83 FR 46403 - Bacteriophage Active Against Xanthomonas citri subsp. citri; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 178 (September 13, 2018)
Federal Register Volume 83, Issue 178 (September 13, 2018)
| Page Range | 46403-46405 | |
| FR Document | 2018-19958 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Rules and Regulations] [Pages 46403-46405] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19958] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0703; FRL-9983-10] Bacteriophage Active Against Xanthomonas citri subsp. citri; 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 lytic bacteriophage active against Xanthomonas citri subsp. citri that are produced in Xanthomonas citri subsp. citri in or on food commodities included in the fruit, citrus groups 10 and 10-10, when used in accordance with label directions and good agricultural practices. OmniLytics, Inc. 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 bacteriophage active against Xanthomonas citri subsp. citri in or on food commodities of the fruit, citrus groups 10 and 10-10 under FFDCA. DATES: This regulation is effective September 13, 2018. Objections and requests for hearings must be received on or before November 13, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0703, 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), [[Page 46404]] 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-2017-0703 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 November 13, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0703, 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 March 21, 2018 (83 FR 12311) (FRL-9974- 76), 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 7F8574) by OmniLytics, Inc., 9100 South 500 West, Sandy, UT 84070. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of the bactericide bacteriophage active against Xanthomonas citri subsp. citri in or on citrus fruit, including orange, grapefruit, pummelo, mandarin, lemon, lime, tangerine, tangelo, and kumquat. That document referenced a summary of the petition prepared by the petitioner OmniLytics, Inc. and available in the docket via http://www.regulations.gov. There were no comments regarding this exemption received in response to the notice of filing. Based upon review of data and other information supporting the petition, EPA is granting a tolerance exemption that differs slightly from what the petition requested. The reason for this difference is explained in Unit III.C. 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 of 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 toxicological and exposure data on bacteriophage active against Xanthomonas citri subsp. citri and considered their 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) Safety Determination for Bacteriophage Active Against Xanthomonas citri subsp. citri.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. The available data demonstrated that bacteriophage active against Xanthomonas citri subsp. citri are not anticipated to be toxic, pathogenic, or infective via any route of exposure. Furthermore, humans, including infants and children, have been exposed to bacteriophage through food and water, where they are commonly found, with no known adverse effects. Although there may be some exposure to residues of bacteriophage active against Xanthomonas citri subsp. citri that are used on citrus fruit in accordance with label directions and good agricultural practices, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not [[Page 46405]] necessary as part of the qualitative assessment conducted for bacteriophage active against Xanthomonas citri subsp. citri. 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 bacteriophage active against Xanthomonas citri subsp. citri. Therefore, an exemption from the requirement of a tolerance is established for residues of lytic bacteriophage active against Xanthomonas citri subsp. citri that are produced in Xanthomonas citri subsp. citri in or on food commodities included in the fruit, citrus groups 10 and 10-10, 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. C. Differences Between Petition and Tolerance Exemption Rule In its petition, the petitioner requested generally that EPA issue an exemption from the requirement of a tolerance for residues of bacteriophage active against Xanthomonas citri subsp. citri in or on citrus fruit, including orange, grapefruit, pummelo, mandarin, lemon, lime, tangerine, tangelo, and kumquat. The petitioner's supporting materials indicated that the actual pesticide that would be used would be safe because the bacteriophage was lytic and were produced in Xanthomonas citri subsp. citri. EPA believes that only bacteriophage that have these same characteristics as the organism tested would be safe and should be exempt from the requirement of a tolerance. Therefore, EPA is issuing a tolerance exemption that differs slightly from the petition by limiting the exemption to residues of the bacteriophage that possess the same characteristics as the bacteriophage that were tested to support this exemption. 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), nor is it considered a regulatory action under Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act, 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 (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 (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 (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: September 4, 2018. 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. 180.1360 to subpart D to read as follows: Sec. 180.1360 Bacteriophage active against Xanthomonas citri subsp. citri; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of lytic bacteriophage active against Xanthomonas citri subsp. citri that are produced in Xanthomonas citri subsp. citri in or on food commodities included in the fruit, citrus groups 10 and 10-10, when used in accordance with label directions and good agricultural practices. [FR Doc. 2018-19958 Filed 9-12-18; 8:45 am] BILLING CODE 6560-50-P
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in response to a petition submitted to Mandates Reform Act (2 U.S.C. 1501 et ENVIRONMENTAL PROTECTION
EPA. The Office of Management and seq.). AGENCY
Budget (OMB) has exempted these types This action does not involve any
of actions from review under Executive 40 CFR Part 180
technical standards that would require
Order 12866, entitled ‘‘Regulatory [EPA–HQ–OPP–2017–0703; FRL–9983–10]
EPA’s consideration of voluntary
Planning and Review’’ (58 FR 51735,
consensus standards pursuant to section
October 4, 1993). Because this action Bacteriophage Active Against
has been exempted from review under 12(d) of the National Technology
Transfer and Advancement Act (15 Xanthomonas citri subsp. citri;
Executive Order 12866, this action is Exemption From the Requirement of a
not subject to Executive Order 13211, U.S.C. 272 note).
