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[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
[Pages 18810-18815]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07563]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0164; FRL-9903-11]

Proquinazid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
proquinazid in or on grape and raisin. DuPont Crop Protection requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA).

DATES: This regulation is effective April 4, 2014. Objections and 
requests for hearings must be received on or before June 3, 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-2012-0164, 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

[[Page 18811]]

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-2012-0164 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 
June 3, 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-2012-0164, 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.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 May 2, 2012 (77 FR 25954) (FRL-9346-1), 
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 1E7972) 
by DuPont Crop Protection, Stine Haskell Research Center, P.O. Box 30, 
Newark, DE 19714-0030. The petition requested that 40 CFR 180.674 be 
amended by establishing tolerances for residues of the fungicide 
proquinazid, 6-Iodo-2-propoxy-3-propyl-3H-quinazolin-4-one, in or on 
imported commodities to include grape at 0.5 parts per million (ppm) 
and raisin at 1.0 ppm. That document referenced a summary of the 
petition prepared by DuPont Crop Protection., 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 
changed one of the requested commodity names from raisin; to grape, 
raisin; and added a significant figure to the numerical grape 
tolerance. The reasons for these changes are explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for proquinazid including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with proquinazid 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.
    Proquinazid has no significant acute toxicity via the oral, dermal, 
or inhalation routes of exposure. It is not an eye or skin irritant and 
does not cause skin sensitization. Based on the results of a 28-day 
dermal study in rats (as well as the dermal lethal dose (LD) study), 
proquinazid is poorly absorbed through the skin.

[[Page 18812]]

    The liver and thyroid are the primary target organs for 
proquinazid. In rodents, body weight/body weight gain reductions, 
increased liver and thyroid organ weights, hypertrophy/hyperplasia, 
liver enzyme induction, and thyroid hormone changes were seen across 
varying durations and routes of exposure in rodents but not in dogs. In 
the 90-day oral rat study, the low dose effects of proquinazid are 
characterized primarily by altered thyroid hormones and associated 
follicular cell hypertrophy in the thyroid. Decrements in body weight 
and nutritional parameters, as well as histopathological changes in the 
liver (including hypertrophy) were observed at higher doses. In a 28-
day oral rat study, hypertrophy of the thyroid and liver was completely 
reversible after a 6 week recovery period. In chronic rodent studies, 
non-neoplastic effects in both mice and rats included thyroid 
follicular hyperplasia and hypertrophy, with associated thyroid hormone 
changes (only investigated in rats), and some marked hepatic lesions, 
i.e., necrosis and hyperplasia (including oval cell hyperplasia in 
rats). In addition, chronic exposure in rats led to increases in the 
incidence of liver and thyroid tumors. The mode of action for the 
thyroid tumors in rats involves early changes in liver enzyme 
regulation that lead to dis-regulation of thyroid hormone homeostasis 
thyroid follicular hypertrophy/hyperplasia, and thyroid follicular 
adenoma formation. Mode of action data were submitted on the thyroid 
follicular cell tumors observed in male rats and the 
cholangiocarcinomas observed in female rats. The hypothesized mode of 
action (i.e., non-genotoxic) for each tumor type (i.e, the thyroid and 
cholangiocarcinoma) was supported by adequate studies that clearly 
identified the sequence of key events, dose-response concordance, and 
temporal relationship to the tumor types. No treatment-related tumors 
were observed in male or female mice. The overall weight-of-evidence 
was considered sufficient to demonstrate that proquinazid thyroid 
follicular tumors are the result of an anti-thyroidal mode of action 
and that a carcinogenic response would not be expected at doses below 
the threshold for changes in liver enzyme regulation leading to dis-
regulation of thyroid hormone homeostasis. The data also shows that 
rats are substantially more sensitive than humans to the development of 
thyroid follicular cell tumors in response to thyroid hormone 
imbalance. Proquinazid induced cholangiocarcinomas in female rats only 
at doses that produced marked liver toxicity and oval cell hyperplasia 
microscopically. In contrast, in both male and female rats, doses that 
produced less severe or no hepatotoxicity or oval cell proliferation 
did not produce chlolangiocarcinomas. Therefore, at high enough doses, 
proquinazid can cause these biochemical and histopathological effects 
in livers of rodents but is unlikely to be carcinogenic at doses below 
those causing these changes. In contrast, in both male and female rats, 
doses that produced less severe or no hepatoxicity or oval cell 
proliferation did not produce cholangiocarcinomas. Therefore, at high 
enough doses, proquinazid can cause these biochemical and 
histopathological effects in livers of rodents but is unlikely to be 
carcinogenic at doses below those causing these changes. Therefore, the 
Agency determined that quantification of risk using a non-linear 
approach (i.e., reference dose (RfD) will adequately protect for all 
chronic toxicity, including carcinogenicity, that could result from 
exposure to proquinazid.
    There is no mutagenicity concerns from in vivo or in vitro genetic 
toxicity assays. Proquinazid was not found to be immunotoxic. No 
evidence of increased quantitative or qualitative susceptibility was 
seen following in utero exposure to proquinazid with rats or rabbits in 
the prenatal developmental studies or in young rats in the 2-generation 
reproduction study. The 2-generation rat reproduction study resulted in 
no effects on reproduction or fertility. The offspring effects 
(decreases in F1 pup weight during lactation) occurred at 
the same dose which caused parental effects (thyroid hypertrophy, 
reduced body weight gain, and food consumption). Evidence of 
developmental delays were observed in developmental toxicity studies in 
rabbits and rats and were characterized by reduced fetal weight and an 
increased incidence of retarded ossification and patent ductus 
arteriosus, respectively. These developmental effects occurred in the 
presence of maternal toxicity and were considered of equal toxicity.
    There is limited evidence for neurotoxicity following oral 
exposures to proquinazid. Following a single exposure, evidence for 
neurotoxicity at the lowest observed adverse effect level (LOAEL) was 
limited to decreased motor activity in both sexes with no behavioral or 
neuropathology changes. At doses above the study LOAEL other effects 
including decreased grip strength and food splay were observed. 
Following repeated (dietary) exposures, there were no treatment-related 
clinical signs of neurotoxicity, behavioral changes or neuropathology. 
Specific information on the studies received and the nature of the 
adverse effects caused by proquinazid as well as the no observed 
adverse effect level (NOAEL) and the LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in document ``Proquinazid: 
Human Health Risk Assessment for the Tolerance on Imported Grapes'' 
dated September 2013 at pages 23 through 35 in docket ID number EPA-HQ-
OPP-2012-0164.

