[Federal Register Volume 67, Number 171 (Wednesday, September 4, 2002)]
[Rules and Regulations]
[Pages 56490-56495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22606]


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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: [email protected].

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
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                                                                             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 [email protected], 
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: [email protected]. 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]
BILLING CODE 6560-50-S