83 FR 3601 - Bacillus thuringiensis Cry51Aa2.834_16; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 18 (January 26, 2018)
Federal Register Volume 83, Issue 18 (January 26, 2018)
| Page Range | 3601-3603 | |
| FR Document | 2018-01519 |
[Federal Register Volume 83, Number 18 (Friday, January 26, 2018)] [Rules and Regulations] [Pages 3601-3603] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-01519] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 174 [EPA-HQ-OPP-2017-0401; FRL-9972-62] Bacillus thuringiensis Cry51Aa2.834_16; 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 residues of the Cry51Aa2.834_16 protein derived from Bacillus thuringiensis in or on cotton, when used as a plant- incorporated protectant. Monsanto Company submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting this exemption from the requirement of a tolerance. This regulation eliminates the need under FFDCA to establish a maximum permissible level for such residues. DATES: This regulation is effective January 26, 2018. Objections and requests for hearings must be received on or before March 27, 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-2017-0401, 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 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-2017-0401 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 March 27, 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-2017-0401, 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 October 23, 2017 (82 FR 49020 (FRL-9967- 370)), EPA issued notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7F8566) by Monsanto Company, 800 North Lindbergh Blvd., St. Louis, MO 63167. The petition requested that 40 CFR part 174 be amended by establishing permanent exemption from the requirement of a tolerance for the plant-pesticide Bacillus thuringiensis Cry51Aa2.834_16 protein in or on cotton. A summary of the petition prepared by the petitioner Monsanto Company, is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice. One modification has been made to the original request for a tolerance exemption: EPA changed ``plant-pesticide'' to ``plant- incorporated protectant'', to align with the Agency's vocabulary, which is published in 40 CFR part 174.3. [[Page 3602]] 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 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 Cry51Aa2.834_16 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Assessment of the Plant- Incorporated Protectant Bacillus thuringiensis Cry51Aa2.834_16.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon available data, EPA concludes that the Cry51Aa2.834_16 protein, which is a modified version of the wild-type Cry51Aa2 protein derived from Bacillus thuringiensis, does not show evidence of toxicity. Moreover, the source is not allergenic, nor is there any significant similarity between the Cry51Aa2.834_16 protein and known toxins and allergens. In addition, the Cry51Aa2.834_16 protein readily digests in simulated gastric fluids and therefore cumulative, chronic, and acute effects are unlikely. Given the lack of toxicity or allergenicity of the Cry51Aa2.834_16 protein, the Agency has not identified any toxicological endpoints for assessing risk. Consequently, the Agency's assessment of exposure is qualitative. In addition, due to the lack of any threshold effects, EPA has determined that the provision to retain a 10X safety factor for the protection of infants and children does not apply. Similarly, the lack of any toxic mode of action or toxic metabolites means that the provision requiring an assessment of cumulative effects does not apply. Oral exposure to Cry51Aa2.834_16 may occur from ingestion of cotton-derived foods, such as refined, bleached, and deodorized (RBD) cottonseed oil. Based on the lack of adverse effects and the rapid digestibility of the protein, however, the Agency does not anticipate any risk from reasonably foreseeable levels of exposure. Residues in drinking water may theoretically be present because cotton PIP plant stubble may release modified Cry51Aa2.834_16 protein into ground water upon decay. However, the protein would not be expected to survive in the soil due to microbial degradation, adherence to soil components, and removal upon drinking water treatment procedures. In addition, oral toxicity testing showed no adverse effects. Moreover, because the PIP is currently only proposed to be used only in plants grown for commercial use, the Agency does not anticipate residential exposures. In the event that future uses are sold for residential use, the Agency does not expect there to be residential, non-occupational dermal or inhalation exposures, due to containment of the Cry51Aa2.834_16 protein within the plant. Based on the lack of any evidence of adverse effects in the toxicological database, dietary exposure to the Cry51Aa2.834_16 protein is not anticipated to pose any harm to the U.S. population. 