83 FR 39373 - Cerevisane (Cell Walls of Saccharomyces cerevisiae Strain LAS117); Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 154 (August 9, 2018)
Federal Register Volume 83, Issue 154 (August 9, 2018)
| Page Range | 39373-39375 | |
| FR Document | 2018-17081 |
[Federal Register Volume 83, Number 154 (Thursday, August 9, 2018)] [Rules and Regulations] [Pages 39373-39375] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17081] ----------------------------------------------------------------------- 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: [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
![Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations 39373
* * * * * Office of Pesticide Programs, disclosed publicly by EPA without prior
[FR Doc. 2018–17080 Filed 8–8–18; 8:45 am] Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
BILLING CODE 6560–50–P Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
(703) 305–7090; email address: 2017–0315, by one of the following
ENVIRONMENTAL PROTECTION BPPDFRNotices@epa.gov. methods:
AGENCY SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
www.regulations.gov. Follow the online
40 CFR Part 180 I. General Information instructions for submitting comments.
[EPA–HQ–OPP–2017–0315; FRL–9980–51] A. Does this action apply to me? Do not submit electronically any
information you consider to be CBI or
Cerevisane (Cell Walls of You may be potentially affected by other information whose disclosure is
Saccharomyces cerevisiae Strain this action if you are an agricultural restricted by statute.
LAS117); Exemption From the producer, food manufacturer, or • Mail: OPP Docket, Environmental
Requirement of a Tolerance pesticide manufacturer. The following Protection Agency Docket Center (EPA/
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
AGENCY: Environmental Protection Classification System (NAICS) codes is NW, Washington, DC 20460–0001.
Agency (EPA). not intended to be exhaustive, but rather • Hand Delivery: To make special
ACTION: Final rule. provides a guide to help readers arrangements for hand delivery or
determine whether this document delivery of boxed information, please
SUMMARY: This regulation establishes an applies to them. Potentially affected follow the instructions at http://
exemption from the requirement of a entities may include: www.epa.gov/dockets/contacts.html.
tolerance for cerevisane (cell walls of • Crop production (NAICS code 111). Additional instructions on commenting
Saccharomyces cerevisiae strain • Animal production (NAICS code or visiting the docket, along with more
LAS117) in or on all food commodities 112). information about dockets generally, is
when used in accordance with label • Food manufacturing (NAICS code
available at http://www.epa.gov/
directions and good agricultural 311).
dockets.
practices. Lesaffre Yeast Corporation • Pesticide manufacturing (NAICS
submitted a petition to EPA under the code 32532). II. Background
Federal Food, Drug, and Cosmetic Act In the Federal Register of March 6,
(FFDCA) requesting an exemption from B. How can I get electronic access to
other related information? 2018 (83 FR 9471) (FRL–9973–27), EPA
the requirement of a tolerance. This issued a document pursuant to FFDCA
regulation eliminates the need to You may access a frequently updated
section 408(d)(3), 21 U.S.C. 346a(d)(3),
establish a maximum permissible level electronic version of 40 CFR part 180
announcing the filing of a pesticide
for residues of cerevisane (cell walls of through the Government Printing
tolerance petition (PP 6F8535) by
Saccharomyces cerevisiae strain Office’s e-CFR site at http://
Technology Sciences Group Inc., 712
LAS117) under FFDCA. www.ecfr.gov/cgi-bin/text-idx?&c=
Fifth Street, Suite A, Davis, CA 95616
DATES: This regulation is effective ecfr&tpl=/ecfrbrowse/Title40/40tab_
(on behalf of Lesaffre Yeast Corporation,
August 9, 2018. Objections and requests 02.tpl.
7475 W Main St., Milwaukee, WI
for hearings must be received on or C. How can I file an objection or hearing 53214). The petition requested that 40
before October 9, 2018, and must be request? CFR 180 be amended by establishing an
filed in accordance with the instructions exemption from the requirement of a
provided in 40 CFR part 178 (see also Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an tolerance for residues of the systemic
Unit I.C. of the SUPPLEMENTARY resistance inducer (SRI) cerevisane (cell
INFORMATION).
objection to any aspect of this regulation
and may also request a hearing on those walls of Saccharomyces cerevisiae
ADDRESSES: The docket for this action, objections. You must file your objection strain LAS117) in or on all food
identified by docket identification (ID) or request a hearing on this regulation commodities. That document referenced
number EPA–HQ–OPP–2017–0315, is in accordance with the instructions a summary of the petition prepared by
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure the petitioner, Technology Sciences
or at the Office of Pesticide Programs proper receipt by EPA, you must Group Inc., (on behalf of Lesaffre Yeast
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– Corporation), which is available in the
in the Environmental Protection Agency OPP–2017–0315 in the subject line on docket via http://www.regulations.gov.
Docket Center (EPA/DC), West William the first page of your submission. All There were no relevant comments
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing received in response to the notice of
Constitution Ave. NW, Washington, DC must be in writing, and must be filing.
