53144 Federal Register / Vol. 77, No. 170 / Friday, August 31, 2012 / Rules and Regulations 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

8. Taking of Private Property 

This rule will not cause a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

9. Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

10. Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

11. Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

12. Energy Effects 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211, Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use. 

13. Technical Standards 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

14. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA)(42 U.S.C. 4321–4370f), and 

have determined that this action is one 

of a category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves the 

establishment of a safety zone, and 

therefore, it is categorically excluded 

from further review under paragraph 

34(g) of Figure 2–1 of the Commandant 

Instruction. A final environmental 

analysis checklist and a categorical 

exclusion determination are available in 

the docket where indicated under 

ADDRESSES. We seek any comments or 

information that may lead to the 

discovery of a significant environmental 

impact from this rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine Safety, Navigation 

(water), Reporting and record keeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR parts 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapters 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T09–0814 to read as 

follows: 

§ 165.T09–0814 Safety Zone; Cleveland 

National Air Show, Cleveland, OH. 

(a) Location. The safety zone will 

encompass a portion of Lake Erie and 

Cleveland Harbor near Burke Lakefront 

Airport from position 41°30′20′′ N and 

081°42′20′′ W to 41°30′50′′ N and 

081°42′49′′ W, to 41°32′09′′ N and 

081°39′49′′ W, to 41°31′53′′ N and 

081°39′24′′ W, then return to the original 

position (NAD 83). 

(b) Enforcement Period. This 

regulation will be enforced from 11:30 

a.m. to 4:30 p.m. on August 30, 2012, 

10:00 a.m. to 4:30 p.m. on August 31, 

2012, and 8:00 a.m. to 6:00 p.m. on 

September 1 through 3, 2012. 

(c) Regulations. (1) In accordance with 

the general regulations in section 165.23 

of this part, entry into, transiting, or 

anchoring within this safety zone is 

prohibited unless authorized by the 

Captain of the Port Buffalo or his 

designated on-scene representative. 

(2) This safety zone is closed to all 

vessel traffic, except as may be 

permitted by the Captain of the Port 

Buffalo or his designated on-scene 

representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port Buffalo is any 

Coast Guard commissioned, warrant or 

petty officer who has been designated 

by the Captain of the Port Buffalo to act 

on his behalf. 

(4) Vessel operators desiring to enter 

or operate within the safety zone shall 

contact the Captain of the Port Buffalo 

or his on-scene representative to obtain 

permission to do so. The Captain of the 

Port Buffalo or his on-scene 

representative may be contacted via 

VHF Channel 16. Vessel operators given 

permission to enter or operate in the 

safety zone must comply with all 

directions given to them by the Captain 

of the Port Buffalo, or his on-scene 

representative. 

Dated: August 22, 2012. 

S.M. Wischmann, 

Captain, U.S. Coast Guard, Captain of the 

Port Buffalo. 

[FR Doc. 2012–21532 Filed 8–30–12; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0116; FRL–9338–2] 

Nitric Acid; 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 nitric acid 

(CAS Reg. No. 7697–37–2) when used as 

an inert ingredient in antimicrobial 

pesticide formulations applied to foodcontact surfaces in public eating places, 

dairy processing equipment, and foodprocessing equipment and utensils at a 

maximum level in the end-use 

concentration of 1,000 parts per million 

(ppm). 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 nitric acid. 

DATES: This regulation is effective 

August 31, 2012. Objections and 

requests for hearings must be received 

on or before October 30, 2012, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 


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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–2012–0116, is 

available at http://www.regulations.gov 

or at the OPP Docket in the 

Environmental Protection Agency 

Docket Center (EPA/DC), located in EPA 

West, 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; email address: 

austin.lisa@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. Potentially 

affected entities may include, but are 

not limited to: 

• 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:// 

ecfr.gpoaccess.gov/cgi/t/text/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–2012–0116 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 October 30, 2012. 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 that does not 

contain any 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 a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2012–0116, 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 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), Mail Code: 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.htm. 