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 the Cry51Aa2.834_16 protein derived from Bacillus thuringiensis. Therefore, an exemption from the requirement of a tolerance is established for residues of the plant-incorporated protectant Bacillus thuringiensis Cry51Aa2.834_16 protein in or on cotton. B. Analytical Enforcement Methodology An analytical method is not required because the lack of adverse effects makes enforcement and monitoring of residues unnecessary to ensure food safety. 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). 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 [[Page 3603]] ``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: December 28, 2017. Hayley Hughes, 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. 174.539 to subpart W to read as follows: Sec. 174.539 Cry51Aa2.834_16 protein; exemption from the requirement of a tolerance. Residues of the Cry51Aa2.834_16 protein, which is a modified protein derived from the Cry51Aa2 protein of Bacillus thuringiensis, in or on cotton are exempt from the requirement of a tolerance, when the Cry51Aa2.834_16 protein is used as a plant-incorporated protectant. [FR Doc. 2018-01519 Filed 1-25-18; 8:45 am] BILLING CODE 6560-50-P
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Seddon Channel unless the vessel is Monday through Friday, excluding legal mail and hand delivery of objections
officially entered in the Gasparilla holidays. The telephone number for the and hearing requests are provided in 40
Marine Parade. Public Reading Room is (202) 566–1744, CFR 178.25(b).
(10) Vessels not officially entered in and the telephone number for the OPP In addition to filing an objection or
the Gasparilla Marine Parade may not Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
enter the parade staging area box within the visitor instructions and additional as described in 40 CFR part 178, please
the following coordinates: 27°53′53″ N, information about the docket available submit a copy of the filing (excluding
082°27′47″ W; 27°53′22″ N, 082°27′10″ at http://www.epa.gov/dockets. any Confidential Business Information
W; 27°52′36″ N, 082°27′55″ W; FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
27°53′02″ N, 082°28′31″ W. Robert McNally, Biopesticides and Information not marked confidential
(c) Enforcement period. This rule will Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be
be enforced from 9 a.m. to 6 p.m. on Office of Pesticide Programs, disclosed publicly by EPA without prior
January 27, 2018. Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
Holly L. Najarian, Pennsylvania Ave. NW, Washington, DC objection or hearing request, identified
Captain, U.S. Coast Guard, Captain of the 20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
Port Saint Petersburg. (703) 305–7090; email address: 2017–0401, by one of the following
[FR Doc. 2018–01564 Filed 1–25–18; 8:45 am] BPPDFRNotices@epa.gov. methods:
BILLING CODE 9110–04–P SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
I. General Information www.regulations.gov. Follow the online
instructions for submitting comments.
ENVIRONMENTAL PROTECTION A. Does this action apply to me? Do not submit electronically any
AGENCY You may be potentially affected by information you consider to be CBI or
this action if you are an agricultural other information whose disclosure is
40 CFR Part 174 producer, food manufacturer, or restricted by statute.
[EPA–HQ–OPP–2017–0401; FRL–9972–62] pesticide manufacturer. The following • Mail: OPP Docket, Environmental
list of North American Industrial Protection Agency Docket Center (EPA/
Bacillus thuringiensis Cry51Aa2.834_ Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave.
16; Exemption From the Requirement not intended to be exhaustive, but rather NW, Washington, DC 20460–0001.
of a Tolerance provides a guide to help readers • Hand Delivery: To make special
determine whether this document arrangements for hand delivery or
AGENCY: Environmental Protection
applies to them. Potentially affected delivery of boxed information, please
Agency (EPA).
entities may include: follow the instructions at http://
ACTION: Final rule. • Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
SUMMARY: This regulation establishes an • Animal production (NAICS code Additional instructions on commenting
exemption from the requirement of a 112). or visiting the docket, along with more
tolerance for residues of the • Food manufacturing (NAICS code information about dockets generally, is
Cry51Aa2.834_16 protein derived from 311). available at http://www.epa.gov/
• Pesticide manufacturing (NAICS dockets.
