Mefenoxam; Pesticide Tolerances, 26722-26727 [2016-10389]
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Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations
WISCONSIN—2008 8-HOUR OZONE NAAQS—Continued
[Primary and secondary]
Designation
Classification
Designated area
Date 1
Date 1
Type
Type
Sheboygan County.
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1 This
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date is July 20, 2012, unless otherwise noted.
Indian country located in each area, unless otherwise noted.
2 Excludes
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4 Attainment date is extended to July 20, 2016.
ENVIRONMENTAL PROTECTION
AGENCY
(7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
40 CFR Part 180
I. General Information
[EPA–HQ–OPP–2015–0014; FRL–9944–82]
A. Does this action apply to me?
Mefenoxam; Pesticide Tolerances
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
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[FR Doc. 2016–09729 Filed 5–3–16; 8:45 am]
BILLING CODE 6560–50–P
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of mefenoxam in
or on rapeseed subgroup 20A. Syngenta
Crop Protection, LLC., requested these
tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective May
4, 2016. Objections and requests for
hearings must be received on or before
July 5, 2016, and must be filed in
accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2015–0014, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
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ADDRESSES:
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B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 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. 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–2015–0014 in the subject line on
the first page of your submission. All
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objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before July 5, 2016. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
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 (excluding
any Confidential Business Information
(CBI)) for inclusion in the public docket.
Information not marked confidential
pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior
notice. Submit the non-CBI copy of your
objection or hearing request, identified
by docket ID number EPA–HQ–OPP–
2015–0014, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on commenting
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of April 6,
2015 (80 FR 18327) (FRL–9924–00),
EPA issued a document pursuant to
FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide petition (PP 4F8323) by
Syngenta Crop Protection, LLC., 410
Swing Road, Greensboro, NC 27419. The
petition requested that 40 CFR 180.546
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be amended by establishing tolerances
for residues of the fungicide
mefenoxam, methyl N-(2,6dimethylphenyl)-N-(methoxyacetyl)-DLalaninate, in or on rapeseed crop
subgroup 20A at 0.05 parts per million
(ppm). That document referenced a
summary of the petition prepared by
Syngenta Crop Protection, LLC, the
registrant, which is available 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. . . .’’
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 mefenoxam
including exposure resulting from the
tolerances established by this action.
EPA’s assessment of exposures and risks
associated with mefenoxam follows.
A. Toxicological Profile
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EPA has evaluated the available
toxicity data and considered its validity,
completeness, and reliability as well as
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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. Mefenoxam is the
enriched R-enantiomer of metalaxyl
which is a racemic mixture that
contains approximately 50% each of the
R- and S-enantiomers. EPA conducted
side-by-side comparison of the available
toxicity data for mefenoxam and
metalaxyl and concluded that
mefenoxam has similar toxicity to that
of metalaxyl. Therefore, the metalaxyl
data may be used to support regulatory
actions for mefenoxam.
The Agency reassessed the toxicity
databases for metalaxyl and mefenoxam
in accordance with current policies and
determined that many of the effects
previously noted in several toxicological
studies are no longer considered to be
adverse (i.e. body weight gain without
changes in absolute body weight;
hepatocyte hypertrophy without
necrosis; enzyme leakage to bloodstream
or disruption of lipid homeostasis). In
rat and dog repeat dose (i.e., subchronic
and chronic) oral toxicity studies, there
were no indications of adverse effects
up to the highest dose tested (HDT).
Adverse effects were only observed
from acute exposure to rats. In the rat
developmental toxicity study of
metalaxyl, maternal toxicity consisted of
dose-related increased incidence of
convulsions that occurred shortly after
dosing, as well as other clinical signs. In
a range-finding acute neurotoxicity
study of mefenoxam, females showed
abnormal functional observation battery
(FOB) findings at lower doses than
males. However, there was no
indication of toxicity up to the HDT in
the mefenoxam subchronic
neurotoxicity study, which confirms the
lack of adverse effects observed in all
other repeated-dose studies.
There was no indication of
developmental toxicity in studies of
mefenoxam or metalaxyl. There was no
indication of immunotoxicity in a
mouse immunotoxicity study of
mefenoxam. Metalaxyl and mefenoxam
have been classified as ‘‘not likely to be
carcinogenic in humans’’ based on the
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results for metalaxyl in the
carcinogenicity study in mice and the
combined chronic toxicity and
carcinogenicity study in rats.
Specific information on the studies
received and the nature of the adverse
effects caused by mefenoxam as well as
the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in document
‘‘Mefenoxam, Human Health Risk
Assessment’’ at pages 14–17 in docket
ID number EPA–HQ–OPP–2015–0014.
