Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 19231 

under 40 CFR 180.920 for sulfonic 

acids, C13-17-sec-alkane, sodium salts 

(CAS Reg. No. 85711–69–9) and sulfonic 

acids, C14-17-sec-alkane, sodium salts 

(CAS Reg. No. 97489–15–1) when used 

as inert ingredients (surfactant) in 

pesticide formulations applied to 

growing crops at not more than 40% by 

weight of the pesticide formulation. 

VII. Statutory and Executive Order 

Reviews 

This action establishes an exemption 

from the requirement of 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 exemption 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 

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). 

VIII. 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: March 10, 2015. 

Susan Lewis, 

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 § 180.920, add alphabetically the 

following inert ingredients to the table 

to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Sulfonic acids, C13-17-sec-alkane, sodium salts (CAS Reg. No. 

85711–69–9).

Not to exceed 40% by weight in non-residential use pesticide 

formulation only.

Surfactant. 

Sulfonic acids, C14-17-sec-alkane, sodium salts (CAS Reg. No. 

97489–15–1).

Not to exceed 40% by weight in non-residential pesticide formulation only.Surfactant. 

* * * * * * * 

[FR Doc. 2015–08218 Filed 4–9–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0798; FRL–9925–02] 

Pyraclostrobin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of pyraclostrobin 

in or on the herb subgroup 19A, dill 

seed, the stone fruit group 12–12, and 

the tree nut group 14–12, except 

pistachio. Interregional Research Project 

Number 4 (IR–4) requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective April 

10, 2015. Objections and requests for 

hearings must be received on or before 


rljohnson on DSK3VPTVN1PROD with RULES
19232 Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 

June 9, 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–2013–0798, 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–2013–0798 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before June 9, 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– 

2013–0798, 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 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 3E8216) by IR–4, 

500 College Road East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR part 180 be 

amended by establishing tolerances for 

residues of the fungicide pyraclostrobin, 

carbamic acid, [2-[[[1-(4-chlorophenyl)- 

1H-pyrazol-3- 

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester and its desmethoxy metabolite 

(methyl-N-[[[1-(4-chlorophenyl)-1Hpyrazol-3- 

yl]oxy]methyl]phenylcarbamate) (BF 

500–3), expressed as parent compound, 

in or on herb, subgroup 19A at 85 ppm; 

and dill, seed at 100 ppm and by 

changing the existing entries for ‘‘fruit, 

stone, group 12’’ at 2.5 ppm to ‘‘fruit, 

stone, group 12–12’’ at 2.5 ppm; and 

‘‘nut, tree, group 14’’ at 0.04 ppm to 

‘‘nut, tree, group 14–12, except 

pistachio’’ at 0.04 ppm. That document 

referenced a summary of the petition 

prepared by BASF, the registrant, which 

is available in the docket, http://

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

Based upon review of the data 

supporting the petition, EPA has 

modified the levels at which tolerances 

are being established for some 

commodities. The reason for these 

changes is explained in Unit IV.C. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for pyraclostrobin 

including exposure resulting from the 

tolerances established by this action. 


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Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 19233 

EPA’s assessment of exposures and risks 

associated with pyraclostrobin 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. 

There are no concerns for 

reproductive susceptibility, 

neurotoxicity, mutagenicity, 

genotoxicity, or immunotoxicity. The 

most consistently observed effects 

resulting from pyraclostrobin exposure 

across species, genders, and treatment 

durations were diarrhea and decreased 

body weight, body weight gain, and 

food consumption. Pyraclostrobin also 

causes intestinal disturbances, as 

indicated by increased incidence of 

diarrhea or duodenum mucosal 

thickening. These intestinal effects 

appeared to be related to the irritating 

action on the mucus membranes as 

demonstrated by irritation seen in the 

primary eye irritation study. In the rat 

acute and subchronic neurotoxicity 

studies, neuropathology and behavior 

changes were not observed. 

