[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Rules and Regulations]
[Pages 13502-13506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-5271]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0659; FRL-9336-6]


Pyriofenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
pyriofenone, (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-
trimethoxy-6-methylphenyl) methanone, including its metabolites and 
degradates, in or on grape and grape, raisin. ISK BioSciences 
Corporation requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 7, 2012. Objections and 
requests for hearings must be received on or before May 7, 2012, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0659. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Heather Garvie, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-0034; email address: <a href="/cdn-cgi/l/email-protection#a0c7c1d2d6c9c58ec8c5c1d4c8c5d2e0c5d0c18ec7cfd6"><span class="__cf_email__" data-cfemail="3d5a5c4f4b54581355585c4955584f7d584d5c135a524b">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0659 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 
May 7, 2012. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0659, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S.

[[Page 13503]]

Crystal Dr., Arlington, VA. Deliveries are only accepted during the 
Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays). Special arrangements 
should be made for deliveries of boxed information. The Docket Facility 
telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 8, 2010 (75 FR 54629) (FRL-
8843-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
0E7731) by ISK BioSciences Corporation, 7470 Auburn Rd., Suite A, 
Concord, OH 44077. The petition requested that 40 CFR part 180 be 
amended by establishing a tolerance for residues of the fungicide 
pyriofenone (5-chloro-2-methoxy-4-methyl-3-pyridinyl)(2,3,4-trimethoxy-
6-methylphenyl) methanone, in or on grape at 0.2 parts per million 
(ppm).
    That notice referenced a summary of the petition prepared by ISK 
BioSciences Corporation, the registrant, which is available in the 
docket, http://www.regulations.gov.
    There were no comments received in response to the notice of 
filing. Based upon review of the data supporting the petition, EPA has 
modified the petitioned for tolerance for pyriofenone by increasing the 
tolerance level for grape and establishing a separate tolerance for 
grape, raisin. The reasons for these changes are explained in Unit 
IV.D.
    These are the first tolerances established for pyriofenone. There 
are no registered uses for pyriofenone in the United States. The 
tolerances were requested in connection with use of pyriofenone on 
grapes grown overseas. These tolerances will allow grapes and processed 
grape commodities containing pyriofenone residues to be imported to the 
United States.

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 pyriofenone including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyriofenone 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. The liver and kidney were affected by treatment with 
pyriofenone, and although more effects were noted with increasing 
duration of exposure, effects were generally not severe. These effects 
included increased liver weight, microscopic changes, and clinical 
chemistry changes in rats, mice, and/or dogs. Kidney effects included 
increased organ weight, microscopic changes, and clinical chemistry 
changes in rats and mice and an increased incidence of chronic 
nephropathy in rats. Clinical signs included vomiting and loose stools 
in dogs and peri-genital staining in mice. Also noted were skin changes 
in the 2-year rat study (atrophy of hair follicles or perifolliculitis) 
and increased cecal weight or distended cecum in rat studies. 
Mutagenicity and carcinogenicity testing was negative and the cancer 
classification for pyriofenone is ``not likely to be carcinogenic to 
humans'' and therefore there is no cancer risk associated with exposure 
to pyriofenone.
    No developmental or reproductive toxicity occurred in the rat 
studies. Abortions were noted in the rabbit developmental study and 
were associated with decreased maternal body weight gain and food 
consumption. There was no evidence of neurotoxicity and a developmental 
neurotoxicity study is not needed for pyriofenone. Immunotoxicity 
testing in rats and mice was negative. Pyriofenone has a low acute 
toxicity by the oral exposure route. Dermal toxicity, inhalation 
toxicity, and ocular irritation studies are not available because these 
exposure routes are not applicable to non-domestic uses. Specific 
information on the studies received and the nature of the adverse 
effects caused by pyriofenone 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 ``Pyriofenone. Human-Health Risk 
Assessment for the Establishment of Tolerances for Pyriofenone 
Fungicide in/on Imported Grapes,'' dated November 1, 2011 at pp. 16-30 
in docket ID number EPA-HQ-OPP-2010-0659.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological 
endpoints for used for human risk assessment is shown in the Table of 
this unit.
    In risk assessments for import commodities, endpoints are typically 
selected for dietary exposure only. Endpoints for incidental oral, 
dermal, and inhalation exposures are not

