[Federal Register: August 3, 2010 (Volume 75, Number 148)]
[Proposed Rules]
[Page 45572-45579]
[DOCID:fr03au10-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 112

[EPA-HQ-OPA-2009-0880; FRL-9184-2]
RIN 2050-AG59

Oil Pollution Prevention; Spill Prevention, Control, and
Countermeasure (SPCC) Rule--Proposed Amendments

AGENCY: Environmental Protection Agency.

ACTION: Proposed rule; compliance date amendment.

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SUMMARY: The U.S. Environmental Protection Agency (EPA or the Agency)
is proposing to amend the date by which certain facilities must prepare
or amend their Spill Prevention, Control, and Countermeasure (SPCC)
Plans, and implement those Plans. This action would allow additional
time for those affected in the regulated community to understand the
revisions to the SPCC rule finalized in December 2008 and November
2009. In light of the recent uncertainty surrounding EPA's review of
the final amendments to the December 2008 rule and the delay of that
rule's effective date, the Agency is proposing to provide an additional
year for certain facilities, with a new compliance date of November 10,
2011. Additionally, the Agency is proposing to further delay the
compliance date for facilities with milk containers, associated piping
and appurtenances that are constructed according to the current
applicable 3-A Sanitary Standards, and subject to the current
applicable Grade ``A'' Pasteurized Milk Ordinance (PMO) or a State
dairy regulatory requirement equivalent to the current applicable PMO.
The delay would allow the Agency to take final action on a January 15,
2009 action that proposed to exempt these containers from the SPCC
requirements. The compliance date would be delayed one year from the
effective date of a final rule specifically addressing SPCC
requirements for these milk containers, associated piping and
appurtenances, or as specified by a rule that otherwise establishes a
new compliance date for these facilities. Both the extension and the
delay would provide sufficient time for facilities to undertake the
actions necessary to prepare or amend their SPCC Plans, as well as
implement them. However, EPA is not proposing to extend the compliance
date for drilling, production and workover facilities that are offshore
or that have an offshore component, or for onshore facilities required
to submit Facility Response Plans (FRPs).

DATES: Comments on this proposed rule must be received by August 18,
2010.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OPA-2009-0880, by one of the following methods:
    (1) http://www.regulations.gov. Follow the on-line instructions for
submitting comments.
    (2) E-mail<EMAIL_ADDRESS>Attention Docket ID No. EPA-HQ-
OPA-2009-0880.
    (3) Fax:<PHONE_NUMBER>, Attention Docket ID No. EPA-HQ-OPA-2009-
0880.
    (4) Mail: EPA Docket Center (EPA/DC), Docket ID No. EPA-HQ-OPA-
2009-0880, Mail Code 2822T, 1200 Pennsylvania Ave., NW., Washington, DC
20460.
    (5) Hand Delivery: EPA Docket Center (EPA/DC), EPA West, Room 3334,
1301 Constitution Ave., NW., Washington DC 20460. Attention Docket ID
No. EPA-HQ-OPA-2009-0880. 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: EPA's policy is that 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 or e-mail.
    The Federal regulations.gov Web site 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. 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 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 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 to make an appointment to view the docket is (202)
566-0276.

FOR FURTHER INFORMATION CONTACT: For general information on the SPCC
rule, 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 (703) 412-
3323. For more detailed information on specific aspects of this
proposed rule, contact either Vanessa Principe 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. General Information

A. Does this action apply to me?

    In the table below, EPA is providing a list of potentially affected
entities. However, this proposed action may affect other entities not
listed below. The Agency's goal is to provide a guide for readers to
consider regarding entities that potentially could be affected by this
action. If you have questions regarding the applicability of this
action to a particular entity, consult the person listed in the
preceding section titled FOR FURTHER INFORMATION CONTACT.

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          Industry sector                        NAICS code
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Oil Production....................  211111
Farms.............................  111, 112
Electric Utility Plants...........  2211
Petroleum Refining and Related      324
 Industries.
Chemical Manufacturing............  325
Food Manufacturing................  311, 312
Manufacturing Facilities Using and  311, 325
 Storing Animal Fats and Vegetable
 Oils.
Metal Manufacturing...............  331, 332
Other Manufacturing...............  31-33
Real Estate Rental and Leasing....  531-533
Retail Trade......................  441-446, 448, 451-454
Contract Construction.............  23
Wholesale Trade...................  42
Other Commercial..................  492, 541, 551, 561-562
Transportation....................  481-488
Arts Entertainment & Recreation...  711-713
Other Services (Except Public       811-813
 Administration).
Petroleum Bulk Stations and         4247
 Terminals.
Education.........................  61
Hospitals & Other Health Care.....  621, 622
Accommodation and Food Services...  721, 722
Fuel Oil Dealers..................  45431
Gasoline stations.................  4471
Information Finance and Insurance.  51, 52
Mining............................  212
Warehousing and Storage...........  493
Religious Organizations...........  813110
Military Installations............  928110
Pipelines.........................  4861, 48691
Government........................  92
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B. 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.
     Make sure to submit your comments by the comment period
deadline identified.

