[Federal Register Volume 75, Number 56 (Wednesday, March 24, 2010)]
[Rules and Regulations]
[Pages 14086-14091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-6498]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0092; FRL-8814-2]


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 Swiss chard and bushberry subgroup 13-07B. This 
regulation additionally amends an existing tolerance in or on 
strawberry. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective March 24, 2010. Objections and 
requests for hearings must be received on or before May 24, 2010, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0092. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: 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; e-mail address: [email protected].

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 cite at http://www.gpoaccess.gov/ecfr. To 
access the OPPTS harmonized test guidelines referenced in this document 
electronically, please go to http://www.epa.gpo/oppts and select ``Test 
Methods and Guidelines.''

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. 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-2009-0092 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before May 24, 2010.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2009-0092, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).

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Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of April 8, 2009 (74 FR 15971) (FRL-8407-
4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8E7481) 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 combined residues of the herbicide 
clopyralid, (3,6-dichloro-2-pyridinecarboxylic acid), in or on Swiss 
chard at 5.0 parts per million (ppm) and bushberry subgroup 13-07B at 
6.0 ppm. This petition additionally requested that EPA establish a 
tolerance with regional restrictions in or on strawberry, annual at 4.0 
ppm. That notice referenced a summary of the petition prepared on 
behalf of IR-4 by Dow AgroSciences, the registrant, which is available 
to the public in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance levels on Swiss chard and bushberry 
subgroup 13-07B. The reason for these changes is 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure for the petitioned-for 
tolerances for residues of clopyralid on Swiss chard at 3.0 ppm; 
bushberry subgroup 13-07B at 0.50 ppm; and strawberry at 4.0 ppm. EPA's 
assessment of exposures and risks associated with establishing 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    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 (HDT). 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 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 (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document: ``Human Health Risk Assessment to 
Evaluate New Uses on Swiss Chard, Bushberry Subgroup (13-07B), and 
Strawberry (Regional Restriction),'' at pages 26-30 in docket ID number 
EPA-HQ-OPP-2009-0092.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a benchmark dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by

[[Page 14088]]

dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the level of 
concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for clopyralid used for 
human risk assessment can be found at http://www.regulations.gov in the 
document: ``Human Health Risk Assessment to Evaluate New Uses on Swiss 
Chard, Bushberry Subgroup (13-07B), and Strawberry (Regional 
Restriction),'' at pages 16-18 in docket ID number EPA-HQ-OPP-2009-
0092.

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.
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA used tolerance-
level residues, Dietary Exposure Evaluation Model (DEEM) default 
processing factors, and 100 percent crop treated (PCT) for all proposed 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA used tolerance-level 
residues, DEEM default processing factors, and 100 PCT for all proposed 
commodities.
    iii. Cancer. Based on the evidence discussed in Unit III.A., EPA 
has determined that clopyralid is ``not likely to be carcinogenic to 
humans.'' Therefore, a quantitative exposure assessment to evaluate 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for clopyralid. Tolerance level residues and 100 PCT were assumed for 
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for 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), and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of clopyralid for 
surface water are estimated to be 45.0 parts per billion (ppb) for 
acute exposures and 11.9 ppb for chronic exposures. For ground water, 
the EDWC is estimated to be 0.39 ppb for both acute exposures and 
chronic exposures for non-cancer assessments.
    The Agency also considered available surface and ground water 
monitoring data from the United States Geological Survey (USGS) 
National Water Quality Assessment Data Warehouse (http://water.usgs.gov/nawqa/) for clopyralid. Groundwater concentrations as 
high as 13 ppb have been detected in Alabama and surface water 
concentrations of up to 42 ppb have been detected in North Carolina, 
Illinois, and Ohio. Clopyralid is a persistent chemical that partitions 
to water. Degradation is driven by aerobic aquatic metabolism, though 
this pathway is not directly characterized through a guideline study. 
The degradation behavior for clopyralid best fits second-order 
kinetics, though first-order kinetics are used to derive and 
parameterize FIRST and SCIGROW models. In this case, second-order 
kinetics provide a substantially larger half-life estimate than first-
order kinetics. These modeling limitations likely account for the 
higher concentrations in groundwater from the monitoring data versus 
the groundwater EDWCs. Peak surface water concentrations from 
monitoring data are slightly below the EDWC (45.0 ppb) used to estimate 
the contribution to drinking water for the acute dietary risk 
assessment. Therefore, EPA believes 45.0 ppb is a reasonable, high end 
estimate to be used in risk assessment.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 45.0 ppb was used to 
assess the contribution to drinking water. The EDWC of 11.9 ppb was 
used to assess the contribution to drinking water for chronic dietary 
risk assessment.
    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 residential turf, 
which could result in residential exposures. EPA assessed residential 
exposure using the following assumptions: Short-term inhalation 
exposure for adults applying clopyralid to residential turf by push-
type spreaders, low-pressure hand sprayers, and garden hose end 
sprayers; short-term postapplication exposure for toddlers from 
incidental oral contact with treated turf (hand-to-mouth exposure); 
short-term postapplication incidental oral ingestion of granules from 
treated turf; and intermediate-term postapplication exposure for 
toddlers from incidental oral contact with treated turf (hand-to-mouth 
exposure). 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.
    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

