82_FR_58107 82 FR 57872 - Bacillus subtilis Strain BU1814; Exemption From the Requirement of a Tolerance

82 FR 57872 - Bacillus subtilis Strain BU1814; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 235 (December 8, 2017)

Page Range57872-57874
FR Document2017-26518

This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus subtilis strain BU1814 in or on all food commodities when used in accordance with label directions and good agricultural practices. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus subtilis strain BU1814 under FFDCA.

Federal Register, Volume 82 Issue 235 (Friday, December 8, 2017)
[Federal Register Volume 82, Number 235 (Friday, December 8, 2017)]
[Rules and Regulations]
[Pages 57872-57874]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-26518]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0687; FRL-9969-96]


Bacillus subtilis Strain BU1814; 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 Bacillus subtilis strain BU1814 in or on 
all food commodities when used in accordance with label directions and 
good agricultural practices. BASF Corporation submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus subtilis strain BU1814 under FFDCA.

DATES: This regulation is effective December 8, 2017. Objections and 
requests for hearings must be received on or before February 6, 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-2016-0687, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave., NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0687 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 6, 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-2016-0687, 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 February 7, 2017 (82 FR 9555) (FRL-9956-
86), 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 6F8490) by BASF Corporation, 26 Davis Dr., P.O. Box 13528, 
Research Triangle Park, NC 27709. The petition requested that 40 CFR 
part 180 be amended by establishing an exemption from the requirement 
of a tolerance for residues of the fungicide Bacillus subtilis strain 
BU1814 in or on all food commodities. That document referenced a 
summary of the petition prepared by the petitioner BASF Corporation, 
which is available in the docket via http://www.regulations.gov. There 
were no

[[Page 57873]]

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.''
    EPA evaluated the available toxicity and exposure data on Bacillus 
subtilis strain BU1814 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 those data can be found within the document 
entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for Bacillus subtilis strain BU1814.'' This document, as well as other 
relevant information, is available in the docket for this action as 
described under ADDRESSES. The available data indicate that Bacillus 
subtilis strain BU1814 showed no toxicity, no pathogenicity, and no 
infectivity via the acute oral, pulmonary, and intravenous routes of 
exposure. Based upon its evaluation, 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 
Bacillus subtilis strain BU1814. Therefore, an exemption from the 
requirement of a tolerance is established for residues of Bacillus 
subtilis strain BU1814 in or on all food commodities when used in 
accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required because EPA is establishing an 
exemption from the requirement of a tolerance without any numerical 
limitation.

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 
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 ``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: November 27, 2017.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Add Sec.  180.1348 to subpart D to read as follows:


Sec.  180.1348   Bacillus subtilis strain BU1814; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus subtilis strain BU1814 in or on all food 
commodities when used in

[[Page 57874]]

accordance with label directions and good agricultural practices.

[FR Doc. 2017-26518 Filed 12-7-17; 8:45 am]
 BILLING CODE 6560-50-P



                                              57872                  Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations

