Document ID: EPA-HQ-OPP-2022-0363-0003
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances: Nitric Acid; Exemption
Posted Date: 2022-11-08T05:00Z

[Federal Register Volume 87, Number 215 (Tuesday, November 8, 2022)]
[Rules and Regulations]
[Pages 67375-67379]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-23978]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2022-0363; FRL-10247-01-OCSPP]

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 (pH adjuster) applied to crops and raw 
agricultural commodities pre- and post-harvest, limited to no more than 
10% by weight in the pesticide formulation. Technology Sciences Group, 
Inc. on behalf of Organisan Corporation, 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 when used in accordance with the terms of 
the exemption.

DATES: This regulation is effective November 8, 2022. Objections and 
requests for hearings must be received on or before January 9, 2023, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2022-0363, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room and OPP Docket is (202) 566-1744. For the latest status 
information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration 
Division (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Office of the Federal Register's e-CFR site at 
https://www.ecfr.gov/current/title-40.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2022-0363 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 
January 9, 2023. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b), although the Office 
of the Administrative Law Judges, which houses the Hearing Clerk, 
encourages parties to file objections and hearing requests 
electronically. See https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2022-0363, by one of 
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at https://www.epa.gov/dockets.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 22, 2022 (87 FR 37287) (FRL-9410-
02), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11643) by 
Technology Sciences Group, Inc., 1150 18th Street NW, Suite 1000 
Washington, DC 20036 on behalf of Organisan Corporation, P.O. Box 2085, 
Carrollton, GA 30112. The petition requested that 40 CFR 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 (pH adjuster) in pesticide formulations applied to crops and 
raw agricultural commodities pre- and post-harvest, limited to no more 
than 10% by weight in the pesticide formulation under 40 CFR 180.910. 
That document referenced a summary of the petition prepared by 
Technology Sciences Group, Inc. on behalf of Organisan Corporation, the 
petitioner, which is available in the docket, https://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

[[Page 67376]]

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(c)(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 or exemption 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 harm to human health. In order 
to determine the risks from aggregate exposure to pesticide inert 
ingredients, the Agency considers the toxicity of the inert in 
conjunction with possible exposure to residues of the inert ingredient 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings. If EPA is able to 
determine that a 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 FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure to 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. There is limited acute and no repeated dose 
studies on the toxicity of dilute forms of nitric acid following oral 
exposure. However, the toxicity of dilute nitric acid is expected to 
result from the formation of nitrate. Sodium nitrate is a water soluble 
inorganic salt that readily dissociates into sodium and the nitrate 
anion (NO3-). Therefore, toxicity data on sodium 
nitrate were used to characterize toxicity due to exposure to nitric 
acid.
    The acute inhalation toxicity of nitric acid is low at 
concentrations <=70%. The lethal concentration is greater than 2.65 
milligrams/liter (mg/L) in acute inhalation studies with nitric acid. 
Based on acute toxicity data on sodium nitrate, nitric acid is expected 
to have low oral acute toxicity. No acute data are available on the 
dermal route of exposure, eye and dermal irritation, and skin 
sensitization potential of nitric acid due to its corrosive nature at 
high concentrations.
    Several repeated dose studies were available for sodium nitrate. In 
a 6-week oral toxicity study in rats, sodium nitrate was administered 
in the diet. The only effect observed was decreased body weight gain at 
2,500 milligrams/kilogram/day (mg/kg/day), which is not considered 
adverse. There were no increased incidences in tumor formation in 
multiple carcinogenicity studies in rats and mice up to the highest 
dose tested (5,000 mg/kg/day in mice and 2,500 mg/kg/day in rats). 
Also, there were no treatment related maternal, reproductive or 
developmental effects observed in multiple reproduction and 
developmental toxicity studies in rats, mice, hamsters, and rabbits up 
to the highest doses tested (41 mg/kg/day in mice and hamsters and 66 
mg/kg/day in rats and rabbits).
    There were several human epidemiological data available for review. 
In these studies, sodium nitrate concentrations were evaluated in water 
sources for reported cases of children with cyanosis due to 
methemoglobinemia. Overall, studies found that wells used to supply 
water to children with cyanosis due to methemoglobinemia contained 
nitrate levels >1.8 mg/kg/day. Methemoglobinemia was not observed in 
infants consuming water containing less than 1.6 mg/kg/day of sodium 
nitrate.

