82_FR_1211 82 FR 1208 - Propiconazole; Extension of Tolerance for Emergency Exemptions

82 FR 1208 - Propiconazole; Extension of Tolerance for Emergency Exemptions

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 3 (January 5, 2017)

Page Range1208-1210
FR Document2016-31827

This regulation extends a time-limited tolerance for combined residues of the fungicide propiconazole and its metabolites in or on avocado at 10 parts per million (ppm) for an additional 3-year period. This tolerance will expire and is revoked on December 31, 2019. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on avocado trees. In addition, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA.

Federal Register, Volume 82 Issue 3 (Thursday, January 5, 2017)
[Federal Register Volume 82, Number 3 (Thursday, January 5, 2017)]
[Rules and Regulations]
[Pages 1208-1210]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31827]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0682; FRL-9956-54]


Propiconazole; Extension of Tolerance for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation extends a time-limited tolerance for combined 
residues of the fungicide propiconazole and its metabolites in or on 
avocado at 10 parts per million (ppm) for an additional 3-year period. 
This tolerance will expire and is revoked on December 31, 2019. This 
action is in response to EPA's granting of an emergency exemption under 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on avocado trees. In addition, the 
Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to establish 
a time-limited tolerance or exemption from the requirement for a 
tolerance for pesticide chemical residues in food that will result from 
the use of a pesticide under an emergency exemption granted by EPA 
under FIFRA.

DATES: This regulation is effective January 5, 2017. Objections and 
requests for hearings must be received on or before March 6, 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-2016-0682, 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 L. 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).

[[Page 1209]]

     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, 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-2016-0682 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
received by the Hearing Clerk on or before March 6, 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-2016-0682, 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

    EPA originally issued a final rule, published in the Federal 
Register of May 11, 2011 (76 FR 27261) (FRL-8873-2), which announced 
that on its own initiative under FFDCA section 408, 21 U.S.C. 346a, it 
established a time-limited tolerance for the combined residues of 
propiconazole and its metabolites in or on avocado at 10 ppm, with an 
expiration date of December 31, 2013. Subsequently, EPA published a 
final rule in the Federal Register of December 27, 2013 (78 FR 78746) 
(FRL-9904-15) to extend (revise) the expiration date for this tolerance 
to December 31, 2016. EPA established the tolerance because FFDCA 
section 408(l)(6) requires EPA to establish a time-limited tolerance or 
exemption from the requirement for a tolerance for pesticide chemical 
residues in food that will result from the use of a pesticide under an 
emergency exemption granted by EPA under FIFRA section 18. Such 
tolerances can be established without providing notice or period for 
public comment.
    In 2014, EPA received a request to extend the use of propiconazole 
on avocado for an additional 3 years (under a quarantine exemption) due 
to the disease situation remaining an emergency condition, warranting 
authorization of use of propiconazole under a quarantine exemption. 
After having reviewed the submission, EPA concurred that emergency 
conditions exist. EPA authorized under FIFRA section 18 the use of 
propiconazole on avocado trees for control of laurel wilt disease in 
Florida.
    EPA assessed the potential risks presented by residues of 
propiconazole in or on avocado. In doing so, EPA considered the safety 
standard in FFDCA section 408(b)(2), and decided that the necessary 
tolerance under FFDCA section 408(l)(6) would be consistent with the 
safety standard and with FIFRA section 18. The data and other relevant 
material have been evaluated and discussed in the final rule published 
in the Federal Register of May 11, 2011. Based on that data and 
information considered, the Agency reaffirms that extension of the 
time-limited tolerance will continue to meet the requirements of FFDCA 
section 408(l)(6). Therefore, the time-limited tolerance is extended 
for an additional 3-year period. EPA will publish a document in the 
Federal Register to remove the revoked tolerance from the Code of 
Federal Regulations (CFR). Although this tolerance will expire and is 
revoked on December 31, 2019, under FFDCA section 408(l)(5), residues 
of the pesticide not in excess of the amounts specified in the 
tolerance remaining in or on avocado after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA and the application occurred prior to the revocation of the 
tolerance. EPA will take action to revoke this tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.