Tolerance
entitled ‘‘Actions Concerning V. Congressional Review Act
Regulations That Significantly Affect AGENCY: Environmental Protection
Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review Agency (EPA).
FR 28355, May 22, 2001), or Executive Act (5 U.S.C. 801 et seq.), EPA will ACTION: Final rule.
Order 13045, entitled ‘‘Protection of submit a report containing this rule and
Children from Environmental Health SUMMARY: This regulation establishes an
other required information to the U.S.
Risks and Safety Risks’’ (62 FR 19885, exemption from the requirement of a
Senate, the U.S. House of
April 23, 1997), nor is it considered a tolerance for residues of lytic
Representatives, and the Comptroller bacteriophage active against
regulatory action under Executive Order General of the United States prior to
13771, entitled ‘‘Reducing Regulations Xanthomonas citri subsp. citri that are
publication of the rule in the Federal produced in Xanthomonas citri subsp.
and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
FR 9339, February 3, 2017). This action citri in or on food commodities included
rule’’ as defined by 5 U.S.C. 804(2). in the fruit, citrus groups 10 and 10–10,
does not contain any information
collections subject to OMB approval List of Subjects in 40 CFR Part 180 when used in accordance with label
under the Paperwork Reduction Act, 44 directions and good agricultural
U.S.C. 3501 et seq., nor does it require Environmental protection, practices. OmniLytics, Inc. submitted a
any special considerations under Administrative practice and procedure, petition to EPA under the Federal Food,
Executive Order 12898, entitled Agricultural commodities, Pesticides Drug, and Cosmetic Act (FFDCA),
‘‘Federal Actions to Address and pests, Reporting and recordkeeping requesting an exemption from the
Environmental Justice in Minority requirements. requirement of a tolerance. This
Populations and Low-Income regulation eliminates the need to
Dated: September 4, 2018.
Populations’’ (59 FR 7629, February 16, establish a maximum permissible level
Richard P. Keigwin, Jr., for residues of bacteriophage active
1994).
Since tolerances and exemptions that Director, Office of Pesticide Programs. against Xanthomonas citri subsp. citri in
are established on the basis of a petition or on food commodities of the fruit,
under FFDCA section 408(d), such as Therefore, 40 CFR chapter I is citrus groups 10 and 10–10 under
the tolerance exemption in this action, amended as follows: FFDCA.
do not require the issuance of a DATES: This regulation is effective
proposed rule, the requirements of the PART 180—[AMENDED]
September 13, 2018. Objections and
Regulatory Flexibility Act (5 U.S.C. 601 requests for hearings must be received
et seq.) do not apply. ■ 1. The authority citation for part 180
continues to read as follows: on or before November 13, 2018, and
This action directly regulates growers, must be filed in accordance with the
food processors, food handlers, and food Authority: 21 U.S.C. 321(q), 346a and 371. instructions provided in 40 CFR part
retailers, not States or tribes. As a result, 178 (see also Unit I.C. of the
this action does not alter the ■ 2. Add § 180.1359 to subpart D to read
as follows: SUPPLEMENTARY INFORMATION).
relationships or distribution of power
and responsibilities established by ADDRESSES: The docket for this action,
§ 180.1359 Bacteriophage active against identified by docket identification (ID)
Congress in the preemption provisions Erwinia amylovora; exemption from the
of FFDCA section 408(n)(4). As such, number EPA–HQ–OPP–2017–0703, is
requirement of a tolerance. available at http://www.regulations.gov
EPA has determined that this action will
not have a substantial direct effect on An exemption from the requirement or at the Office of Pesticide Programs
States or tribal governments, on the of a tolerance is established for residues Regulatory Public Docket (OPP Docket)
relationship between the national of lytic bacteriophage active against in the Environmental Protection Agency
government and the States or tribal Erwinia amylovora that are produced in Docket Center (EPA/DC), West William
governments, or on the distribution of Erwinia amylovora in or on apple and Jefferson Clinton Bldg., Rm. 3334, 1301
power and responsibilities among the pear, when used in accordance with Constitution Ave. NW, Washington, DC
various levels of government or between 20460–0001. The Public Reading Room
label directions and good agricultural
the Federal Government and Indian is open from 8:30 a.m. to 4:30 p.m.,
practices.
