
[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Rules and Regulations]
[Pages 71523-71528]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28640]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0429; FRL-9902-15]


Quinclorac; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of 
quinclorac in or on rapeseed, subgroup 20A. BASF Corporation requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective November 29, 2013. Objections and 
requests for hearings must be received on or before January 28, 2014, 
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-2012-0429, 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: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2012-0429 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 
January 28, 2014. 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-2012-0429, 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 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.html.
    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 July 25, 2012 (77 FR 43562) (FRL-9353-
6), 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 
2E8035) by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research 
Triangle Park, NC 27709-3528. 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 rapeseed, subgroup 20A at 1.0 parts per million (ppm). That document 
referenced a summary of the petition prepared 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.
    EPA has revised this tolerance level based on analysis of the 
residue field trial data using the Organization for Economic Co-
operation and Development (OECD) tolerance calculation procedures. The 
reason for this change is explained in Unit IV.D.

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

[[Page 71524]]

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 low acute toxicity by oral, inhalation, and dermal 
routes of exposure. It is minimally irritating to the eye and non-
irritating to the skin. Quinclorac is a skin sensitizer.
    Subchronic toxicity includes, decreased body weight gains, 
increased water intake, increased liver enzymes, and focal chronic 
interstitial nephritis (rats). Chronic toxic effects include body 
weight decrement, increase in kidney, and liver weights, and hydropic 
degeneration of the kidneys (dogs). At high doses, chronic toxicity 
also includes increased incidences of pancreatic acinar cell 
hyperplasia, and adenomas (rats). Neurotoxic effects were not observed 
in any of the acute, subchronic and chronic studies with 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 much 
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 at the highest dose tested 
(HDT) (438 milligrams/kilogram/day (mg/kg/day)). In the 2-generation 
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. Offspring toxicity 
consisted of decreased pup weight, developmental delays and a possible 
marginal effect on pup viability. No reproductive toxicity occurred at 
the HDT (480 mg/kg/day).
    There are no mutagenicity concerns. 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). Quinclorac was negative in a mammalian cell in vitro 
cytogenetic chromosomal aberration assay in Chinese hamster ovary cells 
(CHO). 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 of cancer, a quantification of cancer risk is not warranted 
because the chronic reference dose (RfD) will adequately account for 
all chronic effects, including carcinogenicity, likely to result from 
exposure to quinclorac.
    Neurotoxic effects were not observed in any of the acute, 
subchronic and chronic studies with quinclorac. Due to lack of evidence 
of neurotoxic effects, the Agency has determined that no acute, 
subchronic, or developmental neurotoxicity studies are required for 
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://www.regulations.gov in document ``Quinclorac: Risk Assessment to 
Support Permanent Tolerance for Rapeseed Subgroup 20A without U.S. 
Registration'' in docket ID number EPA-HQ-OPP-2012-0429.

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 (LOC) 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 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 Table 1 of this unit.

[[Page 71525]]



  Table 1--Summary of Toxicological Doses and Endpoints for Quinclorac for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary....................  NOAEL = 200 mg/kg/    Acute RfD = 2.0 mg/  Developmental toxicity study in
(Females 13-50 years of age).....   day.                  kg/day.              rabbits.
                                   UFA = 10x...........  aPAD = 2.0 mg/kg/    LOAEL = 600 mg/kg/day based on
                                   UFH = 10x...........   day.                 increased early resorptions and
                                   FQPA SF = 1x........                        postimplantation loss, decreased
                                                                               live fetuses, decreased fetal
                                                                               body weight. These fetal effects
                                                                               are presumed to occur after a
                                                                               single dose.
----------------------------------------------------------------------------------------------------------------
Acute dietary....................  None................  None...............  No acute dietary endpoint selected
(General population including                                                  based on the absence of an
 infants and children).                                                        appropriate endpoint attributed
                                                                               to a single dose.
----------------------------------------------------------------------------------------------------------------
Chronic dietary..................  NOAEL = 37.5 mg/kg/   Chronic RfD = 0.38   Carcinogenicity study in mice.
(All populations)................   day.                  mg/kg/day.          LOAEL = 150 mg/kg/day based on
                                   UFA = 10x...........  cPAD = 0.38 mg/kg/    decreased body weight.
                                   UFH = 10x...........   day.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Incidental oral short-term.......  NOAEL =.............  LOC for MOE = 100..  Developmental toxicity study in
(1 to 30 days)...................  70 mg/kg/day........                        rabbits.
                                   UFA = 10x...........                       LOAEL = 200 mg/kg/day based on
                                   UFH = 10x...........                        decreased maternal body weight
                                   FQPA SF = 1x........                        gain, and food consumption, and
                                                                               increased water consumption.
----------------------------------------------------------------------------------------------------------------
Dermal short-term................  None................  None...............  No adverse effects were seen in
(1 to 30 days)...................                                              dermal studies
----------------------------------------------------------------------------------------------------------------
Dermal intermediate-term.........  None................  None...............  Same
(1 to 6 months)..................
----------------------------------------------------------------------------------------------------------------
Inhalation short-term (1 to 30     Inhalation (or oral)  Residential LOC for  Developmental toxicity study in
 days).                             study.                MOE = 100.           rabbits.
and intermediate-term (1 to 6      NOAEL = 70 mg/kg/day                       Maternity toxicity LOAEL = 200 mg/
 months).                           (inhalation                                kg/day based on decreased
                                    absorption rate =                          maternal body weight gain and
                                    100%).                                     food consumption, and increased
                                   UFA = 10x...........                        water consumption.
                                   UFH = 10x...........
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Inhalation.......................  None................  None...............  Long-term inhalation exposure is
(1 to 6 months)..................                                              not anticipated under current use
                                                                               scenarios.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Quantification of risk using the chronic RfD will adequately account for all
                                    chronic effects, including carcinogenicity, which 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 = milligrams/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. 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. Such effects were identified 
for quinclorac. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 2003-2008 National Health and Nutrition Examination 
Survey, What We Eat in America (NHANES/WWEIA). As to residue levels in 
food, the acute dietary assessment assumes 100% crop treated (PCT) 
along with tolerance or maximum residue level estimates for quinclorac 
and its methyl ester metabolite. It used dietary exposure evaluation 
model (DEEM) default processing factors and an empirical processing 
factor for oil commodities of rapeseed subgroup 20A.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 2003-2008, 
NHANES/WWEIA. As to residue levels in food, the chronic dietary 
assessment used the same residue levels, processing factors and 100 PCT 
assumptions used in the acute dietary assessment.
    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.

