[Federal Register: December 26, 2006 (Volume 71, Number 247)]
[Proposed Rules]
[Page 77357-77360]
[DOCID:fr26de06-18]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 112

[EPA-HQ-OPA-2006-0949; FRL-8258-4]
RIN 2050-AG36

Oil Pollution Prevention; Non-Transportation Related Onshore
Facilities

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency is proposing to extend the
dates by which facilities must prepare or amend Spill Prevention,
Control, and Countermeasure Plans (SPCC Plans), and implement those
Plans. This action would allow the Agency time to promulgate further
revisions to the July 17, 2002 SPCC rule (in addition to those
published elsewhere in this Federal Register) before owners and
operators are required to meet requirements of the rule related to
preparing or amending, and implementing SPCC Plans. EPA expects to
propose further revisions to the SPCC rule in 2007.

DATES: Written comments must be received by January 25, 2007.

ADDRESSES: Comments should be directed to Docket ID No. EPA-HQ-OPA-
2006-0949. Comments may be submitted by one of the following methods:
    (1) Federal Rulemaking Portal: http://www.regulations.gov. Follow

the on-line instructions for submitting comments; or
    (2) Mail: The mailing address of the docket for this rulemaking is
EPA Docket Center (EPA/DC), Docket ID No. EPA-HQ-OPA-2006-0949, EPA
West, Room B102, 1301 Constitution Ave., NW., Washington, DC 20460.
    (3) Hand Delivery: Such deliveries are only accepted during the
Docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information.
    Please note that per EPA's policy, all comments received will be
included in the public docket without change, and may be made available
online at http://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
regulations.gov.
    Please also note that the Federal regulations.gov website is an
``anonymous access'' system, which means that EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of the
comment and along 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.
    All documents in the docket are listed in the docket index at
http://www.regulations.gov. Although listed in the index, some

information is not publicly available (i.e., CBI or other information
whose disclosure is restricted by a statute). Certain 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 at http://www.regulations.gov or in hard copy at the EPA

Docket Center, EPA/DC, EPA West, Room B102, 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 to make an appointment to view the docket is (202)
566-0276.

FOR FURTHER INFORMATION CONTACT: For general information, contact the
Superfund, TRI, EPCRA, RMP and Oil Information Center at<PHONE_NUMBER>
or TDD<PHONE_NUMBER> (hearing impaired). In the Washington, DC
metropolitan area, call<PHONE_NUMBER> or TDD<PHONE_NUMBER>. For more
detailed information on specific aspects of this proposed rule, contact
either Vanessa Rodriguez at<PHONE_NUMBER><EMAIL_ADDRESS>
or Mark W. Howard at<PHONE_NUMBER> (howard.markw@epa.gov), U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460-0002, Mail Code 5104A.

SUPPLEMENTARY INFORMATION:

I. Authority

    33 U.S.C. 1251 et seq.; 33 U.S.C. 2720; E.O. 12777 (October 18,
1991), 3 CFR, 1991 Comp., p. 351.

II. Background

    On July 17, 2002, the Agency published a final rule that amended
the SPCC regulations (see 67 FR 47042). The rule became effective on
August 16, 2002. The final rule included compliance dates in Sec.
112.3 for preparing, amending, and implementing SPCC Plans. The
original compliance dates were amended on January 9, 2003 (see 68 FR
1348), again on April 17, 2003 (see 68 FR 18890), a third time on
August 11, 2004 (see 69 FR 48794), and a fourth time on February 17,
2006 (see 71 FR 8462).
    Under the current provisions in Sec.  112.3(a) and (b), a facility
that was in operation on or before August 16, 2002 must make any
necessary amendments to its SPCC Plan and fully implement it by October
31, 2007; a facility that came into operation after August 16, 2002,
but before October 31, 2007, must prepare and fully implement an SPCC
Plan on or before October 31, 2007. In addition, Sec.  112.3(c)
requires onshore and offshore mobile facilities to prepare or amend and
implement SPCC Plans on or before October 31, 2007.
    Elsewhere in today's Federal Register, EPA finalized a set of SPCC
rule amendments that address certain targeted areas of the SPCC
requirements and a number of issues and concerns raised by the
regulated community. As highlighted in the EPA Regulatory Agenda and
the 2005 OMB report on ``Regulatory Reform of the U.S. Manufacturing
Sector,'' EPA is considering further amendments to address other areas
where regulatory reform may be appropriate. For these additional areas,
the Agency expects to issue a proposed rule in 2007. Areas where
regulatory reform may be appropriate include, and are not limited to,
oil and natural gas exploration and production, farms, and Tier I
facilities. Because the Agency may not be able to promulgate such
regulatory amendments before the current October 31, 2007 compliance
date for SPCC becomes effective, EPA believes it is appropriate to
provide an extension of the compliance date.

