[Federal Register Volume 86, Number 214 (Tuesday, November 9, 2021)]
[Rules and Regulations]
[Pages 62101-62104]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24268]



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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0326; FRL-9180-01-OCSPP]


Calcium Bisulfate; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of calcium bisulfate when used as an inert 
ingredient (acidifying/buffering agent) in antimicrobial formulations 
applied to food-contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils, 
limited to 2,000 parts per million (ppm). Burdock Group on behalf of 
SCG Solutions, 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 bisulfate.

DATES: This regulation is effective November 9, 2021. Objections and 
requests for hearings must be received on or before January 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-2021-0326, 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-2021-0326 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 
January 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-2021-0326, 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 June 28, 2021 (86 FR 33890) (FRL-10025-
08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11436) by 
the Burdock Group (859 Outer Road, Orlando, FL 32814) on behalf of SCG 
Solutions, LLC (1358 South 9th St., DePere, WI 54115). 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 
bisulfate when used as an inert ingredient (acidifying/buffering agent) 
in antimicrobial formulations applied to food-contact surfaces in 
public eating places, dairy-processing equipment, and food-processing 
equipment and utensils, limited to 2,000 parts per million (ppm) in the 
final formulation. That document referenced a summary of the petition 
prepared by the Burdock Group on behalf of SCG Solutions, 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 polyoxyethylene polymers and fatty 
acids; carriers such as clay and

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

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    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 bisulfate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with calcium bisulfate 
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 bisulfate 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 Bisulfate; 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-
2021-0326.
    Calcium bisulfate readily dissociates to the bisulfate anion and 
the respective calcium cation. Similarly, sodium bisulfate readily 
dissociates to the bisulfate anion and the sodium cation. Since the 
bisulfate anion is converted to sulfate in aqueous solution, toxicology 
studies for sodium sulfate are generally considered relevant for sodium 
bisulfate and calcium bisulfate. Therefore, toxicity data on sodium 
sulfate are used as surrogate data for calcium bisulfate.
    The acute oral and dermal toxicity of calcium bisulfate is low in 
rats. It is slightly irritating to the rabbit skin. It is expected to 
be mildly irritating to the eyes.
    Based on the toxicity database for sodium sulfate, no toxicity is 
observed in a 30-day oral toxicity study and developmental study in 
rats at >2,000 mg/kg/day. No toxicity and no tumors are seen in a 27 
and 44-week oral toxicity study in rats up to 400 mg/kg/day, the 
highest dose tested. No mutagenicity is seen in the Ames test.
    Neurotoxicity and immunotoxicity toxicity studies are not available 
for review. However, no evidence of neurotoxicity or immunotoxicity is 
seen in the available studies.
    Calcium bisulfate is expected to readily undergo hydrolysis and 
dissociate to calcium ions and sulfate ions in the body. Sulfate anions 
are excreted mainly in the urine.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that calcium bisulfate has 
a very low overall toxicity. No toxicity was observed in any of the 
available studies. In the 30-day oral and the developmental toxicity 
studies with the calcium bisulfate surrogate (sodium sulfate), no 
toxicity is seen at >2,000 mg/kg/day which is well above the limit dose 
of 1,000 mg/kg/day. In addition, calcium bisulfate readily dissociates 
to the bisulfate anion and the calcium cation. Bisulfate/sulfate anion 
is a naturally occurring constituent in many food substances as well as 
an essential component in a large number of mammalian (human) metabolic 
processes. The sulfate anion is a normal constituent in the body, 
predominantly resulting from the body's metabolism of sulfur-containing 
food sources such as foods containing the essential amino acids 
cysteine and methionine. Sulfate anions are vital components in a 
number of human biosynthetic pathways such as cartilage production and 
the formation of pancreatic digestive enzymes. Also, the sulfate anion 
is an important conjugate in the Phase II conjugation/elimination of 
oxidized (OH) aromatic ring metabolites and for hydroxyl steroid 
hormones. The Agency did not identify an endpoint of concern for risk 
assessment purposes because no signs of toxicity were observed, and 
calcium and sulfate ions are present ubiquitously in the human body. 
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 
bisulfate is not necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to calcium bisulfate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from calcium bisulfate in food as follows:
    Dietary exposure (food and drinking water) to calcium bisulfate may 
occur following ingestion of foods with residues from their use in 
accordance with this exemption. However, a quantitative dietary 
exposure

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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).
    Calcium bisulfate 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 low toxicity of the calcium 
bisulfate, a quantitative residential exposure assessment was not 
conducted and is not necessary.
    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 
bisulfate 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 calcium bisulfate do 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. Based on the lack of threshold effects, EPA has not identified 
any toxicological endpoints of concern and is conducting a qualitative 
assessment of calcium bisulfate. 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 calcium 
bisulfate, 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 calcium 
bisulfate residues. Therefore, the establishment of exemptions from the 
requirement of a tolerance under 40 CFR 180.940(a) for residues of 
calcium bisulfate 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 at a maximum end-use concentration of 2,000 ppm 
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 bisulfate in or on any food commodities. EPA is establishing a 
limitation on the amount of calcium bisulfate that may be used in 
pesticide formulations. This limitation will be enforced through the 
pesticide registration process under the Federal Insecticide, 
Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA 
will not register any pesticide formulation for food use that exceeds 
2,000 ppm calcium bisulfate in the final pesticide formulation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180. 940(a) for calcium bisulfate when used as 
an inert ingredient (acidifying/buffering agent) in antimicrobial 
formulations applied to food-contact surfaces in public eating places, 
dairy-processing equipment, and food-processing equipment and utensils 
under 40 CFR 180.940(a), limited to 2,000 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

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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: November 1, 2021.
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, in paragraph (a), amend table 180.940(a) by adding 
in alphabetical order an entry for the inert ingredient ``Calcium 
bisulfate'' to read as follows:


Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

                                                Table 180.940(a)
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                        Inert ingredients                          CAS Reg. No.               Limits
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                                                  * * * * * * *
Calcium bisulfate...............................................  ..............  When ready for use, the end-
                                                                                   use concentration is not to
                                                                                   exceed 2,000 ppm.
 
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[FR Doc. 2021-24268 Filed 11-8-21; 8:45 am]
BILLING CODE 6560-50-P


