82 FR 57135 - Bacillus thuringiensis Cry14Ab-1 Protein in or on Soybean; Temporary Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 231 (December 4, 2017)
Federal Register Volume 82, Issue 231 (December 4, 2017)
| Page Range | 57135-57137 | |
| FR Document | 2017-26080 |
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)] [Rules and Regulations] [Pages 57135-57137] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26080] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA-HQ-OPP-2017-0113; FRL-9970-43] Bacillus thuringiensis Cry14Ab-1 Protein in or on Soybean; Temporary Exemption From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a temporary exemption from the requirement of a tolerance for residues of the Bacillus thuringiensis Cry14Ab-1 protein in or on soybean, when used as a plant-incorporated protectant (PIP) in soybean plants, in accordance with the terms of Experimental Use Permit (EUP) No. 264-EUP-151. Bayer CropScience LP., submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the temporary tolerance exemption. This regulation eliminates the need under FFDCA to establish a maximum permissible level for residues of Cry14Ab-1 protein. The temporary tolerance exemption expires on April 1, 2020. DATES: This regulation is effective December 4, 2017. Objections and requests for hearings must be received on or before February 2, 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-2017-0113, 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 [[Page 57136]] 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 174 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-2017-0113 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 February 2, 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-2017-0113, 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 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 6F8541) by Bayer CropScience LP., 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petitioner requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of the plant-pesticide Bacillus thuringiensis Cry14Ab-1 in or on soybean. That document referenced a summary of the petition prepared by the petitioner Bayer CropScience LP, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the Notice of Filing. EPA is establishing a temporary exemption that varies slightly from the request, as explained in Unit III.C. III. Final Rule A. EPA's Safety Determination Section 408(r) of FFDCA authorizes EPA to establish a temporary exemption from the requirement of a tolerance for residues covered by an experimental use permit issued under the Federal Insecticide, Fungicide, and Rodenticide Act. That section states that the provisions of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA section 408(r). 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.'' EPA evaluated the available toxicity and exposure data on Bacillus thuringiensis Cry14Ab-1 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. In summary, the available data does not indicate any adverse effects due to toxicity or allergenicity of the Cry14Ab-1 protein. A full explanation of the data upon which EPA relied and its risk assessments based on that data can be found within the document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for the Plant-Incorporated Protectant Pesticide Bacillus thuringiensis Cry14Ab-1.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. There is likely to be exposure to Cry14Ab-1 through consumption of soybean plants containing the pesticide, and there is potential for exposure in drinking water. There is unlikely to be residential or non- occupational exposure due to incorporation within the plant and the lack of availability at this time of the plant for residential uses. Although FFDCA section 408(b)(2)(C) provides for an additional tenfold margin of safety for infants and children in the case of threshold effects, EPA has determined that there are no such [[Page 57137]] effects due to the lack of toxicity and allergenicity for this PIP. As a result, an additional margin of safety for the protection of infants and children is unnecessary. Based upon its evaluation, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the Cry14Ab-1 protein in or on soybean. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the lack of toxicity and allergenicity for the Bacillus thuringiensis Cry14Ab-1 protein. Therefore, a temporary exemption is established for residues of this plant-incorporated protectant Bacillus thuringiensis Cry14Ab-1 protein in or on soybean. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes because EPA is establishing a temporary exemption from the requirement of a tolerance without any numerical limitation for which enforcement is unnecessary. C. Revisions to the Requested Tolerance Exemption EPA's final rule revises the request from ``plant-pesticide'' to ``plant-incorporated protectant'' to align with the Agency's language published in 40 CFR 174.3; adds the term ``temporary'' to reflect that this exemption is linked to the pending experimental use permit action, and is published in part 174 rather than part 180, since PIP tolerance exemptions are published in part 174. 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or 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 174 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 13, 2017. Richard P. Keigwin, Jr., Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 174--[AMENDED] 0 1. The authority citation for part 174 continues to read as follows: Authority: 7 U.S.C. 136-136y; 21 U.S.C. 321(q), 346a and 371. 0 2. Add Sec. 174.538 to subpart W to read as follows: Sec. 174.538 Bacillus thuringiensis Cry14Ab-1 protein in soybean; temporary exemption from the requirement of a tolerance. Residues of the protein Cry14Ab-1 in or on soybean are temporarily exempt from the requirement of a tolerance when used as a plant- incorporated protectant in soybean plants in accordance with the terms of Experimental Use Permit No. 264-EUP-151. This temporary exemption from the requirement of a tolerance expires on April 1, 2020. [FR Doc. 2017-26080 Filed 12-1-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Rules and Regulations 57135
environmental health or safety risks that reference, Intergovernmental relations, ENVIRONMENTAL PROTECTION
the EPA has reason to believe may New Source Review, Ozone, Particulate AGENCY
disproportionately affect children, per matter, Reporting and recordkeeping
the definition of ‘‘covered regulatory requirements, Volatile organic 40 CFR Part 174
action’’ in section 2–202 of the compounds. [EPA–HQ–OPP–2017–0113; FRL–9970–43]
Executive Order. This action is not Authority: 42 U.S.C. 7401 et seq.
subject to Executive Order 13045 Bacillus thuringiensis Cry14Ab–1
because it does not impose additional Dated: October 31, 2017.
Protein in or on Soybean; Temporary
requirements beyond those imposed by Deborah Jordan,
Exemption From the Requirement of a
state law. Acting Regional Administrator, Region IX. Tolerance
H. Executive Order 13211: Actions That Part 52, chapter I, title 40 of the Code
of Federal Regulations is amended as AGENCY: Environmental Protection
Significantly Affect Energy Supply, Agency (EPA).
Distribution, or Use follows:
ACTION: Final rule.
This action is not subject to Executive PART 52—APPROVAL AND
Order 13211, because it is not a PROMULGATION OF SUMMARY: This regulation establishes a
significant regulatory action under IMPLEMENTATION PLANS temporary exemption from the
Executive Order 12866. requirement of a tolerance for residues
■ 1. The authority citation for part 52 of the Bacillus thuringiensis Cry14Ab–1
I. National Technology Transfer and continues to read as follows: protein in or on soybean, when used as
Advancement Act (NTTAA) a plant-incorporated protectant (PIP) in
Authority: 42 U.S.C. 7401 et seq.
Section 12(d) of the NTTAA directs soybean plants, in accordance with the
the EPA to use voluntary consensus Subpart F—California terms of Experimental Use Permit (EUP)
standards in its regulatory activities No. 264–EUP–151. Bayer CropScience
unless to do so would be inconsistent ■ 2. Section 52.220 is amended by LP., submitted a petition to EPA under
with applicable law or otherwise adding paragraphs (c)(199)(i)(A)(10) and the Federal Food, Drug, and Cosmetic
impractical. The EPA believes that this (c)(429)(i)(E)(3) to read as follows: Act (FFDCA), requesting the temporary
action is not subject to the requirements tolerance exemption. This regulation
§ 52.220 Identification of plan—in part.
of section 12(d) of the NTTAA because eliminates the need under FFDCA to
application of those requirements would * * * * * establish a maximum permissible level
(c) * * * for residues of Cry14Ab–1 protein. The
be inconsistent with the CAA. (199) * * *
temporary tolerance exemption expires
J. Executive Order 12898: Federal (i) * * *
(A) * * * on April 1, 2020.
Actions To Address Environmental
(10) Previously approved on January DATES: This regulation is effective
Justice in Minority Populations and
Low-Income Populations 26, 1999 in paragraph (c)(199)(i)(A)(8) of December 4, 2017. Objections and
this section and now deleted with requests for hearings must be received
The EPA lacks the discretionary replacement in (c)(429)(i)(E)(3), on or before February 2, 2018, and must
authority to address environmental Regulation 2, Rule 4 adopted on June be filed in accordance with the
justice in this rulemaking. 15, 1994. instructions provided in 40 CFR part
K. Congressional Review Act (CRA) * * * * * 178 (see also Unit I.C. of the
(429) * * * SUPPLEMENTARY INFORMATION).