20460–0001. The Public Reading Room received by the Hearing Clerk on or III. Final Rule
is open from 8:30 a.m. to 4:30 p.m., before October 9, 2018. Addresses for
Monday through Friday, excluding legal mail and hand delivery of objections A. EPA’s Safety Determination
holidays. The telephone number for the and hearing requests are provided in 40 Section 408(c)(2)(A)(i) of FFDCA
Public Reading Room is (202) 566–1744, CFR 178.25(b). allows EPA to establish an exemption
and the telephone number for the OPP In addition to filing an objection or from the requirement for a tolerance (the
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Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk legal limit for a pesticide chemical
the visitor instructions and additional as described in 40 CFR part 178, please residue in or on a food) only if EPA
information about the docket available submit a copy of the filing (excluding determines that the exemption is ‘‘safe.’’
at http://www.epa.gov/dockets. any Confidential Business Information Section 408(c)(2)(A)(ii) of FFDCA
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket. defines ‘‘safe’’ to mean that ‘‘there is a
Robert McNally, Biopesticides and Information not marked confidential reasonable certainty that no harm will
Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be result from aggregate exposure to the
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![39374 Federal Register / Vol. 83, No. 154 / Thursday, August 9, 2018 / Rules and Regulations
pesticide chemical residue, including resulting in physiological changes, cerevisiae strain LAS117) at any
all anticipated dietary exposures and all including the reinforcement of plant cell exposure level.
other exposures for which there is walls and the production of
IV. Statutory and Executive Order
reliable information.’’ This includes antimicrobial compounds, e.g.,
Reviews
exposure through drinking water and in hydrogen peroxide (an oxidant active
residential settings but does not include against a wide variety of This action establishes an exemption
occupational exposure. Pursuant to microorganisms) and phytoalexins from the requirement of a tolerance
FFDCA section 408(c)(2)(B), in (which inhibit mycelium growth and under FFDCA section 408(d) in
establishing or maintaining in effect an the fruitification of susceptible fungal response to a petition submitted to EPA.
exemption from the requirement of a pathogens), that impart resistance The Office of Management and Budget
tolerance, EPA must take into account against fungal diseases. (OMB) has exempted these types of
the factors set forth in FFDCA section Based on the data submitted in actions from review under Executive
408(b)(2)(C), which require EPA to give support of this petition and the Order 12866, entitled ‘‘Regulatory
special consideration to exposure of Agency’s assessment of that data, EPA Planning and Review’’ (58 FR 51735,
infants and children to the pesticide concludes that there is a reasonable October 4, 1993). Because this action
chemical residue in establishing a certainty that no harm will result to the has been exempted from review under
tolerance or tolerance exemption and to U.S. population, including infants and Executive Order 12866, this action is
‘‘ensure that there is a reasonable children from aggregate exposures to a not subject to Executive Order 13211,
certainty that no harm will result to cerevisane (cells walls of entitled ‘‘Actions Concerning
infants and children from aggregate Regulations That Significantly Affect
Saccharomyces cerevisiae strain
exposure to the pesticide chemical Energy Supply, Distribution, or Use’’ (66
LAS117). This conclusion is based on
residue. . . .’’ Additionally, FFDCA FR 28355, May 22, 2001) or Executive
the lack of toxicity associated with this
section 408(b)(2)(D) requires that EPA Order 13045, entitled ‘‘Protection of
pesticide chemical residue; the available
consider ‘‘available information Children from Environmental Health
toxicology data indicate that the active
concerning the cumulative effects of [a Risks and Safety Risks’’ (62 FR 19885,
ingredient is of low toxicity and is not
particular pesticide’s] . . . residues and April 23, 1997); nor is it considered a
a developmental toxicant or a mutagen;
other substances that have a common regulatory action under Executive Order
therefore, no toxicological endpoints
mechanism of toxicity.’’ FFDCA section 13771, entitled ‘‘Reducing Regulations
were identified. Accordingly, given the
408(b)(2)(C) provides that EPA shall and Controlling Regulatory Costs’’ (82
lack of threshold effects, the FQPA FR 9339, February 3, 2017). This action
apply an additional tenfold (10X) Safety Factor need not be retained. The
margin of safety for infants and children does not contain any information
Agency has conducted a qualitative collections subject to OMB approval
in the case of threshold effects to assessment of exposure and determined
account for prenatal and postnatal under the Paperwork Reduction Act
that dietary and drinking water (PRA), 44 U.S.C. 3501 et seq., nor does
toxicity and the completeness of the exposure from the pesticide use is
database on toxicity and exposure it require any special considerations
expected to be negligible since under Executive Order 12898, entitled
unless EPA determines based on reliable significant residues are not expected
data that a different margin of safety ‘‘Federal Actions to Address
due to low application rates and rapid Environmental Justice in Minority
will be safe for infants and children.
degradation rates following application. Populations and Low-Income
This additional margin of safety is
Non-occupational exposures are not Populations’’ (59 FR 7629, February 16,
commonly referred to as the FQPA
expected since cerevisane (cells walls of 1994).
