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clethodim (Select) Pesticide Tolerances for Emergency Exemptions 12/01


ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301202; FRL-6817-1]
RIN 2070-AB78

 
Clethodim; 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 clethodim and its metabolites and their 
sulphoxides and sulphones in or on tall fescue forage and tall fescue 
hay. This action is in response to EPA's granting of an emergency 
exemption under section 18 of the Federal Insecticide, Fungicide, and 
Rodenticide Act authorizing use of the pesticide on tall fescue. This 
regulation establishes a maximum permissible level for residues of 
clethodim in these food commodities. The tolerances will expire and are 
revoked on June 30, 2004.

DATES: This regulation is effective December 31, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301202, 
must be received by EPA on or before March 1, 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 control number OPP-301202 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-6463]; and e-mail address: 
Madden.Barbara@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 theFederal 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.
    2.In person. The Agency has established an official record for this 
action under docket control number OPP-301202. 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, 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 a tolerance for combined residues of the 
herbicide clethodim, [(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one]
and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, 
expressed as clethodim, in or on tall fescue forage at 10 parts per 
million (ppm) and tall fescue hay at 20 ppm. These tolerances will 
expire and are revoked on June 30, 2004. EPA will publish a document in 
the Federal Register to remove the revoked tolerance 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 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 Federal Insecticide, 
Fungicide, and Rodenticide Act (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.

