Document ID: EPA-HQ-OPP-2021-0642-0005
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Calcium Sulfate
Posted Date: 2022-03-11T05:00Z

[Federal Register Volume 87, Number 48 (Friday, March 11, 2022)]
[Rules and Regulations]
[Pages 13945-13948]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05213]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0642; FRL-9536-01-OCSPP]

Calcium Sulfate; 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 calcium sulfate when used as an inert 
ingredient in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils, limited to 100 parts per million 
(ppm) in the final formulation. Exponent, Inc. on behalf of Tygrus, 
LLC, submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), requesting establishment of an exemption from the 
requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of calcium sulfate 
when used in accordance with this exemption.

DATES: This regulation is effective March 11, 2022. Objections and 
requests for hearings must be received on or before May 10, 2022, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2021-0642, is available at 
https://www.regulations.gov or at the Office of Pesticide Programs 
Regulatory Public Docket (OPP Docket) in the Environmental Protection 
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., 
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The 
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is open to visitors by 
appointment only. For the latest status information on EPA/DC services 
and access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta 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(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2021-0642 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 10, 2022. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2021-0642, 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 November 23, 2021 (86 FR 66512) (FRL-
8792-05), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11565) by Exponent, Inc., 1150 Connecticut Ave. NW, Suite 1100, 
Washington, DC 20036 on behalf of Tygrus, LLC, 1132 E. Big Beaver Road, 
Troy, MI 48083. The petition requested that 40 CFR 180.940(a) be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of calcium sulfate when used as an inert 
ingredient in antimicrobial formulations applied to food-contact 
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils, limited to 100 parts per million 
(ppm) in the final formulation. That document referenced a summary of 
the petition prepared by Exponent, Inc. on behalf of Tygrus, LLC, the 
petitioner, which is available in the docket, https://www.regulations.gov. There were no 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

[[Page 13946]]

polyoxyethylene polymers and fatty acids; carriers such as clay and 
diatomaceous earth; thickeners such as carrageenan and modified 
cellulose; wetting, spreading, and dispersing agents; propellants in 
aerosol dispensers; microencapsulating agents; and emulsifiers. The 
term ``inert'' is not intended to imply nontoxicity; the ingredient may 
or may not be chemically active. Generally, EPA has exempted inert 
ingredients from the requirement of a tolerance based on the low 
toxicity of the individual inert ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(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. 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 harm 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 calcium sulfate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with calcium sulfate 
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 calcium sulfate 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 ``Calcium Sulfate; Human Health 
Risk Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as an Inert 
Ingredient in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2021-0642.
    Acute oral toxicity, primary dermal and eye irritation, acute 
inhalation toxicity and dermal sensitization studies are available for 
calcium sulfate. The acute oral toxicity of calcium sulfate is low. The 
acute oral LD50 (lethal dose) in rats is greater than 2,000 milligrams/
kilogram (mg/kg). Acute inhalation toxicity is also low; the 
LC50 (lethal concentration) in rats is greater than 2.61 
milligrams/liter (mg/L). A study conducted in rabbits indicates it is 
not irritating to the skin or eye. A study conducted in the guinea pig 
indicates it is not a dermal sensitizer.
    Based on the toxicity database for calcium sulfate, no toxicity is 
observed in a combined repeated dose toxicity study with the 
reproduction/developmental screening test in rats at the limit dose of 
1,000 mg/kg/day. No mutagenicity is seen in the Ames or in the 
mammalian erythrocyte micronucleus tests.
    Neurotoxicity and immunotoxicity toxicity studies for calcium 
sulfate are not available for review. However, no evidence of 
neurotoxicity or immunotoxicity is seen in the available studies.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that calcium sulfate has a 
very low overall toxicity. No toxicity was observed in any of the 
available studies. Since no endpoint of concern was identified for the 
acute and chronic dietary exposure assessment and short and 
intermediate dermal and inhalation exposure, a quantitative risk 
assessment for calcium sulfate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to calcium sulfate, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance and from existing uses. 
EPA assessed dietary exposures from calcium sulfate in food as follows:
    Dietary exposure (food and drinking water) to calcium sulfate may 
occur following ingestion of foods with residues from use in accordance 
with this exemption (e.g., ingesting foods that come in contact with 
surfaces treated with pesticide formulations containing calcium 
sulfate), as well as non-pesticidal uses in food (see 21 CFR 184.1230). 
However, a quantitative dietary exposure assessment was not conducted 
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).
    Calcium sulfate may be used in pesticide products and non-pesticide 
products that may be used in and around the home (e.g., for lawn and 
garden pest control, indoor pest control) and in personal care 
products. A quantitative residential exposure assessment was not 
conducted since a toxicological endpoint for risk assessment was not 
identified.
    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 toxicity in the available data, calcium 
sulfate and its

[[Page 13947]]

metabolites are not expected to share a common mechanism of toxicity 
with other chemicals; therefore, section 408(b)(2)(D)(v) does not 
apply.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database unless EPA concludes that 
a different margin of safety will be safe for infants and children. 
Based on the lack of threshold effects, EPA has not identified any 
toxicological endpoints of concern and is conducting a qualitative 
assessment of calcium sulfate. 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. Based on an 
assessment of calcium sulfate, EPA has concluded that there are no 
toxicological endpoints of concern for the U.S. population, including 
infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on calcium 
sulfate, EPA has determined that there is a reasonable certainty that 
no harm will result to the general population, or to infants and 
children, from aggregate exposure to calcium sulfate residues. 
Therefore, the establishment of an exemption from the requirement of a 
tolerance under 40 CFR 180.940(a) for residues of calcium sulfate 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 
limited to 100 ppm in the final formulation, 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 not establishing a numerical tolerance for residues of 
calcium sulfate in or on any food commodities. EPA is establishing a 
limitation on the amount of calcium sulfate that may be used in 
antimicrobial pesticide formulations applied to food-contact surfaces 
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils. This limitation will be enforced 
through the pesticide registration process under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq. EPA will not register any such antimicrobial pesticide 
formulation that exceeds 100 ppm of calcium sulfate when ready for use.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180. 940(a) for calcium sulfate when used as 
an inert ingredient in antimicrobial formulations applied to food-
contact surfaces in public eating places, dairy-processing equipment, 
and food-processing equipment and utensils limited to 100 ppm in the 
final formulation.

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). 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 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: March 3, 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 ``Calcium Sulfate'' to read as follows:

[[Page 13948]]

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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                                                  * * * * * * *
Calcium Sulfate.....................  7778-18-9...............  When ready for use, the end-use concentration is
                                                                 not to exceed 100 ppm.
 
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[FR Doc. 2022-05213 Filed 3-10-22; 8:45 am]
BILLING CODE 6560-50-P