[Federal Register: December 10, 2008 (Volume 73, Number 238)]
[Rules and Regulations]
[Page 74972-74977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de08-10]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0672; FRL-8390-8]
Mefenpyr-diethyl and Metabolites; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of the
herbicide safener, mefenpyr-diethyl (CAS Reg. No. 135590-91-9), also
known as 1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-1H-pyrazole-3,5-
dicarboxylic acid, diethyl ester and its 2,4-dichlorophenyl-pyrazoline
metabolites, applied at a rate no greater than 0.053 pounds safener per
acre per growing season, in or on the rotational crop commodities
soybean seed, soybean hay, soybean forage and canola seed. Bayer
CropScience requested these tolerances under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective December 10, 2008. Objections and
requests for hearings must be received on or before February 9, 2009,
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- 0672. All documents in the
docket are listed in the docket index available at http://
www.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: Karen Samek, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 347-8825; e-mail address: samek.karen@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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
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 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 electronically available documents 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 40 CFR part 180 through the
Government Printing Office's e-CFR site at http://www.gpoaccess.gov/
ecfr. To access the OPPTS Harmonized Guidelines referenced in this
document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/
home/guidelin.htm.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of FFDCA, 21 U.S.C. 346a, 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. 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-2007-0672 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 February 9, 2009.
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 your copies, identified by docket ID
number EPA-HQ-OPP-2007-0672, 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 Facility'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 August 22, 2007 (72 FR 47008) (FRL-8145-
1), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), announcing the filing of
a pesticide petition (PP 7E7224) by Bayer CropScience, 2 T.W.,
Alexander Drive, P.O. Box 12014, Research Triangle Park, NC 27709. The
petition requested that 40 CFR 180.509 be amended for the herbicide
safener, mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-
1H-pyrazole-3,5-dicarboxylic acid, diethyl ester and its 2,4-
dichlorophenyl-pyrazoline metabolites by increasing the maximum
allowable seasonal use rate to 0.053 lb safener/acre(A), as well as,
establishing rotation crop tolerances on soybean seed at 0.02 parts per
million (ppm); soybean forage at 0.1ppm; soybean hay at 0.1 ppm; and
canola seed at 0.02 ppm. That notice referenced a summary of the
petition prepared by Bayer CropScience, 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.
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
[[Page 74974]]
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....''
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
tolerances for residues of the herbicide safener, mefenpyr-diethyl, in
or on soybean seed at 0.02 ppm, soybean forage at 0.1 ppm, soybean hay
at 0.1 ppm, and canola seed at 0.02 ppm; as well as the petitioned-for
request to increase the maxium allowable seasonal use rate from 0.026
lb safener/A to 0.053 lb safener/A. EPA's assessment of exposures and
risks associated with establishing tolerances 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.
Mefenpyr-diethyl has low acute toxicity by the oral, dermal, and
inhalation routes of exposure. It is not a dermal irritant but is a
slight dermal sensitizer and ocular irritant. Metabolism studies
indicate that mefenpyr-diethyl is rapidly metabolized, widely
distributed, and primarily excreted via the urine. Repeat exposure via
the dermal route did not induce any treatment-related effects at dose
levels up to and including the limit dose. Repeated exposure studies
via the oral route demonstrated that the target organs are the liver
and hematopoietic system in dogs, mice, and rats. Mefenpyr-diethyl was
negative for carcinogenicity in rats and mice, and classified as ``not
likely to be carcinogenic to humans.'' Mefenpyr-diethyl did not show
any genotoxic potential. Developmental toxicity was not observed in the
rat at the limit dose (1,000 milligrams/kilogram/day (mg/kg/day)) but
was observed in the rabbit (abortions) at the same dose level producing
maternal toxicity. Mefenpyr-diethyl did not induce any signs of
reproductive toxicity or neurotoxic potential. The developmental
toxicity studies in rats and rabbits, as well as the reproductive
toxicity study in rats, did not demonstrate any prenatal or postnatal
sensitivity. There is a lack of evidence of neurotoxicity in any study
on mefenpyr-diethyl and therefore there is no concern for neurotoxicity
resulting from exposure to mefenpyr-diethyl.
