82 FR 35120 - Pseudomonas chlororaphis strain AFS009; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 144 (July 28, 2017)
Federal Register Volume 82, Issue 144 (July 28, 2017)
| Page Range | 35120-35122 | |
| FR Document | 2017-15741 |
[Federal Register Volume 82, Number 144 (Friday, July 28, 2017)] [Rules and Regulations] [Pages 35120-35122] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-15741] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0284; FRL-9961-77] Pseudomonas chlororaphis strain AFS009; 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 Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices. AFS009 Plant Protection, 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 Pseudomonas chlororaphis strain AFS009 under FFDCA. DATES: This regulation is effective July 28, 2017. Objections and requests for hearings must be received on or before September 26, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0284, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0284 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 September 26, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0284, 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 June 22, 2016 (81 FR 40594) (FRL-9947- 32), 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 5F8410) by AFS009 Plant Protection, Inc., 104 T.W. Alexander Dr., Building 18, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Pseudomonas chlororaphis subsp. aurantiaca strain AFS009 in or on all food commodities. That document referenced a summary of the petition prepared by the petitioner AFS009 Plant Protection, Inc., which is available in the docket via http://www.regulations.gov. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit III.C. Since the time the original notice of filing was published, the petitioner provided additional data on the identity [[Page 35121]] of the active ingredient to EPA. After reviewing these data, EPA now considers the correct identity of the active ingredient to be Pseudomonas chlororaphis strain AFS009 and not Pseudomonas chlororaphis subsp. aurantiaca strain AFS009. In order to give the public an opportunity to comment on this new information, EPA republished its receipt of this tolerance exemption petition filing with an updated and accurate description in the Federal Register of December 20, 2016 (81 FR 92758) (FRL-9956-04) and placed a revised petition from AFS009 Plant Protection, Inc. into the docket. There were no comments received in response to the republished notice of filing. III. Final Rule A. EPA's Safety Determination Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .'' Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider ``available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.'' EPA evaluated the available toxicological and exposure data on Pseudomonas chlororaphis strain AFS009 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its assessments based on those data can be found within the June 1, 2017, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Pseudomonas chlororaphis strain AFS009.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that Pseudomonas chlororaphis strain AFS009 is not likely to be toxic, is not pathogenic, and is not infective. Although there may be some exposure to residues when used on all food commodities 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 Pseudomonas chlororaphis strain AFS009. 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 Pseudomonas chlororaphis strain AFS009. Therefore, an exemption from the requirement of a tolerance is established for residues of Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology Due to the lack of toxicity, infectivity, and pathogenicity of Pseudomonas chlororaphis strain AFS009, EPA has determined that there is no need for an analytical method to measure and detect residues in or on food. C. Response to Comments One comment on the Notice of Filing was received. That comment opposed allowing residues of this pesticide on food but provided no additional information to support a conclusion that the substance is unsafe. EPA evaluated the available information on Pseudomonas chlororaphis strain AFS009, including toxicity and potential exposure, and concluded, in accordance with the statutory requirements of the FFDCA, that the exemption would be safe. The commenter has provided no basis for a different conclusion. IV. Statutory and Executive Order Reviews This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled ``Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require [[Page 35122]] EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). V. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: June 23, 2017. Richard P. Keigwin, Jr., Director, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180--[AMENDED] 0 1. The authority citation for part 180 continues to read as follows: Authority: 21 U.S.C. 321(q), 346a and 371. 0 2. Add Sec. 180.1341 to subpart D to read as follows: Sec. 180.1341 Pseudomonas chlororaphis strain AFS009; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Pseudomonas chlororaphis strain AFS009 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2017-15741 Filed 7-27-17; 8:45 am] BILLING CODE 6560-50-P
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Authority: 21 U.S.C. 321(q), 346a and 371. Constitution Ave. NW., Washington, DC must be in writing, and must be
■ 2. In § 180.612, add alphabetically 20460–0001. The Public Reading Room received by the Hearing Clerk on or
‘‘Sugarcane, cane’’ in the table in is open from 8:30 a.m. to 4:30 p.m., before September 26, 2017. Addresses
paragraph (a) to read as follows: Monday through Friday, excluding legal for mail and hand delivery of objections
holidays. The telephone number for the and hearing requests are provided in 40
§ 180.612 Topramezone; tolerances for Public Reading Room is (202) 566–1744, CFR 178.25(b).
