83 FR 9440 - Lipochitooligosaccharide (LCO) SP104; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 44 (March 6, 2018)
Federal Register Volume 83, Issue 44 (March 6, 2018)
| Page Range | 9440-9442 | |
| FR Document | 2018-04534 |
[Federal Register Volume 83, Number 44 (Tuesday, March 6, 2018)] [Rules and Regulations] [Pages 9440-9442] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-04534] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0080; FRL-9973-39] Lipochitooligosaccharide (LCO) SP104; 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 lipochitooligosaccharide (LCO) SP104 in or on all food commodities when used in accordance with label directions and good agricultural practices. Monsanto Company 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 LCO SP104 under FFDCA. DATES: This regulation is effective March 6, 2018. Objections and requests for hearings must be received on or before May 7, 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-2017-0080, 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-2017-0080 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 May 7, 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-2017-0080, 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 [[Page 9441]] 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 June 8, 2017 (82 FR 26641) (FRL-9961- 14), 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 6F8520) by Monsanto Company, 1300 I (Eye) St. NW, Suite 450 East, Washington, DC 20005. The petition requested that 40 CFR 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the plant growth regulator LCO SP104 in or on raw agricultural commodities and processed foods. That document referenced a summary of the petition prepared by the petitioner, Monsanto Company, which is available in the docket via http://www.regulations.gov. There were no 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 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 Food Quality Protection Act Safety Factor (FQPA 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 LCO SP104 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. Lipochitooligosaccharides (LCOs) are signaling molecules produced by bacteria, which are involved in the initiation of plant-microbe endosymbiosis (the scenario when a microbe colonizes a plant) in an estimated 70-80% of terrestrial plants. As a pesticide, LCO SP104, a synthetically produced LCO, is intended for use as a plant growth regulator (PGR) to increase growth and decrease stress in growing crops. Typical of a PGR, LCO SP104 should be applied at low concentrations because use at high concentrations can result in detrimental effects to the plant. LCO SP104 is structurally similar to naturally occurring LCOs. Humans are exposed to naturally occurring LCOs as they are present in the roots of food crops and in the bacteria and fungi that are associated with the roots of these crops. Molecules identical to LCO breakdown products (such as chitin) are also present in insects, crustaceans, fungi, bacteria, and humans, and are regularly consumed by humans as part of a normal diet. Based on the data submitted in support of this petition (summarized in Unit II. B., below) and the comprehensive risk assessment conducted by the Agency (included in the Docket for this action), EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to LCO SP104, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is not acutely toxic and, based upon a weight of the evidence (WOE) approach, it has been determined not to be a developmental toxicant, a mutagen, or toxic via repeat oral exposure (i.e. not subchronically toxic via the oral route). As such the Agency has not identified any endpoints of concern for LC SP104 and has conducted a qualitative assessment of exposure. The Agency has determined that residues of LCO SP104 in drinking water are not expected when products are used according to label instructions. The active ingredient is applied at low concentrations, is very soluble in water, and will dissociate within minutes once applied. Non-occupational exposures are not expected since LCO SP104 is not intended for residential use. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found within the January 22, 2018, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Lipochitooligosaccharide (LCO) SP104.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that LCO SP104 is of low acute toxicity and no toxicological endpoints have been identified for this compound. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of LCO SP104. Therefore, EPA is establishing an exemption from the requirement of a tolerance for residues of LCO SP104. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes due to the lack of concern about safety for LCO SP104 at any exposure level. IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption 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 [[Page 9442]] 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, 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: February 23, 2018. Richard 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. 180.1353 to subpart D to read as follows: Sec. 180.1353 Lipochitooligosaccharide (LCO) SP104; exemption from the requirement of a tolerance. Residues of the biochemical pesticide Lipochitooligosaccharide (LCO) SP104 (which has been used in accordance with label directions and good agricultural practices) are exempt from the requirement of a tolerance in or on all food commodities. [FR Doc. 2018-04534 Filed 3-5-18; 8:45 am] BILLING CODE 6560-50-P
![9440 Federal Register / Vol. 83, No. 44 / Tuesday, March 6, 2018 / Rules and Regulations
EPA APPROVED MASSACHUSETTS REGULATIONS
State
State citation Title/subject EPA approval date 1 Explanations
effective date
* * * * * * *
310 CMR 7.30 ... Massport/Logan Airport 6/30/2017 3/6/2018 .......................... Revises the existing commercial parking freeze lim-
Parking Freeze. [Insert Federal Register its and requires the Massachusetts Port Authority
citation]. to complete several studies to evaluate ways to
further support alternative transit options.
