32662 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

(2) The veteran was receiving serviceconnected disability compensation on 

the date of death; 

(3) The veteran would have been 

receiving service-connected disability 

compensation on the date of death, but 

for the receipt of military retired pay or 

non-service-connected disability 

pension; or 

(4) The Secretary determines the 

veteran is eligible for a burial allowance 

under § 3.1708. 

(c) Amount payable. The amount 

payable under this section will not 

exceed the cost of transporting the 

remains to the national cemetery closest 

to the veteran’s last place of residence 

in which burial space is available, and 

is subject to the limitations set forth in 

paragraph (d) of this section. 

(d) Reimbursable transportation 

expenses. (1) VA will reimburse 

reasonable transportation expenses, 

including but not limited to the costs of 

shipment via common carrier (i.e., 

procuring permits for shipment, a 

shipping case, sealing of the shipping 

case, and applicable Federal taxes) and 

costs of transporting the remains to the 

place of burial. 

(2) A reasonable transportation 

expense is an expense that is usual and 

customary in the context of burial 

transportation, with a corresponding 

charge that is the usual and customary 

charge made to the general public for 

the same or similar services. 

(Authority: 38 U.S.C. 2303, 2308) 

Burial Benefits: Other 

§ 3.1710 Escheat (payment of burial 

benefits to an estate with no heirs). 

VA will not pay burial benefits if the 

payment would escheat (that is, would 

be turned over to the State because there 

are no heirs to the estate of the person 

to whom such benefits would be paid). 

(Authority: 38 U.S.C. 501(a)) 

§ 3.1711 Effect of contributions by 

government, public, or private 

organizations. 

(a) Contributions by government or 

employer. With respect to claims for a 

plot or interment allowance under 

§ 3.1707, if VA has evidence that the 

U.S., a State, any agency or political 

subdivision of the U.S. or of a State, or 

the employer of the deceased veteran 

has paid or contributed payment to the 

veteran’s plot or interment expenses, 

VA will pay the claimant up to the 

lesser of: 

(1) The allowable statutory amount; or 

(2) The amount of the total plot or 

interment expenses minus the amount 

of expenses paid by any or all of the 

organizations described in this 

paragraph (a). 

(b) Burial expenses paid by other 

agencies of the U.S. (1) Burial allowance 

when Federal law or regulation also 

provides for payment. VA cannot pay 

the non-service-connected burial 

allowance when any Federal law or 

regulation also specifically provides for 

the payment of the deceased veteran’s 

burial, funeral, or transportation 

expenses. However, VA will pay the 

non-service-connected burial allowance 

when a Federal law or regulation allows 

the payment of burial expenses using 

funds due, or accrued to the credit of, 

the deceased veteran (such as Social 

Security benefits), but the law or 

regulation does not specifically require 

such payment. In such cases, VA will 

pay the maximum amount specified in 

38 U.S.C. 2302. 

(2) Payment by military service 

department. VA will not pay or will 

recoup the non-service-connected burial 

allowance for deaths occurring during 

active service or for other deaths for 

which the service department pays the 

burial, funeral, or transportation 

expenses. 

(3) When a veteran dies while 

hospitalized. When a veteran dies while 

hospitalized at the expense of the U.S. 

government (including, but not limited 

to, death in a VA facility) and benefits 

would be otherwise payable under 10 

U.S.C. 1482 and a provision of this 

subpart B, only one of these benefits is 

payable. VA will attempt to locate a 

relative of the veteran or another person 

entitled to reimbursement under 

§ 3.1702(b) and will ask that person to 

elect between these benefits. 

(Authority: 38 U.S.C. 2302, 2303(b)) 

§ 3.1712 Effect of forfeiture on payment of 

burial benefits. 

(a) Forfeiture for fraud. VA will pay 

burial benefits, if otherwise in order, 

based on a deceased veteran who 

forfeited his or her right to receive 

benefits due to fraud under § 3.901, 

Fraud. However, VA will not pay burial 

benefits to a claimant who participated 

in fraudulent activity that resulted in 

forfeiture under § 3.901. 

(b) Forfeiture for treasonable acts or 

for subversive activity. VA will not pay 

burial benefits based on a period of 

service commencing before the date of 

commission of the offense if either the 

veteran or the claimant has forfeited the 

right to all benefits except insurance 

payments under § 3.902, Forfeiture for 

treasonable acts, or § 3.903, Forfeiture 

for subversive activities, because of a 

treasonable act or subversive activities, 

unless the offense was pardoned by the 

President of the U.S. 

