[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]
[Page 13136-13141]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12mr08-32]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0331; FRL-8351-7]
Spiromesifen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for combined residues
of spiromesifen and its enol metabolite in or on bean, dry; bean,
succulent; bean, edible podded; and cowpea, forage. Interregional
Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective March 12, 2008. Objections and
requests for hearings must be received on or before May 12, 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-2007-0331. 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: Shaja R. Brothers, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 308-3194; e-mail address:
brothers.shaja@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
[[Page 13137]]
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-2007-0331 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 May 12, 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-2007-0331 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 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 May 9, 2007 (72 FR 26375) (FRL-8128-1),
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 7E7195)
by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.607 be amended by establishing
tolerances for combined residues of the insecticide spiromesifen, (2-
oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on bean, edible,
podded at 1.4 ppm; bean, succulent at 0.10 ppm; bean, dry at 0.02 ppm;
cowpea, forage at 35 ppm; cattle, fat at 0.20 ppm; cattle, meat at 0.01
ppm; cattle, meat byproducts at 0.30 ppm; goat, fat at 0.20 ppm; goat,
meat at 0.01 ppm; goat, meat byproducts at 0.30 ppm; hog, fat at 0.20
ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.30 ppm; horse,
fat at 0.20 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at0.30
ppm; sheep, fat at 0.20 ppm; sheep, meat at 0.01 ppm; sheep, meat
byproducts at 0.30 ppm; and milk at 0.01 ppm. This notice referenced a
summary of the petition prepared by Bayer Crop Science, 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
revised tolerance expressions for bean, edible, podded; cowpea, forage;
milk, whole; milk, fat; in meat of cattle, goats, horses, and sheep; in
meat, byproducts, of cattle, goats, horses, and sheep; and in fat of
cattle, goats, horses, and sheep. A tolerance for cowpea, hay was also
included. The reason for these changes is explained in Unit IV.C.
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 FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA 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 for the petitioned-for tolerances
for combined residues of spiromesifen on bean, dry at 0.02 ppm; bean,
succulent at 0.10 ppm; bean, edible podded at 0.80 ppm; cowpea, forage
at 30 ppm; cowpea, hay at 86 ppm; cattle, fat at 0.10 ppm; cattle, meat
at 0.02 ppm; cattle, meat byproducts at 0.15 ppm; goat, fat at 0.10
ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.15 ppm; horse,
fat at 0.10 ppm; horse, meat at 0.02 ppm; horse, meat
[[Page 13138]]
byproducts at 0.15 ppm; sheep, fat at 0.10 ppm; sheep, meat at 0.02
ppm; sheep, meat byproducts at 0.15 ppm; milk at 0.01 ppm; and milk,
fat at 0.20 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerances follow.
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.
Spiromesifen shows low acute toxicity via the oral, dermal and
inhalation routes of exposure. It was neither an eye nor dermal
irritant, but showed moderate potential as a contact sensitizer in a
Magnusson and Kligman maximization assay. Acute dietary-exposure limits
for all populations, including infants and children, were not necessary
because an endpoint of concern attributable to a single exposure (dose)
was not identified from the oral toxicity studies. In addition, there
are no developmental concerns based on rat and/or rabbit developmental
toxicity studies. The rat two-generation reproduction study was
selected for chronic dietary, as well as long-term dermal- and
inhalation-exposure risk assessments.
In the 2-generation reproduction study in rat the following effects
were noted at the lowest observed adverse effect level (LOAEL):
Significantly decreased spleen weight (absolute and relative in
parental females and F1 males) and significantly decreased growing
ovarian follicles in females. Spiromesifen shows no significant
developmental or reproductive effects, is not likely to be carcinogenic
based on bioassays in rat and mouse, and lacks in vivo and in vitro
mutagenic effects. Spiromesifen is not a neurotoxic chemical based on
results of acute and subchronic neurotoxicity studies.