II. 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.

III. Background

    On July 17, 2002, the Agency published a final rule that amended
the Spill Prevention, Control and Countermeasure (SPCC) regulation (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 dates for complying with amendments to the
SPCC

regulations have been amended a number of times: On January 9, 2003 (68
FR 1348), on April 17, 2003 (68 FR 18890), on August 11, 2004 (69 FR
48794), on February 17, 2006 (71 FR 8462), on May 16, 2007 (72 FR
27444), and again on June 19, 2009 (74 FR 29136). These extensions
alleviated the need for individual extension requests and provided
additional time for the regulated community to, among other things:
Understand the July 2002 SPCC amendments and the implications of the
litigation (see 69 FR 29728, May 25, 2004 and 73 FR 71941, November 26,
2008); 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 amendments to the SPCC rule as finalized in
December 2006, December 2008, and November 2009; and to understand the
material presented in the SPCC Guidance for Regional Inspectors before
preparing or amending their SPCC Plans. All of these changes and
amendments were promulgated to provide increased clarity, to tailor
requirements to particular industry sectors, and to streamline certain
requirements for those facility owners or operators subject to the
rule. The current date under Sec.  112.3(a), (b) and (c) by which
owners/operators of facilities must prepare or amend their SPCC Plans,
and implement those Plans, is November 10, 2010.
    In accordance with the January 20, 2009 White House memorandum
entitled, ``Regulatory Review,'' and the memorandum from the Office of
Management and Budget entitled, ``Implementation of Memorandum
Concerning Regulatory Review'' (M-09-08, January 21, 2009) (OMB
memorandum), the effective date of the December 2008 rulemaking was
delayed until April 4, 2009 (74 FR 5900, February 3, 2009) and then
until January 14, 2010 (74 FR 14736, April 1, 2009). The Agency took
this action to ensure that the rule reflected proper consideration of
all relevant facts. In the February 3, 2009 notice, EPA requested
public comment on the extension of the effective date and its duration,
and on the regulatory amendments contained in the December 2008 final
rule. Upon reviewing the record for the amendments and the additional
comments, EPA promulgated further amendments to the SPCC rule on
November 13, 2009 (74 FR 58784), making limited changes to the December
2008 amendments. The effective date for both the December 5, 2008 and
the November 13, 2009 final rule is January 14, 2010, with a compliance
date of November 10, 2010. Because of the uncertainty that surrounded
EPA's review of the final amendments to the December 5, 2008 rule,
publication of final rule amendments on November 13, 2009 and the delay
of the effective date, the Agency is now proposing to further extend
the compliance date for certain facilities.
    On January 15, 2009, EPA proposed to exempt from the SPCC
requirements milk containers, associated piping and appurtenances
provided they are constructed according to current applicable 3-A
Sanitary Standards, and are subject to the current applicable PMO or a
State dairy regulatory requirement equivalent to the current applicable
PMO (74 FR 2461). The Agency also proposed that the capacity of these
milk containers would not be included in a facility's total oil storage
capacity calculation. This action proposes to further delay the
compliance date for facilities that would be impacted by the proposed
rule to exempt milk containers, associated piping and appurtenances.

IV. Proposal To Amend Compliance Date

    Under the current provisions in Sec.  112.3(a), the owner or
operator of a facility that was in operation on or before August 16,
2002 must maintain the facility's SPCC Plan, make any necessary
amendments to the Plan, and fully implement it by November 10, 2010;
the owner or operator of a facility that came into operation after
August 16, 2002, but before November 10, 2010, must prepare and fully
implement an SPCC Plan on or before November 10, 2010. Under Sec.
112.3(b), the owner or operator of a facility (excluding oil production
facilities) that becomes operational after November 10, 2010 must
prepare and implement a Plan before beginning operations; the owner or
operator of an oil production facility that becomes operational after
November 10, 2010 must prepare and implement a Plan within six months
after beginning operations. In addition, Sec.  112.3(c) requires the
owners and operators of onshore and offshore mobile or portable
facilities to prepare, implement, and maintain an SPCC Plan, and to
amend it, if necessary to ensure compliance with this part, on or
before November 10, 2010. The owner or operator of any onshore or
offshore mobile or portable facility that becomes operational after
November 10, 2010, must prepare and implement a Plan before beginning
operations.
    This proposed rule would amend the dates in Sec.  112.3(a), (b) and
(c) by which the owners/operators of facilities (except drilling,
production or workover facilities that are offshore or that have an
offshore component, and all onshore facilities required to have and
submit FRPs \1\) must prepare or amend their SPCC Plans, and implement
those Plans, to November 10, 2011, which is one year from the current
SPCC compliance date of November 10, 2010. This proposed extension of
the compliance date does not apply to drilling, production or workover
facilities that are completely offshore or that have both onshore and
offshore components (e.g., an oil production facility with offshore
wellheads connected to an onshore tank battery by submerged flowlines).
For offshore drilling, production or workover facilities, the Agency is
concerned about the need to have the most up-to-date SPCC Plans due to
the unusual combination of characteristics of these facilities:
Continuous flow of oil at the facility, potential discharges being
limited only by the capacity and pressure of the underground reservoir,
and discharges that would have immediate and direct impact on water.
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    \1\ Offshore FRP facilities are addressed in the exception to
the compliance date extension as part of the drilling, production or
workover facilities that are offshore or that have an offshore
component.
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    For onshore facilities, the Agency is concerned that further
extending the existing compliance date for facilities with large oil
storage capacities could further increase the potential to cause
substantial harm if a discharge were to occur. Onshore facilities with
large oil storage capacities have the potential to cause substantial
harm as identified under the FRP regulation (40 CFR 112.20 and 112.21).
FRP facilities are those with storage capacities of 1 million gallons
or more that could cause substantial harm \2\ or those with storage
capacities at or above 42,000 gallons and that transfer oil to or from
a vessel over water. The Agency believes that FRP facilities should
also have the most up-to-date SPCC Plans. It should be noted the Agency
has not changed any