This action is subject to the CRA, and
(i) * * * ADDRESSES: The docket for this action,
the EPA will submit a rule report to
(E) * * * identified by docket identification (ID)
each House of the Congress and to the
(3) Regulation 2, ‘‘Permits,’’ Rule 4, number EPA–HQ–OPP–2017–0113, is
Comptroller General of the United
‘‘Emissions Banking,’’ adopted on available at http://www.regulations.gov
States. This action is not a ‘‘major rule’’
December 19, 2012. or at the Office of Pesticide Programs
as defined by 5 U.S.C. 804(2).
* * * * * Regulatory Public Docket (OPP Docket)
L. Petitions for Judicial Review ■ 3. Section 52.248 is amended by in the Environmental Protection Agency
Under section 307(b)(1) of the Clean adding paragraph (c) to read as follows: Docket Center (EPA/DC), West William
Air Act, petitions for judicial review of Jefferson Clinton Bldg., Rm. 3334, 1301
§ 52.248 Identification of plan—conditional Constitution Ave. NW., Washington, DC
this action must be filed in the United approval.
States Court of Appeals for the 20460–0001. The Public Reading Room
appropriate circuit by February 2, 2018. * * * * * is open from 8:30 a.m. to 4:30 p.m.,
Filing a petition for reconsideration by (c) The EPA is conditionally Monday through Friday, excluding legal
the Administrator of this final rule does approving a California State holidays. The telephone number for the
not affect the finality of this rule for the Implementation Plan (SIP) revision Public Reading Room is (202) 566–1744,
purposes of judicial review nor does it submitted on April 22, 2013, updating and the telephone number for the OPP
extend the time within which a petition Regulation 2—Permits, Rule 4— Docket is (703) 305–5805. Please review
for judicial review may be filed, and Emissions Banking. The conditional the visitor instructions and additional
shall not postpone the effectiveness of approval is based on a commitment information about the docket available
such rule or action. This action may not from the State to submit a SIP revision at http://www.epa.gov/dockets.
that will correct the identified
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be challenged later in proceedings to FOR FURTHER INFORMATION CONTACT:
enforce its requirements (see section deficiencies in this rule. If the State fails Robert McNally, Biopesticides and
307(b)(2)). to meet its commitment by November 1, Pollution Prevention Division (7511P),
2018, the conditional approval is treated Office of Pesticide Programs,
List of Subjects in 40 CFR Part 52 as a disapproval. Environmental Protection Agency, 1200
Environmental protection, Air [FR Doc. 2017–25927 Filed 12–1–17; 8:45 am] Pennsylvania Ave. NW., Washington,
pollution control, Incorporation by BILLING CODE 6560–50–P DC 20460–0001; main telephone
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number: (703) 305–7090; email address: 2017–0113, by one of the following 408(c)(2)(A)(ii) of FFDCA defines ‘‘safe’’
BPPDFRNotices@epa.gov. methods: to mean that ‘‘there is a reasonable
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// certainty that no harm will result from
www.regulations.gov. Follow the online aggregate exposure to the pesticide
I. General Information instructions for submitting comments. chemical residue, including all
A. Does this action apply to me? Do not submit electronically any anticipated dietary exposures and all
information you consider to be CBI or other exposures for which there is
You may be potentially affected by other information whose disclosure is reliable information.’’ This includes
this action if you are an agricultural restricted by statute. exposure through drinking water and in
producer, food manufacturer, or • Mail: OPP Docket, Environmental residential settings but does not include
pesticide manufacturer. The following Protection Agency Docket Center (EPA/ occupational exposure. Pursuant to
list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave. FFDCA section 408(c)(2)(B), in
Classification System (NAICS) codes is NW., Washington, DC 20460–0001. establishing or maintaining in effect an
not intended to be exhaustive, but rather • Hand Delivery: To make special exemption from the requirement of a
provides a guide to help readers arrangements for hand delivery or tolerance, EPA must take into account
determine whether this document delivery of boxed information, please the factors set forth in FFDCA section
applies to them. Potentially affected follow the instructions at http:// 408(b)(2)(C), which require EPA to give
entities may include: www.epa.gov/dockets/contacts.html. special consideration to exposure of
• Crop production (NAICS code 111). Additional instructions on commenting infants and children to the pesticide
• Animal production (NAICS code or visiting the docket, along with more chemical residue in establishing a
112). information about dockets generally, is tolerance or tolerance exemption and to
• Food manufacturing (NAICS code ‘‘ensure that there is a reasonable
available at http://www.epa.gov/
311). certainty that no harm will result to
dockets.
