80_FR_9249 80 FR 9215 - Bacillus Subtilis Strain IAB/BS03; Exemption From the Requirement of a Tolerance

80 FR 9215 - Bacillus Subtilis Strain IAB/BS03; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 34 (February 20, 2015)

Page Range9215-9217
FR Document2015-03465

This regulation establishes an exemption from the requirement of a tolerance for residues of the fungicide Bacillus subtilis strain IAB/BS03 in or on all food commodities when used in accordance with label directions and good agricultural practices. Investigaciones y Aplicaciones Biotechnologicas (IAB, S.L.) 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 IAB/BS03.

Federal Register, Volume 80 Issue 34 (Friday, February 20, 2015)
[Federal Register Volume 80, Number 34 (Friday, February 20, 2015)]
[Rules and Regulations]
[Pages 9215-9217]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-03465]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0574; FRL-9920-62]


Bacillus Subtilis Strain IAB/BS03; 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 fungicide Bacillus subtilis strain 
IAB/BS03 in or on all food commodities when used in accordance with 
label directions and good agricultural practices. Investigaciones y 
Aplicaciones Biotechnologicas (IAB, S.L.) 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 IAB/BS03.

DATES: This regulation is effective February 20, 2015. Objections and 
requests for hearings must be received on or before April 21, 2015, 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-2013-0574 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

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

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

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

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

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing 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-2013-0574 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 
April 21, 2015. 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

[[Page 9216]]

objection or hearing request, identified by docket ID number EPA-HQ-
OPP-2013-0574, 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 and Statutory Findings

    In the Federal Register of September 12, 2013 (78 FR 56185) (FRL-
9399-7), 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 3F8177) by IAB, S.L. (Investigaciones y Aplicaciones 
Biotecnologicas S.L.), Avda, Paret del Patriarca 11-B, Ap. 30, 46113 
Moncada (Valencia) Spain. The petition requested that 40 CFR part 180 
be amended by establishing an exemption from the requirement of a 
tolerance for residues of Bacillus subtilis strain IAB/BS03. That 
document referenced a summary of the petition prepared by the 
petitioner IAB, S.L., at http://www.regulations.gov which was not 
available in the docket due to an administrative error.
    In the Federal Register of December 3, 2014 (79 FR 71713) (FRL-
9919-58), EPA reopened the comment period on this petition (PP 3F8177) 
for 30 days to allow comments on the petition. Two comments received in 
response to the notice of filing. EPA's response is located in Unit 
III. D.

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 the Agency consider ``available information concerning 
the cumulative effects of (a particular pesticide's) . . . residues and 
other substances that have a common mechanism of toxicity.''
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of and to 
make a determination on aggregate exposure to Bacillus subtilis strain 
IAB/BS03. EPA has evaluated the available toxicity data and considered 
its validity, completeness, and reliability as well as the relationship 
of the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. A full explanation of the data upon which EPA relied and a 
summary of its risk assessment based on that data can be found within 
October 15, 2014 document entitled ``Federal Food, Drug, and Cosmetic 
Act (FFDCA) Considerations for Bacillus subtilis strain IAB/BS03.'' 
This document, as well as other relevant information, is available in 
the docket for this action as described under ADDRESSES.
    Based upon that 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 IAB/BS03. Therefore, EPA is establishing an 
exemption from the requirement of a tolerance for residues of Bacillus 
subtilis strain IAB/BS03 in or on all food commodities when used in 
accordance with label directions and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons contained in the document entitled, ``Federal Food, Drug, 
and Cosmetic Act (FFDCA) Considerations for Bacillus subtilis strain 
IAB/BS03'' and because the Agency is establishing an exemption from the 
requirement of a tolerance without any numerical limitation.

C. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), which is a joint United 
Nations Food and Agriculture Organization/World Health Organization 
food standards program, and it is recognized as an international food 
safety standards-setting organization in trade agreements to which the 
United States is a party.
    The Codex has not established a MRL for Bacillus subtilis strain 
IAB/BS03.