Bacillus thuringiensis in or on cotton,
code 32532).
when used as a plant-incorporated II. Background
protectant. Monsanto Company B. How can I get electronic access to
submitted a petition to EPA under the other related information? In the Federal Register of October 23,
Federal Food, Drug, and Cosmetic Act You may access a frequently updated 2017 (82 FR 49020 (FRL–9967–370)),
(FFDCA), requesting this exemption electronic version of 40 CFR part 174 EPA issued notice pursuant to FFDCA
from the requirement of a tolerance. through the Government Printing section 408(d)(3), 21 U.S.C. 346a(d)(3),
This regulation eliminates the need Office’s e-CFR site at http:// announcing the filing of a pesticide
under FFDCA to establish a maximum www.ecfr.gov/cgi-bin/text- tolerance petition (PP 7F8566) by
permissible level for such residues. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Monsanto Company, 800 North
DATES: This regulation is effective 40tab_02.tpl. Lindbergh Blvd., St. Louis, MO 63167.
January 26, 2018. Objections and The petition requested that 40 CFR part
requests for hearings must be received C. How can I file an objection or hearing 174 be amended by establishing
on or before March 27, 2018, and must request? permanent exemption from the
be filed in accordance with the Under FFDCA section 408(g), 21 requirement of a tolerance for the plant-
instructions provided in 40 CFR part U.S.C. 346a(g), any person may file an pesticide Bacillus thuringiensis
178 (see also Unit I.C. of the objection to any aspect of this regulation Cry51Aa2.834_16 protein in or on
SUPPLEMENTARY INFORMATION). and may also request a hearing on those cotton. A summary of the petition
ADDRESSES: The docket for this action, objections. You must file your objection prepared by the petitioner Monsanto
identified by docket identification (ID) or request a hearing on this regulation Company, is available in the docket via
number EPA–HQ–OPP–2017–0401, is in accordance with the instructions http://www.regulations.gov. There were
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure no comments received in response to
or at the Office of Pesticide Programs proper receipt by EPA, you must the notice.
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– One modification has been made to
daltland on DSKBBV9HB2PROD with RULES
in the Environmental Protection Agency OPP–2017–0401 in the subject line on the original request for a tolerance
Docket Center (EPA/DC), West William the first page of your submission. All exemption: EPA changed ‘‘plant-
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing pesticide’’ to ‘‘plant-incorporated
Constitution Ave. NW, Washington, DC must be in writing, and must be protectant’’, to align with the Agency’s
20460–0001. The Public Reading Room received by the Hearing Clerk on or vocabulary, which is published in 40
is open from 8:30 a.m. to 4:30 p.m., before March 27, 2018. Addresses for CFR part 174.3.
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III. Final Rule in simulated gastric fluids and therefore B. Analytical Enforcement Methodology
cumulative, chronic, and acute effects An analytical method is not required
A. EPA’s Safety Determination
are unlikely. because the lack of adverse effects
Section 408(c)(2)(A)(i) of FFDCA
Given the lack of toxicity or makes enforcement and monitoring of
allows EPA to establish an exemption
from the requirement for a tolerance (the allergenicity of the Cry51Aa2.834_16 residues unnecessary to ensure food
legal limit for a pesticide chemical protein, the Agency has not identified safety.
residue in or on food) only if EPA any toxicological endpoints for
IV. Statutory and Executive Order
determines that the exemption is ‘‘safe.’’ assessing risk. Consequently, the
Reviews
Section 408(c)(2)(A)(ii) of FFDCA Agency’s assessment of exposure is
qualitative. In addition, due to the lack This action establishes an exemption
defines ‘‘safe’’ to mean that ‘‘there is a
of any threshold effects, EPA has from the requirement of a tolerance
reasonable certainty that no harm will
determined that the provision to retain under FFDCA section 408(d) in
result from aggregate exposure to the
a 10X safety factor for the protection of response to a petition submitted to EPA.