III. Proposal to Extend the Compliance Dates

    This proposed rule would extend the dates in Sec.  112.3(a), (b)
and (c) by which a facility must prepare or amend and implement its
SPCC Plan. As a result of

this proposed rule, a facility that was in operation on or before
August 16, 2002 would have to make any necessary amendments to its SPCC
Plan, and implement that Plan, on or before July 1, 2009. This would
allow owners and operators of SPCC regulated facilities time to prepare
or amend and implement its SPCC Plan in accordance with the
modifications to the 2002 SPCC requirements the EPA plans to propose in
2007. A facility that came into operation after August 16, 2002 would
have to prepare and implement an SPCC Plan on or before July 1, 2009.
    This proposed rule would similarly extend the compliance dates in
Section 112.3(c) for mobile facilities. Under this proposal, a mobile
facility must prepare or amend and implement an SPCC Plan on or before
July 1, 2009.
    The Agency believes the extension of the compliance date proposed
in this notice is warranted for several reasons. The Agency is not in a
position, at this time, to indicate all the areas for possible
regulatory reform that may be addressed as part of a 2007 SPCC
proposal. This extension would allow those potentially affected in the
regulated community an opportunity to make changes to their facilities
and to their SPCC Plans necessary to comply with the revised
requirements expected to be proposed in 2007, rather than with the
existing requirements.
    Further, the Agency believes that this proposed extension of the
compliance dates would also provide facilities time necessary to fully
understand the regulatory relief offered by revisions to the 2002 SPCC
rule as finalized elsewhere in today's Federal Register.\1\
---------------------------------------------------------------------------

    \1\ As stated in the rules, facilities must maintain their
existing plans, to the extent they are required to have one.
However, facilities that want to take advantage of the regulatory
changes being finalized today may do so, but the owner and operator
of the facility will need to modify their existing plan accordingly.
---------------------------------------------------------------------------

    In addition, the Agency intends to issue revisions to the SPCC
Guidance for Regional Inspectors, to address both the revisions
finalized elsewhere in today's Federal Register, and the upcoming
revisions expected to be proposed in 2007. The guidance document is
designed to facilitate an understanding of the rule's applicability, to
help clarify the role of the inspector in the review and evaluation of
the performance-based SPCC requirements, and to provide a consistent
national policy on SPCC-related issues. The guidance also is available
to both the owners and operators of facilities that may be subject to
the requirements of the SPCC rule and to the general public on the
Agency's Web site at http://www.epa.gov/oilspill. The Agency believes

that this proposed extension would provide the regulated community the
opportunity to understand the material presented in the revised
guidance before preparing or amending their SPCC Plans.
    The Agency is seeking comment on this proposal to extend the date
by which SPCC Plans must be amended and implemented in accordance with
amendments to the SPCC Rule. Any alternative approaches presented must
include appropriate rationale and supporting data in order for the
Agency to be able to consider them for final action.

IV. Applicability to Farms

    Elsewhere in today's Federal Register, EPA finalized an extension
of the compliance dates for the owner or operator of a farm, as defined
in Sec.  112.2, to prepare or amend and implement the farm's SPCC Plan
until the effective date of a rule addressing whether to provide
differentiated requirements for farms. The Agency will be conducting
additional information collection and analysis to determine if
differentiated SPCC requirements may be appropriate for farms. The
Agency will be working with USDA to collect data that would more
accurately characterize oil handling at these facilities, thereby
allowing the Agency to focus on priorities where substantial
environmental improvements can be obtained.
    Today's proposal does not affect this extended compliance date for
farms. To the extent that the revisions EPA intends to propose in 2007
address differentiated requirements for farms, the ultimate compliance
date for farms and other facilities may be the same. In any case, the
Agency will announce the new compliance date for farms in the Federal
Register.