Specific information on the studies received and the nature of the
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document
entitled ``Spiromesifen: Human Health Risk Assessment for a Section 3
Registration on Beans;'' pages 44-52 at www.regulations.gov. The
referenced document is available in docket EPA-HQ-OPP-2007-0331.
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 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 spiromesifen used for
human risk assessment can be found at http://www.regulations.gov in the
document entitled ``Spiromesifen: Human Health Risk Assessment for a
Section 3 Registration on Beans;'' pages 18-19; docket ID number EPA-
HQ-OPP-2007-0331.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in (40
CFR 180.607). EPA assessed dietary exposures from spiromesifen 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 1-day or single exposure.
No such effects were identified in the toxicological studies for
spiromesifen; 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 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for all commodities with existing and proposed
tolerances except for the leafy-green and leafy-Brassica vegetable
subgroups (4A and 5B). An additional metabolite, BSN 2060-4-
hydroxymethyl, was observed in the metabolism studies of lettuce only.
Since this metabolite's toxicity is expected to be comparable to the
parent compound, it was included in the risk assessment for leafy crops
(subgroups 4A and 5B), but not in the tolerance expression. To account
for this additional toxicity exposure, the recommended tolerance level
was multiplied by a correction factor of 1.3x. For all commodities,
100%CT as well as DEEM\TM\ Version 7.81 default processing factors were
used.
iii. Cancer. Spiromesifen has been classified as ``not likely to be
carcinogenic to humans.'' Therefore, a cancer dietary risk assessment
was not performed.
2. Dietary exposure from drinking water.The Agency lacks sufficient
monitoring data to complete a comprehensive dietary exposure analysis
and risk assessment for spiromesifen 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
spiromesifen. 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.
Parent spiromesifen is not likely to persist in the environment as
it readily undergoes both biotic and abiotic degradation; however, its
primary degradate BSN2060 is expected to persist. While parent
spiromensifen strongly sorbs to sediment and is not likely to be
mobile, its enol degradate does not sorb to sediment and is expected to
leach into groundwater. Spiromesifen has limited solubility in water
and is some cases has been
[[Page 13139]]
reported to have a practical solubility limit of 40 to 50 [mu]g/L. The
pesticide degrades primarily through aerobic soil metabolism and
hydrolysis; however, in clear shallow water it will readily undergo
photolysis. Field studies indicate that spiromesifen readily dissipates
with dissipation half lives ranging from 2 to 10 days. The compound is
not likely to bioconcentrate appreciably given its relatively rapid
degradation and depuration.
Spiromesifen and BSN 2060-enol are the predominant residues in
drinking water. BSN 2060-enol may account for 75% of the total acute
exposure and for over 90% for chronic exposure. Estimated drinking
water concentrations (EDWCs) were generated for the total toxic residue
which includes spiromesifen, the -enol and -carboxy metabolites, and
unextracted material. The highest estimated surface water
concentrations occurred with the NC sweet potato scenario.
Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentration (EEC) of
spiromesifen for chronic exposure is estimated to be 11 parts per
billion (ppb) for surface water. The EEC for chronic exposure is
estimated to be 28 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 of value 28 ppb was used to access
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).
Spiromesifen is not registered for use on any sites that would
result in residential exposure.
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 spiromesifen and any other
substances and spiromesifen 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 spiromesifen 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 Web site 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 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 is no evidence of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to spiromesifen. In the prenatal developmental
toxicity studies in rats and rabbits and in the two-generation
reproduction study in rats, developmental toxicity to the offspring
occurred at equivalent or higher doses than parental toxicity.
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 spiromesifen is complete.
ii. There is no indication that spiromesifen 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 spiromesifen 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%CT and tolerance-level residues or higher. Conservative ground
and surface water modeling estimates were used. Residential exposure is
not expected as spiromesifen will be registered for agricultural and
greenhouse/ornamental uses only. These assessments will not
underestimate the exposure and risks posed by spiromesifen.