B. Toxicological Points of Departure/
Levels of Concern
Once a pesticide’s toxicological
profile is determined, EPA identifies
toxicological points of departure (POD)
and levels of concern to use in
evaluating the risk posed by human
exposure to the pesticide. For hazards
that have a threshold below which there
is no appreciable risk, the toxicological
POD is used as the basis for derivation
of reference values for risk assessment.
PODs are developed based on a careful
analysis of the doses in each
toxicological study to determine the
dose at which no adverse effects are
observed (the NOAEL) and the lowest
dose at which adverse effects of concern
are identified (the LOAEL). Uncertainty/
safety factors are used in conjunction
with the POD to calculate a safe
exposure level—generally referred to as
a population-adjusted dose (PAD) or a
reference dose (RfD)—and a safe margin
of exposure (MOE). 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
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 https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/assessinghuman-health-risk-pesticides.
A summary of the toxicological
endpoints for mefenoxam used for
human risk assessment is shown in
Table 1 of this unit.
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TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR MEFENOXAM FOR USE IN HUMAN HEALTH RISK
ASSESSMENT
Point of departure
and uncertainty/safety factors
RfD, PAD, LOC for
risk assessment
Study and toxicological effects
Acute dietary (General population including infants, children, and females 13–50
years of age.
NOAEL = 50 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Acute RfD = 0.5 mg/
kg/day.
aPAD = 0.5 mg/kg/
day
Metalaxyl Prenatal Developmental Toxicity—Rat
LOAEL = 250 mg/kg/day based on dose-related increases in
clinical signs of toxicity (e.g., post-dosing convulsions).
Chronic dietary (All populations)
No endpoint was identified. No systemic toxicity was observed in any toxicity study where the animals were
administered metalaxyl or mefenoxam in the diet. Acute dietary assessment is protective of all other durations
of exposure.
Incidental oral short-term (1 to
30 days) and intermediateterm (1 to 6 months).
NOAEL = 50 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Dermal short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
No endpoint was identified. No systemic toxicity was observed at the limit dose (1,000 mg/kg/day) in rabbits
treated with metalaxyl during a 21-day dermal toxicity study.
For converting oral to dermal doses for risk assessment, the Dermal Absorption Factor (DAF) = 35%.
Inhalation short-term (1 to 30
days) and intermediate-term
(1 to 6 months).
NOAEL = 50 mg/kg/
day.
UFA = 10x
UFH = 10x
FQPA SF = 1x
Note: Toxicity via the
inhalation and oral
routes are assumed to be
equivalent.
Cancer (Oral, dermal, inhalation).
Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on the absence of treatment-related increases in tumor incidence in adequately conducted carcinogenicity studies in rats and mice treated with
metalaxyl.
Exposure/Scenario
LOC for MOE = 100
LOC for MOE = 100
Metalaxyl Prenatal Developmental Toxicity—Rat
LOAEL = 250 mg/kg/day based on dose-related increases in
clinical signs of toxicity (e.g., post-dosing convulsions).
Metalaxyl Prenatal Developmental Toxicity—Rat
LOAEL = 250 mg/kg/day based on dose-related increases in
clinical signs of toxicity (e.g., post-dosing convulsions).
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level of concern. mg/kg/day =
milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, c =
chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in
sensitivity among members of the human population (intraspecies).
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C. Exposure Assessment
1. Dietary exposure from food and
feed uses. In evaluating dietary
exposure to mefenoxam, EPA
considered exposure under the
petitioned-for tolerances as well as all
existing mefenoxam tolerances in 40
CFR 180.546 and metalaxyl tolerances
40 CFR 180.408. EPA assessed dietary
exposures from mefenoxam/metalaxyl
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.
Such effects were identified for
mefenoxam. In estimating acute dietary
exposure, EPA used food consumption
information from the United States
Department of Agriculture (USDA)
2003–2008 National Health and
Nutrition Examination Survey/What We
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Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA
conducted a somewhat refined acute
dietary exposure assessment for the
proposed food use of mefenoxam on the
rapeseed subgroup 20A and the existing
uses of both metalaxyl and mefenoxam.
Residues were assumed to be present at
tolerance levels in plant commodities,
with additional factors applied to
certain plant commodities to include all
residues of concern for risk assessment.
Tolerance-level residues adjusted
upward to account for metalaxyl/
mefenoxam residues of concern in
livestock commodities were used and
based on data from metabolism studies
on goats and hens. DEEM default and
empirical processing factors were used
as available. It was assumed that 100%
of the crops were treated (100% CT).
ii. Chronic exposure. No such effects
were identified in the toxicological
studies for mefenoxam; therefore, a
quantitative chronic dietary exposure
assessment is unnecessary.