B. Toxicological Endpoints
For hazards that have a threshold below which there is no
appreciable risk, a toxicological point of departure (POD) is
identified as the basis for derivation of reference values for risk
assessment. The POD may be defined as 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) or a Benchmark Dose (BMD) approach
is sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the POD 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
dietary risks by comparing aggregate food and water 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 POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and
residential exposure to the POD to ensure that the margin of exposure
(MOE) called for by the product of all applicable UFs is not exceeded.
This latter value is referred to as the Level of Concern (LOC).
For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk. Thus, the Agency estimates
risk in terms of the probability of an occurrence of the adverse effect
greater than that expected in a lifetime. 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/
pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for mefenpyr-diethyl for
human risk assessment is shown in Table 1 of this unit.
Table 1.--Summary of Toxicological Doses and Endpoints for Mefenpyr-diethyl for Use in Dietary and Non-
Occupational Human Health risk Assessments
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RfD, PAD, Level of
Exposure/Scenario Point of Departure and Concern for Risk Study and Toxicological
Uncertainty Factors Assessment Effects
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Acute Dietary (General population, No hazard was identified in any toxicity study for this duration of
including infants and children) exposure.
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Acute Dietary (Females 13-49 years of No hazard was identified in any toxicity study for this duration of
age) exposure.
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Chronic Dietary (All populations) NOAEL = 51 mg/kg/day Chronic RfD = 0.51 mg/ Chronic oral toxicity
UFA = 10x.............. kg/day study (dog).
UFH = 10x.............. cPAD = 0.51 mg/kg/day.. LOAEL = 260 mg/kg/day,
FQPA SF = 1x........... based on increased
liver weight in both
sexes, cholestasis,
and increased alkaline
phosphates.
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[[Page 74975]]
Cancer Classification: Not likely to be carcinogenic to humans.
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Point of Departure = A data point or an estimated point that is derived from observed dose-response data and
used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant
human exposures. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect level.
UF=uncertainty factor. UFA = extrapolated from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies). PAD = population adjusted dose (a = acute, c
= chronic). RfD = reference dose.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mefenpyr-diethyl, EPA considered exposure under the
petitioned-for tolerances, as well as all existing mefenpyr-diethyl
tolerances in 40 CFR 180.509. The residue of concern for both risk
assessment and tolerance setting purposes in plants and animals is the
parent compound, mefenpyr-diethyl, and its 2,4-dichlorophenyl-
pyrazoline metabolites. EPA assessed dietary exposures from mefenpyr-
diethyl 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 mefenpyr-diethyl;
therefore, a quantitative acute dietary exposure assessment is
unnecessary.
ii. Chronic exposure. A highly conservative chronic dietary risk
assessment was conducted for food and drinking water for mefenpyr-
diethyl. In conducting the chronic dietary exposure assessment EPA used
the food consumption data from the USDA 1994-1996 and 1998 Continuing
Survey of Food Intake by Individuals. As to residue levels in food, EPA
assumed that 100% of crops with requested uses of mefenpyr-diethyl are
treated and that all treated crops contain residues at the tolerance
level.
No new magnitude of the residue data, reflecting the new proposed
seasonal rate of 0.053 lb safener/A, were submitted for the primary
crop commodities. It is, however, noted that the field trial data that
were previously submitted in support of the petition to establish
tolerances for primary crops were conducted at an exaggerated rate of
0.089 lb/safener/A. Therefore, the Agency has determine that the
established tolerances for primary crop commodities remain adequate to
support the proposed higher application rate.
iii. Cancer. Based on the results of carcinogenicity studies in
rats and mice, EPA classified mefenpyr-diethyl as a ``Not likely to be
carcinogenic to humans;'' therefore, an exposure assessment for
assessing cancer risk is unnecessary for this chemical.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue or PCT information in the dietary
assessment for mefenpyr-diethyl. Tolerance level residues and 100 PCT
were assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for mefenpyr-diethyl in drinking water. These simulation
models take into account data on the physical, chemical, and fate/
transport characteristics of mefenpyr-diethyl. 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 First Index Reservoir Screening Tool (FIRST) and
Screening Concentration in Ground Water (SCI-GROW) models, the
estimated drinking water concentrations (EDWCs) of mefenpyr-diethyl and
its transformation products for chronic exposures for non-cancer
assessments are estimated to be 3 parts per billion (ppb) for surface
water and 4 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 4 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). No products
containing mefenpyr-diethyl are available for sale in the residential
market because of the crops specified on the applicable labels. As
such, a residential risk assessment was not conducted.