tribes. Thus, EPA has determined that Monday through Friday, excluding legal
[FR Doc. 2018–19954 Filed 9–12–18; 8:45 am] holidays. The telephone number for the
Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10, BILLING CODE 6560–50–P Public Reading Room is (202) 566–1744,
1999), and Executive Order 13175, and the telephone number for the OPP
Docket is (703) 305–5805. Please review
daltland on DSKBBV9HB2PROD with RULES
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR the visitor instructions and additional
67249, November 9, 2000), do not apply information about the docket available
to this action. In addition, this action at http://www.epa.gov/dockets.
does not impose any enforceable duty or FOR FURTHER INFORMATION CONTACT:
contain any unfunded mandate as Robert McNally, Biopesticides and
described under Title II of the Unfunded Pollution Prevention Division (7511P),
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![46404 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations
Office of Pesticide Programs, objection or hearing request, identified reasonable certainty that no harm will
Environmental Protection Agency, 1200 by docket ID number EPA–HQ–OPP– result from aggregate exposure to the
Pennsylvania Ave. NW, Washington, DC 2017–0703, by one of the following pesticide chemical residue, including
20460–0001; main telephone number: methods: all anticipated dietary exposures and all
(703) 305–7090; email address: • Federal eRulemaking Portal: http:// other exposures for which there is
BPPDFRNotices@epa.gov. www.regulations.gov. Follow the online reliable information.’’ This includes
SUPPLEMENTARY INFORMATION: instructions for submitting comments. exposure through drinking water and in
Do not submit electronically any residential settings but does not include
I. General Information information you consider to be CBI or occupational exposure. Pursuant to
A. Does this Action Apply to Me? other information whose disclosure is FFDCA section 408(c)(2)(B), in
restricted by statute. establishing or maintaining in effect an
You may be potentially affected by • Mail: OPP Docket, Environmental exemption from the requirement of a
this action if you are an agricultural Protection Agency Docket Center (EPA/ tolerance, EPA must take into account
producer, food manufacturer, or DC), (28221T), 1200 Pennsylvania Ave. the factors set forth in FFDCA section
pesticide manufacturer. The following NW, Washington, DC 20460–0001. 408(b)(2)(C), which require EPA to give
list of North American Industrial • Hand Delivery: To make special special consideration to exposure of
Classification System (NAICS) codes is arrangements for hand delivery or infants and children to the pesticide
not intended to be exhaustive, but rather delivery of boxed information, please chemical residue in establishing a
provides a guide to help readers follow the instructions at http:// tolerance or tolerance exemption and to
determine whether this document www.epa.gov/dockets/contacts.html. ‘‘ensure that there is a reasonable
applies to them. Potentially affected Additional instructions on commenting certainty that no harm will result to
entities may include: or visiting the docket, along with more infants and children from aggregate
• Crop production (NAICS code 111). information about dockets generally, is exposure to the pesticide chemical
• Animal production (NAICS code residue. . . .’’ Additionally, FFDCA
available at http://www.epa.gov/
112). section 408(b)(2)(D) requires that EPA
dockets.
• Food manufacturing (NAICS code consider ‘‘available information
311). II. Background concerning the cumulative effects of [a
• Pesticide manufacturing (NAICS In the Federal Register of March 21, particular pesticide’s] . . . residues and
code 32532). 2018 (83 FR 12311) (FRL–9974–76), other substances that have a common
B. How can I get electronic access to EPA issued a document pursuant to mechanism of toxicity.’’
other related information? FFDCA section 408(d)(3), 21 U.S.C. EPA evaluated the available
346a(d)(3), announcing the filing of a toxicological and exposure data on
You may access a frequently updated bacteriophage active against
pesticide tolerance petition (PP 7F8574)
electronic version of 40 CFR part 180 Xanthomonas citri subsp. citri and
by OmniLytics, Inc., 9100 South 500
through the Government Printing considered their validity, completeness,
West, Sandy, UT 84070. The petition
Office’s e-CFR site at http://www.ecfr. and reliability, as well as the
requested that 40 CFR part 180 be
gov/cgi-bin/text-idx?&c=ecfr&tpl=/ relationship of this information to
amended by establishing an exemption
ecfrbrowse/Title40/40tab_02.tpl. human risk. A full explanation of the
C. How can I file an objection or from the requirement of a tolerance for
residues of the bactericide data upon which EPA relied and its risk
hearing request? assessment based on those data can be
Under FFDCA section 408(g), 21 bacteriophage active against
Xanthomonas citri subsp. citri in or on found within the document entitled
U.S.C. 346a(g), any person may file an ‘‘Federal Food, Drug, and Cosmetic Act
objection to any aspect of this regulation citrus fruit, including orange, grapefruit,
pummelo, mandarin, lemon, lime, (FFDCA) Safety Determination for
and may also request a hearing on those Bacteriophage Active Against
objections. You must file your objection tangerine, tangelo, and kumquat. That
document referenced a summary of the Xanthomonas citri subsp. citri.’’ This
or request a hearing on this regulation document, as well as other relevant
in accordance with the instructions petition prepared by the petitioner
OmniLytics, Inc. and available in the information, is available in the docket
provided in 40 CFR part 178. To ensure for this action as described under
proper receipt by EPA, you must docket via http://www.regulations.gov.