                                              § 180.665 Sedaxane; tolerances for                                 number EPA–HQ–OPP–2016–0687, is                      in accordance with the instructions
                                              residues.                                                          available at http://www.regulations.gov              provided in 40 CFR part 178. To ensure
                                                  (a) * * *                                                      or at the Office of Pesticide Programs               proper receipt by EPA, you must
                                                                                                                 Regulatory Public Docket (OPP Docket)                identify docket ID number EPA–HQ–
                                                                                                 Parts per       in the Environmental Protection Agency               OPP–2016–0687 in the subject line on
                                                             Commodity                            million        Docket Center (EPA/DC), West William                 the first page of your submission. All
                                              Beet, sugar, roots .......................                  0.01   Jefferson Clinton Bldg., Rm. 3334, 1301              objections and requests for a hearing
                                              Canola, seed ..............................                 0.01   Constitution Ave., NW., Washington,                  must be in writing, and must be
                                              Cotton, gin byproducts ...............                      0.01   DC 20460–0001. The Public Reading                    received by the Hearing Clerk on or
                                              Cotton, undelinted seed .............                       0.01   Room is open from 8:30 a.m. to 4:30                  before February 6, 2018. Addresses for
                                              Grain, cereal, forage, fodder and                                  p.m., Monday through Friday, excluding               mail and hand delivery of objections
                                                straw, group 16 .......................                   0.10   legal holidays. The telephone number                 and hearing requests are provided in 40
                                              Grain, cereal, group 15 ..............                      0.01   for the Public Reading Room is (202)                 CFR 178.25(b).
                                              Pea and bean, dried shelled, ex-                                   566–1744, and the telephone number for                 In addition to filing an objection or
                                                cept soybean, subgroup 6C ....                         0.01                                                           hearing request with the Hearing Clerk
                                                                                                                 the OPP Docket is (703) 305–5805.
                                              Peanut ........................................          0.01                                                           as described in 40 CFR part 178, please
                                              Peanut, hay ................................             0.08      Please review the visitor instructions
                                                                                                                 and additional information about the                 submit a copy of the filing (excluding
                                              Potato .........................................         0.02
                                              Potato, wet peel ..........................             0.075      docket available at http://www.epa.gov/              any Confidential Business Information
                                              Rapeseed, subgroup 20A ...........                       0.01      dockets.                                             (CBI)) for inclusion in the public docket.
                                              Soybean, forage .........................                0.05      FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                                      Information not marked confidential
                                              Soybean, hay ..............................              0.04      Robert McNally, Biopesticides and                    pursuant to 40 CFR part 2 may be
                                              Soybean, seed ............................               0.01      Pollution Prevention Division (7511P),               disclosed publicly by EPA without prior
                                              Vegetable, foliage of legume, ex-
                                                                                                                 Office of Pesticide Programs,                        notice. Submit the non-CBI copy of your
                                                cept soybean, subgroup 7A ....                            0.01                                                        objection or hearing request, identified
                                                                                                                 Environmental Protection Agency, 1200
                                                                                                                                                                      by docket ID number EPA–HQ–OPP–
                                              *        *        *        *        *                              Pennsylvania Ave. NW., Washington,
                                                                                                                                                                      2016–0687, by one of the following
                                              [FR Doc. 2017–26519 Filed 12–7–17; 8:45 am]                        DC 20460–0001; main telephone
                                                                                                                                                                      methods:
                                              BILLING CODE 6560–50–P
                                                                                                                 number: (703) 305–7090; email address:                 • Federal eRulemaking Portal: http://
                                                                                                                 BPPDFRNotices@epa.gov.                               www.regulations.gov. Follow the online
                                                                                                                 SUPPLEMENTARY INFORMATION:                           instructions for submitting comments.
                                              ENVIRONMENTAL PROTECTION                                           I. General Information                               Do not submit electronically any