residues. and the telephone number for the OPP In addition to filing an objection or
(a) * * * Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
the visitor instructions and additional as described in 40 CFR part 178, please
Parts per information about the docket available submit a copy of the filing (excluding
Commodity million any Confidential Business Information
at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
* * * * * Robert McNally, Biopesticides and Information not marked confidential
Sugarcane, cane ........................ 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
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
[FR Doc. 2017–15744 Filed 7–27–17; 8:45 am]
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
BILLING CODE 6560–50–P
number: (703) 305–7090; email address: 2016–0284, by one of the following
BPPDFRNotices@epa.gov. methods:
• Federal eRulemaking Portal: http://
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
AGENCY
I. General Information instructions for submitting comments.
40 CFR Part 180 Do not submit electronically any
A. Does this action apply to me? information you consider to be CBI or
[EPA–HQ–OPP–2016–0284; FRL–9961–77] You may be potentially affected by other information whose disclosure is
this action if you are an agricultural restricted by statute.
Pseudomonas chlororaphis strain • Mail: OPP Docket, Environmental
producer, food manufacturer, or
AFS009; Exemption From the Protection Agency Docket Center (EPA/
pesticide manufacturer. The following
Requirement of a Tolerance DC), (28221T), 1200 Pennsylvania Ave.
list of North American Industrial
AGENCY: Environmental Protection Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
Agency (EPA). not intended to be exhaustive, but rather • Hand Delivery: To make special
ACTION: Final rule. provides a guide to help readers arrangements for hand delivery or
determine whether this document delivery of boxed information, please
SUMMARY: This regulation establishes an applies to them. Potentially affected follow the instructions at http://
exemption from the requirement of a entities may include: www.epa.gov/dockets/contacts.html.
tolerance for residues of Pseudomonas • Crop production (NAICS code 111). Additional instructions on commenting
chlororaphis strain AFS009 in or on all • Animal production (NAICS code or visiting the docket, along with more
food commodities when used in 112). information about dockets generally, is
accordance with label directions and • Food manufacturing (NAICS code available at http://www.epa.gov/
good agricultural practices. AFS009 311). dockets.
Plant Protection, Inc. submitted a • Pesticide manufacturing (NAICS
II. Background
petition to EPA under the Federal Food, code 32532).
Drug, and Cosmetic Act (FFDCA), In the Federal Register of June 22,
B. How can I get electronic access to 2016 (81 FR 40594) (FRL–9947–32),
requesting an exemption from the
other related information? EPA issued a document pursuant to
requirement of a tolerance. This
regulation eliminates the need to You may access a frequently updated FFDCA section 408(d)(3), 21 U.S.C.
establish a maximum permissible level electronic version of 40 CFR part 180 346a(d)(3), announcing the filing of a
for residues of Pseudomonas through the Government Printing pesticide tolerance petition (PP 5F8410)
chlororaphis strain AFS009 under Office’s e-CFR site at http:// by AFS009 Plant Protection, Inc., 104
FFDCA. www.ecfr.gov/cgi-bin/text- T.W. Alexander Dr., Building 18,
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Research Triangle Park, NC 27709. The
DATES: This regulation is effective July
40tab_02.tpl. petition requested that 40 CFR part 180
28, 2017. Objections and requests for be amended by establishing an
hearings must be received on or before C. How can I file an objection or hearing exemption from the requirement of a
September 26, 2017, and must be filed request? tolerance for residues of Pseudomonas
in accordance with the instructions Under FFDCA section 408(g), 21 chlororaphis subsp. aurantiaca strain
provided in 40 CFR part 178 (see also U.S.C. 346a(g), any person may file an AFS009 in or on all food commodities.
Unit I.C. of the SUPPLEMENTARY objection to any aspect of this regulation That document referenced a summary of
INFORMATION). and may also request a hearing on those the petition prepared by the petitioner
ADDRESSES: The docket for this action, objections. You must file your objection AFS009 Plant Protection, Inc., which is
asabaliauskas on DSKBBXCHB2PROD with RULES
identified by docket identification (ID) or request a hearing on this regulation available in the docket via http://
number EPA–HQ–OPP–2016–0284, is in accordance with the instructions www.regulations.gov. One comment was
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure received on the notice of filing. EPA’s
or at the Office of Pesticide Programs proper receipt by EPA, you must response to this comment is discussed
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– in Unit III.C.
