[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Proposed Rules]
[Pages 13006-13017]
[FR Doc No: 2014-04882]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2014-0065; FRL-9903-64-OAR]
RIN 2060-AR80

Protection of Stratospheric Ozone: The 2014 and 2015 Critical Use
Exemption from the Phaseout of Methyl Bromide

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing uses
that

qualify for the critical use exemption (CUE) and the amount of methyl
bromide that may be produced or imported for those uses for both the
2014 and 2015 control periods. EPA is proposing this action under the
authority of the Clean Air Act to reflect consensus decisions taken by
the Parties to the Montreal Protocol on Substances that Deplete the
Ozone Layer at the Twenty-Fourth and Twenty-Fifth Meetings of the
Parties. EPA is also proposing to amend the regulatory framework to
remove provisions related to sale of pre-phaseout inventory for
critical uses. EPA is seeking comment on the list of critical uses, on
EPA's determination of the specific amounts of methyl bromide that may
be produced and imported for those uses, and on the amendments to the
regulatory framework.

DATES: Comments must be submitted by April 21, 2014. Any party
requesting a public hearing must notify the contact person listed below
by 5 p.m. Eastern Standard Time on March 12, 2014. If a hearing is
requested it will be held on March 24, 2014. EPA will post information
regarding a hearing, if one is requested, on the Ozone Protection Web
site www.epa.gov/ozone/strathome.html. Persons interested in attending
a public hearing should consult with the contact person below regarding
the location and time of the hearing.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2014-0065, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Phone:<PHONE_NUMBER>.
     U.S. Mail: Docket EPA-HQ-OAR-2014-0065, U.S. Environmental
Protection Agency, EPA Docket Center, Air and Radiation Docket, Mail
Code 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460
     Hand Delivery or Courier: Docket EPA-HQ-OAR-2014-0065, EPA
Docket Center--Public Reading Room, EPA West Building, Room 3334, 1301
Constitution Avenue NW., Washington, DC 20004. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OAR-
2014-0065. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or email. The
www.regulations.gov Web site is an ``anonymous access'' system, which
means EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through www.regulations.gov your email
address will be automatically captured and included as part of the
comment that is placed in the public docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed on the
www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through
www.regulations.gov or in hard copy at the Air and Radiation Docket,
EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington,
DC. 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<PHONE_NUMBER>, and the telephone number for the
Air and Radiation Docket is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: For further information about this
proposed rule, contact Jeremy Arling by telephone at<PHONE_NUMBER>, or
by email at<EMAIL_ADDRESS>or by mail at U.S. Environmental
Protection Agency, Stratospheric Protection Division, Stratospheric
Program Implementation Branch (6205J), 1200 Pennsylvania Avenue NW.,
Washington, DC 20460. You may also visit the methyl bromide section of
the Ozone Depletion Web site of EPA's Stratospheric Protection Division
at www.epa.gov/ozone/mbr for further information about the methyl
bromide critical use exemption, other Stratospheric Ozone Protection
regulations, the science of ozone layer depletion, and related topics.

SUPPLEMENTARY INFORMATION: This proposed rule concerns Clean Air Act
(CAA) restrictions on the consumption, production, and use of methyl
bromide (a Class I, Group VI controlled substance) for critical uses
during calendar years 2014 and 2015. Under the Clean Air Act, methyl
bromide consumption (consumption is defined under section 601 of the
CAA as production plus imports minus exports) and production were
phased out on January 1, 2005, apart from allowable exemptions, such as
the critical use and the quarantine and preshipment (QPS) exemptions.
With this action, EPA is proposing and seeking comment on the uses that
will qualify for the critical use exemption as well as specific amounts
of methyl bromide that may be produced and imported for proposed
critical uses for the 2014 and 2015 control periods. EPA also seeks
comment on the amendments to the regulatory framework to remove
provisions related to sale of pre-phaseout inventory for critical uses.

Table of Contents

I. General Information
    A. Regulated Entities
    B. What Should I Consider When Preparing My Comments?
II. What Is Methyl Bromide?
III. What Is the Background to the Phaseout Regulations for Ozone-
Depleting Substances?
IV. What Is the Legal Authority for Exempting the Production and
Import of Methyl Bromide for Critical Uses Authorized by the Parties
to the Montreal Protocol?
V. What Is the Critical Use Exemption Process?
    A. A. Background of the Process
    B. How Does This Proposed Rule Relate to Previous Critical Use
Exemption Rules?
    C. Proposed Critical Uses
    D. Proposed Critical Use Amounts
    E. Amending the Critical Stock Allowance Framework
    F. The Criteria in Decisions IX/6 and Ex. I/4
    G. Emissions Minimization
VI. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review

    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination with
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children from
Environmental Health and Safety Risks
    H. Executive Order 13211: Actions that Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act
    J. Executive Order 12898: Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. Regulated Entities

    Entities and categories of entities potentially regulated by this
proposed action include producers, importers, and exporters of methyl
bromide; applicators and distributors of methyl bromide; and users of
methyl bromide that applied for the 2014 and 2015 critical use
exemption including growers of vegetable crops, fruits, and nursery
stock, and owners of stored food commodities and structures such as
grain mills and processors. This list is not intended to be exhaustive,
but rather to provide a guide for readers regarding entities likely to
be regulated by this proposed action. To determine whether your
facility, company, business, or organization could be regulated by this
proposed action, you should carefully examine the regulations
promulgated at 40 CFR part 82, subpart A. If you have questions
regarding the applicability of this action to a particular entity,
consult the person listed in the preceding section.

B. What should I consider when preparing my comments?

    1. Confidential Business Information. Do not submit confidential
business information (CBI) to EPA through www.regulations.gov or email.
Clearly mark the part or all of the information that you claim to be
CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark
the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. In addition
to one complete version of the comment that includes information
claimed as CBI, a copy of the comment that does not contain the
information claimed as CBI must be submitted for inclusion in the
public docket.
    2. Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date, and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

II. What is methyl bromide?

    Methyl bromide is an odorless, colorless, toxic gas which is used
as a broad-spectrum pesticide and is controlled under the CAA as a
Class I ozone-depleting substance (ODS). Methyl bromide was once widely
used as a fumigant to control a variety of pests such as insects,
weeds, rodents, pathogens, and nematodes. Information on methyl bromide
can be found at http://www.epa.gov/ozone/mbr.
    Methyl bromide is also regulated by EPA under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and other statutes
and regulatory authority, as well as by States under their own statutes
and regulatory authority. Under FIFRA, methyl bromide is a restricted
use pesticide. Restricted use pesticides are subject to Federal and
State requirements governing their sale, distribution, and use. Nothing
in this proposed rule implementing Title VI of the Clean Air Act is
intended to derogate from provisions in any other Federal, State, or
local laws or regulations governing actions including, but not limited
to, the sale, distribution, transfer, and use of methyl bromide.
Entities affected by this proposal must comply with FIFRA and other
pertinent statutory and regulatory requirements for pesticides
(including, but not limited to, requirements pertaining to restricted
use pesticides) when producing, importing, exporting, acquiring,
selling, distributing, transferring, or using methyl bromide. The
provisions in this proposed action are intended only to implement the
CAA restrictions on the production, consumption, and use of methyl
bromide for critical uses exempted from the phaseout of methyl bromide.