III. 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 is a joint United Nations Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. 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 propiconazole on avocado.

IV. Statutory and Executive Order Reviews

    This action establishes 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

[[Page 1210]]

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).

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: December 20, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, 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. In Sec.  180.434, revise the entry for ``avocado'' in the table 
under paragraph (b) to read as follows:


Sec.  180.434   Propiconazole; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                            Expiration/
                 Commodity                    Parts per     revocation
                                               million         date
------------------------------------------------------------------------
Avocado....................................           10        12/31/19
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2016-31827 Filed 1-4-17; 8:45 am]
 BILLING CODE 6560-50-P



                                                  1208                 Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Rules and Regulations

                                                  2000), nor will it impose substantial                          circuit by March 6, 2017. Filing a                          reference, Intergovernmental relations,
                                                  direct costs on tribal governments or                          petition for econsideration by the                          Particulate matter, Volatile organic
                                                  preempt tribal law.                                            Administrator of this final rule does not                   compounds.
                                                     The Congressional Review Act, 5                             affect the finality of this action for the                    Dated: December 15, 2016.
                                                  U.S.C. 801 et seq., as added by the Small                      purposes of judicial review nor does it
                                                                                                                                                                             Heather McTeer Toney,
                                                  Business Regulatory Enforcement                                extend the time within which a petition
                                                  Fairness Act of 1996, generally provides                       for judicial review may be filed, and                       Regional Administrator, Region 4.
                                                  that before a rule may take effect, the                        shall not postpone the effectiveness of                         40 CFR part 52 is amended as follows:
                                                  agency promulgating the rule must                              such rule or action. Parties with
                                                  submit a rule report, which includes a                         objections to this direct final rule are                    PART 52—APPROVAL AND
                                                  copy of the rule, to each House of the                         encouraged to file a comment in                             PROMULGATION OF
                                                  Congress and to the Comptroller General                        response to the parallel notice of                          IMPLEMENTATION PLANS
                                                  of the United States. EPA will submit a                        proposed rulemaking for this action
                                                  report containing this action and other                        published in the proposed rules section                     ■ 1. The authority citation for part 52
                                                  required information to the U.S. Senate,                       of today’s Federal Register, rather than                    continues to read as follows:
                                                  the U.S. House of Representatives, and                         file an immediate petition for judicial
                                                  the Comptroller General of the United                          review of this direct final rule, so that                       Authority: 42 U.S.C. 7401 et seq.
                                                  States prior to publication of the rule in                     EPA can withdraw this direct final rule
                                                  the Federal Register. A major rule                                                                                         Subpart L—Georgia
                                                                                                                 and address the comment in the
                                                  cannot take effect until 60 days after it                      proposed rulemaking. This action may
                                                  is published in the Federal Register.                          not be challenged later in proceedings to                   ■  2. In § 52.570, the table in paragraph
                                                  This action is not a ‘‘major rule’’ as                         enforce its requirements. See section                       (c) is amended by revising the entry
                                                  defined by 5 U.S.C. 804(2).                                    307(b)(2).                                                  ‘‘391–3–1–.01’’ to read as follows:
                                                     Under section 307(b)(1) of the CAA,
                                                                                                                 List of Subjects in 40 CFR Part 52                          § 52.570    Identification of plan.
                                                  petitions for judicial review of this
                                                  action must be filed in the United States                        Environmental protection, Air                             *       *    *       *      *
                                                  Court of Appeals for the appropriate                           pollution control, Incorporation by                             (c) * * *
                                                                                                                EPA APPROVED GEORGIA REGULATIONS
                                                                                                                                State effective
                                                          State citation                         Title/subject                                                         EPA approval date                      Explanation
                                                                                                                                     date

                                                  391–3–1–.01 ......................   Definitions .........................           8/14/2016         1/5/2017, [insert Federal Register citation].