4. Cumulative effects. 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
mefenpyr-diethyl and any other substances and mefenpyr-diethyl 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 mefenpyr-diethyl 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 policy statements
released by EPA's Office of Pesticide Programs concerning common
mechanism determinations and procedures for cumulating effects from
substances found to have a common mechanism on EPA's website at http://
www.epa.gov/pesticides/cumulative/.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) 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 (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for mefenpyr-diethyl includes rat and rabbit
developmental toxicity studies and a two-generation reproduction
toxicity study in rats. There was no evidence of increased
[[Page 74976]]
susceptibility of in utero rats or rabbits in the prenatal
developmental studies or of young rats in the two-generation
reproduction study.
Developmental toxicity was not observed in the rat at the limit
dose (1,000 mg/kg/day). The only effects observed in the rat
developmental toxicity study were decreased body-weight gain and food
efficiency during the first week of dosing and increased spleen weights
in the maternal animal and a marginal decrease in fetal body weight/
body-weight gain during lactation (postnatal study). In the rabbit
developmental toxicity study, developmental toxicity (abortion) was
observed at the same dose level producing maternal toxicity (250 mg/kg/
day).
In the reproduction study, parental toxicity consisted of decreased
body weight and body-weight gain, and an increase in spleen weight and
in the severity (not incidence) of splenic extramedullary hematopoiesis
in females. In the pups, decreased body weight and body-weight gains
were observed at the same dose levels as the parental animals. The
NOAEL is 82 mg/kg/day (1,000 ppm) for both the parental animal and
offspring.
3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
i. The toxicity database for mefenpyr-diethyl is complete, with the
exception of immunotoxicity studies which are new data requirements
under the revised Part 158 Toxicology Data Requirements (40 CFR part
158). In the absence of these studies, EPA has evaluated the available
toxicity data for mefenpyr-diethyl and determined that an additional
database uncertainty factor is not needed, based on the following
conclusions:
No acute and subchronic Neurotoxcity studies are available, however
there is no evidence of neurotoxicity in the toxicology database on
mefenpyr-diethyl, which includes subchronic, chronic, developmental
toxicity, and reproduction studies performed at dose of 250 mg/kg/day
and above. Therefore, based on the above considerations, the Agency
does not believe that conducting acute and subchronic neurotoxicity
studies will result in a NOAEL less than the NOAEL of 51 mg/kg/day
already set for mefenpyr-diethyl; therefore additional neurotoxicity
studies are not necessary and the 10x safety factor can be reduced to
1x.
Considering that the application of mefenpyr-diethyl will be by
either aerial application or spray boom equipment, the 28-day
inhalation study is required as confirmatory data. However, the
additional uncertainty factor for database uncertainties does not need
to be applied since the MOE is >1,000 and significant inhalation
exposures of concern are not anticipated.
EPA considered the entire toxicity database for mefenpyr-diethyl
for potential adverse effects on the thymus and spleen as indications
of potential immunotoxicity and noted enlarged spleens; more severe
hematopoiesis and hemosiderin deposits and increased spleen weights
were observed in mice at doses greater than the limit dose. However,
these were determined to be non-specific changes not indicative of
immunotoxicity. Therefore, based on the above considerations, EPA does
not believe that conducting a special series (Harmonized Guideline
870.7800), immunotoxicity study will result in a NOAEL less than the
NOAEL of 51 mg/kg/day already set for mefenpyr-diethyl and an
additional uncertainty factor for database uncertainties does not need
to be applied.
ii. There is no indication that mefenpyr-diethyl 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 mefenpyr-diethyl results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the two-generation
reproduction study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed
assuming 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to mefenpyr-diethyl in drinking water. These
assessments will not underestimate the exposure and risks posed by
mefenpyr-diethyl.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic pesticide exposures are
safe by comparing aggregate exposure estimates to the aPAD and cPAD.
The aPAD and cPAD represent the highest safe exposures, taking into
account all appropriate SFs. EPA calculates the aPAD and cPAD by
dividing the POD by all applicable UFs. For linear cancer risks, EPA
calculates the probability of additional cancer cases given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the POD to ensure that the MOE called for
by the product of all applicable UFs is not exceeded.
