83 FR 46401 - Bacteriophage Active Against Erwinia amylovora; 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 | 46401-46403 | |
| FR Document | 2018-19954 |
[Federal Register Volume 83, Number 178 (Thursday, September 13, 2018)] [Rules and Regulations] [Pages 46401-46403] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19954] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2017-0702; FRL-9983-18] Bacteriophage Active Against Erwinia amylovora; 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 Erwinia amylovora that are produced in Erwinia amylovora in or on apple and pear, 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 Erwinia amylovora in or on apple and pear 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-2017-0702, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0702 in the subject line on [[Page 46402]] 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-2017-0702, 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 6, 2018 (83 FR 9471) (FRL-9973- 27), 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 7F8573) 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 Erwinia amylovora in or on apple and pear. 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 Erwinia amylovora 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 Erwinia amylovora.'' 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 Erwinia amylovora 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 Erwinia amylovora that are used on apple and pear 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 necessary as part of the qualitative assessment conducted for bacteriophage active against Erwinia amylovora. 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 Erwinia amylovora. Therefore, an exemption from the requirement of a tolerance is established for residues of lytic bacteriophage active against Erwinia amylovora that are produced in Erwinia amylovora in or on apple and pear, 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 Erwinia amylovora in or on apple and pear. The petitioner's supporting materials indicated that the actual pesticide that would be used would be safe because the bacteriophage were lytic and were produced in Erwinia amylovora. 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 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) [[Page 46403]] 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. 180.1359 to subpart D to read as follows: Sec. 180.1359 Bacteriophage active against Erwinia amylovora; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of lytic bacteriophage active against Erwinia amylovora that are produced in Erwinia amylovora in or on apple and pear, when used in accordance with label directions and good agricultural practices. [FR Doc. 2018-19954 Filed 9-12-18; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations 46401
Transfer and Advancement Act Parts per in the Environmental Protection Agency
Commodity
(NTTAA) (15 U.S.C. 272 note). million Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
VII. Congressional Review Act Leafy Greens, subgroup 4–16A 2.0 Constitution Ave. NW, Washington, DC
Pursuant to the Congressional Review Leaf petiole vegetable subgroup 20460–0001. The Public Reading Room
Act (5 U.S.C. 801 et seq.), EPA will 22B .......................................... 3.0
Nut, tree, group 14–12 ............... 0.01
is open from 8:30 a.m. to 4:30 p.m.,
submit a report containing this rule and Monday through Friday, excluding legal
Soybean, seed ............................ 0.01
other required information to the U.S. Tomato, dried ............................. 0.50 holidays. The telephone number for the
Senate, the U.S. House of Vegetable, cucurbit, group 9 ...... 0.70 Public Reading Room is (202) 566–1744,
Representatives, and the Comptroller Vegetable, fruiting, group 8–10 .. 0.20 and the telephone number for the OPP
General of the United States prior to Vegetable, tuberous and corm, Docket is (703) 305–5805. Please review
publication of the rule in the Federal subgroup 1C ........................... 0.01 the visitor instructions and additional
Register. This action is not a ‘‘major information about the docket available
rule’’ as defined by 5 U.S.C. 804(2). (b) Section 18 emergency exemptions. at http://www.epa.gov/dockets.
[Reserved] FOR FURTHER INFORMATION CONTACT:
List of Subjects in 40 CFR Part 180 (c) Tolerances with regional
Robert McNally, Biopesticides and
Environmental protection, registrations. [Reserved]
Pollution Prevention Division (7511P),
Administrative practice and procedure, (d) Indirect or inadvertent residues.
Office of Pesticide Programs,
Agricultural commodities, Pesticides [Reserved]
[FR Doc. 2018–19951 Filed 9–12–18; 8:45 am]
Environmental Protection Agency, 1200
and pests, Reporting and recordkeeping
Pennsylvania Ave. NW, Washington, DC
requirements. BILLING CODE 6560–50–P
20460–0001; main telephone number:
Dated: September 5, 2018. (703) 305–7090; email address:
Richard P. Keigwin, Jr., ENVIRONMENTAL PROTECTION BPPDFRNotices@epa.gov.
Director, Office of Pesticide Programs. AGENCY SUPPLEMENTARY INFORMATION:
Therefore, 40 CFR chapter I is
I. General Information
amended as follows: 40 CFR Part 180
[EPA–HQ–OPP–2017–0702; FRL–9983–18] A. Does this action apply to me?
PART 180—[AMENDED]
You may be potentially affected by
■ 1. The authority citation for part 180 Bacteriophage Active Against Erwinia this action if you are an agricultural
continues to read as follows: amylovora; Exemption from the producer, food manufacturer, or
Requirement of a Tolerance pesticide manufacturer. The following
Authority: 21 U.S.C. 321(q), 346a and 371.
AGENCY: Environmental Protection list of North American Industrial
■ 2. Add § 180.700 to subpart C to read Classification System (NAICS) codes is
as follows: Agency (EPA).
not intended to be exhaustive, but rather
ACTION: Final rule.