D. Response to Comments

    Two general comments were filed opposing the establishment of any 
tolerance or exemption. The Agency recognizes that some individuals 
believe that no residue of pesticides should be allowed on foods; 
however, under the existing legal framework provided by section 408 of 
the Federal Food, Drug and Cosmetic Act (FFDCA), EPA is authorized to 
establish pesticide tolerances or exemptions where persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by the statute. Based on the available 
information, EPA has determined that the use of Bacillus subtilis 
strain IAB/BS03 is safe.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to the Agency. 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

[[Page 9217]]

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 final rule, 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, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: February 4, 2015.
Jack E. Housenger,
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.  180.1329 to subpart D to read as follows:


Sec.  180.1329  Bacillus subtilis strain IAB/BS03, exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus subtilis strain IAB/BS03 in or on all food 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2015-03465 Filed 2-19-15; 8:45 am]
BILLING CODE 6560-50-P



                                                               Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations                                          9215

                                             the Federal Government and Indian                       *      *      *      *       *                        Pennsylvania Ave. NW., Washington,
                                             tribes. Thus, the Agency has determined                 [FR Doc. 2015–03458 Filed 2–19–15; 8:45 am]           DC 20460–0001; main telephone
                                             that Executive Order 13132, entitled                    BILLING CODE 6560–50–P                                number: (703) 305–7090; email address:
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                                                                       BPPDFRNotices@epa.gov.
                                             1999) and Executive Order 13175,                                                                              SUPPLEMENTARY INFORMATION:
                                             entitled ‘‘Consultation and Coordination                ENVIRONMENTAL PROTECTION
                                             with Indian Tribal Governments’’ (65 FR                 AGENCY                                                I. General Information
                                             67249, November 9, 2000) do not apply                                                                         A. Does this action apply to me?
                                             to this final rule. In addition, this final             40 CFR Part 180
                                                                                                                                                              You may be potentially affected by
                                             rule does not impose any enforceable                    [EPA–HQ–OPP–2013–0574; FRL–9920–62]
                                                                                                                                                           this action if you are an agricultural
                                             duty or contain any unfunded mandate
                                                                                                     Bacillus Subtilis Strain IAB/BS03;                    producer, food manufacturer, or
                                             as described under Title II of the
                                                                                                     Exemption From the Requirement of a                   pesticide manufacturer. The following
                                             Unfunded Mandates Reform Act of 1995
                                                                                                     Tolerance                                             list of North American Industrial
                                             (UMRA) (2 U.S.C. 1501 et seq.).
                                                This action does not involve any                                                                           Classification System (NAICS) codes is
                                                                                                     AGENCY:  Environmental Protection                     not intended to be exhaustive, but rather
                                             technical standards that would require                  Agency (EPA).
                                             Agency consideration of voluntary                                                                             provides a guide to help readers
                                                                                                     ACTION: Final rule.                                   determine whether this document
                                             consensus standards pursuant to section
                                             12(d) of the National Technology                                                                              applies to them. Potentially affected
                                                                                                           This regulation establishes an
                                                                                                     SUMMARY:
                                             Transfer and Advancement Act of 1995                                                                          entities may include:
                                                                                                exemption from the requirement of a
                                             (NTTAA) (15 U.S.C. 272 note).                                                                                    • Crop production (NAICS code 111).
                                                                                                tolerance for residues of the fungicide
                                                                                                                                                              • Animal production (NAICS code
                                             VII. Congressional Review Act                      Bacillus subtilis strain IAB/BS03 in or
                                                                                                                                                           112).
                                                                                                on all food commodities when used in
                                                Pursuant to the Congressional Review accordance with label directions and                                     • Food manufacturing (NAICS code
                                             Act (5 U.S.C. 801 et seq.), EPA will                                                                          311).
                                                                                                good agricultural practices.
                                             submit a report containing this rule and Investigaciones y Aplicaciones                                          • Pesticide manufacturing (NAICS
                                             other required information to the U.S.                                                                        code 32532).
                                                                                                Biotechnologicas (IAB, S.L.) submitted a
                                             Senate, the U.S. House of                          petition to EPA under the Federal Food,                    B. How can I get electronic access to
                                             Representatives, and the Comptroller               Drug, and Cosmetic Act (FFDCA),                            other related information?