(Authority: 38 U.S.C. 6103, 6104, 6105) 

Cross Reference: § 3.1(aa), for the definition 

of ‘‘fraud.’’ 

§ 3.1713 Eligibility based on status before 

1958. 

When any person dies who had a 

status under any law in effect on 

December 31, 1957, that afforded 

entitlement to burial benefits, burial 

benefits will be paid, if otherwise in 

order, even though such status does not 

meet the service requirements of 38 

U.S.C. chapter 23. 

(Authority: 38 U.S.C. 2305) 

[FR Doc. 2014–13230 Filed 6–5–14; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0922; FRL–9910–50] 

Sodium Bisulfate; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of sodium 

bisulfate when used as an inert 

ingredient in antimicrobial formulations 

on food contact surfaces in public eating 

places, dairy processing equipment and 

food processing equipment and utensils 

at no more than 2,000 ppm in final 

formulation. Exponent on behalf of 

Ecolab, Inc. submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting 

establishment of an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of sodium bisulfate. 

DATES: This regulation is effective June 

6, 2014. Objections and requests for 

hearings must be received on or before 

August 5, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0922, 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), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 32663 

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: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; 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 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. 

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–2012–0922 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 August 5, 2014. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing (excluding 

any Confidential Business Information 

(CBI)) for inclusion in the public docket. 

Information not marked confidential 

pursuant to 40 CFR part 2 may be 

disclosed publicly by EPA without prior 

notice. Submit the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0922, 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. Petition for Exemption 

In the Federal Register of January 16, 

2013 (78 FR 3377) (FRL–9375–4), EPA 

issued a document pursuant to FFDCA 

section 408, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP IN– 

10526) by Ecolab, Inc., 370 N. Wabasha 

Street, St. Paul, MN 55102. The petition 

requested that 40 CFR 180.940(a) be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of sodium bisulfate (CAS Reg. 

No. 7681–38–1) when used as an inert 

ingredient in antimicrobial pesticide 

formulations applied to food contact 

surfaces in public eating places, dairy 

processing equipment and food 

processing equipment and utensils at no 

more than 2,000 ppm in final 

formulation. That document referenced 

a summary of the petition prepared by 

Exponent, 1150 Connecticut Ave. NW., 

Suite 1100, Washington, DC 20036, the 

petitioner, which is available in the 

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

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for 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. . . .’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

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32664 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with FFDCA section 

408(c)(2)(A), and the factors specified in 

FFDCA section 408(c)(2)(B), 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 sodium bisulfate 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with sodium bisulfate 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by sodium bisulfate as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

are discussed in this unit. 

The acute oral toxicity of sodium 

bisulfate is low. The acute oral LD50 in 

male rats was 2,800 mg/kg. It was 

minimally irritating to the rabbit’s skin 

and mildly irritating to the eyes. An 

acute inhalation study was available 

with sodium sulfate. Inhalation toxicity 

was not observed at 0.01 mg/l (the only 

dose tested). No dermal toxicity or 

dermal sanitization studies were 

available in the database. 

Due to the lack of data for sodium 

bisulfate, both human metabolic 

processes and toxicity data for sodium 

sulfate were used for the risk 

characterization. Both sodium bisulfate 

and sodium sulfate readily undergo 

hydrolysis and dissociate to sodium 

ions and sulfate ions in the body. 

Sodium sulfate was administered to 

male Sprague-Dawley rats at a dietary 

concentration of 0.84% (approximately 

320–400 mg/kg/day) for 27 and 44 

weeks. There was no mortality, tumors, 

body weight change or significant 

changes in food and/or water 

consumption. The NOAEL was ∼320– 

400 mg/kg/day. In another study, male 

Sprague-dawley rats were given in diet 

0.0, 0.125, 0.250, 0.5, 1 and 2% sodium 

sulfate (approximately 0, 125, 250, 500, 

1,000 and 2,000 mg/kg/day) for 4 weeks. 

No changes in food and water 

consumption, body weight gain, food 

conversion efficiency, urine production 

or diarrhea. Blood hemoglobin, white 

blood count, serum alkaline 

phosphatase, inorganic phosphate and 

gross organ pathology were also 

unaffected. The NOAEL was 2,000 mg/ 

kg/day (highest dose tested). A LOAEL 

was not observed in this study. 