Safety Factor (SF). In applying this
Saccharomyces cerevisiae strain Since tolerances and exemptions that
provision, EPA either retains the default
LAS117) is not intended for residential are established on the basis of a petition
value of 10X, or uses a different
use. Given the lack of toxicity, this under FFDCA section 408(d), such as
additional safety factor when reliable
minimal exposure aggregated with the the tolerance exemption in this action,
data available to EPA support the choice
background levels already present in do not require the issuance of a
of a different factor.
EPA evaluated the available toxicity commonly consumed foods that contain proposed rule, the requirements of the
and exposure data on cerevisane (cell baker’s yeast, or beer, wine, and liquor Regulatory Flexibility Act (RFA) (5
walls of Saccharomyces cerevisiae do not pose a risk of concern. A full U.S.C. 601 et seq.) do not apply.
strain LAS117) and considered their explanation of the data upon which EPA This action directly regulates growers,
validity, completeness, and reliability, relied, its risk assessment, and other food processors, food handlers, and food
as well as the relationship of this supporting documents is available in retailers, not States or tribes. As a result,
information to human risk. EPA also the docket for this action as described this action does not alter the
considered available information under ADDRESSES. relationships or distribution of power
concerning the variability of the Based on its safety determination, and responsibilities established by
sensitivities of major identifiable EPA is establishing an exemption from Congress in the preemption provisions
subgroups of consumers, including the requirement of a tolerance for of FFDCA section 408(n)(4). As such,
infants and children. residues of cerevisane (cell walls of EPA has determined that this action will
Cerevisane is a whole cell wall extract Saccharomyces cerevisiae strain not have a substantial direct effect on
of Saccharomyces cerevisiae strain LAS117) in or on all food commodities States or tribal governments, on the
LAS117. Saccharomyces cerevisiae is a when used in accordance with label relationship between the national
common source of yeast, commonly directions and good agricultural government and the States or tribal
sradovich on DSK3GMQ082PROD with RULES
used in the manufacturing of beers, practices. governments, or on the distribution of
wines, and liquor intended for human power and responsibilities among the
B. Analytical Enforcement Methodology
consumption because of its ability to various levels of government or between
ferment sugars into ethanol. An analytical method is not required the Federal Government and Indian
Cerevisane is a systemic resistance for enforcement purposes due to the tribes. Thus, EPA has determined that
inducer (SRI) that aids in the up- lack of concern about safety for Executive Order 13132, entitled
regulation of plant defense genes cerevisane (cell walls of Saccharomyces ‘‘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, other required information to the U.S. PART 180—[AMENDED]
entitled ‘‘Consultation and Coordination Senate, the U.S. House of
with Indian Tribal Governments’’ (65 FR Representatives, and the Comptroller ■ 1. The authority citation for part 180
67249, November 9, 2000), do not apply General of the United States prior to continues to read as follows:
to this action. In addition, this action publication of the rule in the Federal Authority: 21 U.S.C. 321(q), 346a and 371.
does not impose any enforceable duty or Register. This action is not a ‘‘major
contain any unfunded mandate as ■ 2. Add § 180.1357 to subpart D to read
rule’’ as defined by 5 U.S.C. 804(2). as follows:
described under Title II of the Unfunded
Mandates Reform Act (UMRA) (2 U.S.C. List of Subjects in 40 CFR Part 180
§ 180.1357 Cerevisane (cell walls of
1501 et seq.). Saccharomyces cerevisiae strain LAS117);
This action does not involve any Environmental protection,
Administrative practice and procedure, exemption from the requirement of a
technical standards that would require tolerance.
EPA’s consideration of voluntary Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping Residues of the biochemical pesticide
consensus standards pursuant to section
requirements. cerevisane (cell walls of Saccharomyces
12(d) of the National Technology
cerevisiae strain LAS117) are exempt
Transfer and Advancement Act Dated: July 31, 2018. from the requirement of a tolerance in
(NTTAA) (15 U.S.C. 272 note).
Richard P. Keigwin, Jr., or on all food commodities, when used
V. Congressional Review Act Director, Office of Pesticide Programs. in accordance with label directions and
Pursuant to the Congressional Review good agricultural practices.
Act (5 U.S.C. 801 et seq.), EPA will Therefore, 40 CFR chapter I is [FR Doc. 2018–17081 Filed 8–8–18; 8:45 am]
submit a report containing this rule and amended as follows: BILLING CODE 6560–50–P
sradovich on DSK3GMQ082PROD with RULES
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Document Created: 2018-08-09 01:11:07
Document Modified: 2018-08-09 01:11:07
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| 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). | |
| Contact | Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 39373 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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