[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07563]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Proquinazid; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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
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
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.
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
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
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.
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-
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.
Table 1--Summary of Toxicological Doses and Endpoints for Proquinazid 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 (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.
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
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
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
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
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
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
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,
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
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:
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
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.
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
Dated: March 25, 2014.
Acting Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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:
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