Daily Rules, Proposed Rules, and Notices of the Federal Government
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).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
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
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:
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.
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
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.
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
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 NO
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
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
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
A summary of the toxicological endpoints for nitric acid used for human risk assessment is shown in the Table of this unit.
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.
EPA assessed dietary exposures from nitric acid in food as follows:
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
Third, EPA assumes that 100% of the material present on food contact surfaces will migrate to food.
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.
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
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
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.
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.
Because no short-term adverse effect was identified, nitric acid is not expected to pose a short-term risk.
Because no intermediate-term adverse effect was identified, nitric acid is not expected to pose an intermediate-term risk.
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.
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.
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.
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
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
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
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).
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
21 U.S.C. 321(q), 346a and 371.
(a) * * *