II. Petition for Exemption 

In the Federal Register of April 7, 

2000 (65 FR 18324) (FRL–6499–7), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

9E6029) by Ecolab Inc., 370 N. Wabasha 

Street, St. Paul, MN 55102. The petition 

requested that 40 CFR 180.940 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of nitric acid (CAS Reg. No. 

7697–37–2) when used as an inert 

ingredient in antimicrobial pesticide 

formulations applied to food-contact 

surfaces in public eating places, dairy 

processing equipment, and foodprocessing equipment and utensils at a 

maximum level in the end-use 

concentration of 1,000 parts per million 

(ppm). That notice referenced a 

summary of the petition prepared by 

Ecolab Inc., the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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 


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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 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, 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 nitric acid 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with nitric acid 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 nitric acid 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. 

Nitric acid is a highly corrosive 

inorganic acid. In a concentrated form, 

nitric acid is corrosive at the site of 

contact and does not elicit systemic 

toxicity. Acute dermal and eye 

exposures to concentrated forms of 

nitric acid can result in skin burns and 

irreversible eye corrosion. Acute 

inhalation exposure to nitric acid can 

result in severe respiratory irritation 

followed by pulmonary edema. Acute 

ingestion of nitric acid may result in 

ulceration, hemorrhage and perforation 

of the esophagus and stomach. 

The U.S. Occupational Safety and 

Health Administration (OSHA) 

Permissible Exposure Limit (PEL) for 

nitric acid as well as the American 

Conference of Governmental Industrial 

Hygienists (ACGIH) Threshold Limit 

Value (TLV) for nitric acid is 2 ppm (5 

milligrams/meter (mg/m3)). 

While there are no data on the toxicity 

of dilute forms of nitric acid following 

oral exposure, the toxicity of dilute 

nitric acid would be expected to be 

comparable to the toxicity of the NO3- 

anion known as nitrate. 

Sodium nitrate. Several studies were 

available for sodium nitrate. These 

studies included a 6-week oral toxicity 

range-finding study, chronic/ 

carcinogenicity studies in rodents and a 

2-generation toxicity study in rabbits. In 

a 6-week oral toxicity study in F344 

rats, sodium nitrate was administered in 

the diet. Signs of toxicity were 

manifested as decreased body weight 

gain at ≥5% (approximately 2,500 

milligrams/kilograms/day (mg/kg/day)). 

In the International Agency for Research 

On Cancer (IARC) Monographs on the 

Evaluation of Carcinogenic Risks to 

Humans (Vol 94), the carcinogenic 

potential of sodium nitrate was 

evaluated in several studies in rodents. 

In two studies in mice, no evidence of 

carcinogenic activity of sodium nitrate 

alone was observed in the drinking 

water at concentrations up to 

approximately 5,000 mg/kg/day. In four 

studies in rats, no increased incidence 

of tumors was observed when sodium 

nitrate alone was administered in the 

drinking water or in the diet at 

concentrations up to approximately 

2,500 mg/kg/day. Therefore, IARC 

concluded that there is inadequate 

evidence in humans for the 

carcinogenicity of nitrate in food or 

drinking water. 

There were no treatment related 

effects observed in the 2-generation 

reproduction study in rabbits. In 

addition, the Food and Drug 

Administration (FDA) sponsored several 

reproductive and developmental studies 

in rodents, hamsters and rabbits treated 

with sodium nitrate. No adverse effects 

were observed in maternal reproductive 

parameters nor was there fetotoxicity or 

fetal malformations up to the maximum 

doses tested in each species (41 mg/kg/ 

day in mice and hamsters and 66 mg/ 

kg/day in rats and rabbits). 

Immunotoxicity studies for nitric acid 

were not available for review. However, 

there was no evidence of potential 

immunotoxicity in any of the submitted 

studies. Therefore, nitric acid is not 

expected to be immunotoxic. 

There were three human 

epidemiological studies available for 

review. These epidemiological studies 

reported that cases of infant 

methemoglobinemia are associated with 

exposure to nitrate in drinking water. 