In the rat developmental toxicity 

study, developmental toxicity including 

an increased incidence of dilated renal 

pelvis and cervical ribs occurred at a 

dose greater than the dose causing 

maternal toxicity (including decreased 

body weights and body weight gains 

and reduced food consumption and 

reduced food efficiency). The rabbit 

developmental toxicity study indicates 

qualitative evidence of increased 

developmental susceptibility based on 

increased resorptions per litter, 

increased post-implantation loss and 

dams with total resorptions, in the 

presence of maternal toxicity (reduced 

body weight gain, food consumption, 

and food efficiency). In a dose rangefinding 1-generation reproduction 

study, systemic toxicity was manifested 

as decreased body weight and body 

weight gain in both the parents and 

offspring. The effects occurred at the 

same dose levels for both parental and 

the offspring, but the decrease in pup 

weight was more than that in the 

parental animals. However, the body 

weight effect was not found in the 

guideline 2-generation reproduction 

study in either parental or offspring 

animals at similar dose level. No 

reproductive toxicity was seen. 

Pyraclostrobin has been classified as 

not likely to be carcinogenic to humans 

based on the lack of treated related 

increase in tumor incidence in 

adequately conducted carcinogenicity 

studies in rats and mice. Pyraclostrobin 

did not cause mutagenicity or 

genotoxicity in the in vivo and in vitro 

assays, nor did it cause immunotoxicity 

in T-cell dependent antibody response 

assays in mice with preliminary review. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by pyraclostrobin as well 

as the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Pyraclostrobin—Human Health Risk 

Assessment for a Section 3 Registration 

of New Uses on Herb Subgroup 19A and 

Dill Seed, Plus Crop Group Conversions 

on Stone Fruit Group 12–12 and Tree 

Nut Group 14–12’’ at page 29 in docket 

ID number EPA–HQ–OPP–2013–0798. 

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 pyraclostrobin used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRACLOSTROBIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Acute dietary (Females 13–50 

years of age).

NOAEL = 5.0 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 0.05 

mg/kg/day.

aPAD = 0.05 mg/kg/

day 

Developmental Toxicity—Rabbit 

LOAEL = 10.0 mg/kg/day based on developmental toxicity findings of increased resorptions. 

Acute dietary (General population including infants and 

children).

NOAEL = 300 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Acute RfD = 3.0 mg/

kg/day.

aPAD = 3.0 mg/kg/

day 

Acute Neurotoxicity—Rat 

LOAEL = 1,000 mg/kg/day based on decreased body weight 

gain in males. 

Chronic dietary (All populations) NOAEL = 3.4 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.034 

mg/kg/day.

cPAD = 0.034 mg/

kg/day 

Carcinogenicity—Rat 

LOAEL = 9.2 mg/kg/day based on decreased body weight, kidney tubular casts and atrophy in both sexes; increased incidence of liver necrosis and erosion/ulceration of the glandular-stomach and fore-stomach in males. 


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19234 Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR PYRACLOSTROBIN FOR USE IN HUMAN HEALTH RISK

ASSESSMENT—Continued 

Exposure/scenario 

Point of departure 

and uncertainty/ 

safety factors 

RfD, PAD, LOC for 

risk assessment Study and toxicological effects 

Incidental oral short-term (1 to 

30 days) and intermediateterm (1 to 6 months).

NOAEL = 5.8 mg/kg/

day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Subchronic Toxicity—Dog 

LOAEL = 12.9 mg/kg/day based on increased incidence of diarrhea, clinical chemistry changes, duodenum mucosal hypertrophy, and decreased body weight and food efficiency. 

Dermal short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Oral study NOAEL = 

5.0 mg/kg/day 

(dermal absorption 

rate = 14%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental Toxicity—Rabbit 

LOAEL = 10.0 mg/kg/day based on developmental toxicity findings of increased resorptions and maternal toxicity based on 

decreased food efficiency. 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Inhalation study 

NOAEL = 0.010 

mg/kg/day.

UFA = 3x 

UFH = 10x 

FQPA SF = 1x 

fHandler = 

16.7 L/min 

HECHandler = 

0.00131 mg/L 

HECBystander = 

0.00023 mg/L 

HEDHandler = 

0.038 mg/kg/day 

LOC for MOE = 30 .. Inhalation Toxicity—Rat 

LOAEL = 6.9 mg/kg/day (air concentration = 0.03 mg/L) based 

on duodenum mucosal hyperplasia and respiratory system 

findings including alveolar histiocytosis and olfactory atrophy/

necrosis in nasal tissue. 