compliance dates with respect to the FRP regulations. Therefore, EPA is
not proposing to extend the compliance date for drilling, production or
workover facilities that are offshore or that have an offshore
component, or all onshore facilities required to submit FRPs, due to
the threats these facilities pose of significant oil spills to waters
of the U.S. or adjoining shorelines.
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    \2\ A facility may pose ``substantial harm'' according to the
FRP rule if it (1) has a total oil storage capacity greater than or
equal to 42,000 gallons and it transfers oil over water to/from
vessels; or (2) has a total oil storage capacity greater than or
equal to one million gallons and meets one of the following
conditions: (a) Does not have sufficient secondary containment for
the capacity of the largest aboveground oil storage tank in each
aboveground storage area; (b) is located at a distance such that a
discharge from the facility could cause ``injury'' to fish,
wildlife, and sensitive environments; (c) is located at a distance
such that a discharge from the facility would shut down a public
drinking water intake; or (d) has had, within the past five years, a
reportable discharge greater than or equal to 10,000 gallons.
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    The Agency is also proposing to delay the compliance date for
facilities with milk containers, associated piping and appurtenances.
The delay would be effective for facilities with milk containers that
are constructed according to the current applicable 3-A Sanitary
Standards, and subject to the current applicable Grade ``A''
Pasteurized Milk Ordinance (PMO) or a State dairy regulatory
requirement equivalent to the current applicable PMO. The delay would
be for one year from the effective date of a final rule addressing the
SPCC requirements specifically for these milk containers, associated
piping and appurtenances, or as specified by a rule that otherwise
establishes a compliance date for these facilities. The Agency would
establish the new compliance date and publish it in the Federal
Register as part of any final action on the proposed exemption (74 FR
2461). The delay for these facilities is intended to provide the owner
or operator of these facilities the opportunity to fully understand any
regulatory amendments that may be finalized.
    The Agency is making changes to the regulatory text in Sec.  112.3
to reflect how the compliance date extension would apply for different
facilities, as provided for in the proposed rule.

Proposal To Extend Compliance Date by One Year

    This proposed rule would extend for most facilities the dates in
Sec.  112.3(a), (b) and (c) by which the owner or operator must prepare
or amend and implement an SPCC Plan. Exclusions to this compliance date
extension are described below. Today's proposed rule amends and
combines the current Sec.  112.3(a) with the current Sec.  112.3(b)(1)
and (c) to:
     Amend the compliance date for a facility, including a
mobile or portable facility, in operation on or before August 16, 2002
that requires the owner or operator to make any necessary amendments to
an SPCC Plan and fully implement the amended Plan by November 10,
2011.\3\
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    \3\ To be eligible for the compliance extension, owners or
operators of facilities in operation before August 16, 2002 must
continue to maintain their existing SPCC Plans.
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     Amend the compliance date for a facility, including a
mobile or portable facility, which came into operation after August 16,
2002, but before November 10, 2011, that requires the owner or operator
to prepare and fully implement an SPCC Plan on or before November 10,
2011.
     Amend the compliance date for a facility, including a
mobile or portable facility, (except an oil production facility \4\)
which becomes operational after November 10, 2011 that requires the
owner or operator to prepare and implement an SPCC Plan before
beginning operations.
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    \4\ On December 5, 2008 (73 FR 74236) EPA finalized an amendment
to allow a new oil production facility (i.e., one that becomes
operational after the compliance date) a period of six months after
the start of operations to prepare and implement an SPCC Plan.
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     Incorporate the language under the current Sec.  112.3(c)
for mobile or portable facilities (such as an onshore drilling or
workover rig, or a portable fueling facility) to amend the compliance
date for these facilities to November 10, 2011 and maintain the
language that allows mobile or portable facilities to prepare a general
Plan.
    An extension of the compliance date for these facilities is
appropriate because it provides the owners or operators of SPCC-
regulated facilities the opportunity to fully understand the regulatory
amendments offered by revisions to the SPCC rule promulgated on
December 5, 2008 (73 FR 74236) and November 13, 2009 (74 FR 58784).\5\
Given the delay in the effective date for the December 2008 rule
amendment, and the uncertainty that surrounded the final amendments
because of this delay, this proposed extension would allow potentially
affected facilities an additional year beyond the current compliance
date of November 10, 2010 to make any changes to their facilities and
SPCC Plans to comply with the revised SPCC requirements. Considering
that the changes in the final November 2009 amendments were very
limited, and that most of the December 2008 amendments offered
compliance options and regulatory burden relief, a limited timeframe
for this extension is appropriate. A one-year period from the current
compliance date provides sufficient time to understand and implement
the streamlined amendments to the SPCC rule.
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    \5\ A facility owner or operator in operation before August 16,
2002 must continue to maintain an existing Plan. A facility owner or
operator who wants to take advantage of the 2002, 2006, 2008, and
2009 regulatory changes may do so, but will need to modify the
existing Plan accordingly. Additionally, an owner or operator may
need to amend the Plan prior to the new compliance date to address
facility modifications for which more stringent requirements apply.
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    The Agency seeks comment on the proposed compliance date by which
owners and operators would be required to prepare, amend, and implement
SPCC Plans in accordance with amendments to the SPCC rule. Any
alternative dates suggested must include appropriate rationale and
supporting data for the Agency to be able to consider them for final
action.

