[Federal Register: December 28, 2007 (Volume 72, Number 248)]
[Rules and Regulations]
[Page 73631-73635]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28de07-14]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0114; FRL-8343-2]
Fluroxypyr; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of fluroxypyr and its metabolite in or on pome fruit, group 11; millet
(grain, forage, hay and proso millet straw). Interregional Research
Project Number 4 (IR-4) requested these tolerances under the Federal
Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 28, 2007. Objections and
requests for hearings must be received on or before February 26, 2008,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0114. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6463; 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 entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
Pesticide manufacturing (NAICS code 32532), e.g.,
agricultural workers; commercial applicators; farmers; greenhouse,
nursery, and floriculture workers; residential users.
This listing is not intended to be exhaustive, but rather to
provide a guide for readers regarding entities likely to be affected by
this action. Other types of entities not listed in this unit could also
be affected. The North American Industrial Classification System
(NAICS) codes have been provided to assist you and others in
determining whether this action might apply to certain entities. If you
have any questions regarding the applicability of this action to a
particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, any person may file an objection to
any aspect of this regulation and may also request a hearing on those
objections. You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in 40 CFR part
178. To ensure proper receipt by EPA, you must identify docket ID
number EPA-HQ-OPP-2007-0114 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 as required by 40 CFR part 178 on or
before February 26, 2008.
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit this copy, identified by docket ID number
EPA-HQ-OPP-2007-0114, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One
[[Page 73632]]
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA.
Deliveries are only accepted during the Docket's normal hours of
operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays). Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Petition for Tolerance
In the Federal Register of April 4, 2007 (72 FR 16352) (FRL-8119-
2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
6E7168) by Interregional Research Project Number 4 (IR-4), 500 College
Road East, Suite 201 W, Princeton, NJ 08540. The petition requested
that 40 CFR 180.535 be amended by establishing tolerances for combined
residues of the herbicide fluroxypyr, 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate]
and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetic acid], in or on pome, fruit, group 11 at 0.02
parts per million (ppm); millet, grain at 0.5 ppm; millet, forage at
12.0 ppm; millet, hay at 20.0 ppm; millet, proso, grain at 0.5 ppm;
millet, proso, straw at 12.0 ppm; millet, proso, forage at 12.0 ppm;
millet, proso, hay at 20.0 ppm; millet, pearl, grain at 0.5 ppm;
millet, pearl, forage at 12.0 ppm; and millet, pearl, hay at 20.0 ppm.
That notice referenced a summary of the petition prepared by Dow
AgroSciences, the registrant, which is available to the public in the
docket, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
determined that separate tolerances for proso and pearl millet grain,
forage, and hay are not needed since these commodities are covered by
the tolerances being established for millet grain, millet forage and
millet hay.
EPA is also deleting all the tolerances in Sec. 180.535(b) for
field and sweet corn, onion, and sorghum commodities that are no longer
needed since they have expired. The deletions under Sec. 180.535(b)
are time-limited tolerances that were established under section 18
emergency exemptions that have since expired and have been superceded
by the establishment of general tolerances for the same commodities
under Sec. 180.535(a).
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of 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) of FFDCA 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) of FFDCA 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. . .
.'' These provisions were added to FFDCA by the Food Quality Protection
Act (FQPA) of 1996.
Consistent with section 408(b)(2)(D) of FFDCA, and the factors
specified in section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for
tolerance for combined residues of fluroxypyr, 1-methylheptyl ester [1-
methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetate]
and its metabolite fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetic acid] on fruit, pome, group 11 at 0.02 ppm;
millet, grain at 0.5 ppm; millet, forage at 12.0 ppm; millet, hay at
20.0 ppm and millet, proso, straw at 12.0 ppm. EPA's assessment of
exposures and risks associated with establishing the tolerance follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by fluroxypyr as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studiescan be found at http://www.regulations.gov
in document Fluroxypyr: Human Health Risk
Assessment to Support Proposed New Uses on Pome Fruits and Millet at
Attachment 2 page 27 - 30 in docket ID number EPA-HQ-OPP-2007-
0114.