§ 180.700 Afidopyropen; Tolerances for provides a guide to help readers
residues. SUMMARY: This regulation establishes an determine whether this document
(a) General. Tolerances are exemption from the requirement of a applies to them. Potentially affected
established for residues of tolerance for residues of lytic entities may include:
afidopyropen, including its metabolites bacteriophage active against Erwinia • Crop production (NAICS code 111).
and degradates, in or on the amylovora that are produced in Erwinia • Animal production (NAICS code
commodities in the table below. amylovora in or on apple and pear, 112).
Compliance with the tolerance levels when used in accordance with label • Food manufacturing (NAICS code
specified below is to be determined by directions and good agricultural 311).
practices. OmniLytics, Inc. submitted a • Pesticide manufacturing (NAICS
measuring only afidopyropen,
petition to EPA under the Federal Food, code 32532).
[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-
[(cyclopropylcarbonyl)oxy]- Drug, and Cosmetic Act (FFDCA), B. How can I get electronic access to
1,3,4,4a,5,6,6a,12,12a,12b-decahydro- requesting an exemption from the other related information?
6,12-dihydroxy-4,6a,12b-trimethyl-11- requirement of a tolerance. This
You may access a frequently updated
oxo-9-(3-pyridinyl)-2H,11H- regulation eliminates the need to
electronic version of 40 CFR part 180
naphtho[2,1-b]pyrano[3,4-e]pyran-4- establish a maximum permissible level
through the Government Printing
yl]methyl cyclopropanecarboxylate, in for residues of bacteriophage active
Office’s e-CFR site at http://www.ecfr.
or on the following food commodities: against Erwinia amylovora in or on
gov/cgi-bin/text-idx?&c=ecfr&tpl=/
apple and pear under FFDCA.
ecfrbrowse/Title40/40tab_02.tpl.
Parts per DATES: This regulation is effective
Commodity million September 13, 2018. Objections and C. How can I file an objection or hearing
requests for hearings must be received request?
Almond, hulls .............................. 0.15
Apple, wet pomace ..................... 0.05 on or before November 13, 2018, and Under FFDCA section 408(g), 21
Brassica, head and stem, group must be filed in accordance with the U.S.C. 346a(g), any person may file an
5–16 ........................................ 0.50 instructions provided in 40 CFR part objection to any aspect of this regulation
Brassica, leafy greens, subgroup 178 (see also Unit I.C. of the and may also request a hearing on those
4–16B ...................................... 5.0 SUPPLEMENTARY INFORMATION). objections. You must file your objection
daltland on DSKBBV9HB2PROD with RULES
Citrus, oil ..................................... 0.40
ADDRESSES: The docket for this action, or request a hearing on this regulation
Cotton, gin byproducts ............... 2.0
Cotton, undelinted seed ............. 0.08
identified by docket identification (ID) in accordance with the instructions
Fruit, citrus, group 10–10 ........... 0.15 number EPA–HQ–OPP–2017–0702, is provided in 40 CFR part 178. To ensure
Fruit, pome, group 11–10 ........... 0.02 available at http://www.regulations.gov proper receipt by EPA, you must
Fruit, stone, group 12–12 ........... 0.03 or at the Office of Pesticide Programs identify docket ID number EPA–HQ–
Grain, aspirated fractions ........... 0.15 Regulatory Public Docket (OPP Docket) OPP–2017–0702 in the subject line on
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![46402 Federal Register / Vol. 83, No. 178 / Thursday, September 13, 2018 / Rules and Regulations
the first page of your submission. All that differs slightly from what the have been exposed to bacteriophage
objections and requests for a hearing petition requested. The reason for this through food and water, where they are
must be in writing, and must be difference is explained in Unit III.C. commonly found, with no known
received by the Hearing Clerk on or adverse effects. Although there may be
III. Final Rule
before November 13, 2018. Addresses some exposure to residues of
for mail and hand delivery of objections A. EPA’s Safety Determination bacteriophage active against Erwinia
and hearing requests are provided in 40 Section 408(c)(2)(A)(i) of FFDCA amylovora that are used on apple and
CFR 178.25(b). allows EPA to establish an exemption pear in accordance with label directions
In addition to filing an objection or and good agricultural practices, there is
from the requirement of a tolerance (the
hearing request with the Hearing Clerk a lack of concern due to the lack of
legal limit for a pesticide chemical
as described in 40 CFR part 178, please potential for adverse effects. EPA also
residue in or on a food) only if EPA
submit a copy of the filing (excluding determined that retention of the Food
determines that the exemption is ‘‘safe.’’
any Confidential Business Information Quality Protection Act (FQPA) safety
Section 408(c)(2)(A)(ii) of FFDCA
(CBI)) for inclusion in the public docket. factor was not necessary as part of the
defines ‘‘safe’’ to mean that ‘‘there is a
Information not marked confidential qualitative assessment conducted for
reasonable certainty that no harm will
pursuant to 40 CFR part 2 may be bacteriophage active against Erwinia
disclosed publicly by EPA without prior result from aggregate exposure to the
pesticide chemical residue, including amylovora.