Cancer (Oral, dermal, inhalation).Classification: ‘‘Not Likely to be Carcinogenic to Humans’’ based on the absence of significant tumor increases 

in two adequate rodent carcinogenicity studies. 

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). HEC = Human Equivalent Concentration. HED = Human Equivalent Dose. f = 

Respiratory frequency. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to pyraclostrobin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing pyraclostrobin tolerances in 40 

CFR 180.582. EPA assessed dietary 

exposures from pyraclostrobin 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 pyraclostrobin. 

In estimating acute dietary exposure, 

EPA used Dietary Exposure Evaluation 

Model software with the Food 

Commodity Intake Database (DEEM– 

FCID) Version 3.16, which uses food 

consumption data from the U.S. 

Department of Agriculture’s (USDA’s) 

National Health and Nutrition 

Examination Survey, What We Eat in 

America (NHANES/WWEIA) from 2003 

through 2008. As to residue levels in 

food, EPA used tolerance-level residues 

or highest field trial residues, 100 

percent crop treated (PCT), and 

empirical or default processing factors. 

Experimentally-derived processing 

factors were used for fruit juices, 

tomato, sugarcane, and wheat 

commodities. For all other processed 

commodities, DEEM default processing 

factors were assumed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the USDA’s 2003–2008 NHANES/ 

WWEIA. As to residue levels in food, 

EPA included tolerance-level or average 

field trial residues, average PCT 

estimates when available, and empirical 

processing factors. Experimentallyderived processing factors were used for 

fruit juices, tomato, sugar cane, and 

wheat commodities. For all other 

processed commodities, DEEM default 

processing factors were assumed. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that pyraclostrobin does not 

pose a cancer risk to humans. Therefore, 

a dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

FFDCA authorizes EPA to use available 

data and information on the anticipated 

residue levels of pesticide residues in 

food and the actual levels of pesticide 

residues that have been measured in 

food. If EPA relies on such information, 

EPA must require pursuant to FFDCA 

section 408(f)(1) that data be provided 5 

years after the tolerance is established, 

modified, or left in effect, demonstrating 

that the levels in food are not above the 

levels anticipated. For the present 

action, EPA will issue such data call-ins 

as are required by FFDCA section 

408(b)(2)(E) and authorized under 

FFDCA section 408(f)(1). Data will be 

required to be submitted no later than 

5 years from the date of issuance of 

these tolerances. 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

• Condition a: The data used are 

reliable and provide a valid basis to 


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show what percentage of the food 

derived from such crop is likely to 

contain the pesticide residue. 

• Condition b: The exposure estimate 

does not underestimate exposure for any 

significant subpopulation group. 

• Condition c: Data are available on 

pesticide use and food consumption in 

a particular area, the exposure estimate 

does not understate exposure for the 

population in such area. In addition, the 

Agency must provide for periodic 

evaluation of any estimates used. To 

provide for the periodic evaluation of 

the estimate of PCT as required by 

FFDCA section 408(b)(2)(F), EPA may 

require registrants to submit data on 

PCT. 

The Agency estimated the PCT for 

existing uses as follows: 

Almonds 40%; apples 15%; apricots 

25%; barley 10%; green beans <2.5%; 

blueberries 45%; broccoli 5%; cabbage 

10%; caneberries 50%; cantaloupes 

15%; carrots 35%; cauliflower <2.5%; 

celery <2.5%; cherries 50%; corn 10%; 

cotton <2.5%; cotton (seed treatment) 

10%; cucumber 10%; dry beans/peas 

10%; garlic 10%; grapefruit 30%; grapes 

30%; hazelnuts (filberts) 20%; lemons 

<2.5%; lettuce 5%; nectarines 10%; 

onions 25%; oranges 5%; peaches 20%; 

peanuts 25%; pears 15%; green peas 

5%; pecans <2.5%; peppers 10%; 

pistachios 30%; plums/prunes 5%; 

potatoes 20%; pumpkins 20%; rice 

<1%; soybeans 5%; soybeans (seed 

treatment) 5%; spinach 5%; squash 

15%; strawberries 65%; sugar beets 

45%; sweet corn 5%; tangelos 15%; 

tangerines 10%; tomatoes 25%; walnuts 

<1%; watermelons 30%; wheat 5%; 

wheat (seed treatment) <1%. 

