined and revised to read:
the use of a pesticide..* may pose a risk of inducing in
humans an oncogenic, teratogenic, fetotoxic, reproductive
effect, or a chronic or delayed toxic effect, which
risk is of concern in terms of either the degree of risk
to individual humans or the number of humans at some risk,
based upon;
(a) the effects demonstrated in humans or experimental
animals,
(b) the known or predicted levels of exposure of various
groups of humans, and
(c) the use of appropriate methods of evaluating data
and relating such data to human risk.
Under this proposed criterion, the Agency would determine,
from the body of available evidence, whether the pesticide
use may pose a risk of inducing in humans an oncogenic,
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teratogenic, fetotoxic, or reproductive effect, or another
type of serious chronic or delayed toxic effect. Mutagenic
risks would be covered under a separate risk criterion.
The changes in this criterion are intended to improve the
current criteria by requiring that exposure information be
considered as an integral part of the decision to initiate a
Special Review, as is the legislative intent of the PIFRA
section 3(c)(8). The Agency will determine the degree to
which humans would be exposed and whether adequate data
exist to estimate risk. The Agency would evaluate the quality
of the data available and determine whether the data would
support a regulatory action on the pesticide of concern.
3. Mutagenic Effects.
EPA believes that the unique character of mutagenic
effects justifies establishing a separate risk criterion for
such effects. This criterion for initiating a Special Review
is as follows:
the use of a pesticide... may pose a risk of inducing a
mutagenic effect in humans, based upon effects
demonstrated;
(a) in one or more appropriate test systems, if there is
sufficient evidence that the test substance or its
metabolites will reach mammalian germinal cells, or
(b) in epidemiological or other data indicating mutagenic
effects in humans,
unless, in either case, the potential exposure of human
populations is sufficiently low that significant
mutagenic risk to humans is not likely to occur.
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The changes reflected in the proposed criterion are intended
to eliminate the ambiguity of the existing criterion (162.11(a)
(3)(ii)(A)] and to give better guidance as to the kinds of
mutagenic effects which might cause concern. The existing
criterion states that "multitest evidence" is required to
initiate a Special Review. However, this criterion does not
indicate the kinds of mutagenicity tests that might indicate
a hazard to man. Furthermore, it seems to preclude action
based on one study.
The proposed criterion could be satisfied in either of two
ways. First, if the Administrator concluded from the results
of appropriate testing that the test substance causes changes
in genetic material and, also, that it will reach mammalian
germinal cells, the Special Review process would be initiated,
unless the Administrator also determined that the
exposure or potential for exposure to human populations is
insufficient to result in significant .risk. The term "ger-
minal cells" is intended to encompass reproductive cells in
all stages of development. Some mutagenic test systems
provide evidence that the test substance has the ability to
cause changes in genetic material and can reach mammalian
germinal cells. By providing evidence of mutations directly
in the offspring of mammalian test species, these test systems
can produce results strongly indicative of the ability to
induce heritable changes in human populations. Therefore, it
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is possible that one such test system, properly administered,
could suffice for the purposes of this criterion, provided
that there is actual or potential exposure to human popula-
tions. In other risk determinations, evidence of potential
mutagenicity would consist of results from test systems that
are, of themselves, less indicative of the ability to cause
mutations in human populations. In such instances, relatively
more evidence would be necessary to cause the Administrator
to conclude that genetic change will occur and that mammalian
germinal cells will come into contact with the test substance.
Second, the criterion could be satisfied by direct evidence
of heritable genetic change in human populations. Although
the capability does not exist currently, the Agency believes
that epidemiclogical studies may provide this evidence in
the future.
4. Hazard to Wildlife.
The Agency believes that the criteria in 162.11(a)(3}(i)(B)
pertaining to acute effects on mammals, birds, and aquatic
organisms and the criterion in 162.11(a)(3)(ii)(C) regarding
wildlife population reduction should be condensed into one
criterion, except that separate criteria for endangered
species are warranted (discussed below). This criterion
for initiating a Special Review should be revised to read:
the use of a pesticide... may result incresidues of
the pesticide product or its ingredients, impurities,
metabolites or other degradation products in the
environment of nontarget organisms at levels which:
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equal or exceed concentrations acutely or chronically
toxic to such organisms, or which produce adverse
reproductive effects in such organisms,
as determined from tests conducted on representative
species or from other appropriate data.
The Agency has had difficulty in implementing the existing
criterion. The present acute toxicity criteria for wildlife
are based solely on a theoretical calculation of residue on
animal or bird feed or in an aquatic organism's immediate
habitat (e.g., a 6-inch layer of water). The present criteria
are met if the theoretical residue exceeds a toxicity level
determined by laboratory tests (e.g., LD5Q, LC5g). However,
this set of criteria does not consider the concentrations
that wildlife in the natural environment are actually or
likely to be exposed to. The proposed criterion requires
that actual or expected concentrations of a pesticide in the
environment meet or exceed acute or chronic toxicity levels
for an organism.
5. Hazard to Threatened or Endangered Species.
In order to bring the Agency criteria into compliance
with the Endangered Species Act of 1973, the Agency believes
that the applicable part of 162.IK a)(3)(ii)(C) should be
revised to read:
the use of a pesticide... may pose a risk to
the continued existence of any endangered or threatened
species designated by the Secretary of the Interior
or the Secretary of Commerce under the Endangered
Species Act of 1973, as amended, or
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may result in the destruction or other adverse modi-
fication of any habitat designated by the Secretary
of the Interior or the Secretary of Commerce under
the Endangered Species Act as a critical habitat
for any such endangered or threatened species.
