[Federal Register Volume 87, Number 42 (Thursday, March 3, 2022)]
[Rules and Regulations]
[Pages 11965-11970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04368]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0292; FRL-9420-01-OCSPP]


Polyammonium Bisulfate; 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 Polyammonium bisulfate (PABS) (CAS Reg. 
No. 10043-02-4), herein referred to as PABS, when used as an inert 
ingredient (carrier, adjuvant, buffer and stabilizer) in/on growing 
crops and raw agricultural commodities pre- and post-harvest, limited 
to 40% in pesticide non-residential formulations and 5% in pesticide 
formulations for residential use. An exemption is also established for 
its use in antimicrobial formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, food-processing 
equipment and utensils, limited to 250 parts per million (ppm). Spring 
Regulatory Sciences on behalf of Earth Science Laboratories, Inc., 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting the establishment of exemptions from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of PABS.

DATES: This regulation is effective March 3, 2022. Objections and 
requests for hearings must be received on or before May 2, 2022, 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-2021-0292, 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 is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echevarria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
<a href="/cdn-cgi/l/email-protection#580a1c1e0a16372c313b3d2b183d2839763f372e"><span class="__cf_email__" data-cfemail="73213735213d1c071a101600331603125d141c05">[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:

[[Page 11966]]

    <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 
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, 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-2021-0292 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 
May 2, 2022. 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 (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-2021-0292, by one of 
the following methods:
    <bullet> 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.
    <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 https://www.epa.gov/dockets/contacts.html. 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 1, 2021 (86 FR 29229) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11410) by 
the Spring Regulatory Sciences (6620 Cypresswood Dr., Suite 250 Spring, 
TX 77379) on behalf of Earth Science Laboratories, Inc., (113 SE 22nd 
Street, Suite 1, Bentonville, AR 72712). The petition requested that 40 
CFR 180.910 be amended by establishing an exemption from the 
requirement of a tolerance for residues of PABS (CAS Reg. No. 10043-02-
4) when used as an inert ingredient (carrier, adjuvant, buffer and as a 
stabilizer) in pesticide formulations applied in/on growing crops pre- 
and post-harvest, and in antimicrobial formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
food-processing equipment and utensils under 40 CFR 180.940(a). That 
document referenced a summary of the petition prepared by Spring 
Regulatory Sciences on behalf of Earth Science Laboratories, Inc., the 
petitioner, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
limited the maximum concentration of PABS to not more than 40% in 
pesticide formulations for non-residential use and not more than 5% in 
pesticide formulations for residential use under 40 CFR 180.910 and 
limited the maximum concentration of PABS to 250 ppm under 40 CFR 
180.940(a). These limitations are based on the Agency's risk assessment 
which can be found at https://www.regulations.gov in document 
``Polyammonium Bisulfate; Human Health Risk Assessment and Ecological 
Effects Assessment to Support Proposed Amendment to the Tolerance 
Exemption When Used as an Inert Ingredient in Pesticide Formulations'' 
in docket ID number EPA-HQ-OPP-2021-0292.

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 . . .'' and specifies factors EPA is to consider in 
establishing an exemption.
    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 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.

[[Page 11967]]