                                              AGENCY                                                                                                                  information you consider to be CBI or
                                                                                                                 A. Does this action apply to me?                     other information whose disclosure is
                                              40 CFR Part 180                                                                                                         restricted by statute.
                                                                                                                    You may be potentially affected by
                                              [EPA–HQ–OPP–2016–0687; FRL–9969–96]                                this action if you are an agricultural                 • Mail: OPP Docket, Environmental
                                                                                                                 producer, food manufacturer, or                      Protection Agency Docket Center (EPA/
                                              Bacillus subtilis Strain BU1814;                                   pesticide manufacturer. The following                DC), (28221T), 1200 Pennsylvania Ave.,
                                              Exemption From the Requirement of a                                list of North American Industrial                    NW., Washington, DC 20460–0001.
                                              Tolerance                                                          Classification System (NAICS) codes is                 • Hand Delivery: To make special
                                                                                                                 not intended to be exhaustive, but rather            arrangements for hand delivery or
                                              AGENCY:  Environmental Protection                                                                                       delivery of boxed information, please
                                              Agency (EPA).                                                      provides a guide to help readers
                                                                                                                 determine whether this document                      follow the instructions at http://
                                              ACTION: Final rule.                                                                                                     www.epa.gov/dockets/contacts.html.
                                                                                                                 applies to them. Potentially affected
                                              SUMMARY:    This regulation establishes an                         entities may include:                                Additional instructions on commenting
                                              exemption from the requirement of a                                   • Crop production (NAICS code 111).               or visiting the docket, along with more
                                              tolerance for residues of Bacillus subtilis                           • Animal production (NAICS code                   information about dockets generally, is
                                              strain BU1814 in or on all food                                    112).                                                available at http://www.epa.gov/
                                              commodities when used in accordance                                   • Food manufacturing (NAICS code                  dockets.
                                              with label directions and good                                     311).                                                II. Background
                                              agricultural practices. BASF                                          • Pesticide manufacturing (NAICS
                                                                                                                 code 32532).                                            In the Federal Register of February 7,
                                              Corporation submitted a petition to EPA                                                                                 2017 (82 FR 9555) (FRL–9956–86), EPA
                                              under the Federal Food, Drug, and                                  B. How can I get electronic access to                issued a document pursuant to FFDCA
                                              Cosmetic Act (FFDCA), requesting an                                other related information?                           section 408(d)(3), 21 U.S.C. 346a(d)(3),
                                              exemption from the requirement of a                                                                                     announcing the filing of a pesticide
                                                                                                                   You may access a frequently updated
                                              tolerance. This regulation eliminates the                                                                               tolerance petition (PP 6F8490) by BASF
                                                                                                                 electronic version of 40 CFR part 180
                                              need to establish a maximum                                                                                             Corporation, 26 Davis Dr., P.O. Box
                                                                                                                 through the Government Printing
                                              permissible level for residues of Bacillus                                                                              13528, Research Triangle Park, NC
                                                                                                                 Office’s e-CFR site at http://www.
                                              subtilis strain BU1814 under FFDCA.                                                                                     27709. The petition requested that 40
                                                                                                                 ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/
                                              DATES: This regulation is effective                                ecfrbrowse/Title40/40tab_02.tpl.                     CFR part 180 be amended by
                                              December 8, 2017. Objections and                                                                                        establishing an exemption from the
                                              requests for hearings must be received                             C. How can I file an objection or hearing            requirement of a tolerance for residues
sradovich on DSK3GMQ082PROD with RULES




