80 FR 7971 - Pyrimethanil; Pesticide Tolerances

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 30 (February 13, 2015)

This regulation establishes a tolerance for residues of pyrimethanil in or on pomegranate at 5.0 parts per million (ppm). Janssen PMP requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

[Federal Register Volume 80, Number 30 (Friday, February 13, 2015)]
[Rules and Regulations]
[Pages 7971-7975]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-02949]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0530; FRL-9922-07]


Pyrimethanil; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
pyrimethanil in or on pomegranate at 5.0 parts per million (ppm). 
Janssen PMP requested these tolerances under the Federal Food, Drug, 
and Cosmetic Act (FFDCA).

DATES: This regulation is effective February 13, 2015. Objections and 
requests for hearings must be received on or before April 14, 2015, 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-2014-0530, 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: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Publishing 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-2014-0530 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 
April 14, 2015. 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-2014-0530, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of December 17, 2014 (79 FR 75107) (FRL-
9918-90), EPA issued a document pursuant to

[[Page 7972]]

FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of 
a pesticide petition (PP 3F8213) by Janssen PMP, Janssen Pharmaceutica 
NV, 1125 Trenton-Harbourton Rd Titusville, NJ 08560-0200. The petition 
requested that the 40 CFR 180.518 be amended by establishing a 
tolerance for residues of the fungicide pyrimethanil in or on 
pomegranate at 5.0 parts per million (ppm). That document referenced a 
summary of the petition prepared by Janssen PMP, the registrant, which 
is available in the docket, http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

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 pyrimethanil including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with pyrimethanil 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. Pyrimethanil is of low acute lethality by the oral, dermal, 
and inhalation routes. It is a slight eye irritant, is not irritating 
to the skin, and it is not a dermal sensitizer. A single oral dose of 
1,000 milligram/kilogram (mg/kg) produced a number of acute signs of 
neurotoxicity, including ataxia, dilated pupils, and decreases in motor 
activity, hind limb grip strength, and body temperature. However, there 
was no evidence of neurotoxicity with repeated dosing in a subchronic 
neurotoxicity study in rats. The major target organs of repeated oral 
exposure were the liver, kidney, and the thyroid. These effects were 
accompanied by decreased body weight. Reproductive toxicity was not 
observed, and developmental effects (e.g., decreased fetal weight, 
retarded ossification, extra ribs) were observed only at maternally 
toxic doses. Special short-term exposure studies demonstrated increased 
liver uridine diphosphate glucuronosyl transferase (UDPGT) activity 
leading to decreases in thyroid hormones (T3, T4) and compensatory 
increases in thyroid-stimulating hormone (TSH) in adult rats.
    Thyroid adenomas were seen in rats following long-term exposure, 
and it was concluded that they were mediated via disruption of the 
thyroid/pituitary axis. There were no concerns for mutagenicity. The 
EPA has classified pyrimethanil as ``Not Likely To Be Carcinogenic To 
Humans At Doses That Do Not Alter Rat Thyroid Hormone Homeostasis.'' 
This decision was based on the following:
    1. There were treatment-related increases in thyroid follicular 
cell tumors in male and female Sprague-Dawley rats at doses which were 
considered adequate to assess carcinogenicity; however, rats are 
substantially more sensitive than humans are to the development of 
thyroid follicular cell tumors in response to thyroid hormone 
imbalance.
    2. There were no treatment-related tumors seen in male or female 
CD-1 mice at doses which were considered adequate to assess 
carcinogenicity.
    3. There is no mutagenicity concern and there is no evidence for 
thyroid carcinogenesis mediated through a mutagenic mode of action.
    4. The non-neoplastic toxicological evidence (i.e., thyroid growth, 
thyroid hormonal changes) indicated that pyrimethanil was inducing a 
disruption in the thyroid-pituitary hormonal status. The overall 
weight-of-evidence was considered sufficient to indicate that 
pyrimethanil induced thyroid follicular tumors through a non-linear, 
antithyroid mode of action.
    For these reasons, EPA determined that quantification of 
carcinogenic risk is not required and that the no observed adverse 
effect level (NOAEL) (17 mg/kg/day) established for deriving the 
chronic reference dose (cPAD) would be protective of cancer effects. 
Due to the non-linear mode of action of pyrimethanil, exposure at the 
NOAEL is not expected to alter thyroid hormone homeostasis nor result 
in thyroid tumor formation.
    Specific information on the studies received and the nature of the 
adverse effects caused by pyrimethanil as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of August 1, 2012 (77 FR 45499) (FRL-
9354-7).

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 pyrimethanil used for 
human risk assessment is discussed in Unit III. B. of the final rule 
published in the Federal Register of August 1, 2012 (77 FR 45500) (FRL-
9354-7).

