[Federal Register Volume 87, Number 87 (Thursday, May 5, 2022)]
[Rules and Regulations]
[Pages 26691-26694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09622]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0545; FRL-9761-01-OCSPP]


Cell Walls of Saccharomyces Cerevisiae; Tolerance Exemption

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 cell walls of Saccharomyces cerevisiae 
(also known as yeast cell walls or YCWs) when used as a carrier inert 
ingredient in pesticide formulations in pre-harvest applications to 
crops. SciReg, Inc., on behalf of Eden Research, submitted a petition 
to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of cell walls of Saccharomyces cerevisiae on food or feed 
commodities when used in accordance with this exemption.

DATES: This regulation is effective May 5, 2022. Objections and 
requests for hearings must be received on or before July 5, 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-2018-0545, 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 and OPP Docket is (202) 566-1744. Due to the public health 
concerns related to COVID-19, the EPA Docket Center (EPA/DC) and 
Reading Room is open to visitors by

[[Page 26692]]

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 (7505T), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (202) 566-1030; email address: 
<a href="/cdn-cgi/l/email-protection#34667072667a5b405d575147745144551a535b42"><span class="__cf_email__" data-cfemail="75273133273b1a011c161006351005145b121a03">[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 
https://www.ecfr.gov/current/title-40.

C. 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-2018-0545 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 
July 5, 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-2018-0545, by one of 
the following methods.
    <bullet> 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.
    <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 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 October 18, 2018 (83 FR 52787), EPA 
issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, 
announcing the receipt of a pesticide petition (PP IN-11175) filed by 
SciReg, Inc. (12733 Director's Loop, Woodbridge, VA 22192), on behalf 
of Eden Research. The petition requested that 40 CFR 180.920 be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of cell walls of Saccharomyces cerevisiae (also known as yeast 
cell walls or YCWs) when used as a carrier inert ingredient in 
pesticide formulations applied pre-harvest to crops. That document 
included a summary of the petition prepared by the petitioner and 
solicited comments on the petitioner's request. The Agency did not 
receive any public comments.

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 the 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 the FFDCA 
defines ``safe'' to mean that EPA has determined 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 it 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 an exemption 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 shown 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 and considered its

[[Page 26693]]

validity, completeness and reliability and the relationship of this 
information 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. 
EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure to YCWs, including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with YCWs follows.

A. Toxicological Profile

    YCWs are obtained by hydrolyzing intact yeast (Saccharomyces 
cerevisiae) cells. Given the long history of safe dietary exposure to 
strains of S. cerevisiae through their use in food, beverages, and 
nutritional supplements, YCWs are expected to be non-toxic. Although no 
toxicity information is available for YCWs, data from the major 
chemical components of YCWs ([beta]-glucan and mannan) are used to 
assess the safety of YCWs.
    The acute oral toxicity of [beta]-glucan is low, with an 
LD<INF>50</INF> >2,000 mg/kg. The repeated-dose toxicity for the major 
components of YCWs is low. No adverse effects were observed in 
subchronic studies in mice or rats or in a screening reproductive 
toxicity study in rats with [beta]-glucan.
    No oral chronic or carcinogenicity studies are available for YCWs 
or its components. However, there is low concern for genotoxicity or 
mutagenicity, based on negative results in mammalian and bacterial 
genotoxicity tests with [beta]-glucan and mannan. No evidence of 
neurotoxicity or immunotoxicity is seen in the available studies.

B. Toxicological Points of Departure/Levels of Concern

    No toxicological endpoint of concern for YCWs has been identified 
in the database.

C. Exposure Assessment

    1. Dietary exposure. Dietary exposure (food and drinking water) may 
occur from the current pesticidal uses of cell walls of Saccharomyces 
cerevisiae strain LAS117 as well as the proposed pre-harvest use of 
YCWs in crops (e.g., eating foods treated with pesticide formulations 
containing YCWs, and drinking water exposures). Dietary exposure may 
also occur from non-pesticidal exposure (e.g. YCW dietary supplements). 
However, no endpoint of concern was identified. Therefore, a 
quantitative acute or chronic dietary exposure assessment is not 
necessary for YCWs.
    2. Residential exposure. The current pesticidal uses of cell walls 
of Saccharomyces cerevisiae strain LAS117 as well as the proposed pre-
harvest use of YCWs in crops are not anticipated to result in 
residential exposure. Residential exposure may occur from non-
pesticidal uses (e.g., skin care products). However, no toxicological 
endpoint of concern was identified. Therefore, a quantitative 
assessment for residential exposure was not performed.
    3. Cumulative effects from substances with a common mechanism of 
toxicity. Unlike pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to YCWs and any other 
substances, and YCWs do not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this action, 
therefore, EPA has assumed that YCWs do not have a common mechanism of 
toxicity with other substances.

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. As 
part of its qualitative assessment, the Agency did not use safety 
factors for assessing risk to YCWs, and no additional safety factor is 
needed for assessing risk to infants and children. Based on the low 
toxicity in the available studies, 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 YCWs, 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 YCW residues. 
Therefore, the establishment of an exemption from the requirement of a 
tolerance under 40 CFR 180.920 for residues of YCWs when used as a 
carrier inert ingredient in pesticide formulations in pre-harvest 
applications to crops is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
YCWs in or on any food commodities.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). Codex is a joint United Nations Food and Agriculture 
Organization/World Health Organization food standards program, and it 
is recognized as an international food safety standards-setting 
organization in trade agreements to which the United States is a party. 
EPA may establish a tolerance that is different from a Codex MRL; 
however, FFDCA section 408(b)(4) requires that EPA explain the reasons 
for departing from the Codex level.
    The Codex has not established a MRL for YCWs.

VI. Conclusion

    Taking into consideration all available information on YCWs, 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 YCW residues. 
Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for YCWs when used as an inert 
ingredient (carrier) in pesticide formulations.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance 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

[[Page 26694]]

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: April 29, 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.  180.920, amend Table 1 to 180.920 by adding in alphabetical 
order an entry for ``Cell Walls of Saccharomyces cerevisiae'' to read 
as follows:


Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

                           Table 1 to 180.920
------------------------------------------------------------------------
           Inert ingredients              Limits            Uses
------------------------------------------------------------------------
 
                                * * * * *
Cell Walls of Saccharomyces cerevisiae  .........  Carrier.
 
                                * * * * *
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[FR Doc. 2022-09622 Filed 5-4-22; 8:45 am]
BILLING CODE 6560-50-P


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