    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 for PABS including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with PABS 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 PABS 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.
    Acute toxicity studies were conducted with ET-3000, a mixture 
containing PABS. According to these studies acute oral toxicity is low, 
as the lethal dose (LD<INF>50</INF>) is 1,750 milligrams/kilogram (mg/
kg) in rats, and the acute dermal toxicity in rats is also low, the 
LD<INF>50</INF> is greater than 5,000 mg/kg. PABS is also not toxic via 
acute inhalation exposure, as the lethal concentration (LC50) is 
greater than 2.09 mg/L in rats. PABS is, however, corrosive to rabbit 
skin and the results were equivocal in a dermal sensitization study in 
mice.
    Based on the available data on surrogate chemicals, PABS is 
expected to cause anemia and diarrhea at doses greater than 1,000 mg/
kg/day following subchronic exposure in rats. In a chronic and 
multigeneration toxicity study in which carcinogenicity was also 
evaluated, hyperplasia of the glandular stomach and occult blood in the 
feces were observed at 144 mg/kg/day in rats. No reproduction toxicity 
or fetal susceptibility was observed in this study. In another chronic/
carcinogenicity toxicity study in rats, chronic nephropathy was 
observed at approximately 564 mg/kg/day. No evidence of carcinogenicity 
was observed in either study.
    No mutagenicity, genotoxicity, or chromosomal aberrations were seen 
in a battery of mutagenicity tests with the surrogate chemicals except 
in the case of sodium metabisulfite. Sodium metabisulfite was negative 
in the Ames test and a mammalian bone marrow chromosome aberration 
test. However, positive results were observed in a mammalian cell 
chromosome aberration assay and sister chromatid exchange assays in 
human lymphoctyes, and a questionably positive result was observed in 
an in vivo mammalian cell chromosome aberration assay. The mutagenicity 
results are equivocal for sodium metabisulfite.
    Neurotoxicity and immunotoxicity toxicity studies are not available 
for review. However, no evidence of neurotoxicity or immunotoxicity was 
seen in the available studies.

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/pesticides/factsheets/riskassess.htm.
    No acute endpoint was identified; therefore, an acute assessment is 
not necessary. The combined chronic toxicity/carcinogenicity study in 
rats was selected for chronic dietary exposure as well as all other 
exposure scenarios (incidental oral, dermal and inhalation). In this 
study, the NOAEL is 72 mg/kg/day, and the LOAEL is 144 mg/kg/day based 
on hyperplasia of the glandular stomachs and occult blood in the feces. 
This represents the lowest NOAEL in the database in the most sensitive 
species. The standard uncertainty factors (UFs) were applied to account 
for interspecies (10x) and intraspecies (10x) variations. The default 
value of 100% was used for the dermal and inhalation absorption 
factors.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to PABS, EPA considered exposure under the proposed exemption 
from the requirement of a tolerance. EPA assessed dietary exposures 
from PABS in food as follows:
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) 2003-2008 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 PABS. 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 ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,'' 
(D361707, S. Piper, 2/25/09) and can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    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

[[Page 11968]]

of active ingredient in agricultural products are generally at least 50 
percent of the product and often can be much higher. However, due to 
dietary risk concerns in assessing this petition request, the Agency 
assumed that a product consisted of 40 percent PABS instead of 50 
percent, as mentioned above. 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 Agency considers the 
active ingredient with the highest tolerance level for that commodity 
as the guide to assess the total potential level of inert ingredient 
residues on that commodity. 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 conservative assumption 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 40% in the pesticide product 
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 PABS will be limited to 40% in pesticide non-residential 
formulations that will be applied to crops and raw agricultural 
commodities pre- and post-harvest.
    To assess dietary exposure to PABS due to its use in antimicrobial 
products, the EPA calculated the daily dietary dose (DDD) and the 
estimated daily intake (EDI) as described in the Food and Drug 
Administration (FDA) model. The assessment considered: Application 
rates (limited to 250 ppm), residual solution or quantity of solution 
remaining on the treated surface without rinsing with potable water, 
surface area of the treated surface which comes into contact with food, 
pesticide migration fraction, and body weight. These assumptions are 
based on FDA Food Contact Surface Sanitizing Solution Dietary Exposure 
Assessment Model (2003).
    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 PABS, 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, and hard surface disinfection on walls, floors, tables). PABS 
may be used as an inert ingredient in pesticide products that are 
registered for specific uses that may result in residential exposure, 
specifically in antimicrobial formulations applied to food-contact 
surfaces and utensils. 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. Children's residential exposure includes 
total exposures associated with contact with treated lawns (dermal and 
hand-to-mouth exposures). A conservative residential exposure and risk 
assessments was completed for pesticide products containing PABS as an 
inert ingredient. Due to risks of concern resulting from aggregate 
exposure to PABS, the petitioner requested a limitation of 5% in 
products for residential use. Therefore, the Agency conducted an 
assessment to represent conservative residential exposure by assessing 
PABS (outdoor scenarios) and in disinfectant-type uses (indoor 
scenarios) at no more than 5% in the final formulation. The Agency 
assessed pesticide products containing PABS using exposure scenarios 
used by OPP's Antimicrobials Division to represent conservative 
residential handler exposure. Further details of this residential 
exposure and risk analysis can be found at https://www.regulations.gov 
in the memorandum entitled: ``JITF Inert Ingredients. Residential and 
Occupational Exposure Assessment Algorithms and Assumptions Appendix 
for the Human Health Risk Assessments to Support Proposed Exemption 
from the Requirement of a Tolerance When Used as Inert Ingredients in 
Pesticide Formulations,'' (D364751, 5/7/09, Lloyd/LaMay in docket ID 
number EPA-HQ-OPP-2008-0710).
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to PABS and any other 
substances. PABS does not appear to produce a toxic metabolite produced 
by other substances. For the purposes of this tolerance exemption, 
therefore, EPA has assumed that PABS 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 website at https://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 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