The proposed criteria would consider whether the habitat
of any endangered or threatened species might be adversely affected
by pesticides. The Endangered Species Act of 1973 requires
the Agency to consult with the Secretary of Interior or the
Secretary of Commerce on these issues. Therefore, these
proposed revisions would make the criteria consistent with
the Agency's obligations under the Act.
6. Other Adverse Effects.
In order to be able to consider risks to man or the
environment which may not be covered by the preceding risk
criteria, the Agency believes that the following criterion
should be added:
the use of a pesticide...may otherwise pose a risk to
humans or to the environment which is of sufficient
magnitude to merit a determination whether the use of
the pesticide product offers offsetting social, economic,
or environmental benefits that justify initial or continued
registration.
While the existing 162.11 criteria are intended to define
most hazards which might constitute unreasonable adverse
effects, they may not encompass all possible types of hazard
to man or the environment.
The proposed criterion would enable the Agency to initiate
the Special Review process for potentially serious effects
which do not meet or exceed the other risk criteria. An
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example of such an effect might be the potential for an acutely
toxic pesticide to contaminate groundwater despite label
restrictions specifically prescribed to avoid such contamination.
By proceeding through the Special Review process the need to
immediately initiate formal hearings, which are resource-intensive
for all involved parties, could be avoided; the Agency could
choose the procedure which best protects health and the
environment while using resources efficiently.
7. Lack of Emergency Treatments.
The proposed regulation deletes the existing criterion in
162.11(a)(3)(iii), which addresses the lack of a known treat-
ment to ameliorate toxic effects in man resulting from a
single exposure. The Agency recognizes that for many pesti-
cide products it is not possible to specify an effective
environment which may not be covered by the preceding risk
antidote for accidental poisoning. Accordingly, the deter-
mination the Agency considers to be important for the Special
Review process is whether the lack of an effective antidotal
treatment poses a significant risk to health, given the
particular packaging, labeling, methods of application, and
characteristics of the product. If such a risk does exist,
the Agency would investigate the feasibility of various
regulatory alternatives to reduce the risk to acceptable
levels. The proposed criterion for acute toxicity above
would apply to risks of serious acute injury resulting from
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product toxicity, whether or not the risks result from lack
of an effective antidote. Consequently, the Agency believes
that a separate criterion is no longer necessary.
V. Proposed Procedural Changes to the RPAR Process.
As mentioned previously, the 1972 legislation required
that all previously registered pesticides on the U.S. market
be reregistered. This involved the review of approximately
35,000 pesticide formulations. The extensive reviews and
documentation associated with the reregistration review of
all these pesticide formulations would have been extremely
costly. In response to this problem, the 1978 amendments to.
the FIFRA allowed a generic registration standards program
to be created. The approximately 35,000 active registrations
can be covered by approximately 600 Registration Standards,
each representing a single active ingredient. These approxi-
mately 600 active ingredients have been grouped into 48
"clusters"/ and these clusters have been ranked for review.
The manner in which the review priority of these clusters
was set, and a more detailed explanation of the cluster
concept is set forth in a Federal Register notice published
November 14, 1980 (45 FR 75488).
As part of the Registration Standard program, data on the
toxicology, chemistry, environmental effects, and environmental
fate of an active ingredient are reviewed for all formulations
of that active ingredient. The Registration standard will
summarize these data and present any risk concerns identified
during the review; in fact, most risk concerns that are
identified occur during reregistration reviews.
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However, risk concerns may also be identified from reviews
conducted outside the reregistraton process. Such reviews may
result from new applications for registration or from information
submitted by individuals, research or educational institutions.
A. Registrant Notification.
When the Agency concludes tentatively that effects
data, together with preliminary information on exposure,
indicate that a risk criterion may have been met, registrants
will receive private notification that the Agency is considering
issuing a Notice of Special Review (see §154.14 and II.C.2. in
this preamble). Although this notification is private, a docket
will be established which will record this notification and all
related information. After the decision is made whether to
issue a Notice of Special Review, this notification and infor-
mation will be available to the public (see §154.20 and V.D.
in this preamble).
The registrant notification would consist of the toxic
effects findings, the route(s) of exposure, and general
information concerning the assumed level of exposure. The
registrant would have 30 days from the receipt of notification
to dispute in writing the validity of the Agency's conclusions
or to present in writing any information in response to this
notification.
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B. Current Benefits Review (CBR).
After the Agency has determined the validity of a study
or evidence which indicates a hazardous effect to health or
the environment from the use of a pesticide a Current Benefits
Review (CBR) would be initiated on the chemical. Such a
review can be completed in approximately 90 days. Therefore,
the Agency would have a preliminary benefits profile for the
chemical at approximately the same time the risk assessment
is being evaluated.
However, benefits information would not be relied on to
decide whether or not to initiate a Special Review. A benefits
profile will help the Agency decide whether to allow a pesticide
use which has an indicated risk to continue while data and reviews
are being developed. Also, a preliminary benefits profile would
aid the Agency in developing- a realistic regulatory position
and in developing early regulatory options.