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regarding EPA's efforts to determine which chemicals have a common 
mechanism of toxicity and to evaluate the cumulative effects of such 
chemicals, see EPA's website at 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 Food Quality 
Protection Act safety factor (FQPA 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 except for 
immunotoxicity, acute neurotoxicity, and subchronic neurotoxicity 
testing. Recent changes to 40 CFR part 158 require acute and subchronic 
neurotoxicity testing (OPPTS Guideline 870.6200), and immunotoxicity 
testing (OPPTS Guideline 870.7800) for pesticide registration; however, 
the existing data are sufficient for endpoint selection for exposure/
risk assessment scenarios, and for evaluation of the requirements under 
the FQPA. There are no clinical or micropathological indications of 
neurotoxicity or immunotoxicity in the available subchronic and chronic 
studies in multiple species. Although hydrocephalus was observed in the 
rabbit developmental toxicity study, it was only observed at a dose 
that also caused severe maternal toxicity, including mortality. The 
endpoints selected for risk assessment are considered adequately 
protective of prenatal and/or postnatal toxicity; therefore, an 
additional database uncertainty factor is not needed to account for 
potential immunotoxicity or neurotoxicity.
    ii. In the rabbit developmental toxicity study, neuropathology 
(hydrocephalus) was observed at the HDT. However, the concern for this 
effect is considered low because it occurred at a dose that caused 
severe maternal toxicity, including 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 from in utero exposure to rats or rabbits in the 
prenatal developmental studies or exposure to 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 PCT and tolerance-level residue data. Based on both modeling and 
monitoring data, EPA made reasonable (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 exposure of children as well as 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 pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases given the 
estimated aggregate exposure. Short-term, intermediate-term, and 
chronic-term risks are evaluated by comparing the estimated aggregate 
food, water, and residential exposure to the POD to ensure that the MOE 
called for by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute dietary consumption of food and 
drinking water. Using the exposure assumptions discussed in this unit 
for acute exposure, the acute dietary exposure from food and water to 
clopyralid will occupy 9% of the aPAD for children 1 to 2 years old, 
the population group receiving the greatest exposure.
    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 23% of the cPAD for 
children 1 to 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. While there is 
potential for toddlers to ingest granular formulations of clopyralid 
directly from treated turf, due to the episodic nature of granule 
ingestion, this source of exposure was not included in the short-term 
aggregate assessment. Therefore, 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 5,500 for adult handlers from inhalation exposure and 
1,700 for children 1 to 2 years old from incidental oral (hand-to-
mouth) exposure. The LOC is for MOEs lower than 100. Therefore, the 
aggregate MOEs for short-term exposure are not of concern to EPA.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic

[[Page 14090]]

exposure to food and water (considered to be a background exposure 
level).
    Clopyralid is currently registered for uses that could result in 
intermediate-term residential exposure and the Agency has determined 
that it is appropriate to aggregate chronic exposure to clopyralid 
through food and water with intermediate-term exposures for clopyralid. 
Using the exposure assumptions described in this unit for intermediate-
term exposures, EPA has concluded the combined intermediate-term food, 
water, and residential exposures result in an aggregate MOE of 390 for 
children 1 to 2 years old from incidental oral (hand-to-mouth) 
exposure. The LOC is for MOEs lower than 100. Therefore, the aggregate 
MOE for intermediate-term exposure is not of concern to EPA.
    5. Aggregate cancer risk for U.S. population. Based on the adequate 
cancer studies in rats and mice, EPA has concluded that 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

    There are no Codex or Mexican maximum residue limits (MRLs) for 
residues of clopyralid in or on the requested commodities. There are 
Canadian MRLs for residues of clopyralid at 1.0 ppm on strawberry and 
0.1 ppm on blueberry. While the Canadian MRL for strawberry harmonizes 
with the existing U.S. tolerance for strawberry at 1.0 ppm, the revised 
U.S. tolerance on strawberry at 4.0 ppm cannot be harmonized with the 
Canadian MRL because the residue field trial data supporting the 
revised tolerance resulted in residues that were higher than 1.0 ppm. 
Additionally, the U.S. tolerance on bushberry subgroup 13-07B (at 0.50 
ppm) cannot be harmonized with the Canadian MRL on blueberry (at 0.1 
ppm) because residue field trial data supporting the U.S. tolerance 
resulted in residues that were higher than 0.1 ppm.

C. Revisions to Petitioned-For Tolerances

    Based on analysis of the residue field trial data supporting the 
petition, EPA revised the proposed tolerances on Swiss chard from 5.0 
ppm to 3.0 ppm and bushberry subgroup 13-07B from 6.0 ppm to 0.50 ppm. 
The Agency revised the tolerance levels based on analysis of the 
residue field trial data using the Agency's Tolerance Spreadsheet in 
accordance with the Agency's Guidance for Setting Pesticide Tolerances 
Based on Field Trial Data. Additionally, EPA revised the introductory 
text in paragraph (a) to clarify in the tolerance expression (1) that, 
as provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of clopyralid not specifically mentioned; 
and (2) that compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established for residues of clopyralid, 
(3,6-dichloro-2-pyridinecarboxylic acid), in or on Swiss chard at 3.0 
ppm; bushberry subgroup 13-07B at 0.50; and strawberry at 4.0 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, 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 section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 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,

[[Page 14091]]

Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 12, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.431, paragraph (a) is amended as follows:
    i. Revise the introductory text.
    ii. In the table, revise the entry for ``Strawberry'', and add 
alphabetically ``Bushberry subgroup 13-07B'' and ``Swiss chard'' to 
read as follows:


Sec.  180.431  Clopyralid; tolerances for residues.

    (a) General.. Tolerances are established for residues of the 
herbicide clopyralid, including its metabolites and degradates, in or 
on the commodities in the table below from its application in the acid 
form or in the form of its salts. Compliance with the tolerance levels 
specified below is to be determined by measuring only clopyralid, (3,6-
dichloro-2-pyridinecarboxylic acid), in or on the following 
commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Bushberry subgroup 13-07B............................               0.50
                                * * * * *
Strawberry...........................................                4.0
Swiss chard..........................................                3.0
                                * * * * *
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-6498 Filed 3-23-10; 8:45 am]
BILLING CODE 6560-50-S