[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]


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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 
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.

[[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 
(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

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