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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.

[[Page 67377]]

    There were no effects that could be attributed to a single dose in 
the database. Therefore, an acute oral POD was not selected. Chronic 
dietary, incidental oral, dermal and inhalation short- and 
intermediate-term exposures were based on the POD of 1.6 mg/kg/day, 
based on the concentration of sodium nitrate (1.6 mg/kg/day) in water 
at which methemoglobinemia was not observed in infants.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to nitric acid, EPA considered exposure that may occur from 
the existing and proposed uses of nitric acid. EPA assessed dietary 
exposures from nitric acid in food as follows:
    No adverse effects attributable to a single dietary exposure of 
nitric acid were seen in the toxicity databases. Therefore, an acute 
dietary risk assessment is not necessary.
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 4.02, EPA used 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) 2005-2010 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no 
residue data were submitted for nitric acid. In the absence of specific 
residue data, EPA has developed an approach which uses surrogate 
information to derive upper bound exposure estimates for the subject 
inert ingredient. Upper bound exposure estimates are based on the 
highest tolerance for a given commodity from a list of high use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Update to 
D361707: Dietary Exposure and Risk Assessments for the Inerts.'' (12/
21/2021) and can be found at http://www.regulations.gov in docket ID 
number EPA-HQ-OPP-2018-0090.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest levels of 
tolerances would be no higher than the concentration of the active 
ingredient.
    The Agency believes the assumptions used to estimate dietary 
exposures lead to an extremely conservative assessment of dietary risk 
due to a series of compounded conservatisms.
    First, assuming that the level of residue for an inert ingredient 
is equal to the level of residue for the active ingredient will 
overstate exposure. The concentrations of active ingredient in 
agricultural products are generally at least 50 percent of the product 
and often can be much higher. Further, pesticide products rarely have a 
single inert ingredient; rather there is generally a combination of 
different inert ingredients used which additionally reduces the 
concentration of any single inert ingredient in the pesticide product 
in relation to that of the active ingredient.
    Second, the conservatism of this methodology is compounded by EPA's 
decision to assume that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Finally, a third compounding conservatism is EPA's assumption that all 
foods contain the inert ingredient at the highest tolerance level. In 
other words, EPA assumed 100 percent of all foods are treated with the 
inert ingredient at the rate and manner necessary to produce the 
highest residue legally possible for an active ingredient. In summary, 
EPA chose a very conservative method for estimating what level of inert 
residue could be on food, then used this methodology to choose the 
highest possible residue that could be found on food and assumed that 
all food contained this residue. No consideration was given to 
potential degradation between harvest and consumption even though 
monitoring data shows that tolerance level residues are typically one 
to two orders of magnitude higher than actual residues in food when 
distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data. EPA did assume 
that nitric acid will be limited to 10% in pesticide non-residential 
formulations that will be applied to crops and raw agricultural 
commodities pre- and post-harvest.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for nitric acid, a 
conservative drinking water concentration value of 100 ppb based on 
screening level modeling was used to assess the contribution to 
drinking water for the chronic dietary risk assessments for parent 
compound. These values were directly entered into the dietary exposure 
model.
    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, for lawn and garden pest control, indoor pest control, 
termiticides, flea and tick control on pets and hard surface 
disinfection on walls, floors, tables).
    Short-term residential exposure for adults combines high end dermal 
and inhalation handler exposure from indoor hard surface, aerosol 
sprays with a high-end post application dermal exposure from contact 
with treated lawns and results in an MOE of 6.2. Short-term residential 
exposure for children includes total exposures associated with contact 
with treated lawns (dermal and hand-to-mouth exposures) and results in 
an MOE of 20.
    Intermediate-term residential exposure for adults includes high-end 
post application dermal exposure from contact with treated lawns and 
results in an MOE of 148. Intermediate-term residential exposure for 
children includes total exposures associated with contact with treated 
lawns (dermal and hand-to-mouth exposures) and result in an MOE of 11.
    Because EPA's level of concern for nitric acid is an MOE below 1 
these MOEs are not of concern.
    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