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 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 proquinazid used for 
human risk assessment is shown in Table 1. of this unit. Because only 
oral exposure are anticipated for imported grapes, no other endpoints 
are relevant such as dermal and inhalation exposures.

[[Page 18813]]

  Table 1--Summary of Toxicological Doses and Endpoints for Proquinazid for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
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Acute dietary (General population  NOAEL = 50 mg/kg/bw   Acute RfD = aPAD =   Acute Neurotoxicity Study-Rat.
 including infants and children).   UFA = 10x.            0.050 mg/kg/bw.     LOAEL = 100 mg/kg/bw based on
                                   UFH = 10x...........                        decreased motor activity seen in
                                   FQPA SF = 10x.......                        females on day 1.
                                   UFDB................
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Chronic dietary (All populations)  NOAEL= 1.2 mg/kg/day  Chronic RfD = cPAD   Chronic Toxicity/Carcinogenicity
                                   UFA = 13x...........   = 0.004 mg/kg/day.   Study-Rat.
                                   UFH = 10x...........                       LOAEL = 12 mg/kg/day based on
                                   FQPA SF = 10x.......                        increases in non-neoplastic liver
                                   UFDB................                        lesions and changes in thyroid
                                                                               hormones and thyroid pathology.
                                  ------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  A non linear approach (i.e., RfD will adequately protect for all chronic
                                    toxicity, including carcinogenicity, that could result from exposure to
                                    proquinazid. The cPAD for proquinazid will protect for carcinogenic effects
                                    because it is below the level that caused changes in liver enzyme regulation
                                    and liver toxicity.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest observed adverse effect level. mg/kg/bw =
  milligram/kilogram/body weight. 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). UFDB = to account for the absence of data or other data deficiency. 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 proquinazid, EPA considered exposure under the petitioned-
for tolerances as well as all existing proquinazid tolerances in 40 CFR 
180.674. EPA assessed dietary exposures from proquinazid 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 proquinazid. 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/WWIA). As 
to residue levels in food, EPA used tolerance level residues and 100% 
percent crop treated (PCT). Default processing factors were used for 
grape juice. The Agency considers these to be highly conservative 
assessments.
    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, EPA used tolerance level 
residues and 100% PCT.
    iii. Cancer. Quantification of risk using a non-linear approach 
(i.e., RfD will adequately protect for all chronic toxicity, including 
carcinogenicity, which could result from exposure to proquinazid. 
Cancer risk was assessed using the same exposure estimates as discussed 
in Unit III.C.1.ii., chronic exposure.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for proquinazid. Tolerance level residues and/or 100% CT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. There is no drinking water 
exposure in the U.S. associated with the establishment of an import 
tolerance.
    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). Proquinazid is not 
registered for any specific use patterns that would result in 
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 proquinazid to share a common mechanism of 
toxicity with any other substances, and proquinazid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
proquinazid 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. No evidence of increased 
quantitative or qualitative susceptibility was seen following in utero 
exposure to proquinazid with rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study. The 2-generation rat reproduction study resulted in no effects 
on reproduction or fertility. The