                                             General of the United States prior to              requesting an exemption from the
                                             publication of the rule in the Federal                                                                          You may access a frequently updated
                                                                                                requirement of a tolerance. This                           electronic version of 40 CFR part 180
                                             Register. This action is not a ‘‘major             regulation eliminates the need to
                                             rule’’ as defined by 5 U.S.C. 804(2).                                                                         through the Government Publishing
                                                                                                establish a maximum permissible level
                                                                                                                                                           Office’s e-CFR site at http://
                                             List of Subjects in 40 CFR Part 180                for residues of Bacillus subtilis strain
                                                                                                                                                           www.ecfr.gov/cgi-bin/text-
                                                                                                IAB/BS03.
                                                Environmental protection,                                                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                DATES: This regulation is effective                        40tab_02.tpl.
                                             Administrative practice and procedure,
                                                                                                February 20, 2015. Objections and
                                             Agricultural commodities, Pesticides               requests for hearings must be received                     C. How can I file an objection or hearing
                                             and pests, Reporting and recordkeeping on or before April 21, 2015, and must                                  request?
                                             requirements.                                      be filed in accordance with the                              Under FFDCA section 408(g), 21
                                                Dated: February 10, 2015.                       instructions provided in 40 CFR part                       U.S.C. 346a(g), any person may file an
                                             Susan Lewis,                                       178 (see also Unit I.C. of the                             objection to any aspect of this regulation
                                             Director, Registration Division, Office of         SUPPLEMENTARY INFORMATION).                                and may also request a hearing on those
                                             Pesticide Programs.                                ADDRESSES: The docket for this action,                     objections. You must file your objection
                                                Therefore, 40 CFR chapter I is                  identified by docket identification (ID)                   or request a hearing on this regulation
                                             amended as follows:                                number EPA–HQ–OPP–2013–0574 is                             in accordance with the instructions
                                                                                                available at http://www.regulations.gov                    provided in 40 CFR part 178. To ensure
                                             PART 180—[AMENDED]                                 or at the Office of Pesticide Programs                     proper receipt by EPA, you must
                                                                                                Regulatory Public Docket (OPP Docket)                      identify docket ID number EPA–HQ–
                                             ■ 1. The authority citation for part 180
                                                                                                in the Environmental Protection Agency                     OPP–2013–0574 in the subject line on
                                             continues to read as follows:
                                                                                                Docket Center (EPA/DC), West William                       the first page of your submission. All
                                                Authority: 21 U.S.C. 321(q), 346a and 371.      Jefferson Clinton Bldg., Rm. 3334, 1301                    objections and requests for a hearing
                                             ■ 2. In § 180.464, add alphabetically the          Constitution Ave. NW., Washington, DC                      must be in writing, and must be
                                             following commodities to the table in              20460–0001. The Public Reading Room                        received by the Hearing Clerk on or
                                             paragraph (a) to read as follows:                  is open from 8:30 a.m. to 4:30 p.m.,                       before April 21, 2015. Addresses for
                                                                                                Monday through Friday, excluding legal                     mail and hand delivery of objections
                                             § 180.464 Dimethenamid; tolerances for             holidays. The telephone number for the
                                             residues.
                                                                                                                                                           and hearing requests are provided in 40
                                                                                                Public Reading Room is (202) 566–1744,                     CFR 178.25(b).
                                                (a) * * *                                       and the telephone number for the OPP                         In addition to filing an objection or
                                                                                                Docket is (703) 305–5805. Please review                    hearing request with the Hearing Clerk
                                                                                 Parts per
                                                       Commodity                  million       the visitor instructions and additional                    as described in 40 CFR part 178, please
Rmajette on DSK2VPTVN1PROD with RULES




                                                                                                information about the docket available                     submit a copy of the filing (excluding
                                                                                                at http://www.epa.gov/dockets.                             any Confidential Business Information
                                                 *        *          *         *          *     FOR FURTHER INFORMATION CONTACT:                           (CBI)) for inclusion in the public docket.
                                             Cotton, gin byproducts .........               1.5 Robert McNally, Biopesticides and                          Information not marked confidential
                                             Cottonseed subgroup 20C ...                  0.01 Pollution Prevention Division (7511P),                      pursuant to 40 CFR part 2 may be
                                                 *        *          *         *          *     Office of Pesticide Programs,                              disclosed publicly by EPA without prior
                                                                                                Environmental Protection Agency, 1200                      notice. Submit the non-CBI copy of your