In most cases, EPA uses available data 

from United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

proprietary market surveys, and the 

National Pesticide Use Database for the 

chemical/crop combination for the most 

recent 6–7 years. EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

public and private market survey data 

for that use, averaging across all 

observations, and rounding to the 

nearest 5%, except for those situations 

in which the average PCT is less than 

one. In those cases, 1% is used as the 

average PCT and 2.5% is used as the 

maximum PCT. EPA uses a maximum 

PCT for acute dietary risk analysis. The 

maximum PCT figure is the highest 

observed maximum value reported 

within the recent 6 years of available 

public and private market survey data 

for the existing use and rounded up to 

the nearest multiple of 5%. 

The Agency believes that the three 

conditions discussed in Unit III.C.1.iv. 

have been met. With respect to 

Condition a, PCT estimates are derived 

from Federal and private market survey 

data, which are reliable and have a valid 

basis. The Agency is reasonably certain 

that the percentage of the food treated 

is not likely to be an underestimation. 

As to Conditions b and c, regional 

consumption information and 

consumption information for significant 

subpopulations is taken into account 

through EPA’s computer-based model 

for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available reliable information on 

the regional consumption of food to 

which pyraclostrobin may be applied in 

a particular area. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for pyraclostrobin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

pyraclostrobin. 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 for Groundwater 

(PRZM–GW) models, the estimated 

drinking water concentrations (EDWCs) 

of pyraclostrobin for acute exposures are 

estimated to be 35.6 parts per billion 

(ppb) for surface water and 0.02 ppb for 

ground water. Chronic exposures for 

non-cancer assessments are estimated to 

be 2.3 ppb for surface water and 0.02 

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 35.6 ppb was 

used to assess the contribution to 

drinking water. For chronic dietary risk 

assessment, the water concentration of 

value 2.3 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). 

Pyraclostrobin is currently registered 

for the following uses that could result 

in residential handler and postapplication exposures: Treated gardens, 

fruit or nut trees, tomato transplants, 

and turf. EPA assessed residential 

exposure using the following 

assumptions: Short-term adult handler 

exposures via the dermal and inhalation 

routes resulting from application of 

pyraclostrobin to gardens, trees, and 

turf. Short-term dermal post-application 

exposures were assessed for adults, 

youth 11 to 16 years old, and children 

6 to 11 years old. Short-term dermal and 

incidental oral exposures were assessed 

for children 1 to <2 years old. Based on 

the registered uses of pyraclostrobin on 

residential and golf course turf, 

intermediate-term post-application 

exposures are possible. However, since 

the short- and intermediate-term 

endpoints and PODs for dermal and oral 

routes are the same, the short-term 

exposure and risk estimates are 

considered to be protective of potential 

intermediate-term exposure and risk. 

For the aggregate assessment, 

inhalation and dermal exposures were 

not aggregated together because the 

toxicity effect from the inhalation route 

of exposure was different than the effect 

from the dermal route of exposure. The 

scenarios with the highest residential 

exposures that were used in the shortterm aggregate assessment for 

pyraclostrobin are as follows: 

• Adult short-term aggregate 

assessment—residential dermal postapplication exposure via activities on 

treated turf. 

• Youth (11–16 years old) short-term 

aggregate assessment—residential 

dermal exposure from post-application 

golfing on treated turf. 

• Children (6–11 years old) shortterm aggregate assessment—residential 

dermal exposures from post-application 

activities in treated gardens. 

• Children (1<2 years old) short-term 

aggregate assessment—residential 

dermal and hand-to-mouth exposures 

from post-application exposure to 

treated turf. 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of FFDCA 


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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 pyraclostrobin to 

share a common mechanism of toxicity 

with any other substances, and 

pyraclostrobin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that pyraclostrobin does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at 

http://www.epa.gov/pesticides/

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no evidence that pyraclostrobin 

results in increased susceptibility in rats 

or rabbits in the prenatal developmental 

studies or in young rats in the 2- 

generation reproduction study. 