Exceptions to the Proposal To Extend Compliance Date by One Year

    The Agency is not proposing to extend the compliance date for
drilling, production and workover facilities that are offshore or that
have an offshore component; or for onshore facilities required to have
and submit FRPs. The Agency is particularly concerned about the
potential for immediate environmental impacts resulting from oil spills
to waters of the U.S. or adjoining shorelines posed by these
facilities. All of these facilities have potentially significant
quantities of oil that could be discharged to navigable waters or
adjoining shorelines. Offshore drilling, production and workover
facilities (and those with an offshore component) have a constant flow
of oil associated with them and discharges could be in amounts that far
exceed the oil storage capacity of the facility. As in the case of the
recent Gulf of Mexico oil spill, the Agency is concerned that any
potential oil discharge may be limited only by the capacity and
pressure of the underground petroleum reservoir. The Agency's concern
regarding these facilities is reflected in the fact that they have a
greater number of requirements under the SPCC rule because of their
location over waters of the U.S. or adjoining shorelines (40 CFR
112.11). In addition to those facilities completely offshore, the
Agency has identified many onshore facilities with offshore components,
as in the case of over-water production platforms. While these
facilities have their tank batteries located onshore, their wellhead
and portions of the flow lines are below the surface of the water.
Offshore components include, but are not limited to, flow lines,
gathering lines, wellheads, shut in valves, pressure control and
sensing devices, cathodic protection devices and related piping and
appurtenances. Because the Agency is equally concerned with the
potential for immediate environmental impacts resulting from oil spills
from a facility's offshore components, it is also excluding these
facilities from the proposed extension. FRP facilities are those with
storage capacities of 1

million gallons or more that could cause substantial harm, or those
with storage capacities at or above 42,000 gallons and that transfer
oil to or from a vessel over water. The Agency is proposing to exclude
all onshore FRP facilities from the extension because of their large
oil storage capacities and their potential to cause substantial harm in
the event of a discharge as identified under the FRP regulation (40 CFR
112.20).
    Today's proposed rule amends the current Sec.  112.3(b)(1) to
maintain the existing compliance date for this subset of facilities,
and combines it with the current Sec.  112.3(c) provision to indicate
that the existing compliance date also applies to mobile or portable
facilities within this subset:
     Maintain the existing compliance date for a drilling,
production and workover facility, including a mobile or portable
facility, that is offshore or that has an offshore component; or of an
onshore facility required to have and submit an FRP, that was in
operation on or before August 16, 2002, that requires the owner or
operator to make any necessary amendments to an SPCC Plan and fully
implement the amended Plan by November 10, 2010.\6\
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    \6\ As noted previously, owners or operators of facilities in
operation before August 16, 2002 must continue to maintain existing
SPCC Plans.
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     Maintain the existing compliance date for a drilling,
production and workover facility, including a mobile or portable
facility, that is offshore or that has an offshore component; or of an
onshore facility required to have and submit an FRP, that came into
operation after August 16, 2002, but before November 10, 2010, that
requires the owner or operator to prepare and fully implement an SPCC
Plan on or before November 10, 2010.
     Maintain the existing compliance date for a facility
(except an oil production facility \7\) that is either: a drilling,
production and workover facility, including a mobile or portable
facility, that is offshore or that has an offshore component; or an
onshore facility required to have and submit an FRP, that becomes
operational after November 10, 2010, that requires the owner or
operator to prepare and implement an SPCC Plan before beginning
operations.
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    \7\ On December 5, 2008 (73 FR 74236) EPA finalized an amendment
to allow a new oil production facility (i.e., one that becomes
operational after the compliance date) a period of six months after
the start of operations to prepare and implement an SPCC Plan.
---------------------------------------------------------------------------

     Incorporate language under the current 112.3(c) to
maintain the existing compliance date for mobile or portable facilities
that fall within this subset of facilities (such as a barge mounted
offshore drilling or workover rig), and maintains the language that
allows mobile or portable facilities to prepare a general Plan.
    The Agency seeks comment on the proposed exceptions to the
compliance date extension. Any alternative exceptions suggested must
include appropriate rationale and supporting data for the Agency to be
able to consider them for final action.

