Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations 2315 

submission requirement. Because 

Oregon submitted this SIP to address 

the applicable requirements of CAA 

section 110(a)(2)(D)(i)(I) with respect to 

the 2006 24-hour PM2.5 NAAQS, it need 

only demonstrate that the SIP is 

adequate to prohibit emissions that 

significantly contribute to 

nonattainment or interfere with 

maintenance of the 2006 24-hour PM2.5

NAAQS in other states. Any emissions 

that have such impacts with respect to 

other NAAQS must be addressed as 

appropriate in the CAA section 

110(a)(2)(D)(i)(I) SIP submissions for 

those other NAAQS. In its May 14, 

2014, action, the EPA proposed to 

conclude that Oregon’s 2010 Interstate 

Transport SIP submission addressed the 

requirements of CAA section 

110(a)(2)(D)(i)(I) with respect to the 

2006 24-hour PM2.5 NAAQS (79 FR 

27528). The commenter has offered no 

data or evidence to suggest that the 

submission does not do so. 

III. Final Action 

The EPA is approving the portion of 

the June 28, 2010, SIP submission from 

Oregon that addresses the interstate 

transport requirements of CAA section 

110(a)(2)(D)(i)(I) for the 2006 24-hour 

PM2.5 NAAQS. The EPA is determining 

that Oregon’s existing SIP contains 

adequate provisions to ensure that air 

emissions from Oregon will not 

significantly contribute to 

nonattainment or interfere with 

maintenance of the 2006 24-hour PM2.5

NAAQS in any other state. This action 

is being taken under section 110 of the 

CAA. 

IV. Statutory and Executive Order 

Reviews 

Under the CAA, the Administrator is 

required to approve a SIP submission 

that complies with the provisions of the 

CAA and applicable Federal regulations. 

42 U.S.C. 7410(k); 40 CFR 52.02(a). 

Thus, in reviewing SIP submissions, the 

EPA’s role is to approve state choices, 

provided that they meet the criteria of 

the CAA. Accordingly, this action 

merely approves state law as meeting 

Federal requirements and does not 

impose additional requirements beyond 

those imposed by state law. For that 

reason, this action: 

• Is not a ‘‘significant regulatory 

action’’ subject to review by the Office 

of Management and Budget under 

Executive Order 12866 (58 FR 51735, 

October 4, 1993); 

• Does not impose an information 

collection burden under the provisions 

of the Paperwork Reduction Act (44 

U.S.C. 3501 et seq.); 

• Is certified as not having a 

significant economic impact on a 

substantial number of small entities 

under the Regulatory Flexibility Act (5 

U.S.C. 601 et seq.); 

• Does not contain any unfunded 

mandate or significantly or uniquely 

affect small governments, as described 

in the Unfunded Mandates Reform Act 

of 1995 (Pub. L. 104–4); 

• Does not have Federalism 

implications as specified in Executive 

Order 13132 (64 FR 43255, August 10, 

1999); 

• Is not an economically significant 

regulatory action based on health or 

safety risks subject to Executive Order 

13045 (62 FR 19885, April 23, 1997); 

• Is not a significant regulatory action 

subject to Executive Order 13211 (66 FR 

28355, May 22, 2001); 

• Is not subject to requirements of 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (15 U.S.C. 272 note) because 

this action does not involve technical 

standards; and does not provide the 

EPA with the discretionary authority to 

address, as appropriate, 

disproportionate human health or 

environmental effects, using practicable 

and legally permissible methods, under 

Executive Order 12898 (59 FR 7629, 

February 16, 1994). 

