[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Rules and Regulations]
[Pages 58045-58050]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22754]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0569; FRL-9361-5]
Clopyralid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of
clopyralid in or on multiple commodities which are identified and
discussed later in this document. This regulation additionally removes
several established individual tolerances, as they will be superseded
by inclusion in subgroup tolerances. Interregional Research Project
Number 4 (IR-4) requested these tolerances under the Federal Food,
Drug, and Cosmetic Act (FFDCA).
DATES: This regulation is effective September 19, 2012. Objections and
requests for hearings must be received on or before November 19, 2012,
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-2011-0569, is available at http://www.regulations.gov or at the OPP Docket in the Environmental
Protection Agency Docket Center (EPA/DC), located in EPA West, 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 http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Laura Nollen, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number: (703) 305-7390; email address: Nollen.Laura@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to those
engaged in the following activities:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather 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 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 http://ecfr.gpoaccess.gov/cgi/t/text/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-2011-0569 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
November 19, 2012. 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 that does not contain any 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 a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0569, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be
[[Page 58046]]
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), Mail Code: 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 http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Summary of Petitioned-for Tolerances
In the Federal Register of August 26, 2011 (76 FR 53372) (FRL-8884-
9), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 1E7882)
by IR-4, 500 College Road East, Suite 201W., Princeton, NJ 08540. The
petition requested that 40 CFR 180.431 be amended by establishing
tolerances for residues of the herbicide clopyralid, (3,6-dichloro-2-
pyridinecarboxylic acid), in or on apple at 0.05 parts per million
(ppm); brassica, leafy greens, subgroup 5B at 5.0 ppm; rapeseed
subgroup 20A, except gold of pleasure, seed at 3.0 ppm; rapeseed
subgroup 20A, except gold of pleasure, meal at 6.0 ppm; and rapeseed
subgroup 20A, except gold of pleasure, forage at 3.0 ppm. That notice
referenced a summary of the petition prepared on behalf of IR-4 by Dow
AgroSciences, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Additionally, in the Federal Register of July 25, 2012 (77 FR
43562) (FRL-9353-6), EPA issued a notice pursuant to FFDCA section
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide
petition (PP 2E8013) by IR-4. The petition requested that 40 CFR
180.431 be amended by establishing tolerances for residues of the
herbicide clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or
on teff, forage at 9.0 ppm; teff, grain at 3.0 ppm; teff, straw at 9.0
ppm; and teff, hay at 9.0 ppm. That notice referenced a summary of the
petition prepared on behalf of IR-4 by Dow AgroSciences, the
registrant, which is available in docket ID number EPA-HQ-OPP-2012-
0309, http://www.regulations.gov. There were no comments received in
response to the notice of filing.
Based upon review of the data supporting the petition, EPA has
determined that the proposed tolerance on rapeseed subgroup 20A, except
gold of pleasure, forage is not necessary. Additionally, EPA has
determined that several established tolerances should be removed.
Finally, the Agency determined that the proposed tolerance on rapeseed
subgroup 20A, except gold of pleasure, meal should be established as a
tolerance on rapeseed, meal. The reasons for these changes are
explained in Unit IV.C.
III. Aggregate Risk Assessment and Determination of Safety
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue * *
*.''
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 clopyralid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with clopyralid 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.
Clopyralid has low acute toxicity via the oral, dermal, and
inhalation routes of exposure. It is not a dermal irritant or
sensitizer, but it is a severe eye irritant in its acid form. No
consistent mammalian target organ was identified in the clopyralid
toxicological studies submitted to the Agency. Effects were noted in
various organs and systems in different species, including increases in
liver weight, changes in clinical chemistry and blood cell parameters,
skin lesions, and decreases in body weight gain.
In subchronic mouse studies, decreased body weights were observed
in males and females. Following chronic exposure, effects in dogs
included reductions in red blood cell parameters, increased liver
weight (males), and vacuolated adrenal cortical cells (females).
Additionally, skin lesions and clinical chemistry changes (decreased
serum glucose, protein, and albumin) were observed at the highest dose
tested. In the rat, epithelial hyperplasia, thickening of the limiting
ridge of the stomach, and decreased body weight were observed following
chronic exposure. There were no clinical indications of neurotoxicity
or immunotoxicity in the subchronic or chronic toxicity studies.