III. What Is the background to the phaseout regulations for ozone-
depleting substances?

    The regulatory requirements of the stratospheric ozone protection
program that limit production and consumption of ozone-depleting
substances are in 40 CFR part 82, subpart A. The regulatory program was
originally published in the Federal Register on August 12, 1988 (53 FR
30566), in response to the 1987 signing and subsequent ratification of
the Montreal Protocol on Substances that Deplete the Ozone Layer
(Montreal Protocol). The Montreal Protocol is the international
agreement aimed at reducing and eliminating the production and
consumption of stratospheric ozone-depleting substances. The United
States was one of the original signatories to the 1987 Montreal
Protocol and the United States ratified the Protocol in 1988. Congress
then enacted, and President George H.W. Bush signed into law, the Clean
Air Act Amendments of 1990 (CAAA of 1990) which included Title VI on
Stratospheric Ozone Protection, codified as 42 U.S.C. Chapter 85,
Subchapter VI, to ensure that the United States could satisfy its
obligations under the Protocol. EPA issued regulations to implement
this legislation and has since amended the regulations as needed.
    Methyl bromide was added to the Protocol as an ozone-depleting
substance in 1992 through the Copenhagen Amendment to the Protocol. The
Parties to the Montreal Protocol (Parties) agreed that each developed
country's level of methyl bromide production and consumption in 1991
should be the baseline for establishing a freeze on the level of methyl
bromide production and consumption for developed countries. EPA
published a final rule in the Federal Register on December 10, 1993 (58
FR 65018), listing methyl bromide as a Class I, Group VI controlled
substance. This rule froze U.S. production and consumption at the 1991
baseline level of 25,528,270 kilograms, and set forth the percentage of
baseline allowances for methyl bromide granted to companies in each
control period (each calendar year) until 2001, when the complete
phaseout would occur. This

phaseout date was established in response to a petition filed in 1991
under sections 602(c)(3) and 606(b) of the CAAA of 1990, requesting
that EPA list methyl bromide as a Class I substance and phase out its
production and consumption. This date was consistent with section
602(d) of the CAAA of 1990, which, for newly listed Class I ozone-
depleting substances provides that ``no extension [of the phaseout
schedule in section 604] under this subsection may extend the date for
termination of production of any class I substance to a date more than
7 years after January 1 of the year after the year in which the
substance is added to the list of class I substances.''
    At the Seventh Meeting of the Parties (MOP) in 1995, the Parties
agreed to adjustments to the methyl bromide control measures and agreed
to reduction steps and a 2010 phaseout date for developed countries
with exemptions permitted for critical uses. At that time, the United
States continued to have a 2001 phaseout date in accordance with
section 602(d) of the CAAA of 1990. At the Ninth MOP in 1997, the
Parties agreed to further adjustments to the phaseout schedule for
methyl bromide in developed countries, with reduction steps leading to
a 2005 phaseout. The Parties also established a phaseout date of 2015
for Article 5 countries.

IV. What is the legal authority for exempting the production and import
of methyl bromide for critical uses authorized by the parties to the
Montreal Protocol?

    In October 1998, the U.S. Congress amended the Clean Air Act to
prohibit the termination of production of methyl bromide prior to
January 1, 2005, to require EPA to align the U.S. phaseout of methyl
bromide with the schedule specified under the Protocol, and to
authorize EPA to provide certain exemptions. These amendments were
contained in Section 764 of the 1999 Omnibus Consolidated and Emergency
Supplemental Appropriations Act (Pub. L. 105-277, October 21, 1998) and
were codified in section 604 of the CAA, 42 U.S.C. 7671c. The amendment
that specifically addresses the critical use exemption appears at
section 604(d)(6), 42 U.S.C. 7671c(d)(6). EPA revised the phaseout
schedule for methyl bromide production and consumption in a rulemaking
on November 28, 2000 (65 FR 70795), which allowed for the reduction in
methyl bromide consumption specified under the Protocol and extended
the phaseout to 2005 while creating a placeholder for critical use
exemptions. EPA amended the regulations to allow for an exemption for
quarantine and preshipment (QPS) purposes through an interim final rule
on July 19, 2001 (66 FR 37751), and a final rule on January 2, 2003 (68
FR 238).
    On December 23, 2004 (69 FR 76982), EPA published a rule (the
``Framework Rule'') that established the framework for the critical use
exemption, set forth a list of approved critical uses for 2005, and
specified the amount of methyl bromide that could be supplied in 2005
from stocks and new production or import to meet the needs of approved
critical uses. EPA subsequently published rules applying the critical
use exemption framework for each of the annual control periods from
2006 to 2012. In the 2013 rule, EPA amended the framework to remove
certain requirements related to sale of pre-phaseout inventory for
critical uses.
    Under authority of section 604(d)(6) of the CAA, EPA is proposing
the uses that will qualify as approved critical uses for two separate
control periods (2014 and 2015) as well as the amount of methyl bromide
that may be produced or imported to satisfy those uses in each of those
years. EPA is also proposing to amend the regulatory framework to
remove additional provisions related to sale of pre-phaseout inventory
for critical uses. The proposed critical uses and amounts for 2014
reflect Decision XXIV/5, taken at the Twenty-Fourth Meeting of the
Parties in November 2012. The proposed critical uses and amounts for
2015 reflect Decision XXV/4, taken at the Twenty-Fifth Meeting of the
Parties in October 2013.
    In accordance with Article 2H(5) of the Montreal Protocol, the
Parties have issued several Decisions pertaining to the critical use
exemption. These include Decisions IX/6 and Ex. I/4, which set forth
criteria for review of critical uses. The status of Decisions is
addressed in NRDC v. EPA, (464 F.3d 1, D.C. Cir. 2006) and in EPA's
``Supplemental Brief for the Respondent,'' filed in NRDC v. EPA and
available in the docket for this proposed action. In this proposed rule
on critical uses for 2014 and 2015, EPA is honoring commitments made by
the United States in the Montreal Protocol context.

V. What is the critical use exemption process?

A. Background of the Process

    Article 2H of the Montreal Protocol established the critical use
exemption provision. At the Ninth Meeting of the Parties in 1997, the
Parties established the criteria for an exemption in Decision IX/6. In
that Decision, the Parties agreed that ``a use of methyl bromide should
qualify as `critical' only if the nominating Party determines that: (i)
The specific use is critical because the lack of availability of methyl
bromide for that use would result in a significant market disruption;
and (ii) there are no technically and economically feasible
alternatives or substitutes available to the user that are acceptable
from the standpoint of environment and health and are suitable to the
crops and circumstances of the nomination.'' EPA promulgated these
criteria in the definition of ``critical use'' at 40 CFR 82.3. In
addition, the Parties decided that production and consumption, if any,
of methyl bromide for critical uses should be permitted only if a
variety of conditions have been met, including that all technically and
economically feasible steps have been taken to minimize the critical
use and any associated emission of methyl bromide, that research
programs are in place to develop and deploy alternatives and
substitutes, and that methyl bromide is not available in sufficient
quantity and quality from existing stocks of banked or recycled methyl
bromide.
    EPA requested critical use exemption applications through Federal
Register notices published on June 14, 2011 (76 FR 34700) (for the 2014
control period) and on May 17, 2012 (77 FR 29341) (for the 2015 control
period). Applicants submitted data on their use of methyl bromide, the
technical and economic feasibility of using alternatives, ongoing
research programs into the use of alternatives in their sector, and
efforts to minimize use and emissions of methyl bromide.
    EPA reviews the data submitted by applicants, as well as data from
governmental and academic sources, to establish whether there are
technically and economically feasible alternatives available for a
particular use of methyl bromide, and whether there would be a
significant market disruption if no exemption were available. In
addition, an interagency workgroup reviews other parameters of the
exemption applications such as dosage and emissions minimization
techniques and applicants' research or transition plans. As required in
section 604(d)(6) of the CAA, for each exemption period, EPA consults
with the United States Department of Agriculture (USDA) and other
departments and institutions of the Federal government that have
regulatory authority related to methyl bromide. This assessment process
culminates in the development of the U.S. critical use nomination
(CUN). Annually since 2003, the U.S.

