Phosphoric Acid; Exemption From the Requirement of a Tolerance, 12872-12875 [2022-04852]
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Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Rules and Regulations
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this action 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. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a ‘‘major rule’’ as
defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the CAA,
petitions for judicial review of this
action must be filed in the United States
Court of Appeals for the appropriate
circuit by May 9, 2022. Filing a petition
for reconsideration by the Administrator
of this final rule does not affect the
finality of this action for the purposes of
judicial review nor does it extend the
time within which a petition for judicial
review may be filed, and shall not
postpone the effectiveness of such rule
or action. This action may not be
challenged later in proceedings to
enforce its requirements. See section
307(b)(2).
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Carbon monoxide,
Incorporation by reference,
Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter,
Reporting and recordkeeping
requirements, Sulfur oxides, Volatile
organic compounds.
Dated: February 28, 2022.
Daniel Blackman,
Regional Administrator, Region 4.
For the reasons stated in the
preamble, EPA amends 40 CFR part 52
as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
Subpart II—North Carolina
§ 52.1770
[Amended]
2. In § 52.1770(c)(3), the table is
amended by removing the heading for
‘‘Section 2.0800 Transportation
Facilities,’’ and the entries for ‘‘Section
2.0801,’’ ‘‘Section 2.0802,’’ ‘‘Section
2.0803,’’ and ‘‘Section 2.0804.’’
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■
[FR Doc. 2022–04833 Filed 3–7–22; 8:45 am]
BILLING CODE 6560–50–P
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2020–0214; FRL–9380–01–
OCSPP]
Phosphoric Acid; Exemption From the
Requirement of a Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of phosphoric
acid (CAS Reg. No. 7664–38–2) when
used as an inert ingredient (pH adjuster)
in antimicrobial formulations applied to
food-contact surfaces in public eating
places, dairy-processing equipment,
food-processing equipment and utensils.
Technology Sciences Group Inc., on
behalf of the Clorox Services Company
(Representing Clorox Professional
Products Company), submitted a
petition to EPA under the Federal Food,
Drug, and Cosmetic Act (FFDCA),
requesting the establishment of an
exemption from the requirement of a
tolerance. This regulation eliminates the
need to establish a maximum
permissible level for residues of
phosphoric acid when used in
accordance with this exemption.
DATES: This regulation is effective
March 8, 2022. Objections and requests
for hearings must be received on or
before May 9, 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).
SUMMARY:
The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPP–2020–0214, 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
closed to visitors with limited
exceptions. The staff continues to
provide remote customer service via
email, phone, and webform. For the
ADDRESSES:
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latest status information on EPA/DC
services and docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Marietta Echeverria, 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: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Office of the Federal
Register’s e-CFR site at https://
www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a, 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–2020–0214 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 9, 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
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(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–
2020–0214, by one of the following
methods:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
online instructions for submitting
comments. Do not submit electronically
any information you consider to be CBI
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/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 May 29,
2020 (85 FR 32338) (FRL–10009–84),
EPA issued a document pursuant to
FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide
petition (IN–11392) by Technology
Sciences Group Inc., (1150 18th Street
NW, Suite 1000, Washington, DC
20036), on behalf of the Clorox Services
Company (Representing Clorox
Professional Products Company) (P.O.
Box 493, Pleasanton, CA 94566–0803).
The petition requested that 40 CFR
180.940(a) be amended by establishing
an exemption from the requirement of a
tolerance for residues of phosphoric
acid when used as an inert ingredient
(pH adjuster) in antimicrobial
formulations applied to food-contact
surfaces in public eating places, dairyprocessing equipment, food-processing
equipment and utensils. That document
referenced a summary of the petition
prepared by Technology Sciences Group
Inc., on behalf of on behalf of the Clorox
Services Company (Representing Clorox
Professional Products Company), the
petitioner, which is available in the
docket, https://www.regulations.gov.