Sodium sulfate showed no mutagenic 

effect in the Ames test using various 

strains of S. typhimurium (TA1535, 

TA1537, TA100, TA98) both with and 

without S9 activation. 

No carcinogenicity studies were 

available in the database. The National 

Toxicology Program (NTP), 

International Agency for Research on 

Cancer (IARC), and Occupational Safety 

& Health Administration (OSHA) have 

not listed sodium bisulfate as a 

carcinogen. A DEREK analysis was 

performed on sodium bisulfate and no 

structural alerts were detected. EPA 

concluded that sodium bisulfate is 

unlikely to pose a carcinogenic risk to 

humans based on lack of mutagenicity 

concerns for sodium sulfate, lack of any 

structural alerts for carcinogenicity, lack 

of any systemic toxicity at doses up to 

2,800 mg/kg/day, and its metabolism to 

form a sulfate which is natural 

constituent present in the body. 

Sodium sulfate was included in a test 

of a method for rapid assessment of 

teratogenicity. Pregnant ICR/SIM mice 

were given a saturated aqueous solution 

of sodium sulfate orally by gavage to 

deliver a dose of 2,800 mg/kg/day on 

days 8–12 of gestation. No maternal 

deaths occurred and the average 

maternal weight gain during the 

treatment period was not significantly 

different from that of water-treated 

controls. Twenty-four litters were 

delivered alive, and none were resorbed. 

The mean numbers of neonates 

delivered alive and dead in each litter 

and the survival of neonates on day 3 

were not statistically significantly 

different from those of controls. Only 

body weight on day 1 was statistically 

significantly greater than that of 

controls. The maternal and 

developmental NOAEL = 2,800 mg/kg 

bw, the only dose tested. 

No immunotoxicity, neurotoxicity or 

reproductive toxicity studies were 

available in the database. 

Sodium bisulfate mammalian 

metabolism is essentially that of the 

sodium cation and sulfate anion. As 

previously noted, when sodium 

bisulfate is added to food products 

containing water or after ingestion of 

sodium bisulfate it ionizes to sodium 

ions, hydrogen ions and sulfate ions. 

Following ingestion, sulfate anions are 

predominantly not absorbed from the 

gastrointestinal tract and are excreted 

unchanged in urine. However, the 

sulfate anion is a normal constituent in 

the body, predominantly resulting from 

the body’s metabolism of sulfurcontaining food sources such as foods 

containing the essential amino acids 

cysteine and methionine. Sulfate anions 

are vital components in a number of 

human biosynthetic pathways such as 

cartilage production and the formation 

of pancreatic digestive enzymes. 

Additionally, the sulfate anion is also an 

important conjugate in the Phase II 

conjugation/elimination of oxidized 

(OH) aromatic ring metabolites and for 

hydroxyl steroid hormones, such as 

estrogen, where it acts as a transport 

agent to target organ tissue receptors. 

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. 

There was no hazard identified in 

repeat dose developmental studies at 

the limit dose of 2,800 mg/kg/day of 

sodium sulfate to either parental 

animals or their offspring. No effects 

were seen in two subchronic oral 

toxicity up to approximately 2,000 mg/ 

kg/day of sodium sulfate. Based on the 

metabolism of sodium bisulfate to 

sulfate and sodium ions, both of which 

are essential components in the human 

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Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 32665 

metabolic processes, there is a lack of 

toxicological concern. Thus, due to its 

low potential hazard and lack of hazard 

endpoint, the Agency has determined 

that a quantitative risk assessment using 

safety factors applied to a point of 

departure protective of an identified 

hazard endpoint is not appropriate. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sodium bisulfate, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance (40 CFR 

180.940(a)) such as food in contact with 

sanitized counters in public eating 

places, utensils, dairy processing 

equipment and food processing 

equipment as well as other uses which 

may result in dietary exposure. 

However, because no hazard was 

identified for the acute and chronic 

dietary assessment (food and drinking 

water), or for the short-, intermediate-, 

and long-term residential assessments, 

no quantitative aggregate exposure 

assessments were performed. 

2. Dietary exposure from drinking 

water. Residues of sodium bisuflate 

from uses in food contact sanitizing 

solutions, utensil, dairy processing 

equipment and food processing 

equipment may enter drinking water. 