pesticide chemical residue, including
infants and children does not apply. The Office of Management and Budget
all anticipated dietary exposures and all
Similarly, the lack of any toxic mode of (OMB) has exempted these types of
other exposures for which there is
reliable information.’’ This includes action or toxic metabolites means that actions from review under Executive
exposure through drinking water and in the provision requiring an assessment of Order 12866, entitled ‘‘Regulatory
residential settings but does not include cumulative effects does not apply. Planning and Review’’ (58 FR 51735,
occupational exposure. Pursuant to October 4, 1993). Because this action
Oral exposure to Cry51Aa2.834_16 has been exempted from review under
FFDCA section 408(c)(2)(B), in may occur from ingestion of cotton-
establishing or maintaining in effect an Executive Order 12866, this action is
derived foods, such as refined, not subject to Executive Order 13211,
exemption from the requirement of a bleached, and deodorized (RBD)
tolerance, EPA must take into account entitled ‘‘Actions Concerning
cottonseed oil. Based on the lack of Regulations That Significantly Affect
the factors set forth in FFDCA section adverse effects and the rapid
408(b)(2)(C), which require EPA to give Energy Supply, Distribution, or Use’’ (66
digestibility of the protein, however, the FR 28355, May 22, 2001), or Executive
special consideration to exposure of Agency does not anticipate any risk
infants and children to the pesticide Order 13045, entitled ‘‘Protection of
from reasonably foreseeable levels of Children from Environmental Health
chemical residue in establishing a exposure. Residues in drinking water
tolerance or tolerance exemption and to Risks and Safety Risks’’ (62 FR 19885,
may theoretically be present because April 23, 1997). This action does not
‘‘ensure that there is a reasonable cotton PIP plant stubble may release
certainty that no harm will result to contain any information collections
modified Cry51Aa2.834_16 protein into subject to OMB approval under the
infants and children from aggregate ground water upon decay. However, the
exposure to the pesticide chemical Paperwork Reduction Act (PRA) (44
protein would not be expected to U.S.C. 3501 et seq.) nor does it require
residue . . . .’’ Additionally, FFDCA survive in the soil due to microbial
section 408(b)(2)(D) requires that EPA any special considerations under
degradation, adherence to soil Executive Order 12898, entitled
consider ‘‘available information components, and removal upon
concerning the cumulative effects of [a ‘‘Federal Actions to Address
drinking water treatment procedures. In Environmental Justice in Minority
particular pesticide’s] . . . residues and addition, oral toxicity testing showed no
other substances that have a common Populations and Low-Income
adverse effects. Moreover, because the Populations’’ (59 FR 7629, February 16,
mechanism of toxicity.’’ PIP is currently only proposed to be
EPA evaluated the available toxicity 1994).
used only in plants grown for Since tolerances and exemptions that
and exposure data on Cry51Aa2.834_16
commercial use, the Agency does not are established on the basis of a petition
and considered its validity,
completeness, and reliability, as well as anticipate residential exposures. In the under FFDCA section 408(d), such as
the relationship of this information to event that future uses are sold for the tolerance exemption in this action,
human risk. A full explanation of the residential use, the Agency does not do not require the issuance of a
data upon which EPA relied and its risk expect there to be residential, non- proposed rule, the requirements of the
assessment based on that data can be occupational dermal or inhalation Regulatory Flexibility Act (RFA) (5
found within the document entitled exposures, due to containment of the U.S.C. 601 et seq.) do not apply.