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iii. Cancer. Based on the data
summarized in Unit III.A., EPA has
concluded that mefenoxam does not
pose a cancer risk to humans. Therefore,
a dietary exposure assessment for the
purpose of assessing cancer risk is
unnecessary.
iv. Anticipated residue and percent
crop treated (PCT) information. EPA did
not use anticipated residue and/or PCT
information in the dietary assessment
for mefenoxam. Tolerance-level residues
and/or 100% CT 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 mefenoxam in drinking water. These
simulation models take into account
data on the physical, chemical, and fate/
transport characteristics of mefenoxam.
Further information regarding EPA
drinking water models used in pesticide
exposure assessment can be found at
https://www2.epa.gov/pesticide-science-
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and-assessing-pesticide-risks/aboutwater-exposure-models-used-pesticide.
Based on the Surface Water
Concentration Calculator (SWCC) and
the Pesticide Root Zone Model-Ground
Water (PRZM GW), the estimated
drinking water concentrations (EDWCs)
of mefenoxam for acute exposures are
estimated to be 741 parts per billion
(ppb) for surface water and 3,700 ppb
for ground water. These modeled
estimates of drinking water
concentrations were directly entered
into the dietary exposure model.
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).
Mefenoxam is currently registered for
the following uses that could result in
residential exposures: Residential turf
and ornamentals, including nonbearing
citrus trees. EPA assessed residential
exposure using the following
assumptions: Residential handler
exposure is expected to be short-term in
duration. Intermediate-term exposures
are not likely because of the intermittent
nature of applications by homeowners.
Residential post-application exposure
was assessed based on short-term
incidental oral risk estimates for
children 1 < 2 years old. Dermal postapplication risk assessments were not
conducted because an adverse systemic
dermal hazard was not identified for
mefenoxam. Further information
regarding EPA standard assumptions
and generic inputs for residential
exposures may be found at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/standardoperating-procedures-residentialpesticide.
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.’’ EPA has not
found mefenoxam to share a common
mechanism of toxicity with any other
substances, and mefenoxam does not
appear to produce a toxic metabolite
produced by other substances. For the
purposes of this tolerance action,
therefore, EPA has assumed that
mefenoxam does not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
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chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s Web site at https://
www2.epa.gov/pesticide-science-andassessing-pesticide-risks/cumulativeassessment-risk-pesticides
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.
There is no evidence that mefenoxam
results in increased susceptibility from
in utero exposure to rats or rabbits in
the prenatal developmental studies or
exposure to young rats in the 2generation reproduction study.
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 metalaxyl
and mefenoxam is complete.
ii. In the rat prenatal developmental
toxicity with metalaxyl, maternal
animals exhibited clinical signs
indicative of neurobehavioral effects as
previously discussed.
In the range-finding acute
neurotoxicity study with mefenoxam,
females exhibited abnormal functional
observation battery (FOB) findings at
doses lower than in males. In the
subchronic neurotoxicity study with
mefenoxam, there were no indications
of neurotoxicity up to the HDT. In
metalaxyl and mefenoxam treated adult
animals, clinical signs and abnormal
FOB findings were noted. However, a
developmental neurotoxicity (DNT)
study is not required for metalaxyl or
mefenoxam because (1) there are no
indications of increased susceptibility
for infants or children; (2) the
convulsions observed in the rat prenatal
developmental toxicity study occurred
in the maternal animals with no effects
being observed in the young; (3) the
convulsions occurred only after a bolus
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dose; (4) the available developmental
and range-finding acute neurotoxicity
studies provided clear NOAELs and
LOAELs for evaluating effects; (5) the
current POD is below the level at which
any effects were seen in either study,
and (6) there were no other indications
of neurotoxicity in the mefenoxam or
metalaxyl databases, which include a
subchronic (adult rat) neurotoxicity
study for mefenoxam. Therefore, there is
no need for a developmental
neurotoxicity study or additional UFs to
account for neurotoxicity.
iii. In metalaxyl and mefenoxam
treated animals, there was no evidence
of increased susceptibility following
pre-/postnatal exposure in the prenatal
developmental toxicity studies or the
reproduction and fertility effects study.
There is no evidence that mefenoxam
results in increased susceptibility in in
utero rats or rabbits in the prenatal
developmental studies or in young rats
in the 2-generation reproduction study.
iv. There are no residual uncertainties
identified in the exposure databases.