Fluroxypyr has low acute toxicity by the oral and dermal routes and
moderate acute toxicity by the inhalation route. The kidney is the
target organ for fluroxypyr following oral exposure to rats, mice, and
dogs. In the rat, increased kidney weight and death were observed in
both sexes in the 90-day feeding study, increased kidney weight and
chronic progressive glomerulonephropathy were observed in both sexes in
the chronic study. Increased kidney weight was observed in the maternal
rat in the developmental toxicity study, and kidney effects (deaths due
to renal failure; increased kidney weight, and microscopic kidney
lesions) were observed in both sexes in the 2-generation reproduction
study. Although kidney toxicity (early signs of acute tubular
nephrosis) was observed in dogs in the 28-day feeding study, no kidney
effects or other treatment related toxicity was seen in the chronic
feeding study in dogs. Increased kidney lesions (increased incidences
of renal papillary necrosis and regenerative nephrosis in females) were
observed in mice following long-term exposure. Treatment related deaths
were noted in maternal rats (600 milligrams/kilograms/day (mg/kg/day))
and rabbits (400 mg/kg/day). Endpoints for risk assessment were based
on kidney effects seen in the database. There was no evidence of
increased susceptibility (quantitative/qualitative) following in utero
exposure to the acid and the ester in rats and rabbits, or following
prenatal and/or postnatal exposure in rats. There are no neurotoxicity
concerns from the acute and subchronic neurotoxicity studies, and the
weight of the evidence indicates a lack of concern for developmental
neurotoxicity. Therefore, a developmental neurotoxicity study (DNT) is
not required. Fluroxypyr is classified as ``not likely'' as a human
carcinogen and there was no concern for its mutagenicity potential.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose
[[Page 73633]]
at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account uncertainties
inherent in the extrapolation from laboratory animal data to humans and
in the variations in sensitivity among members of the human population
as well as other unknowns. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm
.
A summary of the toxicological endpoints for fluroxypyr used for
human risk assessment can be found at http://www.regulations.gov in
document Fluroxypyr: Human Health Risk Assessment to Support Proposed
New Uses on Pome Fruits and Millet at page 11 in docket ID number EPA-
HQ-OPP-2007-0114.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fluroxypyr, EPA considered exposure from the petitioned-for
tolerances as well as all existing fluroxypyr tolerances in (40 CFR
180.535). EPA assessed dietary exposures from fluroxypyr in food as
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a single exposure.
No such effects were identified in the toxicological studies for
fluroxypyr; therefore, a quantitative acute dietary exposure assessment
is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals
(CSFII). As to residue levels in food, assumed all foods for which
there are tolerances were treated and contain tolerance-level residues.
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA has concluded that fluroxypyr is ``not likely to be
carcinogenic to humans.'' Consequently, a quantitative cancer exposure
and risk assessment is not appropriate for fluroxypyr.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for fluroxypyr in drinking water. Because
the Agency does not have comprehensive monitoring data, drinking water
concentration estimates are made by reliance on simulation or modeling
taking into account data on the environmental fate characteristics of
fluroxypyr. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm
.
Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Groundwater (SCI-
GROW) models, the estimated environmental concentrations (EECs) of
fluroxypyr for chronic exposures are estimated to be 3.28 ppb for
surface water and 0.04 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration value of 3.28 ppb was used to
assess the contribution to drinking water.
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).
Fluroxypyr is currently registered for the following residential
non-dietary sites: Application to residential turf grass and
recreational sites such as golf courses, parks, and sports fields. EPA
assessed residential exposure using the following assumptions:
Residential handlers may receive short-term dermal and inhalation
exposure to fluroxypyr when mixing, loading and applying the
formulations. However, toxicity by the dermal route of exposure is not
expected; therefore only inhalation daily doses for residential
handlers were calculated. Adults and children may be exposed to
fluroxypyr residues from dermal contact with turf during post-
application activities. Toddlers may receive short- and intermediate-
term oral exposure from incidental ingestion during post-application
activities. A dermal risk assessment for post-application exposures was
not conducted because a dermal endpoint was not selected. Therefore,
only the following post-application exposure scenarios resulting from
lawn treatment were assessed:
i. Toddlers' incidental ingestion of pesticide residues on lawns
from hand-to-mouth transfer,
ii. Object-to-mouth transfer from mouthing of pesticide-treated
turfgrass, and
iii. Incidental ingestion of soil from pesticide-treated
residential areas.
4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA 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.''
Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to fluroxypyr and any other
substances and fluroxypyr 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 fluroxypyr 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
EPA's website at http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional (``10X'') tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database on toxicity and
exposure unless EPA determines based on reliable data that a different
margin of safety will be safe for infants and children. This additional
margin of safety is commonly referred to as the
[[Page 73634]]
FQPA safety factor. In applying this provision, EPA either retains the
default value of 10X when reliable data do not support the choice of a
different factor, or, if reliable data are available, EPA uses a
different additional FQPA safety factor value based on the use of
traditional UFs and/or special FQPA safety factors, as appropriate.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased susceptibility (quantitative/qualitative) following in utero
exposure to the fluroxypyr in rats and rabbits, or following prenatal
and/or postnatal exposure in rats. There are no neurotoxicity concerns
from the acute and subchronic neurotoxicity studies, and the weight of
the evidence indicates a lack of concern for developmental
neurotoxicity.