                                        VerDate Sep<11>2014   21:59 Feb 19, 2015   Jkt 235001   PO 00000   Frm 00027   Fmt 4700   Sfmt 4700   E:\FR\FM\20FER1.SGM   20FER1


                                             9216              Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations

                                             objection or hearing request, identified                pesticide chemical residue, including                 with label directions and good
                                             by docket ID number EPA–HQ–OPP–                         all anticipated dietary exposures and all             agricultural practices.
                                             2013–0574, by one of the following                      other exposures for which there is
                                                                                                                                                           B. Analytical Enforcement Methodology
                                             methods:                                                reliable information.’’ This includes
                                               • Federal eRulemaking Portal: http://                 exposure through drinking water and in                  An analytical method is not required
                                             www.regulations.gov. Follow the online                  residential settings, but does not include            for enforcement purposes for the
                                             instructions for submitting comments.                   occupational exposure. Pursuant to                    reasons contained in the document
                                             Do not submit electronically any                        FFDCA section 408(c)(2)(B), in                        entitled, ‘‘Federal Food, Drug, and
                                             information you consider to be CBI or                   establishing or maintaining in effect an              Cosmetic Act (FFDCA) Considerations
                                             other information whose disclosure is                   exemption from the requirement of a                   for Bacillus subtilis strain IAB/BS03’’
                                             restricted by statute.                                  tolerance, EPA must take into account                 and because the Agency is establishing
                                               • Mail: OPP Docket, Environmental                     the factors set forth in FFDCA section                an exemption from the requirement of a
                                             Protection Agency Docket Center (EPA/                   408(b)(2)(C), which require EPA to give               tolerance without any numerical
                                             DC), (28221T), 1200 Pennsylvania Ave.                   special consideration to exposure of                  limitation.
                                             NW., Washington, DC 20460–0001.                         infants and children to the pesticide                 C. International Residue Limits
                                               • Hand Delivery: To make special                      chemical residue in establishing a
                                             arrangements for hand delivery or                       tolerance or tolerance exemption, and to                In making its tolerance decisions, EPA
                                             delivery of boxed information, please                   ‘‘ensure that there is a reasonable                   seeks to harmonize U.S. tolerances with
                                             follow the instructions at http://                      certainty that no harm will result to                 international standards whenever
                                             www.epa.gov/dockets/contacts.html.                      infants and children from aggregate                   possible, consistent with U.S. food
                                             Additional instructions on commenting                   exposure to the pesticide chemical                    safety standards and agricultural
                                             or visiting the docket, along with more                 residue. . . .’’ Additionally, FFDCA                  practices. EPA considers the
                                             information about dockets generally, is                 section 408(b)(2)(D) requires that the                international maximum residue limits
                                             available at http://www.epa.gov/                        Agency consider ‘‘available information               (MRLs) established by the Codex
                                             dockets.                                                concerning the cumulative effects of (a               Alimentarius Commission (Codex),
                                                                                                     particular pesticide’s) . . . residues and            which is a joint United Nations Food
                                             II. Background and Statutory Findings                                                                         and Agriculture Organization/World
                                                                                                     other substances that have a common
                                                In the Federal Register of September                 mechanism of toxicity.’’                              Health Organization food standards
                                             12, 2013 (78 FR 56185) (FRL–9399–7),                                                                          program, and it is recognized as an
                                                                                                        Consistent with FFDCA section
                                             EPA issued a document pursuant to                                                                             international food safety standards-
                                                                                                     408(b)(2)(D), EPA has reviewed the
                                             FFDCA section 408(d)(3), 21 U.S.C.                                                                            setting organization in trade agreements
                                                                                                     available scientific data and other
                                             346a(d)(3), announcing the filing of a                                                                        to which the United States is a party.
                                                                                                     relevant information in support of this
                                             pesticide tolerance petition (PP 3F8177)                                                                        The Codex has not established a MRL
                                                                                                     action. EPA has sufficient data to assess
                                             by IAB, S.L. (Investigaciones y                                                                               for Bacillus subtilis strain IAB/BS03.
                                                                                                     the hazards of and to make a
