82 FR 14636 - Polyglycerol Polyricinoleate; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 54 (March 22, 2017)
Federal Register Volume 82, Issue 54 (March 22, 2017)
| Page Range | 14636-14639 | |
| FR Document | 2017-05703 |
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)] [Rules and Regulations] [Pages 14636-14639] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05703] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0606; FRL-9959-12] Polyglycerol Polyricinoleate; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of polyglycerol polyricinoleate when used as an inert ingredient in a pesticide chemical formulation. AgroFresh 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 polyglycerol polyricinoleate on food or feed commodities. DATES: This regulation is effective March 22, 2017. Objections and requests for hearings must be received on or before May 22, 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-2016-0606, 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: Michael Goodis, Registration Division (7505P), 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. Can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, 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-2016-0606 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 May 22, 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-2016-0606, by one of the following methods. Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. II. Background and Statutory Findings In the Federal Register of December 20, 2016 (81 FR 927580) (FRL- 9956-04), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN- 10970) filed by AgroFresh Inc., 400 Arcola Road, P.O. Box 7000 (RC3356), Collegeville, PA 19426. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of polyglycerol polyricinoleate (CAS Reg. No. 29894-35-7). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments. 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 use in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing an exemption from the requirement of a tolerance 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 . . .'' and specifies [[Page 14637]] factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Polyglycerol polyricinoleate conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers: a. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. b. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. c. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). d. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. e. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. f. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. g. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF 3 - or longer chain length as specified in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e). h. The polymer's number average MW of 2,500 daltons is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Thus, polyglycerol polyricinoleate meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to polyglycerol polyricinoleate. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that polyglycerol polyricinoleate could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of polyglycerol polyricinoleate is 2,500 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since polyglycerol polyricinoleate conforms to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. V. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found polyglycerol polyricinoleate to share a common mechanism of toxicity with any other substances, and polyglycerol polyricinoleate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that polyglycerol polyricinoleate does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. VI. Additional Safety Factor for the Protection of Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of polyglycerol polyricinoleate, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VII. Determination of Safety Based on the conformance to the criteria used to identify a low- risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of polyglycerol polyricinoleate. VIII. Other Considerations A. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint [[Page 14638]] United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for polyglycerol polyricinoleate. IX. Conclusion Accordingly, EPA finds that exempting residues of polyglycerol polyricinole from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive 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 in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled ``Consultation and Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). XI. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 16, 2017. Michael Goodis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: PART 180 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. In Sec. 180.960, add alphabetically the entry ``Polyglycerol polyricinoleate; minimum number average molecular weight (in amu), 2,500'' to the table to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Polyglycerol polyricinoleate; minimum number average 29894-35-7 molecular weight (in amu), 2,500....................... * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2017-05703 Filed 3-21-17; 8:45 am] BILLING CODE 6560-50-P
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[FR Doc. 2017–05708 Filed 3–21–17; 8:45 am] SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http://
BILLING CODE 6560–50–P www.regulations.gov. Follow the online
I. General Information
instructions for submitting comments.
A. Does this action apply to me? Do not submit electronically any
ENVIRONMENTAL PROTECTION information you consider to be CBI or
You may be potentially affected by
AGENCY other information whose disclosure is
this action if you are an agricultural
restricted by statute.
producer, food manufacturer, or
40 CFR Part 180 • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
[EPA–HQ–OPP–2016–0606; FRL–9959–12] list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
Polyglycerol Polyricinoleate; Tolerance not intended to be exhaustive, but rather
Exemption • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
AGENCY: Environmental Protection determine whether this document delivery of boxed information, please
Agency (EPA). applies to them. Potentially affected follow the instructions at http://
ACTION: Final rule. entities may include: www.epa.gov/dockets/contacts.html.
• Crop production (NAICS code 111). Additional instructions on
SUMMARY: This regulation establishes an • Animal production (NAICS code commenting or visiting the docket,
exemption from the requirement of a 112). along with more information about
tolerance for residues of polyglycerol • Food manufacturing (NAICS code dockets generally, is available at http://
polyricinoleate when used as an inert 311). www.epa.gov/dockets.
ingredient in a pesticide chemical • Pesticide manufacturing (NAICS
formulation. AgroFresh Inc., submitted code 32532). II. Background and Statutory Findings
a petition to EPA under the Federal In the Federal Register of December
Food, Drug, and Cosmetic Act (FFDCA), B. How can I get electronic access to
20, 2016 (81 FR 927580) (FRL–9956–04),
requesting an exemption from the other related information?