Department of State has submitted a CUN to the United Nations
Environment Programme (UNEP) Ozone Secretariat. The Methyl Bromide
Technical Options Committee (MBTOC) and the Technology and Economic
Assessment Panel (TEAP), which are advisory bodies to Parties to the
Montreal Protocol, review each Party's CUN and make recommendations to
the Parties on the nominations. The Parties then make Decisions on the
authorization of critical use exemptions for particular Parties,
including how much methyl bromide may be supplied for the exempted
critical uses. EPA then provides an opportunity for public comment on
the amounts and specific uses of methyl bromide that the agency is
proposing to exempt.
    On January 31, 2012, the United States submitted the tenth
Nomination for a Critical Use Exemption for Methyl Bromide for the
United States of America to the Ozone Secretariat of UNEP. This
nomination contained the request for 2014 critical uses. In February
2012, MBTOC sent questions to the United States concerning technical
and economic issues in the 2014 nomination. The United States
transmitted responses to MBTOC in March, 2012. In May 2012, the MBTOC
provided their interim recommendations on the U.S. nomination in the
May TEAP Progress Report. In that report, MBTOC posed questions about
the U.S. nominations for dried fruit, dried cured ham, and
strawberries. The United States responded to those questions in August
2012. These documents, together with reports by the advisory bodies
noted above, are in the public docket for this rulemaking. The proposed
critical uses and amounts reflect the analysis contained in those
documents.
    On January 24, 2013, the United States submitted the eleventh
Nomination for a Critical Use Exemption for Methyl Bromide for the
United States of America to the Ozone Secretariat of UNEP. This
nomination contained the request for 2015 critical uses. In February
and March 2013, MBTOC sent questions to the United States concerning
technical and economic issues in the 2015 nomination. The United States
transmitted responses to MBTOC in March, 2013. In May 2013, the MBTOC
provided its interim recommendations on the U.S. nomination in the May
TEAP Progress Report and posed additional questions about the U.S.
nominations. The United States responded to those questions in August
2013. These documents, together with reports by the advisory bodies
noted above, are in the public docket for this rulemaking. The proposed
critical uses and amounts reflect the analyses contained in those
documents.

B. How does this proposed rule relate to previous critical use
exemption rules?

    The December 23, 2004, Framework Rule established the framework for
the critical use exemption program in the United States, including
definitions, prohibitions, trading provisions, and recordkeeping and
reporting obligations. The preamble to the Framework Rule included
EPA's determinations on key issues for the critical use exemption
program.
    Since publishing the Framework Rule, EPA has annually promulgated
regulations to exempt specific quantities of production and import of
methyl bromide, to determine the amounts that may be supplied from pre-
phaseout inventory, and to indicate which uses meet the criteria for
the exemption program for that year. See 71 FR 5985 (February 6, 2006),
71 FR 75386 (December 14, 2006), 72 FR 74118 (December 28, 2007), 74 FR
19878 (April 30, 2009), 75 FR 23167 (May 3, 2010), 76 FR 60737
(September 30, 2011), 77 FR 29218 (May 17, 2012), and 78 FR 43797 (July
22, 2013).
    Unlike in previous years, EPA today proposes critical uses for both
2014 and 2015. EPA is proposing to do so to expedite the issuance of
2015 allowances. EPA has received repeated comments in recent years
that a failure to issue CUE allowances in a timely fashion places
manufacturers and distributors, who need to plan for the upcoming
growing season, in a difficult position. For 2013, the final rule was
not effective until July 22, 2013, and EPA recognizes that this late
date could cause difficulties for growers as well as manufacturers and
distributors. EPA seeks to avoid such difficulties for 2015 by issuing
the authorization for that year in this rulemaking.
    Today's proposed action continues the approach established in the
2013 rule for determining the amounts of Critical Use Allowances (CUAs)
to be allocated for critical uses. A CUA is the privilege granted
through 40 CFR part 82 to produce or import 1 kilogram (kg) of methyl
bromide for an approved critical use during the specified control
period. A control period is a calendar year. See 40 CFR 82.3. The two
control periods at issue in this rule are 2014 and 2015. Each year's
allowances expire at the end of that control period and, as explained
in the Framework Rule, are not bankable from one year to the next.
    The 2013 Rule also removed from the regulatory framework the
restriction that limits the sale of inventory for critical uses through
allocations of Critical Stock Allowances (CSA). A CSA was the right
granted through 40 CFR part 82 to sell 1 kg of methyl bromide from
inventory produced or imported prior to the January 1, 2005, phaseout
date for an approved critical use during the specified control period.
Under the framework, the sale of pre-phaseout inventories for critical
uses in excess of the amount of CSAs held by the seller was prohibited.
Today, EPA is proposing to remove all of the remaining provisions in 40
CFR part 82 related to critical stock allowances.

C. Proposed Critical Uses

    In Decision XXIV/5, taken in November 2012, the Parties to the
Protocol agreed ``to permit, for the agreed critical-use categories for
2014 set forth in table A of the annex to the present decision for each
party, subject to the conditions set forth in the present decision and
in decision Ex.I/4 to the extent that those conditions are applicable,
the levels of production and consumption for 2014 set forth in table B
of the annex to the present decision, which are necessary to satisfy
critical uses . . .'' The following uses are those set forth in table A
of the annex to Decision XXIV/5 for the United States:

 Commodities
 Mills and food processing structures
 Cured pork
 Strawberry--field

    In Decision XXV/4, taken in October 2013, the Parties to the
Protocol agreed ``[t]o permit, for the agreed critical-use categories
for 2015 set forth in table A of the annex to the present decision for
each party, subject to the conditions set forth in the present decision
and in decision Ex.I/4 to the extent that those conditions are
applicable, the levels of production and consumption for 2015 set forth
in table B of the annex to the present decision, which are necessary to
satisfy critical uses . . .'' The following uses are those set forth in
table A of the annex to Decision XXV/4 for the United States:

 Cured pork
 Strawberry--field

    EPA is proposing to modify the table in 40 CFR part 82, subpart A,
appendix L to reflect the agreed critical use categories identified in
Decision XXIV/5 and Decision XXV/4. EPA is proposing to amend the table
of critical uses and critical users based on the authorizations in
Decision XXIV/5 and Decision XXV/4 and the technical analyses contained
in the 2014 and 2015 U.S. nominations that assess data