There were no comments regarding this ADDRESSES.
identify docket ID number EPA–HQ– The available data demonstrated that
OPP–2017–0703 in the subject line on exemption received in response to the
bacteriophage active against
the first page of your submission. All notice of filing.
Xanthomonas citri subsp. citri are not
objections and requests for a hearing Based upon review of data and other
anticipated to be toxic, pathogenic, or
must be in writing, and must be information supporting the petition,
infective via any route of exposure.
received by the Hearing Clerk on or EPA is granting a tolerance exemption
Furthermore, humans, including infants
before November 13, 2018. Addresses that differs slightly from what the
and children, have been exposed to
for mail and hand delivery of objections petition requested. The reason for this
bacteriophage through food and water,
and hearing requests are provided in 40 difference is explained in Unit III.C.
where they are commonly found, with
CFR 178.25(b). III. Final Rule no known adverse effects. Although
In addition to filing an objection or there may be some exposure to residues
hearing request with the Hearing Clerk A. EPA’s Safety Determination
of bacteriophage active against
as described in 40 CFR part 178, please Section 408(c)(2)(A)(i) of FFDCA Xanthomonas citri subsp. citri that are
submit a copy of the filing (excluding allows EPA to establish an exemption
daltland on DSKBBV9HB2PROD with RULES
used on citrus fruit in accordance with
any Confidential Business Information from the requirement of a tolerance (the label directions and good agricultural
(CBI)) for inclusion in the public docket. legal limit for a pesticide chemical practices, there is a lack of concern due
Information not marked confidential residue in or on a food) only if EPA to the lack of potential for adverse
pursuant to 40 CFR part 2 may be determines that the exemption is ‘‘safe.’’ effects. EPA also determined that
disclosed publicly by EPA without prior Section 408(c)(2)(A)(ii) of FFDCA retention of the Food Quality Protection
notice. Submit the non-CBI copy of your defines ‘‘safe’’ to mean that ‘‘there is a Act (FQPA) safety factor was not
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![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 46405
necessary as part of the qualitative Executive Order 12866, this action is Transfer and Advancement Act (15
assessment conducted for bacteriophage not subject to Executive Order 13211, U.S.C. 272 note).
active against Xanthomonas citri subsp. entitled ‘‘Actions Concerning
V. Congressional Review Act
citri. Regulations That Significantly Affect
Based upon its evaluation, EPA Energy Supply, Distribution, or Use’’ (66 Pursuant to the Congressional Review
concludes that there is a reasonable FR 28355, May 22, 2001), or Executive Act (5 U.S.C. 801 et seq.), EPA will
certainty that no harm will result to the Order 13045, entitled ‘‘Protection of submit a report containing this rule and
U.S. population, including infants and Children from Environmental Health other required information to the U.S.
children, from aggregate exposure to Risks and Safety Risks’’ (62 FR 19885, Senate, the U.S. House of
residues of bacteriophage active against April 23, 1997), nor is it considered a Representatives, and the Comptroller
Xanthomonas citri subsp. citri. regulatory action under Executive Order General of the United States prior to
Therefore, an exemption from the 13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal
requirement of a tolerance is established and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
for residues of lytic bacteriophage active FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2).
against Xanthomonas citri subsp. citri does not contain any information
that are produced in Xanthomonas citri List of Subjects in 40 CFR Part 180
collections subject to OMB approval
subsp. citri in or on food commodities under the Paperwork Reduction Act, 44 Environmental protection,
included in the fruit, citrus groups 10 U.S.C. 3501 et seq., nor does it require Administrative practice and procedure,
and 10–10, when used in accordance any special considerations under Agricultural commodities, Pesticides
with label directions and good Executive Order 12898, entitled and pests, Reporting and recordkeeping
agricultural practices. ‘‘Federal Actions to Address requirements.