                                              on or before February 6, 2018, and must                            request?                                             of the fungicide Bacillus subtilis strain
                                              be filed in accordance with the                                      Under FFDCA section 408(g), 21                     BU1814 in or on all food commodities.
                                              instructions provided in 40 CFR part                               U.S.C. 346a(g), any person may file an               That document referenced a summary of
                                              178 (see also Unit I.C. of the                                     objection to any aspect of this regulation           the petition prepared by the petitioner
                                              SUPPLEMENTARY INFORMATION).                                        and may also request a hearing on those              BASF Corporation, which is available in
                                              ADDRESSES: The docket for this action,                             objections. You must file your objection             the docket via http://
                                              identified by docket identification (ID)                           or request a hearing on this regulation              www.regulations.gov. There were no


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                                                                Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations                                            57873

                                              comments received in response to the                    children, from aggregate exposure to                  relationship between the national
                                              notice of filing.                                       residues of Bacillus subtilis strain                  government and the States or tribal
                                                                                                      BU1814. Therefore, an exemption from                  governments, or on the distribution of
                                              III. Final Rule
                                                                                                      the requirement of a tolerance is                     power and responsibilities among the
                                              A. EPA’s Safety Determination                           established for residues of Bacillus                  various levels of government or between
                                                 Section 408(c)(2)(A)(i) of FFDCA                     subtilis strain BU1814 in or on all food              the Federal Government and Indian
                                              allows EPA to establish an exemption                    commodities when used in accordance                   tribes. Thus, EPA has determined that
                                              from the requirement for a tolerance (the               with label directions and good                        Executive Order 13132, entitled
                                              legal limit for a pesticide chemical                    agricultural practices.                               ‘‘Federalism’’ (64 FR 43255, August 10,
                                              residue in or on a food) only if EPA                    B. Analytical Enforcement Methodology                 1999), and Executive Order 13175,
                                              determines that the exemption is ‘‘safe.’’                                                                    entitled ‘‘Consultation and Coordination
                                                                                                        An analytical method is not required                with Indian Tribal Governments’’ (65 FR
                                              Section 408(c)(2)(A)(ii) of FFDCA                       because EPA is establishing an
                                              defines ‘‘safe’’ to mean that ‘‘there is a                                                                    67249, November 9, 2000), do not apply
                                                                                                      exemption from the requirement of a                   to this action. In addition, this action
                                              reasonable certainty that no harm will                  tolerance without any numerical
                                              result from aggregate exposure to the                                                                         does not impose any enforceable duty or
                                                                                                      limitation.                                           contain any unfunded mandate as
                                              pesticide chemical residue, including
                                              all anticipated dietary exposures and all               IV. Statutory and Executive Order                     described under Title II of the Unfunded
                                              other exposures for which there is                      Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                              reliable information.’’ This includes                                                                         1501 et seq.).
                                                                                                         This action establishes a tolerance
                                              exposure through drinking water and in                  exemption under FFDCA section 408(d)                     This action does not involve any
                                              residential settings but does not include               in response to a petition submitted to                technical standards that would require
                                              occupational exposure. Pursuant to                      EPA. The Office of Management and                     EPA’s consideration of voluntary
                                              FFDCA section 408(c)(2)(B), in                          Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                              establishing or maintaining in effect an                of actions from review under Executive                12(d) of the National Technology
                                              exemption from the requirement of a                     Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                              tolerance, EPA must take into account                   Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                              the factors set forth in FFDCA section                  October 4, 1993). Because this action                 V. Congressional Review Act
                                              408(b)(2)(C), which require EPA to give                 has been exempted from review under
                                              special consideration to exposure of                    Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                              infants and children to the pesticide                   not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
                                              chemical residue in establishing a                      entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                              tolerance or tolerance exemption and to                 Regulations That Significantly Affect                 other required information to the U.S.
                                              ‘‘ensure that there is a reasonable                     Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                              certainty that no harm will result to                   FR 28355, May 22, 2001), or Executive                 Representatives, and the Comptroller
                                              infants and children from aggregate                     Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                              exposure to the pesticide chemical                      Children from Environmental Health                    publication of the rule in the Federal
                                              residue . . . .’’ Additionally, FFDCA                   Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                              section 408(b)(2)(D) requires that EPA                  April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
                                              consider ‘‘available information                        contain any information collections
                                              concerning the cumulative effects of [a                 subject to OMB approval under the                     List of Subjects in 40 CFR Part 180
                                              particular pesticide’s] . . . residues and              Paperwork Reduction Act (PRA), 44                       Environmental protection,
                                              other substances that have a common                     U.S.C. 3501 et seq., nor does it require              Administrative practice and procedure,
                                              mechanism of toxicity.’’                                any special considerations under                      Agricultural commodities, Pesticides
                                                 EPA evaluated the available toxicity                 Executive Order 12898, entitled                       and pests, Reporting and recordkeeping
                                              and exposure data on Bacillus subtilis                  ‘‘Federal Actions to Address                          requirements.
                                              strain BU1814 and considered its                        Environmental Justice in Minority
                                              validity, completeness, and reliability,                                                                        Dated: November 27, 2017.
                                                                                                      Populations and Low-Income
                                              as well as the relationship of this                     Populations’’ (59 FR 7629, February 16,               Richard P. Keigwin, Jr.,
                                              information to human risk. A full                       1994).                                                Director, Office of Pesticide Programs.
                                              explanation of the data upon which EPA                     Since tolerances and exemptions that
                                                                                                                                                              Therefore, 40 CFR chapter I is
                                              relied and its risk assessment based on                 are established on the basis of a petition
                                                                                                                                                            amended as follows:
                                              those data can be found within the                      under FFDCA section 408(d), such as
                                              document entitled ‘‘Federal Food, Drug,                 the tolerance exemption in this action,               PART 180—[AMENDED]
                                              and Cosmetic Act (FFDCA)                                do not require the issuance of a
                                              Considerations for Bacillus subtilis                    proposed rule, the requirements of the                ■ 1. The authority citation for part 180
                                              strain BU1814.’’ This document, as well                 Regulatory Flexibility Act (RFA) (5                   continues to read as follows:
                                              as other relevant information, is                       U.S.C. 601 et seq.) do not apply.
                                              available in the docket for this action as                 This action directly regulates growers,                Authority: 21 U.S.C. 321(q), 346a and 371.
                                              described under ADDRESSES. The                          food processors, food handlers, and food              ■ 2. Add § 180.1348 to subpart D to read
                                              available data indicate that Bacillus                   retailers, not States or tribes. As a result,         as follows:
                                              subtilis strain BU1814 showed no                        this action does not alter the
sradovich on DSK3GMQ082PROD with RULES




