[Federal Register Volume 67, Number 15 (Wednesday, January 23, 2002)]
[Rules and Regulations]
[Pages 3113-3118]
From the Federal Register Online via the Government Printing 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:
mcneilly.dennis@epa.gov.
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
[[Page 3114]]
``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:
furlow.calvin@epa.gov.
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
[[Page 3117]]
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 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: 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).
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