Rule2022-04368
Polyammonium Bisulfate; Exemption From the Requirement of a Tolerance
Primary source
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Published
March 3, 2022
Effective
March 3, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 42 (Thursday, March 3, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
<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, 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: <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/contacts.html">https://www.epa.gov/dockets/contacts.html</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 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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.epa.gov/pesticides/factsheets/riskassess.htm">https://www.epa.gov/pesticides/factsheets/riskassess.htm</a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.epa.gov/pesticides/cumulative">https://www.epa.gov/pesticides/cumulative</a>.
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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</html>Indexed from Federal Register on March 3, 2022.
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