[[Page 7973]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to pyrimethanil, EPA considered exposure under the petitioned-
for tolerances as well as all existing pyrimethanil tolerances in 40 
CFR 180.518. EPA assessed dietary exposures from pyrimethanil in food 
as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single exposure.
    Such effects were identified for pyrimethanil. In estimating acute 
dietary exposure, EPA used food consumption information from the United 
States Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
As to residue levels in food, EPA assumed default processing factors 
(as necessary), empirical processing factors for orange and apple 
juice, tolerance-level residues, and 100 percent crop treated (PCT) for 
all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 2003-2008 
NHNES/WWEIA. As to residue levels in food, EPA assumed default 
processing factors (as necessary), empirical processing factors for 
orange and apple juice, tolerance-level residues, and 100 PCT for all 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that pyrimethanil should be classified as ``Not Likely to be 
Carcinogenic to Humans at Doses That Do Not Alter Rat Thyroid Hormone 
Homeostasis''. Therefore a separate cancer exposure assessment was not 
performed.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for pyrimethanil. Tolerance-level residues and/or 
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 pyrimethanil in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of pyrimethanil. 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 Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of 
pyrimethanil for acute exposures are estimated to be 86.5 parts per 
billion (ppb) for surface water and 4.8 ppb for ground water. For 
chronic exposures for non-cancer assessments, they are estimated to be 
29.4 ppb for surface water and 4.8 ppb for ground water. Modeled 
estimates of drinking water concentrations were directly entered into 
the dietary exposure model.
    For acute dietary risk assessment, the water concentration value of 
86.5 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 29.4 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).
    Pyrimethanil 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 pyrimethanil to share a common mechanism of 
toxicity with any other substances, and pyrimethanil does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
pyrimethanil does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act Safety Factor (FQPA 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 prenatal and postnatal 
toxicology database for pyrimethanil includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. As discussed in Unit III.A., there was no evidence of 
increased quantitative or qualitative susceptibility of fetuses or 
offspring following exposure to pyrimethanil in these studies.
    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 pyrimethanil is complete.
    ii. Although there is evidence of neurotoxicity in the acute 
neurotoxicity study, concern is low since effects were only seen at the 
limit dose, effects are well-characterized with clearly established 
NOAEL/LOAEL values, and the selected endpoints are protective for the 
observed effects. The thyroid has been shown to be one of the target 
organs in adult animals for pyrimethanil-induced toxicity thus raising 
a potential concern for thyroid toxicity in the young. EPA, however 
concluded that there is no concern for thyroid toxicity in the young 
based on the following weight of evidence considerations: The effects 
seen on the thyroid and the liver database, while treatment-related, 
are not severe in nature; and in each of the studies that show an 
effect on thyroid hormone levels, as well as in all studies chosen for 
PODs selection, there is a wide dose spread (~10-fold difference 
between NOELs and LOAELs) which provides a measure of protection for 
any potential effects linked to decreased thyroid hormone levels in 
offspring.
    iii. There is no evidence that pyrimethanil results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or

[[Page 7974]]

in young rats in the 2-generation reproduction study.
    iv. The exposure databases are sufficient to determine the nature/
magnitude of the residue in food and dietary analyses are unlikely to 
underestimate risk of exposure from pyrimethanil.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to pyrimethanil will occupy 38% 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 
pyrimethanil from food and water will utilize 78% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. There are no residential uses for pyrimethanil.
    3. Short-term risk. Short-term 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, pyrimethanil 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-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 pyrimethanil.
    4. Aggregate cancer risk for U.S. population. The Agency determined 
that the thyroid tumors seen in rat studies arise through a non-linear 
mode of action and the NOAEL (17 mg/kg/day) established for deriving 
the cRfD is not expected to alter thyroid hormone homeostasis nor 
result in thyroid tumor formation. Thus, the chronic risk assessment 
addresses any cancer risk. Based on the results of chronic risk 
assessment, EPA concludes that aggregate exposure to pyrimethanil will 
not cause a 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 pyrimethanil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (high-performance liquid 
chromatography (HPLC)) 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: 
[email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for pyrimethanil in or on 
pomegranate.

V. Conclusion

    Therefore, a tolerance is established for residues of pyrimethanil, 
in or on pomegranate at 5.0 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes a tolerance 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 action has been 
exempted from review under Executive Order 12866, this action 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 action 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 action 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 action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as

[[Page 7975]]

described under Title II of the Unfunded Mandates Reform Act (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 (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: February 6, 2015.
Daniel J. Rosenblatt,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--AMENDED

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

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


0
2. In Sec.  180.518, alphabetically add the commodity ``Pomegranate'' 
to the table in paragraph (a)(1) to read as follows:


Sec.  180.518  Pyrimethanil; tolerance for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Pomegranate.................................................         5.0
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-02949 Filed 2-12-15; 8:45 am]
BILLING CODE 6560-50-P