However, because no hazard was 

identified for the acute and chronic 

dietary assessment, or for the short-, 

intermediate-, and long-term residential 

assessments as listed in this unit, no 

quantitative aggregate exposure 

assessments were performed. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Residential (dermal and inhalation) 

exposure from food contact surface 

sanitizing solutions for public eating 

places, dairy-processing equipment, 

food-processing equipment and utensils 

are possible. Since an endpoint for risk 

assessment was not identified, a 

quantitative residential exposure 

assessment for sodium bisulfate was not 

conducted. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found sodium bisulfate 

to share a common mechanism of 

toxicity with any other substances, and 

sodium bisulfate does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that sodium bisulfate 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 

The toxicity database for sodium 

bisulfate is adequate for assessment of 

risks to infants and children and the 

potential exposure is adequately 

characterized given the low toxicity of 

the chemical and formation of sulfate 

ion. No hazard was identified and there 

is no residual uncertainty regarding 

prenatal and/or postnatal toxicity. No 

acute or subchronic neurotoxicity 

studies are available, but there were no 

clinical signs of neurotoxicity or any 

systemic toxicity observed in the 

available database at doses up to 2,800 

mg/kg/day. No developmental, 

reproductive, or teratogenic effects were 

seen in the available studies at doses up 

to and including 2,800 mg/kg/day. 

Based on this information, there is no 

concern at this time for increased 

sensitivity to infants and children to 

sodium bisulfate when used as an inert 

ingredient in pesticide formulations for 

food contact surface sanitizing 

applications and a safety factor analysis 

has not been used to assess risk. For the 

same reason, EPA has determined that 

an additional safety factor is not needed 

to protect the safety of infants and 

children. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on sodium bisulfate, EPA 

has determined that there is a 

reasonable certainty that no harm to any 

population subgroup, including infants 

and children, will result from aggregate 

exposure to sodium bisulfate under 

reasonable foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.940(a) for residues of sodium 

bisulfate when used as an inert 

ingredient in pesticide formulations 

applied to food contact surface 

sanitizing solutions for public eating 

places, dairy processing equipment, 

food processing equipment and utensils 

at no more than 2,000 ppm in 

formulation, is safe under FFDCA 

section 408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is not establishing a numerical 

tolerance for residues of sodium 

bisulfate in or on any food commodities. 

EPA is establishing a limitation on the 

amount of sodium bisulfate that may be 

used in pesticide formulations. The 

limitation will be enforced through the 

pesticide registration process under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), 7 U.S.C. 136 

et seq. EPA will not register any 

pesticide for sale or distribution that 

contains greater than 2,000 ppm of 

sodium bisulfate in the pesticide 

formulation. 

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 Nation 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 sodium bisulfate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for sodium 

bisulfate (CAS Reg. No. 7681–38–1) 

when used as an inert ingredient in 

antimicrobial pesticide formulations 

applied to food contact surface 

sanitizing solutions for public eating 

places, dairy processing equipment, 

food processing equipment and utensils 

at no more than 2,000 ppm in 

formulation. 

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32666 Federal Register / Vol. 79, No. 109 / Friday, June 6, 2014 / Rules and Regulations 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled ‘‘Regulatory 

Planning and Review’’ (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001) or Executive 

Order 13045, entitled ‘‘Protection of 

Children from Environmental Health 

Risks and Safety Risks’’ (62 FR 19885, 

April 23, 1997). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA) (44 

U.S.C. 3501 et seq.), nor does it require 

any special considerations under 

Executive Order 12898, entitled 

‘‘Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations’’ (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under FFDCA section 408(d), such as 

the 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 final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of FFDCA section 408(n)(4). As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

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

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: June 2, 2014. 

Lois Rossi, 

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 § 180.940, in the table in 

paragraph (a), alphabetically add the 

following inert ingredient to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. No. Limits 

*******

Sodium bisulfate ........................................ 7681–38–1 When ready for use, the end-use concentration is not to exceed 2,000 ppm. 

*******

[FR Doc. 2014–13229 Filed 6–5–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0654 and EPA–HQ– 

OPP–2013–0655; FRL–9910–38] 

Flutriafol; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes, 

amends, and removes tolerances for 

residues of flutriafol in or on multiple 

commodities which are identified and 

discussed later in this document. 

Cheminova A/S c/o Cheminova, Inc. 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective June 

6, 2014. Objections and requests for 

hearings must be received on or before 

August 5, 2014, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0654 and 

EPA–HQ–OPP–2013–0655, 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 

mstockstill on DSK4VPTVN1PROD with RULES