No developmental toxicity was observed in the rat at doses that
caused maternal mortality and decreased body weight gains. In the
rabbit developmental toxicity study, decreased fetal body weights and
hydrocephalus were observed at a dose that caused severe maternal
toxicity including a high rate of mortality, clinical signs of
toxicity, decreased body weight gains, and gastric mucosal lesions.
Reproductive toxicity was not observed in the rat, but mean pup weight
reductions and relative liver weight increases were observed at doses
that caused parental toxicity (decreased body weight/weight gain and
food consumption and gastric lesions).
There was no evidence of carcinogenic potential in the rat and
mouse 2-year carcinogenicity studies. Further, there were no positive
findings for mutagenicity or clastogenicity observed in a battery of
mutagenicity studies (including bacterial reverse gene mutation, in
vitro and in vivo host-mediated assays in Salmonella and Saccharomyces,
in vivo chromosomal aberrations, unscheduled DNA synthesis, and
dominant lethal activity studies). Based on the results of these
studies, EPA has determined that clopyralid is ``not likely to be
carcinogenic to humans.''
Specific information on the studies received and the nature of the
adverse effects caused by clopyralid as well as the no-observed-
adverse-effect-level
[[Page 58047]]
(NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the
toxicity studies can be found at http://www.regulations.gov in
document, ``Clopyralid. Human Health Risk Assessment for New Uses on
Apples, Teff, Brassica Leafy Greens, and Rapeseed'' at pages 32-35 in
docket ID number EPA-HQ-OPP-2011-0569.
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 http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for clopyralid used for
human risk assessment is shown in Table 1 of this unit. EPA notes that
in the last final rule for clopyralid, published in the Federal
Register of March 24, 2010 (75 FR 14086) (FRL-8814-2), the Agency
identified an acute dietary toxicological POD based on decreased
maternal body weight in the rat developmental toxicity study. However,
upon reevaluation of the toxicological database for clopyralid, EPA
determined that the effect is not the result of a single dose, and is
not appropriate for an acute dietary endpoint. Additionally, while the
last final rule included endpoints and points of departure for
intermediate-term residential scenarios, including postapplication
incidental oral exposure for children, the Agency has reevaluated this
scenario and has determined that for clopyralid, residential exposure
to children on turf is not likely to occur over an intermediate-term
duration (i.e., 1 month to 6 months). Further, intermediate-term
exposures are not expected for residential handlers, based on the use
pattern.
Table 1--Summary of Toxicological Doses and Endpoints for Clopyralid for Use in Human Health Risk Assessment
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Point of departure and
Exposure/Scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
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Acute dietary (Females 13-50 years An appropriate endpoint for a single exposure was not identified.
of age and general population,
including infants and children).
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Chronic dietary (All populations).. NOAEL = 15 mg/kg/day.. Chronic RfD = 0.15 mg/ 2-Year Combined Chronic
UFA = 10x............. kg/day. Toxicity/Carcinogenicity
UFH = 10x............. cPAD = 0.15 mg/kg/day. (oral)--rat LOAEL = 150 mg/
FQPA SF = 1x.......... kg/day based on increased
epithelial hyperplasia and
thickening of the limiting
ridge of the stomach in
both sexes.
Incidental oral short-term (1 to 30 NOAEL = 75 mg/kg/day LOC for MOE = 100..... Developmental Toxicity
days). UFA = 10x. (oral)--rat LOAEL = 250 mg/
UFH = 10x............. kg/day based on decreased
FQPA SF = 1x.......... body weight gain and food
consumption during
gestation days 6-9.
Inhalation short-term (1 to 30 Inhalation (or oral) LOC for MOE = 100..... Developmental Toxicity
days). study NOAEL = 75 mg/ (oral)--rat LOAEL = 250 mg/
kg/day. kg/day based on decreased
(inhalation absorption body weight gain and food
rate = 100%). consumption during
UFA = 10x............. gestation days 6-9.
UFH = 10x.............
FQPA SF = 1x..........
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Cancer (Oral, dermal, inhalation).. ``Not likely to be carcinogenic to humans.'' Cancer risk is not of concern.