[[Page 13504]]

selected for import tolerances due to lack of potential occupational or 
residential exposure. No adverse effects attributable to a single 
exposure were identified for pyriofenone; therefore, an acute dietary 
endpoint was not selected for pyriofenone.
    Consideration was given to selecting abortions/premature delivery 
from the rabbit developmental study as an endpoint for assessing acute 
dietary risk. Typically, abortions observed early in the pregnancy in a 
developmental toxicity study are assumed to be attributable to a single 
exposure and thus appropriate for acute dietary risk assessment.
    In the rabbit developmental toxicity study, abortions occurred in 2 
does on gestation day 18 at the highest dose tested (300 milligram/
kilogram/day (mg/kg/day). In this case the abortions were determined 
not to be attributable to a single exposure since the abortions 
occurred late in gestation (GD 18) and prior to which both does had 
significantly lower-food consumption resulting in lower body weight or 
body weight gain. In the range-finding study, abortions and premature 
delivery seen in 2 does also showed an association to the lower body 
weight and food consumption. Thus, the potential nutrient deficiency 
and maternal toxicity resulting from loss in body weight and lower food 
consumption were assumed to result in the abortions/premature delivery 
rather than the test compound.
    For the chronic dietary risk assessment, a NOAEL of 9 mg/kg/day was 
selected based on the increased incidence of chronic nephropathy seen 
in female rats at 46 mg/kg/day (LOAEL) in the 2-year carcinogenicity 
study. Typically, chronic nephropathy occurs as spontaneous lesions in 
geriatric rats and in some cases, exposure to a chemical may exacerbate 
this kidney lesion. In this case, however, chronic nephropathy was 
considered to be adverse because the incidences of this lesion was 
significantly increased in females at 46 mg/kg/day (30/35) and also at 
the next higher dose of 254 mg/kg/day (36/45, p<0.005). In the chronic 
study with dogs, the effects (e.g., clinical signs, alterations in 
clinical pathology, organ weights, or histopathology) were determined 
to be not adverse since the findings were isolated, highly variable, 
and/or there was a lack of dose-response or a clear target organ for 
toxicity.

   Table--Summary of Toxicological Doses and Endpoints for Pyriofenone for Use in Human Health Risk Assessment
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                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                 effects
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Acute dietary........................  An acute dietary endpoint was not selected because toxicity from a single
                                        dose was not identified in the hazard database.
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Chronic dietary (All populations)....  NOAEL= 9 mg/kg/day.....  Chronic RfD = 0.09.....  Chronic toxicity/
                                       UFA = 10x..............  mg/kg/day..............   carcinogenicity study--
                                       UFH = 10x..............  cPAD = 0.09............   rat
                                       FQPA SF = 1x...........  mg/kg/day..............  NOAEL = 9 mg/kg/day
                                                                                          based on increased
                                                                                          nephropathy seen in
                                                                                          female rats at LOAEL =
                                                                                          46 mg/kg/day.
                                      --------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....  Classification: ``Not likely to be Carcinogenic to Humans''.
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FQPA SF = FQPA Safety Factor. LOAEL = lowest observed adverse effect level.
LOC = Level of Concern. mg/kg/day = milligram/kilogram/day. NOAEL = no observed adverse effect level. PAD =
  population adjusted dose (a = acute, c = chronic). RfD = reference dose. UFA = extrapolation from animal to
  human (intraspecies). UFH = potential variation in sensitivity among members of the human population
  (interspecies).

    Specific information on the toxicological endpoints for pyriofenone 
can be found at http://www.regulations.gov in document ``Pyriofenone. 
Human-Health Risk Assessment for the Establishment of Tolerances for 
Pyriofenone Fungicide in/on Imported Grapes,'' dated November 1, 2011 
at pp.16-30 in docket ID number EPA-HQ-OPP-2010-0659.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyriofenone, EPA considered exposure under the petitioned-
for tolerances. EPA assessed dietary exposures from pyriofenone 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. No such effects were 
identified in the toxicological studies for pyriofenone; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide 
Continuing Surveys of Food Intakes by Individuals (CSFII). As to 
residue levels in food, EPA conducted an unrefined, screening-level 
chronic dietary risk assessment assuming tolerance level residues for 
grapes, raisins, and all other processed grape commodities; and 100% of 
all grapes are treated with pyriofenone.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that pyriofenone does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue information in the dietary 
assessment for pyriofenone. Tolerance level residues and/or 100 PCT 
were assumed for all food commodities.
    2. Dietary exposure from drinking water. Pyriofenone is not 
registered for use in the United States; therefore, exposure to 
pyriofenone in drinking water is not expected.
    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). Pyriofenone 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

[[Page 13505]]