The SIP is not approved to apply on 

any Indian reservation land or in any 

other area where EPA or an Indian tribe 

has demonstrated that a tribe has 

jurisdiction. In those areas of Indian 

country, the rule does not have tribal 

implications as specified by Executive 

Order 13175 (65 FR 67249, November 9, 

2000), nor will it impose substantial 

direct costs on tribal governments or 

preempt tribal law. 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. The EPA will 

submit a report containing this action 

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. A major rule cannot take effect 

until 60 days after it is published in the 

Federal Register. This action is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

Under section 307(b)(1) of the CAA, 

petitions for judicial review of this 

action must be filed in the United States 

Court of Appeals for the appropriate 

circuit by March 17, 2015. Filing a 

petition for reconsideration by the 

Administrator of this final rule does not 

affect the finality of this action for the 

purposes of judicial review nor does it 

extend the time within which a petition 

for judicial review may be filed, and 

shall not postpone the effectiveness of 

such rule or action. This action may not 

be challenged later in proceedings to 

enforce its requirements. (See section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Nitrogen dioxide, Ozone, 

Particulate matter, Reporting and 

recordkeeping requirements, Sulfur 

oxides, and Volatile organic 

compounds. 

Authority: 42 U.S.C. 7401 et seq. 

Dated: December 31, 2014. 

Michelle Pirzadeh, 

Acting Regional Administrator, Region 10. 

40 CFR part 52 is amended as follows: 

PART 52—APPROVAL AND 

PROMULGATION OF 

IMPLEMENTATION PLANS 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart MM—Oregon 

■ 2. In § 52.1990 is amended by adding 

paragraph (b) to read as follows: 

§ 52.1990 Interstate Transport for the 2006 

24-hour PM2.5 NAAQS. 

* * * * * 

(b) The EPA approves the portion of 

Oregon’s SIP submitted on June 28, 

2010 (cover letter dated June 23, 2010) 

addressing the requirements of CAA 

section 110(a)(2)(D)(i)(I) for the 2006 24- 

hour PM2.5 NAAQS. 

[FR Doc. 2015–00645 Filed 1–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2014–0540; FRL–9920–54] 

Fosetyl-Al; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of Aluminum tris 

(O-ethylphosphonate) (fosetyl-Al) in or 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
2316 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations 

on pepper/eggplant, subgroup 8–10B. 

Bayer CropScience requested these 

tolerances under the Federal Food, 

Drug, and Cosmetic Act (FFDCA). 

DATES: This regulation is effective 

January 16, 2015. Objections and 

requests for hearings must be received 

on or before March 17, 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–2014–0540, 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 Printing Office’s e-CFR 

site at http://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http://

www.epa.gov/ocspp and select ‘‘Test 

Methods and Guidelines.’’ 

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–2014–0540 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 March 17, 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– 

2014–0540, 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 November 

7, 2014 (79 FR 66347) (FRL–9918–69), 

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 3E8182) by Bayer 

CropScience, 2 T.W. Alexander Dr., P.O. 

Box 12014, Research Triangle Park, NC 

27709. The petition requested that 40 

CFR 180.415 be amended by 

establishing tolerances for residues of 

the fungicide fosetyl-Al, aluminum tris 

(O-ethylphosphonate), in or on pepper/ 

eggplant, subgroup 8–10B at 0.01 parts 

per million (ppm) and non-bell (chili) 

pepper, dried fruit at 0.01 ppm. That 

document referenced a summary of the 

petition prepared by Bayer CropScience, 

the registrant, which is available in the 

docket, http://www.regulations.gov. 

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit IV.C. 

Based upon review of the data 

supporting the petition, EPA is not 

establishing a separate tolerance for 

residues of fosetyl-Al on pepper, nonbell (chili), dry fruit. The reason for this 

is explained in Unit IV.D. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

Consistent with FFDCA section 

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

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 fosetyl-Al 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations 2317 

including exposure resulting from the 

tolerances established by this action. 

EPA’s assessment of exposures and risks 

associated with fosetyl-Al follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The major target organs following 

repeated oral exposure to fosetyl-Al are 

the reproductive system in the dog 

(testicular degeneration: Spermatocytic 

and/or spermatidic giant cells in the 

lumen of the seminiferous tubules) and 

the urinary system in the rat 

(histopathological changes in the 

kidney, impairment of calcium/

phosphorus metabolism, calculi and 

hyperplasia in the urinary tract, bladder 

tumors). There is no concern for 

increased quantitative or qualitative 

susceptibility of the young following in 

utero (rats and rabbits) and pre-and 

postnatal exposure (rats) to fosetyl-Al. 