There were no relevant 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
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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 exemption 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. Under FFDCA
section 408(c)(2)(B), EPA must take into
account, among other considerations,
the factors in subparagraphs (C) and (D)
of subsection (b)(2). Section 408(b)(2)(C)
of FFDCA requires EPA to give special
consideration to exposure of infants and
children to the pesticide chemical
residue in establishing a tolerance and
to ‘‘ensure that there is a reasonable
certainty that no harm will result to
infants and children from aggregate
exposure to the pesticide chemical
residue . . . .’’
EPA establishes exemptions from the
requirement of a tolerance only in those
cases where it can be clearly
demonstrated that the risks from
aggregate exposure to pesticide
chemical residues under reasonably
foreseeable circumstances will pose no
appreciable risks to human health. In
order to determine the risks from
aggregate exposure to pesticide inert
ingredients, the Agency considers the
toxicity of the inert in conjunction with
possible exposure to residues of the
inert ingredient through food, drinking
water, and through other exposures that
occur as a result of pesticide use in
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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 for phosphoric acid
including exposure resulting from the
exemption established by this action.
EPA’s assessment of exposures and risks
associated with phosphoric 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 the relevant phosphoric acid as well
as the no-observed-adverse-effect-level
(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
www.regulations.gov in the document
‘‘Phosphoric Acid; 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–2020–
0214.
The acute oral and dermal toxicities
are low in rats and rabbits treated with
phosphoric acid. Phosphoric acid
solutions of pH <2.5 are corrosive. It is
not a skin sensitizer.
Repeated dose studies show that
phosphoric acid is not toxic at doses up
to 500 mg/kg/day in rats. No parental,
developmental, offspring, or
reproduction toxicity is seen up to 500
mg/kg/day. No fetal susceptibility is
observed.
There is no evidence of
immunotoxicity or neurotoxicity in the
available studies. Phosphoric acid is
negative for mutagenicity and
chromosome aberrations. No tumors or
cancer are observed in studies with rats.
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Phosphoric acid is absorbed by
ingestion, inhalation, and dermal
contact and is distributed in the body as
phosphate. Absorbed phosphate is
filtered in the kidneys and partially
reabsorbed. It is excreted mainly in the
feces as calcium phosphate.
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B. Toxicological Points of Departure/
Levels of Concern
Phosphoric acid is an essential
constituent of humans in the bones,
teeth, and in many enzyme systems.
Free phosphate ion (PO43¥) is the major
form in which phosphorus is absorbed
from the diet. The Institute of Medicine
(US) Standing Committee on the
Scientific Evaluation of Dietary
Reference Intakes for Calcium,
Phosphorus, Magnesium, Vitamin D,
and Fluoride evaluated phosphorus and
established tolerable upper intake levels
(ULs), 4,000 mg/day (approximately 57
mg/kg/day) for adults and 3,000 mg/day
(approximately 200 mg/kg/day) for
children 1 to 8 years of age.
Furthermore, EFSA has established an
acceptable daily intake (ADI) for
phosphates, expressed as phosphorus,
of 40 mg/kg body weight per day.
Because a calculated cRfD from animal
studies would result in values that are
at least 8 times lower than the estimated
acceptable consumption for humans
(40–57 mg/kg/day), use of animal data is
considered exceedingly conservative.
Additionally, the adverse effects
observed in animals occurred at doses
well above the limit dose. Therefore,
toxicity endpoints were not selected,
and a qualitative risk assessment was
performed for phosphoric acid.
C. Exposure Assessment
1. Dietary exposure from drinking
water, food and feed uses. In evaluating
dietary exposure to phosphoric acid,
EPA considered exposure under the
proposed exemption from the
requirement of a tolerance. EPA
assessed dietary exposures from
phosphoric acid in food as follows:
Dietary exposure (food and drinking
water) to phosphoric acid may occur
following ingestion of foods with
residues from their use in accordance
with this exemption and its use as a
food additive. However, a quantitative
dietary exposure assessment was not
conducted and is not necessary since a
toxicological endpoint for risk
assessment was not identified.