V. Statutory and Executive Order Reviews

A. Executive Order 12866--Regulatory Planning and Review

    Under the terms of Executive Order 12866, this action has been
judged as not a ``significant regulatory action'' because it would
extend the compliance dates in Sec.  112.3, but would have no other
substantive effect. However, because of its interconnection with the
related SPCC rule amendments finalized elsewhere in this Federal
Register notice (see discussion above in section III), which is a
significant action under the terms of Executive Order 12866, this
action was nonetheless submitted to OMB for review.

B. Paperwork Reduction Act

    This rule does not impose an information collection burden under
the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act 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. Small entity is defined as: (1) A
small business as defined in the Small Business Administration's (SBA)
regulations at 13 CFR 121.201; (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 that is
independently owned and operated and is not dominant in its field.
    After considering the economic impacts of today's proposed rule on
small entities, the Agency concludes that this action would 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
and 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 regulatory burden, or otherwise has a positive
economic effect on all of the small entities subject to the rule.
    This proposed rule would relieve the regulatory burden for small
entities by extending the compliance dates in Sec.  112.3.
    After considering the economic impacts of today's proposed rule on
small entities, I certify that this action will not have a significant
economic impact on a substantial number of small entities.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local, and tribal
governments and the private sector. Under section 202 of UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures to State, local, and tribal governments, in
the aggregate, or to the private sector, of $100 million or more in any
one year. Before promulgating an EPA rule for which a written statement
is needed, section 205 of UMRA generally requires EPA to identify and
consider a reasonable number of regulatory alternatives and adopt the
least costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule. The provisions of section 205 do
not apply when they are inconsistent with applicable law. Moreover,
section 205 allows EPA to adopt an alternative other than the least
costly, most-effective or least burdensome alternative if the
Administrator publishes with the final rule an explanation why that
alternative was not adopted.
    Before EPA establishes any regulatory requirements that may
significantly or uniquely affect small governments, including tribal
governments, it must have developed under section 203 of UMRA a small
government agency plan. The plan must provide for notifying potentially
affected small governments, enabling officials of affected small
governments to have meaningful and timely input in the development of
EPA regulatory proposals with significant Federal intergovernmental
mandates, and informing, educating, and advising small governments on
compliance with the regulatory requirements.
    EPA has determined that this proposed rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
for State, local, and tribal governments, in the aggregate, or the
private sector in any one year. This proposed rule would reduce burden
and costs for all facilities.
    EPA has determined that this proposed rule contains no regulatory
requirements that might significantly or uniquely affect small
governments. As was explained above, the effect of the proposed rule
would be to reduce burden and costs for owners and operators of all
facilities, including small governments that are subject to the rule.

E. Executive Order 13132--Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive Order to include regulations that 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.''
    This proposed rule does not have federalism implications. It would
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. Under CWA section 311(o), States
may impose additional requirements, including more stringent
requirements, relating to the prevention of oil discharges to navigable
waters. EPA encourages States to supplement the Federal SPCC regulation
and recognizes that some States have more stringent requirements (56 FR
54612, (October 22, 1991). This proposed rule would not preempt State
law or regulations. Thus, Executive Order 13132 does not apply to this
proposed rule.

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

    On November 6, 2000, the President issued Executive Order 13175 (65
FR 67249) entitled, ``Consultation and Coordination with Indian Tribal
Governments.'' Executive Order 13175 took effect on January 6, 2001,
and revokes Executive Order 13084 (Tribal Consultation) as of that
date.
    Today's proposed rule would not significantly or uniquely affect
communities of Indian tribal governments. Therefore, the Agency has not
consulted with a representative organization of tribal groups.

G. Executive Order 13045--Protection of Children From Environmental
Health and Safety Risk

    Executive Order 13045, ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866; and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency.
    EPA interprets Executive Order 13045 as applying only to those
regulatory actions that are based on health or safety risks, such that
the analysis required under section 5-501 of the Order has the
potential to influence the regulation. This proposed rule is not
subject to Executive Order 13045 because it is not economically
significant as defined in Executive Order 12866, and because the Agency
does not have reason to believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children.

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.

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, section 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 such as materials specifications, test methods,
sampling procedures, and business practices that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards.
    This proposed rule does not involve technical standards. Therefore,
NTTAA does not apply.

List of Subjects in 40 CFR Part 112

    Environmental protection, Oil pollution, Penalties, Reporting and
recordkeeping requirements.

    Dated: December 12, 2006.
Stephen L. Johnson,
Administrator.