                                                             *                         *                            *                          *                       *                      *                      *



                                                  *      *       *       *       *                               Act (FFDCA) requires EPA to establish                       Docket is (703) 305–5805. Please review
                                                  [FR Doc. 2016–31753 Filed 1–4–17; 8:45 am]                     a time-limited tolerance or exemption                       the visitor instructions and additional
                                                  BILLING CODE 6560–50–P                                         from the requirement for a tolerance for                    information about the docket available
                                                                                                                 pesticide chemical residues in food that                    at http://www.epa.gov/dockets.
                                                                                                                 will result from the use of a pesticide                     FOR FURTHER INFORMATION CONTACT:
                                                  ENVIRONMENTAL PROTECTION                                       under an emergency exemption granted                        Michael L. Goodis, Registration Division
                                                  AGENCY                                                         by EPA under FIFRA.                                         (7505P), Office of Pesticide Programs,
                                                                                                                 DATES: This regulation is effective                         Environmental Protection Agency, 1200
                                                  40 CFR Part 180                                                January 5, 2017. Objections and requests                    Pennsylvania Ave. NW., Washington,
                                                  [EPA–HQ–OPP–2016–0682; FRL–9956–54]                            for hearings must be received on or                         DC 20460–0001; main telephone
                                                                                                                 before March 6, 2017, and must be filed                     number: (703) 305–7090; email address:
                                                  Propiconazole; Extension of Tolerance                          in accordance with the instructions                         RDFRNotices@epa.gov.
                                                  for Emergency Exemptions                                       provided in 40 CFR part 178 (see also
                                                                                                                                                                             SUPPLEMENTARY INFORMATION:
                                                  AGENCY:  Environmental Protection                              Unit I.C. of the SUPPLEMENTARY
                                                                                                                 INFORMATION).                                               I. General Information
                                                  Agency (EPA).
                                                  ACTION: Final rule.                                            ADDRESSES: The docket for this action,                      A. Does this action apply to me?
                                                                                                                 identified by docket identification (ID)
                                                  SUMMARY:   This regulation extends a                           number EPA–HQ–OPP–2016–0682, is                                You may be potentially affected by
                                                  time-limited tolerance for combined                            available at http://www.regulations.gov                     this action if you are an agricultural
                                                  residues of the fungicide propiconazole                        or at the Office of Pesticide Programs                      producer, food manufacturer, or
                                                  and its metabolites in or on avocado at                        Regulatory Public Docket (OPP Docket)                       pesticide manufacturer. The following
                                                  10 parts per million (ppm) for an                              in the Environmental Protection Agency                      list of North American Industrial
                                                  additional 3-year period. This tolerance                       Docket Center (EPA/DC), West William                        Classification System (NAICS) codes is
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  will expire and is revoked on December                         Jefferson Clinton Bldg., Rm. 3334, 1301                     not intended to be exhaustive, but rather
                                                  31, 2019. This action is in response to                        Constitution Ave. NW., Washington, DC                       provides a guide to help readers
                                                  EPA’s granting of an emergency                                 20460–0001. The Public Reading Room                         determine whether this document
                                                  exemption under the Federal                                    is open from 8:30 a.m. to 4:30 p.m.,                        applies to them. Potentially affected
                                                  Insecticide, Fungicide, and Rodenticide                        Monday through Friday, excluding legal                      entities may include:
                                                  Act (FIFRA) authorizing use of the                             holidays. The telephone number for the                         • Crop production (NAICS code 111).
                                                  pesticide on avocado trees. In addition,                       Public Reading Room is (202) 566–1744,                         • Animal production (NAICS code
                                                  the Federal Food, Drug, and Cosmetic                           and the telephone number for the OPP                        112).


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                                                                     Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Rules and Regulations                                          1209

                                                    • Food manufacturing (NAICS code                      II. Background and Statutory Findings                  pesticide not in excess of the amounts
                                                  311).                                                      EPA originally issued a final rule,                 specified in the tolerance remaining in
                                                    • Pesticide manufacturing (NAICS                      published in the Federal Register of                   or on avocado after that date will not be
                                                  code 32532).                                            May 11, 2011 (76 FR 27261) (FRL–8873–                  unlawful, provided the pesticide is
                                                    B. How can I get electronic access to                 2), which announced that on its own                    applied in a manner that was lawful
                                                  other related information?                              initiative under FFDCA section 408, 21                 under FIFRA and the application
                                                    You may access a frequently updated                   U.S.C. 346a, it established a time-                    occurred prior to the revocation of the
                                                  electronic version of 40 CFR part 180                   limited tolerance for the combined                     tolerance. EPA will take action to revoke
                                                  through the Government Printing                         residues of propiconazole and its                      this tolerance earlier if any experience
                                                  Office’s e-CFR site at http://                          metabolites in or on avocado at 10 ppm,                with, scientific data on, or other
                                                  www.ecfr.gov/cgi-bin/text-                              with an expiration date of December 31,                relevant information on this pesticide
                                                  idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                    2013. Subsequently, EPA published a                    indicate that the residues are not safe.
                                                  40tab_02.tpl.                                           final rule in the Federal Register of                  III. International Residue Limits
                                                    C. How can I file an objection or                     December 27, 2013 (78 FR 78746) (FRL–
                                                  hearing request?                                                                                                  In making its tolerance decisions, EPA
                                                                                                          9904–15) to extend (revise) the                        seeks to harmonize U.S. tolerances with
                                                    Under FFDCA section 408(g), 21                        expiration date for this tolerance to
                                                  U.S.C. 346a, any person may file an                                                                            international standards whenever
                                                                                                          December 31, 2016. EPA established the                 possible, consistent with U.S. food
                                                  objection to any aspect of this regulation              tolerance because FFDCA section                        safety standards and agricultural
                                                  and may also request a hearing on those                 408(l)(6) requires EPA to establish a                  practices. EPA considers the
                                                  objections. You must file your objection                time-limited tolerance or exemption                    international maximum residue limits
                                                  or request a hearing on this regulation                 from the requirement for a tolerance for               (MRLs) established by the Codex
                                                  in accordance with the instructions                     pesticide chemical residues in food that               Alimentarius Commission (Codex), as
                                                  provided in 40 CFR part 178. To ensure                  will result from the use of a pesticide                required by FFDCA section 408(b)(4).
                                                  proper receipt by EPA, you must                         under an emergency exemption granted                   The Codex is a joint United Nations
                                                  identify docket ID number EPA–HQ–                       by EPA under FIFRA section 18. Such                    Food and Agriculture Organization/
                                                  OPP–2016–0682 in the subject line on                    tolerances can be established without                  World Health Organization food
                                                  the first page of your submission. All                  providing notice or period for public                  standards program, and it is recognized
                                                  requests must be in writing, and must be                comment.                                               as an international food safety
                                                  received by the Hearing Clerk on or                        In 2014, EPA received a request to                  standards-setting organization in trade
                                                  before March 6, 2017. Addresses for                     extend the use of propiconazole on                     agreements to which the United States
                                                  mail and hand delivery of objections                    avocado for an additional 3 years (under               is a party. EPA may establish a tolerance
                                                  and hearing requests are provided in 40                 a quarantine exemption) due to the                     that is different from a Codex MRL;
                                                  CFR 178.25(b).                                          disease situation remaining an                         however, FFDCA section 408(b)(4)
                                                    In addition to filing an objection or                 emergency condition, warranting                        requires that EPA explain the reasons
                                                  hearing request with the Hearing Clerk                  authorization of use of propiconazole                  for departing from the Codex level.
                                                  as described in 40 CFR part 178, please                 under a quarantine exemption. After                       The Codex has not established a MRL
                                                  submit a copy of the filing (excluding                  having reviewed the submission, EPA                    for propiconazole on avocado.
                                                  any Confidential Business Information                   concurred that emergency conditions
                                                  (CBI)) for inclusion in the public docket.              exist. EPA authorized under FIFRA                      IV. Statutory and Executive Order
                                                  Information not marked confidential                     section 18 the use of propiconazole on                 Reviews
                                                  pursuant to 40 CFR part 2 may be                        avocado trees for control of laurel wilt                  This action establishes a tolerance
                                                  disclosed publicly by EPA without prior                 disease in Florida.                                    under FFDCA section 408(d) in
                                                  notice. Submit the non-CBI copy of your                    EPA assessed the potential risks                    response to a petition submitted to the
                                                  objection or hearing request, identified                presented by residues of propiconazole                 Agency. The Office of Management and
                                                  by docket ID number EPA–HQ–OPP–                         in or on avocado. In doing so, EPA                     Budget (OMB) has exempted these types
                                                  2016–0682, by one of the following                      considered the safety standard in                      of actions from review under Executive
                                                  methods:                                                FFDCA section 408(b)(2), and decided                   Order 12866, entitled ‘‘Regulatory
                                                    • Federal eRulemaking Portal: http://                 that the necessary tolerance under                     Planning and Review’’ (58 FR 51735,
                                                  www.regulations.gov. Follow the online                  FFDCA section 408(l)(6) would be                       October 4, 1993). Because this action
                                                  instructions for submitting comments.                   consistent with the safety standard and                has been exempted from review under
                                                  Do not submit electronically any                        with FIFRA section 18. The data and                    Executive Order 12866, this action is
                                                  information you consider to be CBI or                   other relevant material have been                      not subject to Executive Order 13211,
                                                  other information whose disclosure is                   evaluated and discussed in the final rule              entitled ‘‘Actions Concerning
                                                  restricted by statute.                                  published in the Federal Register of                   Regulations That Significantly Affect
                                                    • Mail: OPP Docket, Environmental                     May 11, 2011. Based on that data and                   Energy Supply, Distribution, or Use’’ (66
                                                  Protection Agency Docket Center (EPA/                   information considered, the Agency                     FR 28355, May 22, 2001) or Executive
                                                  DC), (28221T), 1200 Pennsylvania Ave.                   reaffirms that extension of the time-                  Order 13045, entitled ‘‘Protection of
                                                  NW., Washington, DC 20460–0001.                         limited tolerance will continue to meet                Children from Environmental Health
                                                    • Hand Delivery: To make special                      the requirements of FFDCA section                      Risks and Safety Risks’’ (62 FR 19885,
                                                  arrangements for hand delivery or                       408(l)(6). Therefore, the time-limited                 April 23, 1997). This action does not
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  delivery of boxed information, please                   tolerance is extended for an additional                contain any information collections
                                                  follow the instructions at http://                      3-year period. EPA will publish a                      subject to OMB approval under the
                                                  www.epa.gov/dockets/contacts.html.                      document in the Federal Register to                    Paperwork Reduction Act (PRA) (44
                                                    Additional instructions on                            remove the revoked tolerance from the                  U.S.C. 3501 et seq.), nor does it require
                                                  commenting or visiting the docket,                      Code of Federal Regulations (CFR).                     any special considerations under
                                                  along with more information about                       Although this tolerance will expire and                Executive Order 12898, entitled
                                                  dockets generally, is available at http://              is revoked on December 31, 2019, under                 ‘‘Federal Actions To Address
                                                  www.epa.gov/dockets.                                    FFDCA section 408(l)(5), residues of the               Environmental Justice in Minority


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                                                  1210               Federal Register / Vol. 82, No. 3 / Thursday, January 5, 2017 / Rules and Regulations

                                                  Populations and Low-Income                                 Dated: December 20, 2016.                           Rockville, MD 20857, or by telephone at
                                                  Populations’’ (59 FR 7629, February 16,                 Daniel J. Rosenblatt,                                  301–594–4353.
                                                  1994).                                                  Acting Director, Registration Division, Office         SUPPLEMENTARY INFORMATION:
                                                     Since tolerances and exemptions that                 of Pesticide Programs.
                                                                                                                                                           I. Background
                                                  are established on the basis of a petition                Therefore, 40 CFR chapter I is
                                                  under FFDCA section 408(d), such as                     amended as follows:                                 Section 602 of Public Law 102–585,
                                                  the tolerance in this final rule, do not                                                                 the ‘‘Veterans Health Care Act of 1992,’’
                                                  require the issuance of a proposed rule,                PART 180—[AMENDED]                               enacted section 340B of the PHSA,
                                                  the requirements of the Regulatory                                                                       ‘‘Limitation on Prices of Drugs
                                                  Flexibility Act (RFA) (5 U.S.C. 601 et                  ■ 1. The authority citation for part 180         Purchased by Covered Entities,’’
                                                  seq.), do not apply.                                    continues to read as follows:                    codified at 42 U.S.C. 256b. The 340B
                                                                                                             Authority: 21 U.S.C. 321(q), 346a and 371.    Program permits covered entities ‘‘to
                                                     This action directly regulates growers,                                                               stretch scarce Federal resources as far as
                                                  food processors, food handlers, and food                ■ 2. In § 180.434, revise the entry for
                                                                                                                                                           possible, reaching more eligible patients
                                                  retailers, not States or tribes, nor does               ‘‘avocado’’ in the table under paragraph
                                                                                                                                                           and providing more comprehensive
                                                  this action alter the relationships or                  (b) to read as follows:
                                                                                                                                                           services.’’ H.R. REP. No. 102–384(II), at
                                                  distribution of power and                               § 180.434 Propiconazole; tolerances for          12 (1992). Eligible covered entity types
                                                  responsibilities established by Congress                residues.                                        are defined in section 340B(a)(4) of the
                                                  in the preemption provisions of FFDCA                                                                    PHSA. Section 340B of the PHSA
                                                                                                          *      *     *      *       *
                                                  section 408(n)(4). As such, the Agency                     (b) * * *                                     instructs HHS to enter into a
                                                  has determined that this action will not                                                                 pharmaceutical pricing agreement (PPA)
                                                  have a substantial direct effect on States                                                  Expiration/  with certain drug manufacturers. When
                                                  or tribal governments, on the                                              Parts   per
                                                                                                            Commodity          million        revocation   a drug manufacturer signs a PPA, it is
                                                  relationship between the national                                                              date      opting into the 340B Program and it
                                                  government and the States or tribal                                                                      agrees to the statutory requirement that
                                                  governments, or on the distribution of                  Avocado ........              10        12/31/19
                                                                                                                                                           the prices charged for covered
                                                  power and responsibilities among the                        *         *         *         *          *   outpatient drugs to covered entities will
                                                  various levels of government or between                                                                  not exceed defined 340B ceiling prices,
                                                  the Federal Government and Indian                       *      *     *      *       *                    which are based on quarterly pricing
                                                  tribes. Thus, the Agency has determined                 [FR Doc. 2016–31827 Filed 1–4–17; 8:45 am]       data obtained from the Centers for
                                                  that Executive Order 13132, entitled                    BILLING CODE 6560–50–P                           Medicare & Medicaid Services (CMS).
                                                  ‘‘Federalism’’ (64 FR 43255, August 10,                                                                  Section 7102 of the Patient Protection
                                                  1999) and Executive Order 13175,                                                                         and Affordable Care Act (Pub. L. 111–
                                                  entitled ‘‘Consultation and Coordination                                                                 148) as amended by section 2302 of the
                                                                                                          DEPARTMENT OF HEALTH AND
                                                  with Indian Tribal Governments’’ (65 FR                                                                  Health Care and Education
                                                                                                          HUMAN SERVICES