[[Page 18814]]

offspring effects (decreases in F1 pup weight during 
lactation) occurred at the same dose which caused parental effects 
(thyroid hypertrophy, reduced body weight gain, and food consumption). 
Evidence of developmental delays were observed in developmental 
toxicity studies in rabbits and rats were characterized by reduced 
fetal weight and an increased incidence retarded ossification and paten 
ductus arteriosus, respectively. These developmental effects occurred 
in the presence of maternal toxicity. For the rats, the developmental 
effects were seen in the presence of clear maternal toxicity, including 
a marked reduction in body weight gain after adjustment for uterine 
contents and were considered to be of equal severity.
    3. Conclusion. In determining whether there are reliable data to 
amend or remove the presumptive 10X FQPA safety factor, EPA considered 
the following factors:
    i. The toxicity database for proquinazid required by 40 CFR Part 
158 is complete. However, there remains some uncertainty regarding the 
potential for proquinazid effects on the thyroid in the young. Effects 
on the thyroid (manifested as changes in hormones, weight, and 
histopathology) following proquinazid exposure were consistently 
observed in adult animals (rats) following subchronic and chronic 
exposures. Thyroid effects, however, were not assessed in studies 
involving neo- or postnatal animals, and EPA is lacking data showing 
the comparative effect of proquinazid on the thyroid in adult and neo- 
and postnatal animals.
    ii. There is only limited evidence that proquinazid is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity. There is limited 
evidence for neurotoxicity following oral exposures to proquinazid. 
Following a single exposure, evidence for neurotoxicity at the LOAEL 
was limited to decreased motor activity in both sexes with no 
behavioral or neuropathology changes. At doses above the study LOAEL 
other effects including decreased grip strength and foot splay were 
observed. Following repeated (dietary) exposures, there were no 
treatment-related clinical signs of neurotoxicity, behavioral changes, 
or neuropathology.
    iii. As discussed in Unit III.D.2., there is no evidence that 
proquinazid results in increased susceptibility with 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% CT and tolerance-level residues. Drinking water is not a factor 
because this is an import tolerance assessment. These assessments will 
not underestimate the exposure and risks posed by proquinazid.
    Despite the lack of any indication of sensitivity in the young and 
the very conservative exposure assessment, EPA has determined that it 
lacks reliable data to choose a FQPA safety factor other than the 
default value of 10X given (1) the absence of data on thyroid effects 
on the young, including comparative thyroid data on adults and the 
young, and (2) the fact that thyroid effects were the most sensitive 
effect seen in adult animals. At the same time, after considering all 
of the data on proquinazid toxicity and exposure, EPA has also 
determined that application of a FQPA safety factor of 10X, in 
conjunction with inter- and intraspecies safety factors, will result in 
a risk assessment that protects the safety of infants and children. 
Although there is some uncertainty as to whether the young might have 
greater sensitivity to proquinazid's thyroid effects due to the absence 
of comparative thyroid data, two developmental studies and a 
reproduction study have otherwise shown no indication of sensitivity in 
the young to proquinazid. Additionally, the exposure assessment 
provides an extra margin of safety given that it is based on the 
conservative assumption that all grapes, and all food products derived 
from grapes (e.g., raisins, grape juice, wine), consumed in the United 
States bear residues of proquinazid at the appropriate tolerance level. 
This assumption is particularly conservative here because proquinazid 
is not registered for use in the United States. Taking into account all 
of these considerations, EPA concludes that no safety factor in 
addition to the inter- and intraspecies factors, and the default FQPA 
safety factor is needed to protect the safety of infants and children.

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 dietary exposure from food to proquinazid will occupy 
18% of the aPAD for children 1-2 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 
proquinazid from food will utilize 47% of the cPAD for children 1-2 
years old the population group receiving the greatest exposure. There 
are no residential uses for proquinazid. Based on the explanation in 
Unit III.C.3., regarding residential use patterns, chronic residential 
exposure to residues of proquinazid is not expected.
    3. Aggregate cancer risk for U.S. population. The cPAD of 0.004 mg/
kg/day will be protective of both non-cancer and cancer effects, 
including rat tumors (liver, thyroid, and cholangiocarcinomas). As 
discussed in Unit III.E., aggregate exposure to proquinazid is below 
the cPAD.
    4. 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 proquinazid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (gas chromatography with electron 
capture detection) is available to enforce the proposed tolerances for 
residues of proquinazid on grape commodities.
    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

[[Page 18815]]

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 proquinazid. However, the 
tolerances established in this rule are harmonized with Canadian MRLs.

C. Revisions to Petitioned-For Tolerances

    The Agency is changing the proposed commodity definition for 
raisins from raisin to grape, raisin. The change in the commodity 
definition is to make the tolerance consistent with Agency naming-
conventions for commodities and crop groups. No changes are recommended 
for the proposed tolerance levels, but the grape tolerance is being 
revised from 0.5 to 0.50 to correct the number of significant figures.

V. Conclusion

    Therefore, tolerances are established for residues of proquinazid 
in or on grape at 0.50 ppm and grape, raisin 1.0 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 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: March 25, 2014.
Marty Marnell,
Acting Director, 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. Add Sec.  180.674 to read as follows:

Sec.  180.674  Proquinazid; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide, proquinazid, including its metabolites and degradates, in or 
on the commodities listed in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only proquinazid, [6-Iodo-2-propoxy-3-propyl-3H-
quinazolin-4-one), in or on the following commodities:

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Grape \1\...............................................            0.50
Grape, raisin \1\.......................................            1.0
------------------------------------------------------------------------
\1\ No U.S. registrations for Proquinazid.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. 2014-07563 Filed 4-3-14; 8:45 am]
BILLING CODE 6560-50-P
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