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/ 2002
/ September
/ Wednesday, September 04, 2002
[Federal Register: September 4, 2002 (Volume 67, Number 171)]
[Rules and Regulations]
[Page 56490-56495]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04se02-11]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2002-0227; FRL-7197-7]
Cypermethrin and an Isomer Zeta-cypermethrin; Pesticide
Tolerances for Emergency Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of zeta-cypermethrin (S-cyano(3-phenoxyphenyl) methyl
([plusmn]))(cis-trans3-(2,2-dichloroethenyl)-2,2
dimethylcyclopropanecarboxylate and its inactive R-isomers in or on
flax (seed and meal) and mustard seed in connection with crisis
exemptions declared by the state of North Dakota under section 18 of
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
authorizing use of the pesticide on flax and mustard. This regulation
establishes a maximum permissible levels for residues of zeta-
cypermethrin and its inactive R-isomers in these food commodities. The
tolerances will expire and are revoked on June 30, 2005.
DATES: This regulation is effective September 4, 2002. Objections and
requests for hearings, identified by docket ID number OPP-2002-0227,
must be received on or before November 4, 2002.
ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket ID number OPP-2002-0227 in the
subject line on the first page of your response.
FOR FURTHER INFORMATION CONTACT: By mail: Libby Pemberton, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 308-9364; e-mail address: Sec-18-
Mailbox@epamail.epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected categories and entities may include, but are not
limited to:
------------------------------------------------------------------------
Examples of
Categories NAICS codes potentially
affected entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Additional Information, Including Copies of This
Document and Other Related Documents?
1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/. A frequently updated electronic
version of 40 CFR part 180 is available at http://www.access.gpo.gov/
nara/cfr/cfrhtml--00/Title--40/40cfr180--00.html, a beta site currently
under development. To access the OPPTS Harmonized Guidelines referenced
in this document, go directly to the guidelines at http://www.epa.gov/
opptsfrs/home/guidelin.htm.
2. In person. The Agency has established an official record for
this action under docket ID number OPP-2002-0227. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI). This official
record includes the documents that are physically located in the
docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
II. Background and Statutory Findings
EPA, on its own initiative, in accordance with sections 408(e) and
408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a, is establishing tolerances for combined residues of the
insecticide zeta-cypermethrin (S-cyano(3-phenoxyphenyl) methyl
([plusmn]))(cis-trans 3-(2,2-dichloroethenyl)-2,2
dimethylcyclopropanecarboxylate and its inactive R-isomers, in or on
flax (seed and meal) and mustard seed at 0.2 parts per million (ppm).
These tolerances will expire and are revoked on June 30, 2005. EPA will
publish a document in the Federal Register to remove the revoked
tolerances from the Code of Federal Regulations.
Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for
pesticide chemical residues in food that will result from the use of a
pesticide under an emergency exemption granted by EPA under section 18
of FIFRA. Such tolerances can be established without providing notice
or period for public comment. EPA does not intend for its actions on
section 18 related tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to
establish a tolerance or an exemption from the requirement of a
tolerance on its own initiative, i.e., without having received any
petition from an outside party.
Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical
[[Page 56491]]
residue in or on a food) only if EPA determines that the tolerance is
``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to mean that
``there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.'' This includes exposure through drinking
water and in residential settings, but does not include occupational
exposure. Section 408(b)(2)(C) requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
Section 18 of the FIFRA authorizes EPA to exempt any Federal or
State agency from any provision of FIFRA, if EPA determines that
``emergency conditions exist which require such exemption.'' This
provision was not amended by the Food Quality Protection Act (FQPA).
EPA has established regulations governing such emergency exemptions in
40 CFR part 166.
Recently, EPA has received objections to a tolerance it established
for zeta-cypermethrin and its inactive R-isomers on a different food
commodity. The objections were filed by the Natural Resources Defense
Council (NRDC) and raised several issues regarding aggregate exposure
estimates and the additional safety factor for the protection of
infants and children. Although these objections concern separate
rulemaking proceedings under the FFDCA, EPA has considered whether it
is appropriate to extend the emergency exemption tolerances for zeta-
cypermethrin and its inactive R-isomers while the objections are still
pending.