Furthermore, a benefits profile early in the process
would aid the Agency in knowing where to focus a more de-
tailed benefits analysis. Such an analysis would be ini-
tiated if a significant risk is found to be associated with
a specific pesticide use or uses. However, a full benefits
evaluation may not be undertaken unless cancellation is
being considered as a possible regulatory action for a pesti-
cide use or uses.
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C. Significance of Risk - Decision Whether to Initiate
a Special Review
Following notification to the registrants of the Agency's
concerns, if the Agency determines that a significant risk
is not associated with a pesticide use or uses, a Federal
Register notice will be issued which explains the Agency's
previous risk concerns, gives the basis for the Agency's tentative
determination that there is not a significant risk associated
with a use or uses of a pesticide, announces the availability
of the Registration Standard or, for reviews conducted outside
the reregistration process, the availability of an Agency
support document, and solicits public comment on the Agency
determination (see §154.16). Following a public comment period,
the Agency will issue a final determination on whether a
significant risk may be associated with a pesticide use or
uses.
If a significant risk is associated with a pesticide use
or uses, a Notice of Special Review will be issued in the
Federal Register for the pesticide use or uses of concern.
This notice will announce: the Agency's risk concerns and
reasons for the determination of a significant risk; the
assumptions and data used in the analyses; the nature and
strength of the conclusions; and the avail'ability of the
Registration Standard or Agency support document. The notice
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will, also, solicit public comment and request additional
information on the chemical (see §154.18). If a public
meeting has been planned for these risk issues, this notice
will announce such a meeting; these meetings may include
presentations before the SAP. As a rule, the time allowed
for public comment during any part of the review will be
flexible, depending on the complexity of the issues.
The major steps and decision points that would usually
lead to an initiation of a Special Review, as well as those
that would usually comprise the Special Review process, itself,
are outlined in Table 1. However, the Agency may, at any
time after initiating a Special Review, conduct the review
without going through all or any of the steps described
below, or the Agency may issue a notice of intent to cancel
or suspend a pesticide or any uses thereof without first
conducting a Special Review.
Reviews conducted for a new registration application may
result in a Special Review risk criterion being met. When this
occurs a risk/benefit analysis will be performed by the Agency.
After this analysis is made, the Agency will tentatively
decide whether to register any of these new pesticide uses.
The Agency's proposed decision and rationale will be presented
to the public for review and comment before a final decision
is made.
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D. Administrative Record.
After a Special Review is initiated, the Agency will
establish an administrative record, which will contain the
information and analyses on which the Agency bases its deter-
minations, as well as copies of all public notices, written
comments, and transcripts from public meetings. All documents,
in the administrative record except those which may not lawfully
be disclosed, will be available for public inspection.
E. The Special Review Process.
1. Public Discussions.
After the Notice of Special Review has been issued,
additional information is gathered and analyzed on effects,
exposure, and benefits from a pesticide. The Agency will
promote open discussions with environmental groups, registrants,
and other interested parties. The discussions will focus on
the chemical at issue and possible ways to reduce its potential
risk to health or the environment. These discussions may
be conducted in small groups, or the Agency may choose to
hold informal, public meetings. This period of discussions
may vary in length, depending on the complexity of the issues.
The registrants may agree to voluntarily take action to
reduce risks. Among those actions which could reduce potential
effects or exposure are changing the use patterns, lowering
application rates, requiring protective clothing or respirators
for applicators, label warnings, changing production methods,
etc. In addition, the registrant may offer to cancel certain
uses.
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When assessing voluntary actions or any regulatory option,
the Agency must take many factors into consideration. Obviously,
voluntary actions will only have merit if it can be shown that
such actions would reduce risk to "acceptable" levels. The
Current Benefits Review generated earlier on the pesticide at
issue may have contributed to the Agency's basis for regulatory
options, since alternative pesticides would have been identified
and the possibility of substituting alternative pesticides
taken into consideration. Another consideration will be the
enforceability of any regulatory action. For example, the
Agency must consider if protective clothing requirements are
enforceable or likely to be complied with in a given situation.
Some discussions with the registrants must be private.
The confidentiality of certain production and use information
is protected by law. However, these meetings will be announced
and summarized in a public docket; therefore, any other
interested party can request a meeting with the Agency on the
same topic. Furthermore, to the extent possible without
violating confidential business information, any issues
discussed or other information presented in these meetings
will be made available in the public docket.
If, as a result of discussions, the Agency determines
that the registrants are able to reduce the risks to acceptable
levels, a Notice of Preliminary Determination will be published
in the Federal Register which identifies the Agency's previous
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risk concerns with the pesticide, explains how the Agency
feels these concerns can be resolved, and gives the basis
for the Agency's proposed regulatory decision (see §154.28(a)(2)).
This notice will solicit public comments on the Agency's
position and proposed resolution. After the public comment
period, the Agency will review and evaluate public comments
before announcing its final regulatory decision (see §154.33).
Therefore, the public will have full access to and play a
vital role in the decision making process.
Following a final regulatory decision any Registration
Standard which had been completed for the chemical will be
amended to reflect that decision. The Registration Standard
will discuss the previous risk concerns and how these concerns
were resolved.
Moreover, to help prevent these discussions from becoming
unnecessarily drawn out, approximately 90 days after these
discussions begin, the Agency will determine whether to
continue these discussions to seek voluntary resolutions or,
instead, propose imposition of involuntary regulatory measures.
