Fenhexamid; Pesticide Tolerance, 19150-19154 [E8-7038]
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Federal Register / Vol. 73, No. 69 / Wednesday, April 9, 2008 / Rules and Regulations
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).
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X. 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).
SUMMARY: This regulation establishes a
tolerance for residues of fenhexamid in
or on asparagus. Interregional Research
Project Number 4 (IR-4) requested this
tolerance under the Federal Food, Drug,
and Cosmetic Act (FFDCA).
DATES: This regulation is effective April
9, 2008. Objections and requests for
hearings must be received on or before
June 9, 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).
ENVIRONMENTAL PROTECTION
AGENCY
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2007–0303. To access the
electronic docket, go to https://
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
https://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.
40 CFR Part 180
SUPPLEMENTARY INFORMATION:
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 31, 2008.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention Division, Office of Pesticide
Programs.
Therefore, 40 CFR chapter I is
amended as follows:
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1220 is revised to read
as follows:
I
§ 180.1220 1-Methylcyclopropene;
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of the 1-Methylcyclopropene in or on
fruits and vegetables when:
(a) Used as a post harvest plant
growth regulator, i.e., for the purpose of
inhibiting the effects of ethylene.
(b) Applied or used outdoors for preharvest treatments.
[FR Doc. E8–7458 Filed 4–8–08; 8:45 am]
BILLING CODE 6560–50–S
ADDRESSES:
I. General Information
[EPA–HQ–OPP–2007–0303; FRL–8357–2]
Fenhexamid; Pesticide Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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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
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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.
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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 https://
www.regulations.gov, you may access
this Federal Register document
electronically through the EPA Internet
under the ‘‘Federal Register’’ listings at
https://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 https://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–2007–0303 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 June 9, 2008.
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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–2007–0303, by one of the
following methods:
• Federal eRulemaking Portal: https://
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 June 27,
2007 (72 FR 35237) (FRL–8133–4), 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 7E7187) by IR-4,
500 College Road East, Suite 201 W,
Princeton, NJ 08540. The petition
requested that 40 CFR 180.553 be
amended by establishing a tolerance for
residues of the fungicide, fenhexamid,
(N-2,3-dichloro-4-hydroxyphenyl)-1methyl cyclohexanecarboxamide), in or
on asparagus at 0.02 parts per million
(ppm). This notice referenced a
summary of the petition prepared by
Arysta LifeScience, the registrant, which
is available to the public in the docket,
https://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
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
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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
tolerance for residues of fenhexamid on
asparagus at 0.02 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. In general, the
toxicology studies conducted on
fenhexamid demonstrated that it has
few or no biologically significant toxic
effects at relatively low dose levels in
many animal studies and only mild or
no toxic effects at high dose levels
which often approach or exceed the
limit dose. In subchronic and chronic
oral studies, the most toxicologically
significant effects were anemia in dogs,
and decreased body weights, increased
food consumption and mild liver and/
or kidney effects in rats and mice.
Fenhexamid is not acutely toxic,
neurotoxic, carcinogenic, or mutagenic
and is not a developmental or
reproductive toxicant. Although no
increased susceptibility of fetuses was
demonstrated in developmental toxicity
studies in rats and rabbits, equivocal
results, with respect to evaluating
potentially increased sensitivity of
pups, were observed in the reproduction
study in rats. Specific information on
the studies received and the nature of
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the adverse effects caused by
fenhexamid as well as the no-observedadverse-effect-level (NOAEL) and the
lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies are
discussed in the final rule published in
the Federal Register of April 13, 2000
(65 FR 19842) (FRL–6553-7)https://
www.epa.gov/fedrgstr/EPA-PEST/2000/
April/Day-13/p9144.htm.
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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 https://
www.epa.gov/fedrgstr/EPA-PEST/1997/
November/Day-26/p30948.htm.
A summary of the toxicological
endpoints for fenhexamid used for
human risk assessment can be found at
https://www.regulations.gov in document
Fenhexamid Human Health Risk
Assessment for a Proposed Section 3
Registration for Use on Asparagus on
pages 25-26 in docket ID number EPA–
HQ–OPP–2007–0303.