Although there is qualitative evidence 

of increased susceptibility in the 

prenatal development study in rabbits, 

the Agency did not identify any residual 

uncertainties after establishing toxicity 

endpoints and traditional UFs to be 

used in the risk assessment of 

pyraclostrobin. The degree of concern 

for prenatal and/or postnatal toxicity is 

low. 

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 

pyraclostrobin is complete. 

ii. There is no indication that 

pyraclostrobin is a neurotoxic chemical. 

Effects seen in the acute and subchronic 

neurotoxicity studies in rats are 

considered to reflect perturbations in 

mitochondrial respiration leading to 

effects on energy production rather than 

signs of neurotoxicity; therefore, there is 

no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no evidence that 

pyraclostrobin results in increased 

susceptibility in rats in the prenatal 

developmental study or in young rats in 

the 2-generation reproduction study. 

The prenatal rabbit developmental 

toxicity study showed qualitative 

evidence of increased susceptibility to 

prenatal rabbits; however, this study 

was chosen for endpoint selection for 

the acute dietary (females 13–49) and 

short-term dermal exposure scenarios. 

This study has a clearly defined NOAEL 

of 5.0 mg/kg/day. EPA did not identify 

any residual uncertainties after 

establishing toxicity endpoints and 

traditional UFs to be used in the risk 

assessment of pyraclostrobin. The 

degree of concern for prenatal and/or 

postnatal toxicity is low. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The acute dietary exposure assessments 

were performed assuming 100 PCT and 

tolerance-level or highest field trial 

residues. The chronic dietary exposure 

assessments were performed using 

average PCT estimates, when available, 

and tolerance-level or highest field trial 

residues. These data are reliable and are 

not expected to underestimate risks to 

adults or children. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to 

pyraclostrobin in drinking water. EPA 

used similarly conservative assumptions 

to assess post-application exposure of 

children as well as incidental oral 

exposure of toddlers. These assessments 

will not underestimate the exposure and 

risks posed by pyraclostrobin. 

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. Using the exposure assumptions 

discussed in this unit for acute 

exposure, the acute dietary exposure 

from food and water to pyraclostrobin 

will occupy 87% of the aPAD for 

females 13–49 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 pyraclostrobin 

from food and water will utilize 27% of 

the cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. Based on the explanation in 

Unit III.C.3., regarding residential use 

patterns, chronic residential exposure to 

residues of pyraclostrobin is not 

expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Pyraclostrobin is 

currently registered for uses that could 

result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to pyraclostrobin. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

MOEs of 110 for children 1–2 years old, 

380 for children 6–11 years old, 1,600 

for youth 11–16 years old, and 230 for 

adults from post-application exposures. 

Because EPA’s level of concern for 

pyraclostrobin is a MOE of 100 or 

below, these MOEs are not of concern. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Pyraclostrobin is currently registered for 

uses that could result in intermediateterm residential exposure; however, 

since the short- and intermediate-term 

endpoints and PODs for dermal and oral 

routes are the same, the short-term 

exposure and risk estimates are 

considered to be protective of potential 

intermediate-term exposure and risk 

and an intermediate-term aggregate 

assessment was not performed. 


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Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 19237 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

pyraclostrobin is not expected to pose a 

cancer risk to humans. 

6. 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 

pyraclostrobin residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Two adequate methods are available 

to enforce the tolerance expression for 

residues of pyraclostrobin and the 

metabolite BF 500–3 in or on plant 

commodities: A liquid chromatography 

with tandem mass spectrometry (LC/

MS/MS) method, BASF Method D9908; 

and a high-performance LC with 

ultraviolet detection (HPLC/UV) 

method, Method D9904. The methods 

may be found in the Pesticide Analytical 

Manual, Volume I. 