‘‘Federal Food, Drug, and Cosmetic Act Cry51Aa2.834_16 protein within the This action directly regulates growers,
(FFDCA) Assessment of the Plant- plant. food processors, food handlers, and food
Incorporated Protectant Bacillus Based on the lack of any evidence of retailers, not States or tribes. As a result,
thuringiensis Cry51Aa2.834_16.’’ This adverse effects in the toxicological this action does not alter the
document, as well as other relevant database, dietary exposure to the relationships or distribution of power
information, is available in the docket Cry51Aa2.834_16 protein is not and responsibilities established by
for this action as described under anticipated to pose any harm to the U.S. Congress in the preemption provisions
ADDRESSES. population. EPA concludes that there is of FFDCA section 408(n)(4). As such,
Based upon available data, EPA a reasonable certainty that no harm will EPA has determined that this action will
concludes that the Cry51Aa2.834_16 result to the U.S. population, including not have a substantial direct effect on
protein, which is a modified version of infants and children, from aggregate States or tribal governments, on the
the wild-type Cry51Aa2 protein derived exposure to residues of the relationship between the national
from Bacillus thuringiensis, does not Cry51Aa2.834_16 protein derived from government and the States or tribal
daltland on DSKBBV9HB2PROD with RULES
show evidence of toxicity. Moreover, Bacillus thuringiensis. Therefore, an governments, or on the distribution of
the source is not allergenic, nor is there exemption from the requirement of a power and responsibilities among the
any significant similarity between the tolerance is established for residues of various levels of government or between
Cry51Aa2.834_16 protein and known the plant-incorporated protectant the Federal Government and Indian
toxins and allergens. In addition, the Bacillus thuringiensis Cry51Aa2.834_16 tribes. Thus, EPA has determined that
Cry51Aa2.834_16 protein readily digests protein in or on cotton. Executive Order 13132, entitled
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‘‘Federalism’’ (64 FR 43255, August 10, ENVIRONMENTAL PROTECTION I. General Information
1999), and Executive Order 13175, AGENCY A. Does this action apply to me?
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR 40 CFR Part 180 You may be potentially affected by
67249, November 9, 2000), do not apply this action if you are an agricultural
to this action. In addition, this action [EPA–HQ–OPP–2016–0578; FRL–9970–96] producer, food manufacturer, or
does not impose any enforceable duty or pesticide manufacturer. The following
contain any unfunded mandate as Calcium Salts of Phosphorous Acid; list of North American Industrial
described under Title II of the Unfunded Exemption From the Requirement of a Classification System (NAICS) codes is
Mandates Reform Act (UMRA) (2 U.S.C. Tolerance not intended to be exhaustive, but rather
1501 et seq.). provides a guide to help readers
AGENCY: Environmental Protection determine whether this document
This action does not involve any
Agency (EPA). applies to them. Potentially affected
technical standards that would require
entities may include:
EPA’s consideration of voluntary ACTION: Final rule. • Crop production (NAICS code 111).
consensus standards pursuant to section • Animal production (NAICS code
12(d) of the National Technology SUMMARY: This regulation establishes an 112).
Transfer and Advancement Act exemption from the requirement of a • Food manufacturing (NAICS code
(NTTAA) (15 U.S.C. 272 note). tolerance for the calcium salts of 311).
V. Congressional Review Act phosphorous acid. Verdesian Life • Pesticide manufacturing (NAICS
Sciences, LLC., submitted a petition to code 32532).
Pursuant to the Congressional Review EPA under the Federal Food, Drug, and B. How can I get electronic access to
Act (5 U.S.C. 801 et seq.), EPA will Cosmetic Act (FFDCA). This regulation other related information?
submit a report containing this rule and eliminates the need to establish a
other required information to the U.S. maximum permissible level for residues You may access a frequently updated
Senate, the U.S. House of of calcium salts of phosphorous acid electronic version of 40 CFR part 180
Representatives, and the Comptroller under FFDCA when used in accordance through the Government Printing
General of the United States prior to with the terms of the exemption. Office’s e-CFR site at http://
publication of the rule in the Federal www.ecfr.gov/cgi-bin/text-idx?&c=
Register. This action is not a ‘‘major DATES: This regulation is effective ecfr&tpl=/ecfrbrowse/Title40/40tab_
rule’’ as defined by 5 U.S.C. 804(2). January 26, 2018. Objections and 02.tpl.
requests for hearings must be received
List of Subjects in 40 CFR Part 174 on or before March 27, 2018, and must C. How can I file an objection or hearing
be filed in accordance with the request?