                                              toxicity, no pathogenicity, and no                      relationships or distribution of power                § 180.1348 Bacillus subtilis strain BU1814;
                                              infectivity via the acute oral,                         and responsibilities established by                   exemption from the requirement of a
                                                                                                                                                            tolerance.
                                              pulmonary, and intravenous routes of                    Congress in the preemption provisions
                                              exposure. Based upon its evaluation,                    of FFDCA section 408(n)(4). As such,                    An exemption from the requirement
                                              EPA concludes that there is a reasonable                EPA has determined that this action will              of a tolerance is established for residues
                                              certainty that no harm will result to the               not have a substantial direct effect on               of Bacillus subtilis strain BU1814 in or
                                              U.S. population, including infants and                  States or tribal governments, on the                  on all food commodities when used in


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                                              57874             Federal Register / Vol. 82, No. 235 / Friday, December 8, 2017 / Rules and Regulations

                                              accordance with label directions and                    6450; email address: winchester.erik@                 technical person listed under FOR
                                              good agricultural practices.                            epa.gov.                                              FURTHER INFORMATION CONTACT.
                                              [FR Doc. 2017–26518 Filed 12–7–17; 8:45 am]               For general information contact: The
                                                                                                      TSCA-Hotline, ABVI-Goodwill, 422                      IV. Good Cause Finding
                                              BILLING CODE 6560–50–P
                                                                                                      South Clinton Ave., Rochester, NY                        EPA finds that there is ‘‘good cause’’
                                                                                                      14620; telephone number: (202) 554–                   under the Administrative Procedure Act
                                              ENVIRONMENTAL PROTECTION                                1404; email address: TSCA-Hotline@                    (5 U.S.C. 553(b)(3)(B)) to withdraw the
                                              AGENCY                                                  epa.gov.                                              direct final rule discussed in this
                                                                                                      SUPPLEMENTARY INFORMATION:
                                                                                                                                                            document without prior notice and
                                              40 CFR Part 770                                                                                               comment. For this document, notice and
                                                                                                      I. Does this action apply to me?                      comment is impracticable and
                                              [EPA–HQ–OPPT–2017–0245; FRL–9971–38]                       A list of potentially affected entities is         unnecessary because EPA is under a
                                                                                                      provided in the Federal Register of                   time limit to publish this withdrawal. It
                                              RIN 2070–AK36
                                                                                                      October 25, 2017 (82 FR 49287). If you                was determined that this document is
                                              Voluntary Consensus Standards                           have questions regarding the                          not subject to the 30-day delay of
                                              Update; Formaldehyde Emission                           applicability of this action to a                     effective date generally required by 5
                                              Standards for Composite Wood                            particular entity, consult the technical              U.S.C. 553(d) as there is good cause for
                                              Products; Withdrawal of Direct Final                    person listed under FOR FURTHER                       the withdrawal to be effective
                                              Rule                                                    INFORMATION CONTACT.                                  immediately. This withdrawal must
                                                                                                                                                            become effective prior to the effective
                                              AGENCY: Environmental Protection                        II. What rule is being withdrawn?                     date of the direct final rule being
                                              Agency (EPA).                                              In the October 25, 2017 Federal                    withdrawn, as EPA explained in the
                                              ACTION: Direct final rule; withdrawal.                  Register, EPA published both a direct                 direct final rule itself.
                                                                                                      final rule (see 82 FR 49287) and
                                              SUMMARY:   In the Federal Register of                   proposed rule (see 82 FR 49302) (FRL–                 V. Statutory and Executive Order
                                              October 25, 2017, EPA published both a                  9962–80) pursuant to section 601 of                   Reviews
                                              direct final rule and proposed rule to                  TSCA that would have updated several                     This document withdraws regulatory
                                              update the voluntary consensus                          of the voluntary consensus standards                  requirements that have not gone into
                                              standards that originally published in                  incorporated by reference at § 770.99 as              effect. As such, the Agency has
                                              the Toxics Substances Control Act                       published on December 12, 2016 (see 81                determined that this withdrawal will
                                              (TSCA) Title VI formaldehyde emission                   FR 89674) (FRL–9949–90). These                        not have any adverse impacts, economic
                                              standards for composite wood products                   voluntary consensus standards have                    or otherwise. The statutory and