III. Emergency Exemption for Clethodim on Tall Fescue and FFDCA 
Tolerances

    Missouri is the second leading State in beef cows and grass hay 
production. These cows are predominantly raised on tall fescue (Festuca 
arundinacea) forage and hay because of its adaptation to the 
environmental conditions in Missouri. Tall fescue is susceptible to an 
endopyte-fungus Acremonium coenophialum which produces peptide ergot 
alkaloids that are toxic to cattle. Over the last decade a great deal 
of information has been developed about the causal relationship of the 
fungal endophyte-fescue relationship and the true nature of the toxic 
interactions. This increased awareness was aided by the identification 
of the primary toxic compound of A. coenophialum called ergovaline 
which is found in the highest concentration in the seedhead and seed of 
tall fescue. Therefore control of these reproductive structures will 
help reduce the overall concentration of ergovaline.
    The toxic effects of ergovaline include: reproductive problems, 
summer syndrome (weight loss), staggers, reduced milk production, and 
fescue foot (poor circulation leading to loss of hind feet). The 
reproductive problems include reduction in pregnancy rates from 86 to 
91% in endophyte-free pastures down to 67 to 72% in endophyte-infected 
pastures (a 22% reduction). Decreased milk production has been 
demonstrated with beef cattle showing a 25% reduction in milk 
production and Polled Hereford cows showing a 40% reduction in milk 
production. This reduced milk production will directly reduce calf 
survival. Another related syndrome is a hyperthermia response. This is 
believed to be a peripheral vasoconstriction associated with the 
endophyte. This leads to a reduced temperature in the legs and tail, an 
increase temperature in the core body, increased respiration, open 
mouthed breathing, and reduced average daily weight gain.
    Currently, there are no pesticides registered for control of tall 
fescue seedheads in pasture or hay fields. Tests of vaccines and use of 
anthelmintics (anti-parasitoids) have provided only short-term relief 
(days) to cattle from the problem. Non-chemical control methods include 
pasture renovation and reseeding to non-endophytic fescue, rotation to 
non-fescue pastures, dilution with legumes, supplementing the feed with 
grain to reduce the amount of toxin ingested, controlled grazing (heavy 
foraging reduces seedhead formation), ammoniate hay to neutralize the 
toxic effects of ergovaline, and mechanically removing the seedheads 
with mowing. Taken singly or together these cultural methods do not 
provide an effective, economic long-term relief from the problem. 
Pasture renovation or dilution with legumes does not stop the 
reintroduction of endophyte-fescue. Rotation to non-fescue pastures is 
difficult because other pasture grasses do not grow as well therefore, 
there are very few non-fescue pastures. Supplementing grazing with 
other grains is expensive due to the cost of the grain, and the 
equipment to feed it. Controlled heavy grazing to remove seedheads is 
difficult because of the heavy flush of vegetative growth coincides 
with seedhead formation in the spring. Ammoniating hay is not effective 
in a pasture situation. Mechanical mowing to remove seedheads requires 
mowing the fields two to four times during the season and is costly in 
terms of time and money. EPA has authorized under FIFRA section 18 the 
use of clethodim on tall fescue to suppress stem and seedhead formation 
in tall fescue pasture or hay to reduce toxin producing endophyte-
fungus in Missouri. After having reviewed the submission, EPA concurs 
that emergency conditions exist for this State.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of clethodim in or on tall 
fescue forage and tall fescue hay. 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, 2004, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerance remaining in or on tall 
fescue forage and tall fescue hay 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 
this tolerance 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 clethodim 
meets EPA's registration requirements for use on tall fescue or whether 
a permanent tolerance for this use would be appropriate. Under these 
circumstances, EPA does not believe that these tolerances serve as a 
basis for registration of clethodim 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 Missouri to use this pesticide on this crop 
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 
clethodim, contact the Agency's Registration Division at the address 
provided underFOR 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 (62 FR 62961, November 26, 1997) (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 clethodim 
and to make a determination on aggregate exposure, consistent with 
section 408(b)(2), for time-limited tolerances for combined residues of 
clethodim in or on tall fescue forage at 10 ppm and tall fescue hay at 
20 ppm.
    No fescue residue data were submitted for this specific emergency 
exemption request. The proposed use rate of clethodim for tall fescue 
is approximately one-eighth of the rate registered for use on alfalfa 
and clover. Therefore, the use of alfalfa and clover was translated to 
tall fescue for this section 18 use. The established tolerances for 
meat and milk are adequate to cover this section 18 use. According to 
Table 1 of OPPTS 860.1000 and the recommended and established 
tolerances for clethodim, the maximum theoretical dietary burdens were 
determined for beef and dairy cattle. Based on previous feeding 
studies, the secondary residues in meat and milk will not exceed the 
established tolerances as a result of this section 18 use.
    Residues of clethodim in or on tall fescue are not expected to 
increase dietary exposure. Since tall fescue is not consumed by humans, 
any exposure to residues of clethodim from this emergency exeption will 
result from the consumption of meat or milk. The use of clethodim on 
tall fescue is not expected to result in exceedances of the tolerances 
that already exist for meat and milk. Therefore, establishing the tall 
fescue tolerance will not increase the most recent estimated aggregate 
risks resulting from use of clethodim, as discussed in the September 
17, 2001 Federal Register (66 FR 47971, FRL-6800-9) final rule 
establishing tolerances for combined residues of clethodim in or on 
green onion, leaf lettuce, the Brassica head and stem subgroup, flax 
seed, flax meal, mustard seed, canola seed and canola meal, because in 
that prior action, risk was estimated assuming all meat and milk 
products contained tolerance level residues. Refer to the September 17, 
2001 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.
    An endpoint for acute dietary exposure was not identified since no 
effects were observed in oral toxicity studies that could be 
attributable to a single dose. Short-term and intermediate-term 
aggregate exposure takes into account residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Clethodim is not registered for use on any sites that would 
result in residential exposure. Therefore, short-term and intermediate-
term aggregate risks were not assessed. Clethodim has been classified 
as a group E carcinogen. Therefore, clethodim is not expected to pose a 
cancer risk to humans. Therefore, the only exposure scenario the Agency 
assessed is for chronic (non-cancer) exposures to clethodim.
    Using the Dietary Exposure Evaluation Model (DEEMTM), an 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to clethodim for 
each commodity. The following assumptions were made for the chronic 
exposure assessments: The 3-day average of consumption for each sub-
population is combined with residues to determine average exposure as 
milligram/kilogram/day (mg/kg/day). The chronic analysis was performed 
using tolerance level residues for all crops and livestock commodities. 
The projected percent crop treated (PCT) data (2% for lettuce, broccoli 
and cauliflower, 15% for cabbage, 25% for onion, and 1% for brussels 
sprouts), weighted average PCT treated data for existing registrations, 
and 100% crop treated (CT) data for all other uses.
    Using the exposure assumptions described above, EPA has concluded 
that exposure to clethodim from food will utilize less than 1% of the 
chronic population adjusted dose (cPAD) for the U.S. population, less 
than 1% of the cPAD for females (13-50 years) and less than 1% of the 
cPAD for children 1-6 years old. There are no residential uses for 
clethodim that result in chronic residential exposure to clethodim. In 
addition, there is potential for chronic dietary exposure to clethodim 
in drinking water. After calculating drinking water levels of 
comparision (DWLOCs) and comparing them to the estimated environmental 
concentration (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 1:
                                   Table 1.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Clethodim
---------------------------------------------------------------------------------------------------------------------------------
                                                                Surface Water EEC   Ground Water EEC    Chronic DWLOC
  Population Subgroup         cPAD (mg/kg)      % cPAD (Food)          (ppb)              (ppb)              (ppb)
----------------------------------------------------------------------------------------------------------------------------------
U.S. population (total)          0.01             0.0030                6.1               0.08                250
----------------------------------------------------------------------------------------------------------------------------------
Children 1-6 years               0.01             0.0061                6.1               0.08                 40
---------------------------------------------------------------------------------------------------------------------------------
Females 13-50 years              0.01             0.0023                6.1               0.08                230
---------------------------------------------------------------------------------------------------------------------------------
    Based on these risk assessments, EPA concludes that there is a 
reasonable certainty that no harm will result to the general 
population, and to infants and children from aggregate exposure to 
clethodim residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    As discuseed in the September 17, 2001 Federal Register document 
(66 FR 47971), an adequate enforcement methodology is available to 
enforce the tolerance expression. The methods may be requested from: 
Francis Griffith, Analytical Chemistry Branch, Environmental Science 
Center, 701 Mapes Road, Fort George G. Mead, Maryland, 20755-5350; 
telephone
number: (410) 305-2905; e-mail address: griffith.francis@epa.gov.