B. Analytical Enforcement Methodology Environmental Justice in Minority Dated: September 4, 2018.
Populations and Low-Income Richard P. Keigwin, Jr.,
An analytical method is not required Populations’’ (59 FR 7629, February 16,
because EPA is establishing an Director, Office of Pesticide Programs.
1994).
exemption from the requirement of a Therefore, 40 CFR chapter I is
Since tolerances and exemptions that
tolerance without any numerical amended as follows:
are established on the basis of a petition
limitation.
under FFDCA section 408(d), such as PART 180—[AMENDED]
C. Differences Between Petition and the tolerance exemption in this action,
Tolerance Exemption Rule do not require the issuance of a ■ 1. The authority citation for part 180
In its petition, the petitioner proposed rule, the requirements of the continues to read as follows:
requested generally that EPA issue an Regulatory Flexibility Act (5 U.S.C. 601
Authority: 21 U.S.C. 321(q), 346a and 371.
exemption from the requirement of a et seq.) do not apply.
This action directly regulates growers, ■ 2. Add § 180.1360 to subpart D to read
tolerance for residues of bacteriophage as follows:
active against Xanthomonas citri subsp. food processors, food handlers, and food
citri in or on citrus fruit, including retailers, not States or tribes. As a result, § 180.1360 Bacteriophage active against
orange, grapefruit, pummelo, mandarin, this action does not alter the Xanthomonas citri subsp. citri; exemption
lemon, lime, tangerine, tangelo, and relationships or distribution of power from the requirement of a tolerance.
kumquat. The petitioner’s supporting and responsibilities established by An exemption from the requirement
materials indicated that the actual Congress in the preemption provisions of a tolerance is established for residues
pesticide that would be used would be of FFDCA section 408(n)(4). As such, of lytic bacteriophage active against
safe because the bacteriophage was lytic EPA has determined that this action will Xanthomonas citri subsp. citri that are
and were produced in Xanthomonas not have a substantial direct effect on produced in Xanthomonas citri subsp.
citri subsp. citri. EPA believes that only States or tribal governments, on the citri in or on food commodities included
bacteriophage that have these same relationship between the national in the fruit, citrus groups 10 and 10–10,
characteristics as the organism tested government and the States or tribal when used in accordance with label
would be safe and should be exempt governments, or on the distribution of directions and good agricultural
from the requirement of a tolerance. power and responsibilities among the practices.
Therefore, EPA is issuing a tolerance various levels of government or between
[FR Doc. 2018–19958 Filed 9–12–18; 8:45 am]
exemption that differs slightly from the the Federal Government and Indian
BILLING CODE 6560–50–P
petition by limiting the exemption to tribes. Thus, EPA has determined that
residues of the bacteriophage that Executive Order 13132, entitled
possess the same characteristics as the ‘‘Federalism’’ (64 FR 43255, August 10, ENVIRONMENTAL PROTECTION
bacteriophage that were tested to 1999), and Executive Order 13175, AGENCY
support this exemption. entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR 40 CFR Part 180
IV. Statutory and Executive Order 67249, November 9, 2000), do not apply
Reviews to this action. In addition, this action [EPA–HQ–OPP–2017–0525; FRL–9983–31]
This action establishes a tolerance does not impose any enforceable duty or
Pepino Mosaic Virus, Strain CH2,
exemption under FFDCA section 408(d) contain any unfunded mandate as
Isolate 1906; Exemption From the
in response to a petition submitted to described under Title II of the Unfunded
Requirement of a Tolerance
EPA. The Office of Management and Mandates Reform Act (2 U.S.C. 1501 et
daltland on DSKBBV9HB2PROD with RULES
Budget (OMB) has exempted these types seq.). AGENCY: Environmental Protection
of actions from review under Executive This action does not involve any Agency (EPA).
Order 12866, entitled ‘‘Regulatory technical standards that would require ACTION: Final rule.
Planning and Review’’ (58 FR 51735, EPA’s consideration of voluntary
October 4, 1993). Because this action consensus standards pursuant to section SUMMARY: This regulation establishes an
has been exempted from review under 12(d) of the National Technology exemption from the requirement of a
VerDate Sep<11>2014 17:40 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 E:\FR\FM\13SER1.SGM 13SER1](https://thefederalregister.org/doc/83_FR_46581/page/3.svg)
Document Created: 2018-09-13 01:01:32
Document Modified: 2018-09-13 01:01:32
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective September 13, 2018. Objections and requests for hearings must be received on or before November 13, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). | |
| Contact | Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: | |
| FR Citation | 83 FR 46403 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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