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to fenhexamid, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing fenhexamid tolerances in (40
CFR 180.553). EPA assessed dietary
exposures from fenhexamid 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 fenhexamid;
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, DEEM default
processing factors, and assumed 100%
crop treated.
iii. Cancer. Based on the studies of
carcinogenicity studies in rats and mice,
EPA has concluded that fenhexamid is
‘‘not likely to be carcinogenic to
humans.’’ Consequently, a quantitative
cancer exposure and risk assessment is
not appropriate for fenhexamid.
2. Dietary exposure from drinking
water. The Agency lacks sufficient
monitoring data to complete a
comprehensive dietary exposure
analysis and risk assessment for
fenhexamid 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
fenhexamid. Further information
regarding EPA drinking water models
used in pesticide exposure assessment
can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
Based on the First Index Reservoir
Screening Tool (FIRST) and Screening
Concentration in Ground Water (SCIGROW) models, the estimated
environmental concentrations (EECs) of
fenhexamid for surface water are
estimated to be 29 parts per billion
(ppb) for acute and 1.1 ppb for chronic
exposure. The EECs for groundwater are
estimated to be 0.0007 ppb for acute and
chronic exposure.
Modeled estimates of drinking water
concentrations were directly entered
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into the dietary exposure model. For
chronic dietary risk assessment, the
water concentration of value 1.1 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 nonoccupational, non-dietary exposure
(e.g., for lawn and garden pest control,
indoor pest control, termiticides, and
flea and tick control on pets).
Fenhexamid 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
fenhexamid and any other substances
and fenhexamid 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 fenhexamid 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 https://
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 tenfold (‘‘10X’’) margin of
safety for infants and children in the
case of threshold effects to account for
pre-natal and post-natal 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.
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2. Pre-natal and post-natal sensitivity.
In the rat and the rabbit developmental
toxicity studies, neither quantitative nor
qualitative evidence of increased
susceptibility of fetuses to in utero
exposure to fenhexamid was observed.
In the rat reproduction study,
qualitative susceptibility was evidenced
as significantly decreased pup body
weights in both generations during the
lactation period (on lactation days 7, 14,
and 21 in the F2 generation and
lactation days 14 and 21 in the F1
generation offspring) in the presence of
lesser maternal toxicity (alterations in
clinical chemistry parameters and
decreased organ weights without
collaborative histopathology).
Considering the overall toxicity profile
and the doses and endpoints selected
for risk assessment for fenhexamid, the
degree of concern for the effects
observed in this study was characterized
as low, noting that there is a clear
NOAEL and well-characterized dose
response for the offspring effects
observed and that these effects occurred
in the presence of parental toxicity. No
residual uncertainties were identified.
The NOAEL of 17 milligrams/kilograms
day (mg/kg/day) from the chronic dog
study used to establish the chronic
Reference Dose (cRfD) for the General
Population is lower than the NOAEL of
38.2 mg/kg/day in the reproduction
study in which the offspring effects of
concern were observed (LOAEL = 406
mg/kg/day), and is therefore protective
of any potential offspring effects.
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 toxicology data base is
complete; there are no residual
uncertainties in the expose database.
ii. Developmental neurotoxicity
studies are not required for fenhexamid,
and no additional uncertainty factors
are needed based on the following
weight-of-the-evidence considerations:
The lack of evidence of abnormalities
in the development of the fetal nervous
system in the pre/post natal studies; and
Neither brain weight nor
histopathological examination of the
nervous system was affected in the
subchronic and chronic studies.
Decreased body temperatures observed
in male rats in the acute neurotoxicity
study were also not considered to be
toxicologically significant.
iii. As discussed above in Unit III D.,
there are no residual uncertainties for
pre and/or post natal sensitivity.
iv. The dietary (food) exposure
assessment utilizes existing and
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proposed tolerance level residues and
assumes 100% of crops treated with
fenhexamid. The assessment is based on
reliable data and is not expected to
underestimate exposure/risk.
Fenhexamid is not registered for use
sites that would result in residential
exposure. Conservative assumptions are
used in the drinking water models. The
drinking water exposure assessment is
not expected to underestimate
exposure/risk.
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 longterm 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 toxicological
endpoint attributable to a single (acute)
dietary exposure was identified.
Therefore, acute risk from exposure to
fenhexamid is not expected.
2. Chronic risk. Using the exposure
assumptions described in this unit for
chronic exposure, EPA has concluded
that exposure to fenhexamid from food
and water will utilize 27% of the cPAD
for children 1-2 years old, the
subpopulation at the greatest exposure.