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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 clopyralid, EPA considered exposure under the petitioned-
for tolerances as well as all existing clopyralid tolerances in 40 CFR
180.431. EPA assessed dietary exposures from clopyralid 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 clopyralid; 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 Continuing Surveys of Food Intakes by
[[Page 58048]]
Individuals (CSFII). As to residue levels in food, EPA assumed
tolerance-level residues, 100 percent crop treated (PCT) estimates, and
DEEMTM ver. 7.81 default processing factors.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that clopyralid 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 or PCT information in the dietary
assessment for clopyralid. Tolerance level residues or 100 PCT were
assumed for all food commodities.
2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for clopyralid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of clopyralid. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
Based on the First Index Reservoir Screening Tool (FIRST) model,
the estimated drinking water concentration (EDWC) of clopyralid for
chronic exposures is estimated to be 11.9 parts per billion (ppb) for
surface water. The Agency also considered available monitoring data
from the United States Geological Survey (USGS) National Water Quality
Assessment Data Warehouse (http://water.usgs.gov/nawqa/) for
clopyralid. For ground water monitoring data, the peak observed value
for detectable levels of clopyralid was 0.5288 ppb (Oregon) with a
nationwide mean value of 0.065 ppb. Therefore, the EDWC of clopyralid
for chronic exposures is estimated to be 0.5288 ppb for ground water.
For chronic dietary risk assessment, the water concentration of
value 11.9 ppb was used to assess the contribution to drinking water.
3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
Clopyralid is currently registered for use on lawns, turf, and
ornamentals in residential and public areas, which could result in
residential exposures. EPA assessed residential exposure using the
following assumptions: Short-term inhalation exposure for adult
residential handlers and short-term postapplication exposure for
children from incidental oral contact with treated turf (hand-to-mouth,
object-to-mouth and soil ingestion). Although dermal exposure is
anticipated from residential use of clopyralid, risks via the dermal
route of exposure are not of concern for clopyralid; therefore, dermal
risks were not quantitatively assessed for residential exposure.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
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 clopyralid to share a common mechanism of
toxicity with any other substances, and clopyralid does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
clopyralid 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 http://www.epa.gov/pesticides/cumulative.
D. Safety Factor for Infants and Children
1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. There was no evidence of
increased prenatal and/or postnatal qualitative or quantitative
susceptibility in the available studies in the toxicology database,
including the rat and rabbit developmental toxicity studies and a 2-
generation reproduction toxicity study in rats. In the developmental
rat study, no developmental effects were seen at doses that caused
maternal toxicity. In the rabbit developmental study, hydrocephalus and
decreased mean fetal weight were observed at a dose that caused severe
maternal toxicity, including mortality. In the 2-generation
reproduction study, decreased pup weights and increased relative liver
weights were observed at the same level that resulted in parental
toxicity (decreased body weights, body weight gains and food
consumption and slight focal hyperkeratotic changes in the gastric
squamous mucosa).
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 clopyralid is complete. EPA has waived
the requirement of a 28-day inhalation toxicity study in rats (OCSPP
Guideline 870.3465) based on the low volatility and low acute
inhalation toxicity for clopyralid, as well as the selection of
conservative and adequately protective points of departure from oral
studies for clopyralid. As the 28-day inhalation toxicity study was not
required, oral studies were considered for use with route-to-route
extrapolation for the short-term adult handler inhalation exposure
assessment. For short-term inhalation exposure, the maternal toxicity
NOAEL of 75 mg/kg/day from the rat developmental toxicity study was
selected based on mortality, decreased maternal body weight gain, and
decreased food consumption at the LOAEL of 250 mg/kg/day. This study
was chosen because it was of the appropriate duration and route, and it
provided the most sensitive NOAEL. This endpoint is protective of
potential pre- and postnatal toxicity because developmental toxicity in
the rabbit was only seen in the presence of significant maternal
toxicity (maternal/developmental NOAEL = 250 mg/kg/day), and
developmental toxicity in the rat was not observed up to a maternally
toxic dose. As such, it is considered to be a conservative endpoint for
this exposure scenario.
ii. In the rabbit developmental toxicity study, neuropathology
(hydrocephalus) was observed at the highest dose tested. However, the
concern for this effect is considered low because it occurred at a dose
that caused severe maternal toxicity, including a
[[Page 58049]]
high rate of mortality and decreased body weight gain and food
consumption. Further, there was no evidence of neurotoxicity in the rat
developmental or reproduction studies or in the available subchronic or
chronic studies; therefore, there is no need for a developmental
neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no evidence that clopyralid 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 chronic dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to clopyralid in drinking water. EPA used similarly
conservative assumptions to assess postapplication incidental oral
exposure of toddlers. These assessments will not underestimate the
exposure and risks posed by clopyralid.