Factors taken into account by EPA included how close the Agency is
to concluding the proceedings on the objections, the nature of the
current action, whether NRDC's objections raised frivolous issues, and
the extent to which the issues raised by NRDC had already been
considered by EPA. Although NRDC's objections are not frivolous, the
other factors all support extending these tolerances at this time.
First, the objections proceeding is not near to conclusion. NRDC's
objections raise complex legal, scientific, policy, and factual matters
and EPA has just initiated a 60 day public comment period on them (June
19 2002, 67 FR 41628) (FRL-7167-7). Second, the nature of the current
actions are extremely time-sensitive as they address emergency
situations. Third, the issues raised by NRDC are not new matters but
questions that have been the subject of considerable study by EPA and
comment by stakeholders. Accordingly, EPA is proceeding with
establishing the tolerances for zeta-cypermethrin and its inactive R-
isomers.
III. Emergency Exemption for Zeta-Cypermethrin on Flax and Mustard and
FFDCA Tolerances
On May 31 and July 30, 2002, the North Dakota Department of
Agriculture availed itself of the authority to declare the existence of
crisis situations within the state, thereby authorizing use under FIFRA
section 18 of Z-cypermethrin on mustard grown for seed to produce the
condiment for control of crucifer flea beetle (Phyllotreta cruciferae
(Goeze) and on flax to control grasshoppers, respectively.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of zeta-cypermethrin and its
inactive R-isomers, in or on flax (seed and meal) and mustard seed. In
doing so, EPA considered the safety standard in FFDCA section
408(b)(2), and EPA decided that the necessary tolerance under FFDCA
section 408(l)(6) would be consistent with the safety standard and with
FIFRA section 18. Consistent with the need to move quickly on the
emergency exemption in order to address an urgent non-routine situation
and to ensure that the resulting food is safe and lawful, EPA is
issuing this tolerance without notice and opportunity for public
comment as provided in section 408(l)(6). Although these tolerances
will expire and are revoked on June 30, 2005, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerances remaining in or on flax (seed and meal) and
mustard seed after that date will not be unlawful, provided the
pesticide is applied in a manner that was lawful under FIFRA, and the
residues do not exceed a level that was authorized by these tolerances
at the time of that application. EPA will take action to revoke these
tolerances earlier if any experience with, scientific data on, or other
relevant information on this pesticide indicate that the residues are
not safe.
Because these tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether zeta-
cypermethrin meets EPA's registration requirements for use on flax and
mustard or whether permanent tolerances for these uses would be
appropriate. Under these circumstances, EPA does not believe that these
tolerances serve as a basis for registration of zeta-cypermethrin by a
State for special local needs under FIFRA section 24(c). Nor do these
tolerances serve as the basis for any State other than North Dakota to
use this pesticide on these crops under section 18 of FIFRA without
following all provisions of EPA's regulations implementing section 18
as identified in 40 CFR part 166. For additional information regarding
the emergency exemption for zeta-cypermethrin, contact the Agency's
Registration Division at the address provided under FOR FURTHER
INFORMATION CONTACT.
IV. Aggregate Risk Assessment and Determination of Safety
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances November 26, 1997 (62 FR 62961) (FRL-5754-7).
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action. EPA has sufficient data to assess the hazards of zeta-
cypermethrin and its inactive R-isomers and to make a determination on
aggregate exposure, consistent with section 408(b)(2), for time-limited
tolerances for combined residues of zeta-cypermethrin and its inactive
R-isomers in or on flax (seed and meal) and mustard seed at 1.0 ppm.