There are no residential uses for
fenhexamid that result in chronic
residential exposure to fenhexamid.
3. Aggregate cancer risk for U.S.
population. The Agency has classified
fenhexamid as a ‘‘not likely’’ human
carcinogen based on lack of evidence of
carcinogenicity in male and female rats
as well as in male and female mice, and
on the lack of genotoxicity in an
acceptable battery of mutagenicity
studies. Therefore, fenhexamid is not
expected to pose a cancer risk.
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 fenhexamid
residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology
(high performance liquid
chromatography (HPLC) method using
electrochemical detection (ECD)) is
available to enforce the tolerance
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19153
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 established or proposed
Canadian, Mexican or Codex MRLs for
fenhexamid on asparagus, therefore
there are no issues for international
harmonization for this current petition.
V. Conclusion
Therefore, the tolerance is established
for residues of fenhexamid, (N-2,3dichloro-4-hydroxyphenyl)-1-methyl
cyclohexanecarboxamide), in or on
asparagus at 0.02 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
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09APR1
19154
Federal Register / Vol. 73, No. 69 / Wednesday, April 9, 2008 / Rules and Regulations
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 26, 2008.
Daniel C. Kenny,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
sroberts on PROD1PC70 with RULES
I
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
I
Authority: 21 U.S.C. 321(q), 346a and 371.
VerDate Aug<31>2005
16:48 Apr 08, 2008
Jkt 214001
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
§180.553 Fenhexamid; tolerances for
website to view the docket index or
residues.
access available documents. All
(a) * * *
documents in the docket are listed in
the docket index available in
Commodity
Parts per million
regulations.gov. Although listed in the
*
*
*
*
* index, some information is not publicly
available, e.g., Confidential Business
Asparagus .......................
0.02 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.
[FR Doc. E8–7038 Filed 4–8–08; 8:45 am]
Publicly available docket materials are
BILLING CODE 6560–50–S
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the OPP
ENVIRONMENTAL PROTECTION
Regulatory Public Docket in Rm. S–
AGENCY
4400, One Potomac Yard (South Bldg.),
2777 S. Crystal Dr., Arlington, VA. The
40 CFR Part 180
Docket Facility is open from 8:30 a.m.
[EPA–HQ–OPP–2007–0426; FRL–8356–9]
to 4 p.m., Monday through Friday,
excluding legal holidays. The Docket
Buprofezin; Pesticide Tolerance
Facility telephone number is (703) 305–
AGENCY: Environmental Protection
5805.
Agency (EPA).
FOR FURTHER INFORMATION CONTACT:
ACTION: Final rule.
Susan Stanton, Registration Division
(7505P), Office of Pesticide Programs,
SUMMARY: This regulation establishes
Environmental Protection Agency, 1200
tolerances for residues of buprofezin in
Pennsylvania Ave., NW., Washington,
or on berry, low growing , subgroup 13DC 20460–0001; telephone number:
07G; okra; olive; olive, oil; pepper,
(703) 305-5218; e-mail address:
nonbell; radicchio; vegetable, fruiting,
stanton.susan@epa.gov.
group 8, except nonbell pepper; and
SUPPLEMENTARY INFORMATION:
vegetable, leafy, except Brassica, group
4, except head lettuce and radicchio;
I. General Information
and increases the existing tolerance for
A. Does this Action Apply to Me?
residues of buprofezin in or on head
You may be potentially affected by
lettuce. Interregional Research Project
this action if you are an agricultural
Number 4 (IR-4) requested these
producer, food manufacturer, or
tolerances under the Federal Food,
pesticide manufacturer. Potentially
Drug, and Cosmetic Act (FFDCA). This
affected entities may include, but are
regulation also removes existing
not limited to those engaged in the
tolerances for residues of buprofezin in
following activities:
or on leaf lettuce and tomato and
• Crop production (NAICS code 111),
modifies 40 CFR 180.511 by removing
e.g., agricultural workers; greenhouse,
the third column (Expiration/
nursery, and floriculture workers;
Revocation Date) from the table in
farmers.
paragraph (a), since it is no longer
• Animal production (NAICS code
applicable.
112), e.g., cattle ranchers and farmers,
DATES: This regulation is effective April
dairy cattle farmers, livestock farmers.