[[Page 67378]]

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 website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    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.
    The Agency has concluded that there is reliable data to determine 
that infants and children will be safe if the FQPA SF of 10x is reduced 
to 1X for the chronic dietary assessment for the following reasons. 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 ages 8 days 
to 5 months). There is no indication of immunotoxicity or neurotoxicity 
in the available studies. Additionally, no offspring susceptibility or 
reproduction toxicity was observed in the available studies. Based on 
the adequacy of the toxicity database, the conservative nature of the 
exposure assessment and the lack of concern for prenatal and postnatal 
sensitivity, the Agency has concluded that there is reliable data to 
determine that infants and children will be safe if the FQPA SF of 10X 
is reduced to 1X.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
nitric acid is not expected to pose an acute risk.
    2. Chronic risk. A chronic aggregate risk assessment takes into 
account chronic exposure estimates from dietary consumption of food and 
drinking water. Using the exposure assumptions described in this unit 
for chronic exposure, EPA has concluded that chronic exposure to nitric 
acid from food and water will utilize 37% of the cPAD for children 1 to 
2 years old, the population group receiving the greatest exposure.
    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).
    Nitric acid may be used as an inert ingredient in pesticide 
products that are registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to nitric acid.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA concluded that the combined short-term aggregated 
food, water, and residential pesticide exposures result in MOEs of 4 
for adults. Adult residential exposure combines high end dermal and 
inhalation handler exposure from liquids/trigger sprayer/home garden 
with a high-end post application dermal exposure from contact with 
treated lawns. EPA has concluded the combined short-term aggregated 
food, water, and residential pesticide exposures result in an aggregate 
MOE of 2 for children. Children's residential exposure includes total 
exposures associated with contact with treated lawns (dermal and hand-
to-mouth exposures). Because EPA's level of concern for nitric acid is 
an MOE below 1, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Nitric acid may be used as an inert ingredient in pesticide 
products that are registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to nitric acid.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the intermediate-
term aggregated food, water, and residential exposures result in 
aggregate MOEs of 10 for adults. Adult residential exposure includes 
high end post application dermal exposure from contact with treated 
lawns. EPA has concluded the combined intermediate-term aggregated 
food, water, and residential exposures result in an aggregate MOE of 2 
for children. Children's residential exposure includes total exposures 
associated with contact with treated lawns (dermal and hand-to-mouth 
exposures). Because EPA's level of concern for nitric acid is an MOE 
below 1, these MOEs are not of concern.
    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.

V. Other Considerations

Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
nitric acid in or on any food commodities. EPA is establishing a 
limitation on the amount of nitric acid that may be used in pesticide 
formulations. This limitation will be enforced through the pesticide 
registration process under the Federal Insecticide, Fungicide, and 
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register 
any pesticide formulation for food use that exceeds 10% nitric acid in 
the final pesticide formulations.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established

[[Page 67379]]

for residues of nitric acid (CAS Reg. No. 7697-37-2) when used as an 
inert ingredient (pH adjuster) in pesticide formulations applied to 
crops and raw agricultural commodities pre- and post-harvest under 40 
CFR 180.910, limited to no more than 10% by weight in the pesticide 
formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 
exemption in this final rule, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
Tribal Governments, on the relationship between the National Government 
and the States or Tribal Governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian Tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: October 31, 2022.
Jennifer Saunders,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending 
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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

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

0
2. In Sec.  180.910, amend table 1 by adding, in alphabetical order the 
inert ingredient ``Nitric acid (CAS Reg. No. 7697-37-2)'' to read as 
follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

                                               Table 1 to 180.910
----------------------------------------------------------------------------------------------------------------
            Inert ingredients                          Limits                               Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Nitric acid (CAS Reg. No. 7697-37-2)....  10% by weight in pesticide        pH adjuster.
                                           formulation.
 
                                                  * * * * * * *
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[FR Doc. 2022-23978 Filed 11-7-22; 8:45 am]
BILLING CODE 6560-50-P