Oil Production Facilities Beginning Operations After the Compliance
Date

    The Agency is proposing to amend the current Sec.  112.3(b)(2) to
distinguish the two separate compliance dates that would apply to oil
production facilities that become operational after the proposed
compliance dates. The Agency is also moving this provision to Sec.
112.3(c). These changes are intended to reflect the amendments and
rearranged provisions for Sec.  112.3(a), (b), and (c). The new Sec.
112.3(c) would be amended to:
     Maintain the existing compliance date for an oil
production facility that is offshore or that has an offshore component;
or of an onshore oil production facility required to submit an FRP,
that becomes operational after November 10, 2010, and could reasonably
be expected to have a discharge as described in Sec.  112.1(b), that
requires the owner or operator to prepare and implement a Plan within
six months after beginning operations.
     Amend the compliance date for an onshore oil production
facility (i.e. one that is not required to submit an FRP) that becomes
operational after November 10, 2011, and could reasonably be expected
to have a discharge as described in Sec.  112.1(b), that requires the
owner or operator to prepare and implement a Plan within six months
after beginning operations.
    The Agency seeks comment on the proposed extension of the
compliance date by which owners and operators would be required to
prepare, amend, and implement SPCC Plans in accordance with amendments
to the SPCC rule. Any alternative dates or approaches suggested must
include appropriate rationale and supporting data for the Agency to be
able to consider them for final action.

Proposal for Facilities With Milk Containers, Associated Piping and
Appurtenances

    The Agency is proposing to further delay the compliance date for
the owners and operators of facilities with milk containers, associated
piping and appurtenances that are constructed according to the current
applicable 3-A Sanitary Standards, and subject to the current
applicable Grade ``A'' Pasteurized Milk Ordinance (PMO) or a State
dairy regulatory requirement equivalent to the current applicable PMO.
The Agency is taking this action for facilities that would be affected
by any final determination on the proposed rule to exempt these milk
containers from SPCC requirements (74 FR 2461; January 15, 2009). The
compliance date would be delayed to one year from the effective date of
a final rule addressing the SPCC requirements specifically for these
milk containers, associated piping and appurtenances, or as specified
by a rule that otherwise establishes a new compliance date for these
facilities.\8\ The Agency would establish the new compliance date and
publish it in the Federal Register as part of any final action on the
proposed exemption. The delay for these facilities is intended to
provide the owner or operator of the facility the opportunity to fully
understand any new regulatory amendments for milk containers,
associated piping and appurtenances. Today's proposed rule amends Sec.
112.3(b)(2) to:
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    \8\ As noted previously in Sec.  112.3(a) and (b)(1), to be
eligible for the compliance extension, owners or operators of
facilities in operation before August 16, 2002 must continue to
maintain existing SPCC Plans. This includes facilities with milk
containers, associated piping and appurtenances.
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     Further delay the compliance date for any facility that
has milk containers, associated piping and appurtenances that are
constructed according to the current applicable 3-A Sanitary Standards,
and subject to the current applicable Grade ``A'' Pasteurized Milk
Ordinance (PMO) or a State dairy regulatory requirement equivalent to
the current applicable PMO. The delay would be for one year from the
effective date of a final rule addressing the SPCC requirements
specifically for these milk containers, associated piping and
appurtenances, or as specified by a rule that otherwise establishes a
new compliance date for these facilities.
    The Agency seeks comment on the proposed delay of the compliance
date by which owners and operators of facilities that have milk
containers, associated piping and appurtenances would be required to
prepare, amend, and implement SPCC Plans in accordance with amendments
to the SPCC rule. Any alternative dates or approaches suggested must
include appropriate rationale and supporting data for the Agency to be
able to consider them for final action.