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 and U.S. residue 

definitions for pyraclostrobin residues 

on plant commodities are different. The 

Codex definition is pyraclostrobin, 

whereas the U.S. definition is 

pyraclostrobin and its desmethoxy 

metabolite. Codex has not established 

MRLs for pyraclostrobin on herbs or dill 

seed, and therefore there are no 

harmonization issues for those 

commodities. Codex has established 

MRLs for some members of the stone 

fruit group, i.e., cherries (3 mg/kg), 

peach/nectarine (0.3 mg/kg), and plums 

(0.8 ppm), but does not have a group 

tolerance. EPA has decided to issue a 

single group tolerance as requested for 

the stone fruit crop group, rather than 

harmonize with the individual MRLs for 

cherry, peach/nectarine, and plum, 

because adequate data supports the crop 

group tolerance. Codex has established 

a tree nut group tolerance at 0.02 mg/ 

kg. The U.S. tolerance cannot be 

lowered, as it includes parent and a 

metabolite, each at 0.02 ppm, or 0.04 

ppm total. 

C. Revisions to Petitioned-for Tolerances 

The tolerances being established for 

the herb subgroup 19A (40 ppm) and 

dill seed (40 ppm) are different than 

what the petitioner requested (85 ppm 

and 100 ppm, respectively). The 

requested tolerance levels for the herb 

subgroup 19A and dill seed were based 

on the use of field trial data without 

adjustment for the exaggerated 

application rate (2.7X) represented by 

those trials. Each of the two applications 

of pyraclostrobin were conducted at 

2.7X the label rate, and the total 

seasonal rate was 2.7X the label rate. 

Using the assumption of 

proportionality, i.e., that the residue 

levels are proportional to the rate of 

application, the residue results may be 

adjusted to the concentrations expected 

at the 1X rate. The tolerance estimates 

at the 1X rate are 40 ppm for herb 

subgroup 19A and 40 ppm for dill seed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of pyraclostrobin, carbamic 

acid, [2-[[[1-(4-chlorophenyl)-1Hpyrazol-3- 

yl]oxy]methyl]phenyl]methoxy-, methyl 

ester and its desmethoxy metabolite 

(methyl-N-[[[1-(4-chlorophenyl)-1Hpyrazol-3- 

yl]oxy]methyl]phenylcarbamate) (BF 

500–3), expressed as parent compound, 

in or on herb, subgroup 19A at 40 ppm; 

and dill, seed at 40 ppm. Additionally, 

the existing entries for ‘‘fruit, stone, 

group 12’’ at 2.5 ppm is modified to 

read ‘‘fruit, stone, group 12–12’’ at 2.5 

ppm; and ‘‘nut, tree, group 14’’ at 0.04 

ppm is modified to read ‘‘nut, tree, 

group 14–12, except pistachio’’ at 0.04 

ppm. 

VI. Statutory and Executive Order 

Reviews 

This action 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 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 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). 


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19238 Federal Register / Vol. 80, No. 69 / Friday, April 10, 2015 / Rules and Regulations 

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: April 1, 2015. 

Susan Lewis, 

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 § 180.582: 

■ a. Add alphabetically the entries for 

‘‘Dill, seed’’, ‘‘Fruit, stone, group 12– 

12’’, ‘‘Herb subgroup19A’’, and ‘‘Nut, 

tree, group 14–12, except pistachio’’ to 

the table in paragraph (a)(1). 

■ b. Remove the entries for ‘‘Fruit, 

stone, group 12’’, and ‘‘Nut, tree, group 

14’’ in the table in paragraph (a)(1). 

The amendments read as follows: 

§ 180.582 Pyraclostrobin; tolerances for 

residues. 

(a) * * * 

(1) * * * 

Commodity Parts per 

million 

* * * * * 

Dill, seed ............................... 40 

* * * * * 

Fruit, stone, group 12–12 ..... 2.5 

* * * * * 

Herb subgroup 19A .............. 40 

* * * * * 

Nut, tree, group 14–12, except pistachio .................... 0.04 

* * * * * 

* * * * * 

[FR Doc. 2015–08079 Filed 4–9–15; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

41 CFR Part 300–3 

[FTR Amendment 2015–02; FTR Case 2014– 

301; Docket No. 2014–0012; Sequence No. 

1] 

RIN 3090–AJ44 

Federal Travel Regulation (FTR); 

Terms and Definitions for ‘‘Marriage’’, 

‘‘Spouse’’, and ‘‘Domestic 

Partnership’’ 

AGENCY: Office of Government-wide 

Policy, U.S. General Services 

Administration (GSA). 

