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[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several established individual tolerances, as they will be superseded 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).
                                    ----------------------------------------------------------------------------
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..........
                                    ----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..  ``Not likely to be carcinogenic to humans.'' Cancer risk is not of concern.
----------------------------------------------------------------------------------------------------------------
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
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