The most recent estimated aggregate risks resulting from the use of
zeta-cypermethrin and its inactive R-isomers are discussed in the
Federal Register for February 12, 2002 (67 FR 6422) (FRL-6818-8). Final
Rule establishing tolerances for residues of zeta-cypermethrin and its
inactive R-isomers in or, on edible podded legume vegetables (crop
subgroup 6A) at 0.5 ppm; succulent, shelled peas and beans (crop
subgroup 6B) at 0.1 ppm; dried, shelled peas and beans, except soybean
(crop subgroup 6C) at 0.05 ppm; soybean, seed at 0.05 ppm; fruiting
vegetables, except cucurbits (crop group 8) at 0.2 ppm; sorghum, grain
at 0.5 ppm; sorghum, forage at 0.1 ppm; sorghum, stover at 5.0 ppm;
wheat, grain at 0.2 ppm; wheat, forage at 3.0 ppm; wheat, hay at 6.0
ppm; wheat, straw at 7.0 ppm; aspirated grain fractions at 10.0 ppm;
meat of cattle, goats, hogs, horses, sheep at 0.2 ppm, because in that
prior action, risks were estimated assuming tolerance level residues in
all commodities for
[[Page 56492]]
established tolerances, as well as those for which action was being
proposed, such as in this flax and mustard exemption use. Refer to the
February 12, 2002, Federal Register document for a detailed discussion
of the aggregate risk assessments and determination of safety. EPA
relies upon that risk assessment and the findings made in the Federal
Register document in support of this action. Below is a brief summary
of the aggregate risk assessment.
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. A summary of the toxicological dose and endpoints for zeta-
cypermethrin for use in human risk assessment is discussed in Unit
III.A of the Federal Register of February 12, 2002 (67 FR 6422).
EPA assessed risk scenarios for zeta-cypermethrin and its inactive
R-isomers under acute, chronic, and short-term and intermediate-term
exposures.
The Dietary Exposure Evaluation Model (DEEMTM) analysis
evaluated the individual food consumption as reported by respondents in
the U.S. Department of Agriculture (USDA) 1989-1992 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII) and
accumulated exposure to the chemical for each commodity.
The following assumptions were made for the acute exposure
assessments: Tolerance level residues were assumed and it was also
assumed that 100% of the crops and other commodities with proposed or
established cypermethrin or zeta-cypermethrin tolerances contained
those residues. Deem default processing factors were used for all
commodities in this assessment. All exposures are tier 1 estimates that
are extremely conservative and likely overestimate actual dietary
exposure.
Using these exposure assessments, EPA concluded that zeta-
cypermethrin and its inactive R-isomers exposure from food consumption
will utilize 22% of the acute population adjusted dose (aPAD) for the
U.S. population, 21% of the aPAD for females 13-years and older, and
24% of the aPAD for infants (> 1-year old), and 33% of the aPAD for
children (1-6 years old), the subpopulation at greatest exposure. In
addition, despite the potential for acute dietary exposure to zeta-
cypermethrin and its inactive R-isomers in drinking water, after
calculating drinking water levels of concern (DWLOCs) and comparing
them to conservative model estimated environmental concentrations
(EECs) of zeta-cypermethrin in surface and ground water, EPA does not
expect the aggregate exposure to exceed 100% of the aPAD, as shown in
the following Table 1:
Table 1.--Aggregate Risk Assessment for Acute Exposure to Zeta-Cypermethrin and its inactive R-isomers
----------------------------------------------------------------------------------------------------------------
aPAD
milligrams/ %aPAD Surface Ground Acute DWLOC
Population Subgroup kilogram (food) water EEC water EEC (ppb)
(mg/kg) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.10 22 8.9 0.006 2,700
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.10 21 8.9 0.006 2,400
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.10 33 8.9 0.006 670
----------------------------------------------------------------------------------------------------------------
The following assumptions were made for the chronic exposure
assessments: Tolerance level residues were assumed and it was also
assumed that 100% of the crops and other commodities with proposed or
established cypermethrin or zeta-cypermethrin tolerances contained
those residues. Deem default processing factors were used for all
commodities in this assessment. All exposures are Tier 1 estimates that
are extremely conservative and likely overestimate actual dietary
exposure.
