RrraBT-OOCUMENTATlON
PAGE
L REPORT NO.
S. Raclptooft Acc*nlon Mo.
4. TKtaMd Subtitle
COMPOUND 1081 - Decision Document
S. Report Date
2/80
7. AuttKMti)
EPA, OPP, REGISTRATION DIVISION
ft. Rarformlnc Organization Rept. No:
540/09- 90-105
t. Pxteimtng Organization Nam* and Address
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
10. Pro|«ct/Ta«li/Work Unit No.
11. Contract(C) or Grant(G) No.
(C)
(G)
12. Sponsoring Organization Nam* and Addrats
SAME AS #9 .
11. Type of Report & Period Covered
14.
IS. Supplementary Notes
16. Abstract (Limit: 200 words)
This Position Document addresses the risks and benefits of pesticide products
containing the subject active ingredient. The Agency has determined that the use
of products containing the subject active ingredient may meet or exceed a risk
criterion described in 40 CFR Part 154. Potential hazards will be examined
further to determine the nature and extent of the risk, and considering the
benefits of the subject active ingredient, whether such risks cause unreasonable
adverse effects on the environment.
17. Document Analysis a. Descriptors
PESTICIDES, STANDARDS, REGULATIONS, MANUFACTURING, CHEMISTRY, TOXICOIOGY,
RESIDUES, ECOLOGY, PATH OF POLLUTANTS
b. ld«ntlA*f»/Op*n-Cnded Terms
e. COSATI Field/Group
1C. Availability Statement
PUBLICLY AVAILABLE
(S«e ANSI-Z39.18)
EJBD
ARCHIVE
EPA
540-
09-
90-
105
19. Security Class (This Report)
UNCLASSIFIED
2Q. Security Class (This Pace)
UNCLASSIFIED
21. No. of Pages
11
22. Price
$•• Instruction* on Reverse
OPTIONAL FORM 272 (4-77)
(Formerly NTIS-35)
Department of Commerce
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540/09-90-105
ENVIRONMENTAL PROTECTION AGENCY
[OPP-30000-8B]
PESTICIDE PRODUCTS CONTAINING
FLUOROACETAMIDE (COMPOUND 1081)
NOTICE OF DETERMINATION CONCERNING THE REBUTTABLE
PRESUMPTION AGAINST REGISTRATION
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of Determination and Availability of
**
Position Document Concerning Fluoroacetamide (Compound
1081).
SUMMARY: This notice announces the termination of the
rebuttable presumption against registration (RPAR) of
* •
pesticide products containing Fluoroacetamide (Compound
1081-), pursuant to 40" CFR 16:2.11
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SUPPLEMENTARY INFORMATION:
I. INTRODUCTION
On December 1, 1976, the Environmental Protection
Agency issued a notice of rebuttable presumption against
registration and continued registration (RPAR) of pesticide
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products containing Fluoroacetamide (Compound 1081)
published in the FEDERAL REGISTER of December 1, 1976
(41 FR 5279,2), a compound currently registered in the
United States as a rodenticide, and thereby initiated
the Agency's public review of the risks of Compound
1081. This notice constitutes the Agency's Notice of
Determination pursuant to 40 CFR 162.11(a)(5)(i), terminating
the Compound 1081 RPAR.
The presumption against Compound 1081 was based on
lack of emergency treatment, acute toxicity to mammalian
and avian species, and significant reduction of non-target
populations and fatalities to members of endangered
species. The risk information submitted in response
to the RPAR notice did not satisfy the Agency's risk concerns
At the time the rebuttable presumption against registration
was issued, two registrants held registrations for
Compound 1081 pesticide products. In 1978, the holder
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of one registration requested a voluntary cancellation.
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Thereafter/ the sole remaining registrant of Compound
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1081 products voluntarily agreed to modifications in
the terms and conditions of registration, which have the
result of substantially reducing the risks posed by
Compound 1081. Since label amendments regarding use
restrictions and modified use directions have been proposed
and accepted, the likelihood of exposure to humans,
non-target mammals, birds, and endangered species is
very remote. Accordingly, the Agency has concluded that
the presumption against Compound 1081 has been rebutted.
II. LEGAL BACKGROUND
In order to obtain a registration for a pesticide
under the Federal Insecticide, Fungicide, and Rodenticide
Act ("FIFRA"), a manufacturer must demonstrate that the
pesticide statisfies the statutory standard for registration.