    For the reasons set forth in the preamble, title 40 CFR, chapter I,
part 112 of the Code of Federal Regulations is proposed to be amended
as follows:

PART 112--OIL POLLUTION PREVENTION

    1. The authority citation for part 112 continues to read as
follows:

    Authority: 33 U.S.C. 1251 et seq.; 33 U.S.C. 2720; E.O. 12777
(October 18, 1991), 3 CFR, 1991 Comp., p. 351.

    2. Section 112.3 amended by revising paragraphs (a)(1) and (b)(1)
as proposed to be amended elsewhere in this Federal Register on
December 26, 2006 and revising paragraph (c) to read as follows:

Subpart A--[Amended]

Sec.  112.3  Requirement to prepare and implement a Spill Prevention,
Control, and Countermeasure Plan.

* * * * *
    (a) * * *
    (1) If your onshore or offshore facility was in operation on or
before August 16, 2002, you must maintain your Plan, but must amend it,
if necessary to ensure compliance with this part, and implement the
Plan no later than July 1, 2009. If your onshore or offshore facility
becomes operational after August 16, 2002, through July 1, 2009, and
could reasonably be expected to have a discharge as described in Sec.
112.1(b), you must prepare and implement a Plan on or before July 1,
2009.
* * * * *
    (b)(1) If you are the owner or operator of an onshore or offshore
facility that becomes operational after July 1, 2009, and could
reasonably be expected to have a discharge as described in Sec.
112.1(b), you must prepare and implement a Plan before you begin
operations.
* * * * *
    (c) If you are the owner or operator of an onshore or offshore
mobile facility, such as an onshore drilling or workover rig, barge
mounted offshore drilling or workover rig, or portable fueling
facility, you must prepare, implement, and maintain a facility Plan as
required by this section. You must maintain your Plan, but must amend
and implement it, if necessary to ensure compliance with this part, on
or before July 1, 2009. If your onshore or offshore mobile facility
becomes operational after July 1, 2009, and could reasonably be
expected to have a discharge as described in Sec.  112.1(b), you must
prepare and implement a Plan before you begin operations. This
provision does not require that you prepare a new Plan each time you
move the facility to a new site. The Plan may be a general Plan. When
you move the mobile or portable facility, you must locate and install
it using the discharge prevention practices outlined in the Plan for
the facility. The Plan is applicable only while the facility is in a
fixed (non-transportation) operating mode.
* * * * *
 [FR Doc. E6-21507 Filed 12-22-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register: August 9, 2006 (Volume 71, Number 153)]
[Notices]
[Page 45555-45557]
[DOCID:fr09au06-82]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2005-0253; FRL-8066-9]

Propylene Oxide (PPO) Reregistration Eligibility Decision; Notice
of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: This notice announces the availability of EPA's Reregistration
Eligibility Decision (RED) for the pesticide propylene oxide (PPO), and
opens a public comment period on this document. This comment period is
intended to provide an additional opportunity for public input; in
particular, the Agency is seeking comments regarding what additional
measures, beyond emission control techniques, are available to protect
bystanders from unsafe exposure to PPO resulting from use in vacuum-
sealed pressurized chambers. The Agency's risk assessments and other
related documents also are available in the PPO docket. PPO is an
insecticidal fumigant/sterilant used both to control bacteria
contamination, mold contamination, insect infestations, and microbial
spoilage of food products as well as to control stored product insects
in nonfood products. PPO is registered for use on several food items
such as processed spices, cocoa (beans and

powder), and in-shell and processed nutmeats (except peanuts). PPO also
has nonfood uses for cosmetic articles, gums, ores, packaging,
pigments, pharmaceutical materials, and discarded nutshells prior to
disposal. EPA has reviewed PPO through the public participation process
that the Agency uses to involve the public in developing pesticide
reregistration and tolerance reassessment decisions. Through these
programs, EPA is ensuring that all pesticides meet current health and
safety standards.

DATES: Comments must be received on or before October 10, 2006.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0253, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0253. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://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 regulations.gov or e-
mail. The Federal regulations.gov website 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 e-mail comment directly to EPA without going through
regulations.gov, your e-mail address will be automatically captured and
included as part of the comment that is placed in the 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.
    Docket: All documents in the docket are listed in the docket index.
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 in the electronic docket at http://www.regulations.gov
,or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT: Eric Olson, Special Review and
Reregistration Division (7508P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides. Since others also may be interested, the Agency
has not attempted to describe all the specific entities that may be
affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the person
listed under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. 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. 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. 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.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What Action is the Agency Taking?