B. International Residue Limits

    There are no established Codex maximum residue limits for residues 
of clethodim in or on tall fescue forage or hay. Therefore, there are 
no questions with respect to Codex/U.S. tolerance compatibility.

C. Conditions

    One application may be made. A maximum of 0.031 pound active 
ingredient may be applied per acre. Clethodim is not to be applied 
within 15 days of grazing, feeding, or harvesting (cutting) forage or 
hay.

VI. Conclusion

    Therefore, the tolerance is established for combined residues of 
clethodim, [(E)-()-2-[1-[[(3-chloro-2-
propenyl)oxy]imino]propyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-
cyclohexen-1-one]
and its metabolites containing the 5-(2-
ethylthiopropyl)cyclohexene-3-one and 5-(2-ethylthiopropyl)-5-
hydroxycyclohexene-3-one moieties and their sulphoxides and sulphones, 
expressed as clethodim, in or on tall fescue forage at 10 ppm and tall 
fescue hay at 20 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. The 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 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 control number OPP-301202 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 March 1, 
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 (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. 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 (202) 260-4865.
    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 control number OPP-301202, 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 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: December 19, 2001.
Peter Caulkins,
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 371.

    2. Section 180.458 is amended by adding paragraph (b) to read as 
follows:


Sec. 180.458  Clethodim; tolerances for residues.

* * * * *
    (b)Section 18 emergency exemptions. Time-limited tolerances are 
established for the combined residues of clethodim, [(E)-
()-2-[1-[[(3-chloro-2-propenyl)oxy]imino]propyl]-5-[2-
(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one]
and its metabolites 
containing the 5-(2-ethylthiopropyl)cyclohexene-3-one and 5-(2-
ethylthiopropyl)-5-hydroxycyclohexene-3-one moieties and their 
sulphoxides and sulphones, expressed as clethodim in connection with 
use of the pesticide under section 18 emergency exemptions granted by 
EPA. These tolerances will expire and are revoked on the date specified 
in the following table:


------------------------------------------------------------------------
                                                  Expiration/revocation
          Commodity           Parts per million            date
------------------------------------------------------------------------
Fescue, tall, forage........                 10                  6/30/04
Fescue, tall, hay...........                 20                  6/30/04
------------------------------------------------------------------------
* * * * *

[FR Doc. 01-32105 Filed 12-28-01; 8:45 am]