Such involuntary restrictions include cancellation, denial of
registration, or change of classification.
2. Preliminary Determinations.
When registrants are unable, or unwilling, to voluntarily
amend the terms and conditions of registration in a manner that
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would lessen sufficiently any risks resulting from the uses
of the pesticide, the Agency will prepare to take action to cancel
suspend or amend the terms and conditions of registration to
eliminate any unreasonable adverse effects associated with the
use of the pesticide.
The Agency's proposed action will include an analysis of
the benefits of each use of the pesticide, considering the
availability and cost of alternative control methods. Also,
this analysis will determine the effects of the proposed
action on production and prices of agricultural commodities,
retail food prices, and the agricultural economy.
The USDA may be requested to participate in development
of the analysis by responding to specific questions, augmenting
the Agency's economic information previously summarized in the
Current Benefits Review, or generating a benefits analysis
targeted to specific uses. All potential sources of data will
be explored in an attempt to provide a fully definitive
assessment of the effects the proposed action will have on
pesticide uses, commodity markets, consumers, communities, and
national economic activity.
In accordance with statutory requirements, the Agency
will conduct a risk/benefit analysis to determine whether the
use of the pesticide causes "unreasonable adverse effects"
on health or the environment prior to issuing a proposed notice
of intent to cancel, suspend, or deny registration for certain
or all uses of the pesticide. The Agency's proposed action
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will be announced in the Federal Register in a Notice of
Preliminary Determination (see §154.28).
3. Review and Comment on Preliminary Determination.
As required by section 25(d) of the FIFRA, the Agency
will submit the proposed action to the Scientific Advisory
Panel (SAP) for comments on the scientific basis of the
proposed action (see §154.28(b)). The Panel's review would
be conducted in accordance with the peer review notice published
in December 1981 (40 CFR 61502) regarding corroborative
scientific review. At the same time, as required by section
6(b) of the FIFRA, the Agency will submit the proposed action
to the United States Department of Agriculture (USDA) for
comment on the benefits issues and agricultural impacts (see
§154.28(b)). As specified in sections 6(b) and 25(d) of the
FIFRA, the USDA and the SAP will have at least 30 days to provide
comments to the Agency. During this period, the Agency will
also solicit comments from the public.
4. Final Determination.
The Agency will evaluate all comments received from the
USDA, the SAP, and the public to the proposed action and
consider whether the proposal should be modified prior to
issuance as a final action. The Agency will evaluate comments
and revise the proposed action where appropriate. A Notice
of Final Determination will be issued in the Federal Register
announcing the final action (see §154.33). As required by
the FIFRA, the notice will include comments received from
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the SAP and the USDA and the Agency's responses to these
comments. The final action will be implemented after issuance
in the Federal Register, unless an affected party requests
that an administrative hearing be held according to procedures
set forth in 40 CFR Part 164.
VI. Request for Comments.
The Agency encourages and solicits public comment on this
proposed rule. Comments are sought on all aspects of the
proposed criteria and the proposed process, but, in particular,
the Agency seeks comments on:
1. The Agency is especially concerned with groundwater contamin-
ation, as well as surface water contamination, by pesticides.
Groundwater contamination may expose large populations, is very
difficult to clean up, and may indicate more widespread, future
contamination. Therefore, the Agency has considered establishing
a specific risk criterion for the initiation of a Special
Review when groundwater is found to be contaminated by pesti-
cides. The proposal does not include a specific criterion because
the Agency believes the other criteria provide an adequate
basis for initiating a Special Review to address groundwater
contamination, and no specific criterion is necessary. In ad-
dition, the Agency emphasizes its concerns regarding groundwater
contamination in the preamble; such contamination will cause
the Agency to further investigate the significance of risk
(see IV.C.).
However, the Agency solicits comments on the appropriate-
ness of establishing a specific criterion for groundwater
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contamination by pesticides and solicits suggested language
for such a criterion.
2. Should the Agency omit the Notice of Special Review and,
instead, make the first public notice the Notice of Preliminary
Determination? Issuance of a Notice of Special Review will
raise public concerns over the continued use of a pesticide,
before the Agency has determined what actions, if any, are
necessary to reduce the risks associated with use of the pesti-
cide. If the Agency's first public notice was the Notice of
Preliminary Determination, the public would be better informed
of the potential risk and, at the same time, the means to reduce
the risk. In addition, elimination of the Notice of Special
Review would conserve Agency resources that would be required
to develop the Notice of Special Review and analyze all
comments submitted in response to it.
On the other hand, elimination of the Notice of Special
Review will delay public notification of potential adverse
effects associated with the use of a pesticide. Furthermore,
because the public was not involved earlier, the Notice of
Preliminary Determination may lack significant information
that might have been provided in response to the Notice of
Special Review. Moreover, in those instances where the
Agency's concerns would have been resolved through voluntary
actions by registrants, the Agency will have needlessly
spent resources to develop an in-depth benefits analysis, a
use-by-use risk/benefit determination, an analysis of regul-
atory options for reducing the risks associated with each
use, and the Notice of Preliminary Determination.
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VII. Statutory Review.
In accordance with the PIFRA sec. 25(a), this proposal was
submitted to the U.S. Department of Agriculture for comments.
(To Reader: Discussion will be added here after
USDA comments are received.)
Copies were also supplied to the Committee on Agriculture
of the U.S. House of Representatives and the Committee on
Agriculture, Forestry and Nutrition of the U.S. Senate for
comment.