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. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
clopyralid is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
clopyralid from food and water will utilize 25% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
clopyralid is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Clopyralid is
currently registered for uses that could result in short-term
residential exposure, and the Agency has determined that it is
appropriate to aggregate chronic exposure through food and water with
short-term residential exposures to clopyralid.
Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 5,300 for the
general population and 1,700 for children 1-2 years old. Because EPA's
level of concern for clopyralid is a MOE of 100 or below, these MOEs
are not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
clopyralid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
clopyralid.
5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, clopyralid is not expected to pose a cancer risk to humans.
6. 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 clopyralid residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
The following adequate enforcement methodology is available in The
Pesticide Analytical Manual Vol. II to enforce the tolerance expression
for plant commodities: a gas chromatography/electron-capture detection
(GC/ECD) method.
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 clopyralid in or on the
commodities associated with these petitions.
C. Revisions to Petitioned-for Tolerances
Based on the data supporting the petitions, EPA has determined that
the proposed tolerance on rapeseed subgroup 20A, except gold of
pleasure, forage at 3.0 ppm is not necessary because the commodity is
not a significant livestock feed item. Additionally, the Agency has
determined that the established tolerances in or on crambe, seed; flax,
seed; mustard, seed; and rapeseed, seed should be removed because they
are superseded by inclusion in rapeseed, subgroup 20A, except gold of
pleasure at 3.0 ppm. EPA is also removing the established tolerance on
mustard greens, as it is superseded by inclusion in brassica, leafy
greens, subgroup 5B. Finally, the Agency determined that the proposed
tolerance on rapeseed subgroup 20A, except gold of pleasure, meal at
6.0 ppm should be established on rapeseed, meal at 6.0 ppm. The EPA may
establish an individual tolerance on a processed commodity that is a
member of rapeseed subgroup 20A. However, the Agency will not establish
a subgroup tolerance for processed foods prepared from crops covered by
a group tolerance, as outlined in 40 CFR 180.40, paragraph (f).
Therefore, a separate tolerance for the processed commodity is
appropriate.
V. Conclusion
Therefore, tolerances are established for residues of clopyralid,
(3,6-dichloro-
[[Page 58050]]
2-pyridinecarboxylic acid), in or on apple at 0.05 ppm; brassica, leafy
greens, subgroup 5B at 5.0 ppm; rapeseed, subgroup 20A, except gold of
pleasure at 3.0 ppm; rapeseed, meal at 6.0 ppm; teff, forage at 9.0
ppm; teff, grain at 3.0 ppm; teff, hay at 9.0 ppm; and teff, straw at
9.0 ppm. This regulation additionally removes established tolerances in
or on crambe, seed; flax, seed; mustard greens; mustard, seed; and
rapeseed, seed.
VI. Statutory and Executive Order Reviews
This final rule 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 final rule has
been exempted from review under Executive Order 12866, this final rule
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 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 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 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 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 final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
VII. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 10, 2012.
Lois Rossi,
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. 180.431, paragraph (a) is amended by removing the
commodities ``Crambe, seed''; ``Flax, seed''; ``Mustard greens'';
``Mustard, seed''; and ``Rapeseed, seed'' from the table and by adding,
alphabetically, the following commodities to the table to read as
follows:
Sec. 180.431 [Amended]
(a) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Apple....................................................... 0.05
* * * * *
Brassica, leafy greens, subgroup 5B......................... 5.0
* * * * *
Rapeseed, meal.............................................. 6.0
Rapeseed, subgroup 20A, except gold of pleasure............. 3.0
* * * * *
Teff, forage................................................ 9.0
Teff, grain................................................. 3.0
Teff, hay................................................... 9.0
Teff, straw................................................. 9.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2012-22754 Filed 9-18-12; 8:45 am]
BILLING CODE 6560-50-P