EPA issued a document pursuant to
requirement of a tolerance. This You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
regulation eliminates the need to electronic version of 40 CFR part 180 announcing the receipt of a pesticide
establish a maximum permissible level through the Government Printing petition (PP IN–10970) filed by
for residues of polyglycerol Office’s e-CFR site at http:// AgroFresh Inc., 400 Arcola Road, P.O.
polyricinoleate on food or feed www.ecfr.gov/cgi-bin/text- Box 7000 (RC3356), Collegeville, PA
commodities. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 19426. The petition requested that 40
DATES: This regulation is effective 40tab_02.tpl. CFR 180.960 be amended by
March 22, 2017. Objections and requests establishing an exemption from the
C. Can I file an objection or hearing
for hearings must be received on or requirement of a tolerance for residues
request?
before May 22, 2017, and must be filed of polyglycerol polyricinoleate (CAS
Under FFDCA section 408(g), 21 Reg. No. 29894–35–7). That document
in accordance with the instructions
U.S.C. 346a, any person may file an included a summary of the petition
provided in 40 CFR part 178 (see also
objection to any aspect of this regulation prepared by the petitioner and solicited
Unit I.C. of the SUPPLEMENTARY
and may also request a hearing on those comments on the petitioner’s request.
INFORMATION).
objections. You must file your objection The Agency did not receive any
ADDRESSES: The docket for this action, or request a hearing on this regulation comments.
identified by docket identification (ID) in accordance with the instructions Section 408(c)(2)(A)(i) of FFDCA
number EPA–HQ–OPP–2016–0606, is provided in 40 CFR part 178. To ensure allows EPA to establish an exemption
available at http://www.regulations.gov proper receipt by EPA, you must from the requirement for a tolerance (the
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– legal limit for a pesticide chemical
Regulatory Public Docket (OPP Docket) OPP–2016–0606 in the subject line on residue in or on a food) only if EPA
in the Environmental Protection Agency the first page of your submission. All determines that the exemption is ‘‘safe.’’
Docket Center (EPA/DC), West William objections and requests for a hearing Section 408(c)(2)(A)(ii) of FFDCA
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be defines ‘‘safe’’ to mean that ‘‘there is a
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or reasonable certainty that no harm will
20460–0001. The Public Reading Room before May 22, 2017. Addresses for mail result from aggregate exposure to the
is open from 8:30 a.m. to 4:30 p.m., and hand delivery of objections and pesticide chemical residue, including
Monday through Friday, excluding legal hearing requests are provided in 40 CFR all anticipated dietary exposures and all
holidays. The telephone number for the 178.25(b). other exposures for which there is
Public Reading Room is (202) 566–1744, In addition to filing an objection or reliable information.’’ This includes
and the telephone number for the OPP hearing request with the Hearing Clerk exposure through drinking water and
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please use in residential settings, but does not
the visitor instructions and additional submit a copy of the filing (excluding include occupational exposure. Section
information about the docket available any Confidential Business Information 408(b)(2)(C) of FFDCA requires EPA to
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket. give special consideration to exposure
FOR FURTHER INFORMATION CONTACT: Information not marked confidential of infants and children to the pesticide
jstallworth on DSK7TPTVN1PROD with RULES
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be chemical residue in establishing an
(7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior exemption from the requirement of a
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your tolerance and to ‘‘ensure that there is a
Pennsylvania Ave. NW., Washington, objection or hearing request, identified reasonable certainty that no harm will
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP– result to infants and children from
number: (703) 305–7090; email address: 2016–0606, by one of the following aggregate exposure to the pesticide
RDFRNotices@epa.gov. methods. chemical residue . . .’’ and specifies
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United Nations Food and Agriculture any special considerations under Agency consideration of voluntary
Organization/World Health Executive Order 12898, entitled consensus standards pursuant to section
Organization food standards program, ‘‘Federal Actions to Address 12(d) of the National Technology
and it is recognized as an international Environmental Justice in Minority Transfer and Advancement Act
food safety standards-setting Populations and Low-Income (NTTAA) (15 U.S.C. 272 note).
organization in trade agreements to Populations’’ (59 FR 7629, February 16,
which the United States is a party. EPA XI. Congressional Review Act
1994).
may establish a tolerance that is Since tolerances and exemptions that Pursuant to the Congressional Review
different from a Codex MRL; however, are established on the basis of a petition Act (5 U.S.C. 801 et seq.), EPA will
FFDCA section 408(b)(4) requires that under FFDCA section 408(d), such as submit a report containing this rule and
EPA explain the reasons for departing the tolerance in this final rule, do not other required information to the U.S.
from the Codex level. require the issuance of a proposed rule, Senate, the U.S. House of
The Codex has not established a MRL the requirements of the Regulatory Representatives, and the Comptroller
for polyglycerol polyricinoleate. Flexibility Act (RFA) (5 U.S.C. 601 et General of the United States prior to
IX. Conclusion seq.), do not apply. publication of the rule in the Federal
This action directly regulates growers, Register. This action is not a ‘‘major
Accordingly, EPA finds that
food processors, food handlers, and food rule’’ as defined by 5 U.S.C. 804(2).