(To Reader: Discussion will be added here after
any Committee comments are received.)
VI11. Regulatory Review Requirements .
A. Executive Order 1229J.
Under Executive Order 12291, EPA must judge whether
a regulation is "major" and therefore subject to the requirement
of a Regulatory Impact Analysis. EPA has determined that
this proposal is not a major regulation as defined by
Executive Order 12291.
This proposed rule was submitted to the Office of Management
and Budget (OMB) for review, as required by Executive Order
12291. Any comments from OMB to EPA and any EPA response to
those comments are available for public inspection at the
Document Control Office. E-107, 401 M St. S.W., Washington,
D.C. 20460 from 8 a.m. to 4 p.m. Monday through Friday, except
legal holidays.
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B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act, (15 U.S.C. 601,
Pub. L. 96-354, Sept. 19, 1980), EPA hereby certifies that this
proposed rule, if promulgated, would not have a significant
impact on a substantial number of small entities. EPA has
concluded that the number of pesticide registrants subject to
an RPAR review would not be increased as a consequence of the
promulgation of the revisions proposed here, and that the review
criteria and procedures would not have any disproportionate
effect on those pesticide registrants that can be classified as
small entities under the Act.
C. Paperwork Reduction Act
This proposal contains no information collection
requests. Therefore, the Paperwork Reduction Act does not
apply.
IX. LIST OF SUBJECTS IN 40 CFR PART 162
Intergovernmental relations
Packaging and containers
Pesticides and pests
Administrative practices and procedures
Dated:
William D. Ruckelshaus
Administrator
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1.
Data Evaluation
and Risk
Assessment
irt
I
yes
TABLE 1
Issue RS
and
FR Notice
o Risks
o Ration-
ale,
o Solicit
Public
4.
Issue FR
Notice
o Final
position
5.
Issue US and FR
Notice -
o Initiate SR
o Risk concerns
o Request addi-
tional info.
n *5of- mil* r»^w-<«j5|
6*
Discussions
to resolve
risk
Special Review Process
RS = Registration Standard
FR = Federal Register
SR = Special Review
yes
8.
Issue FR
Notice -
o Proposed
resolu-
tion
o Solicit
public
ccnroent
no
9.
Issue FR
Notice
o Final
resolu-
tion
Amend RS
m:
Issue Proposed
Action
Ask for USDA, SAP
and Public
Ccfltnents •
11. Ccmnents from
SAP/USPA
12.
Develop Final
Determination
13.
Issue Final
Determination
and FR Notice
14.
Hearings
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For the reasons sec out in the Preamble, it is proposed that
Title 40 of Code of Federal Regulations be amended by removing
paragraphs (a) and (b) of §162.11, and by adding a new Part 154
to read as follows:
TITLE, CONTENTS,ETC.
§154.1 Special Review Process: Purpose and Scope
(a) Purpose. The purpose of the special review process
is to help the Agency determine whether to initiate procedures to
cancel or deny registration of a pesticide product because uses
of that product may cause unreasonable adverse effects on the
environment, in accordance with sections 3(c)(6) and 6 of the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The
process is intended to insure that: the Agency assesses risks than
may be posed by pesticides, and the benefits of use of those
pesticides, in an open and responsive manner. The issuance of a
Notice of Special Review means that the Agency has determined
that one or more uses of a pesticide may pose significant risks
and that, following completion of the special review process, the
Agency expects to initiate formal proceedings seeking to cancel,
deny, or require modifications to the registration of the product(s)
in question unless it has been shown during the special review
that the Agency's initial determination was erroneous, that the
risks can be reduced to acceptable levels without the need for
formal proceedings, or that the benefits of the pesticide's use
outweigh the risks.
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(b) Scope. This pare sets forth the substantive
standards for initiating a special review of a pesticide product
and the procedures for initiating and conducting the special
review.
(c) Alternative procedures. The Agency expressly reserves
the authority to use alternative procedures for conducting special
reviews or to initiate cancellation or denial proceedings without
first conducting a special review. If the Agency decides to use
alternative procedures for conducting a special review in a
specific case, it will publish a notice in the Federal Register
describing the procedures to be used and why the Agency has
determined that use of such procedures is in the public interest.
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§154.2 Definitions
(a) Except as otherwise defined in this.section, terms
defined in section 2 of FIFRA or in Part 152 shall have the same
definitions for purposes of this part.
(b) The term "pesticide use" means a use of a pesticide
(described in terms of the application site and other applicable
identifying factors) that is included in the labeling of a pesti-.
cide product which is registered, or for which an application
for registration is pending, and the terms and conditions (or
proposed 'terms and conditions) of registration for the use.
(c) The term "validated test" means a test determined by
the Agency to have been conducted and evaluated in a manner.
consistent with accepted scientific procedures.
(d) The term "other significant evidence" means factually
significant information other than a validated test.
(e) The term "Administrator" means the Administrator of
the Environmental Protection Agency or any officer or employee
thereof to whom authority has been delegated to act for the
Administrator.
(f) "Terras and conditions of registration" means the
terms and conditions governing lawful sale, distribution and use
approved in conjunction with registration, including labeling,
use classification, composition, and packaging.
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(g) The term "interested person" means an applicant,
registrant, pesticide user, environmental or labor group, or
other person interested in pesticide regulation.
