[Federal Register Volume 67, Number 15 (Wednesday, January 23, 2002)]
[Rules and Regulations]
[Pages 3113-3118]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1618]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301209; FRL-6818-7]
RIN 2070-AB78


Mepiquat; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
mepiquat (N,N-dimethylpiperidinium) in or on cottonseed at 2.0 parts 
per million (ppm); cotton, gin byproducts at 6.0 ppm; and meat 
byproducts of cattle, goat, hog, horse and sheep at 0.1 ppm. BASF 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act, as amended by the Food Quality Protection Act of 
1996.

DATES: This regulation is effective January 23, 2002. Objections and 
requests for hearings, identified by docket control number OPP-301209, 
must be received by EPA on or before March 25, 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 VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301209 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Dennis McNeilly, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 308-6742; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be 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

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``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.h 
tml, 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 control number OPP-301209. 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

    In the Federal Register of November 15, 2001 (66 FR 57446) (FRL-
6809-6), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of a pesticide petition (PP) for tolerance by 
BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-
3528. This notice included a summary of the petition prepared by BASF 
Corporation, the registrant. There were no comments received in 
response to the notice of filing.
    The petition requested that 40 CFR 180.384 be amended by 
establishing a tolerance for residues of the plant growth regulator 
mepiquat, N,N-dimethylpiperidinium chloride and N,N-
dimethylpiperidinium pentaborate, in or on cottonseed at 2.0 ppm; 
cotton, gin byproducts at 6.0 ppm; and meat byproducts of cattle, goat, 
hog, horse, and sheep at 0.1 ppm.
    The Agency is making the following minor changes to the tolerance 
action proposed in the petition:
    1. The title for the tolerance (Sec. 180.384) will be revised to 
mepiquat (N,N-dimethylpiperidinium) to reflect the fact that the 
tolerance covers both the ``chloride salt'' (mepiquat chloride) and 
``pentaborate salt'' (mepiquat pentaborate) forms of mepiquat.
    2. Paragraph (a) is divided into two paragraphs with paragraph 
(a)(1) reflecting the ``generic '' tolerance for residues of either the 
``chloride salt,'' or ``pentaborate salt,'' or both (e.g., cotton); 
while paragraph (a)(2) reflects those tolerances established only for 
the ``chloride salt '' form of mepiquat, i.e., mepiquat chloride. It is 
possible that in the future the Agency may propose combining these two 
paragraphs; however, mepiquat pentaborate is currently only proposed 
for registration on cotton. The only new commodity in this document for 
both mepiquat chloride and mepiquat pentaborate is cotton gin 
byproducts. The Mepiquat Chloride RED (March 1997) required residue 
data for this commodity, it has now been reviewed and the Agency has 
determined that a separate tolerance is required for this commodity. 
This resulted because of a revision to the Pesticide Assessment 
Guideline (Subdivision O, Residue Chemistry, 9/95) which recognized 
cotton gin byproducts as a raw agricultural commodity of cotton.
    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....''
    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).

III. Aggregate Risk Assessment and Determination of Safety

    A human health risk assessment was previously conducted for 
mepiquat chloride foliar use on cotton and was published in the 
Mepiquat Chloride RED, March 1997. In fact, tolerances have been 
established for mepiquat chloride in/on cottonseed at 2.0 ppm and 
animal commodities at 0.1 ppm. In addition, the Agency recently 
published a risk assessment (65 FR 1790, January 12, 2000) (FRL-6485-4) 
for mepiquat chloride use on grapes and raisins which included the 
previously registered use on cotton. The January 12, 2000, risk 
assessment reflects the most current risk assessment available for 
mepiquat and will be referred to throughout this document. A revised 
risk and exposure analysis for use of mepiquat pentaborate, a 
``pentaborate salt'' of mepiquat being registered for foliar use on 
cotton, was not conducted because exposure to mepiquat chloride from 
use on cotton was evaluated in the Agency's January 12, 2000, risk 
assessment. The registrant was required to submit a complete battery of 
acute toxicity studies, product chemistry data and a dissociation study 
to verify that mepiquat pentaborate application would be 
toxicologically equivalent to mepiquat chloride application and that 
the impurities would remain essentially equivalent or improved (more 
protective of human/ecological health) over current mepiquat chloride 
products. The company maintains, and the Agency has verified that both 
compounds, the ``chloride salt'' version mepiquat chloride and the 
``pentaborate salt'' version mepiquat pentaborate, disassociate in 
water in the same manner and result in the same exposure, both 
qualitatively and quantitatively. Use rates and other label 
restrictions, related to food residue levels and tolerance issues, will 
be the same as for current mepiquat chloride products. Review of the 
product chemistry data confirmed that no new toxicologically 
significant impurities would be involved. 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 and to make a determination on aggregate 
exposure, consistent with section 408(b)(2), for a tolerance for 
residues of mepiquat on cottonseed at 2.0 ppm; cotton, gin byproducts 
at 6.0 ppm; and meat

[[Page 3115]]

byproducts of cattle, goat, hog, horse, and sheep at 0.1 ppm. EPA's 
assessment of exposures and risks associated with establishing the 
tolerance follows.

