Rule2022-09622
Cell Walls of Saccharomyces Cerevisiae; Tolerance Exemption
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 5, 2022
Effective
May 5, 2022
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 87 (Thursday, May 5, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<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 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
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appointment only. For the latest status information on EPA/DC services
and access, visit <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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
<a href="https://www.ecfr.gov/current/title-40">https://www.ecfr.gov/current/title-40</a>.
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: <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 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
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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
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Inert ingredients Limits Uses
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* * * * *
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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