(h) The term "Act" or "FIFRA" means the Federal Insecticide,
Fungicide, and Rodenticide Act, as amended, 7 USC §136 et seq.
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§154.3 Burden of persuasion In determinations under chis part.
In making determinations under this Part the Administrator
shall be guided by the principle that the burden of persuasion
that a pesticide product is entitled to registration or continued
registration for any particular use or under any particular set
of terms and conditions of registration is always on the proponent(s)
of registration.
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§154.4 Criteria for Initiation of Special Review
The Administrator may conduct a special review of a
pesticide use if he determines, based on a validated test or
other significant evidence, that the use of the pesticide
(taking into account the ingredients*, impurities, metabolites,
and degradation products of the pesticide):
(a) May pose a risk of serious acute injury to
humans or domestic animals;
(b) May pose a risk of inducing in humans an oncogenic,
teratogenic, fetotoxic, reproductive effect, or a chronic or
delayed toxic effect, which risk is of concern in terms of either
the degree of risk to individual humans or the number of humans
at some risk, based upon:
(1) effects demonstrated in humans or experimental
animals;
(2) known or predicted levels of exposure of various
groups of humans; and
(3) the use of appropriate methods of evaluating data
and relating such data to human risk.
(c) May pos-e a risk of inducing a mutagenic effect in
humans, based upon effects demonstrated:
(1) in one or more appropriate test systems, if there
is sufficient evidence that the test substance or its metabolites
will reach mammalian germinal cells, or
(2) in epidemiological or other data indicating
mutagenic effects in humans,
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unless in either case the potential exposure of human populations
is sufficiently low that significant mutagenic risk to humans is
not likely to occur;
(d) May result in residues in the environment of non-target
organisms at levels which equal or exceed concentrations acutely
or chronically toxic to such organisms, or which produce adverse
reproductive effects in such organisms, as determined from tests
conducted on representative species or from other appropriate
data;
(e) May pose a risk to the continued existence of any
endangered or threatened species designated by the Secretary of
the Interior or the Secretary of Commerce under the Endangered
Species Act of 1973, as amended;
(f) May result in the destruction or other adverse
modification of any habitat designated by the Secretary of the
Interior or the Secretary of Commerce under the Endangered
Species Act as a critical habitat for any endangered or
threatened species; or
(g) May otherwise pose a risk to humans or to the
environment which is of sufficient magnitude to merit a de-
termination whether the use of the pesticide product offers
offsetting social, economic, or environmental benefits that
justify initial or continued registration.
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§154.10 Peticions Co Begin che Special Review Process. The
Administrator may evaluate a pesticide use under the criteria of
§154.4 either on his own initiative, or at the suggestion.of
any interested person.
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§154.14 Preliminary Notification to Registrant(s) and Applicant(s)
for Registration.
(a) Preliminary Notification. If the Administrator
determines that one or more of the criteria for initiating a
special review may have been met, he shall send written notice
by certified mail to the affected registrant(s) and applicant(s)
setting forth his determination and a general description of
the information which supports it.
(b) Comment Opportunity. Registrant(s) and applicant(s)
may submit written comments in response to the Administrator's
notice. Only written comments received by the Agency within
a period specified in the notice/ which period will not exceed
thirty (30) days after receipt of the notice, will be considered
by the Agency in deciding whether the first public notice
should be issued under $154.16 or under §154.18(c).
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§154.16 Proposed Decision Not to Start a Special Review. If the
Administrator proposes not to initiate a special review after having
given notice under §154.14, he shall publish- in the Federal
Register his proposal and the supporting reasons, and shall
invite public comment on his proposal within a period generally
not less than thirty (30) days. A notice under §154.18(b) may
not be published unless it has been preceded by a notice under
this section. A proposal under this section shall not be based
on the benefits of use of a pesticide product.
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§154.18 Public Announcement of Final Decision Whether To Initiate
a Special Review.
(a) The Administrator shall evaluate the available infor-
mation and the comments received in response to the notice under
§154.14 and any notice issued under -§154.16, and shall publish
a notice under paragraph (b) or (c) of this section,
(b) If the Administrator determines not to initiate a
special review, he shall publish his decision in the Federal
Register with a statement of reasons.
(c) If the Administrator determines that one or more of
the risk criteria set forth in §154.4 have been satisfied, the
Agency shall publish a notice in the Federal Register which.shall
include:
(1) identification of Che pesticide uses for which a
special review has been initiated and an identification of the
criteria which have been satisfied;
(2) a brief discussion of the Agency's reasons for
determining that the criteria have been satisfied;
(3) a statement indicating that EPA has established a
docket for the administrative record of the special review, the
contents of the docket, the location of the docket, and the times
during which the administrative record will be available for
inspection and copying;
(4) an invitation to all interested persons to submit
further information concerning the risks and benefits associated
with each use of the pesticide subject to the special review;
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(5) a brief description of the special review process
and a statement that registrants and applicants bear an affirmative
burden of supporting registration of a pesticide product; and
(6) a date by which information in response to the
Agency's request for further information must be submitted.
(d) In his discretion, the Administrator may request that
the Scientific Advisory Panel hold a public meeting to review the
scientific issues related to the special review.
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§154.20 Administrative Record of the Special Review
(a) Establishment of the administrative record. When Che
Agency first publicly announces Chat it is conducting a special
review of a pesticide, it shall establish an- administrative
record of documents concerning che special review.