submitted by applicants to the CUE program.
    EPA is seeking comment on the technical analyses contained in the
U.S. nominations (available for public review in the docket).
Specifically, EPA requests information regarding any changes to the
registration (including cancellations or registrations), use, or
efficacy of alternatives that have occurred after the nominations were
submitted. EPA recognizes that as the market for alternatives evolves,
the thresholds for what constitutes ``significant market disruption''
or ``technical and economic feasibility'' may change. Such information
has the potential to alter the technical or economic feasibility of an
alternative and could thus cause EPA to modify the analysis that
underpins EPA's determination as to which uses and what amounts of
methyl bromide qualify for the CUE.
    The following are proposed changes to the existing appendix,
starting with changes due to the applications and analysis conducted
for the 2014 control period. For 2014, EPA is proposing to remove
Georgia growers of cucurbits, eggplants, peppers, and tomatoes. These
groups did not submit applications for 2014 and therefore were not
included in the 2014 U.S. nomination.
    EPA is proposing to remove sectors or users that applied for a
critical use in 2014 but that the United States did not nominate for
2014. EPA conducted a thorough technical assessment of each application
and considered the effects that the loss of methyl bromide would have
for each agricultural sector, and whether significant market disruption
would occur as a result. As a result of this technical review, the
United States Government (USG) determined that certain sectors or users
did not meet the critical use criteria in Decision IX/6 and the United
States therefore did not include them in the 2014 Critical Use
Nomination. EPA notified these sectors of their status by letters dated
February 7, 2012. These sectors are orchard replant for California wine
grape growers and Florida growers of eggplants, peppers, and tomatoes.
For each of these uses, EPA found that there are technically and
economically feasible alternatives to methyl bromide.
    Some sectors that were not included in the 2014 Critical Use
Nomination submitted supplemental applications for 2014. These sectors
are: The California Association of Nursery and Garden Centers;
California stone fruit, table and raisin grape, walnut, and almond
growers; ornamental growers in California and Florida; California
strawberry nurseries; stored walnuts; and the U.S. Golf Course
Superintendents Association. For those sectors the USG came to a
decision that the sectors not nominated have not provided rigorous and
convincing evidence that they meet the criteria laid out in Decision
IX/6, and further that no new problem or large yield/quality loss had
been demonstrated that warranted seeking a supplemental authorization
from the Parties to the Montreal Protocol.
    The following are proposed changes to the existing appendix due to
the applications and analysis conducted for the 2015 control period.
For 2015 EPA is proposing to remove California wine grape growers and
Florida growers of eggplants, peppers, tomatoes, and strawberries.
These groups did not submit applications for 2015 and therefore were
not included in the 2015 U.S. nomination.
    EPA is proposing to remove sectors or users that applied for a
critical use in 2015 but that the United States did not nominate for
2015. As described above EPA conducted a thorough technical assessment
of each application and the USG determined that certain sectors or
users did not meet the critical use criteria. EPA notified these
sectors of their status by letters dated March 26, 2013. These sectors
are rice millers, pet food manufacturing facilities, members of the
North American Millers Association, and California entities storing
walnuts, dried plums, figs, and raisins. In addition, EPA is proposing
to remove entities storing dates as a critical use for 2015. While the
United States nominated this sector for 2015, MBTOC did not recommend
that this sector be a critical use in 2015 and the Parties did not
authorize this use.
    EPA has received supplemental applications for 2015 from sectors
that the United States did not nominate for 2015. These sectors are:
Michigan cucurbit, eggplant, pepper, and tomato growers; Florida
eggplant, pepper, tomato, and strawberry growers; the California
Association of Nursery and Garden Centers; California stone fruit,
table and raisin grape, walnut, and almond growers; ornamental growers
in California and Florida; the U.S. Golf Course Superintendents
Association; and stored walnuts, dried plums, figs, and raisins in
California. The USG is currently reviewing these supplemental
applications for 2015 and EPA is not proposing at this time to
authorize critical use for these sectors. EPA is not proposing at this
time to authorize critical use for these sectors but may take future
action as appropriate.
    Finally, EPA is adding information to Column B of appendix L to
clarify which critical uses are approved for which control periods. EPA
is not proposing other changes to the table but is repeating the
following clarifications made in previous years for ease of reference.
The ``local township limits prohibiting 1,3-dichloropropene'' are
prohibitions on the use of 1,3-dichloropropene products in cases where
local township limits on use of this alternative have been reached. In
addition, ``pet food'' under subsection B of Food Processing refers to
food for domesticated dogs and cats. Finally, ``rapid fumigation'' for
commodities refers to instances in which a buyer provides short (two
working days or fewer) notification for a purchase or there is a short
period after harvest in which to fumigate and there is limited silo
availability for using alternatives.

D. Proposed Critical Use Amounts

    Table A of the annex to Decision XXIV/5 lists critical uses and
amounts agreed to by the Parties to the Montreal Protocol for 2014. The
maximum amount of new production and import for U.S. critical uses,
specified in Table B of Decision XXIV/5, is 442,337 kg, minus available
stocks. This figure is equivalent to 1.7% of the U.S. 1991 methyl
bromide consumption baseline of 25,528,270 kg.
    Similarly, Table A of the annex to Decision XXV/4 lists critical
uses and amounts agreed to by the Parties to the Montreal Protocol for
2015. The maximum amount of new production and import for U.S. critical
uses, specified in Table B of Decision XXV/4, is 376,900 kg, minus
available stocks. This figure is equivalent to 1.5% of the U.S. 1991
methyl bromide consumption baseline.
    For 2014 and 2015, EPA is proposing to determine the level of new
production and import according to the framework and as modified by the
2013 Rule. Under this approach, the amount of new production for each
control period would equal the total amount authorized by the Parties
to the Montreal Protocol in their Decisions minus any reductions for
available stocks, carryover, and the uptake of alternatives. These
terms (available stocks, carryover, and the uptake of alternatives) are
discussed in detail below. As established in the 2013 Rule, EPA would
not allocate critical stock allowances. EPA would still determine
whether there are any ``available stocks'' and reduce the new
production allocation by that amount. Applying this approach, EPA is
proposing to allocate allowances to exempt 442,337 kg of new production
and import of methyl bromide for critical uses in 2014 and

376,900 kg of new production and import for 2015.
    Available Stocks: For 2014 and 2015 the Parties indicated that the
United States should use ``available stocks,'' but did not indicate a
minimum amount expected to be taken from stocks. Consistent with EPA's
past practice, EPA is considering what amount, if any, of the existing
stocks may be available to critical users during 2014 and 2015. The
amount of existing stocks reported to EPA as of December 31, 2012, was
627,066 kg.
    The Parties to the Protocol recognized in their Decisions that the
level of existing stocks may differ from the level of available stocks.
Both Decision XXIV/5 and Decision XXV/4 state that ``production and
consumption of methyl bromide for critical uses should be permitted
only if methyl bromide is not available in sufficient quantity and
quality from existing stocks. . . .'' In addition, the Decisions
recognize that ``parties operating under critical-use exemptions should
take into account the extent to which methyl bromide is available in
sufficient quantity and quality from existing stocks. . . .'' Earlier
Decisions also refer to the use of ``quantities of methyl bromide from
stocks that the Party has recognized to be available.'' Thus, it is
clear that individual Parties may determine their level of available
stocks. Section 604(d)(6) of the CAA does not require EPA to adjust the
amount of new production and import to reflect the availability of
stocks; however, as explained in previous rulemakings, making such an
adjustment is a reasonable exercise of EPA's discretion under this
provision.
    In the 2013 CUE Rule (78 FR 43797, July 22, 2013), EPA established
an approach that considered whether a percentage of the existing
inventory was available. In that rule, EPA took comment on whether 0%
or 5% of the existing stocks was available. The final rule found that
0% was available to be allocated for critical use in 2013 for a number
of reasons including: A pattern of significant underestimation of
inventory drawdown; the increasing concentration of critical users in
California while inventory remained distributed nationwide; and the
recognition that the agency cannot compel distributors to sell
inventory to critical users. For further discussion, please see the
2013 CUE Rule. EPA believes these circumstances remain true for 2014
and 2015.
    In addition, the 2013 CUE Rule removed the restriction that
critical stock allowances be expended to sell inventory to critical
uses. As a result, for the first time in the history of the CUE
program, distributors were free to sell their entire remaining
inventory to critical users. At this time, EPA is unable to calculate
what effect this policy change may have had on the remaining inventory,
although the agency will docket end of year inventory data that will be
reported to EPA in February 2014. EPA notes that it may be difficult to
assess the impact of this change, which went into effect in mid-2013,
simply from updated inventory data. EPA solicits comments on whether,
and how, to draw inferences as to the availability of stocks for
critical uses based on inventory figures as of December 31, 2013,
(e.g., whether the magnitude of the reduction in pre-phaseout stocks
could be evidence of the degree of availability for critical uses).
    For these reasons, EPA is proposing to find 0% of the existing
inventory available for 2014 and 2015. EPA specifically invites comment
on whether 0% or 5% of existing inventory will be available to critical
users in 2014 and/or 2015, taking into consideration the recent history
of inventory drawdown, the removal of the critical stock allowance
provisions, the quantity and geographical location of authorized uses,
and the quantity and location of stocks.
    Existing stocks, as of December 31, 2012, were equal to 627,066 kg.
Therefore, 5% would be 31,353 kg. Were EPA to find 5% of existing
stocks to be available, EPA would reduce the amount of new production
for 2014 and/or for 2015 by 31,353 kg. EPA notes that it is not
proposing to allocate a corresponding amount of critical stock
allowances, as had been the case prior to 2013. EPA removed the
requirement to expend critical stock allowances when selling inventory
to critical users in the 2013 CUE Rule. EPA notes that it will receive
updated end of year inventory data in February 2014. EPA anticipates
that inventory will have been further drawn down, and therefore 5% of
the existing stocks, based on the updated data, is likely to be
significantly less than 31,353 kg. EPA solicits comment on whether, if
EPA concludes some portion of existing stocks are ``available,'' EPA
should calculate the portion that is available for 2014 and/or 2015
based on the updated data for inventory as of December 31, 2013.
    Carryover Material: The Parties in paragraph 9 of Decision XXIV/5
``urge parties operating under critical-use exemptions to put in place
effective systems to discourage the accumulation of methyl bromide
produced under the exemptions.'' EPA regulations prohibit methyl
bromide produced or imported after January 1, 2005, under the critical
use exemption from being added to the existing pre-2005 inventory.
Quantities of methyl bromide produced, imported, exported, or sold to
end-users under the critical use exemption in a control period must be
reported to EPA the following year. EPA uses these reports to calculate
the amount of methyl bromide produced or imported under the critical
use exemption, but not exported or sold to end-users in that year. EPA
deducts an amount equivalent to this ``carryover'' from the total level
of allowable new production and import in the year following the year
of the data report. So for example, the amount of carryover from 2012
is factored into the determination for 2014. Carryover material (which
is produced using critical use allowances) is not included in EPA's
definition of existing inventory (which applies to pre-2005 material)
because this would lead to a double-counting of carryover amounts.
    All critical use methyl bromide that companies reported to be
produced or imported in 2012 was sold to end users. 759 MT of critical
use methyl bromide was produced or imported in 2012. Slightly more than
the amount produced or imported was actually sold to end-users. This
additional amount was from distributors selling material that was
carried over from the prior control period. Therefore, EPA is proposing
to apply the carryover deduction of 0 kg to the new production amount
for 2014. EPA's calculation of the amount of carryover at the end of
2012 is consistent with the method used in previous CUE rules, and with
the format in Decision XVI/6 for calculating column L of the U.S.
Accounting Framework. Past U.S. Accounting Frameworks, including the
one for 2012, are available in the public docket for this rulemaking.
    Production, import, and sales data for 2013 will be reported to EPA
in February 2014. Without these data, the agency is unable to calculate
how, or whether, a reduction for carryover would affect the 2015
allocation amount. However, EPA anticipates that the carryover will
remain 0 kg, as it has been at that level since 2009. Based on
information available, EPA believes that the demand for critical use
methyl bromide continues to be high and all material produced or
imported for a particular control period is sold in that control
period. Therefore, while the proposed allocation amount for 2015
assumes 0 kg of carryover in 2013, EPA proposes to use the reported
data to calculate the actual carryover amount

for 2013, and subtract that amount (if any) from the authorization for
new production and import in the final rule.
    Uptake of Alternatives: EPA considers data on the availability of
alternatives that it receives following submission of each nomination
to UNEP. In previous rules EPA has reduced the total CUE amount when a
new alternative has been registered and increased the new production
amount when an alternative is withdrawn, but not above the amount
authorized by the Parties.
    Since the United States submitted the 2014 CUN on January 31, 2012,
the California Department of Pesticide Regulation has proposed control
measures for the use of chloropicrin with the intent of reducing risk
from acute exposures that might occur near fields fumigated with
products containing chloropicrin. Because this regulation is at the
proposed stage and has not been finalized, EPA is unable to state what
effects these changes may have on the availability of methyl bromide
alternatives for 2014. It is more likely that the proposed changes to
the chloropicrin regulation would affect the 2015 control period and
EPA specifically invites comments on the implications for 2015. However
EPA is not proposing to make any reductions for either the 2014 or 2015
control periods because of these uncertainties. The critical use
exemption program has historically only relied on final actions when
determining the availability of alternatives. EPA is not aware of any
other actions regarding alternatives that would lead to either an
increase or decrease in 2014 and 2015.
    EPA is not proposing to make any other modifications to CUE amounts
to account for availability of alternatives. Rates of transition to
alternatives have already been applied for authorized 2014 and 2015
critical use amounts through the nomination and authorization process.
EPA will consider new data received during the comment period and
continues to gather information about methyl bromide alternatives
through the CUE application process, and by other means. EPA also
continues to support research and adoption of methyl bromide
alternatives, and to request information about the economic and
technical feasibility of all existing and potential alternatives.
    Allocation Amounts: EPA is proposing to allocate 2014 critical use
allowances for new production or import of methyl bromide equivalent to
442,337 kg. Because EPA is taking comment on finding 5% of existing
inventory to be available, EPA is also taking comment on an allocation
of 410,984 kg. EPA is also proposing to allocate 2015 critical use
allowances for new production or import of methyl bromide equivalent to
376,900 kg. EPA is also taking comment on whether it should find 5% of
existing inventory to be available, which would result in an allocation
of 345,547 kg. EPA is taking further comment on whether, if EPA
concludes some portion of existing stocks are ``available,'' EPA should
calculate the portion that is available for 2014 and/or 2015 based on
the updated data for inventory to be submitted in February 2014.
    EPA is proposing to allocate the 2014 and 2015 allowances to the
four companies that hold baseline allowances. The proposed allocations,
as in previous years, are in proportion to those baseline amounts, as
shown in the proposed changes to the table in 40 CFR 82.8(c)(1).
Paragraph 3 of Decision XXIV/5 and paragraph 5 of Decision XXV/4 state
that ``parties shall endeavour to license, permit, authorize or
allocate quantities of methyl bromide for critical uses as listed in
table A of the annex to the present decision.'' This is similar to
language in prior Decisions authorizing critical uses. These Decisions
call on Parties to endeavor to allocate critical use methyl bromide on
a sector basis. The proposed Framework Rule contained several options
for allocating critical use allowances, including a sector-by-sector
approach. The agency evaluated various options based on their economic,
environmental, and practical effects. After receiving comments, EPA
determined in the final Framework Rule that a lump-sum, or universal,
allocation, modified to include distinct caps for pre-plant and post-
harvest uses, was the most efficient and least burdensome approach that
would achieve the desired environmental results, and that a sector-by-
sector approach would pose significant administrative and practical
difficulties. For the reasons discussed in the preamble to the 2009 CUE
rule (74 FR 19894), and because of the limited number of authorized
uses, the agency believes that under the approach adopted in the
Framework Rule, the actual critical use will closely follow the sector
breakout listed in the Parties' decisions.

E. Amending the Critical Stock Allowance Framework

    The 2013 Rule removed the provisions at Sec.  82.4(p)(ii) and (iii)
requiring the use of critical stock allowances for sales of inventory
to critical users. In addition, EPA made some necessary conforming
changes to 40 CFR Part 82, which follow from removing those
restrictions including removing the reference to the restriction on
selling inventory pursuant to a CSA from the definition of ``critical
use methyl bromide.''
    The 2013 Rule also stated that EPA believed additional conforming
changes may be appropriate but that it would address those changes in a
future rulemaking. Today EPA is proposing and taking comment on
removing the remaining references to critical stock allowances in 40
CFR Part 82. EPA believes these provisions are no longer necessary if
the agency is not allocating separate critical stock allowances.
Specifically, EPA is proposing to remove the definitions of ``critical
stock allowance,'' ``critical stock allowance holder,'' and
``unexpended critical stock allowance'' from Sec.  82.3. EPA is
proposing to no longer allow for the intercompany transfer of critical
stock allowances at Sec.  82.12(a) \1\ or the exchange of critical use
allowances for critical stock allowances at Sec.  82.12(e). EPA is also
proposing to remove the reporting and recordkeeping requirements
related to critical stock allowances in Sec.  82.13(3) and (4). EPA
invites comment on the necessity of these provisions, the
appropriateness of removing them from the Code of Federal Regulations,
and whether there are other provisions that should be amended in light
of the removal of the requirement to use critical stock allowances for
sales of inventory to critical users.
---------------------------------------------------------------------------

    \1\ This provision allows any critical stock allowance holder
(``transferror'') to transfer critical stock allowances to any
critical stock allowance holder or any methyl bromide producer,
importer, distributor, or third party applicator (``transferee'').
---------------------------------------------------------------------------

    In 2013 EPA held discussions with USDA and the Department of State
on tools that could potentially address immediate and unforeseen needs
for methyl bromide including whether emergency situations may arise
that warrant the use of methyl bromide consistent with the treaty,
recognizing that emergency uses are not intended as a replacement for
CUE uses. In August, EPA held a stakeholder meeting to present, among
other things, the findings of those discussions and noted that the
three agencies had not yet identified any specific situations that
could not be addressed by current mechanisms. The U.S. government is
committed to using flexibility in the Protocol's existing mechanisms as
an avenue to address changes in national circumstance that affect the
transition to alternatives. EPA welcomes comments on specific emergency
situations that may necessitate the use of methyl bromide, consistent
with the

requirements of the Montreal Protocol, and which could be difficult to
address using current tools and authorities.

F. The Criteria in Decisions IX/6 and Ex. I/4

    Decision XXIV/5 and Decision XXV/4 call on Parties to apply the
conditions and criteria listed in Decisions Ex. I/4 (to the extent
applicable) and IX/6 paragraph 1 to exempted critical uses for the 2014
and 2015 control periods. A discussion of the agency's application of
the criteria in paragraph 1 of Decision IX/6 appears in sections V.A.,
and V.C. of this preamble. Section V.C. solicits comments on the
technical and economic basis for determining that the uses listed in
this proposed rule meet the criteria of the critical use exemption. The
CUNs detail how each proposed critical use meets the criteria in
paragraph 1 of Decision IX/6, apart from the criterion located at
(b)(ii), as well as the criteria in paragraphs 5 and 6 of Decision Ex.
I/4.
    The criterion in Decision IX/6 paragraph (1)(b)(ii), which refers
to the use of available stocks of methyl bromide, is addressed in
section V.D. of this preamble. The agency has previously provided its
interpretation of the criterion in Decision IX/6 paragraph (1)(a)(i)
regarding the presence of significant market disruption in the absence
of an exemption. EPA refers readers to the preamble to the 2006 CUE
rule (71 FR 5989, February 6, 2006) as well as to the memo in the
docket titled ``Development of 2003 Nomination for a Critical Use
Exemption for Methyl Bromide for the United States of America'' for
further elaboration. As explained in those documents, EPA's
interpretation of this term has several dimensions, including looking
at potential effects on both demand and supply for a commodity,
evaluating potential losses at both an individual level and at an
aggregate level, and evaluating potential losses in both relative and
absolute terms.
    The remaining considerations are addressed in the nomination
documents including: The lack of available technically and economically
feasible alternatives under the circumstance of the nomination; efforts
to minimize use and emissions of methyl bromide where technically and
economically feasible; the development of research and transition
plans; and the requests in Decision Ex. I/4 paragraphs 5 and 6 that
Parties consider and implement MBTOC recommendations, where feasible,
on reductions in the critical use of methyl bromide and include
information on the methodology they use to determine economic
feasibility.
    Some of these criteria are evaluated in other documents as well.
For example, the United States has considered the adoption of
alternatives and research into methyl bromide alternatives (see
Decision IX/6 paragraph (1)(b)(iii)) in the development of the National
Management Strategy submitted to the Ozone Secretariat in December
2005, updated in October 2009. The National Management Strategy
addresses all of the aims specified in Decision Ex.I/4 paragraph 3 to
the extent feasible and is available in the docket for this rulemaking.
    There continues to be a need for methyl bromide in order to conduct
the research required by Decision IX/6. A common example is an outdoor
field experiment that requires methyl bromide as a standard control
treatment with which to compare the trial alternatives' results. As
discussed in the preamble to the 2010 CUE rule (75 FR 23179, May 3,
2010), research is a key element of the critical use process. Research
on the crops shown in the table in Appendix L to subpart A remains a
critical use of methyl bromide. While researchers may continue to use
newly produced material for field, post-harvest, and emission
minimization studies requiring the use of methyl bromide, EPA
encourages researchers to use pre-phaseout inventory. EPA also
encourages distributors to make inventory available to researchers, to
promote the continuing effort to assist growers to transition critical
use crops to alternatives.

G. Emissions Minimization

    Previous Decisions of the Parties have stated that critical users
shall employ emission minimization techniques such as virtually
impermeable films, barrier film technologies, deep shank injection and/
or other techniques that promote environmental protection, whenever
technically and economically feasible. EPA developed a comprehensive
strategy for risk mitigation through the 2009 Reregistration
Eligibility Decision (RED) for methyl bromide, which is implemented
through restrictions on how methyl bromide products can be used. This
approach means that methyl bromide labels require that treated sites be
tarped (except for California orchard replant where EPA instead
requires deep (18 inches or greater) shank applications). The RED also
incorporated incentives for applicators to use high-barrier tarps, such
as virtually impermeable film (VIF), by allowing smaller buffer zones
around those sites. In addition to minimizing emissions, use of high-
barrier tarps has the benefit of providing pest control at lower
application rates. The amount of methyl bromide nominated by the United
States reflects the lower application rates necessary when using high-
barrier tarps, where such tarps are allowed.
    EPA will continue to work with the U.S. Department of Agriculture--
Agricultural Research Service (USDA-ARS) and the National Institute for
Food and Agriculture (USDA-NIFA) to promote emission reduction
techniques. The federal government has invested substantial resources
into developing and implementing best practices for methyl bromide use,
including emission reduction practices. The Cooperative Extension
System, which receives some support from USDA-NIFA provides locally
appropriate and project-focused outreach education regarding methyl
bromide transition best practices. Additional information on USDA
research on alternatives and emissions reduction can be found at:
http://www.ars.usda.gov/research/programs/programs.htm?NP_CODE=308 and
http://www.csrees.usda.gov/fo/methylbromideicgp.cfm.
    Users of methyl bromide should continue to make every effort to
minimize overall emissions of methyl bromide. EPA also encourages
researchers and users who are using such techniques to inform EPA of
their experiences and to provide such information with their critical
use applications.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    Under Executive Order (EO) 12866 (58 FR 51735, October 4, 1993),
this proposal is a ``significant regulatory action'' because it was
deemed to raise novel legal or policy issues. Accordingly, EPA
submitted this action to the Office of Management and Budget (OMB) for
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21,
2011) and any changes made in response to interagency recommendations
have been documented in the docket for this action.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
The application, recordkeeping, and reporting requirements have already
been established under previous critical use exemption rulemakings.
This rule

does propose to remove requirements related to the recordkeeping and
reporting of critical stock allowances which would decrease the
information collection burden. The Office of Management and Budget
(OMB) has previously approved the information collection requirements
contained in the existing regulations at 40 CFR part 82 under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2060-0482. The OMB control numbers for
EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act

    The RFA generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice-and-comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant economic impact on a substantial number of small entities.
Small entities include small businesses, small organizations, and small
governmental jurisdictions. For purposes of assessing the impacts of
this rule on small entities, small entity is defined as: (1) A small
business as defined by the Small Business Administration's regulations
at 13 CFR 121.201 (see Table below); (2) a small governmental
jurisdiction that is a government of a city, county, town, school
district or special district with a population of less than 50,000; and
(3) a small organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.