The dietary food exposure assessments
were performed based on 100% CT and
tolerance levels or upper bound residue
estimates. EPA made conservative
(protective) assumptions in the ground
and surface water modeling used to
assess exposure to mefenoxam in
drinking water. EPA used similarly
conservative assumptions to assess
postapplication exposure of children as
well as incidental oral exposure of
toddlers. These assessments will not
underestimate the exposure and risks
posed by mefenoxam.
E. Aggregate Risks and Determination of
Safety
EPA determines whether acute and
chronic dietary pesticide exposures are
safe by comparing aggregate exposure
estimates to the acute PAD (aPAD) and
chronic PAD (cPAD). For linear cancer
risks, EPA calculates the lifetime
probability of acquiring cancer 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 appropriate
PODs to ensure that an adequate MOE
exists.
1. Acute risk. The acute aggregate risk
assessment considers exposure
estimates from dietary consumption of
mefenoxam (food and drinking water).
Using the exposure assumptions
discussed in this unit for acute
exposure, the acute dietary exposure
from food and water to mefenoxam will
occupy 95% of the aPAD for children <1
years old, the population group
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receiving the greatest exposure, but this
is below the level of concern.
2. Chronic risk. A chronic aggregate
risk assessment takes into account
chronic exposure estimates from dietary
consumption of food and drinking
water. No adverse effect resulting from
repeated exposure was identified and no
chronic dietary endpoint was selected.
Therefore, mefenoxam is not expected
to pose a chronic risk.
3. Short-term and Intermediate-term
risk. Short-term and intermediate-term
aggregate exposure takes into account
both short-term and intermediate-term
residential exposure plus chronic
exposure to food and water (considered
to be a background exposure level).
Mefenoxam is currently registered for
uses that could result in short-term and
intermediate-term residential exposure,
and the Agency has determined that it
is appropriate to aggregate short-term
and intermediate-term residential
exposures to mefenoxam. Using the
exposure assumptions described in this
unit for short-term and intermediateterm exposures, EPA has concluded the
combined short-term and intermediateterm food, water, and residential
exposures result in aggregate MOEs of
79,000 for adult; and 1,000 for children
1 < 2 years old. Because EPA’s level of
concern for mefenoxam is a MOE of 100
or below, these MOEs are not of
concern.
4. Aggregate cancer risk for U.S.
population. Based on the lack of
evidence of carcinogenicity in two
adequate rodent carcinogenicity studies,
mefenoxam is not expected to pose a
cancer risk to humans.
5. Determination of safety. Based on
these risk assessments, EPA concludes
that there is a reasonable certainty that
no harm will result to the general
population, or to infants and children
from aggregate exposure to mefenoxam
residues.
IV. Other Considerations
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A. Analytical Enforcement Methodology
Several methods are available for
enforcing tolerances: (1) A gas-liquid
chromatography procedure employing
an alkali flame ionization detector
(GLC/AFID); (2) a method using GLC/
nitrogen phosphorus detection; and (3)
a multi-residue method in PAM, Vol 1.
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;
email address: residuemethods@
epa.gov.
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B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level.
The Codex has not established a MRL
for mefenoxam for the rapeseed crop
subgroup 20A.
V. Conclusion
Therefore, tolerances are established
for residues of mefenoxam, methyl N(2,6-dimethylphenyl)-N(methoxyacetyl)-DL-alaninate, in or on
rapeseed subgroup 20A at 0.05 ppm.
VI. Statutory and Executive Order
Reviews
This action establishes tolerances
under FFDCA section 408(d) in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory
Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action
has been exempted from review under
Executive Order 12866, this action is
not subject to Executive Order 13211,
entitled ‘‘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 action 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).
PO 00000
Frm 00060
Fmt 4700
Sfmt 4700
Since tolerances and exemptions that
are established on the basis of a petition
under FFDCA section 408(d), such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action 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 FFDCA
section 408(n)(4). 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 action. In addition, this action
does not impose any enforceable duty or
contain any unfunded mandate as
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C.
1501 et seq.).
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
(NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal
Register. This action 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.
E:\FR\FM\04MYR1.SGM
04MYR1
26727
Federal Register / Vol. 81, No. 86 / Wednesday, May 4, 2016 / Rules and Regulations
Dated: April 21, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
rotational area management program for
fishing year 2016. Framework 27
specifies measures for fishing year 2016,
and includes fishing year 2017 measures
that will go into place as a default
should the next specifications-setting
framework be delayed beyond the start
of fishing year 2017. NMFS has
approved all of the measures
recommended by the Council and
described below. The MagnusonStevens Fishery Conservation and
Management Act (Magnuson-Stevens
Act) permits NMFS to approve, partially
approve, or disapprove measures
proposed by the Council based only on
whether the measures are consistent
with the fishery management plan, the
Magnuson-Stevens Act and its National
Standards, and other applicable law. We
must defer to the Council’s policy
choices unless there is a clear
inconsistency with the law or the FMP.