Alternative Approach to the Proposed Compliance Date Extension

    While the Agency believes that a one-year compliance date extension
is appropriate, as discussed previously, the Agency also is requesting
comments on an alternative approach to extend the compliance date for
these facilities. This approach would extend the compliance date to
either May 10, 2011 or August 10, 2011 for all SPCC regulated
facilities, except for: drilling, production and workover facilities
that are offshore or that have an offshore component, or for onshore
facilities required to have and submit an FRP, which must comply by
November 10, 2010. This alternative approach would not impact the
Agency's proposal to delay the compliance date for facilities with milk
containers, associated piping and appurtenances that are constructed
according to the current applicable 3-A Sanitary Standards, and subject
to the current applicable Grade ``A'' Pasteurized Milk Ordinance (PMO)
or a State dairy regulatory requirement equivalent to the current
applicable PMO.
    Specifically, for SPCC-regulated facilities, the Agency believes
that a compliance date extension is appropriate for these facilities
because of the multiple regulatory amendments to the SPCC rule.
However, we are also requesting comment on whether it would be
appropriate to consider a shorter compliance date extension, such as
either six or nine months for them. In considering the shorter
compliance date extension, we request comments as to the type of
criteria to consider, such as discharge history, size and type of
facility, the ability to come into compliance, or the potential risk
presented. This extension would not apply to drilling, production and
workover facilities that are offshore or that have an offshore
component, or for onshore facilities required to have and submit an
FRP, which must comply by November 10, 2010.
    The Agency seeks comment on the alternative approach to the
proposed compliance date extension. Any alternative dates or approaches
suggested must include appropriate rationale and supporting data for
the Agency to be able to consider them for final action.
Other Considerations
    If an owner or operator of an SPCC-regulated facility requires
additional time to comply with the SPCC rule, he may submit a written
request to the Regional Administrator in accordance with Sec.
112.3(f). Such requests may be granted if the Regional Administrator
finds that the owner or operator cannot comply with all SPCC
requirements by the compliance date as a result of either non-
availability of qualified personnel, or delays in construction or
equipment delivery beyond his control and without the fault of such
owner or operator.
    It should be noted that these proposed compliance date amendments
would affect only the requirements of the July 2002, December 2006,
December 2008, and November 2009 SPCC rule amendments (67 FR 47042,
July 17, 2002; 71 FR 77266, December 26, 2006; 73 FR 74236, December 5,
2008; and 74 FR 29136, November 13, 2009) that are new (i.e.,
requirements that did not exist or were not in effect prior to the 2002
amendments) or more stringent compliance obligations to those that were
in effect in the 1973 SPCC rule. Provisions that provide regulatory
relief to facilities are applicable as of the effective date of the
amendment and would not require revisions to existing Plans ``to ensure
compliance'' (see Sec.  112.3). However, the facility owner or operator
must amend the SPCC Plan to include new or more stringent provisions by
the compliance date.

V. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under the terms of Executive Order 12866 (58 FR 51735, October 4,
1993), this action has been determined to be a ``significant regulatory
action.'' This rule was submitted to the Office of Management and
Budget (OMB) for review. Any changes made in response to OMB's
recommendations have been documented in the docket for this action.

B. Paperwork Reduction Act

    This proposed action does not impose an information collection
burden under the provisions of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq. This proposed rule would merely extend the compliance date
for certain facilities subject to the rule. The Office of Management
and Budget (OMB) has previously approved the information collection
requirements contained in the existing regulations at 40 CFR part 112
under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et
seq. and has assigned OMB control number 2050-0021. The OMB control
numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

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.
    For purposes of assessing the impacts of today's proposed rule on
small entities, small entity is defined as: (1) A small business as
defined by 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, I certify that this proposed 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
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 seeks to extend the compliance date in Sec.
112.3(a) for most facilities by one year and to delay the compliance
date in Sec.  112.3(b)(2) for facilities with milk containers,
associated piping and appurtenances that meet certain conditions for
one year from the effective date of a final rule addressing the SPCC
requirements specifically for these containers, or as specified by a
rule that otherwise establishes a compliance date for these facilities.
The changes in the final November 2009 amendments were very limited,
and the December 2008

amendments offered compliance options and regulatory burden relief. We
have therefore concluded that today's proposed rule will relieve
regulatory burden for all affected small entities. We continue to be
interested in the potential impacts of the proposed rule on small
entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act

    This proposed 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. 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. This proposed
rule would merely extend the compliance date for most facilities
subject to the rule.

E. Executive Order 13132: Federalism

    This proposed rule 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. 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.
    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 proposed action does not have tribal implications, as
specified in Executive Order 13175 (65 FR 67249, November 9, 2000). The
proposed rule would not significantly or uniquely affect communities of
Indian tribal governments. Thus, Executive Order 13175 does not apply
to this action.

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

    This proposed action is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997) because it is not economically significant as
defined in Executive Order 12866, and because the Agency does not
believe the environmental health or safety risks addressed by this
proposed action present a disproportionate risk to children. The public
is invited to submit comments or identify peer-reviewed studies and
data that assess the effects of early life exposure to oil as affected
by the proposed revision to the compliance date.

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

    This action 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. The
overall effect of this action is to decrease the regulatory burden on
facility owners or operators subject to its provisions.

I. National Technology Transfer and Advancement Act

    Section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (``NTTAA''), Pub. L. 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 12898 (59 FR 7629, February 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 does not
affect the level of protection provided to human health or the
environment.