[[Page 11969]]

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 surrogate chemicals to PABS contains a combined 
repeated dose toxicity study with the reproduction/developmental 
toxicity screening test, multi-generation reproduction toxicity and 
mutagenicity studies. There is no indication of immunotoxicity or 
neurotoxicity in the available studies on surrogate chemicals; 
therefore, there is no need to require an immunotoxicity or 
neurotoxicity study. Fetal susceptibility is not observed in the 
available studies. In the multi-generation reproduction toxicity study 
in rats, maternal and offspring toxicity, which manifested as 
hyperplasia of the fore and glandular stomachs, and occult blood in the 
feces were observed at the same dose, 144 mg/kg/day. The cRfD of 0.72 
mg/kg/day is based on the effects seen in this study. No reproduction 
toxicity is seen 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 susceptibility, 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, 
PABS 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 
PABS from food and water will utilize 83% 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).
    PABS is currently 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 from food and water with 
short-term residential exposures to PABS.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 273 for adults. 
For children, the aggregate MOE is 115. Because EPA's level of concern 
for PABS is an MOE of 100 or below, 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).
    PABS is currently 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 PABS.
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 430 for adults. For children the aggregate MOE is 
117. 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 PABS is an MOE of 100 or 
below, these MOEs are not of concern.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, PABS 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 PABS 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 
PABS in or on any food commodities. EPA is establishing a limitation on 
the amount of PABS 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 where PABS exceeds 40% in the final pesticide 
formulations for non-residential use or 5% in the final pesticide 
formulations for indoor and outdoor residential use. EPA will also not 
register any pesticide formulations for antimicrobials where PABS 
exceeds 250 ppm.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for PABS (CAS Reg. No. 10043-02-4) 
when used as an inert ingredient (carrier, adjuvant, buffer, 
stabilizer) in pesticide formulations applied in/on growing crops pre- 
and post-harvest, limited to 40% in non-residential formulations and 5% 
in formulations for residential indoor and outdoor use; and under 40 
CFR 180.940(a) in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, food-
processing equipment and utensils, limited to 250 ppm end-use 
concentration in formulations.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance 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,

[[Page 11970]]

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 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: February 24, 2022.
Marietta Echeverria,
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 to 180.910 by adding in alphabetical 
order the inert ingredient ``Polyammonium Bisulfate (CAS Reg. No. 
10043-02-4)'' 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
------------------------------------------------------------------------
 
                              * * * * * * *
Polyammonium Bisulfate (CAS     Not to exceed 40% in    Carrier,
 Reg. No. 10043-02-4).           non-residential         adjuvant,
                                 formulations. Not to    buffer, and
                                 exceed 5% in outdoor    stabilizer.
                                 and indoor
                                 formulations for
                                 residential use.
 
                              * * * * * * *
------------------------------------------------------------------------


0
3. In Sec.  180.940, amend table 1 to paragraph (a) by adding in 
alphabetical order an entry for ``Polyammonium Bisulfate'' 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) * * *

                        Table 1 to Paragraph (a)
------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Polyammonium Bisulfate.........      10043-02-4  When ready for use, the
                                                  end-use concentration
                                                  is not to exceed 250
                                                  ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2022-04368 Filed 3-2-22; 8:45 am]
BILLING CODE 6560-50-P


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