                                             Aplicaciones Biotecnologicas S.L.),                     determination on aggregate exposure to                D. Response to Comments
                                             Avda, Paret del Patriarca 11–B, Ap. 30,                 Bacillus subtilis strain IAB/BS03. EPA
                                             46113 Moncada (Valencia) Spain. The                                                                              Two general comments were filed
                                                                                                     has evaluated the available toxicity data             opposing the establishment of any
                                             petition requested that 40 CFR part 180                 and considered its validity,
                                             be amended by establishing an                                                                                 tolerance or exemption. The Agency
                                                                                                     completeness, and reliability as well as              recognizes that some individuals believe
                                             exemption from the requirement of a                     the relationship of the results of the
                                             tolerance for residues of Bacillus subtilis                                                                   that no residue of pesticides should be
                                                                                                     studies to human risk. EPA has also                   allowed on foods; however, under the
                                             strain IAB/BS03. That document                          considered available information
                                             referenced a summary of the petition                                                                          existing legal framework provided by
                                                                                                     concerning the variability of the                     section 408 of the Federal Food, Drug
                                             prepared by the petitioner IAB, S.L., at                sensitivities of major identifiable
                                             http://www.regulations.gov which was                                                                          and Cosmetic Act (FFDCA), EPA is
                                                                                                     subgroups of consumers, including                     authorized to establish pesticide
                                             not available in the docket due to an                   infants and children. A full explanation
                                             administrative error.                                                                                         tolerances or exemptions where persons
                                                                                                     of the data upon which EPA relied and                 seeking such tolerances or exemptions
                                                In the Federal Register of December 3,               a summary of its risk assessment based
                                             2014 (79 FR 71713) (FRL–9919–58),                                                                             have demonstrated that the pesticide
                                                                                                     on that data can be found within                      meets the safety standard imposed by
                                             EPA reopened the comment period on                      October 15, 2014 document entitled
                                             this petition (PP 3F8177) for 30 days to                                                                      the statute. Based on the available
                                                                                                     ‘‘Federal Food, Drug, and Cosmetic Act                information, EPA has determined that
                                             allow comments on the petition. Two                     (FFDCA) Considerations for Bacillus
                                             comments received in response to the                                                                          the use of Bacillus subtilis strain IAB/
                                                                                                     subtilis strain IAB/BS03.’’ This                      BS03 is safe.
                                             notice of filing. EPA’s response is                     document, as well as other relevant
                                             located in Unit III. D.                                 information, is available in the docket               IV. Statutory and Executive Order
                                             III. Final Rule                                         for this action as described under                    Reviews
                                                                                                     ADDRESSES.                                               This action establishes a tolerance
                                             A. EPA’s Safety Determination                              Based upon that evaluation, EPA                    exemption under FFDCA section 408(d)
                                                Section 408(c)(2)(A)(i) of FFDCA                     concludes that there is a reasonable                  in response to a petition submitted to
                                             allows EPA to establish an exemption                    certainty that no harm will result to the             the Agency. The Office of Management
                                             from the requirement for a tolerance (the               U.S. population, including infants and                and Budget (OMB) has exempted these
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                                             legal limit for a pesticide chemical                    children, from aggregate exposure to                  types of actions from review under
                                             residue in or on a food) only if EPA                    residues of Bacillus subtilis strain IAB/             Executive Order 12866, entitled
                                             determines that the exemption is ‘‘safe.’’              BS03. Therefore, EPA is establishing an               ‘‘Regulatory Planning and Review’’ (58
                                             Section 408(c)(2)(A)(ii) of FFDCA                       exemption from the requirement of a                   FR 51735, October 4, 1993). Because
                                             defines ‘‘safe’’ to mean that ‘‘there is a              tolerance for residues of Bacillus subtilis           this action has been exempted from
                                             reasonable certainty that no harm will                  strain IAB/BS03 in or on all food                     review under Executive Order 12866,
                                             result from aggregate exposure to the                   commodities when used in accordance                   this action is not subject to Executive