The American Public Health 

Association (APHA) conducted a survey 

to identify clinical cases of infantile 

methemoglobinemia that were 

associated with ingestion of nitratecontaminated water. They concluded 

that greater incidences of 

methemoglobinemia were observed in 

infants consuming >1.8 mg/kg/day of 

sodium nitrate. Methemoglobinemia 

was not observed in any of the studies 

where infants consumed water 

containing less than 1.6 mg/kg/day of 

sodium nitrate. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by nitric acid 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 

‘‘Nitric Acid; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,’’ 

pp. 9–26 in docket ID number EPA–HQ– 

OPP–2012–0116. 

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. 

The chronic reference dose (cRfD) of 

1.6 mg/kg/day and an uncertainty factor 

of 1X were established based on the 

results of the American Public Health 

Association’s epidemiology study in 

infants. The endpoint was based on the 

concentration of sodium nitrate (1.6 mg/ 

kg/day) in water at which 

methemoglobinemia was not observed 

in infants. Data from this study 

represented the most sensitive endpoint 


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in the most sensitive population; 

therefore, the standard uncertainty 

factors were reduced to 1X. 

A summary of the toxicological 

endpoints for nitric acid used for human 

risk assessment is shown in the Table of 

this unit. 

TABLE —SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR NITRIC ACID FOR USE IN HUMAN RISK ASSESSMENT

Exposure/scenario Point of departure and uncertainty/safety factors 

RfD, PAD, LOC for risk assessment Study and toxicological effects 

Acute dietary (all populations).There were no effects that could be attributed to a single dose in the database. Therefore, an acute dietary assessment was not necessary. 

Chronic dietary (All populations).NOAEL= 1.6 mg/kg/day 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

Chronic RfD = 1.6 mg/kg/ 

day 

cPAD = 1.6 mg/kg/day 

APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Incidental oral short-term (1 

to 30 days).

NOAEL= 1.6 mg/kg/day 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

LOC for MOE = 1 APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Incidental oral intermediateterm (1 to 6 months).NOAEL= 1.6 mg/kg/day 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

LOC for MOE = 1 APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Dermal short-term (1 to 30 

days).

NOAEL= 1.6 mg/kg/day 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

LOC for MOE = 1 APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Dermal intermediate-term (1 

to 6 months).

NOAEL= 1.6 mg/kg/day 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

LOC for MOE = 1 APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Inhalation short-term (1 to 

30 days).

NOAEL= 1.6 mg/kg/day 

(inhalation absorption 

rate = 100%) 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

LOC for MOE = 1 APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Inhalation (1 to 6 months) ... NOAEL= 1.6 mg/kg/day 

(inhalation absorption 

rate = 100%) 

UFA = 1x 

UFH = 1x 

FQPA SF = 1x 

LOC for MOE = 1 APHA Human Epidemiological Survey LOAEL = 1.8– 

3.2 mg/kg/day based on early clinical signs of 

methemoglobinemia in excess of 10% in 0–3 

months old infants. 

Cancer (Oral, dermal, inhalation).Not likely to be carcinogenic based on the lack of evidence of carcinogenicity in the submitted studies. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. UFS = use of a short-term study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = population adjusted dose 

(a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

In evaluating dietary exposure to 

nitric acid, EPA considered exposure 

under the petitioned-for exemption from 

the requirement of a tolerance. EPA 

assessed dietary exposures from nitric 

acid in food as follows: 

The requested exemption from the 

requirement of a tolerance for the use of 

nitric acid could allow for uses in food 

contact surface sanitizing solutions in 

which residues of nitric acid could 

migrate to food or otherwise be ingested. 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to nitric acid, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance. In 

the absence of actual dietary exposure 

data resulting from this use, the EPA has 

utilized a conservative, healthprotective method of estimating dietary 

intake that is based upon conservative 

assumptions related to the amount of 

residues that can be transferred to foods 

as a result of the proposed use of nitric 

acid in food contact sanitizing pesticide 

products. This same methodology has 

been utilized by EPA in estimating 

dietary exposures to antimicrobial 

pesticides used in food-handling 

settings. A complete description of the 

approach used to assess dietary 

exposures resulting from food contact 

sanitizing solution uses of nitric acid 

can be found at http:// 

www.regulations.gov in document 

‘‘Nitric Acid; Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,’’ 

pp. 9–26 in docket ID number EPA–HQ– 

OPP–2012–0116. 