* * * * * * *
1
To determine the EPA effective date for a specific provision listed in this table, consult the Federal Register notice cited in this column for
the particular provision.
* * * * * is open from 8:30 a.m. to 4:30 p.m., C. How can I file an objection or hearing
[FR Doc. 2018–04488 Filed 3–5–18; 8:45 am] Monday through Friday, excluding legal request?
BILLING CODE 6560–50–P holidays. The telephone number for the Under FFDCA section 408(g), 21
Public Reading Room is (202) 566–1744, U.S.C. 346a(g), any person may file an
and the telephone number for the OPP objection to any aspect of this regulation
ENVIRONMENTAL PROTECTION Docket is (703) 305–5805. Please review
AGENCY and may also request a hearing on those
the visitor instructions and additional objections. You must file your objection
information about the docket available or request a hearing on this regulation
40 CFR Part 180 at http://www.epa.gov/dockets. in accordance with the instructions
[EPA–HQ–OPP–2017–0080; FRL–9973–39] provided in 40 CFR part 178. To ensure
FOR FURTHER INFORMATION CONTACT:
Lipochitooligosaccharide (LCO) Robert McNally, Biopesticides and proper receipt by EPA, you must
SP104; Exemption From the Pollution Prevention Division (7511P), identify docket ID number EPA–HQ–
Requirement of a Tolerance Office of Pesticide Programs, OPP–2017–0080 in the subject line on
Environmental Protection Agency, 1200 the first page of your submission. All
AGENCY: Environmental Protection Pennsylvania Ave. NW, Washington, DC objections and requests for a hearing
Agency (EPA). 20460–0001; main telephone number: must be in writing, and must be
ACTION: Final rule. (703) 305–7090; email address: received by the Hearing Clerk on or
BPPDFRNotices@epa.gov. before May 7, 2018. Addresses for mail
SUMMARY: This regulation establishes an and hand delivery of objections and
exemption from the requirement of a SUPPLEMENTARY INFORMATION:
hearing requests are provided in 40 CFR
tolerance for lipochitooligosaccharide I. General Information 178.25(b).
(LCO) SP104 in or on all food In addition to filing an objection or
commodities when used in accordance A. Does this action apply to me?
hearing request with the Hearing Clerk
with label directions and good as described in 40 CFR part 178, please
You may be potentially affected by
agricultural practices. Monsanto submit a copy of the filing (excluding
this action if you are an agricultural
Company submitted a petition to EPA any Confidential Business Information
producer, food manufacturer, or
under the Federal Food, Drug, and (CBI)) for inclusion in the public docket.
pesticide manufacturer. The following
Cosmetic Act (FFDCA) requesting an Information not marked confidential
list of North American Industrial
exemption from the requirement of a
Classification System (NAICS) codes is pursuant to 40 CFR part 2 may be
tolerance. This regulation eliminates the
not intended to be exhaustive, but rather disclosed publicly by EPA without prior
need to establish a maximum
provides a guide to help readers notice. Submit the non-CBI copy of your
permissible level for residues of LCO
determine whether this document objection or hearing request, identified
SP104 under FFDCA.
applies to them. Potentially affected by docket ID number EPA–HQ–OPP–
DATES: This regulation is effective 2017–0080, by one of the following
entities may include:
March 6, 2018. Objections and requests methods:
for hearings must be received on or • Crop production (NAICS code 111).
• Federal eRulemaking Portal: http://
before May 7, 2018, and must be filed • Animal production (NAICS code
www.regulations.gov. Follow the online
in accordance with the instructions 112).
instructions for submitting comments.
provided in 40 CFR part 178 (see also • Food manufacturing (NAICS code Do not submit electronically any
Unit I.C. of the SUPPLEMENTARY 311). information you consider to be CBI or
INFORMATION). • Pesticide manufacturing (NAICS other information whose disclosure is
ADDRESSES: The docket for this action, code 32532). restricted by statute.
identified by docket identification (ID) B. How can I get electronic access to • Mail: OPP Docket, Environmental
number EPA–HQ–OPP–2017–0080, is other related information? Protection Agency Docket Center (EPA/
available at http://www.regulations.gov DC), (28221T), 1200 Pennsylvania Ave.
jstallworth on DSKBBY8HB2PROD with RULES
or at the Office of Pesticide Programs You may access a frequently updated NW, Washington, DC 20460–0001.