    Under section 4 of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), EPA is reevaluating existing pesticides to
ensure that they meet current scientific and regulatory standards. EPA
has completed a Reregistration Eligibility Decision (RED) for the
pesticide, PPO under section 4(g)(2)(A) of FIFRA. PPO is an
insecticidal fumigant/sterilant used both to control bacteria
contamination, mold contamination, insect infestations, and

microbial spoilage of food products as well as to control stored
product insects in nonfood products. PPO is registered for use on
several food items such as processed spices, cocoa (beans and powder),
and in-shell and processed nutmeats (except peanuts). PPO also has
nonfood uses for cosmetic articles, gums, ores, packaging, pigments,
pharmaceutical materials, and discarded nutshells prior to disposal.
EPA has determined that the data base to support reregistration is
substantially complete and that products containing PPO are eligible
for reregistration provided the risks are mitigated in the manner
described in the RED. Upon submission of any required product-specific
data under section 4(g)(2)(B) and any necessary changes to the
registration and labeling (either to address concerns identified in the
RED or as a result of product-specific data), EPA will make a final
reregistration decision under section 4(g)(2)(C) for products
containing PPO.
    EPA must review tolerances and tolerance exemptions that were in
effect when the Food Quality Protection Act (FQPA) was enacted in
August 1996, to ensure that these existing pesticide residue limits for
food and feed commodities meet the safety standard established by the
new law. Tolerances are considered reassessed once the safety finding
has been made or a revocation occurs. EPA has reviewed and made the
requisite safety finding for the PPO tolerances.
    EPA is applying the principles of public participation to all
pesticides undergoing reregistration and tolerance reassessment. The
Agency's Pesticide Tolerance Reassessment and Reregistration; Public
Participation Process, published in the Federal Register on May 14,
2004 (69 FR 26819)(FRL-7357-9), explains that in conducting these
programs, EPA is tailoring its public participation process to be
commensurate with the level of risk, extent of use, complexity of
issues, and degree of public concern associated with each pesticide.
Due to its uses, risks, and other factors, PPO was reviewed through the
modified 4-Phase process. Through this process, EPA worked extensively
with stakeholders and the public to reach the regulatory decisions for
PPO.
    The reregistration program is being conducted under Congressionally
mandated time frames, and EPA recognizes the need both to make timely
decisions and to involve the public. The Agency is issuing the PPO RED
for public comment. This comment period is intended to provide an
additional opportunity for public input and a mechanism for initiating
any necessary amendments to the RED. In order to protect bystanders,
the RED requires emission control technologies, such as scrubbers or
acid bubblers, which achieve a performance standard of 99% emission
reduction of PPO from vacuum-sealed pressurized chambers. However, the
Agency is also interested in receiving comments describing other means
to protect bystanders from this use. All comments should be submitted
using the methods in ADDRESSES, and must be received by EPA on or
before the closing date. These comments will become part of the Agency
Docket for PPO. Comments received after the close of the comment period
will be marked ``late.'' EPA is not required to consider these late
comments.
    The Agency will carefully consider all comments received by the
closing date and will provide a Response to Comments Memorandum in the
Docket and regulations.gov. If any comment significantly affects the
document, EPA also will publish an amendment to the RED in the Federal
Register. In the absence of substantive comments requiring changes, the
PPO RED will be implemented as it is now presented.

B. What is the Agency's Authority for Taking this Action?

    Section 4(g)(2) of FIFRA as amended directs that, after submission
of all data concerning a pesticide active ingredient, the Administrator
shall determine whether pesticides containing such active ingredient
are eligible for reregistration, before calling in product-specific
data on individual end-use products and either reregistering products
or taking other ``appropriate regulatory action.''
    Section 408(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a(q), requires EPA to review tolerances and exemptions for
pesticide residues in effect as of August 2, 1996, to determine whether
the tolerance or exemption meets the requirements of section 408(b)(2)
or (c)(2) of FFDCA. This review is to be completed by August 3, 2006.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: August 1, 2006.
Debra Edwards,
Director, Special Review and Reregistration Division, Office of
Pesticide Programs.
[FR Doc. E6-12897 Filed 8-8-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 165 (Monday, August 26, 2013)]
[Notices]
[Pages 52772-52773]
[FR Doc No: 2013-20712]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0450]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Abbreviated New
Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by
September 25, 2013.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0669 and
title ``Abbreviated New Animal Drug Applications.'' Also include the
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Abbreviated New Animal Drug Applications--Section 512(b)(2) and (n)(1)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2) and
(n)(1)) (OMB Control Number 0910-0669)--Extension