[[Page 71526]]

    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for quinclorac. Tolerance or maximum residue levels for quinclorac and 
its methyl ester metabolite 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 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 POD. 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 Food Quality 
Protection Act (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 tolerance or maximum residue levels for residues of concern and 
assumed 100 PCT. 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 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 and its methyl ester metabolite will occupy 1.6% of the 
aPAD for females age 13 to 49 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 
quinclorac and its methyl ester metabolite 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

[[Page 71527]]

(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 to 2 years old. Because EPA's LOC 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. As explained in Unit 
III.A., the cPAD is protective of all effects, including 
carcinogenicity. Based on the chronic risk assessment described in Unit 
III.E.2., there is no concern for any potential carcinogenic effects 
from quinclorac.
    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

    Adequate enforcement methodology for quinclorac (liquid 
chromatography with tandem mass spectrometric detection (LC/MS/MS) 
method (BASF method D9708/1) and quinclorac methyl ester LC/MS/MS 
method (BASF method D9806/02) are 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 the data submitted with the petition, EPA is revising the 
proposed tolerances in or on rapeseed subgroup 20A from 1.0 ppm to 1.5 
ppm. The Agency revised this tolerance level based on analysis of the 
residue field trial data using the Organization for Economic Co-
operation and Development (OECD) tolerance calculation procedures. 
Additionally, the Agency determined that the tolerance expression for 
proposed tolerance on rapeseed subgroup 20A should include quinclorac 
methyl ester.
    The qualitative nature of quinclorac residues in plants was 
considered adequately understood for the currently registered crops, 
based upon the metabolism studies on rice, sorghum, and wheat. 
Additional metabolism data were submitted for quinclorac on canola to 
support use on rapeseed. This study showed a significant level of 
quinclorac methyl ester. The qualitative nature of quinclorac residues 
in livestock is also understood based upon the adequate goat and 
poultry metabolism studies. In earlier risk assessments, EPA had 
concluded that parent is the only residue of concern in both plant and 
livestock commodities for purposes of the tolerance expression and risk 
assessment. For the current action, because of the significant level of 
quinclorac methyl ester found, the Agency concluded that the residue of 
concern on canola is quinclorac and its methyl ester.

V. Conclusion

    Therefore, tolerances are established for residues of the herbicide 
quinclorac, including its metabolites and degradates, in or on the 
following commodity. Compliance with the tolerance levels specified in 
this paragraph is to be determined by measuring only quinclorac, 3,7-
dichloro-8-quinolinecarboxylic acid, and its methyl ester, methyl-3,7-
dichloro-8-quinolinecarboxylate, calculated as the stoichiometric 
equivalent of quinclorac, in or on rapeseed, subgroup 20A at 1.5 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

[[Page 71528]]

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) (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: November 22, 2013.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.463:
0
a. Designate the text of paragraph (a) as paragraph (a)(1).
0
b. Add new paragraph (a)(2).
    The amendments read as follows:


Sec.  180.463  Quinclorac; tolerances for residues.

    (a) * * *
    (2) Tolerances are established for residues of the herbicide 
quinclorac, including its metabolites and degradates, in or on the 
commodity in the following table. Compliance with the tolerance levels 
specified in this paragraph is to be determined by measuring only 
quinclorac, 3,7-dichloro-8-quinolinecarboxylic acid, and its methyl 
ester, methyl-3,7-dichloro-8-quinolinecarboxylate, calculated as the 
stoichiometric equivalent of quinclorac, in or on the commodity.

------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Rapeseed, subgroup 20A \1\................                           1.5
------------------------------------------------------------------------
\1\ There are no U.S. Registrations.

* * * * *
[FR Doc. 2013-28640 Filed 11-27-13; 8:45 am]
BILLING CODE 6560-50-P