Regulatory Public Docket (OPP Docket) electronic version of 40 CFR part 180 • Hand Delivery: To make special
in the Environmental Protection Agency through the Government Printing arrangements for hand delivery or
Docket Center (EPA/DC), West William Office’s e-CFR site at http:// delivery of boxed information, please
Jefferson Clinton Bldg., Rm. 3334, 1301 www.ecfr.gov/cgi-bin/text- follow the instructions at http://
Constitution Ave. NW, Washington, DC idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ www.epa.gov/dockets/contacts.html.
20460–0001. The Public Reading Room 40tab_02.tpl. Additional instructions on commenting
VerDate Sep<11>2014 15:02 Mar 05, 2018 Jkt 244001 PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 E:\FR\FM\06MRR1.SGM 06MRR1](https://thefederalregister.org/doc/83_FR_9484/page/1.svg)
![Federal Register / Vol. 83, No. 44 / Tuesday, March 6, 2018 / Rules and Regulations 9441
or visiting the docket, along with more 408(b)(2)(C) provides that EPA shall practices. EPA has made this
information about dockets generally, is apply an additional tenfold (10X) determination because available
available at http://www.epa.gov/ margin of safety for infants and children toxicology data indicate that the active
dockets. in the case of threshold effects to ingredient is not acutely toxic and,
account for prenatal and postnatal based upon a weight of the evidence
II. Background toxicity and the completeness of the (WOE) approach, it has been determined
In the Federal Register of June 8, 2017 database on toxicity and exposure not to be a developmental toxicant, a
(82 FR 26641) (FRL–9961–14), EPA unless EPA determines based on reliable mutagen, or toxic via repeat oral
issued a document pursuant to FFDCA data that a different margin of safety exposure (i.e. not subchronically toxic
section 408(d)(3), 21 U.S.C. 346a(d)(3), will be safe for infants and children. via the oral route). As such the Agency
announcing the filing of a pesticide This additional margin of safety is has not identified any endpoints of
tolerance petition (PP 6F8520) by commonly referred to as the Food concern for LC SP104 and has
Monsanto Company, 1300 I (Eye) St. Quality Protection Act Safety Factor conducted a qualitative assessment of
NW, Suite 450 East, Washington, DC (FQPA SF). In applying this provision, exposure. The Agency has determined
20005. The petition requested that 40 EPA either retains the default value of that residues of LCO SP104 in drinking
CFR 180 be amended by establishing an 10X, or uses a different additional safety water are not expected when products
exemption from the requirement of a factor when reliable data available to are used according to label instructions.
tolerance for residues of the plant EPA support the choice of a different The active ingredient is applied at low
growth regulator LCO SP104 in or on factor. concentrations, is very soluble in water,
raw agricultural commodities and EPA evaluated the available toxicity and will dissociate within minutes once
processed foods. That document and exposure data on LCO SP104 and applied. Non-occupational exposures
referenced a summary of the petition considered their validity, completeness, are not expected since LCO SP104 is not
prepared by the petitioner, Monsanto and reliability, as well as the intended for residential use. A full
Company, which is available in the relationship of this information to explanation of the data upon which EPA
docket via http://www.regulations.gov. human risk. EPA also considered relied and its risk assessment based on
There were no comments received in available information concerning the those data can be found within the
response to the notice of filing. variability of the sensitivities of major January 22, 2018, document entitled
identifiable subgroups of consumers, ‘‘Federal Food, Drug, and Cosmetic Act
III. Final Rule including infants and children. (FFDCA) Considerations for
A. EPA’s Safety Determination Lipochitooligosaccharides (LCOs) are Lipochitooligosaccharide (LCO) SP104.’’
signaling molecules produced by This document, as well as other relevant
Section 408(c)(2)(A)(i) of FFDCA bacteria, which are involved in the information, is available in the docket
allows EPA to establish an exemption initiation of plant-microbe for this action as described under
from the requirement for a tolerance (the endosymbiosis (the scenario when a ADDRESSES.
legal limit for a pesticide chemical microbe colonizes a plant) in an Based upon its evaluation, EPA
residue in or on a food) only if EPA estimated 70–80% of terrestrial plants. concludes that LCO SP104 is of low
determines that the exemption is ‘‘safe.’’ As a pesticide, LCO SP104, a acute toxicity and no toxicological
Section 408(c)(2)(A)(ii) of FFDCA synthetically produced LCO, is intended endpoints have been identified for this
defines ‘‘safe’’ to mean that ‘‘there is a for use as a plant growth regulator (PGR) compound. Therefore, EPA concludes
reasonable certainty that no harm will to increase growth and decrease stress that there is a reasonable certainty that
result from aggregate exposure to the in growing crops. Typical of a PGR, LCO no harm will result to the U.S.