Using these exposure assumptions the EPA concluded that exposure
to zeta-cypermethrin and its inactive R-isomers from food will utilize
12% of the cPAD for the U.S. population, 11% of the cPAD for females
13-50 years old and 23% of the cPAD for children 1-6 years old, the
subpopulation at greatest exposure. Based on the use pattern, chronic
residential exposure to residues of zeta-cypermethrin and its inactive
R-isomers is not expected. In addition, there is potential for chronic
dietary exposure to zeta-cypermethrin and its inactive R-isomers in
drinking water. After calculating DWLOCs and comparing them to the EECs
for surface and ground water, EPA does not expect the aggregate
exposure to exceed 100% of the cPAD, as shown in the following Table 2:
Table 2.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Zeta-cypermethrin and its inactive R-
isomers
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population Subgroup cPAD mg/kg/day %cPAD (food) water EEC water EEC Chronic
(ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. population 0.18 12 33 .06 5,600
----------------------------------------------------------------------------------------------------------------
Females (13-50 years) 0.18 11 33 .06 4,800
----------------------------------------------------------------------------------------------------------------
Children (1-6 years) 0.18 18 33 .06 1,500
----------------------------------------------------------------------------------------------------------------
Seniors 55+ 0.18 12 33 .06 5,600
----------------------------------------------------------------------------------------------------------------
[[Page 56493]]
Short-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level).
Zeta-cypermethrin is not currently registered for use that could
result in short-term residential exposure; however, cypermethrin does
have indoor and outdoor residential uses and the Agency has determined
that it is appropriate to aggregate chronic food and water and short-
term exposures for zeta-cypermethrin and its inactive R-isomers. EPA
has concluded that food and residential exposures aggregated result in
aggregate margin of exposure (MOEs) of 1,300 for adult males and 600
for children. These aggregate MOEs do not exceed the Agency's level of
concern for aggregate exposure to food and residential uses. In
addition, short-term drinking water levels of concern (DWLOCs) were
calculated and compared to the EECs for chronic exposure of zeta-
cypermethrin and its inactive R-isomers in ground and surface water.
After calculating DWLOCs and comparing them to the EECs for surface and
ground water, EPA does not expect short-term aggregate exposure to
exceed the Agency's level of concern, as shown in the following Table
3:
Table 3.--Aggregate Risk Assessment for Short-Term Exposure to Zeta-cypermethrin and its inactive R-isomers
----------------------------------------------------------------------------------------------------------------
Aggregate MOE Surface Ground
Population subgroup (food + Aggregate level water EEC water EEC Short-term
residential) of concern (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
Adult male 1,300 100 0.46 0.006 3,300
----------------------------------------------------------------------------------------------------------------
Child 600 100 0.46 0.006 830
----------------------------------------------------------------------------------------------------------------
Intermediate-term aggregate exposure takes into account non-
dietary, non-occupational exposure plus chronic exposure to food and
water (considered to be a background exposure level).
Zeta-cypermethrin is not registered for use(s) that could result in
intermediate-term residential exposure; however, cypermethrin does have
indoor and outdoor residential uses, and the Agency has determined that
it is appropriate to aggregate chronic food and water and intermediate-
term exposures for zeta-cypermethrin and its inactive R-isomers. EPA
has concluded that food and residential exposures aggregated result in
an aggregate MOE of 640 for adult males and 300 for children. Thess
aggregate MOEs do not exceed the Agency's level of concern for
aggregate exposure to food and residential uses. In addition,
intermediate-term DWLOCs were calculated and compared to the EECs for
chronic exposure of zeta-cypermethrin and its inactive R-isomers in
ground and surface water. After calculating DWLOCs and comparing them
to the EECs for surface and ground water, EPA does not expect
intermediate-term aggregate exposure to exceed the Agency's level of
concern, as shown in the following Table 4:
Table 4.--Aggregate Risk Assessment for Intermediate-Term Exposure to Zeta-cypermethrin and its inactive R-
isomers
----------------------------------------------------------------------------------------------------------------
Aggregate MOE Surface Ground Intermediate-
Population subgroup (food + Aggregate level water EEC water EEC Term DWLOC
residential) of concern (ppb) (ppb) (ppb)
----------------------------------------------------------------------------------------------------------------
Adult Male 640 100 0.46 0.006 1,500
----------------------------------------------------------------------------------------------------------------
Child 300 100 0.46 0.006 330
----------------------------------------------------------------------------------------------------------------
V. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methods are available for determination of
cypermethrin residues in plants and animal products in PAM II (Method
I). This method involves initial acetone-hexane extraction, followed by
partitioning with water. The organic layer is evaporated, then
redissolved in cyclohexane-methylene chloride and passed through a gel
permeation column. The eluate is evaporated, redissolved in hexane and
passed through a Florisil column. Cypermethrin residues are analyzed by
gas chromatography (GC) with an electron capture detector (ECD). Since
zeta-cypermethrin is an isomer enriched form of cypermethrin, and the
PAM II method is not stereospecific, this method is considered adequate
for enforcement of the proposed tolerances of zeta-cypermethrin and its
inactive R-isomers.