in the Environmental Protection Agency OPP–2016–0284 in the subject line on Since the time the original notice of
Docket Center (EPA/DC), West William the first page of your submission. All filing was published, the petitioner
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing provided additional data on the identity
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of the active ingredient to EPA. After assessments based on those data can be in response to a petition submitted to
reviewing these data, EPA now found within the June 1, 2017, EPA. The Office of Management and
considers the correct identity of the document entitled ‘‘Federal Food, Drug, Budget (OMB) has exempted these types
active ingredient to be Pseudomonas and Cosmetic Act (FFDCA) of actions from review under Executive
chlororaphis strain AFS009 and not Considerations for Pseudomonas Order 12866, entitled ‘‘Regulatory
Pseudomonas chlororaphis subsp. chlororaphis strain AFS009.’’ This Planning and Review’’ (58 FR 51735,
aurantiaca strain AFS009. In order to document, as well as other relevant October 4, 1993). Because this action
give the public an opportunity to information, is available in the docket has been exempted from review under
comment on this new information, EPA for this action as described under Executive Order 12866, this action is
republished its receipt of this tolerance ADDRESSES. not subject to Executive Order 13211,
exemption petition filing with an Based upon its evaluation, EPA entitled ‘‘Actions Concerning
updated and accurate description in the concludes that Pseudomonas Regulations That Significantly Affect
Federal Register of December 20, 2016 chlororaphis strain AFS009 is not likely Energy Supply, Distribution, or Use’’ (66
(81 FR 92758) (FRL–9956–04) and to be toxic, is not pathogenic, and is not FR 28355, May 22, 2001), or Executive
placed a revised petition from AFS009 infective. Although there may be some Order 13045, entitled ‘‘Protection of
Plant Protection, Inc. into the docket. exposure to residues when used on all Children from Environmental Health
There were no comments received in food commodities in accordance with Risks and Safety Risks’’ (62 FR 19885,
response to the republished notice of label directions and good agricultural April 23, 1997). This action does not
filing. practices, there is a lack of concern due contain any information collections
to the lack of potential for adverse subject to OMB approval under the
III. Final Rule effects. EPA also determined that Paperwork Reduction Act (PRA), 44
A. EPA’s Safety Determination retention of the Food Quality Protection U.S.C. 3501 et seq., nor does it require
Act (FQPA) safety factor was not any special considerations under
Section 408(c)(2)(A)(i) of FFDCA
necessary as part of the qualitative Executive Order 12898, entitled
allows EPA to establish an exemption
assessment conducted for Pseudomonas ‘‘Federal Actions to Address
from the requirement for a tolerance (the
chlororaphis strain AFS009. Environmental Justice in Minority
legal limit for a pesticide chemical
Based upon its evaluation, EPA Populations and Low-Income
residue in or on a food) only if EPA Populations’’ (59 FR 7629, February 16,
concludes that there is a reasonable
determines that the exemption is ‘‘safe.’’ 1994).
certainty that no harm will result to the
Section 408(c)(2)(A)(ii) of FFDCA Since tolerances and exemptions that
U.S. population, including infants and
defines ‘‘safe’’ to mean that ‘‘there is a are established on the basis of a petition
children, from aggregate exposure to
reasonable certainty that no harm will under FFDCA section 408(d), such as
residues of Pseudomonas chlororaphis
result from aggregate exposure to the the tolerance exemption in this action,
strain AFS009. Therefore, an exemption
pesticide chemical residue, including do not require the issuance of a
from the requirement of a tolerance is
all anticipated dietary exposures and all proposed rule, the requirements of the
established for residues of Pseudomonas
other exposures for which there is Regulatory Flexibility Act (RFA) (5
chlororaphis strain AFS009 in or on all
reliable information.’’ This includes U.S.C. 601 et seq.) do not apply.
food commodities when used in
exposure through drinking water and in This action directly regulates growers,
accordance with label directions and
residential settings but does not include food processors, food handlers, and food
good agricultural practices.