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                                                               Federal Register / Vol. 80, No. 34 / Friday, February 20, 2015 / Rules and Regulations                                         9217

                                             Order 13211, entitled ‘‘Actions                         submit a report containing this rule and              formal comments received from
                                             Concerning Regulations That                             other required information to the U.S.                multiple stakeholders outlining
                                             Significantly Affect Energy Supply,                     Senate, the U.S. House of                             challenges faced by the regulated
                                             Distribution, or Use’’ (66 FR 28355, May                Representatives, and the Comptroller                  community in fully implementing the
                                             22, 2001) or Executive Order 13045,                     General of the United States prior to                 provisions of the final rule by the
                                             entitled ‘‘Protection of Children from                  publication of the rule in the Federal                February 6, 2015 mandatory compliance
                                             Environmental Health Risks and Safety                   Register. This action is not a ‘‘major                date.
                                             Risks’’ (62 FR 19885, April 23, 1997).                  rule’’ as defined by 5 U.S.C. 804(2).                 DATES: The compliance date for the final
                                             This action does not contain any                                                                              rule published August 6, 2014, at 79 FR
                                             information collections subject to OMB                  List of Subjects in 40 CFR Part 180
                                                                                                                                                           46012, is extended until August 7, 2015.
                                             approval under the Paperwork                              Environmental protection,                           FOR FURTHER INFORMATION CONTACT:
                                             Reduction Act (PRA), 44 U.S.C. 3501 et                  Administrative practice and procedure,                Vincent Babich or Steven Webb
                                             seq., nor does it require any special                   Agricultural commodities, Pesticides                  Standards and Rulemaking Division,
                                             considerations under Executive Order                    and pests, Reporting and recordkeeping                Pipeline and Hazardous Materials Safety
                                             12898, entitled ‘‘Federal Actions to                    requirements.                                         Administration, telephone (202) 366–
                                             Address Environmental Justice in                          Dated: February 4, 2015.                            8553.
                                             Minority Populations and Low-Income
                                                                                                     Jack E. Housenger,                                    SUPPLEMENTARY INFORMATION: On August
                                             Populations’’ (59 FR 7629, February 16,
                                             1994).                                                  Director, Office of Pesticide Programs.               6, 2014 [79 FR 46012], PHMSA in
                                                Since tolerances and exemptions that                                                                       consultation with the Federal Aviation
                                                                                                       Therefore, 40 CFR chapter I is
                                             are established on the basis of a petition                                                                    Administration (FAA) published a final
                                                                                                     amended as follows:
                                             under FFDCA section 408(d), such as                                                                           rule under Docket No. PHMSA–2009–
                                             the tolerance exemption in this final                   PART 180—[AMENDED]                                    0095 (HM–224F) modifying
                                             rule, do not require the issuance of a                                                                        requirements governing the
                                             proposed rule, the requirements of the                  ■ 1. The authority citation for part 180              transportation of lithium cells and
                                             Regulatory Flexibility Act (RFA) (5                     continues to read as follows:                         batteries. The final rule revised hazard
                                             U.S.C. 601 et seq.), do not apply.                                                                            communication and packaging
                                                                                                         Authority: 21 U.S.C. 321(q), 346a and 371.
                                                This action directly regulates growers,                                                                    provisions for lithium batteries to
                                             food processors, food handlers, and food                ■ 2. Add § 180.1329 to subpart D to read              harmonize the Hazardous Materials
                                             retailers, not States or tribes, nor does               as follows:                                           Regulations (HMR; CFR parts 171–180)
                                             this action alter the relationships or                                                                        with applicable provisions of the United
                                                                                                     § 180.1329 Bacillus subtilis strain IAB/
                                             distribution of power and                               BS03, exemption from the requirement of a
                                                                                                                                                           Nations (UN) Model Regulations, the
                                             responsibilities established by Congress                tolerance.                                            International Civil Aviation
                                             in the preemption provisions of FFDCA                                                                         Organization’s Technical Instructions
                                                                                                       An exemption from the requirement
                                             section 408(n)(4). As such, the Agency                                                                        for the Safe Transport of Dangerous
                                                                                                     of a tolerance is established for residues
                                             has determined that this action will not                                                                      Goods by Air (ICAO Technical