9, 2008. Objections and requests for
• Food manufacturing (NAICS code
hearings must be received on or before
311), e.g., agricultural workers; farmers;
June 9, 2008, and must be filed in
greenhouse, nursery, and floriculture
accordance with the instructions
workers; ranchers; pesticide applicators.
provided in 40 CFR part 178 (see also
• Pesticide manufacturing (NAICS
Unit I.C. of the SUPPLEMENTARY
code 32532), e.g., agricultural workers;
INFORMATION ).
commercial applicators; farmers;
ADDRESSES: EPA has established a
greenhouse, nursery, and floriculture
docket for this action under docket
workers; residential users.
identification (ID) number EPA–HQ–
This listing is not intended to be
OPP–2007–0426. To access the
exhaustive, but rather to provide a guide
electronic docket, go to https://
for readers regarding entities likely to be
2. Section 180.553 is amended by
alphabetically adding the following
commodities to/in the table in
paragraph (a) to read as follows:
I
PO 00000
Frm 00016
Fmt 4700
Sfmt 4700
E:\FR\FM\09APR1.SGM
09APR1
Agencies
[Federal Register Volume 73, Number 69 (Wednesday, April 9, 2008)]
[Rules and Regulations]
[Pages 19150-19154]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7038]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0303; FRL-8357-2]
Fenhexamid; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes a tolerance for residues of
fenhexamid in or on asparagus. Interregional Research Project Number 4
(IR-4) requested this tolerance under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective April 9, 2008. Objections and
requests for hearings must be received on or before June 9, 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-2007-0303. To access the
electronic docket, go to https://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 https://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 producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are
[[Page 19151]]
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 https://
www.regulations.gov, you may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at https://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 https://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-2007-0303 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 June 9, 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-2007-0303, by one of the following methods:
Federal eRulemaking Portal: https://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 June 27, 2007 (72 FR 35237) (FRL-8133-
4), 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
7E7187) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ
08540. The petition requested that 40 CFR 180.553 be amended by
establishing a tolerance for residues of the fungicide, fenhexamid, (N-
2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in or
on asparagus at 0.02 parts per million (ppm). This notice referenced a
summary of the petition prepared by Arysta LifeScience, the registrant,
which is available to the public in the docket, https://
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 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 tolerance
for residues of fenhexamid on asparagus at 0.02 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. In general, the toxicology studies conducted on fenhexamid
demonstrated that it has few or no biologically significant toxic
effects at relatively low dose levels in many animal studies and only
mild or no toxic effects at high dose levels which often approach or
exceed the limit dose. In subchronic and chronic oral studies, the most
toxicologically significant effects were anemia in dogs, and decreased
body weights, increased food consumption and mild liver and/or kidney
effects in rats and mice. Fenhexamid is not acutely toxic, neurotoxic,
carcinogenic, or mutagenic and is not a developmental or reproductive
toxicant. Although no increased susceptibility of fetuses was
demonstrated in developmental toxicity studies in rats and rabbits,
equivocal results, with respect to evaluating potentially increased
sensitivity of pups, were observed in the reproduction study in rats.
Specific information on the studies received and the nature of
[[Page 19152]]
the adverse effects caused by fenhexamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of April 13, 2000 (65 FR 19842) (FRL-
6553-7)https://www.epa.gov/fedrgstr/EPA-PEST/2000/April/Day-13/
p9144.htm.
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 https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
A summary of the toxicological endpoints for fenhexamid used for
human risk assessment can be found at https://www.regulations.gov in
document Fenhexamid Human Health Risk Assessment for a Proposed Section
3 Registration for Use on Asparagus on pages 25-26 in docket ID number
EPA-HQ-OPP-2007-0303.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenhexamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenhexamid tolerances in (40 CFR
180.553). EPA assessed dietary exposures from fenhexamid 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
fenhexamid; 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, DEEM default processing factors, and assumed 100% crop
treated.
iii. Cancer. Based on the studies of carcinogenicity studies in
rats and mice, EPA has concluded that fenhexamid is ``not likely to be
carcinogenic to humans.'' Consequently, a quantitative cancer exposure
and risk assessment is not appropriate for fenhexamid.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring data to complete a comprehensive dietary exposure
analysis and risk assessment for fenhexamid 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
fenhexamid. Further information regarding EPA drinking water models
used in pesticide exposure assessment can be found at https://
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 environmental concentrations (EECs) of fenhexamid for surface
water are estimated to be 29 parts per billion (ppb) for acute and 1.1
ppb for chronic exposure. The EECs for groundwater are estimated to be
0.0007 ppb for acute and chronic exposure.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 1.1 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).