List of Subjects in 40 CFR Part 112

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

    Dated: July 28, 2010.
Lisa P. Jackson,
Administrator.
    For the reasons set forth in the preamble, title 40, chapter I, 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 is amended by revising paragraphs (a), (b), and
(c) to read as follows:

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

* * * * *
    (a) If your facility, or mobile or portable 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 amended Plan no later than November 10, 2011. If such
a facility becomes operational after August 16, 2002, through November
10, 2011, 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 November 10, 2011. If such a facility (excluding oil
production facilities) becomes operational after November 10, 2011, 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. You are not required to prepare a new Plan each time you
move a mobile or portable facility to a new site; the Plan may be
general. 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 mobile or
portable facility is in a fixed (non-transportation) operating mode.
    (b) Notwithstanding the provisions of paragraph (a) of this
section:
    (1) If your drilling, production or workover facility, including a
mobile or portable facility, is offshore or has an offshore component;
or your onshore facility is required to have and submit a Facility
Response Plan pursuant to 40 CFR 112.20(a), and 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
amended Plan no later than November 10, 2010. If such a facility
becomes operational after August 16, 2002, through November 10, 2010,
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
November 10, 2010. If such a facility (excluding oil production
facilities) becomes operational after November 10, 2010, 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. You are not required to prepare a new Plan each time you
move a mobile or portable facility to a new site; the Plan may be
general. 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 mobile or
portable facility is in a fixed (non-transportation) operating mode.
    (2) If your facility has milk containers, associated piping and
appurtenances constructed according to current applicable 3-A Sanitary
Standards, and subject to current applicable Grade ``A'' Pasteurized
Milk Ordinance (PMO) or a State dairy regulatory requirement equivalent
to current applicable PMO, the compliance date described in paragraphs
(a) and (b)(1) of this section shall be one year from the effective
date of a final rule addressing SPCC requirements specifically for
these milk containers, associated piping and appurtenances; or until a
rule that otherwise establishes the date by which you must comply with
the provisions of this part.
    (c) If your oil production facility as described in paragraph (a)
of this section becomes operational after November 10, 2011, or as
described in paragraph (b)(1) of this section becomes operational after
November 10, 2010, and could reasonably be expected to have a discharge
as described in Sec.  112.1(b), you must prepare and implement a Plan
within six months after you begin operations.
* * * * *
[FR Doc. 2010-19075 Filed 8-2-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: April 23, 2008 (Volume 73, Number 79)]
[Notices]
[Page 21959-21962]
[DOCID:fr23ap08-84]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0227]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on medical device labeling
regulations.

DATES: Submit written or electronic comments on the collection of
information by June 23, 2008.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Medical Device Labeling Regulations--21 CFR Parts 800, 801, and 809
(OMB Control Number 0910-0485)--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 352), among other things, establishes requirements for the
label or labeling of a medical device so that it is not misbranded and
subject to a regulatory action. Certain provisions under section 502 of
the act require manufacturers, importers, and distributors of medical
devices to disclose information about themselves or the devices, on the
labels or labeling for the devices. Section 502(b) of the act requires
that for packaged devices, the label must bear

