[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Rules and Regulations]
[Pages 63047-63053]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-25135]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0255; FRL-9917-56]


Metrafenone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
metrafenone in or on multiple commodities that are identified and 
discussed later in this document. Interregional Research Project Number 
4 (IR-4) requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective October 22, 2014. Objections and 
requests for hearings must be received on or before December 22, 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-2013-0255, 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), West William Jefferson Clinton 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: Daniel Rosenblatt, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington,

[[Page 63048]]

DC 20460-0001; main telephone number: (703) 305-7090; email address: 
<a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="3e6c7a786c70514a575d5b4d7e5b4e5f10595148">[email protected]</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. 
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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> 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-2013-0255 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 
December 22, 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-2013-0255, by one of 
the following methods:
    <bullet> 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.
    <bullet> Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
    <bullet> Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 25, 2014 (79 FR 10458) (FRL-
9906-77), 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 
3E8211) by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.624 be amended by 
establishing tolerances for residues of the fungicide metrafenone, (3-
bromo-6-methoxy-2-methylphenyl)(2,3,4-trimethoxy-6-
methylphenyl)methanone, in or on apricot at 0.7 parts per million 
(ppm); cherry subgroup 12-12A at 2.0 ppm; fruit, small, vine climbing, 
except fuzzy kiwifruit, subgroup 13-07F at 4.5 ppm; hop, dried cones at 
70 ppm; peach subgroup 12-12B at 0.7 ppm; and vegetable, cucurbit, 
group 9 at 0.5 ppm. The petition also requested to remove the existing 
tolerance in 40 CFR 180.624 for grape at 4.5 ppm upon establishment of 
the proposed tolerances. That document referenced a summary of the 
petition prepared by BASF, the registrant, which is available in the 
docket, http://www.regulations.gov. Comments were received on the 
notice of filing. EPA's response to these comments is discussed in Unit 
IV.C.
    Also, in the Federal Register of May 23, 2014 (79 FR 29729) (FRL-
9910-29), 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 
3F8187) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 
27709, requesting to establish a tolerance in 40 CFR part 180 for 
residues of metrafenone, (3-bromo-6-methoxy-2-methylphenyl)(2,3,4-
trimethoxy-6-methylphenyl)methanone in or on vegetables, fruiting, 
group 8-10 at 1.0 ppm. That document referenced a summary of the 
petition prepared by BASF, which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing 
that was the same as the one submitted for petition 3E8211. EPA's 
response to this comment is discussed in Unit IV.C.
    Lastly, in the Federal Register of September 12, 2013 (78 FR 56185) 
(FRL-9399-7), 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 3F8163) by BASF Corporation, 26 Davis Drive, Research 
Triangle Park, NC 27709, requesting to establish a tolerance in 40 CFR 
part 180 for residues of the fungicide metrafenone, (3-bromo-6-methoxy-
2-methylphenyl)(2,3,4-trimethoxy-6-methylphenyl)methanone, in or on 
fruits, pome group 11-10 at 1.5 ppm. That document referenced a summary 
of the petition prepared by BASF, which is available in the docket, 
http://www.regulations.gov. No comments were received on the notice of 
filing.
    Based upon review of the data supporting the petition, EPA has 
modified the level at which some of the tolerances are being 
established and revised some of the commodity definitions for the 
requested crops. The reasons for these changes are explained in Unit 
IV.D.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA 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

[[Page 63049]]