Also, there is no evidence of 

developmental toxicity, reproductive 

toxicity in the rat, neurotoxicity, or 

immunotoxicity at dose levels that do 

not exceed the limit dose. The 

microscopic finding in the dog testes 

may be considered an isolated finding 

in light of the lack of any functional 

deficits in the rat 2-generation 

reproductive toxicity study and the lack 

of effects on the rat reproductive organs 

following chronic exposure. 

Additionally, a clear no-observedadverse-effect level (NOAEL) was 

established for the effect observed in the 

dog and was selected as a suitable point 

of departure (POD) for the chronic 

dietary (all populations) exposure 

scenario. Fosetyl-Al is negative for 

carcinogenicity except at extremely high 

doses (>limit dose) in rats and mice, and 

it did not show any genotoxic potential 

(classified as not likely to be 

carcinogenic to humans). Fosetyl-Al is 

not acutely toxic via the oral, dermal, 

and inhalation routes. It produces 

severe eye irritation, is not a dermal 

irritant, and is negative for dermal 

sensitization. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by fosetyl-Al as well as 

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

toxicity studies can be found at http:// 

www.regulations.gov in document 

‘‘Fosetyl-Aluminum [Fosetyl-Al]: 

Human Health Risk Assessment for the 

Establishment of Tolerances with No 

U.S. Registration in/on Pepper/eggplant, 

Subgroup 8–10B and Pepper, Non-bell 

(Chili), Dry Fruit’’ in docket ID number 

EPA–HQ–OPP–2014–0540. 

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 fosetyl-Al used for human 

risk assessment is shown in Table 1 of 

this unit. 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOSETYL-AL 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 (General population including infants and 

children).

No hazard or appropriate acute endpoint was identified in the database. 

Chronic dietary (All populations) NOAEL = 250 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 2.5 

mg/kg/day.

cPAD = 2.5 mg/kg/

day 

Chronic oral toxicity (dog). 

LOAEL = 500 mg/kg/day based on increased incidence of testicular degeneration (spermatocytic and/or spermatidic giant 

cells in the lumen of the seminiferous tubules). 

Incidental oral short-term (1 to 

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

NOAEL = 300 mg/

kg/day.

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE <100.

3-generation reproduction (rat). 

LOAEL = 600 mg/kg/day based on decreased body weight 

gains in the F2b generation and urinary tract changes in 

adults. 

Inhalation short-term (1 to 30 

days) and intermediate-term 

(1 to 6 months).

Inhalation (or oral) 

study NOAEL = 

300 mg/kg/day (inhalation absorption 

rate = 100%).

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Residential LOC for 

MOE <100.

3-generation reproduction (rat). 

LOAEL = 600 mg/kg/day based on decreased body weight 

gains in the F2b generation and urinary tract changes in 

adults. 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
2318 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations 

TABLE 1—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FOSETYL-AL 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 

Cancer (Oral, dermal, inhalation).Classification: Not likely to be carcinogenic to humans. 

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 (c = chronic). 

RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity 

among members of the human population (intraspecies). 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to fosetyl-Al, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing fosetylAl tolerances in 40 CFR 180.415. EPA 

assessed dietary exposures from fosetylAl in food as follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicological studies 

for fosetyl-Al; therefore, a quantitative 

acute dietary exposure assessment is 

unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the U.S. Department of 

Agriculture’s (USDA’s) 2003–2008 

National Health and Nutrition 

Examination Survey, What We Eat in 

America, (NHANES/WWEIA). As to 

residue levels in food, EPA’s unrefined 

chronic analysis is based on tolerancelevel residues and 100% crop treated 

(PCT) assumptions. Default processing 

factors were used for all crops except for 

citrus where processing studies showed 

no residue concentration; thus, the 

processing factor was set to one for 

processed citrus commodities. 

iii. Cancer. Based on the data 

summarized in Unit III.A., EPA has 

concluded that fosetyl-Al is not 

carcinogenic to humans. Therefore, a 

dietary exposure assessment for the 

purpose of assessing cancer risk is 

unnecessary. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for fosetyl-Al. 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 fosetyl-Al in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of fosetyl-Al. 