Environmental protection,
instructions provided in 40 CFR part Under FFDCA section 408(g), 21
Administrative practice and procedure,
178 (see also Unit I.C. of the U.S.C. 346a(g), any person may file an
Agricultural commodities, Pesticides
SUPPLEMENTARY INFORMATION). objection to any aspect of this regulation
and pests, Reporting and recordkeeping
and may also request a hearing on those
requirements. ADDRESSES: The docket for this action, objections. You must file your objection
Dated: December 28, 2017. identified by docket identification (ID) or request a hearing on this regulation
Hayley Hughes, number EPA–HQ–OPP–2016–0578, is in accordance with the instructions
Director, Office of Pesticide Programs.
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
or at the Office of Pesticide Programs proper receipt by EPA, you must
Therefore, 40 CFR chapter I is Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
amended as follows: in the Environmental Protection Agency OPP–2016–0578 in the subject line on
Docket Center (EPA/DC), West William the first page of your submission. All
PART 174—[AMENDED] Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
Constitution Ave. NW, Washington, DC must be in writing, and must be
■ 1. The authority citation for part 174 20460–0001. The Public Reading Room received by the Hearing Clerk on or
continues to read as follows: is open from 8:30 a.m. to 4:30 p.m., before March 27, 2018. Addresses for
Authority: 7 U.S.C. 136–136y; 21 U.S.C. Monday through Friday, excluding legal mail and hand delivery of objections
321(q), 346a and 371. holidays. The telephone number for the and hearing requests are provided in 40
Public Reading Room is (202) 566–1744, CFR 178.25(b).
■ 2. Add § 174.539 to subpart W to read and the telephone number for the OPP In addition to filing an objection or
as follows: Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
the visitor instructions and additional as described in 40 CFR part 178, please
§ 174.539 Cry51Aa2.834_16 protein;
exemption from the requirement of a information about the docket available submit a copy of the filing (excluding
tolerance. at http://www.epa.gov/dockets. any Confidential Business Information
FOR FURTHER INFORMATION CONTACT:
(CBI)) for inclusion in the public docket.
Residues of the Cry51Aa2.834_16 Information not marked confidential
protein, which is a modified protein Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), pursuant to 40 CFR part 2 may be
derived from the Cry51Aa2 protein of disclosed publicly by EPA without prior
Bacillus thuringiensis, in or on cotton Office of Pesticide Programs,
daltland on DSKBBV9HB2PROD with RULES
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
are exempt from the requirement of a objection or hearing request, identified
tolerance, when the Cry51Aa2.834_16 Pennsylvania Ave. NW, Washington, DC
20460–0001; main telephone number: by docket ID number EPA–HQ–OPP–
protein is used as a plant-incorporated 2016–0578, by one of the following
protectant. (703) 305–7090; email address:
BPPDFRNotices@epa.gov. methods:
[FR Doc. 2018–01519 Filed 1–25–18; 8:45 am] • Federal eRulemaking Portal: http://
BILLING CODE 6560–50–P SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
VerDate Sep<11>2014 17:29 Jan 25, 2018 Jkt 244001 PO 00000 Frm 00041 Fmt 4700 Sfmt 4700 E:\FR\FM\26JAR1.SGM 26JAR1](https://thefederalregister.org/doc/83_FR_3619/page/3.svg)
Document Created: 2018-10-26 10:03:46
Document Modified: 2018-10-26 10:03:46
| 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 January 26, 2018. Objections and requests for hearings must be received on or before March 27, 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 3601 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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