B. International Residue Limits
No Codex, Canadian, or Mexican maximum residue levels have been
established for residues of zeta-cypermethrin and its inactive R-
isomers in or on these commodities. Therefore, no tolerance
discrepancies exist between countries for this chemical.
VI. Conclusion
Therefore, tolerances are established for combined residues of
zeta-cypermethrin, methyl(E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-
yloxy)phenyl)-3-methoxyacrylate a and the Z isomer of zeta-cypermethin,
methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-
methoxyacrlate in or on flax (seed and meal) and mustard seed at 1.0
ppm.
VII. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. EPA procedural regulations
which govern the submission of objections and requests for hearings
appear in 40 CFR part 178. Although the procedures in those regulations
require some modification to
[[Page 56494]]
reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will
continue to use those procedures, with appropriate adjustments, until
the necessary modifications can be made. The new section 408(g)
provides essentially the same process for persons to ``object'' to a
regulation for an exemption from the requirement of a tolerance issued
by EPA under new section 408(d), as was provided in the old FFDCA
sections 408 and 409. However, the period for filing objections is now
60 days, rather than 30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2002-0227 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before November
4, 2002.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your written request to the
Office of the Hearing Clerk in Rm. 104, Crystal Mall 2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket ID number OPP-2002-0227, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VIII. Regulatory Assessment Requirements
This final rule establishes time limited tolerances under FFDCA
section 408. The Office of Management and Budget (OMB) has exempted
these types of actions from review under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).
Because this rule has been exempted from review under Executive Order
12866 due to its lack of significance, this rule is not subject to
Executive Order 13211, Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355,
May 22, 2001). This final rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor
does it require any special considerations under Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). This action does not
involve any technical standards that would require Agency consideration
of voluntary consensus standards pursuant to section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (NTTAA),
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 exemption under FFDCA section 408, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various
[[Page 56495]]
levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This final rule directly regulates
growers, food processors, food handlers, and food retailers, not
States. This action does not alter the relationships or distribution of
power and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). For these same reasons, the
Agency has determined that this rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This rule will not have substantial
direct effects on tribal governments, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified in Executive Order 13175. Thus, Executive Order 13175 does
not apply to this rule.
IX. Submission to Congress and the Comptroller General
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of this final rule in the Federal Register. This final
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: August 28, 2002.
Deebra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346(a) and 374.
2. Section 180.418 is amended by adding paragraph (b) to read as
follows:
Sec. 180.418 Cypermethrin and an isomer zeta-cypermethrin; tolerances
for residues.
* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for combined residues of zeta-cypermethin, methyl(E)-2-(2-
(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate a and
the Z isomer of zeta-cypermethin, methyl (Z)-2-(2-(6-(2-
cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrlate in connection
with the use of the pesticide under section 18 emergency exemptions
granted by EPA in or on the food commodities in the following table.
The tolerances expire and will be revoked by EPA on the date specified
in the table.
------------------------------------------------------------------------
Expiration/
Commodity Parts per million revocation date
------------------------------------------------------------------------
Flax, meal........................ 0.2 6/30/2005
Flax, seed........................ 0.2 6/30/2005
Mustard, seed..................... 1.0 6/30/2005
------------------------------------------------------------------------
* * * * *
[FR Doc. 02-22606 Filed 8-30-02; 2:45 pm]
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