(b) Concencs of Che administrative record. The adminis-
trative record shall contain:
(1) the Notice of Special Review, any Notice of Preliminary
Determination, and any Notice of Final Determination;
(2) any notice issued under §154.14 or §154.16;
(3) any documents referred to by the Agency in those
notices as relied upon by che Agency;
(4) copies of all written comments responding to any
notice furnished under §154.14 or §154.16 or submitted at any
time during the special review process;
(5) any written response to the Notice of Preliminary
Determination from the Secretary of Agriculture or. the Scientific
Advisory Panel;
(6) a transcript of all public meetings held by the
Scientific Advisory Panel or conducted by the Agency for the
purpose of gathering information; and
(7) memoranda summarizing meetings concerning the
special review, as specified by §154.22.
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(c) Access co the Administrative Record.
(1) The administrative record shall be available for
public inspection during normal business hours of the Agency at a
place or places designated by the Administrator, and an index of
its contents shall be prepared, kept current, and made available
to the public on request.
(2) Information contained in the administrative record
shall not be disclosed to the public to the extent that section
10 of the Act or other statute prohibits its disclosure.
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§ 154.21 Comment opportunity.
After issuance of a. Notice of Special Review that applies to a
use of a pesticide product (or category of products), any person
may submit to the Agency any information, argument, or both,
pertinent to:
(a) Whether the use of a pesticide product satisfies any of
the §154.4 risk criteria, with respect to the composition, labeling,
packaging, and restrictions on use of the product as currently
registrered;
(b) Whether the use of a pesticide product would satisfy any
of the §152.4 risk criteria if its composition, labeling, packaging,
and restrictions on use were approved in accordance with; an
application for registration or amended registration pending
before the Agency (see also §154.22(b));
(c) Whether any risks posed by the use or proposed use of the
product that satisfy the §154.4 risk criteria are unreasonable,
taking into account the economic, social, and environmental costs
and benefits of the use of the product; or
(d) What regulatory action, if any, the' Agency should take
with respect to the use of the product.
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§154.22 Meetings with Interested Persons.
(a) Any interested person may ask to meet with Agency
officials to discuss factual information available to the
Agency, to present any factual information, to respond to
presentations by other persons, or to discuss what regulatory
actions should be taken regarding a pesticide which is or may
be the subject of a special review. If the Agency holds such
meetings concerning a use of a pesticide product, the Agency
will prepare and file in the administrative record a memorandum
of such meetings. The memorandum shall identify the meeting
participants and describe all significant positions taken and
facts set forth. Any written materials presented at the
meeting shall be attached to the memorandum. The Agency will
file the memorandum promptly after the meeting is held.
(b) Meetings described in paragraph (a) of this
section may include meetings held after issuance of a
Notice of Special Review with any registrant who proposes
to change voluntarily the composition, packaging, labeling,
or other terms and conditions of registration of his
pesticide product in a way which he believes
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would reduce Che risks of use of che product so chat it would no
longer meet or exceed the risk criteria of §154.4. Meetings for
this purpose will be most helpful and productive for both registrants
and the Agency if they are requested by registrants shortly after
the issuance of the Notice of Special Review.
(c) The Agency shall prepare an index of such meetings for
each pesticide under special review and shall provide that index
to any interested person upon request.
(d) While the Agency may meet with persons interested in
its decisions insofar as practicable and as time permits, the
Agency will not grant preferential access for its decision-making
process to any particular group.
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§154.24 Informal Public Hearings During a Special Review.
(a) Timing. Ac any time after issuance of a Notice of
Special Review and prior to issuance of a No'tice of Final Deter- •
nination, the Administrator may conduct an informal public hearing
to gather relevant information or otherwise assist Agency
decision-making.
(b) Federal. Register Notice. The Administrator shall
publish advance notice in the Federal Register of any informal
public hearing held under this section. The notice shall contain
the following information:
(1) the time, date, and place of the hearing;
(2) a brief description of the procedures governing
participation in the hearing by interested persons; and
(3) the issues to be considered at the hearing.
(c) Transcript. A verbatim transcript of the hearing
shall be prepared and filed in the administrative record.
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§154.28 Notice of Preliminary Determination.
The Administrator shall prepare a Notice of Preliminary Determin-
ation after the close of the comment period on a Notice of Special
Review.
(a) Contents of Notice. The Notice of Preliminary Determination
shall respond to all significant comments submitted in response
to the Notice of Special Review. For each use of a pesticide
product that was the subject of the Notice of Special Review, the
Notice of Preliminary Determination shall also include, as
appropriate:
(1) a determination whether the use satisfies any "of
the risk criteria set forth in §154.4, and a discussion
of the reasons for the determination;
(2) a. determination of whether any changes in the
composition, packaging, labeling, or restrictions on use of a
pesticide product that were proposed in an application for new
or amended registration submitted after issuance of the Notice of
Special Review would reduce the risk so that the use no longer
would satisfy any of the risk criteria in §154.4;
(3) if the use satisfies any of the risk criteria set
forth in §154.4, a determination of whether the adverse effects
posed by the use are unreasonable, taking into account the economic,
social, and environmental costs and benefits of the use of the
product, and a discussion of reasons for the determination;
(4) if the use is determined to pose an unreasonable
adverse effect, a statement of the regulatory action, if any,
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which Che Agency intends to initiate with respect to the use,
and a discussion of the reasons for initiating that regulatory
action;
(5) a statement that the Administrator is requesting
comments from the Secretary of Agriculture and the Scientific
Advisory Panel on the notices and analysis specified in paragraph
(b) of this section, and that the notices and analyses are
available on request;
(6) instructions to interested persons on how to submit
comments (including the deadline for submission of comments); and
(7) the location of the administrative record (see
§154.20) and the times during which the administrative record
will be available for inspection and copying.