3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
i. The toxicity database for fluroxypyr is complete.
ii. There is no indication that fluroxypyr is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity.
iii. There is no evidence that fluroxypyr results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% crop treated and tolerance-level residues. Conservative ground
and surface water modeling estimates were used. EPA used similarly
conservative assumptions to assess post-application exposure of
children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
fluroxypyr.
E. Aggregate Risks and Determination of Safety
Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
1. Acute risk. None of the toxicology studies available for
fluroxypyr indicated the possibility of an effect of concern occurring
as a result of a single exposure; therefore, fluroxypyr is not expected
to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fluroxypyr from food and water will utilize 1.4% of the cPAD for
children 1-2 years old, the subpopulation group with greatest exposure.
Based on the use patterns, chronic residential exposure to residues of
fluroxypyr is not expected.
3. Short-term risk and intermediate-term. 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).
Fluroxypyr is currently registered for uses that could result in
short-term and intermediate-term residential exposure and the Agency
has determined that it is appropriate to aggregate chronic food and
water and short-term exposures for fluroxypyr.
Using the exposure assumptions described in this unit for short-
term and intermediate-term exposures, EPA has concluded that food,
water, and residential exposures aggregated result in aggregate MOEs of
4,400 to 53,000. The MOE for the U.S. population is 8,200. The most
highly exposed subgroup was Children, 1-2 years old, with an MOE of
4,400.
4. Aggregate cancer risk for U.S. population. There was no evidence
of carcinogenicity in two carcinogenicity studies in rats and mice with
fluroxypyr. Therefore, fluroxypyr is considered ``Not likely to be
carcinogenic to humans.'' Fluroxypyr is not expected to pose a cancer
risk.
5. 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, or to infants and children from aggregate
exposure to fluroxypyr residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (gas chromatography/mass-selective
detector (GC/MSD)) is available to enforce the tolerance expression.
The method may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number: (410) 305-2905; e-mail address:
residuemethods@epa.gov.
B. International Residue Limits
There are no Codex, Canadian or Mexican MRLs for fluroxypyr for
pome fruits or millet.
V. Conclusion
Therefore, tolerances are established for combined residues of
fluroxypyr, 1-methylheptyl ester [1-methylheptyl ((4-amino-3,5-
dichloro-6-fluoro-2-pyridinyl)oxy)acetate] and its metabolite
fluroxypyr [((4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy)acetic
acid] in or on fruit, pome, group 11 at 0.02 ppm; millet, grain at 0.5
ppm; millet, forage at 12.0 ppm; millet, hay at 20.0 ppm and millet,
proso, straw at 12.0 ppm.
Time-limited tolerances were established in 40 CFR 180.535(b) for
residues of fluroxypyr on field and sweet corn, onion, and sorghum
commodities in connection with FIFRA section 18 emergency exemptions
granted by the EPA. All of these time-limited tolerances have expired
and are no longer in force. Permanent tolerances have been established
on these commodities in Sec. 180.535(a). Because expired, time-limited
tolerances for residues of fluroxypyr are without effect, this final
rule removes them from EPA's regulations. EPA finds there is good cause
to make this latter change without prior notice and comment because it
eliminates obsolete portions of the regulation. EPA concludes notice
and comment are unnecessary on such changes.
VI. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA 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, 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) or Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997). 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., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in
[[Page 73635]]
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, 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.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000) do not apply to this rule. In addition, This
rule does not 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).
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).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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 14, 2007.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
0
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.535 is amended by alphabetically adding the following
commodities to the table in paragraph (a), removing the expired time-
limited tolerances in paragraph (b), and reserving it to read as
follows:
Sec. 180.535 Fluroxypyr 1-methylheptyl ester; tolerances for
residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Fruit, pome, group 11...................................... 0.02
* * * * *
Millet, forage............................................. 12.0
Millet, grain.............................................. 0.5
Millet, hay................................................ 20.0
Millet, proso, straw....................................... 12.0
* * * * *
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-25092 Filed 12-27-07; 8:45 am]
BILLING CODE 6560-50-S