A. Toxicological Profile

    The Agency has determined that mepiquat pentaborate and mepiquat 
chloride are not significantly different as to impurities and/or 
toxicologically significant moieties. The registrant has submitted a 
battery of acute toxicity studies for mepiquat pentaborate which 
demonstrate that the acute toxicity is not significantly different from 
that of mepiquat chloride. The registrant has also submitted a 
dissociation study that demonstrates that mepiquat pentaborate 
dissociates in water in an identical physical manner to mepiquat 
chloride. It is the Agency's general policy that toxicology data for 
one ``salt'' support other mineral salts and that no additional 
toxicological data would be required for those entities. Mepiquat 
chloride is already registered for use on cotton and tolerances are 
established in 40 CFR 180.384 for residues of mepiquat chloride in/on 
cottonseed. In addition, tolerances for mepiquat chloride already exist 
for the fat, meat, and meat byproducts of cattle, goats, hogs, horses, 
and sheep (each at 0.1 ppm). The acute toxicity data for technical 
grade mepiquat pentaborate indicate toxicity category III for acute 
oral toxicity, acute dermal, acute inhalation, and primary eye 
irritation. The primary dermal irritation for mepiquat pentaborate is 
category IV, and mepiquat pentaborate is not a skin sensitizer.

B. Toxicological Endpoints

    The Agency has determined that mepiquat pentaborate and mepiquat 
chloride are not significantly different as to impurities and/or 
toxicological significant moieties. Therefore, the toxicological 
endpoints published for mepiquat chloride on January 12, 2000 (65 FR 
1790), pertain to this revision to 40 CFR 180.384. This revision to 40 
CFR 180.384 simply adds tolerances for the pentaborate ``salt'' of 
mepiquat to the existing tolerances for the chloride ``salt'' version 
of mepiquat.
    The Acute Population Adjusted Dose (aPAD) is 0.6 milligrams/
kilograms/day (mg/kg/day) based on a 1-year dog feeding study with a 
90-day dog feeding study supporting the 1-year dog study. The no 
observed adverse effect level (NOAEL) was 58.4 mg/kg/day with an 
Uncertainty Factor of 100 and the FQPA safety factor reduced to 1X. The 
Chronic Population Adjusted Dose (cPAD) is 0.6 mg/kg/day based on the 
1-year dog feeding study with a supporting 90-day dog feeding study. 
The NOAEL was 58.4 mg/kg/day with an Uncertainty Factor of 100 and the 
FQPA safety factor reduced to 1X. Mepiquat chloride is classified as 
``not likely'' to be a human carcinogen.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been 
established (40 CFR 180.384) for the residues of mepiquat, in or on a 
variety of raw agricultural commodities. Tolerances are established for 
cottonseed and for the fat, meat, and meat byproducts of cattle, goats, 
hogs, horses, and sheep at 0.1 ppm. A risk assessment was conducted by 
EPA and published for mepiquat chloride on January 12, 2000, that 
discusses use on cotton as well as all other registered uses of 
mepiquat chloride. Dietary exposure from the use of mepiquat 
pentaborate on cotton will be qualitatively and quantitatively the same 
as for the existing use of mepiquat chloride on cotton. The Agency has 
a disassociation study that confirms the qualitative equivalence and 
the same use rates and other restrictions will ensure equivalent 
quantitative exposure. The company expects that the pentaborate salt 
formulation of mepiquat, mepiquat pentaborate, will replace a 
significant amount of mepiquat chloride use on cotton.
    i. Acute exposure. The acute dietary food exposures (95\th\ 
percentile) occupy only 1.5% of the aPAD for the most highly exposed 
subgroup (children 1-6 years). This is based on a Tier 1 analysis, 
assuming tolerance level residues and 100% crop treated. Percent crop 
treated and/or anticipated residues were not used in the January 12, 
2000, analysis.
    ii. Chronic exposure. The chronic dietary food exposures occupy 
only 0.3% of the cPAD for the most highly exposed subgroup (children 1-
6 years). This is based on a Tier 1 analysis, assuming tolerance level 
residues and 100% crop treated. Percent crop treated and/or anticipated 
residues were or were not used in the January 12, 2000, analysis.
    iii. Cancer. Mepiquat chloride was classified as ``not a likely 
human carcinogen.'' Therefore, a cancer risk assessment was not 
conducted for this risk analysis; nor, was one conducted for the 
January 12, 2000, risk analysis that discussed the use on cotton as 
well as all other mepiquat uses.
    2. Dietary exposure from drinking water. The Agency published a 
risk assessment for mepiquat chloride on January 12, 2000, that 
discusses use on cotton as well as all other registered uses of 
mepiquat chloride. In that analysis risk estimates for exposure to 
mepiquat chloride were below the Agency's level of concern. The Agency 
has reviewed a dissociation study for mepiquat pentaborate that 
demonstrates that mepiquat pentaborate dissociates in an identical 
physical manner to mepiquat chloride in water. Therefore, the analysis 
performed for mepiquat chloride or the ``chloride salt,'' also pertains 
to this mepiquat ``pentaborate salt'' use because the use rate, maximum 
seasonal use rate and other pertinent use factors remain the same as 
for mepiquat chloride or the ``chloride salt.''
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Mepiquat chloride 
and/or mepiquat pentaborate are not registered for use on any sites 
that would result in residential exposure.
    4. Cumulative exposure to substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    EPA does not have, at this time, available data to determine 
whether mepiquat pentaborate and/or mepiquat chloride have a common 
mechanism of toxicity with other substances or how to include this 
pesticide in a cumulative risk assessment. Unlike other pesticides for 
which EPA has followed a cumulative risk approach based on a common 
mechanism of toxicity, mepiquat does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that mepiquat has a 
common mechanism of toxicity with other substances. For information 
regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 
FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children