That standard requires, among other things', that 'the
pesticide perform its intended function without causing
"unreasonable adverse effects" on the environment (section
3(c)(5)). "Unreasonable adverse effects on the environment"
are defined to include "any unreasonable risk to man or
the environment, taking into account the economic,
social, and environmental costs and benefits of the use _
of any pesticide (section 2(bb)). In effect, this standard
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requires a finding that the benefits of .any use :o£ 'the ,
pesticide exceed the risks of that use when the pesticide
is used in accordance with commonly recognized practice.
The burden of proving that a pesticide satisfies the
registration standard continues as long as the registration
remains in effect. Under section 6 of FIFRA, the
Administrator is required to cancel the registration
of a pesticide or modify the terms and conditions of
registration whenever he determines that the pesticide no
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longer satisfies the statutory standard for registration.
The Agency created the RPAR process to facilitate
the identification of pesticide uses which may not satisfy
I/Another part of the statutory standard for registration
Ts that the pesticide must satisfy the labeling requirements
of FIFRA. These requirements are set out in the statutory
definition of "misbranded" (FIFRA Section 2(q)). Among
other things, this section provides that a pesticide is
misbranded If: ""the "labeling . . . tJoes -not-contain
directions for use which are necessary for effecting the
purpose for which the product is intended and if complied
with, together with any . . . (restrictions), imposed
under Section 3(d) . . .' are adequate to protect health
and the environment.
The Agency can require changes to the directions for
use of a pesticide in most circumstances either by finding
that the pesticide is misbranded if the label is not
changed, or by finding that the pesticide would cause
unreasonable adverse effects on the environment, unless
labeling changes are made which accomplish risX reductions.
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the statutory standard for registration and to provide a
public, informal procedure for gathering and evaluating
information about the risks and benefits of these uses.
The regulations governing the RPAR process are set
forth in 40 CFR 162.11. This section provides that a
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rebuttable presumption shall arise if a pesticide meets
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or exceeds any of the risk criteria set out in the
regulations. The Agency announces that an RPAR has arisen
by publishing a notice in the Federal Register. After an
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RPAR is issued, registrants and other interested persons
are invited to review that data upon which the presumption
is based and to submit data and information to rebut the
presumption. Respondents may rebut the presumption of
risk by showing that the Agency's initial determination
of risk was in error or by showing that use of the
pesticide is not likely to result in any significant
exposure to humans, or to animals or plants of concern with
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I/
regard .to the adverse effect in question. Further,
in addition to submitting evidence to rebut the risk
presumption, respondents may submit evidence as to whether
t
the economic, social and environmental benefits of the
use of the pesticide subject to the presumption outweigh
the risks of use.
y40 CFR 162.11(a)(4) provides that registrants and
applicants may rebut a presumption against registration
by sustaining the burden of proving:
11 (i) In the case of a pesticide which meets
or exceeds the criteria for risk set forth in
paragraphs (a)(3)(i) or (iii) that when con-
sidered with the formulation, packaging, method
of use, and proposed restrictions on and direc-
tions for use and widespread and commonly
recognized practices of use, the anticipated
exposure to an applicator or user and to local,
regional or national populations of non-target
organisms is not likely to result in any
significant acute adverse effects; or (ii) In
the case of a pesticide which meets or exceeds
the criteria for risk set forth in paragraph
(a)(3)(ii) that when considered with proposed
restrictions on use and widespread and commonly
recognized practices of use, the pesticide will
not concentrate, persist or accrue to levels in
man or the environment likely to result in any
significant chronic adverse effects; or (iii)
that the determination by the Agency that the-
pesticide meets or exceeds any of the criteria
for risk was in error."
A primary purpose of the RPAR process is to screen
for appropriate action those pesticide uses which pose
risks which are of sufficient concern to require the Agency
to consider whether offsetting benefits justify the risks.
Accordingly, the Agency's approach to rebuttal determinations
concentrates on whether the risk concerns which'are
central to each RPAR proceeding have in fact been answered.
