Document ID: EPA-HQ-OPP-2012-0010-0004
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Quinclorac
Posted Date: 2012-12-21T05:00Z

[Federal Register Volume 77, Number 246 (Friday, December 21, 2012)]
[Rules and Regulations]
[Pages 75561-75566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-30851]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0010; FRL-9372-4]

Quinclorac; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
quinclorac in or on berry, low growing, except strawberry, subgroup 13-
07 H and rhubarb. Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective December 21, 2012. Objections and 
requests for hearings must be received on or before February 19, 2013, 
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-2012-0010, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution 
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information 
about the docket available at 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. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at 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

[[Page 75562]]

identify docket ID number EPA-HQ-OPP-2012-0010 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 February 19, 2013. Addresses for mail and hand delivery of 
objections and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2012-0010, 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 Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at 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 Tolerance

    In the Federal Register of April 4, 2012 (77 FR 20334) (FRL-9340-
4), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
1E7957) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.463 be amended by 
establishing tolerances for residues of the herbicide quinclorac, 3,7-
dichloro-8-quinolinecarboxylic acid, in or on berry, low growing, 
except strawberry, subgroup 13-07H at 1.1 parts per million (ppm) and 
rhubarb at 0.4 ppm. That document referenced a summary of the petition 
prepared on behalf of IR-4 by BASF Corporation, the registrant, which 
is available 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 tolerance levels for the proposed commodities. 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 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 quinclorac including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with quinclorac 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.
    Quinclorac has a low order of acute toxicity via the oral, dermal, 
and inhalation routes of exposure. It is not a skin irritant, but is a 
mild eye irritant and tested positive for dermal sensitization. 
Following subchronic exposures to quinclorac, signs of toxicity 
included decreased body weight gains, increased water intake, increased 
liver enzymes, and focal chronic interstitial nephritis (rats). Chronic 
toxic effects included body weight decrement, increase in kidney and 
liver weights, and hydropic degeneration of the kidneys (dogs). At high 
doses, chronic toxicity also included increased incidences of 
pancreatic acinar cell hyperplasia and adenomas in rats. There was no 
evidence of neurotoxicity in any acute, subchronic and chronic studies 
for quinclorac.
    There was no increased qualitative or quantitative fetal or 
offspring susceptibility in the prenatal developmental or postnatal 
reproduction studies. Developmental toxicity in the rabbit consisted of 
increased resorptions, post-implantation loss, decreased number of live 
fetuses, and reduced fetal body weight. These effects occurred at 
higher doses than the maternal effects of decreased food consumption 
and increased water consumption and decreased body weight gain. In the 
rat, no developmental toxicity was observed up to the highest dose 
tested (HDT). In the 2-generation rat reproduction study, parental 
toxicity and offspring toxicity occurred at the same dose. Parental 
toxicity consisted of reduced body weight in both sexes during 
premating and lactation periods, and offspring toxicity consisted of 
decreased pup weight, developmental delays, and possible marginal 
effect on pup viability. No reproductive toxicity occurred up to the 
HDT in this study.
    Quinclorac is not mutagenic in bacterial assays and does not cause 
unscheduled DNA damage in primary rat hepatocytes. There is also no 
evidence of a genotoxic response in whole animal test systems (in vivo 
mouse bone marrow micronucleus assay) and was negative in a mammalian 
cell in vitro cytogenetic chromosomal aberration assay in Chinese 
hamster ovary cells. Quinclorac produced an equivocal increase in the 
incidence of one type of benign tumor (pancreatic acinar cell adenomas) 
in only one sex of one species of animals (male Wistar rats). There was 
no evidence of carcinogenicity in mice or female rats. Based on this 
limited evidence on cancer, a quantification of cancer risk is not 
warranted because the chronic RfD will adequately account for all 
chronic effects, including carcinogenicity, that may result from 
exposure to quinclorac.
    Specific information on the studies received and the nature of the 
adverse effects caused by quinclorac 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://

[[Page 75563]]

www.regulations.gov in document, ``Quinclorac: First Risk Assessment In 
Support of Registration Review and for New Proposed Use on Rhubarb and 
Berry, low growing, except Strawberry, Subgroup 13-07H,'' pp. 62-65 in 
docket ID number EPA-HQ-OPP-2012-0010.