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. No such effects were identified in the toxicological
studies for spiromesifen; therefore, acute exposure is not expected.
2. Chronic risk.Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
spiromesifen from food and water will utilize 42% of the cPAD for the
population group children 3-5 years old (the greatest exposure). There
are no residential uses for spiromesifen that result in chronic
residential exposure to spiromesifen.
3. Short and intermediate-term risk. Short and Intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
Spiromesifen is 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.
4. Aggregate cancer risk for U.S. population. Spiromesifen has been
classified as ``not likely to be carcinogenic to humans.'' Spiromesifen
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 spiromesifen residues.
[[Page 13140]]
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology, high performance liquid
chromatography/mass spectroscopy (HPLC/MS/MS)/ Method 00631/M001, 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
No Codex, Canadian, or Mexican MRLs have been established for
residues of spiromesifen and its metabolites.
C. Explanation of Tolerance Revisions
1. Bean, edible podded and cowpea, forage. The tolerances were
revised based on analysis with the Agency's tolerance spreadsheet in
accordance with the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP.
2. Cowpea, hay. After reviewing the cowpea residue data, EPA
determined an additional cowpea tolerance was necessary on cowpea hay.
3. Livestock feed and milk. Based on the dietary exposure levels
and the residue data from an available ruminant feeding study, data
indicate that a tolerance of 0.01 ppm is needed in milk, whole, 0.20
ppm in milk, fat, 0.02 ppm is needed for residues of spiromesifen in
the meat of cattle, goats, horses, and sheep, 0.15 ppm in meat,
byproducts, of cattle, goats, horses, and sheep, and 0.10 in the fat of
cattle, goats, horses, and sheep. Based on the transfer coefficients
for livestock tissues and the relatively low dietary burden for swine
of 0.04 ppm for spiromesifen, tolerances in hogs are not needed.
V. Conclusion
Therefore, the tolerances are established for combined residues of
spiromesifen, (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on bean,
dry at 0.02 ppm; bean, succulent at 0.10 ppm; bean, edible podded at
0.80 ppm; cowpea, forage at 30 ppm; cowpea, hay at 86 ppm; cattle, fat
at 0.10 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts at 0.15
ppm; goat, fat at 0.10 ppm; goat, meat at 0.02 ppm; goat, meat
byproducts at 0.15 ppm; horse, fat at 0.10 ppm; horse, meat at 0.02
ppm; horse, meat byproducts at 0.15 ppm; milk at 0.01 ppm; milk, fat at
0.20 ppm; sheep, fat at 0.10 ppm; sheep, meat at 0.02 ppm; and sheep,
meat byproducts at 0.15 ppm.
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 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: March 4, 2008.
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 180.607 is amended by alphabetically adding commodities to
the table in paragraph (a)(1), and by revising the table in paragraph
(a)(2) to read as follows:
Sec. 180.607 Spiromesifen; tolerances for residues.
(a) General. (1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Bean, dry.................................................. 0.02
Bean, edible podded........................................ 0.80
Bean, succulent............................................ 0.10
* * * * *
Cowpea, forage............................................. 30
[[Page 13141]]
Cowpea, hay................................................ 86
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Cattle, fat................................................ 0.10
Cattle, meat............................................... 0.02
Cattle, meat byproducts.................................... 0.15
Goat, fat.................................................. 0.10
Goat, meat................................................. 0.02
Goat, meat byproducts...................................... 0.15
Horse, fat................................................. 0.10
Horse, meat................................................ 0.02
Horse, meat byproducts..................................... 0.15
Milk....................................................... 0.01
Milk, fat.................................................. 0.20
Sheep, fat................................................. 0.10
Sheep, meat................................................ 0.02
Sheep, meat byproducts..................................... 0.15
------------------------------------------------------------------------
[FR Doc. E8-4920 Filed 3-11-08; 8:45 am]
BILLING CODE 6560-50-S