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 pyriofenone to share a common mechanism of 
toxicity with any other substances, and pyriofenone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance assessment action, therefore, EPA has not 
assumed that pyriofenone has 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 the policy statements 
released by EPA's OPP concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10x, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. The toxicological database 
for pyriofenone is complete with regard to pre- and postnatal toxicity, 
and there are no residual uncertainties. As the data summarized in Unit 
III.A. showed, pyriofenone exposure did not result in quantitative or 
qualitative increased sensitivity in the young.
    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 pyriofenone is complete.
    ii. There is no indication that pyriofenone is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that pyriofenone 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 assessment was performed based on 
the assumptions of 100 PCT and tolerance-level residues. This 
assessment will not underestimate the exposure and risks posed by 
pyriofenone.

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. For this action there is potential exposure to 
pyriofenone from food only.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
pyriofenone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
pyriofenone from food only will utilize 1% of the cPAD for children (1-
2 years old), the population group receiving the greatest exposure. 
There are no residential uses for pyriofenone. Based on the explanation 
in Unit III.C.3., regarding residential use patterns, chronic 
residential exposure to residues of pyriofenone is not expected.
    3. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, pyriofenone is classified as ``not likely to be carcinogenic 
to humans.'' EPA does not expect pyriofenone to pose a cancer risk.
    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 pyriofenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    A liquid chromatography/mass spectrometry/mass spectrometry (LC/MS/
MS) method based on the proposed enforcement method (Method ISK 0341/
074208, Revision <greek-i>4) was used to determine residues of 
pyriofenone in or on grapes (Raw Agricultural Commodity (RAC)) and its 
processed fractions for the crop field trial and grape processing 
studies associated with this petition. The validated limit of 
quantitation (LOQ) is 0.01 ppm. This method was adequately validated 
for data collection purposes and a successful independent laboratory 
validation study was conducted. Therefore, the LC/MS/MS method is 
acceptable for use as an enforcement method.
    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: 
<a href="/cdn-cgi/l/email-protection#354750465c5140505850415d5a5146755045541b525a43"><span class="__cf_email__" data-cfemail="c0b2a5b3a9a4b5a5ada5b4a8afa4b380a5b0a1eea7afb6">[email protected]</span></a>.

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 MRL.
    The Codex has not established a MRL for pyriofenone. However, 
review of this tolerance on imported grapes is being conducted with 
Canada, and the U.S. and Canada are harmonized on the residue 
definition and recommended tolerances.

C. Revisions to Petitioned-For Tolerances

    The tolerance level for grape being established by EPA differs from 
that

[[Page 13506]]

proposed in the tolerance petition submitted by the ISK Biosciences 
Corporation. The Agency used the Organization for Economic Cooperation 
and Development tolerance calculation procedures to determine that the 
tolerance level of 0.30 ppm is needed. The petitioner did not propose a 
separate tolerance for grape, raisin, but processing studies showed 
that residues could concentrate, necessitating a higher tolerance of 
0.50 ppm. Finally, EPA has revised the tolerance expression to clarify 
that:
    1. As provided in FFDCA section 408(a)(3), the tolerance covers 
metabolites and degradates of pyriofenone not specifically mentioned.
    2. Compliance with the specified tolerance levels is to be 
determined by measuring only the specific compounds mentioned in the 
tolerance expression.

V. Conclusion

    Therefore, tolerances are established (without U.S. registrations) 
for residues of the fungicide, pyriofenone, including its metabolites 
and degradates, in or on grape at 0.30 ppm and grape, raisin at 0.50 
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
of FFDCA in response to a petition submitted to the Agency. The Office 
of Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994). Since 
tolerances and exemptions that are established on the basis of a 
petition under 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) (Pub. L. 104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: February 17, 2012.
Steven Bradbury,
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. Section 180.660 is added to subpart C to read as follows:


Sec.  180.660  Pyriofenone; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide pyriofenone, including its metabolites and degradates, in or 
on the following commodities listed in the table. Compliance with the 
tolerance levels specified in the table is to be determined by 
measuring only pyriofenone, (5-chloro-2-methoxy-4-methyl-3-
pyridinyl)(2,3,4-trimethoxy-6-methylphenyl) methanone, in or on the 
following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Grape \1\....................................................       0.30
Grape, raisin \1\............................................       0.50
------------------------------------------------------------------------
\1\ There are no U.S. registrations for grape and grape, raisin.

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 2012-5271 Filed 3-6-12; 8:45 am]
BILLING CODE 6560-50-P


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