2. From non-dietary exposure. The
term ‘‘residential exposure’’ is used in
this document to refer to nonoccupational, non-dietary exposure
(e.g., textiles (clothing and diapers),
carpets, swimming pools, and hard
surface disinfection on walls, floors,
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tables). Phosphoric acid may be used in
pesticide products and non-pesticide
products that may be used in and
around the home. Based on the
discussion above regarding the lack of a
toxicological endpoint for phosphoric
acid, a qualitative residential exposure
assessment was conducted.
3. 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.’’
Based on the lack of a toxicological
endpoint, phosphoric acid and its
metabolites are not expected to share a
common mechanism of toxicity with
other chemicals. For the purposes of
this action, therefore, EPA has assumed
that phosphoric acid does not have a
common mechanism of toxicity with
other substances.
D. Safety Factor for Infants and
Children
Section 408(b)(2)(C) of the FFDCA
requires EPA to retain an additional
tenfold margin of safety in the case of
threshold effects 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 has not
identified any toxicological endpoints of
concern and is conducting a qualitative
assessment of phosphoric acid. The
qualitative assessment does not use
safety factors for assessing risk, and no
additional safety factor is needed for
assessing risk to infants and children.
E. Aggregate Risks and Determination of
Safety
Taking into consideration all available
information on phosphoric acid, EPA
has determined that there is a
reasonable certainty that no harm to the
general population or any population
subgroup, including infants and
children, will result from aggregate
exposure to phosphoric acid residues.
Therefore, the establishment of
exemptions from the requirement of a
tolerance under 40 CFR 180.940(a) for
residues of phosphoric acid when used
as an inert ingredient in antimicrobial
pesticide formulations applied to foodcontact surfaces in public eating places,
dairy-processing equipment, and foodprocessing equipment and utensils is
safe under FFDCA section 408.
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V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
VI. Conclusions
Based on the information reviewed by
EPA and described above, an exemption
from the requirement of a tolerance is
established in 40 CFR 180.940(a) for
residues of phosphoric acid (CAS Reg.
No. 7664–38–2) when used as an inert
ingredient (pH adjuster) in antimicrobial
formulations applied to food-contact
surfaces in public eating places, dairyprocessing equipment, food-processing
equipment and utensils.
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),
nor is it considered a regulatory action
under Executive Order 13771, entitled
‘‘Reducing Regulations and Controlling
Regulatory Costs’’ (82 FR 9339, February
3, 2017). 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
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Federal Register / Vol. 87, No. 45 / Tuesday, March 8, 2022 / Rules and Regulations
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 17, 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
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In § 180.940, amend Table 1 to
paragraph (a) by adding in alphabetical
order an entry for ‘‘Phosphoric Acid’’ to
read as follows:
■
§ 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)
Inert ingredients
*
*
*
*
*
Phosphoric Acid .......................................................................................................................................................
*
*
*
*
*
*
*
*
[FR Doc. 2022–04852 Filed 3–7–22; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 751
[EPA–HQ–OPPT–2021–0598; FRL–6015.6–
02–OCSPP]
RIN 2070–AK95
Regulation of Persistent,
Bioaccumulative, and Toxic Chemicals
Under TSCA Section 6(h); Phenol,
Isopropylated Phosphate (3:1); Further
Compliance Date Extension
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
The Environmental Protection
Agency (EPA) is amending the
regulations applicable to phenol,
isopropylated phosphate (3:1) (PIP (3:1))
promulgated under the Toxic
Substances Control Act (TSCA).
Specifically, EPA is extending the
SUMMARY:
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*
*
compliance date applicable to the
prohibition on processing and
distribution in commerce of certain PIP
(3:1)-containing articles, and the PIP
(3:1) used to make those articles, until
October 31, 2024, along with the
compliance date for the associated
recordkeeping requirements for
manufacturers, processors, and
distributors of PIP (3:1)-containing
articles. This final rule follows issuance
of a proposed rule for public comment
on October 28, 2021; comments on the
proposed rule are responded to in this
action.
DATES: This final rule is effective on
March 8, 2022. For purposes of judicial
review and 40 CFR 23.5, this rule shall
be promulgated at 1 p.m. eastern
standard time on March 22, 2022.