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. 

Environmental fate properties suggest 

that fosetyl-Al is not likely to reach 

ground or surface water under most 

conditions, and if it does reach surface 

water, it is expected to degrade rapidly. 

Using the Screening Concentration in 

Ground Water (SCI–GROW) model, the 

estimated drinking water concentration 

(EDWC) of fosetyl-Al for chronic 

exposures for non-cancer assessments is 

estimated to be 0.006 parts per billion 

(ppb) for ground water. Thus, the 

ground water EDWC of 0.006 ppb was 

directly incorporating into the chronic 

dietary risk assessment. 

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). FosetylAl is currently registered for the 

following use that could result in 

residential exposure: Turf. EPA assessed 

residential exposure using the following 

assumptions: Residential handler and 

residential post-application exposures. 

The residential handler assessment 

quantitatively evaluated inhalation 

exposure from hose end sprayer for turf 

applications but not dermal exposure as 

no dermal point of departure was 

identified. There is the potential for 

short-term post-application exposure for 

individuals exposed as a result of being 

in an environment that has been 

previously treated with fosetyl-Al 

(based on contact with treated turf at the 

maximum turf application rate of 17.6 

pounds (lbs) active ingredient/Acre (ai/ 

A)). Incidental oral post-application 

exposure is quantitatively assessed for 

children 1 to <2 years old for exposure 

to treated turf. Dermal post-application 

exposure was not assessed because no 

dermal hazard was identified. Further 

information regarding EPA standard 

assumptions and generic inputs for 

residential exposures may be found at 

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

residential-exposure-sop.html. 

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.’’ 

Although fosetyl-Al shares a similar 

chemical structure with many 

organophosphates (OPs), there is no 

evidence of neurotoxicity or evidence of 

cholinesterase inhibition following 

exposure to fosetyl-Al at dose levels at 

and greater than the limit dose. EPA has 

concluded that fosetyl-Al is a not 

member of the OP cumulative group. 

EPA has not found fosetyl-Al to share a 

common mechanism of toxicity with 

any other substances either, and fosetylAl does not appear to produce a toxic 

metabolite produced by any other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that fosetyl-Al 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 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations 2319 

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. 

There is no evidence of increased 

susceptibility following in utero 

exposure to fosetyl-Al in either the rat 

(at dose levels that do not exceed the 

limit dose) or rabbit developmental 

toxicity study, and there is no evidence 

of increased susceptibility following in 

utero and/or pre-/postnatal exposure in 

the 3-generation reproduction study in 

rats. 

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 fosetyl-Al 

is complete. 

ii. There is no indication that fosetylAl is a neurotoxic chemical and there is 

no need for a developmental 

neurotoxicity study or additional 

uncertainty factors (UFs) to account for 

neurotoxicity. 

iii. There is no evidence that fosetylAl results in increased susceptibility in 

in utero rats or rabbits in the prenatal 

developmental studies or in young rats 

in the 3-generation reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the water modeling used to assess 

exposure to fosetyl-Al 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 fosetyl-Al. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, fosetyl-Al is not 

expected to pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to fosetyl-Al from 

food and water will utilize 12% 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 fosetyl-Al is not expected. 

3. Short-term risk. Fosetyl-Al 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 fosetyl-Al. 

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 3,200 for adult residential 

handlers applying liquid concentrates to 

turf via hose-end sprayer and for 

children, 540 for children’s incidental 

oral post-application exposure from 

contacting treated lawns. Because EPA’s 

level of concern for fosetyl-Al is an 

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). 