EPA assessed dietary exposures from 

nitric acid in food as follows: 

i. Acute exposure. No adverse effects 

attributable to a single exposure of nitric 

acid were seen in the toxicity databases. 

Therefore, an acute dietary exposure 

assessment for nitric acid is not 

necessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, the Agency believes the 

assumptions used to estimate chronic 

dietary exposures lead to an extremely 

conservative assessment of chronic 

dietary risk due to a series of 

compounded conservatisms. First, when 

a surface is treated with a disinfectant, 

a quantity of the disinfectant remains on 

the surface (Residual Solution). In the 

absence of any other data, EPA has used 


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an estimated worst-case concentration 

of 1 mg of solution per square 

centimeter (cm) of treated surface area 

for this quantity. 

Second, the conservatism of this 

methodology is compounded by EPA’s 

decision to assume a worst case scenario 

that all food that an individual 

consumes will come into contact with 

4,000 cm2 of sanitized non-porous foodcontact surfaces. This contact area 

represents all the surface area from 

silverware, china, and glass used by a 

person who regularly eats three meals 

per day at an institutional or public 

facility. The surface area of counter tops 

that comes in contact with food is 

expected to be smaller than the surface 

area for food utensils. As a conservative 

estimate, EPA assumed that 2,000 cm2

of treated counter top surface area, 

comes into contact with an individual’s 

food per day. 

Third, EPA assumes that 100% of the 

material present on food contact 

surfaces will migrate to food. 

iii. Cancer. Sodium nitrate did not 

cause an increase in tumors in rodents 

at doses up to 2,500 mg/kg/day. 

Therefore, based on the weight of 

evidence, nitric acid is not likely to 

cause cancer in humans and a cancer 

dietary exposure assessment is not 

necessary to assess cancer risk. 

2. Dietary exposure from drinking 

water. The proposed use of nitric acid 

will not result in its presence in surface 

water or ground water and therefore not 

contribute to dietary exposure. 

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). 

Nitric acid is not used as an inert 

ingredient in pesticide products that are 

registered for specific uses that may 

result in both indoor and outdoor 

residential exposures. Therefore, a 

residential exposure and risk 

assessment was not conducted for nitric 

acid. 

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 nitric acid to share 

a common mechanism of toxicity with 

any other substances, and nitric acid 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that nitric acid does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

Food Quality Protection Act (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 concern for fetal 

susceptibility. There were no treatment 

related effects observed in the 2- 

generation reproduction study in 

rabbits. Also, the FDA sponsored several 

reproductive and developmental studies 

in rodents, hamsters and rabbits treated 

with sodium nitrate. No adverse effects 

were observed in maternal reproductive 

parameters nor was there fetotoxicity or 

fetal malformations up to the maximum 

doses tested in each species (41 mg/kg/ 

day in mice and hamsters and 66 mg/ 

kg/day in rats and rabbits). Fetal 

susceptibility was not observed in these 

any of these studies. Therefore, there are 

no concerns for residual uncertainties 

concerning prenatal and postnatal 

toxicity. 