    In general. FFDCA section 408 provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal

[[Page 3116]]

and postnatal toxicity and the completeness of the data base on 
toxicity and exposure unless EPA determines that a different margin of 
safety will be safe for infants and children. Margins of safety are 
incorporated into EPA risk assessments either directly through use of a 
margin of exposure (MOE) analysis or through using uncertainty (safety) 
factors in calculating a dose level that poses no appreciable risk to 
humans.
    The Agency has determined that the FQPA safety factor for mepiquat 
is 1X. See the Agency's risk assessment for mepiquat chloride dated 
January 12, 2000, for details. The facts are that mepiquat pentaborate 
is another ``salt'' of mepiquat and that mepiquat pentaborate 
disassociates to mepiquat and therefore the basic toxicology data base 
for mepiquat chloride pertains to mepiquat pentaborate.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. The Agency concludes that residues of mepiquat in 
food and drinking water will not exceed the Agency's level of concern 
(100% of the aPAD). For details see the Agency risk assessment 
published on January 12, 2000.
    2. Chronic risk. The Agency concludes that residues of mepiquat in 
food and drinking water will not exceed the Agency's level of concern 
(100% of the cPAD). For details see the Agency's risk assessment 
published on January 12, 2000.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Mepiquat chloride and 
mepiquat pentaborate are not registered for use on any sites that would 
result in residential exposure. Therefore, the aggregate risk is the 
sum of the risk from food and water, which do not exceed the Agency's 
level of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Mepiquat 
chloride and mepiquat pentaborate are not registered for use on any 
sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which does 
not exceed the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Mepiquat chloride is 
classified as a ``not likely'' human carcinogen and thus not expected 
to pose a cancer risk to humans.
    6. Determination of safety. 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 mepiquat residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. The method may be requested from: Calvin Furlow, 
PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 305-5229; e-mail address: 
[email protected].

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican tolerances established for 
mepiquat on cotton. Thus, there are no international harmonization 
issues for these tolerances.

C. Conditions

    The Agency is requiring as conditions for registration the 
following:
    1. Side-by-side residue field trials conducted with water as the 
diluent in all cotton growing areas of the United States (minimum of 
three).
    2. Developmental neurotoxicity study for mepiquat pentaborate.

V. Conclusion

    Therefore, the tolerance expression in 40 CFR 108.384(a)(1) is 
revised to reflect residues of mepiquat, in or on cottonseed; cotton 
gin by-products; and meat byproducts of cattle, goat, hog, horse, and 
sheep at 2.0, 6.0, and 0.1 ppm, respectively.

VI. 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-301209 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 25, 
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

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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 VI.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 docket control number OPP-301209, 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).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. 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 
petition under FFDCA section 408(d), such as the tolerance 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.

VIII. 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

[[Page 3118]]

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: January 4, 2002.
Richard P. Keigwin, Jr.,
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 180.384 is revised to read as follows:


Sec. 180.384  Mepiquat (N,N-dimethylpiperidinium); tolerances for 
residues.

    (a) General. (1) Tolerances are established for residues of the 
plant growth regulator mepiquat (N,N-dimethylpiperidinium) in or on the 
following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, mbyp                                                         0.1
Cotton, gin by-products                                              6.0
Cottonseed                                                           2.0
Goats, mbyp                                                          0.1
Hogs, mbyp                                                           0.1
Horses, mbyp                                                         0.1
Sheep, mbyp                                                          0.1
------------------------------------------------------------------------

    (2) Tolerances are established for residues of the plant growth 
regulator mepiquat chloride (N,N-dimethylpiperidinium chloride) in or 
on the following commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Cattle, fat                                                          0.1
Cattle, meat                                                         0.1
Goat, fat                                                            0.1
Goat, meat                                                           0.1
Grapes                                                               1.0
Hogs, fat                                                            0.1
Hogs, meat                                                           0.1
Horses, fat                                                          0.1
Horses, meat                                                         0.1
Raisins                                                              5.0
Sheep, fat                                                           0.1
Sheep, meat                                                          0.1
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 02-1618 Filed 1-22-02; 8:45 am]
BILLING CODE 6560-50-P