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The regulations require the Agency to conclude an
RPAR by issuing a Notice of Determination in which the
Agency states and explains its position on the question
of whether the risk presumptions have been rebutted. If
the Agency determines that the presumption has been
rebutted, the Agency will not perform a detailed analysis
•
of the benefits of the use odE the pesticide. Where the
risk trigger has been rebutted, such a benefits analysis
is unnecessary to support a conclusion that the pesticide
does not appear to pose unreasonable adverse effects on
the environment. A conclusion that the presumption has
been rebutted results in the termination of the RPAR
process. The Agency will either approve a pending
registration application or permit the registration of
the pesticide to continue without modification in the terms
and conditions of registration. 40 CFR 162.11(a)(5)(i ).
In the event the presumptions are not rebutted, the
Agency will consider information relating to the social,
economic, and environmental costs and benefits of the
pesticide. If the Administrator determines, after weighing
risks against benefits, that regulatory measures are
necessary to prevent unreasonable adverse effects on the
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environment under section 6(b) or 3(c)(6), he may propose
risk reduction measures ranging from modifications in the
terms and conditions of registration to cancellation or
denial of registration.
FIFRA requires the Agency to submit cancellation
notices issued pursuant to section 6 to the Scientific
•
Advisory Panel for review and comment on the health and
environmental aspects of the proposed decision and to the
Secretary of Agriculture for comments on the impact of
the proposed decision on the agricultural economy. However,
the Agency is not required to submit a decision not to
initiate cancellation proceedings against a pesticide
after RPAR review to either the Scientific Advisory
Panel or the Secretary of Agriculture for review and
comment. Hence, the Agency has no statutory obligation
to refer a decision to terminate an RPAR for external
review.
III. DETERMINATION THAT THE REBUTTABLE PRESUMPTION
HAS BEEN REBUTTED
The Agency has considered information on the risks
associated with the uses of Fluoroacetamide (Compound
1081) including information submitted by registrants and
other interested persons in rebuttal to the Fluoroacetamide
RPAR. Th« Agency's assessment of the risks associated with
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the use of Compound 1081 and its conclusions"regarSThg""""'
whether the use of Compound 1081 under current label
restrictions poses unreasonable adverse effects are
set forth in the Position Document accompanying this
Notice. The Position Document is hereby adopted by the
Agency as its statement of reasons for the determination
announced .in this Notice. For the reasons summarized
below and developed in detail in the Position Document,
the determination of the Agency with respect to Compound
1081 is as 'follows:
a. Determination on risks. The Compound 1081 RPAR
was based on information indicating that Compound 1081
posed the following risks to humans and the environment:
lack of emergency treatment; acute toxicity to mammalian
and avian species; and significant reduction to non-target
populations and fatalities to members of endangered
species.
As developed more fully in the Position Document,
the Agency has determined that the presumption against
Compound 1081 has been rebutted. The sole remaining
registrant voluntarily proposed that certain restrictions
and modified directions for use be incorporated on the
label. The proposed label was approved on November 2,
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1979. With these revisions, the risks cited in the- presump-
tion no longer appear to be of concern, because anticipated"
exposure to Compound 1081 would be insignificant and
would be unlikely to result in any significant acute or
chronic adverse effects in humans and on the environment.
b. Determination on benefits. Under the revised
label,Compound 1081 is registered for use in sewers for
killing Norway rats and roof rats. The Agency did not
perform a detailed analysis of the economic benefits for
this use, because the Agency determined that the pesticide
does not pose any appreciable risk under the current
label.
c. Determination of unreasonable adverse effects.
For the reasons set forth in detail in the accompanying
Position Document, the Agency has determined that the
current -use patterns of Compound 1081 do not pose unreason-
able adverse effects to humans or the environment. Accord-
ingly, the registration of Compound 1081, as voluntarily
modified, will be allowed to continue in effect without
further modification in the terms and conditions of
registration.
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IV. PROCEDURAL MATTERS
' As indicated above, this Notice of Determination
announces the termination of the notice of rebuttable
• •> •" *
presumption against registration of pesticide products
containing Fluoroacetamide (Compound 1081).
• •
Interested persons may obtain copies of the Position
Document by contacting Tim Gardner, Office of Pesticide
Programs, Special Pesticide Review Division, EPA (TS-791),
Room 711-C, Crystal Mall 2, 1921 Jefferson Davis Highway,
Arlington, Virginia 22202, (.703) 557-7400.
Dated: -,,/l^ '
' i I
Steven D. Jcllinek
Assistant /administrator
Toxic Substances
\
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