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 nitric acid 

is adequate as it is based on the use of 

sodium nitrate data for which there is a 

robust toxicity database. The NOAEL 

used for risk assessment was derived 

from the critical toxic effect in the most 

sensitive human subpopulation (infants 

age 8 days to 5 months). 

ii. There is no indication that nitric 

acid is a neurotoxic chemical and there 

is no need for a developmental 

neurotoxicity study or additional UFs to 

account for neurotoxicity. 

iii. There is no indication that nitric 

acid is a immunotoxic chemical and 

there is no need additional UFs to 

account for immunotoxicity. 

iv. There is no evidence that nitric 

acid results in increased susceptibility 

in in utero rodents. Several reproductive 

and developmental studies in rodents, 

hamsters and rabbits showed no 

evidence of increased fetal 

susceptibility at doses as high as 41 mg/ 

kg/day in mice and hamsters and 66 mg/ 

kg/day in rats and rabbits. Further, 

although effects in infants were found in 

an epidemiological study, the cRfD (1.6 

mg/kg/day) is based on a clear NOAEL 

established in that study. 

v. There are no residual uncertainties 

identified in the exposure databases. 

EPA made conservative (protective) 

assumptions regarding dietary exposure 

to nitric acid. This assessment will not 

underestimate the exposure and risks 

posed by nitric acid. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases 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 POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

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, nitric acid 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 nitric acid from 

dietary exposure will utilize 24% of the 

cPAD for children 1–2 years old, the 

population group receiving the greatest 

exposure. There are no residential uses 

for nitric acid. 


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Federal Register / Vol. 77, No. 170 / Friday, August 31, 2012 / Rules and Regulations 53149 

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). 

Because no short-term adverse effect 

was identified, nitric acid is not 

expected to pose a short-term risk. 

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 adverse 

effect was identified, nitric acid is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in adequate 

rodent carcinogenicity studies, nitric 

acid 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 nitric acid 

residues under reasonably foreseeable 

circumstances. Therefore, the 

establishment of an exemption from 

tolerance under 40 CFR 180.940(a) for 

residues of nitric acid when used as an 

inert ingredient in pesticide 

formulations applied to food-contact 

surfaces in public eating places, dairy 

processing equipment, and foodprocessing equipment and utensils at a 

maximum level in the end-use 

concentration of 1,000 ppm, 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 establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

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 U.N. 

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 nitric acid. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for nitric acid 

(CAS No. 7697–37–2) when used as an 

inert ingredient in pesticide 

formulations applied to food-contact 

surfaces in public eating places, dairy 

processing equipment, and foodprocessing equipment and utensils at a 

maximum level in the end-use 

concentration of 1,000 ppm. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104–4). 

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), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. 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 this final rule in the 

Federal Register. This final rule 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: August 17, 2012. 

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: 


EMCDONALD on DSK67QTVN1PROD with RULES
53150 Federal Register / Vol. 77, No. 170 / Friday, August 31, 2012 / Rules and Regulations 

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

■ 2. In § 180.940(a), the table is 

amended by adding alphabetically 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 

*******

Nitric acid .................................................. 7697–37–2 When ready for use, the end-use concentration is not to exceed 1,000 ppm. 

*******

* * * * * 

[FR Doc. 2012–21354 Filed 8–30–12; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 635 

[Docket No. 120306154–2241–02] 

RIN 0648–XC162 

Atlantic Highly Migratory Species; 

Atlantic Bluefin Tuna Fisheries 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Temporary rule; inseason 

General category retention limit 

adjustment. 

SUMMARY: NMFS is adjusting the 

Atlantic tunas General category daily 

Atlantic bluefin tuna (BFT) retention 

limit from one to three large medium or 

giant BFT for the September, October, 

November, and December time periods 

of the 2012 fishing year, based on 

consideration of the regulatory 

determination criteria regarding 

inseason adjustments. This action 

applies to Atlantic tunas General 

category permitted vessels and to Highly 

Migratory Species (HMS) Charter/ 

Headboat category permitted vessels 

when fishing commercially for BFT. 

DATES: Effective September 1, 2012, 

through December 31, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Sarah McLaughlin or Brad McHale, 

978–281–9260. 