occupational exposure. Pursuant to retailers, not States or tribes. As a result,
FFDCA section 408(c)(2)(B), in B. Analytical Enforcement Methodology this action does not alter the
establishing or maintaining in effect an Due to the lack of toxicity, infectivity, relationships or distribution of power
exemption from the requirement of a and pathogenicity of Pseudomonas and responsibilities established by
tolerance, EPA must take into account chlororaphis strain AFS009, EPA has Congress in the preemption provisions
the factors set forth in FFDCA section determined that there is no need for an of FFDCA section 408(n)(4). As such,
408(b)(2)(C), which require EPA to give analytical method to measure and detect EPA has determined that this action will
special consideration to exposure of residues in or on food. not have a substantial direct effect on
infants and children to the pesticide States or tribal governments, on the
chemical residue in establishing a C. Response to Comments relationship between the national
tolerance or tolerance exemption and to One comment on the Notice of Filing government and the States or tribal
‘‘ensure that there is a reasonable was received. That comment opposed governments, or on the distribution of
certainty that no harm will result to allowing residues of this pesticide on power and responsibilities among the
infants and children from aggregate food but provided no additional various levels of government or between
exposure to the pesticide chemical information to support a conclusion that the Federal Government and Indian
residue . . . .’’ Additionally, FFDCA the substance is unsafe. EPA evaluated tribes. Thus, EPA has determined that
section 408(b)(2)(D) requires that EPA the available information on Executive Order 13132, entitled
consider ‘‘available information Pseudomonas chlororaphis strain ‘‘Federalism’’ (64 FR 43255, August 10,
concerning the cumulative effects of [a AFS009, including toxicity and 1999), and Executive Order 13175,
particular pesticide’s] . . . residues and potential exposure, and concluded, in entitled ‘‘Consultation and Coordination
other substances that have a common accordance with the statutory with Indian Tribal Governments’’ (65 FR
mechanism of toxicity.’’ requirements of the FFDCA, that the 67249, November 9, 2000), do not apply
asabaliauskas on DSKBBXCHB2PROD with RULES
EPA evaluated the available exemption would be safe. The to this action. In addition, this action
toxicological and exposure data on commenter has provided no basis for a does not impose any enforceable duty or
Pseudomonas chlororaphis strain different conclusion. contain any unfunded mandate as
AFS009 and considered its validity, described under Title II of the Unfunded
completeness, and reliability, as well as IV. Statutory and Executive Order Mandates Reform Act (UMRA) (2 U.S.C.
the relationship of this information to Reviews 1501 et seq.).
human risk. A full explanation of the This action establishes a tolerance This action does not involve any
data upon which EPA relied and its exemption under FFDCA section 408(d) technical standards that would require
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EPA’s consideration of voluntary DEPARTMENT OF HEALTH AND Medicare, Medicaid or CHIP providers
consensus standards pursuant to section HUMAN SERVICES and suppliers, including categories of
12(d) of the National Technology providers and suppliers, if the Secretary
Transfer and Advancement Act Centers for Medicare & Medicaid determines a moratorium is necessary to
(NTTAA) (15 U.S.C. 272 note). Services prevent or combat fraud, waste, or abuse
under these programs. Section 6401(b)
V. Congressional Review Act 42 CFR Part 424 of the Affordable Care Act added
[CMS–6059–N7]
specific moratorium language applicable
Pursuant to the Congressional Review
to Medicaid at section 1902(kk)(4) of the
Act (5 U.S.C. 801 et seq.), EPA will Act, requiring States to comply with any
submit a report containing this rule and Medicare, Medicaid, and Children’s
Health Insurance Programs: moratorium imposed by the Secretary
other required information to the U.S. unless the State determines that the
Announcement of the Extension of
Senate, the U.S. House of imposition of such moratorium would
Temporary Moratoria on Enrollment of
Representatives, and the Comptroller adversely impact Medicaid
Part B Non-Emergency Ground
General of the United States prior to Ambulance Suppliers and Home Health beneficiaries’ access to care. Section
publication of the rule in the Federal Agencies in Designated Geographic 6401(c) of the Affordable Care Act
Register. This action is not a ‘‘major Locations amended section 2107(e)(1) of the Act to
rule’’ as defined by 5 U.S.C. 804(2). provide that all of the Medicaid
AGENCY: Centers for Medicare & provisions in sections 1902(a)(77) and
List of Subjects in 40 CFR Part 180 Medicaid Services (CMS), HHS. 1902(kk) are also applicable to CHIP.