Details concerning the development of
these measures were contained in the
preamble of the proposed rule and are
not repeated here.
AGENCY:
individual fishing quotas, and sea
scallop access area trip allocations;
creates a new rotational closed area
south of Closed Area 2 to protect small
scallops; opens the northern portion of
the Nantucket Lightship Access Area to
the Limited Access General Category
fleet; transfers 19 percent of the Limited
Access General Category access area
trips from the Mid-Atlantic Access Area
to the northern portion of the Nantucket
Lightship Access Area; and implements
an accountability measure to the fishing
year 2016 Northern Gulf of Maine Total
Allowable Catch as a result of a fishing
year 2015 catch overage.
DATES: Effective May 4, 2016.
ADDRESSES: The Council developed an
environmental assessment (EA) for this
action that describes the action and
other considered alternatives and
provides a thorough analysis of the
impacts of these measures. Copies of the
Framework, the EA, and the Initial
Regulatory Flexibility Analysis (IRFA),
are available upon request from Thomas
A. Nies, Executive Director, New
England Fishery Management Council,
50 Water Street, Newburyport, MA
01950. The EA/IRFA is also accessible
via the Internet at: https://
www.nefmc.org/scallops/ or
https://
www.greateratlantic.fisheries.noaa.gov/
sustainable/species/scallop/.
Copies of the small entity compliance
guide are available from John K.
Bullard, Regional Administrator, NMFS,
Greater Atlantic Regional Fisheries
Office, 55 Great Republic Drive,
Gloucester, MA 01930–2298, or
available on the internet at: https://
www.greateratlantic.fisheries.noaa.gov/
sustainable/species/scallop/.
FOR FURTHER INFORMATION CONTACT:
Travis Ford, Fishery Policy Analyst,
978–281–9233.
SUPPLEMENTARY INFORMATION:
NMFS approves and
implements through regulations the
measures included in Framework
Adjustment 27 to the Atlantic Sea
Scallop Fishery Management Plan,
which the New England Fishery
Management Council adopted and
submitted to NMFS for approval. The
purpose of Framework 27 is to prevent
overfishing, improve yield-per-recruit,
and improve the overall management of
the Atlantic sea scallop fishery.
Framework 27 sets specifications for the
scallop fishery for fishing year 2016,
including days-at-sea allocations,
Background
The Council adopted Framework 27
on December 3, 2015, and submitted a
draft of the framework to NMFS on
December 22, 2015, that presented
Council recommended measures,
rationale, impacts for review, and a draft
EA. NMFS published a proposed rule,
including a reference on how to obtain
the framework and the draft final EA,
for approving and implementing
Framework 27 on February 24, 2016 (81
FR 9151). The proposed rule included a
30-day public comment period that
closed on March 25, 2016. The Council
submitted a final EA to NMFS on March
14, 2016, for approval. This annual
action includes catch, effort, and quota
allocations and adjustments to the
OFL .......................
ABC/ACL (discards
removed) ...........
Incidental Catch ....
Research SetAside (RSA) ......
Observer SetAside .................
ACL for fishery ......
Limited Access
ACL ...................
LAGC ACL ............
LAGC IFQ .............
Limited Access
with LAGC IFQ ..
Limited Access
ACT ...................
Therefore, 40 CFR chapter I is
amended as follows:
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.546, add alphabetically the
entry for ‘‘Rapeseed subgroup 20A’’ to
the table in paragraph (a) to read as
follows:
■
§ 180.546 Mefenoxam; tolerances for
residues.
(a) * * *
Commodity
Parts per
million
*
*
*
*
Rapeseed subgroup 20A ............
*
0.05
*
*
*
*
*
*
*
*
*
*
[FR Doc. 2016–10389 Filed 5–3–16; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 648
[Docket No.: 151210999–6348–02]
RIN 0648–BF59
Fisheries of the Northeastern United
States; Atlantic Sea Scallop Fishery;
Framework Adjustment 27
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Final rule.
asabaliauskas on DSK3SPTVN1PROD with RULES
SUMMARY:
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17:12 May 03, 2016
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Fmt 4700
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Specification of Scallop Overfishing
Limit (OFL), Acceptable Biological
Catch (ABC), Annual Catch Limits
(ACLs), Annual Catch Targets (ACTs),
and Set-Asides for the 2016 Fishing
Year and Default Specifications for
Fishing Year 2017
Table 1 outlines the scallop fishery
catch limits derived from the ABC
values.