(b) Referral to Secretary of Agriculture and Scientific
Advisory Panel. If the Administrator proposes to cancel, deny,
or change the classification of the registration of a pesticide
product which is the subject of a special review, or to hold a
hearing under FIFRA section 6(b)(2) on whether to take any of
those actions, he shall:
(1) prepare a proposed form of a Notice of Intent to
Cancel, a Notice of Intent to Deny Registration, a Notice of
Intent to Hold a Hearing, and/or a Notice of Intent to Change
Classification, as appropriate;
(2) prepare an Agricultural Impact Analysis, analyzing
the impact of the proposed action on production and prices of
agricultural commodities, retail food prices, and otherwise on the
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agriculcural economy;
(3) send Che proposed notices and analysis Co Che
Secretary of Agriculture and the Scientific.Advisory Panel for
comment, as provided by the Act; and
(4) send the Notice of Preliminary Determination and
the other notices and analysis prepared under this section to all
registrants and applicants for registration of products that are
subjects of the special review.
(c) Publication. The Agency shall publish the Notice of
Preliminary Determination in the Federal Register.
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§154.33 NotjLce_g_f_F_i.nal Determination.
(a) Publication and notice to registrants and applicants.
The Administrator shall prepare a Notice of Final Determination
after the close of the comment period on a Notice of Preliminary
Determination. As necessary, the Administrator shall also prepare
Notices of Intent to Cancel, Notices of Denial, Notices of Intent
to Hold a Hearing under FIFHA §6(b)(2), or Notice of Intent to
Change Classification.
(b) Contents. The Notice of Final Determination shall
include:
(1) For each pesticide use subject to the Notice of
Preliminary Determination, the Agency's final determination'with
respect to each use, along with a discussion of the reasons for
the determination;
(2) Any comments submitted by the Secretary of Agri-
culture or the Scientific Advisory Panel, and the responses of
the Administrator to these comments;
(3) The response of the Administrator to any signi-
ficant public comments submitted on the Notice of Preliminary
Determination; and'
(4) Instructions to registrants, applicants for
registration, and other interested persons concerning the pro-
cedures which will be used to implement any regulatory action
which the Administrator has decided upon, including instructions
concerning how to request hearings, if hearings are available
as of right under the Act or have been made available by the
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Administrator under Che Ace.
(c) Publication and Notification of Registrants and Applicants.
The Nocice of Final Determination and any jtfotice of Intent to
Cancel, Notice of Denial, Notice of Intent to Hold a Hearing, or
Notice of Intent to Change Classification shall be published in
the Federal Register. If the Administrator issues a Notice of
Intent to Cancel, Notice of Denial, Notice of Intent to Hold a
Hearing, or Notice of Intent to Change Classification, such
notice, along with the Notice of Final Determination, also shall
be sent by certified mail to all affected registrants and applicants,
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§154.40 Finality of Determinations.
(a) The Administrator will not approve an application for
registration or amended registration of a.pesticide product
except by use of the procedures specified in subsection (c), if:
(1) The application proposes registration of a product
for a use which earlier had been the subject of a notice under
S154.14(a); and
(2) After the Administrator issued the notice, he
determined not to initiate a special review, because of a proposal
by an applicant for registration or amended registration to
change the terms and conditions of registration of the product
in a way which would reduce the risk sufficiently to eliminate
the need for a special review; and
(3) The application for registration or amended regis-
tration now proposes that the terms and conditions which served as
the basis of the earlier determination be eliminated, or be modified
in a way which might increase the risk which was the subject of
the notice under §154.14(a).
(b) The Administrator will not approve an application for
registration or amended registration of a pesticide product
without notice, opportunity for comment, and issuance of a
final determination, as specified in subsection (c), if:
(1) The application proposes registration of a product
for a use which earlier had been the subject of a Notice of
Special Review issued under § 154.13; and
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(2) After the Administrator issue.d chat Notice, he
determined not to issue a notice under FIFRA section 3(c)(6) or
6(b) because of a proposal by an applicant, for registration or
amended registration to change the terms and conditions of regis-
tration of the product in a way which would reduce the risk
sufficiently to eliminate the need for issuance of a notice under
FIFRA section 3(c)(6) or 6(b); and
(3) The application for registration or amended regis-
tration now proposes that the terms and conditions of registration
which served as the basis for the earlier determination now be
eliminated or be modified in a way which might increase the risk
which was the subject of the Notice of Special Review.
(c) An application to which, paragraph (a) or (b) of this
section applies may not be approved until:
(1) the Administrator publishes a notice in the Federal
Register which describes why the application is subject to the
provisions of this section, states that the Administrator proposes
to approve the application and his reasons therefor, solicits
public comment on whether the application should be approved,
and provides a period not less than 30 days for comments to be
submitted; and
(2) if any substantive comments are submitted in response
to the notice, the Administrator publishes a second notice in the
Federal Register responding to the comments.
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