pesticide chemical residue, including SP104 should be applied at low population, including infants and
all anticipated dietary exposures and all concentrations because use at high children, from aggregate exposure to
other exposures for which there is concentrations can result in detrimental residues of LCO SP104. Therefore, EPA
reliable information.’’ This includes effects to the plant. LCO SP104 is is establishing an exemption from the
exposure through drinking water and in structurally similar to naturally requirement of a tolerance for residues
residential settings but does not include occurring LCOs. Humans are exposed to of LCO SP104.
occupational exposure. Pursuant to naturally occurring LCOs as they are
FFDCA section 408(c)(2)(B), in present in the roots of food crops and B. Analytical Enforcement Methodology
establishing or maintaining in effect an in the bacteria and fungi that are An analytical method is not required
exemption from the requirement of a associated with the roots of these crops. for enforcement purposes due to the
tolerance, EPA must take into account Molecules identical to LCO breakdown lack of concern about safety for LCO
the factors set forth in FFDCA section products (such as chitin) are also SP104 at any exposure level.
408(b)(2)(C), which require EPA to give present in insects, crustaceans, fungi,
special consideration to exposure of bacteria, and humans, and are regularly IV. Statutory and Executive Order
infants and children to the pesticide consumed by humans as part of a Reviews
chemical residue in establishing a normal diet. This action establishes a tolerance
tolerance or tolerance exemption and to Based on the data submitted in exemption under FFDCA section 408(d)
‘‘ensure that there is a reasonable support of this petition (summarized in in response to a petition submitted to
certainty that no harm will result to Unit II. B., below) and the EPA. The Office of Management and
infants and children from aggregate comprehensive risk assessment Budget (OMB) has exempted these types
exposure to the pesticide chemical conducted by the Agency (included in of actions from review under Executive
jstallworth on DSKBBY8HB2PROD with RULES
residue. . . .’’ Additionally, FFDCA the Docket for this action), EPA Order 12866, entitled ‘‘Regulatory
section 408(b)(2)(D) requires that EPA concludes that there is a reasonable Planning and Review’’ (58 FR 51735,
consider ‘‘available information certainty of no harm from aggregate October 4, 1993). Because this action
concerning the cumulative effects of [a exposures to LCO SP104, including the has been exempted from review under
particular pesticide’s] . . . residues and consumption of food treated with this Executive Order 12866, this action is
other substances that have a common active ingredient in accordance with not subject to Executive Order 13211,
mechanism of toxicity.’’ FFDCA section label directions and good agricultural entitled ‘‘Actions Concerning
VerDate Sep<11>2014 15:02 Mar 05, 2018 Jkt 244001 PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 E:\FR\FM\06MRR1.SGM 06MRR1](https://thefederalregister.org/doc/83_FR_9484/page/2.svg)
![9442 Federal Register / Vol. 83, No. 44 / Tuesday, March 6, 2018 / Rules and Regulations
Regulations That Significantly Affect V. Congressional Review Act before May 7, 2018, and must be filed
Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review in accordance with the instructions
FR 28355, May 22, 2001) or Executive Act (5 U.S.C. 801 et seq.), EPA will provided in 40 CFR part 178 (see also
Order 13045, entitled ‘‘Protection of submit a report containing this rule and Unit I.C. of the SUPPLEMENTARY
Children from Environmental Health other required information to the U.S. INFORMATION).
Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of ADDRESSES: The docket for this action,
April 23, 1997); nor is it considered a Representatives, and the Comptroller identified by docket identification (ID)
regulatory action under Executive Order General of the United States prior to number EPA–HQ–OPP–2016–0519, is
13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal available at http://www.regulations.gov
and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major or at the Office of Pesticide Programs
FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2). Regulatory Public Docket (OPP Docket)
does not contain any information in the Environmental Protection Agency
collections subject to OMB approval List of Subjects in 40 CFR Part 180 Docket Center (EPA/DC), West William
under the Paperwork Reduction Act Environmental protection, Jefferson Clinton Bldg., Rm. 3334, 1301
(PRA), 44 U.S.C. 3501 et seq., nor does Administrative practice and procedure, Constitution Ave. NW, Washington, DC
it require any special considerations Agricultural commodities, Pesticides 20460–0001. The Public Reading Room
under Executive Order 12898, entitled and pests, Reporting and recordkeeping is open from 8:30 a.m. to 4:30 p.m.,
‘‘Federal Actions to Address requirements. Monday through Friday, excluding legal
Environmental Justice in Minority Dated: February 23, 2018. holidays. The telephone number for the
Populations and Low-Income Richard Keigwin, Jr., Public Reading Room is (202) 566–1744,
Populations’’ (59 FR 7629, February 16, and the telephone number for the OPP
Director, Office of Pesticide Programs.