• Pesticide manufacturing (NAICS infants and children from aggregate
code 32532). II. Background exposure to the pesticide chemical
B. How can I get electronic access to In the Federal Register of June 8, 2017 residue. . . .’’ Additionally, FFDCA
other related information? (82 FR 26641) (FRL–9961–14), EPA section 408(b)(2)(D) requires that EPA
issued a document pursuant to FFDCA consider ‘‘available information
You may access a frequently updated concerning the cumulative effects of [a
section 408(d)(3), 21 U.S.C. 346a(d)(3),
electronic version of 40 CFR part 174 particular pesticide’s] . . . residues and
announcing the filing of a pesticide
through the Government Printing other substances that have a common
tolerance petition (PP 6F8541) by Bayer
Office’s e-CFR site at http:// mechanism of toxicity.’’
CropScience LP., 2 T.W. Alexander Dr.,
www.ecfr.gov/cgi-bin/text-idx? EPA evaluated the available toxicity
Research Triangle Park, NC 27709. The
&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_ and exposure data on Bacillus
petitioner requested that 40 CFR part
02.tpl. thuringiensis Cry14Ab–1 and
180 be amended by establishing a
C. How can I file an objection or hearing temporary exemption from the considered its validity, completeness,
request? requirement of a tolerance for residues and reliability, as well as the
of the plant-pesticide Bacillus relationship of this information to
Under FFDCA section 408(g), 21 human risk. In summary, the available
U.S.C. 346a(g), any person may file an thuringiensis Cry14Ab–1 in or on
soybean. That document referenced a data does not indicate any adverse
objection to any aspect of this regulation effects due to toxicity or allergenicity of
and may also request a hearing on those summary of the petition prepared by the
petitioner Bayer CropScience LP, which the Cry14Ab–1 protein. A full
objections. You must file your objection explanation of the data upon which EPA
or request a hearing on this regulation is available in the docket via http://
www.regulations.gov. There were no relied and its risk assessments based on
in accordance with the instructions that data can be found within the
provided in 40 CFR part 178. To ensure comments received in response to the
Notice of Filing. document entitled ‘‘Federal Food, Drug,
proper receipt by EPA, you must and Cosmetic Act (FFDCA)
identify docket ID number EPA–HQ– EPA is establishing a temporary
exemption that varies slightly from the Considerations for the Plant-
OPP–2017–0113 in the subject line on Incorporated Protectant Pesticide
the first page of your submission. All request, as explained in Unit III.C.