----------------------------------------------------------------------------------------------------------------
                                                                                NAICS small business
                                                                                size standard  (in
                            Category                                   NAICS code        number of  employees or
                                                                                millions of  dollars)
----------------------------------------------------------------------------------------------------------------
Agricultural production........................................  1112--Vegetable and     $0.75 million.
                                                                  Melon farming.
                                                                 1113--Fruit and Nut
                                                                  Tree Farming.
                                                                 1114--Greenhouse,
                                                                  Nursery, and
                                                                  Floriculture
                                                                  Production.
Storage Uses...................................................  115114--Postharvest     $7 million.
                                                                  Crop activities
                                                                  (except Cotton
                                                                  Ginning).
                                                                 311211--Flour Milling.  500 employees.
                                                                 311212--Rice Milling..  500 employees.
                                                                 493110--General         $25.5 million.
                                                                  Warehousing and
                                                                  Storage.
                                                                 493130--Farm Product    $25.5 million.
                                                                  Warehousing and
                                                                  Storage.
Distributors and Applicators...................................  115112--Soil            $7 million.
                                                                  Preparation, Planting
                                                                  and Cultivating.
Producers and Importers........................................  325320--Pesticide and   500 employees.
                                                                  Other Agricultural
                                                                  Chemical
                                                                  Manufacturing.
----------------------------------------------------------------------------------------------------------------

    Agricultural producers of minor crops and entities that store
agricultural commodities are categories of affected entities that
contain small entities. This proposed rule would only affect entities
that applied to EPA for an exemption to the phaseout of methyl bromide.
In most cases, EPA received aggregated requests for exemptions from
industry consortia. On the exemption application, EPA asked consortia
to describe the number and size distribution of entities their
application covered. EPA estimated that 3,218 entities petitioned EPA
for an exemption for the 2005 control period. EPA revised this estimate
in 2011 down to 1,800 end users of critical use methyl bromide. EPA
believes that the number continues to decline as growers cease applying
for the critical use exemption. Since many applicants did not provide
information on the distribution of sizes of entities covered in their
applications, EPA estimated that, based on the above definition,
between one-fourth and one-third of the entities may be small
businesses. In addition, other categories of affected entities do not
contain small businesses based on the above description.
    After considering the economic impacts of this proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities. In
determining whether a rule has a significant economic impact on a
substantial number of small entities, the impact of concern is any
significant adverse economic impact on small entities, since the
primary purpose of the regulatory flexibility analyses is to identify
and address regulatory alternatives ``which minimize any significant
economic impact of the proposed rule on small entities.'' (5 U.S.C.
603-604). Thus, an agency may certify that a rule will not have a
significant economic impact on a substantial number of small entities
if the rule relieves a regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule. Since
this rule would allow the use of methyl bromide for approved critical
uses after the phaseout date of January 1, 2005, this action would
confer a benefit to users of methyl bromide. EPA estimates in the
Regulatory Impact Assessment found in the docket to this rule that the
reduced costs resulting from the de-regulatory creation of the
exemption are approximately $22 million to $31 million on an annual
basis (using a 3% or 7% discount rate respectively). We have therefore
concluded that this proposed rule would relieve regulatory burden for
all small entities.

D. Unfunded Mandates Reform Act

    This action contains no Federal mandates under the provisions of
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C.
1531-1538 for State, local, or tribal governments or the private
sector. The action imposes no enforceable duty on any State, local or
tribal governments or the private sector. Instead, this action would
provide an exemption for the manufacture and use of a phased out
compound and would not impose any new requirements on any entities.
Therefore, this action is not subject to the requirements of sections
202 or 205 of the UMRA. This action is also not subject to the
requirements of section 203 of UMRA because it contains no regulatory
requirements that might significantly or uniquely affect small
governments.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in

Executive Order 13132. This proposed rule is expected to affect
producers, suppliers, importers, and exporters and users of methyl
bromide. Thus, Executive Order 13132 does not apply to this proposed
rule. In the spirit of Executive Order 13132, and consistent with EPA
policy to promote communications between EPA and State and local
governments, EPA specifically solicits comment on this proposed action
from State and local officials.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications, as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000). This rule does
not significantly or uniquely affect the communities of Indian tribal
governments nor does it impose any enforceable duties on communities of
Indian tribal governments. Thus, Executive Order 13175 does not apply
to this action. EPA specifically solicits additional comment on this
proposed action from tribal officials.

G. Executive Order No. 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to EO 13045 (62 FR 19885, April 23,
1997) because it is not economically significant as defined in EO
12866, and because the Agency does not believe the environmental health
or safety risks addressed by this action present a disproportionate
risk to children. This rule affects the level of environmental
protection equally for all affected populations without having any
disproportionately high and adverse human health or environmental
effects on any population.

H. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This proposed rule is not a ``significant energy action'' as
defined in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not likely to have a significant adverse
effect on the supply, distribution, or use of energy. This proposed
rule does not pertain to any segment of the energy production economy
nor does it regulate any manner of energy use. Therefore, we have
concluded that this proposed rule is not likely to have any adverse
energy effects.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Public Law 104-113, 12(d) (15 U.S.C. 272 note)
directs EPA to use voluntary consensus standards in its regulatory
activities unless to do so would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., materials specifications, test methods, sampling
procedures, and business practices) that are developed or adopted by
voluntary consensus standards bodies. NTTAA directs EPA to provide
Congress, through OMB, explanations when the agency decides not to use
available and applicable voluntary consensus standards. This proposed
rulemaking does not involve technical standards. Therefore, EPA is not
considering the use of any voluntary consensus standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States.
    EPA has determined that this proposed rule will not have
disproportionately high and adverse human health or environmental
effects on minority or low-income populations, because it affects the
level of environmental protection equally for all affected populations
without having any disproportionately high and adverse human health or
environmental effects on any population, including any minority or low-
income population. Any ozone depletion that results from this proposed
rule will impact all affected populations equally because ozone
depletion is a global environmental problem with environmental and
human effects that are, in general, equally distributed across
geographical regions in the United States.

List of Subjects in 40 CFR Part 82

    Environmental protection, Chemicals, Exports, Imports, Ozone
depletion.

    Dated: February 14, 2014.
Gina McCarthy,
Administrator.

    For the reasons stated in the preamble, 40 CFR part 82 is proposed
to be amended as follows:

PART 82--PROTECTION OF STRATOSPHERIC OZONE

0
1. The authority citation for part 82 continues to read as follows:

    Authority: 42 U.S.C. 7414, 7601, 7671-7671q.

Sec.  82.3  [Amended]

0
2. Amend Sec.  82.3 by removing the definitions for ``Critical stock
allowance (CSA)'', ``Critical stock allowance (CSA) holder'' and
``Unexpended critical stock allowance (CSA)''.
0
3. Amend Sec.  82.8 by revising the table in paragraph (c)(1) to read
as follows:

Sec.  82.8  Grant of essential use allowances and critical use
allowances.

* * * * *
    (c) * * *
    (1) * * *

----------------------------------------------------------------------------------------------------------------
                                   2014 Critical use   2014 Critical use   2015 Critical use   2015 Critical use
                                  allowances for pre-   allowances for    allowances for pre-   allowances for
             Company                 plant uses *      post-harvest uses     plant uses *      post-harvest uses
                                      (kilograms)        * (kilograms)        (kilograms)        * (kilograms)
----------------------------------------------------------------------------------------------------------------
Great Lakes Chemical Corp. A                 252,236              16,572             227,073               1,969
 Chemtura Company...............
Albemarle Corp..................             103,725               6,815              93,378                 810
ICL-IP America..................              57,321               3,766              51,602                 447
TriCal, Inc.....................               1,785                 117               1,607                  14
                                 -------------------------------------------------------------------------------
    Total.......................             415,067              27,270             373,660               3,240
----------------------------------------------------------------------------------------------------------------
* For production or import of Class I, Group VI controlled substance exclusively for the Pre-Plant or Post-
  Harvest uses specified in appendix L to this subpart for the appropriate control period.