SUPPLEMENTARY INFORMATION: 

Regulations implemented under the 

authority of the Atlantic Tunas 

Convention Act (ATCA; 16 U.S.C. 971 et 

seq.) and the Magnuson-Stevens Fishery 

Conservation and Management Act 

(Magnuson-Stevens Act; 16 U.S.C. 1801 

et seq.) governing the harvest of BFT by 

persons and vessels subject to U.S. 

jurisdiction are found at 50 CFR part 

635. Section 635.27 subdivides the U.S. 

BFT quota recommended by the 

International Commission for the 

Conservation of Atlantic Tunas (ICCAT) 

among the various domestic fishing 

categories, per the allocations 

established in the 2006 Consolidated 

Atlantic HMS Fishery Management Plan 

(Consolidated HMS FMP) (71 FR 58058, 

October 2, 2006) and in accordance with 

implementing regulations. NMFS is 

required under ATCA and the 

Magnuson-Stevens Act to provide U.S. 

fishing vessels with a reasonable 

opportunity to harvest the ICCATrecommended quota. 

The 2010 ICCAT recommendation 

regarding western BFT management 

resulted in baseline U.S. quotas for 2011 

and for 2012 of 923.7 mt (not including 

the 25 mt ICCAT allocated to the United 

States to account for bycatch of BFT in 

pelagic longline fisheries in the 

Northeast Distant Gear Restricted Area). 

The 2011 BFT quota rule (76 FR 39019, 

July 5, 2011) established a quota of 

435.1 mt for the General category fishery 

(the commercial tunas fishery in which 

handgear is used). Each of the General 

category time periods (January, June 

through August, September, October 

through November, and December) is 

allocated a portion of the annual 

General category quota. Through a 

November 2011 final rule implementing 

adjustments to the BFT General and 

Harpoon category regulations (76 FR 

74003, November 30, 2011), the January 

BFT fishery may remain open until the 

January subquota is reached or March 

31 (whichever happens first). Consistent 

with the allocation scheme established 

in the Consolidated HMS FMP and 

implementing regulations, the baseline 

category subquotas were established in 

the 2011 BFT quota rule as follows: 23.1 

mt for January; 217.6 mt for June 

through August; 115.3 mt for 

September; 56.6 mt for October through 

November; and 22.6 mt for January. 

Although NMFS published quota 

specifications for 2012 (77 FR 44161, 

July 27, 2012), the baseline General 

category quota and subquotas as 

codified have not changed from the 

amounts established for the 2011 fishing 

year. 

Unless changed, the General category 

daily retention limit starting on 

September 1 would be the default 

retention limit of one large medium or 

giant BFT (measuring 73 inches (185 

cm) curved fork length (CFL) or greater) 

per vessel per day/trip (§ 635.23(a)(2)). 

This default retention limit applies to 

General category permitted vessels and 

to HMS Charter/Headboat category 

permitted vessels when fishing 

commercially for BFT. 

Adjustment of General Category Daily 

Retention Limit 

Under § 635.23(a)(4), NMFS may 

increase or decrease the daily retention 

limit of large medium and giant BFT 

over a range of zero to a maximum of 

five per vessel based on consideration of 

the relevant criteria provided under 

§ 635.27(a)(8), which include: The 

usefulness of information obtained from 

catches in the particular category for 

biological sampling and monitoring of 

the status of the stock; effects of the 

adjustment on BFT rebuilding and 

overfishing; effects of the adjustment on 

accomplishing the objectives of the 

fishery management plan; variations in 

seasonal BFT distribution, abundance, 

or migration patterns; effects of catch 

rates in one area precluding vessels in 

another area from having a reasonable 

opportunity to harvest a portion of the 

category’s quota; and review of dealer 

reports, daily landing trends, and the 

availability of the BFT on the fishing 

grounds. Unused General category quota 

rolls forward within a fishing year to the 

subsequent subquota time period, e.g., 

from the June through August period to 

the September period, and so on. 

For the 2011 fishing year, NMFS 

adjusted the General category limit from 

the default level of one large medium or 

giant BFT as follows: Two large medium 

or giant BFT for the January subquota 

period (75 FR 79309, December 20, 


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