ADDRESSES: The docket for this action,
identified by docket identification (ID)
number EPA–HQ–OPPT–2021–0598, is
available at https://
www.regulations.gov. Due to the public
health concerns related to COVID–19,
the EPA Docket Center (EPA/DC) and
Reading Room are opened to visitors by
appointment only. For the latest status
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CAS Reg. No.
Limits
*
*
7664–38–2
*
*
information on EPA/DC services and
docket access, visit https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For
technical information contact: Cindy
Wheeler, Existing Chemicals Risk
Management Division, Office of
Pollution Prevention and Toxics,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (202)
566–0484; email address: TSCA-PBTrules@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Executive Summary
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture
(including import), process, distribute
in commerce, or use phenol,
isopropylated phosphate (3:1) (PIP
(3:1)), or PIP (3:1)-containing articles,
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]]>Agencies
[Federal Register Volume 87, Number 45 (Tuesday, March 8, 2022)]
[Rules and Regulations]
[Pages 12872-12875]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04852]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2020-0214; FRL-9380-01-OCSPP]
Phosphoric 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 phosphoric acid (CAS Reg. No. 7664-38-2)
when used as an inert ingredient (pH adjuster) in antimicrobial
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment, food-processing equipment and utensils.
Technology Sciences Group Inc., on behalf of the Clorox Services
Company (Representing Clorox Professional Products Company), submitted
a petition to EPA under the Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting the establishment of an exemption from the
requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of phosphoric acid
when used in accordance with this exemption.
DATES: This regulation is effective March 8, 2022. Objections and
requests for hearings must be received on or before May 9, 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-2020-0214, 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 closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, 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:
[email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2020-0214 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 9, 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
[[Page 12873]]
(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-2020-0214,
by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/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 May 29, 2020 (85 FR 32338) (FRL-10009-
84), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (IN-11392) by
Technology Sciences Group Inc., (1150 18th Street NW, Suite 1000,
Washington, DC 20036), on behalf of the Clorox Services Company
(Representing Clorox Professional Products Company) (P.O. Box 493,
Pleasanton, CA 94566-0803). The petition requested that 40 CFR
180.940(a) be amended by establishing an exemption from the requirement
of a tolerance for residues of phosphoric acid when used as an inert
ingredient (pH adjuster) in antimicrobial formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment,
food-processing equipment and utensils. That document referenced a
summary of the petition prepared by Technology Sciences Group Inc., on
behalf of on behalf of the Clorox Services Company (Representing Clorox
Professional Products Company), the petitioner, which is available in
the docket, https://www.regulations.gov. There were no relevant
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 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 exemption 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. Under FFDCA section 408(c)(2)(B), EPA must take
into account, among other considerations, the factors in subparagraphs
(C) and (D) of subsection (b)(2). Section 408(b)(2)(C) of FFDCA
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing a tolerance
and to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue . . . .''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that 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 for phosphoric acid including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with phosphoric 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 the relevant phosphoric acid as well
as the no-observed-adverse-effect-level (NOAEL) and the lowest-
observed-adverse-effect-level (LOAEL) from the toxicity studies can be
found at https://www.regulations.gov in the document ``Phosphoric Acid;
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-2020-0214.
The acute oral and dermal toxicities are low in rats and rabbits
treated with phosphoric acid. Phosphoric acid solutions of pH <2.5 are
corrosive. It is not a skin sensitizer.
Repeated dose studies show that phosphoric acid is not toxic at
doses up to 500 mg/kg/day in rats. No parental, developmental,
offspring, or reproduction toxicity is seen up to 500 mg/kg/day. No
fetal susceptibility is observed.
There is no evidence of immunotoxicity or neurotoxicity in the
available studies. Phosphoric acid is negative for mutagenicity and
chromosome aberrations. No tumors or cancer are observed in studies
with rats.
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Phosphoric acid is absorbed by ingestion, inhalation, and dermal
contact and is distributed in the body as phosphate. Absorbed phosphate
is filtered in the kidneys and partially reabsorbed. It is excreted
mainly in the feces as calcium phosphate.
