Rule2022-23978
Nitric Acid; Exemption From the Requirement of a Tolerance
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 8, 2022
Effective
November 8, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 215 (Tuesday, November 8, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#53011715011d3c273a303620133623327d343c25"><span class="__cf_email__" data-cfemail="ebb9afadb9a5849f82888e98ab8e9b8ac58c849d">[email protected]</span></a>.
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:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> 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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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 <a href="https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf">https://www.epa.gov/sites/default/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf</a>.
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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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.
<bullet> Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
<bullet> Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 (NO<INF>3</INF><SUP>-</SUP>). 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program</a>.
[[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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides">https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides</a>.
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.
* * * * * * *
----------------------------------------------------------------------------------------------------------------
[FR Doc. 2022-23978 Filed 11-7-22; 8:45 am]
BILLING CODE 6560-50-P
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