                                                                                                     of Bacillus subtilis strain IAB/BS03 in or
                                             have a substantial direct effect on States                                                                    Instructions) and the International
                                                                                                     on all food commodities when used in
                                             or tribal governments, on the                                                                                 Maritime Dangerous Goods (IMDG)
                                                                                                     accordance with label directions and
                                             relationship between the national                                                                             Code. In the August 6, 2014 final rule,
                                                                                                     good agricultural practices.
                                             government and the States or tribal                                                                           PHMSA authorized a mandatory
                                                                                                     [FR Doc. 2015–03465 Filed 2–19–15; 8:45 am]           compliance date of February 6, 2015 (six
                                             governments, or on the distribution of
                                             power and responsibilities among the                    BILLING CODE 6560–50–P                                months after publication in the Federal
                                             various levels of government or between                                                                       Register) for shippers to incorporate the
                                             the Federal Government and Indian                                                                             new requirements into standard
                                             Tribes. Thus, the Agency has                            DEPARTMENT OF TRANSPORTATION                          operating procedures and complete
                                             determined that Executive Order 13132,                                                                        training of affected personnel.
                                                                                                     Pipeline and Hazardous Materials                         The Retail Industry Leaders
                                             entitled ‘‘Federalism’’ (64 FR 43255,
                                                                                                     Safety Administration                                 Association, the Food Marketing
                                             August 10, 1999) and Executive Order
                                             13175, entitled ‘‘Consultation and                                                                            Institute, the National Retail Federation,
                                                                                                     49 CFR Parts 171, 172, 173, and 175                   and the Rechargeable Battery
                                             Coordination with Indian Tribal
                                             Governments’’ (65 FR 67249, November                    [Docket No. PHMSA–2009–0095 (HM–224F)]                Association submitted a joint request for
                                             9, 2000) do not apply to this action. In                                                                      an extension of six months to the
                                                                                                     RIN 2137–AE44                                         current mandatory compliance date.
                                             addition, this action does not impose
                                             any enforceable duty or contain any                                                                           These groups contend that the six
                                                                                                     Hazardous Materials: Transportation of
                                             unfunded mandate as described under                                                                           month transitional period adopted in
                                                                                                     Lithium Batteries
                                             Title II of the Unfunded Mandates                                                                             the final rule did not provide sufficient
                                             Reform Act (UMRA) (2 U.S.C. 1501 et                     AGENCY:  Pipeline and Hazardous                       time to comply with the new
                                             seq.).                                                  Materials Safety Administration                       requirements and has proven extremely
                                                This action does not involve any                     (PHMSA), DOT.                                         challenging for the retail industry to
                                             technical standards that would require                  ACTION: Final rule; extension of                      implement in particular for surface
                                             Agency consideration of voluntary                       compliance date.                                      transportation. The request notes that
                                             consensus standards pursuant to section                                                                       ‘‘generally, the new regulations require
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                                             12(d) of the National Technology                        SUMMARY:   PHMSA is extending for                     that domestic ground shipments of
                                             Transfer and Advancement Act                            modes of transportation other than air                products with lithium batteries adhere
                                             (NTTAA) (15 U.S.C. 272 note).                           the mandatory compliance date of a                    to shipping standards previously only
                                                                                                     final rule published on August 6, 2014,               required for international air and sea
                                             V. Congressional Review Act                             under Docket No. HM–224F from                         transportation’’. The groups further note
                                               Pursuant to the Congressional Review                  February 6, 2015, until August 7, 2015.               that the detailed information necessary
                                             Act (5 U.S.C. 801 et seq.), EPA will                    This extension is made in response to                 for compliance, such as the specific


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Document Created: 2015-12-18 13:01:53
Document Modified: 2015-12-18 13:01:53
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 February 20, 2015. Objections and requests for hearings must be received on or before April 21, 2015, 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 Citation80 FR 9215 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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