1994). Docket is (703) 305–5805. Please review
Therefore, 40 CFR chapter I is the visitor instructions and additional
Since tolerances and exemptions that amended as follows:
are established on the basis of a petition information about the docket available
at http://www.epa.gov/dockets.
under FFDCA section 408(d), such as PART 180—[AMENDED]
the tolerance exemption in this action, FOR FURTHER INFORMATION CONTACT:
do not require the issuance of a ■ 1. The authority citation for part 180 Michael L. Goodis, Director,
proposed rule, the requirements of the continues to read as follows: Registration Division (7505P), Office of
Regulatory Flexibility Act (RFA) (5 Pesticide Programs, Environmental
Authority: 21 U.S.C. 321(q), 346a and 371.
U.S.C. 601 et seq.) do not apply. Protection Agency, 1200 Pennsylvania
■ 2. Add § 180.1353 to subpart D to read Ave. NW, Washington, DC 20460–0001;
This action directly regulates growers, as follows: main telephone number: (703) 305–
food processors, food handlers, and food 7090; email address: RDFRNotices@
retailers, not States or tribes. As a result, § 180.1353 Lipochitooligosaccharide
(LCO) SP104; exemption from the
epa.gov.
this action does not alter the
relationships or distribution of power requirement of a tolerance. SUPPLEMENTARY INFORMATION:
and responsibilities established by Residues of the biochemical pesticide I. General Information
Congress in the preemption provisions Lipochitooligosaccharide (LCO) SP104
of FFDCA section 408(n)(4). As such, (which has been used in accordance A. Does this action apply to me?
EPA has determined that this action will with label directions and good You may be potentially affected by
not have a substantial direct effect on agricultural practices) are exempt from this action if you are an agricultural
States or tribal governments, on the the requirement of a tolerance in or on producer, food manufacturer, or
relationship between the national all food commodities. pesticide manufacturer. The following
government and the States or tribal [FR Doc. 2018–04534 Filed 3–5–18; 8:45 am] list of North American Industrial
governments, or on the distribution of BILLING CODE 6560–50–P Classification System (NAICS) codes is
power and responsibilities among the not intended to be exhaustive, but rather
various levels of government or between provides a guide to help readers
the Federal Government and Indian ENVIRONMENTAL PROTECTION determine whether this document
tribes. Thus, EPA has determined that AGENCY applies to them. Potentially affected
Executive Order 13132, entitled entities may include:
‘‘Federalism’’ (64 FR 43255, August 10, 40 CFR Part 180 • Crop production (NAICS code 111).
1999), and Executive Order 13175, [EPA–HQ–OPP–2016–0519; FRL–9972–96] • Animal production (NAICS code
entitled ‘‘Consultation and Coordination 112).
with Indian Tribal Governments’’ (65 FR Kasugamycin; Pesticide Tolerances • Food manufacturing (NAICS code
67249, November 9, 2000), do not apply 311).
to this action. In addition, this action
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
Agency (EPA). code 32532).
does not impose any enforceable duty or
ACTION: Final rule.
contain any unfunded mandate as B. How can I get electronic access to
described under Title II of the Unfunded SUMMARY: This regulation establishes other related information?
Mandates Reform Act (UMRA) (2 U.S.C. tolerances for residues of kasugamycin You may access a frequently updated
1501 et seq.). in or on the cherry subgroup 12–12A electronic version of EPA’s tolerance
jstallworth on DSKBBY8HB2PROD with RULES
This action does not involve any and walnut. The Interregional Research regulations at 40 CFR part 180 through
technical standards that would require Project Number 4 (IR–4) requested these the Government Printing Office’s e-CFR
EPA’s consideration of voluntary tolerances under the Federal Food, site at http://www.ecfr.gov/cgi-bin/text-
consensus standards pursuant to section Drug, and Cosmetic Act (FFDCA). idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
12(d) of the National Technology DATES: This regulation is effective 40tab_02.tpl.
Transfer and Advancement Act March 6, 2018. Objections and requests To access the OCSPP test guidelines
(NTTAA) (15 U.S.C. 272 note). for hearings must be received on or referenced in this document
VerDate Sep<11>2014 15:02 Mar 05, 2018 Jkt 244001 PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 E:\FR\FM\06MRR1.SGM 06MRR1](https://thefederalregister.org/doc/83_FR_9484/page/3.svg)
Document Created: 2018-11-01 08:49:22
Document Modified: 2018-11-01 08:49:22
| 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 March 6, 2018. Objections and requests for hearings must be received on or before May 7, 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 9440 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR