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 via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31827]


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

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:
RDFRNotices@epa.gov.

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