Document ID: EPA-HQ-OPP-2012-0116-0001
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Nitric Acid
Posted Date: 2012-08-31T04:00Z

[Federal Register Volume 77, Number 170 (Friday, August 31, 2012)]
[Rules and Regulations]
[Pages 53144-53150]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21354]

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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.

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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 food-contact surfaces in public eating places, 
dairy processing equipment, and food-processing 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

[[Page 53145]]

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/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-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 food-processing 
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

[[Page 53146]]

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 no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (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/m\3\)).
    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 nitrate-contaminated 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-observed-adverse-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

[[Page 53147]]

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
----------------------------------------------------------------------------------------------------------------
                                      Point of departure and
         Exposure/scenario              uncertainty/safety    RfD, PAD, LOC for risk    Study and toxicological
                                             factors                assessment                  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     Chronic RfD = 1.6 mg/   APHA Human Epidemiological
                                     UFA = 1x                  kg/day                  Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                 cPAD = 1.6 mg/kg/day     kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                       methemoglobinemia in
                                                                                       excess of 10% in 0-3
                                                                                       months old infants.
Incidental oral short-term (1 to 30  NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 days).                              UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                       methemoglobinemia in
                                                                                       excess of 10% in 0-3
                                                                                       months old infants.
Incidental oral intermediate-term    NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 (1 to 6 months).                    UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      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     LOC for MOE = 1         APHA Human Epidemiological
                                     UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                       methemoglobinemia in
                                                                                       excess of 10% in 0-3
                                                                                       months old infants.
Dermal intermediate-term (1 to 6     NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 months).                            UFA = 1x                                          Survey LOAEL = 1.8-3.2 mg/
                                     UFH = 1x                                          kg/day based on early
                                     FQPA SF = 1x                                      clinical signs of
                                                                                       methemoglobinemia in
                                                                                       excess of 10% in 0-3
                                                                                       months old infants.
Inhalation short-term (1 to 30       NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
 days).                               (inhalation absorption                           Survey LOAEL = 1.8-3.2 mg/
                                      rate = 100%)                                     kg/day based on early
                                     UFA = 1x                                          clinical signs of
                                     UFH = 1x                                          methemoglobinemia in
                                     FQPA SF = 1x                                      excess of 10% in 0-3
                                                                                       months old infants.
Inhalation (1 to 6 months).........  NOAEL= 1.6 mg/kg/day     LOC for MOE = 1         APHA Human Epidemiological
                                      (inhalation absorption                           Survey LOAEL = 1.8-3.2 mg/
                                      rate = 100%)                                     kg/day based on early
                                     UFA = 1x                                          clinical signs of
                                     UFH = 1x                                          methemoglobinemia in
                                     FQPA SF = 1x                                      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, health-protective 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

[[Page 53148]]

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 cm\2\ of 
sanitized non-porous food-contact 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 cm\2\ 
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 non-occupational, 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.

[[Page 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 food-processing 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 food-processing 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.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

[[Page 53150]]

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

0
2. In Sec.  180.940(a), the table is amended by adding alphabetically 
the following inert ingredient to read as follows:

Sec.  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