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 metrafenone including exposure resulting from 
the tolerances established by this action. EPA's assessment of 
exposures and risks associated with metrafenone 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 is the primary target organ for metrafenone in mice, 
rabbits and rats. Effects on the liver were seen in multiple studies 
throughout the database, including subchronic rat studies, the rabbit 
developmental toxicity study, and chronic studies in mice and rats. 
Liver effects observed in subchronic studies included increased liver 
weights, periportal cytoplasmic vacuolation, increased cholesterol, and 
hepatocellular hypertrophy. Liver effects observed in chronic studies 
included those from the subchronic studies as well as increased serum 
gamma glutamyl transferase, eosinophilic alterations, necrosis, 
polyploid hepatocytes, bile duct hyperplasia, liver masses, and 
hepatocellular adenomas. The additional effects in the chronic studies 
indicate a progression of toxicity with time. The effects on the liver 
are consistent with the results of the absorption, distribution, 
metabolism, and excretion (ADME) studies indicating that the highest 
tissue concentrations of metrafenone were found in the liver and 
gastrointestinal tract and that bile is the primary route of excretion.
    Additionally, nephrotoxicity was observed following chronic 
exposure to metrafenone in mice and rats. The kidney effects observed 
in the chronic studies included subacute/chronic interstitial 
inflammation and chronic/progressive nephropathy, cysts, brown pigment 
in renal cells, increased urinary volume, and increased urinary 
protein.
    In a 28-day dermal toxicity study in rats, there were no dermal or 
systemic effects observed up to the highest dose tested of 1,000 mg/kg/
day, the limit dose. In a 28-day immunotoxicity study in female rats, 
no effect on the immune system was observed up to the highest dose 
tested of 1,000 mg/kg/day, the limit dose. This is consistent with the 
rest of the database where no effects on the immune system were 
observed in any study.
    There was no evidence of qualitative or quantitative susceptibility 
in the developmental and reproduction toxicity studies. In the 
developmental rat study, no effects were observed in dams or fetuses up 
to the limit dose of 1,000 mg/kg/day. In the rabbit study, liver 
toxicity (increased liver weights, hypertrophy, and hepatocyte 
vacuolation) was observed in the dams but no developmental effects were 
observed up to the limit dose of 1,000 mg/kg/day.
    In the rat reproduction toxicity study, there was no evidence of 
reproductive toxicity. Effects in the offspring (decreased pup weight) 
occurred at doses similar to those that cause toxicity in the parental 
animals (decreased body weight).
    The required battery of mutagenicity studies was submitted, 
including bacterial reverse mutation assay, mammalian cell mutation 
(CHO cells), in vitro chromosome aberration (CHO cells), micronucleus 
assay and unscheduled DNA synthesis in mammalian cells in culture. 
There is no evidence that metrafenone is genotoxic.
    In the mouse carcinogenicity study, liver tumors (increased 
incidence of hepatocellular adenomas and adenomas plus carcinomas) were 
observed in male mice at the highest dose of 1,109 mg/kg/day. In the 
rat chronic/carcinogenicity study, there was an increased incidence in 
hepatocellular adenomas in females at the high dose of 1,419 mg/kg/day. 
However, the tumors in the rat females were not considered in the 
weight-of-evidence finding because they were associated with excessive 
toxicity to the females, leading to a reduction of the dose during the 
study. The registrant submitted mechanistic studies to support a mode 
of action (MOA) for the liver tumors, but the studies were conducted in 
rats. Although the MOA was considered plausible, the Agency concluded 
the data on rats could not be used to support a MOA finding in mice. 
The Agency concluded that quantification of cancer risk using a non-
linear approach would adequately account for all chronic toxicity 
(including carcinogenicity) that could result from exposure to 
metrafenone. The use of the chronic point of departure is protective 
based on the following reasons:
    <bullet> A treatment-related increase in benign liver tumors was 
seen only in male CD-1 mice at doses that were adequate to assess the 
carcinogenicity.
    <bullet> The liver tumors were observed at doses significantly 
higher (44x) than those currently used for risk assessment.
    <bullet> No treatment-related tumors were seen in female mice.
    <bullet> No treatment-related tumors were seen in male rats and 
liver tumors in female rats were seen only at the Limit Dose which was 
excessively toxic to females; no tumors were seen at the next dose of 
5,000 ppm, which was considered adequate to assess carcinogenicity.
    <bullet> There is no mutagenicity concern for metrafenone
    Specific information on the studies received and the nature of the 
adverse effects caused by metrafenone as well 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 the document titled ``Metrafenone. Human Health 
Risk Assessment for the Section 3 Registration on: Apricot, Cherry 
(Crop Subgroup 12-12A); Fruiting Vegetables (Crop Group 8-10); Fruit, 
Small, Vine Climbing, Except Fuzzy Kiwifruit (Crop Subgroup 13-07F); 
Hops, Dried Cones; Peach (Crop Subgroup 12-12B), Pome Fruit (Crop Group 
11-10), and Vegetable, Cucurbit (Crop Group 9); Evaluation of 
Conditional Data.'' on pages 31-40 in docket ID number EPA-HQ-OPP-2013-
0255.