Bacillus thuringiensis Cry14Ab–1.’’ This
objections and requests for a hearing III. Final Rule document, as well as other relevant
must be in writing, and must be information, is available in the docket
received by the Hearing Clerk on or A. EPA’s Safety Determination
for this action as described under
before February 2, 2018. Addresses for Section 408(r) of FFDCA authorizes ADDRESSES.
mail and hand delivery of objections EPA to establish a temporary exemption There is likely to be exposure to
and hearing requests are provided in 40 from the requirement of a tolerance for Cry14Ab–1 through consumption of
CFR 178.25(b). residues covered by an experimental use soybean plants containing the pesticide,
In addition to filing an objection or permit issued under the Federal and there is potential for exposure in
hearing request with the Hearing Clerk Insecticide, Fungicide, and Rodenticide drinking water. There is unlikely to be
as described in 40 CFR part 178, please Act. That section states that the residential or non-occupational
submit a copy of the filing (excluding provisions of section 408(c)(2) of exposure due to incorporation within
any Confidential Business Information FFDCA apply to exemptions issued the plant and the lack of availability at
(CBI)) for inclusion in the public docket. under FFDCA section 408(r). Section
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this time of the plant for residential
Information not marked confidential 408(c)(2)(A)(i) of FFDCA allows EPA to uses.
pursuant to 40 CFR part 2 may be establish an exemption from the Although FFDCA section 408(b)(2)(C)
disclosed publicly by EPA without prior requirement for a tolerance (the legal provides for an additional tenfold
notice. Submit the non-CBI copy of your limit for a pesticide chemical residue in margin of safety for infants and children
objection or hearing request, identified or on a food) only if EPA determines in the case of threshold effects, EPA has
by docket ID number EPA–HQ–OPP– that the exemption is ‘‘safe.’’ Section determined that there are no such
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effects due to the lack of toxicity and and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
allergenicity for this PIP. As a result, an FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2).
additional margin of safety for the does not contain any information
List of Subjects in 40 CFR Part 174
protection of infants and children is collections subject to OMB approval
unnecessary. under the Paperwork Reduction Act Environmental protection,
Based upon its evaluation, EPA (PRA) (44 U.S.C. 3501 et seq.) nor does Administrative practice and procedure,
concludes that there is reasonable it require any special considerations Agricultural commodities, Pesticides
certainty that no harm will result to the under Executive Order 12898, entitled and pests, Reporting and recordkeeping
U.S. population, including infants and ‘‘Federal Actions to Address requirements.
children, from aggregate exposure to Environmental Justice in Minority Dated: November 13, 2017.
residues of the Cry14Ab–1 protein in or Populations and Low-Income Richard P. Keigwin, Jr.,
on soybean. This includes all Populations’’ (59 FR 7629, February 16,
Director, Office of Pesticide Programs.
anticipated dietary exposures and all 1994).
other exposures for which there is Since tolerances and exemptions that Therefore, 40 CFR chapter I is
reliable information. The Agency has are established on the basis of a petition amended as follows:
arrived at this conclusion based on the under FFDCA section 408(d), such as
lack of toxicity and allergenicity for the the tolerance exemption in this action, PART 174—[AMENDED]
Bacillus thuringiensis Cry14Ab–1 do not require the issuance of a
protein. Therefore, a temporary proposed rule, the requirements of the ■ 1. The authority citation for part 174
exemption is established for residues of Regulatory Flexibility Act (RFA) (5 continues to read as follows:
this plant-incorporated protectant U.S.C. 601 et seq.) do not apply. Authority: 7 U.S.C. 136–136y; 21 U.S.C.
Bacillus thuringiensis Cry14Ab–1 This action directly regulates growers, 321(q), 346a and 371.
protein in or on soybean. food processors, food handlers, and food ■ 2. Add § 174.538 to subpart W to read
retailers, not States or tribes. As a result, as follows:
B. Analytical Enforcement Methodology this action does not alter the
An analytical method is not required relationships or distribution of power § 174.538 Bacillus thuringiensis Cry14Ab–
for enforcement purposes because EPA and responsibilities established by 1 protein in soybean; temporary exemption
is establishing a temporary exemption Congress in the preemption provisions from the requirement of a tolerance.