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 quinclorac used for 
human risk assessment is shown in following Table.

  Table 1--Summary of Toxicological Doses and Endpoints for Quinclorac for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                     Point of departure and
         Exposure/scenario             uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors               assessment                  effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49 years   NOAEL = 200 mg/kg/day.  Acute RfD = 2.0 mg/kg/  Developmental toxicity
 of age).                            UFA = 10x.............   day.                    study in rabbits.
                                     UFH = 10x.............  aPAD = 2.0 mg/kg/day..  LOAEL = 600 mg/kg/day based
                                     FQPA SF = 1x..........                           on increased early
                                                                                      resorptions and
                                                                                      postimplantation loss,
                                                                                      decreased live fetuses,
                                                                                      decreased fetal body
                                                                                      weight.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population       Not applicable. An endpoint for acute dietary exposure to the general
 including infants and children).         population was not selected because there was no available endpoint
                                       attributable to a single exposure that was appropriate for this scenario
                                        (effects observed in the available studies are presumed to require more
                                                                  than one exposure).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)..  NOAEL= 37.5 mg/kg/day.  Chronic RfD = 0.38 mg/  Carcinogenicity study in
                                     UFA = 10x.............   kg/day.                 mice.
                                     UFH = 10x.............  cPAD = 0.38 mg/kg/day.  LOAEL = 150 mg/kg/day based
                                     FQPA SF = 1x..........                           on decreased body weight.
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30       Oral study NOAEL= 70    LOC for MOE = 100.....  Developmental toxicity
 days).                               mg/kg/day (inhalation                           study in rabbits.
                                      absorption rate =                              LOAEL = 200 mg/kg/day based
                                      100%).                                          on decreased maternal body
                                     UFA = 10x.............                           weight gain and food
                                     UFH = 10x.............                           consumption, and increased
                                     FQPA SF = 1x..........                           water consumption.
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term (1 to 30  NOAEL= 70 mg/kg/day...  LOC for MOE = 100.....  Developmental toxicity
 days).                              UFA = 10x.............                           study in rabbits.
                                     UFH = 10x.............                          LOAEL = 200 mg/kg/day based
                                     FQPA SF = 1x..........                           on decreased maternal body
                                                                                      weight gain and food
                                                                                      consumption, and increased
                                                                                      water consumption.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)..   The chronic RfD will adequately account for all chronic effects, including
                                             carcinogenicity, that may result from exposure to quinclorac.
----------------------------------------------------------------------------------------------------------------
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 quinclorac, EPA considered exposure under the petitioned-
for tolerances as well as all existing quinclorac tolerances in 40 CFR 
180.463. EPA assessed dietary exposures from quinclorac 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. EPA identified such an 
effect (increased early resorptions and post-implantation loss, 
decreased live fetuses, and decreased fetal body weight in 
developmental toxicity study in rabbits) for the population subgroup 
females 13 to 49 years old; however, no such effect was identified for 
the general population, including infants and children.
    In estimating acute dietary exposure for females 13-49, the 
population group identified as having an acute dietary exposure, EPA 
used Dietary Exposure Evaluation Model software with the Food Commodity 
Intake Database

[[Page 75564]]