1. Acute risk. An acute aggregate risk assessment takes into
account exposure estimates from acute dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified in the toxicology studies for mefenpyr-diethyl and no
acute dietary endpoint was selected. Therefore, mefenpyr-diethyl is not
expected to pose an acute risk.
2. Chronic risk. Exposure to mefenpyr-diethyl food and drinking
water results in an estimated risk equivalent to <1% of the cPAD for
the general population and all regulated subpopulations, including
infants and children as well.
There are no residential uses for mefenpyr-diethyl, therefore the
aggregate risk assessments include the contribution of risk from
dietary (food and water) sources only.
3. Aggregate cancer risk for U.S. population. Mefenpyr-diethyl was
negative for carcinogenicity in rats and mice and thus is not expected
to pose a cancer risk to humans.
4. 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 mefenpyr-diethyl residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
An enforcement method for plants entitled ``An Analytical Method
for Determination of Residues of AE F107892 (mefenpyr-diethyl) and its
Metabolites in Wheat and Barley by Gas Chromatography using Mass
Selective Detection (Report Supplement to EPA MRID 45457401)'' is
available. Radiovalidation and independent laboratory validation (ILV)
data have been submitted for the plant method. The Agency analytical
lab has concluded that this method is suitable for food tolerance
enforcement of mefenpyr-diethyl and its 2,4-dichlorophenyl-pyrazoline
metabolites. 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.
[[Page 74977]]
B. International Tolerances
No Codex, Canadian, or Mexican maximum residue limits are
established for residues of mefenpyr-diethyl and its metabolites in
crop or livestock commodities; therefore, there are no issues with
international harmonization raised by this action.
V. Conclusions
Therefore, 40 CFR 180.509 is amended for the herbicide safener,
mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-1H-
pyrazole-3,5-dicarboxylic acid, diethyl ester and its 2,4-
dichlorophenyl-pyrazoline metabolites by increasing the maximum
allowable seasonal use rate to 0.053 lb safener/A, as well as rotation
crop tolerances are established for residues of the herbicide safener,
mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-dihydro-5-methyl-1H-
pyrazole-3,5-dicarboxylic acid, diethyl ester and its 2,4-
dichlorophenyl-pyrazoline metabolites in or on soybean seed at 0.02
ppm; soybean forage at 0.1 ppm; soybean hay at 0.1 ppm; and canola seed
at 0.02 ppm.
It should be noted that no new magnitude of the residue data,
reflecting the new proposed seasonal rate of 0.053 lb safener/A, were
submitted for the primary crop commodities. However, field trail data
that were previously submitted in support of the petition to establish
tolerances for primary crops were conducted at an exaggerated rate of
0.089 lb safener/A. Therefore, the Agency determined that the
established tolerances for primary crop commodities remain adequate to
support the proposed higher application rate.
VI. Statutory and Executive Order Reviews
This final rule establishes tolerances 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 final rule has been
exempted from review under Executive Order 12866, this final 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 9, 2000) do not apply to this final rule. In addition,
this final 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 2, 2008.
Donald R. Stubbs,
Acting 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 180.509 is revised to read as follows:
Sec. 180.509 Mefenpyr-diethyl; tolerance for residues.
(a) General. Tolerances are established for residues of the
herbicide safener, mefenpyr-diethyl, 1-(2,4-dichlorophenyl)-4,5-
dihydro-5-methyl-1H-pyrazole-3,5-dicarboxylic acid, diethyl ester and
its 2,4-dichlorophenyl-pyrazoline metabolites, when applied at a rate
no greater than 0.053 pound safener per acre per growing season in or
on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Barley, grain........................................... 0.05
Barley, hay............................................. 0.2
Barley, straw........................................... 0.5
Canola, seed............................................ 0.02
Cattle, meat byproducts................................. 0.1
Goat, meat byproducts................................... 0.1
Hog, meat byproducts.................................... 0.1
Horse, meat byproducts.................................. 0.1
Sheep, meat byproducts.................................. 0.1
Wheat, forage........................................... 0.2
Wheat, grain............................................ 0.05
Wheat, hay.............................................. 0.2
Wheat, straw............................................ 0.5
Soybean forage.......................................... 0.1
Soybean, hay............................................ 0.1
Soybean, seed........................................... 0.02
------------------------------------------------------------------------
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertant residues. [Reserved]
[FR Doc. E8-29112 Filed 12-9-08; 8:45 am]
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