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

[[Page 63050]]

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 metrafenone used for 
human risk assessment is shown in Table 1 of this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Metrafenone 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
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Acute Dietary (General             No appropriate single dose endpoint was identified in the submitted toxicity
 population, including Infants      database.
 and Children and females 13-49).
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 24.9 mg/kg/   Chronic RfD = 0.249  Chronic/Carcinogenicity--rat LOAEL
                                    day                   mg/kg/day.           (mg/kg/day) = 260, based on
                                   UFA = 10x...........  cPAD = 0.249 mg/kg/   hepatotoxicity and nephrotoxicity
                                   UFH = 10x...........   day.                 in both sexes.
                                   FQPA SF = 1x........
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Quantification of cancer risk using a cancer potency factor is not required;
                                    the chronic reference dose is protective of potential cancer risk
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among
  members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to metrafenone, EPA considered exposure under the petitioned-
for tolerances as well as all existing metrafenone tolerances in 40 CFR 
180.624. EPA assessed dietary exposures from metrafenone 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 
metrafenone; therefore, a quantitative acute dietary exposure 
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the 2003-2008 food consumption data from the U.S. 
Department of Agriculture's (USDA) National Health and Nutrition 
Examination Survey, What We Eat in America (NHANES/WWEIA). As to 
residue levels in food, EPA assumed 100 percent crop treated (PCT) and 
tolerance level residues (adjusted to account for additional residues 
of concern).
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that the use of the chronic point of departure is appropriate 
for assessing cancer risk to metrafenone. 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 metrafenone. Tolerance level residues and 100 PCT were assumed for 
all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for metrafenone in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of metrafenone. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS) and Pesticide Root Zone Model Ground Water (PRZM 
GW), the estimated drinking water concentrations (EDWCs) of total 
metrafenone for chronic exposures are estimated to be 14.52 parts per 
billion (ppb) for surface water and 12.3 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 14.52 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
    Metrafenone 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 metrafenone to share a common mechanism of 
toxicity with any other substances, and metrafenone does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
metrafenone 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

[[Page 63051]]

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. There was no evidence of 
qualitative or quantitative susceptibility in the developmental and 
reproduction toxicity studies. In the developmental rat study, no 
effects were observed in dams or fetuses up to the limit dose of 1,000 
mg/kg/day. In the rabbit study, liver toxicity (increased liver 
weights, hypertrophy, and hepatocyte vacuolation) was observed in the 
dams but no developmental effects were observed up to the limit dose of 
1,000 mg/kg/day.
    In the rat reproduction toxicity study, there was no evidence of 
reproductive toxicity. Effects in the offspring (decreased pup weight) 
occurred at doses similar to those which cause toxicity in the parental 
animals (decreased body weight).
    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 metrafenone is complete.
    ii. There is no indication that metrafenone is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that metrafenone results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues (adjusted to account for 
additional residues of concern). EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to metrafenone in drinking water. These assessments will not 
underestimate the exposure and risks posed by metrafenone.

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. 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, 
metrafenone 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 
metrafenone from food and water will utilize 16% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for metrafenone.
    3. Short- and Intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). A short- and 
intermediate-term adverse effect was identified; however, metrafenone 
is not registered for any use patterns that would result in short- and/
or intermediate-term residential exposure. Short- and intermediate-term 
risk is assessed based on short- and intermediate-term residential 
exposure plus chronic dietary exposure. Because there is no short- and 
intermediate-term residential exposure and chronic dietary exposure has 
already been assessed under the appropriately protective cPAD (which is 
at least as protective as the POD used to assess short- and 
intermediate-term risk), no further assessment of short- and 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short- and intermediate-term 
risk for metrafenone.
    4. Aggregate cancer risk for U.S. population. EPA considers the 
chronic aggregate risk assessment to be protective of any aggregate 
cancer risk.
    5. 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 metrafenone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (Method FAMS 105-01, a gas 
chromatography method with electron capture or mass spectrometry 
detector) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
<a href="/cdn-cgi/l/email-protection#037166706a6776666e66776b6c6770436673622d646c75"><span class="__cf_email__" data-cfemail="2d5f485e444958484048594542495e6d485d4c034a425b">[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.
    The Codex has not established MRLs for metrafenone.

