Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Rules and Regulations 7971 

WEST VIRGINIA—1997 ANNUAL PM2.5 NAAQS 

[Primary and secondary] 

Designated Area 

Designation a Classification 

Date 1 Type Date 2 Type 

*******

Martinsburg, WV-Hagerstown, MD: 

Berkeley County .......................................................................................... 11/25/14 Attainment.

*******

a Includes Indian Country located in each county or area, except as otherwise specified. 

1This date is 90 days after January 5, 2005, unless otherwise noted. 

2This date is July 2, 2014, unless otherwise noted. 

* * * * * 

[FR Doc. 2015–02851 Filed 2–12–15; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: 

RDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

B. How can I get electronic access to 

other related information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Publishing Office’s eCFR 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 


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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 thyroidstimulating 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 SpragueDawley 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-observedadverse-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). 


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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 nonoccupational, 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 


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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: residuemethods@

epa.gov. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint 

United Nations Food and Agriculture 

Organization/World Health 

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 


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Federal Register / Vol. 80, No. 30 / Friday, February 13, 2015 / Rules and Regulations 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 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.518, alphabetically add the 

commodity ‘‘Pomegranate’’ to the table 

in paragraph (a)(1) to read as follows: 

§ 180.518 Pyrimethanil; tolerance for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Pomegranate .............................. 5.0 

* * * * * 

* * * * * 

[FR Doc. 2015–02949 Filed 2–12–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 406, 407, and 408 

[CMS–4176–NR] 

Announcement of Ruling: 

Implementing United States v. Windsor 

for Purposes of Entitlement and 

Enrollment in Medicare Hospital 

Insurance and Supplementary Medical 

Insurance 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice of CMS ruling. 

SUMMARY: This document announces a 

CMS Ruling that states the CMS policies 

for implementing United States v. 

Windsor (‘‘Windsor’’), in which the 

Supreme Court held that section 3 of the 

Defense of Marriage Act (DOMA), 

enacted in 1996, is unconstitutional. 

Section 3 of DOMA defined ‘‘marriage’’ 

and ‘‘spouse’’ as excluding same-sex 

marriages and same-sex spouses, and 

effectively precluded the Federal 

government from recognizing same-sex 

marriages and spouses. 

DATES: The CMS ruling announced in 

this document is applicable beginning 

February 9, 2015, with respect to 

appeals pending on, initiated, or 

reopened in accordance with applicable 

rules after February 9, 2015, for 

entitlement and enrollment 

determinations made on or after June 

26, 2013. This ruling does not apply to 

appeals of entitlement and enrollment 

determinations made before June 26, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

Patty Helphenstine (410) 786–0622. 

SUPPLEMENTARY INFORMATION: In 

‘‘Windsor,’’ (570 U.S. 12, 133 S. Ct. 2675 

(2013), the Supreme Court held that 

section 3 of the Defense of Marriage Act 

(DOMA), enacted in 1996 (codified at 1 

U.S.C. 7), is unconstitutional. 

The CMS Administrator signed Ruling 

CMS–4176–R on February 9, 2015. This 

CMS Ruling, as well as other CMS 

Rulings are available at http://

www.cms.gov/Regulations-andGuidance/Guidance/Rulings/

index.html. For the readers’ 

convenience, the text of the CMS Ruling 

4176–R is set forth in the Appendix to 

this notice of CMS ruling. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: February 9, 2015. 

Marilyn Tavenner, 

Administrator, Centers for Medicare & 

Medicaid Services. 

APPENDIX 

CMS Rulings 

Department of Health and Human 

Services 

Centers for Medicare & Medicaid 

Services 

Ruling No.: CMS–4176–R 

Date: February 9, 2015 

Centers for Medicare & Medicaid 

Services (CMS) Rulings are decisions of 

the Administrator of CMS that serve as 

precedential final opinions, orders and 

statements of policy and interpretation. 

They provide clarification and 

interpretation of complex provisions of 

the law or regulations relating to 

Medicare, Medicaid, Utilization and 

Quality Control Peer Review, private 

health insurance, and related matters. 

They are published under the authority 

of the Administrator. 

CMS Rulings are binding on all CMS 

components, Part A and Part B Medicare 

Administrative Contractors (MACs), 

Qualified Independent Contractors 

(QICs), the Provider Reimbursement 

Review Board, the Medicare Geographic 

Classification Review Board, and on the 

Medicare Appeals Council and 

Administrative Law Judges (ALJs) who 

hear Medicare appeals. Rulings promote 

consistency in interpretation of policy 

and adjudication of disputes. 

This Ruling states the CMS policies 

for implementing United States v. 

Windsor, 570 U.S. 12, 133 S. Ct. 2675 

(2013) (‘‘Windsor’’), in which the 

Supreme Court held that section 3 of the 

Defense of Marriage Act (DOMA), 

enacted in 1996 (codified at 1 U.S.C. 7), 

is unconstitutional. Section 3 of DOMA 

defined ‘‘marriage’’ and ‘‘spouse’’ as 

excluding same-sex marriages and samesex spouses, and effectively precluded 

the Federal government from 

recognizing same-sex marriages and 

spouses. 

MEDICARE PROGRAM 

Entitlement and Enrollment in 

Medicare Hospital Insurance (Part A) 

and Medicare Supplementary Medical 

Insurance (Part B) 

CITATIONS: Sections 216(h), 226, 

226A, 1818(c)–(d), 1837(i) and 1839 of 

the Social Security Act (42 U.S.C. 

Sections 416, 426, 426–1, 1395i–2, 

1395p and 1395r); 42 CFR 406.5, 406.10, 

406.13, 406.24, 406.32(c)–(d), 406.33, 

406.34, 407.20, 407.22(a)(5), 407.25(c), 

407.27(b), 408.22 and 408.24. 


Rmajette on DSK2VPTVN1PROD with RULES