Document ID: EPA-HQ-OPP-2017-0315-0004
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: Cerevisane (Cell Walls of Saccharomyces Cerevisiae Strain LAS117)
Posted Date: 2018-08-09T04:00Z

[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)]
[Rules and Regulations]
[Pages 39373-39375]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17081]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0315; FRL-9980-51]

Cerevisane (Cell Walls of Saccharomyces cerevisiae Strain 
LAS117); 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 cerevisane (cell walls of Saccharomyces cerevisiae 
strain LAS117) in or on all food commodities when used in accordance 
with label directions and good agricultural practices. Lesaffre Yeast 
Corporation 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 cerevisane (cell walls of 
Saccharomyces cerevisiae strain LAS117) under FFDCA.

DATES: This regulation is effective August 9, 2018. Objections and 
requests for hearings must be received on or before October 9, 2018, 
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-2017-0315, is available at http://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. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), 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 Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2017-0315 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 
October 9, 2018. 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-2017-0315, by one of 
the following methods:
     Federal eRulemaking Portal: http://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 http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of March 6, 2018 (83 FR 9471) (FRL-9973-
27), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 6F8535) by Technology Sciences Group Inc., 712 Fifth 
Street, Suite A, Davis, CA 95616 (on behalf of Lesaffre Yeast 
Corporation, 7475 W Main St., Milwaukee, WI 53214). The petition 
requested that 40 CFR 180 be amended by establishing an exemption from 
the requirement of a tolerance for residues of the systemic resistance 
inducer (SRI) cerevisane (cell walls of Saccharomyces cerevisiae strain 
LAS117) in or on all food commodities. That document referenced a 
summary of the petition prepared by the petitioner, Technology Sciences 
Group Inc., (on behalf of Lesaffre Yeast Corporation), which is 
available in the docket via http://www.regulations.gov. There were no 
relevant comments received in response to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    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

[[Page 39374]]

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. Pursuant to FFDCA section 
408(c)(2)(B), in establishing or maintaining in effect an exemption 
from the requirement of a tolerance, EPA must take into account the 
factors set forth in FFDCA section 408(b)(2)(C), which require EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance or tolerance 
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. . . .'' Additionally, FFDCA section 
408(b)(2)(D) requires that EPA consider ``available information 
concerning the cumulative effects of [a particular pesticide's] . . . 
residues and other substances that have a common mechanism of 
toxicity.'' FFDCA section 408(b)(2)(C) provides that EPA shall apply an 
additional tenfold (10X) 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 on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA Safety Factor (SF). In 
applying this provision, EPA either retains the default value of 10X, 
or uses a different additional safety factor when reliable data 
available to EPA support the choice of a different factor.
    EPA evaluated the available toxicity and exposure data on 
cerevisane (cell walls of Saccharomyces cerevisiae strain LAS117) and 
considered their validity, completeness, and reliability, as well as 
the relationship of this information to human risk. EPA also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Cerevisane is a whole cell wall extract of Saccharomyces cerevisiae 
strain LAS117. Saccharomyces cerevisiae is a common source of yeast, 
commonly used in the manufacturing of beers, wines, and liquor intended 
for human consumption because of its ability to ferment sugars into 
ethanol.
    Cerevisane is a systemic resistance inducer (SRI) that aids in the 
up-regulation of plant defense genes resulting in physiological 
changes, including the reinforcement of plant cell walls and the 
production of antimicrobial compounds, e.g., hydrogen peroxide (an 
oxidant active against a wide variety of microorganisms) and 
phytoalexins (which inhibit mycelium growth and the fruitification of 
susceptible fungal pathogens), that impart resistance against fungal 
diseases.
    Based on the data submitted in support of this petition and the 
Agency's assessment of that data, EPA concludes that there is a 
reasonable certainty that no harm will result to the U.S. population, 
including infants and children from aggregate exposures to a cerevisane 
(cells walls of Saccharomyces cerevisiae strain LAS117). This 
conclusion is based on the lack of toxicity associated with this 
pesticide chemical residue; the available toxicology data indicate that 
the active ingredient is of low toxicity and is not a developmental 
toxicant or a mutagen; therefore, no toxicological endpoints were 
identified. Accordingly, given the lack of threshold effects, the FQPA 
Safety Factor need not be retained. The Agency has conducted a 
qualitative assessment of exposure and determined that dietary and 
drinking water exposure from the pesticide use is expected to be 
negligible since significant residues are not expected due to low 
application rates and rapid degradation rates following application. 
Non-occupational exposures are not expected since cerevisane (cells 
walls of Saccharomyces cerevisiae strain LAS117) is not intended for 
residential use. Given the lack of toxicity, this minimal exposure 
aggregated with the background levels already present in commonly 
consumed foods that contain baker's yeast, or beer, wine, and liquor do 
not pose a risk of concern. A full explanation of the data upon which 
EPA relied, its risk assessment, and other supporting documents is 
available in the docket for this action as described under ADDRESSES.
    Based on its safety determination, EPA is establishing an exemption 
from the requirement of a tolerance for residues of cerevisane (cell 
walls of Saccharomyces cerevisiae strain LAS117) in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due 
to the lack of concern about safety for cerevisane (cell walls of 
Saccharomyces cerevisiae strain LAS117) at any exposure level.

IV. 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 EPA. 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 action, 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. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA 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, EPA has determined that 
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,

[[Page 39375]]

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 EPA's 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).

V. 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: July 31, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. Add Sec.  180.1357 to subpart D to read as follows:

Sec.  180.1357  Cerevisane (cell walls of Saccharomyces cerevisiae 
strain LAS117); exemption from the requirement of a tolerance.

    Residues of the biochemical pesticide cerevisane (cell walls of 
Saccharomyces cerevisiae strain LAS117) are exempt from the requirement 
of a tolerance in or on all food commodities, when used in accordance 
with label directions and good agricultural practices.

[FR Doc. 2018-17081 Filed 8-8-18; 8:45 am]
 BILLING CODE 6560-50-P