exempting residues of polyglycerol
retailers, not States or tribes, nor does
polyricinole from the requirement of a List of Subjects in 40 CFR Part 180
this action alter the relationships or
tolerance will be safe.
distribution of power and Environmental protection,
X. Statutory and Executive Order responsibilities established by Congress Administrative practice and procedure,
Reviews in the preemption provisions of FFDCA Agricultural commodities, Pesticides
This action establishes an exemption section 408(n)(4). As such, the Agency and pests, Reporting and recordkeeping
from the requirement of a tolerance has determined that this action will not requirements.
under FFDCA section 408(d) in have a substantial direct effect on States
or tribal governments, on the Dated: February 16, 2017.
response to a petition submitted to the
relationship between the national Michael Goodis,
Agency. The Office of Management and
Budget (OMB) has exempted these types government and the States or tribal Director, Registration Division, Office of
governments, or on the distribution of Pesticide Programs.
of actions from review under Executive
Order 12866, entitled ‘‘Regulatory power and responsibilities among the Therefore, 40 CFR chapter I is
Planning and Review’’ (58 FR 51735, various levels of government or between amended as follows:
October 4, 1993). Because this action the Federal Government and Indian
has been exempted from review under tribes. Thus, the Agency has determined PART 180
Executive Order 12866, this action is that Executive Order 13132, entitled
not subject to Executive Order 13211, ‘‘Federalism’’ (64 FR 43255, August 10, ■ 1. The authority citation for part 180
entitled ‘‘Actions Concerning 1999) and Executive Order 13175, continues to read as follows:
Regulations That Significantly Affect entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR Authority: 21 U.S.C. 321(q), 346a and 371.
Energy Supply, Distribution, or Use’’ (66
FR 28355, May 22, 2001) or Executive 67249, November 9, 2000) do not apply ■ 2. In § 180.960, add alphabetically the
Order 13045, entitled ‘‘Protection of to this action. In addition, this action entry ‘‘Polyglycerol polyricinoleate;
Children from Environmental Health does not impose any enforceable duty or minimum number average molecular
Risks and Safety Risks’’ (62 FR 19885, contain any unfunded mandate as weight (in amu), 2,500’’ to the table to
April 23, 1997). This action does not described under Title II of the Unfunded read as follows:
contain any information collections Mandates Reform Act (UMRA) (2 U.S.C.
subject to OMB approval under the 1501 et seq.). § 180.960 Polymers; exemptions from the
Paperwork Reduction Act (PRA) (44 This action does not involve any requirement of a tolerance.
U.S.C. 3501 et seq.), nor does it require technical standards that would require * * * * *
Polymer CAS No.
* * * * * * *
Polyglycerol polyricinoleate; minimum number average molecular weight (in amu), 2,500 ............................................................... 29894–35–7
* * * * * * *
[FR Doc. 2017–05703 Filed 3–21–17; 8:45 am]
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DEPARTMENT OF HEALTH AND correcting document. These corrections technical errors in the CY 2017 PFS
HUMAN SERVICES are effective as if they had been final rule. The corrections contained in
included with the document published this document are consistent with, and
Centers for Medicare & Medicaid November 15, 2016. Accordingly, the do not make substantive changes to, the
Services corrections are applicable beginning policies and payment methodologies
January 1, 2017. that were proposed subject to notice and
42 CFR Parts 405, 410, 411, 414, 417, comment procedures and adopted in the
II. Summary and Correction of Errors
422, 423, 424, 425, and 460 CY 2017 PFS final rule. As a result, the
in the Addenda on the CMS Web Site
[CMS–1654–CN4] corrections made through this correcting
Due to a technical error in the document are intended to resolve
RIN 0938–AS81 allocation of indirect practice expense inadvertent errors so that the rule
(PE) for CPT codes 97161 through accurately reflects the policies adopted
Medicare Program; Revisions to 97168, the incorrect CY 2017 PE relative in the final rule.
Payment Policies Under the Physician value units (RVUs) were included in
Fee Schedule and Other Revisions to Addendum B. The corrected CY 2017 Even if this were a rulemaking to
Part B for CY 2017; Medicare PE RVUs for these codes are reflected in which the notice and comment and
Advantage Bid Pricing Data Release; the corrected Addendum B available on delayed effective date requirements
Medicare Advantage and Part D the CMS Web site at www.cms.gov/ applied, we find that there is good cause
Medical Loss Ratio Data Release; Medicare/Medicare-Fee-for-Service- to waive such requirements.