Fenhexamid 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 fenhexamid and any other
substances and fenhexamid 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 fenhexamid 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 https://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 tenfold (``10X'') margin of safety for infants and
children in the case of threshold effects to account for pre-natal and
post-natal 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.
[[Page 19153]]
2. Pre-natal and post-natal sensitivity. In the rat and the rabbit
developmental toxicity studies, neither quantitative nor qualitative
evidence of increased susceptibility of fetuses to in utero exposure to
fenhexamid was observed. In the rat reproduction study, qualitative
susceptibility was evidenced as significantly decreased pup body
weights in both generations during the lactation period (on lactation
days 7, 14, and 21 in the F2 generation and lactation days 14 and 21 in
the F1 generation offspring) in the presence of lesser maternal
toxicity (alterations in clinical chemistry parameters and decreased
organ weights without collaborative histopathology). Considering the
overall toxicity profile and the doses and endpoints selected for risk
assessment for fenhexamid, the degree of concern for the effects
observed in this study was characterized as low, noting that there is a
clear NOAEL and well-characterized dose response for the offspring
effects observed and that these effects occurred in the presence of
parental toxicity. No residual uncertainties were identified. The NOAEL
of 17 milligrams/kilograms day (mg/kg/day) from the chronic dog study
used to establish the chronic Reference Dose (cRfD) for the General
Population is lower than the NOAEL of 38.2 mg/kg/day in the
reproduction study in which the offspring effects of concern were
observed (LOAEL = 406 mg/kg/day), and is therefore protective of any
potential offspring effects.
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 toxicology data base is complete; there are no residual
uncertainties in the expose database.
ii. Developmental neurotoxicity studies are not required for
fenhexamid, and no additional uncertainty factors are needed based on
the following weight-of-the-evidence considerations:
The lack of evidence of abnormalities in the development of the
fetal nervous system in the pre/post natal studies; and
Neither brain weight nor histopathological examination of the
nervous system was affected in the subchronic and chronic studies.
Decreased body temperatures observed in male rats in the acute
neurotoxicity study were also not considered to be toxicologically
significant.
iii. As discussed above in Unit III D., there are no residual
uncertainties for pre and/or post natal sensitivity.
iv. The dietary (food) exposure assessment utilizes existing and
proposed tolerance level residues and assumes 100% of crops treated
with fenhexamid. The assessment is based on reliable data and is not
expected to underestimate exposure/risk. Fenhexamid is not registered
for use sites that would result in residential exposure. Conservative
assumptions are used in the drinking water models. The drinking water
exposure assessment is not expected to underestimate exposure/risk.
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 toxicological endpoint attributable to a single
(acute) dietary exposure was identified. Therefore, acute risk from
exposure to fenhexamid is not expected.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
fenhexamid from food and water will utilize 27% of the cPAD for
children 1-2 years old, the subpopulation at the greatest exposure.
There are no residential uses for fenhexamid that result in chronic
residential exposure to fenhexamid.
3. Aggregate cancer risk for U.S. population. The Agency has
classified fenhexamid as a ``not likely'' human carcinogen based on
lack of evidence of carcinogenicity in male and female rats as well as
in male and female mice, and on the lack of genotoxicity in an
acceptable battery of mutagenicity studies. Therefore, fenhexamid is
not expected to pose a cancer risk.
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 fenhexamid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography (HPLC) method using electrochemical detection (ECD)) 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 established or proposed Canadian, Mexican or Codex
MRLs for fenhexamid on asparagus, therefore there are no issues for
international harmonization for this current petition.
V. Conclusion
Therefore, the tolerance is established for residues of fenhexamid,
(N-2,3-dichloro-4-hydroxyphenyl)-1-methyl cyclohexanecarboxamide), in
or on asparagus at 0.02 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
[[Page 19154]]
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 26, 2008.
Daniel C. Kenny,
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 180.553 is amended by alphabetically adding the following
commodities to/in the table in paragraph (a) to read as follows:
Sec. 180.553 Fenhexamid; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
* * * * *
Asparagus............................................ 0.02
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. E8-7038 Filed 4-8-08; 8:45 am]
BILLING CODE 6560-50-S