Environmental protection, ACTION: Extension of temporary In the February 2, 2011 Federal
Administrative practice and procedure, moratoria. Register (76 FR 5862), CMS published a
final rule with comment period titled,
Agricultural commodities, Pesticides SUMMARY: This document announces the ‘‘Medicare, Medicaid, and Children’s
and pests, Reporting and recordkeeping extension of statewide temporary Health Insurance Programs; Additional
requirements. moratoria on the enrollment of new Screening Requirements, Application
Dated: June 23, 2017. Medicare Part B non-emergency ground Fees, Temporary Enrollment Moratoria,
Richard P. Keigwin, Jr., ambulance providers and suppliers and Payment Suspensions and Compliance
Medicare home health agencies, Plans for Providers and Suppliers,’’
Director, Office of Pesticide Programs.
subunits, and branch locations in which implemented section 1866(j)(7) of
Therefore, 40 CFR chapter I is Florida, Illinois, Michigan, Texas, the Act by establishing new regulations
amended as follows: Pennsylvania, and New Jersey, as at 42 CFR 424.570. Under
applicable, to prevent and combat fraud, § 424.570(a)(2)(i) and (iv), CMS, or CMS
PART 180—[AMENDED] waste, and abuse. This extension also in consultation with the Department of
applies to the enrollment of new non- Health and Human Services’ Office of
■ 1. The authority citation for part 180 emergency ground ambulance suppliers Inspector General (HHS–OIG) or the
continues to read as follows: and home health agencies, subunits, and Department of Justice (DOJ), or both,
branch locations in Medicaid and the may impose a temporary moratorium on
Authority: 21 U.S.C. 321(q), 346a and 371. Children’s Health Insurance Program in newly enrolling Medicare providers and
■ 2. Add § 180.1341 to subpart D to read those states. suppliers if CMS determines that there
as follows: DATES: Applicable July 29, 2017. is a significant potential for fraud,
FOR FURTHER INFORMATION CONTACT: waste, or abuse with respect to a
§ 180.1341 Pseudomonas chlororaphis Steve Manning, (410) 786–1691. particular provider or supplier type, or
strain AFS009; exemption from the News media representatives must particular geographic locations, or both.
requirement of a tolerance. contact CMS’ Public Affairs Office at At § 424.570(a)(1)(ii), CMS stated that it
(202) 690–6145 or email them at press@ would announce any temporary
An exemption from the requirement moratorium in a Federal Register
of a tolerance is established for residues cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
document that includes the rationale for
of Pseudomonas chlororaphis strain the imposition of such moratorium. This
AFS009 in or on all food commodities I. Background document fulfills that requirement.
when used in accordance with label In accordance with section
directions and good agricultural A. CMS’ Implementation of Temporary
1866(j)(7)(B) of the Act, there is no
practices. Enrollment Moratoria
judicial review under sections 1869 and
[FR Doc. 2017–15741 Filed 7–27–17; 8:45 am] Under the Patient Protection and 1878 of the Act, or otherwise, of the
Affordable Care Act (Pub. L. 111–148), decision to impose a temporary
BILLING CODE 6560–50–P
as amended by the Health Care and enrollment moratorium. A provider or
Education Reconciliation Act of 2010 supplier may use the existing appeal
(Pub. L. 111–152) (collectively known as procedures at 42 CFR part 498 to
the Affordable Care Act), the Congress administratively appeal a denial of
provided the Secretary with new tools billing privileges based on the
and resources to combat fraud, waste, imposition of a temporary moratorium;
asabaliauskas on DSKBBXCHB2PROD with RULES
and abuse in Medicare, Medicaid, and however, the scope of any such appeal
the Children’s Health Insurance is limited solely to assessing whether
Program (CHIP). Section 6401(a) of the the temporary moratorium applies to the
Affordable Care Act added a new provider or supplier appealing the
section 1866(j)(7) to the Social Security denial. Under § 424.570(c), CMS denies
Act (the Act) to provide the Secretary the enrollment application of a provider
with authority to impose a temporary or supplier if the provider or supplier is
moratorium on the enrollment of new subject to a moratorium. If the provider
VerDate Sep<11>2014 17:01 Jul 27, 2017 Jkt 241001 PO 00000 Frm 00066 Fmt 4700 Sfmt 4700 E:\FR\FM\28JYR1.SGM 28JYR1](https://thefederalregister.org/doc/82_FR_35264/page/3.svg)
Document Created: 2017-07-28 03:10:15
Document Modified: 2017-07-28 03:10:15
| 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 July 28, 2017. Objections and requests for hearings must be received on or before September 26, 2017, 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: (703) 305-7090; email | |
| FR Citation | 82 FR 35120 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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