                                                  67249, November 9, 2000) do not apply                                                                    Reconciliation Act (Pub. L. 111–152)
                                                  to this action. In addition, this action                42 CFR Part 10                                   (HCERA) (hereinafter referred to as the
                                                  does not impose any enforceable duty or                                                                  ‘‘Affordable Care Act’’), added section
                                                  contain any unfunded mandate as                         RIN 0906–AA89                                    340B(d)(1)(B)(vi) of the PHSA, which
                                                  described under Title II of the Unfunded                                                                 provides for the imposition of sanctions
                                                                                                          340B Drug Pricing Program Ceiling
                                                  Mandates Reform Act (UMRA) (2 U.S.C.                                                                     in the form of civil monetary penalties,
                                                                                                          Price and Manufacturer Civil Monetary
                                                  1501 et seq.).                                                                                           which—
                                                                                                          Penalties Regulation                                (I) shall be assessed according to
                                                     This action does not involve any
                                                  technical standards that would require                  AGENCY: Health Resources and Services            standards established in regulations to
                                                  Agency consideration of voluntary                       Administration, Department of Health             be promulgated by the Secretary;
                                                                                                          and Human Services (HHS).                           (II) shall not exceed $5,000 for each
                                                  consensus standards pursuant to section
                                                                                                          ACTION: Final rule.
                                                                                                                                                           instance   of overcharging a covered
                                                  12(d) of the National Technology
                                                                                                                                                           entity that may have occurred; and
                                                  Transfer and Advancement Act                                                                                (III) shall apply to any manufacturer
                                                                                                          SUMMARY: The Health Resources and
                                                  (NTTAA) (15 U.S.C. 272 note).                                                                            with an agreement under Section 340B
                                                                                                          Services Administration (HRSA)
                                                  V. Congressional Review Act                             administers section 340B of the Public           of the PHSA that knowingly and
                                                                                                          Health Service Act (PHSA), referred to           intentionally charges a covered entity a
                                                    Pursuant to the Congressional Review                  as the ‘‘340B Drug Pricing Program’’ or          price for purchase of a drug that exceeds
                                                  Act (5 U.S.C. 801 et seq.), EPA will                    the ‘‘340B Program.’’ This final rule will the maximum applicable price under
                                                  submit a report containing this rule and                apply to all drug manufacturers that are subsection 340B(a)(1).
                                                  other required information to the U.S.                  required to make their drugs available to           The Affordable Care Act also added
                                                  Senate, the U.S. House of                               covered entities under the 340B                  section 340B(d)(1)(B)(i)(I) of the PHSA,
                                                  Representatives, and the Comptroller                    Program. This final rule sets forth the          which requires ‘‘[d]eveloping and
                                                  General of the United States prior to                   calculation of the 340B ceiling price and publishing through an appropriate
                                                  publication of the rule in the Federal                  application of civil monetary penalties          policy or regulatory issuance, precisely
                                                  Register. This action is not a ‘‘major                  (CMPs).                                          defined standards and methodology for
asabaliauskas on DSK3SPTVN1PROD with RULES




                                                  rule’’ as defined by 5 U.S.C. 804(2).                                                                    the calculation of ceiling prices . . .’’
                                                                                                          DATES: This rule is effective March 6,
                                                  List of Subjects in 40 CFR Part 180                                                                      CMPs provide a critical enforcement
                                                                                                          2017.                                            mechanism for HHS if manufacturers do
                                                    Environmental protection,                             FOR FURTHER INFORMATION CONTACT:                 not comply with statutory pricing
                                                  Administrative practice and procedure,                  CAPT Krista Pedley, Director, Office of          obligations under the 340B Program.
                                                  Agricultural commodities, Pesticides                    Pharmacy Affairs (OPA), Healthcare               HHS is also finalizing this rule to
                                                  and pests, Reporting and recordkeeping                  Systems Bureau (HSB), HRSA, 5600                 provide increased clarity in the
                                                  requirements.                                           Fishers Lane, Mail Stop 08W05A,                  marketplace for all 340B Program


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Document Created: 2018-02-01 14:51:28
Document Modified: 2018-02-01 14:51:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective January 5, 2017. Objections and requests for hearings must be received on or before March 6, 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).
ContactMichael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation82 FR 1208 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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