(DEEM-FCID) Version 3.16, which uses food consumption data from the 
U.S. Department of Agriculture's National Health and Nutrition 
Examination Survey, What We Eat in America, (NHANES/WWEIA), conducted 
from 2003-2008. As to residue levels in food, EPA assumed 100 percent 
crop treated (PCT) and tolerance-level residues for all commodities. In 
addition, DEEM version 7.81 default processing factors were used when 
appropriate.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA's 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA assumed 100 PCT and 
tolerance-level residues for all commodities. In addition, DEEM version 
7.81 default processing factors were used when appropriate.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that a nonlinear RfD approach is appropriate for assessing 
cancer risk to quinclorac. Cancer risk was assessed using the same 
exposure estimates as discussed in Unit III.C.1.ii.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for quinclorac. Tolerance level residues and/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 quinclorac in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of quinclorac. 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 Tier I Rice Model, Version 1.0, the estimated drinking 
water concentrations (EDWCs) of quinclorac for surface water are 
estimated to be 511 parts per billion (ppb) for acute and chronic 
exposures. Based on the Screening Concentration in Ground Water (SCI 
GROW) model, the EDWCs for ground water are estimated to be 29 ppb for 
acute and chronic exposures.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute and chronic dietary 
risk assessments, the water concentration value of 511 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). Quinclorac is 
currently registered for the following uses that could result in 
residential exposures: Turf grass and ornamentals. EPA assessed 
residential exposure using the following assumptions: Short-term 
inhalation exposures for residential handlers from mixing, loading, and 
applying quinclorac to residential turf and short-term postapplication 
incidental oral exposures (hand-to-mouth activities) of children from 
contact with treated turf. Intermediate-term exposures resulting from 
adult handler and postapplication exposures were not assessed due to a 
lack of a dermal point of departure. Incidental oral scenarios for 
children are considered to be short-term only. 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 quinclorac to share a common mechanism of 
toxicity with any other substances, and quinclorac does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
quinclorac 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. The toxicology database for 
quinclorac consists of developmental toxicity studies in rats and 
rabbits and a 2-generation reproduction study in rats. There is no 
indication of increased qualitative or quantitative susceptibility of 
rats or rabbit fetuses to in utero and/or postnatal exposure in the 
developmental and reproductive toxicity data.
    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 quinclorac is complete.
    ii. There is no indication that quinclorac is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that quinclorac results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to quinclorac in drinking water. EPA used similarly 
conservative assumptions to assess incidental oral exposures (hand-to-
mouth activities) of toddlers to quinclorac. These assessments will not 
underestimate the exposure and risks posed by quinclorac.

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

[[Page 75565]]

PODs to ensure that an adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to quinclorac will occupy 1.6% of the aPAD for females 13-49, the 
population group for which a potential acute risk was identified.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
quinclorac from food and water will utilize 8.9% of the cPAD for 
infants less than 1 year of age, 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 
quinclorac 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). Quinclorac 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 quinclorac.
    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 2,100 for adults 
and 1,600 for children 1-2 years old. Because EPA's level of concern 
for quinclorac 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, 
quinclorac 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 
quinclorac.
    5. Aggregate cancer risk for U.S. population. Based on the 
discussion in Unit III.A., EPA has concluded that the cPAD is 
protective of possible cancer effects.
    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 quinclorac residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An adequate gas chromatography with electron capture detection (GC/
ECD) method (BASF Method A8902), is available to enforce the tolerance 
expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for quinclorac.

C. Revisions to Petitioned-for Tolerances

    Based on analysis of the residue field trial data supporting the 
petition, EPA revised the proposed tolerances on berry, low growing, 
except strawberry, subgroup 13-07H from 1.1 ppm to 1.5 ppm and rhubarb 
from 0.4 ppm to 0.5 ppm. The Agency revised these tolerance levels 
based on analysis of the residue field trial data using the 
Organization for Economic Co-operation and Development (OECD) tolerance 
calculation procedures.

V. Conclusion

    Therefore, tolerances are established for residues of quinclorac, 
3,7-dichloro-8-quinolinecarboxylic acid, in or on berry, low growing, 
except strawberry, subgroup 13-07H at 1.5 ppm; and rhubarb at 0.5 ppm.

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

[[Page 75566]]

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) (2 U.S.C. 
1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 12, 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.  180.463, add alphabetically the following commodities to 
the table in paragraph (a) to read as follows:

Sec.  180.463  Quinclorac; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Berry, low growing, except strawberry, subgroup 13-07H..             1.5
 
                                * * * * *
Rhubarb.................................................             0.5
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2012-30851 Filed 12-20-12; 8:45 am]
BILLING CODE 6560-50-P