Medicare Advantage Provider Network Payment/PhysicianFeeSched/ Undertaking further notice and
Requirements; Expansion of Medicare index.html. comment procedures to incorporate the
Diabetes Prevention Program Model; corrections in this document into the
III. Waiver of Proposed Rulemaking CY 2017 PFS final rule or delaying the
Medicare Shared Savings Program
Requirements; Corrections Under 5 U.S.C. 553(b) of the effective date of the corrections would
Administrative Procedure Act (the be contrary to the public interest
AGENCY: Centers for Medicare & APA), the agency is required to publish because it is in the public interest to
Medicaid Services (CMS), HHS. a notice of the proposed rule in the ensure that the rule accurately reflects
ACTION: Final rule; correction. Federal Register before the provisions our policies as of the date they take
of a rule take effect. Similarly, section effect. Further, such procedures would
SUMMARY: This document corrects 1871(b)(1) of the Social Security Act
technical errors in the addenda to the be unnecessary because we are not
(the Act) requires the Secretary to making any substantive revisions to the
final rule published in the November provide for notice of the proposed rule
15, 2016, Federal Register entitled, final rule, but rather, we are simply
in the Federal Register and provide a correcting the Federal Register
‘‘Medicare Program; Revisions to period of not less than 60 days for
Payment Policies under the Physician document to reflect the policies that we
public comment. In addition, section previously proposed, received public
Fee Schedule and Other Revisions to 553(d) of the APA and section
Part B for CY 2017; Medicare Advantage comment on, and subsequently finalized
1871(e)(1)(B)(i) of the Act mandate a 30- in the final rule. For these reasons, we
Bid Pricing Data Release; Medicare day delay in effective date after issuance
Advantage and Part D Medical Loss believe there is good cause to waive the
or publication of a rule. Sections requirements for notice and comment
Ratio Data Release; Medicare Advantage 553(b)(B) and 553(d)(3) of the APA
Provider Network Requirements; and delay in effective date.
provide for exceptions from the APA
Expansion of Medicare Diabetes notice and comment, and delay in Dated: March 16, 2017.
Prevention Program Model; Medicare effective date requirements; in cases in Ann C. Agnew,
Shared Savings Program Requirements.’’ which these exceptions apply, sections Executive Secretary to the Department,
DATES: This correcting document is 1871(b)(2)(C) and 1871(e)(1)(B)(ii) of the Department of Health and Human Services.
effective March 21, 2017 and is Act provide exceptions from the notice [FR Doc. 2017–05675 Filed 3–21–17; 8:45 am]
applicable beginning January 1, 2017. and 60-day comment period and delay BILLING CODE 4120–01–P
FOR FURTHER INFORMATION CONTACT: in effective date requirements of the Act
Jessica Bruton (410) 786–5991. as well. Section 553(b)(B) of the APA
SUPPLEMENTARY INFORMATION: and section 1871(b)(2)(C) of the Act
authorize an agency to dispense with FEDERAL COMMUNICATIONS
I. Background normal notice and comment rulemaking COMMISSION
In the addenda to FR Doc 2016–26668 procedures for good cause if the agency
(81 FR 80170 through 80562), the final makes a finding that the notice and 47 CFR Part 54
rule entitled, ‘‘Medicare Program; comment process is impracticable,
Revisions to Payment Policies under the unnecessary, or contrary to the public
[WC Docket No. 10–90; FCC 16–33, 16–64,
Physician Fee Schedule and Other interest, and includes a statement of the and 16–143]
Revisions to Part B for CY 2017; finding and the reasons for it in the rule.
Medicare Advantage Bid Pricing Data In addition, section 553(d)(3) of the Connect America Fund
Release; Medicare Advantage and Part D APA and section 1871(e)(1)(B)(ii) allow
Medical Loss Ratio Data Release; the agency to avoid the 30-day delay in AGENCY:Federal Communications
Medicare Advantage Provider Network effective date where such delay is Commission.
jstallworth on DSK7TPTVN1PROD with RULES
Requirements; Expansion of Medicare contrary to the public interest and the
Diabetes Prevention Program Model; agency includes in the rule a statement ACTION: Final rule; announcement of
Medicare Shared Savings Program of the finding and the reasons for it. effective date.
Requirements’’ there was a technical In our view, this correcting document
error in an element of the payment does not constitute a rulemaking that SUMMARY: In this document, the Federal
calculation for several services that is would be subject to these requirements. Communications Commission
identified and corrected in this This document merely corrects (Commission) announces that the Office
VerDate Sep<11>2014 16:33 Mar 21, 2017 Jkt 241001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\FR\FM\22MRR1.SGM 22MRR1](https://thefederalregister.org/doc/82_FR_14690/page/4.svg)
Document Created: 2017-03-22 03:58:35
Document Modified: 2017-03-22 03:58:35
| 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 March 22, 2017. Objections and requests for hearings must be received on or before May 22, 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 | Michael Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 82 FR 14636 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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