notice. Submit the non-CBI copy of your Based upon its evaluation, EPA
objection or hearing request, identified all anticipated dietary exposures and all
concludes that there is a reasonable
by docket ID number EPA–HQ–OPP– other exposures for which there is
certainty that no harm will result to the
2017–0702, by one of the following reliable information.’’ This includes
U.S. population, including infants and
methods: exposure through drinking water and in
children, from aggregate exposure to
• Federal eRulemaking Portal: http:// residential settings but does not include
residues of bacteriophage active against
www.regulations.gov. Follow the online occupational exposure. Pursuant to
Erwinia amylovora. Therefore, an
instructions for submitting comments. FFDCA section 408(c)(2)(B), in
exemption from the requirement of a
Do not submit electronically any establishing or maintaining in effect an
tolerance is established for residues of
information you consider to be CBI or exemption from the requirement of a
lytic bacteriophage active against
other information whose disclosure is tolerance, EPA must take into account
Erwinia amylovora that are produced in
restricted by statute. the factors set forth in FFDCA section
Erwinia amylovora in or on apple and
• Mail: OPP Docket, Environmental 408(b)(2)(C), which require EPA to give
pear, when used in accordance with
Protection Agency Docket Center (EPA/ special consideration to exposure of
label directions and good agricultural
DC), (28221T), 1200 Pennsylvania Ave., infants and children to the pesticide
practices.
NW, Washington, DC 20460–0001. chemical residue in establishing a
• Hand Delivery: To make special tolerance or tolerance exemption and to B. Analytical Enforcement Methodology
arrangements for hand delivery or ‘‘ensure that there is a reasonable An analytical method is not required
delivery of boxed information, please certainty that no harm will result to because EPA is establishing an
follow the instructions at http:// infants and children from aggregate exemption from the requirement of a
www.epa.gov/dockets/contacts.html. exposure to the pesticide chemical tolerance without any numerical
Additional instructions on commenting residue. . . .’’ Additionally, FFDCA limitation.
or visiting the docket, along with more section 408(b)(2)(D) requires that EPA
information about dockets generally, is consider ‘‘available information C. Differences Between Petition and
available at http://www.epa.gov/ concerning the cumulative effects of [a Tolerance Exemption Rule
dockets. particular pesticide’s] . . . residues and In its petition, the petitioner
other substances that have a common requested generally that EPA issue an
II. Background mechanism of toxicity.’’ exemption from the requirement of a
In the Federal Register of March 6, EPA evaluated the available tolerance for residues of bacteriophage
2018 (83 FR 9471) (FRL–9973–27), EPA toxicological and exposure data on active against Erwinia amylovora in or
issued a document pursuant to FFDCA bacteriophage active against Erwinia on apple and pear. The petitioner’s
section 408(d)(3), 21 U.S.C. 346a(d)(3), amylovora and considered their supporting materials indicated that the
announcing the filing of a pesticide validity, completeness, and reliability, actual pesticide that would be used
tolerance petition (PP 7F8573) by as well as the relationship of this would be safe because the bacteriophage
OmniLytics, Inc., 9100 South 500 West, information to human risk. A full were lytic and were produced in
Sandy, UT 84070. The petition explanation of the data upon which EPA Erwinia amylovora. EPA believes that
requested that 40 CFR part 180 be relied and its risk assessment based on only bacteriophage that have these same
amended by establishing an exemption those data can be found within the characteristics as the organism tested
from the requirement of a tolerance for document entitled ‘‘Federal Food, Drug, would be safe and should be exempt
residues of the bactericide and Cosmetic Act (FFDCA) Safety from the requirement of a tolerance.
bacteriophage active against Erwinia Determination for Bacteriophage Active Therefore, EPA is issuing a tolerance
amylovora in or on apple and pear. That Against Erwinia amylovora.’’ This exemption that differs slightly from the
document referenced a summary of the document, as well as other relevant petition by limiting the exemption to
petition prepared by the petitioner information, is available in the docket residues of bacteriophage that possess
OmniLytics, Inc. and available in the for this action as described under the same characteristics as the
daltland on DSKBBV9HB2PROD with RULES
docket via http://www.regulations.gov. ADDRESSES. bacteriophage that were tested to
There were no comments regarding this The available data demonstrated that support this exemption.
exemption received in response to the bacteriophage active against Erwinia
notice of filing. amylovora are not anticipated to be IV. Statutory and Executive Order
Based upon review of data and other toxic, pathogenic, or infective via any Reviews
information supporting the petition, route of exposure. Furthermore, This action establishes a tolerance
EPA is granting a tolerance exemption humans, including infants and children, exemption under FFDCA section 408(d)
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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),
VerDate Sep<11>2014 17:40 Sep 12, 2018 Jkt 244001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\FR\FM\13SER1.SGM 13SER1](https://thefederalregister.org/doc/83_FR_46579/page/3.svg)
Document Created: 2018-09-13 01:01:36
Document Modified: 2018-09-13 01:01:36
| 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, | |
| FR Citation | 83 FR 46401 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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