ACTION: Final rule. 

SUMMARY: The General Services 

Administration (GSA) is amending the 

Federal Travel Regulation (FTR) by 

adding terms and definitions for 

‘‘Marriage’’ and ‘‘Spouse’’, and by 

revising the definition of ‘‘Domestic 

Partnership’’. 

DATES: This rule is effective April 10, 

2015, subject to retroactivity principles 

as discussed herein. 

FOR FURTHER INFORMATION CONTACT: For 

clarification of content, contact Mr. Rick 

Miller, Office of Government-wide 

Policy (MA), Travel and Relocation 

Policy Division, U.S. General Services 

Administration, at 202–501–3822 or 

email at rodney.miller@gsa.gov. Contact 

the U.S. General Services 

Administration, Regulatory Secretariat 

Division (MVCB), 1800 F Street NW., 

Washington, DC 20405–0001, 202–501– 

4755, for information pertaining to 

status or publication schedules. Please 

cite FTR Amendment 2015–02, FTR 

Case 2014–301. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 3 of the Defense of Marriage 

Act (DOMA), codified at 1 U.S.C. 7, 

provided that, when used in Federal 

law, the term ‘‘marriage’’ would mean 

only a legal union between one man and 

one woman as husband and wife, and 

that the term ‘‘spouse’’ referred only to 

a person of the opposite sex who is a 

husband or a wife. Because of DOMA, 

the Federal Government had been 

prohibited from recognizing marriages 

of same-sex couples for all Federal 

purposes, including travel and 

relocation entitlements. 

On June 17, 2009, President Obama 

signed a Presidential Memorandum on 

Federal Benefits and NonDiscrimination stating that ‘‘[t]he heads 

of all other executive departments and 

agencies, in consultation with the Office 

of Personnel Management, shall conduct 

a review of the benefits provided by 

their respective departments and 

agencies to determine what authority 

they have to extend such benefits to 

same-sex domestic partners of Federal 

employees.’’ As part of its review, GSA 

identified a number of changes to the 

Federal Travel Regulation (FTR) that 

could be made. Subsequently, on June 2, 

2010, President Obama signed a 

Presidential Memorandum directing 

agencies to immediately take actions, 

consistent with existing law, to extend 

certain benefits, including travel and 

relocation benefits, to same-sex 

domestic partners of Federal employees, 

and where applicable, to the children of 

same-sex domestic partners of Federal 

employees. 

GSA published an interim rule and a 

final rule, respectively in the Federal 

Register on November 3, 2010, and on 

September 28, 2011 (75 FR 67629 and 

76 FR 59914), that fulfilled the 

Presidential Memorandum by, among 

other things, amending the definition of 

‘‘immediate family’’ in the FTR to 

include same-sex domestic partners and 

their dependents. 

On June 26, 2013, in United States v. 

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

(2013), the Supreme Court of the United 

States (Supreme Court) held Section 3 of 

DOMA unconstitutional. As a result of 

this decision, GSA is now able to extend 

travel and relocation entitlements to 

Federal employees who are legally 

married to spouses of the same sex. 

Pursuant to 5 U.S.C. 5707, the 

Administrator of General Services is 

authorized to prescribe necessary 

regulations to implement laws regarding 

Federal employees who are traveling 

while in the performance of official 

business away from their official 

stations. Similarly, 5 U.S.C. 5738 

mandates that the Administrator of 

General Services prescribe regulations 

relating to official relocation. The 

overall implementing authority is the 

Federal Travel Regulation (FTR), 

codified in Title 41 of the Code of 

Federal Regulations, Chapters 300–304 

(41 CFR Chapters 300–304). 

GSA published a proposed rule in the 

Federal Register on June 26, 2014 (79 

FR 36279). The proposed rule 

recommended adding a definition for 

the terms ‘‘Marriage’’ and ‘‘Spouse’’, 

and revising the definition of the term 

‘‘Domestic Partnership’’. 

B. Summary of Comments Received 

In response to the proposed rule, GSA 

received comments from six different 

entities (one Federal agency, one 

Federal employee, two individuals, and 

two associations). Some comments 

received were generally supportive as to 


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