B. Toxicological Points of Departure/Levels of Concern
Phosphoric acid is an essential constituent of humans in the bones,
teeth, and in many enzyme systems. Free phosphate ion
(PO43-) is the major form in which phosphorus is
absorbed from the diet. The Institute of Medicine (US) Standing
Committee on the Scientific Evaluation of Dietary Reference Intakes for
Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride evaluated
phosphorus and established tolerable upper intake levels (ULs), 4,000
mg/day (approximately 57 mg/kg/day) for adults and 3,000 mg/day
(approximately 200 mg/kg/day) for children 1 to 8 years of age.
Furthermore, EFSA has established an acceptable daily intake (ADI) for
phosphates, expressed as phosphorus, of 40 mg/kg body weight per day.
Because a calculated cRfD from animal studies would result in values
that are at least 8 times lower than the estimated acceptable
consumption for humans (40-57 mg/kg/day), use of animal data is
considered exceedingly conservative. Additionally, the adverse effects
observed in animals occurred at doses well above the limit dose.
Therefore, toxicity endpoints were not selected, and a qualitative risk
assessment was performed for phosphoric acid.
C. Exposure Assessment
1. Dietary exposure from drinking water, food and feed uses. In
evaluating dietary exposure to phosphoric acid, EPA considered exposure
under the proposed exemption from the requirement of a tolerance. EPA
assessed dietary exposures from phosphoric acid in food as follows:
Dietary exposure (food and drinking water) to phosphoric acid may
occur following ingestion of foods with residues from their use in
accordance with this exemption and its use as a food additive. However,
a quantitative dietary exposure assessment was not conducted and is not
necessary since a toxicological endpoint for risk assessment was not
identified.
2. 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).
Phosphoric acid may be used in pesticide products and non-pesticide
products that may be used in and around the home. Based on the
discussion above regarding the lack of a toxicological endpoint for
phosphoric acid, a qualitative residential exposure assessment was
conducted.
3. 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.''
Based on the lack of a toxicological endpoint, phosphoric acid and
its metabolites are not expected to share a common mechanism of
toxicity with other chemicals. For the purposes of this action,
therefore, EPA has assumed that phosphoric acid does not have a common
mechanism of toxicity with other substances.
D. Safety Factor for Infants and Children
Section 408(b)(2)(C) of the FFDCA requires EPA to retain an
additional tenfold margin of safety in the case of threshold effects 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 has not identified any toxicological endpoints of concern
and is conducting a qualitative assessment of phosphoric acid. The
qualitative assessment does not use safety factors for assessing risk,
and no additional safety factor is needed for assessing risk to infants
and children.
E. Aggregate Risks and Determination of Safety
Taking into consideration all available information on phosphoric
acid, EPA has determined that there is a reasonable certainty that no
harm to the general population or any population subgroup, including
infants and children, will result from aggregate exposure to phosphoric
acid residues. Therefore, the establishment of exemptions from the
requirement of a tolerance under 40 CFR 180.940(a) for residues of
phosphoric acid when used as an inert ingredient in antimicrobial
pesticide formulations applied to food-contact surfaces in public
eating places, dairy-processing equipment, and food-processing
equipment and utensils is safe under FFDCA section 408.
V. Other Considerations
Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
VI. Conclusions
Based on the information reviewed by EPA and described above, an
exemption from the requirement of a tolerance is established in 40 CFR
180.940(a) for residues of phosphoric acid (CAS Reg. No. 7664-38-2)
when used as an inert ingredient (pH adjuster) in antimicrobial
formulations applied to food-contact surfaces in public eating places,
dairy-processing equipment, food-processing equipment and utensils.
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), nor is it considered a
regulatory action under Executive Order 13771, entitled ``Reducing
Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3,
2017). 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
[[Page 12875]]
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 17, 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
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1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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2. In Sec. 180.940, amend Table 1 to paragraph (a) by adding in
alphabetical order an entry for ``Phosphoric Acid'' 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)
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Inert ingredients CAS Reg. No. Limits
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* * * * * * *
Phosphoric Acid........................ 7664-38-2
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[FR Doc. 2022-04852 Filed 3-7-22; 8:45 am]
BILLING CODE 6560-50-P