C. Response to Comments

    EPA received a comment to the Notice of Filing that made a request 
to reconsider ``loosening tolerances'' for several pesticide petitions, 
including for metrafenone. The commenter points to an American Academy 
of Pediatrics Policy statement regarding pesticide exposure in 
children, a Centers for Disease Control and Prevention report on human 
exposure to environmental chemicals, and a President's Cancer Panel 
regarding reducing environmental cancer risks in supporting the request 
to reconsider the tolerance amendments proposed for metrafenone.
    The Agency understands the commenter's concerns and recognizes that 
some individuals believe that

[[Page 63052]]

certain pesticide chemicals should not be permitted in our food, or 
that pesticide tolerances should be ``significantly tightened'' as the 
commenter notes. However, the existing legal framework provided by 
section 408 of FFDCA states that tolerances may be set when EPA 
determines that aggregate exposure to that pesticide is safe, i.e., 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the pesticide chemical residue. When making this 
determination, EPA considers the toxicity, including any potential 
carcinogenicity, of the pesticide and all anticipated dietary exposures 
and all other exposures for which there is reliable information. EPA 
also gives special consideration to the potential susceptibility and 
exposures of infants and children to the pesticide chemical residue 
when making this determination. For metrafenone, the Agency has 
considered all the available data, including all available data 
concerning the potential for carcinogenicity of metrafenone and its 
metabolites, and concluded after conducting a risk assessment, that 
there is a reasonable certainty that no harm will result from aggregate 
human exposure to metrafenone and that, accordingly, the metrafenone 
tolerances are safe.
    A second comment was received stating that ``I do no support use of 
this toxic chemical anywhere on earth.'' Additionally, the commenter 
wrote that ``any chemical should be fully investigated for its harm 
before being released for use.'' As noted above, the Agency understands 
the commenter's concerns and recognizes that some individuals believe 
that pesticide chemicals should not be permitted in our food or for use 
anywhere. As to being investigated for its harm, metrafenone has an 
extensive toxicity database that has been fully evaluated by EPA. As 
noted above, the Agency has considered all the available data and 
concluded that there is a reasonable certainty that no harm will result 
from aggregate human exposure to metrafenone and that, accordingly, the 
metrafenone tolerances are safe.

D. Revisions to Petitioned-For Tolerances

    EPA has modified some of the tolerances that were originally 
requested in the petition. Instead of the requested tolerance for 
cucurbit vegetables at 0.5 ppm, EPA is establishing the tolerance at 
0.50 ppm, in order to avoid the situation where a field sample 
containing residues significantly above the tolerance (0.54 ppm, for 
example) would be considered non-violative. For the same reason, EPA is 
revising the requested tolerances of 0.7 ppm in the peach subgroup (12-
12B) and in apricot to 0.70 ppm.
    EPA has also revised the tolerance for residues of metrafenone in 
fruiting vegetables from 1.0 ppm to 0.90 ppm based on available residue 
data and using the Organisation for Economic Cooperation and 
Development/Maximum Residue Limit (OECD MRL) tolerance calculation 
procedures.

 V. Conclusion

    Therefore, tolerances are established for residues of metrafenone, 
including its metabolites and degradates, in or on apricot at 0.70 ppm; 
cherry subgroup 12-12A at 2.0 ppm; fruit, pome, group 11-10 at 1.5 ppm; 
fruit, small, vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
4.5 ppm; hop, dried cones at 70 ppm; peach subgroup 12-12B at 0.70 ppm; 
vegetable, cucurbit, group 9 at 0.50 ppm; and vegetable, fruiting, 
group 8-10 at 0.90 ppm.
    In addition, the existing tolerance on grapes is being removed as 
unnecessary since a tolerance is being set for crop subgroup 13-07F, 
which includes grape. The tolerance for raisins is still required and 
is not being deleted.

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 tolerances 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: October 10, 2014.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

[[Page 63053]]

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 180.624 is amended by removing the entry for ``grape'', and 
by alphabetically adding the following commodities to the table in 
paragraph (a) to read as follows:


Sec.  180.624  Metrafenone; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------
Apricot.................................................            0.70
Cherry subgroup 12-12A..................................            2.0
Fruit, pome, group 11-10................................            1.5
Fruit, small, vine climbing, except fuzzy kiwifruit,                4.5
 subgroup 13-07F........................................
 
                                * * * * *
Hop, dried cones........................................           70
Peach subgroup 12-12B...................................            0.70
Vegetable, cucurbit, group 9............................            0.50
Vegetable, fruiting, group 8-10.........................            0.90
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-25135 Filed 10-21-14; 8:45 am]
BILLING CODE 6560-50-P


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