Because no intermediate-term nonoccupational exposures are expected, 

fosetyl-Al is not expected to pose an 

intermediate-term risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion in 

Unit III.A, fosetyl-Al 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 fosetyl-Al 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Rhone-Poulenc Method No. AR 154– 

97 underwent successfully independent 

laboratory validation for use as an 

enforcement analytical method. 

Although the tolerance expression 

includes only parent fosetyl-Al, Method 

AR 154–97 was validated for both 

fosetyl-Al and its metabolite, 

phosphorous acid. 

In support of the pepper trials, the 

registrant made use of a data collection 

method, Method No. 00861/M001, 

which achieved a lower Limit of 

Quantitation (LOQ) than Method AR 

154–97. Method No. 00861/M001 is an 

HPLC–MS/MS (high performance liquid 

chromatography–tandem mass 

spectrometry) method that uses the 

same extraction solvent as Method AR 

154–97. Sufficient method validation 

data were submitted with the field trial 

data to support a LOQ of 0.01 ppm for 

fosetyl-Al residues in pepper (bell and 

non-bell). As EPA encourages the 

development of improved analytical 

methods and because both methods use 

the same extraction solvent, EPA 

considers Method No. 00861/M001 to 

also be a suitable enforcement method 

for peppers. Thus, both methods 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 fosetyl-Al. 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER
2320 Federal Register / Vol. 80, No. 11 / Friday, January 16, 2015 / Rules and Regulations 

C. Response to Comments 

The Agency received a comment 

expressing concerns about allowing 

residues of pesticides on eggplant and 

peppers. The Agency understands the 

commenter’s concerns and recognizes 

that some individuals believe that no 

residue of pesticides should be allowed 

because of potential effects. However, 

under the existing legal framework 

provided by FFDCA section 408, EPA is 

authorized to establish pesticide 

tolerances where persons seeking such 

tolerances have demonstrated that the 

pesticide meets the safety standard 

imposed by the statute. Based on its 

assessment of the available data, the 

Agency has concluded there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

residues of fosetyl-Al. 

D. Revisions to Petitioned-For 

Tolerances 

EPA is not establishing a separate 

tolerance for residues of fosetyl-Al in or 

on pepper, non-bell (chili), dry fruit. 

The residues found on the dried 

commodity will be covered by the 

tolerance for residues of fosetyl-Al in or 

on pepper/eggplant, subgroup 8–10B; 

therefore, no separate tolerance is 

needed. 

V. Conclusion 

Therefore, tolerances are established 

for residues of fosetyl-Al, aluminum tris 

(O-ethylphosphonate), in or on pepper/ 

eggplant, subgroup 8–10B at 0.01 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 final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (2 U.S.C. 1501 et seq.). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA) (15 U.S.C. 272 note). 

VII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of the rule in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: December 23, 2014. 

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 § 180.415, add alphabetically 

‘‘Pepper/eggplant, subgroup 8–10’’ to 

the table in paragraph (a) to read as 

follows: 

§ 180.415 Aluminum tris (Oethylphosphonate); tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Pepper/eggplant, subgroup 

8–10B1 .............................. 0.01 

* * * * * 

1There are no U.S. registrations as of December 23, 2014. 

* * * * * 

[FR Doc. 2015–00491 Filed 1–15–15; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 571 

[Docket No. NHTSA–2011–0107] 

RIN 2127–AL56 

Federal Motor Vehicle Safety 

Standards; Electric-Powered Vehicles; 

Electrolyte Spillage and Electrical 

Shock Protection 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation (DOT). 

ACTION: Final rule; response to petitions 

for reconsideration and technical 

corrections. 

SUMMARY: This document denies a 

petition for reconsideration of Federal 

Motor Vehicle Safety Standard (FMVSS) 

No. 305, ‘‘Electric-powered vehicles; 

electrolyte spillage, and electrical shock 

protection’’ from Nissan Motor 

Company (Nissan) requesting the use of 

a megohmmeter as an alternative 

measurement method for the electrical 

isolation test procedure. Further, this 


asabaliauskas on DSK5VPTVN1PROD with FRONTMATTER