* * * * *
0
4. Amend Sec.  82.12 by revising paragraph (a) and removing paragraph
(e) to read as follows:

Sec.  82.12  Transfers of allowances for class I controlled substances.

    (a) Inter-company transfers. (1) Until January 1, 1996, for all
class I controlled substances, except for Group VI, and until January
1, 2005, for Group VI, any person (``transferor'') may transfer to any
other person (``transferee'') any amount of the transferor's
consumption allowances or production allowances, and effective January
1, 1995, for all class I controlled substances any person
(``transferor'') may transfer to any other person (``transferee'') any
amount of the transferor's Article 5 allowances. After January 1, 2002,
any essential-use allowance holder (including those persons that hold
essential-use allowances issued by a Party other than the United
States) (``transferor'') may transfer essential-use allowances for CFCs
to a metered dose inhaler company solely for the manufacture of
essential MDIs. After January 1, 2005, any critical use allowance
holder (``transferor'') may transfer critical use allowances to any
other person (``transferee'').
* * * * *
0
5. Amend Sec.  82.13 by:
0
a. Revising paragraphs (f)(3)(iv) and (g)(4)(vii); and
0
b. Removing and reserving paragraphs (bb)(2)(iv) and (cc)(2)(iv)
    The revised text reads as follows.

Sec.  82.13  Recordkeeping and reporting requirements for class I
controlled substances.

* * * * *
    (f) * * *
    (3) * * *
    (iv) The producer's total of expended and unexpended production
allowances, consumption allowances, Article 5 allowances, critical use
allowances (pre-plant), critical use allowances (post-harvest), and
amount of essential-use allowances and destruction and transformation
credits conferred at the end of that quarter;
* * * * *
    (g) * * *
    (4) * * *
    (vii) The importer's total sum of expended and unexpended
consumption allowances by chemical as of the end of that quarter and
the total sum of expended and unexpended critical use allowances (pre-
plant) and unexpended critical use allowances (post-harvest);
* * * * *
0
6. Amend Subpart A by revising Appendix L to read as follows:

Appendix L to Subpart A of Part 82--Approved Critical Uses and Limiting
Critical Conditions for Those Uses for the 2014 and 2015 Control
Periods

----------------------------------------------------------------------------------------------------------------
             Column A                             Column B                                Column C
----------------------------------------------------------------------------------------------------------------
                                                                             Limiting critical conditions that
                                     Approved critical user, location of    exist, or that the approved critical
      Approved critical uses               use, and control period          user reasonably expects could arise
                                                                             without methyl bromide fumigation:
----------------------------------------------------------------------------------------------------------------
                                                 PRE-PLANT USES
----------------------------------------------------------------------------------------------------------------
Strawberry Fruit.................  California growers. Control periods     Moderate to severe black root rot or
                                    2014 and 2015.                          crown rot.
                                                                           Moderate to severe yellow or purple
                                                                            nutsedge infestation.
                                                                           Moderate to severe nematode
                                                                            infestation.
                                                                           Local township limits prohibiting 1,3-
                                                                            dichloropropene.
----------------------------------------------------------------------------------------------------------------
                                                POST-HARVEST USES
----------------------------------------------------------------------------------------------------------------
Food Processing..................  (a) Rice millers in the U.S. who are    Moderate to severe beetle, weevil, or
                                    members of the USA Rice Millers         moth infestation.
                                    Association. Control period 2014.      Presence of sensitive electronic
                                                                            equipment subject to corrosion.
                                   (b) Pet food manufacturing facilities   Moderate to severe beetle, moth, or
                                    in the U.S. who are members of the      cockroach infestation.
                                    Pet Food Institute. Control period     Presence of sensitive electronic
                                    2014.                                   equipment subject to corrosion.
                                   (c) Members of the North American       Moderate to severe beetle
                                    Millers' Association in the U.S.        infestation.
                                    Control period 2014.                   Presence of sensitive electronic
                                                                            equipment subject to corrosion.
Commodities......................  California entities storing walnuts,    Rapid fumigation required to meet a
                                    dried plums, figs, raisins, and dates   critical market window, such as
                                    (in Riverside county only) in           during the holiday season.
                                    California. Control period 2014.
Dry Cured Pork Products..........  Members of the National Country Ham     Red legged ham beetle infestation.
                                    Association and the Association of     Cheese/ham skipper infestation.
                                    Meat Processors, Nahunta Pork Center   Dermested beetle infestation.
                                    (North Carolina), and Gwaltney and     Ham mite infestation.
                                    Smithfield Inc. Control periods 2014
                                    and 2015.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2014-04882 Filed 3-6-14; 8:45 am]
BILLING CODE 6560-50-P


June 25   29, 2002 Episode ° Plots provide ozone concentration and wind vectors ID Description AP Apex JN Jean JO Joe Neal MQ Mesquite PL Hendersen PV Palo Verde School LV Las Vegas Airport NE Nellis Air Force CAL CalWash 3 Monitoring Stations


[Federal Register: January 22, 2008 (Volume 73, Number 14)]
[Notices]
[Page 3731-3732]
[DOCID:fr22ja08-73]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0408]

Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is reannouncing the invitation
for participation in its Regulatory Site Visit Training Program (RSVP).
This training program is intended to give CBER regulatory review,
compliance, and other relevant staff an opportunity to visit biologics
facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and
operations. The purpose of this notice is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.

DATES:  Submit a written or electronic request for participation in
this program by February 21, 2008. The request should include a
description of your facility relative to products regulated by CBER.
Please specify the physical address of the site(s) you are offering.
Facilities should also be advised that if a site visit involves a
separate physical location of another firm under contract to the
applicant that this site must be in agreement to participate in the
program, as well as have a satisfactory compliance history.

ADDRESSES:  If your biologics facility is interested in offering a site
visit or learning more about this training opportunity for CBER staff,
or if your

biologics facility responded to a previous RSVP notice announced in the
Federal Register, you should submit a request to participate in the
program to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic requests to http://www.fda.gov/dockets/ecomments or

http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Lonnie Warren Myers, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research (HFM-49), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX: 301-827-
3079, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products including blood and
blood products, vaccines, and cellular, tissue, and gene therapies.
CBER is committed to advancing the public health through innovative
activities that help ensure the safety, effectiveness, and timely
delivery of biological products to patients. To support this primary
goal, CBER has initiated various training and development programs to
promote high performance of its compliance staff, regulatory review
staff, and other relevant staff. CBER seeks to continuously enhance and
update review efficiency and quality, and the quality of its regulatory
efforts and interactions, by providing CBER staff with a better
understanding of the biologics industry and its operations. Further,
CBER seeks to improve: (1) Its understanding of current industry
practices, and regulatory impacts and needs; and (2) communication
between CBER staff and industry. CBER initiated its RSVP in 2005, and
through these annual notices, is requesting those firms that have
previously applied and are still interested in participating, to
reaffirm their interest, as well as encouraging new interested parties
to apply.

II. RSVP

A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the
facility, small groups of CBER staff may observe operations of
biologics establishments, including for example blood and tissue
establishments. The visits may include packaging facilities, quality
control and pathology/toxicology laboratories, and regulatory affairs
operations. These visits, or any part of the program, are not intended
as a mechanism to inspect, assess, judge, or perform a regulatory
function, but are meant to improve mutual understanding and to provide
an avenue for open dialogue between the biologics industry and CBER.

B. Site Selection

    All travel expenses associated with the site visits will be the
responsibility of CBER; therefore, selection of potential facilities
will be based on the coordination of CBER's priorities for staff
training as well as the limited available resources for this program.
In addition to logistical and other resource factors to consider, a key
element of site selection is a successful compliance record with CBER
or another agency for which we have a memorandum of understanding.

    Dated: January 11, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-1006 Filed 1-18-08; 8:45 am]

BILLING CODE 4160-01-S