TABLE 1—SCALLOP CATCH LIMITS (MT)
FOR FISHING YEARS 2016 AND 2017
FOR THE LIMITED ACCESS AND LIMITED ACCESS GENERAL CATEGORY
(LAGC) INDIVIDUAL FISHING QUOTA
(IFQ) FLEETS
2016
2017
(default)
68,418
68,418
37,852
23
37,852
23
567
567
379
36,884
379
36,884
34,855
2,029
1,845
34,855
2,029
1,845
184
184
18,290
18,290
This action deducts 1.25 million lb
(567 mt) of scallops annually for 2016
and 2017 from the ABC and sets it aside
E:\FR\FM\04MYR1.SGM
04MYR1
]]>Agencies
[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Rules and Regulations]
[Pages 26722-26727]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10389]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0014; FRL-9944-82]
Mefenoxam; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes tolerances for residues of
mefenoxam in or on rapeseed subgroup 20A. Syngenta Crop Protection,
LLC., requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).
DATES: This regulation is effective May 4, 2016. Objections and
requests for hearings must be received on or before July 5, 2016, 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: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2015-0014, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number: (703) 305-7090; email address: RDFRNotices@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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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. 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-2015-0014 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
July 5, 2016. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
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 (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2015-0014, by one of
the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at https://www.epa.gov/dockets.
II. Summary of Petitioned-For Tolerance
In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8323) by Syngenta Crop Protection, LLC., 410 Swing Road, Greensboro,
NC 27419. The petition requested that 40 CFR 180.546
[[Page 26723]]
be amended by establishing tolerances for residues of the fungicide
mefenoxam, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-
alaninate, in or on rapeseed crop subgroup 20A at 0.05 parts per
million (ppm). That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available 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. . .
.''
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 mefenoxam including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with mefenoxam 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. Mefenoxam is the enriched R-enantiomer of metalaxyl which is
a racemic mixture that contains approximately 50% each of the R- and S-
enantiomers. EPA conducted side-by-side comparison of the available
toxicity data for mefenoxam and metalaxyl and concluded that mefenoxam
has similar toxicity to that of metalaxyl. Therefore, the metalaxyl
data may be used to support regulatory actions for mefenoxam.
The Agency reassessed the toxicity databases for metalaxyl and
mefenoxam in accordance with current policies and determined that many
of the effects previously noted in several toxicological studies are no
longer considered to be adverse (i.e. body weight gain without changes
in absolute body weight; hepatocyte hypertrophy without necrosis;
enzyme leakage to bloodstream or disruption of lipid homeostasis). In
rat and dog repeat dose (i.e., subchronic and chronic) oral toxicity
studies, there were no indications of adverse effects up to the highest
dose tested (HDT).
Adverse effects were only observed from acute exposure to rats. In
the rat developmental toxicity study of metalaxyl, maternal toxicity
consisted of dose-related increased incidence of convulsions that
occurred shortly after dosing, as well as other clinical signs. In a
range-finding acute neurotoxicity study of mefenoxam, females showed
abnormal functional observation battery (FOB) findings at lower doses
than males. However, there was no indication of toxicity up to the HDT
in the mefenoxam subchronic neurotoxicity study, which confirms the
lack of adverse effects observed in all other repeated-dose studies.
There was no indication of developmental toxicity in studies of
mefenoxam or metalaxyl. There was no indication of immunotoxicity in a
mouse immunotoxicity study of mefenoxam. Metalaxyl and mefenoxam have
been classified as ``not likely to be carcinogenic in humans'' based on
the results for metalaxyl in the carcinogenicity study in mice and the
combined chronic toxicity and carcinogenicity study in rats.
Specific information on the studies received and the nature of the
adverse effects caused by mefenoxam as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level
(LOAEL) from the toxicity studies can be found at https://www.regulations.gov in document ``Mefenoxam, Human Health Risk
Assessment'' at pages 14-17 in docket ID number EPA-HQ-OPP-2015-0014.
B. Toxicological Points of Departure/Levels of Concern
Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). 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 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 https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for mefenoxam used for
human risk assessment is shown in Table 1 of this unit.
[[Page 26724]]
Table 1--Summary of Toxicological Doses and Endpoints for Mefenoxam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure
Exposure/Scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population NOAEL = 50 mg/kg/day Acute RfD = 0.5 mg/ Metalaxyl Prenatal Developmental
including infants, children, and UFA = 10x........... kg/day. Toxicity--Rat
females 13-50 years of age. UFH = 10x........... aPAD = 0.5 mg/kg/ LOAEL = 250 mg/kg/day based on
FQPA SF = 1x........ day. dose-related increases in
clinical signs of toxicity (e.g.,
post-dosing convulsions).