    On November 16, 1988, the President signed into law the Generic
Animal Drug and Patent Restoration Act (GADPTRA) (Pub. L. 100-670).
Under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act), as amended by GADPTRA, any person may file an
abbreviated new animal drug application (ANADA) seeking approval of a
generic copy of an approved new animal drug. The information required
to be submitted as part of an abbreviated application is described in
section 512(n)(1) of the FD&C Act. Among other things, an abbreviated
application is required to contain information to show that the
proposed generic drug is bioequivalent to, and has the same labeling
as, the approved drug referenced in the abbreviated application. FDA
allows applicants to submit a complete ANADA or to submit information
in support of an ANADA for phased review followed by the submission of
an Administrative ANADA when FDA finds that all the applicable
technical sections for an ANADA are complete. FDA requests that an
applicant accompany ANADAs and requests for phased review of data to
support ANADAs with the Form FDA 356v to ensure efficient and accurate
processing of information to support approval of the generic new animal
drug.
    In the Federal Register of April 30, 2013 (78 FR 25279), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. One comment was received; however the
comment was not responsive to any of the four topics solicited by the
notice. Therefore, FDA does not address the comment here.
    FDA estimates the burden of this collection of information as
follows:

                                                   Table 1--ANADAs: Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
              FD&C act section 512 (b)(2)                   FDA form        Number of     responses per   Total annual   Average  burden    Total hours
                                                                           respondents     respondent       responses     per  response
--------------------------------------------------------------------------------------------------------------------------------------------------------
ANADA..................................................            356v              18               1              18            159             2,862
Phased Review With Administrative ANADA................            356v               3               5              15             31.8             477
                                                        ------------------------------------------------------------------------------------------------
    Total..............................................  ..............  ..............  ..............  ..............  ...............           3,339
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    ANADA paperwork burden (section 512(b)(2) of the FD&C Act). Over
the past 5 fiscal years, from October 2007 through September 2012, FDA
has received an average of 21 ANADAs per year. FDA estimates that
preparing the paperwork required under 21 U.S.C. 360b(n)(1) to be
contained in an ANADA, whether all of the information is submitted with
the ANADA or the applicant submits information for phased review
followed by an Administrative ANADA that references that information,
will take approximately 159 hours. (FDA is estimating that each ANADA
that uses the phased review process will have approximately five phased
reviews per application. Therefore, assuming that three respondents
will take advantage of the phased review option per year and an average
of five phased reviews are submitted per application, times 31.8 hours
per phased review, equals 477 total hours per year or 159 hours per
application.)
    Although over the last 5 fiscal years all sponsors chose to submit
traditional ANADAs, some sponsors did indicate an interest in using the
phased review option in the future. FDA believes that, with time, more
and more sponsors will take advantage of the phased review option as it
provides greater flexibility and estimates that there will be three
respondents for the phased review option. FDA also estimates that
sponsors of ANADAs take approximately 25 percent less time to put
together the information to support an ANADA than a new animal drug
application (NADA) because they only need to provide evidence of
bioequivalence and not the data required in a NADA to support a full
demonstration of safety and effectiveness.

    Form FDA 356v. FDA requests that an applicant fills out and sends
in a Form FDA 356v with an ANADA, and with requests for phased review
of data to support ANADAs, to ensure efficient and accurate processing
of information to support the approval of a generic new animal drug.
    Records and reports that are required post approval are described
in 21 CFR 514.80, and that paperwork is already covered by that rule in
OMB control number 0910-0284.

    Dated: August 20, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-20712 Filed 8-23-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 17, 2006 (Volume 71, Number 73)]
[Notices]
[Page 19718-19719]
[DOCID:fr17ap06-53]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PH06-39-000]

Alexander's of Brooklyn II, LLC; Notice of Petition for Exemption
From the Requirements of the Public Utility Holding Company Act of 2005

April 10, 2006.
    Take notice that on March 31, 2006, Alexander's of Brooklyn II, LLC
filed a notification of exemption pursuant to section 18 CFR 366.3(a)
and 366.4(b)(1), seeking exemption from the requirements of the Public
Utility Holding Company Act of 2005.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of

intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible online at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 21, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5620 Filed 4-14-06; 8:45 am]

BILLING CODE 6717-01-P