Rule2022-04852
Phosphoric Acid; Exemption From the Requirement of a Tolerance
Primary source
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Published
March 8, 2022
Effective
March 8, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 45 (Tuesday, March 8, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-04852]
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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
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
<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 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#386a7c7e6a76574c515b5d4b785d4859165f574e"><span class="__cf_email__" data-cfemail="de8c9a988c90b1aab7bdbbad9ebbaebff0b9b1a8">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
<bullet> Crop production (NAICS code 111).
<bullet> Animal production (NAICS code 112).
<bullet> Food manufacturing (NAICS code 311).
<bullet> Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, 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:
<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 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, <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
[[Page 12874]]
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
(PO<INF>4</INF><SUP>3-</SUP>) 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
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. 180.940, 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
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