------------------------------------------------------------------------------
Chronic dietary (All populations) No endpoint was identified. No systemic toxicity was observed in any toxicity
study where the animals were administered metalaxyl or mefenoxam in the
diet. Acute dietary assessment is protective of all other durations of
exposure.
------------------------------------------------------------------------------
Incidental oral short-term (1 to NOAEL = 50 mg/kg/day LOC for MOE = 100.. Metalaxyl Prenatal Developmental
30 days) and intermediate-term UFA = 10x........... Toxicity--Rat
(1 to 6 months). UFH = 10x........... LOAEL = 250 mg/kg/day based on
FQPA SF = 1x........ dose-related increases in
clinical signs of toxicity (e.g.,
post-dosing convulsions).
------------------------------------------------------------------------------
Dermal short-term (1 to 30 days) No endpoint was identified. No systemic toxicity was observed at the limit
and intermediate-term (1 to 6 dose (1,000 mg/kg/day) in rabbits treated with metalaxyl during a 21-day
months). dermal toxicity study.
For converting oral to dermal doses for risk assessment, the Dermal
Absorption Factor (DAF) = 35%.
------------------------------------------------------------------------------
Inhalation short-term (1 to 30 NOAEL = 50 mg/kg/day LOC for MOE = 100.. Metalaxyl Prenatal Developmental
days) and intermediate-term (1 UFA = 10x........... Toxicity--Rat
to 6 months). UFH = 10x........... LOAEL = 250 mg/kg/day based on
FQPA SF = 1x........ dose-related increases in
Note: Toxicity via clinical signs of toxicity (e.g.,
the inhalation and post-dosing convulsions).
oral routes are
assumed to be
equivalent..
------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation) Classification: ``Not Likely to be Carcinogenic to Humans'' based on the
absence of treatment-related increases in tumor incidence in adequately
conducted carcinogenicity studies in rats and mice treated with metalaxyl.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
members of the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to mefenoxam, EPA considered exposure under the petitioned-for
tolerances as well as all existing mefenoxam tolerances in 40 CFR
180.546 and metalaxyl tolerances 40 CFR 180.408. EPA assessed dietary
exposures from mefenoxam/metalaxyl 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.
Such effects were identified for mefenoxam. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) 2003-2008 National Health and
Nutrition Examination Survey/What We Eat in America (NHANES/WWEIA). As
to residue levels in food, EPA conducted a somewhat refined acute
dietary exposure assessment for the proposed food use of mefenoxam on
the rapeseed subgroup 20A and the existing uses of both metalaxyl and
mefenoxam. Residues were assumed to be present at tolerance levels in
plant commodities, with additional factors applied to certain plant
commodities to include all residues of concern for risk assessment.
Tolerance-level residues adjusted upward to account for metalaxyl/
mefenoxam residues of concern in livestock commodities were used and
based on data from metabolism studies on goats and hens. DEEM default
and empirical processing factors were used as available. It was assumed
that 100% of the crops were treated (100% CT).
ii. Chronic exposure. No such effects were identified in the
toxicological studies for mefenoxam; therefore, a quantitative chronic
dietary exposure assessment is unnecessary.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that mefenoxam does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
iv. Anticipated residue and percent crop treated (PCT) information.
EPA did not use anticipated residue and/or PCT information in the
dietary assessment for mefenoxam. Tolerance-level residues and/or 100%
CT 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 mefenoxam in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of mefenoxam. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at https://www2.epa.gov/pesticide-science-
[[Page 26725]]
and-assessing-pesticide-risks/about-water-exposure-models-used-
pesticide.
Based on the Surface Water Concentration Calculator (SWCC) and the
Pesticide Root Zone Model-Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of mefenoxam for acute exposures
are estimated to be 741 parts per billion (ppb) for surface water and
3,700 ppb for ground water. These modeled estimates of drinking water
concentrations were directly entered into the dietary exposure model.
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).
Mefenoxam is currently registered for the following uses that could
result in residential exposures: Residential turf and ornamentals,
including nonbearing citrus trees. EPA assessed residential exposure
using the following assumptions: Residential handler exposure is
expected to be short-term in duration. Intermediate-term exposures are
not likely because of the intermittent nature of applications by
homeowners. Residential post-application exposure was assessed based on
short-term incidental oral risk estimates for children 1 < 2 years old.
Dermal post-application risk assessments were not conducted because an
adverse systemic dermal hazard was not identified for mefenoxam.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.
