Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 39373 

* * * * * 

[FR Doc. 2018–17080 Filed 8–8–18; 8:45 am] 

BILLING CODE 6560–50–P 

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. 

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: 

BPPDFRNotices@epa.gov. 

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 


sradovich on DSK3GMQ082PROD with RULES
39374 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 

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 upregulation 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, 


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Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. Add § 180.1357 to subpart D to read 

as follows: 

§ 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 


sradovich on DSK3GMQ082PROD with RULES