from the requirement of a tolerance of FFDCA section 408(n)(4). As such, Residues of the protein Cry14Ab–1 in
without any numerical limitation for EPA has determined that this action will or on soybean are temporarily exempt
which enforcement is unnecessary. not have a substantial direct effect on from the requirement of a tolerance
States or tribal governments, on the when used as a plant-incorporated
C. Revisions to the Requested Tolerance
relationship between the national protectant in soybean plants in
Exemption government and the States or tribal accordance with the terms of
EPA’s final rule revises the request governments, or on the distribution of Experimental Use Permit No. 264–EUP–
from ‘‘plant-pesticide’’ to ‘‘plant- power and responsibilities among the 151. This temporary exemption from the
incorporated protectant’’ to align with various levels of government or between requirement of a tolerance expires on
the Agency’s language published in 40 the Federal Government and Indian April 1, 2020.
CFR 174.3; adds the term ‘‘temporary’’ tribes. Thus, EPA has determined that [FR Doc. 2017–26080 Filed 12–1–17; 8:45 am]
to reflect that this exemption is linked Executive Order 13132, entitled BILLING CODE 6560–50–P
to the pending experimental use permit ‘‘Federalism’’ (64 FR 43255, August 10,
action, and is published in part 174 1999), and Executive Order 13175,
rather than part 180, since PIP tolerance entitled ‘‘Consultation and ENVIRONMENTAL PROTECTION
exemptions are published in part 174. Coordination with Indian Tribal AGENCY
IV. Statutory and Executive Order Governments’’ (65 FR 67249, November
Reviews 9, 2000), do not apply to this action. In 40 CFR Part 174
addition, this action does not impose [EPA–HQ–OPP–2017–0115; FRL–9969–94]
This action establishes an exemption any enforceable duty or contain any
from the requirement of a tolerance unfunded mandate as described under Pseudomonas fluorescens 4-
under FFDCA section 408(d) in Title II of the Unfunded Mandates hydroxyphenylpyruvate dioxygenase
response to a petition submitted to EPA. Reform Act (UMRA) (2 U.S.C. 1501 et (HPPD–4); Exemption From the
The Office of Management and Budget seq.). Requirement of a Tolerance
(OMB) has exempted these types of This action does not involve any
actions from review under Executive technical standards that would require AGENCY: Environmental Protection
Order 12866, entitled ‘‘Regulatory EPA’s consideration of voluntary Agency (EPA).
Planning and Review’’ (58 FR 51735, consensus standards pursuant to section ACTION: Final rule.
October 4, 1993). Because this action 12(d) of the National Technology
has been exempted from review under Transfer and Advancement Act SUMMARY: This regulation establishes an
Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note). exemption from the requirement of a
not subject to Executive Order 13211, tolerance for residues of the HPPD–4
entitled ‘‘Actions Concerning V. Congressional Review Act protein derived from the 4-
Regulations That Significantly Affect Pursuant to the Congressional Review hydroxyphenylpyruvate dioxygenase
Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will enzyme of Pseudomonas fluorescens in
ethrower on DSK3G9T082PROD with RULES
FR 28355, May 22, 2001); Executive submit a report containing this rule and or on all food commodities, when used
Order 13045, entitled ‘‘Protection of other required information to the U.S. as a plant-incorporated protectant inert
Children from Environmental Health Senate, the U.S. House of ingredient. Bayer CropScience LP
Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller submitted a petition to EPA under the
April 23, 1997); or Executive Order General of the United States prior to Federal Food, Drug, and Cosmetic Act
13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal (FFDCA), requesting this exemption
VerDate Sep<11>2014 17:52 Dec 01, 2017 Jkt 244001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\04DER1.SGM 04DER1](https://thefederalregister.org/doc/82_FR_57366/page/3.svg)
Document Created: 2017-12-02 00:40:07
Document Modified: 2017-12-02 00:40:07
| 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 December 4, 2017. Objections and requests for hearings must be received on or before February 2, 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, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 57135 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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