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.'' EPA has not found mefenoxam
to share a common mechanism of toxicity with any other substances, and
mefenoxam does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that mefenoxam does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides
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. There is no evidence that
mefenoxam results in increased susceptibility from in utero exposure to
rats or rabbits in the prenatal developmental studies or exposure to
young rats in the 2-generation reproduction study.
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 metalaxyl and mefenoxam is complete.
ii. In the rat prenatal developmental toxicity with metalaxyl,
maternal animals exhibited clinical signs indicative of neurobehavioral
effects as previously discussed.
In the range-finding acute neurotoxicity study with mefenoxam,
females exhibited abnormal functional observation battery (FOB)
findings at doses lower than in males. In the subchronic neurotoxicity
study with mefenoxam, there were no indications of neurotoxicity up to
the HDT. In metalaxyl and mefenoxam treated adult animals, clinical
signs and abnormal FOB findings were noted. However, a developmental
neurotoxicity (DNT) study is not required for metalaxyl or mefenoxam
because (1) there are no indications of increased susceptibility for
infants or children; (2) the convulsions observed in the rat prenatal
developmental toxicity study occurred in the maternal animals with no
effects being observed in the young; (3) the convulsions occurred only
after a bolus dose; (4) the available developmental and range-finding
acute neurotoxicity studies provided clear NOAELs and LOAELs for
evaluating effects; (5) the current POD is below the level at which any
effects were seen in either study, and (6) there were no other
indications of neurotoxicity in the mefenoxam or metalaxyl databases,
which include a subchronic (adult rat) neurotoxicity study for
mefenoxam. Therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. In metalaxyl and mefenoxam treated animals, there was no
evidence of increased susceptibility following pre-/postnatal exposure
in the prenatal developmental toxicity studies or the reproduction and
fertility effects study. There is no evidence that mefenoxam results in
increased susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance levels or upper bound residue estimates. EPA
made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to mefenoxam in drinking water.
EPA used similarly conservative assumptions to assess postapplication
exposure of children as well as incidental oral exposure of toddlers.
These assessments will not underestimate the exposure and risks posed
by mefenoxam.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an
adequate MOE exists.
1. Acute risk. The acute aggregate risk assessment considers
exposure estimates from dietary consumption of mefenoxam (food and
drinking water). Using the exposure assumptions discussed in this unit
for acute exposure, the acute dietary exposure from food and water to
mefenoxam will occupy 95% of the aPAD for children <1 years old, the
population group
[[Page 26726]]
receiving the greatest exposure, but this is below the level of
concern.
2. Chronic risk. A chronic aggregate risk assessment takes into
account chronic exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from repeated exposure was
identified and no chronic dietary endpoint was selected. Therefore,
mefenoxam is not expected to pose a chronic risk.
3. Short-term and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account both short-term
and intermediate-term residential exposure plus chronic exposure to
food and water (considered to be a background exposure level).
Mefenoxam is currently registered for uses that could result in short-
term and intermediate-term residential exposure, and the Agency has
determined that it is appropriate to aggregate short-term and
intermediate-term residential exposures to mefenoxam. Using the
exposure assumptions described in this unit for short-term and
intermediate-term exposures, EPA has concluded the combined short-term
and intermediate-term food, water, and residential exposures result in
aggregate MOEs of 79,000 for adult; and 1,000 for children 1 < 2 years
old. Because EPA's level of concern for mefenoxam is a MOE of 100 or
below, these MOEs are not of concern.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, mefenoxam is not expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to mefenoxam residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Several methods are available for enforcing tolerances: (1) A gas-
liquid chromatography procedure employing an alkali flame ionization
detector (GLC/AFID); (2) a method using GLC/nitrogen phosphorus
detection; and (3) a multi-residue method in PAM, Vol 1.
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; email address:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for mefenoxam for the rapeseed
crop subgroup 20A.
V. Conclusion
Therefore, tolerances are established for residues of mefenoxam,
methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on
rapeseed subgroup 20A at 0.05 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``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 action 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 FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This action 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 FFDCA section 408(n)(4). 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
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 (NTTAA) (15 U.S.C. 272 note).
VII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
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
the rule in the Federal Register. This action 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.
[[Page 26727]]
Dated: April 21, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.
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. In Sec. 180.546, add alphabetically the entry for ``Rapeseed
subgroup 20A'' to the table in paragraph (a) to read as follows:
Sec. 180.546 Mefenoxam; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
* * * * *
Rapeseed subgroup 20A...................................... 0.05
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-10389 Filed 5-3-16; 8:45 am]
BILLING CODE 6560-50-P