                                              final rule on December 12, 2016. In                     been updated, withdrawn, or                           Executive Order review requirements
                                              addition, in the direct final rule and                  superseded since publication of the                   applicable to the direct final rule being
                                              proposed rule the EPA amended the                       original final rule in 2016. Additionally,            withdrawn were discussed in the
                                              testing requirements for panel producers                the direct final rule would have                      October 25, 2017 (82 FR 49287) Federal
                                              and third-party certifiers establishing                 amended testing requirements for                      Register document. Those review
                                              correlation between approved quality                    demonstration of equivalence and                      requirements do not apply to this action
                                              control test methods and either the                     correlation between approved quality                  because it is a withdrawal and does not
                                              ASTM E1333–14 test chamber, or, upon                    control test methods and either the                   contain any new or amended
                                              showing equivalence, the ASTM                           ASTM E1333–14 test chamber, or, upon                  requirements.
                                              D6007–14 test chamber. As noted in the                  showing equivalence in accordance
                                                                                                      with § 770.20(d), the ASTM D6007–14                   VI. Congressional Review Act (CRA)
                                              direct final rule, if EPA received adverse
                                              comment on the proposed amendments,                     test chamber under § 770.20(d)(2)(i).                    Pursuant to the CRA (5 U.S.C. 801 et
                                              the Agency would publish a timely                          Since the direct final rule and                    seq.), EPA will submit a report
                                              withdrawal of the direct final rule in the              proposed rule’s publication, EPA has                  containing this rule and other required
                                              Federal Register informing the public                   received a comment on the proposed                    information to the U.S. Senate, the U.S.
                                              that the direct final action will not take              amendments to the voluntary consensus                 House of Representatives, and the
                                              effect. The Agency did receive adverse                  standard updating action that the                     Comptroller General of the United
                                              comment on the proposed rule                            Agency considers to be adverse. As a                  States prior to publication of the rule in
                                              amendments, and is therefore                            result of receiving an adverse comment,               the Federal Register. This action is not
                                              withdrawing the direct final rule and                   EPA is withdrawing the direct final rule              a ‘‘major rule’’ as defined by 5 U.S.C.
                                              will instead proceed with a final rule                  published in the Federal Register on                  804(2). Section 808 of the CRA allows
                                              based on the proposed rule after                        October 25, 2017. All comments are                    the issuing agency to make a rule
                                              considering all public comments.                        available for review in the public                    effective sooner than otherwise
                                              DATES: Effective December 8, 2017, the
                                                                                                      docket. EPA will address the public                   provided by CRA if the agency makes a
                                              direct final rule published in the                      comments received on this action in a                 good cause finding that notice and
                                              Federal Register of October 25, 2017 (82                subsequent final rule.                                public procedure is impracticable,
                                              FR 49287) (FRL–9962–84), is                                                                                   unnecessary, or contrary to the public
                                                                                                      III. How do I access the docket?
                                              withdrawn.                                                                                                    interest. As required by 5 U.S.C. 808(2),
                                                                                                         To access the docket, please go to                 this determination is supported by a
                                              FOR FURTHER INFORMATION CONTACT:    For                 http://www.regulations.gov and follow                 brief statement in Unit IV.
sradovich on DSK3GMQ082PROD with RULES




                                              technical information contact: Erik                     the online instructions using the docket
                                              Winchester, National Program                            ID number EPA–HQ–OPPT–2017–0245.                      List of Subjects in 40 CFR Part 770
                                              Chemicals Division, Office of Pollution                 Additional information about the                        Environmental protection,
                                              Prevention and Toxics, Environmental                    Docket Facility is also provided under                Formaldehyde, Incorporation by
                                              Protection Agency, 1200 Pennsylvania                    ADDRESSES in the October 25, 2017 (82                 reference, Reporting and recordkeeping
                                              Ave., NW., Washington, DC 20460–                        FR 49287) Federal Register document. If               requirements, Third-party certification,
                                              0001; telephone number: (202) 564–                      you have questions, consult the                       Toxic substances, Wood.


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Document Created: 2017-12-08 01:43:18
Document Modified: 2017-12-08 01:43:18
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective December 8, 2017. Objections and requests for hearings must be received on or before February 6, 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).
ContactRobert 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
FR Citation82 FR 57872 

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