the name and place of business of the manufacturer, packer, or
distributor as well as an accurate statement of the quantity of the
contents. Section 502(f) of the act requires that the labeling for a
device must contain adequate directions for use. FDA may however, grant
an exemption, if the agency determines that the adequate directions for
use labeling requirements are not necessary for the particular case, as
it relates to protection of the public health.
    FDA regulations under parts 800, 801, and 809 (21 CFR parts 800,
801, and 809) require disclosure of specific information by
manufacturers, importers, and distributors of medical devices about
themselves or the devices, on the label or labeling for the devices to
health professionals and consumers. FDA issued these regulations under
the authority of sections 201, 301, 502, and 701 of the act (21 U.S.C.
321, 331, 352, and 371). Most of the regulations under parts 800, 801,
and 809 are derived from requirements of section 502 of the act, which
provides in part, that a device shall be misbranded if among other
things, its label or labeling fails to bear certain required
information concerning the device, is false or misleading in any
particular way, or fails to contain adequate directions for use.
    Reporting Burden
    Sections 800.10(a)(3) and 800.12(c) require that the label for
contact lens cleaning solutions bear a prominent statement alerting
consumers of the tamper-resistant feature. Further, Sec.  800.12
requires that packaged contact lens cleaning solutions contain a
tamper-resistant feature, to prevent malicious adulteration.
    Section 800.10(b)(2) requires that the labeling for liquid
ophthalmic preparations packed in multiple-dose containers provide
information on the duration of use and the necessary warning
information to afford adequate protection from contamination during
use.
    Section 801.1 requires that the label for a device in package form,
contain the name and place of business of the manufacturer, packer, or
distributor.
    Section 801.5 requires that labeling for a device include
information on intended use as defined under Sec.  801.4 and provide
adequate directions to assure safe use by the lay consumers.
    Section 801.61 requires that the principal display panel of an
over-the-counter (OTC) device in package form must bear a statement of
the identity of the device. The statement of identity of the device
must include the common name of the device followed by an accurate
statement of the principal intended actions of the device.
    Section 801.62 requires that the label for an OTC device in package
form must bear a statement of declaration of the net quantity of
contents. The label must express the net quantity in terms of weight,
measure, numerical count, or a combination of numerical count and
weight, measure, or size.
    Section 801.109 establishes labeling requirements for prescription
devices, in which the label for the device must describe the
application or use of the device, and contain a cautionary statement
restricting the device for sale by, or on the order of an appropriate
professional.
    For prescription by a licensed practitioner, Sec.  801.110
establishes labeling requirements for a prescription device delivered
to the ultimate purchaser or user. The device must be accompanied by
labeling bearing the name and address of the licensed practitioner,
directions for use, and cautionary statements if any, provided by the
order.
    Section 801.150(e) requires a written agreement between firms
involved when a non-sterile device is assembled or packaged with
labeling that identifies the final finished device as sterile, for
which the device is ultimately introduced into interstate commerce to
an establishment or contract manufacturer to be sterilized. When a
written agreement complies with the requirements under Sec.
801.150(e), FDA takes no regulatory action against the device as being
misbranded or adulterated. In addition, Sec.  801.150(e) requires that
each pallet, carton, or other designated unit, be conspicuously marked
to show its non-sterile nature when introduced into interstate
commerce, and while being held prior to sterilization.
    Section 801.405(b)(1) provides for labeling requirements for
articles, including repair kits, re-liners, pads, and cushions,
intended for use in temporary repairs and refitting of dentures for lay
persons. Section 801.405(b)(1) also requires that the labeling contain
the word ``emergency'' preceding and modifying each indication-for-use
statement for denture repair kits and the word ``temporary'' preceding
and modifying each indication-for-use statement for re-liners, pads,
and cushions.
    Section 801.405(c) provides for labeling requirements that contain
essentially the same information described under Sec.  801.405(b)(1).
The information is intended to enable a lay person to understand the
limitations of using OTC denture repair kits, and denture re-liners,
pads, and cushions.
    Section 801.420(c)(1) requires that manufacturers or distributors
of hearing aids develop a user instructional brochure to be provided by
the dispenser of the hearing aid to prospective users. The brochure
must contain detailed information on the use and maintenance of the
hearing aid.
    Section 801.420(c)(4) establishes requirements that the user
instructional brochure or separate labeling, provide for technical data
elements useful for selecting, fitting, and checking the performance of
a hearing aid. In addition, Sec.  801.420(c)(4) provides for testing
requirements to determine that the required data elements must be
conducted in accordance with the American National Standards
Institute's (ANSI) ``Specification of Hearing Aid Characteristics,''
ANSI S3.22-1996 (ASA 70-1996); (Revision of ANSI S3.22-1987), which is
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51.
    Section 801.421(b) establishes requirement for the hearing aid
dispenser to provide prospective users with a copy of the user
instructional brochure along with an opportunity to review comments,
either orally or by the predominant method of communication used during
the sale.
    Section 801.421(c) establishes requirements for the hearing aid
dispenser to provide a copy of the user instructional brochure to the
prospective purchaser of any hearing aid upon request or, if the
brochure is unavailable, provide the name and address of the
manufacturer or distributor from which it may be obtained.
    Section 801.430(d) establishes labeling requirements for menstrual
tampons to provide information on signs, risk factors, and ways to
reduce the risk of Toxic Shock Syndrome (TSS).
    Section 801.430(e)(2) requires menstrual tampon package labels to
provide information on the absorbency term based on testing required
under Sec.  801.430(f) and an explanation of selecting absorbencies
that reduce the risk of contracting TSS.
    Section 801.430(f) establishes requirements that manufacturers of
menstrual tampons devise and follow an ongoing sampling plan for
measuring the absorbency of menstrual tampons. Further, manufacturers
must use the method and testing parameters described under this
section.
    Section 801.435(b), (c), and (h) establishes requirements for
condom labeling to bear an expiration date that

is supported by testing that demonstrates the integrity of three random
lots of the product.
    Section 809.10(a) and (b) establishes requirements that a label for
an in vitro diagnostic device and the accompanying labeling (package
insert), must contain information identifying its intended use,
instructions for use and lot or control number, and source.
    Section 809.10(d)(1) provides that the labeling requirements for
general purpose laboratory reagents may be exempt from the requirements
of Sec.  809.10(a) and (b), if the labeling contains information
identifying its intended use, instructions for use, lot or control
number, and source.
    Section 809.10(e) provides that the labeling for ``Analytic
Specific Reagents'' (ASRs) must provide information identifying the
quantity or proportion or each reagent ingredient, instructions for
use, lot or control number, and source.
    Section 809.10(f) provides that, the labeling for OTC test sample
collection systems for drugs of abuse must include information on the
intended use, specimen collection instructions, identification system,
and information about use of the test results. In addition, Sec.
809.10(f) requires that this information be in a language appropriate
for the intended users.
    Section 809.30(d) requires that advertising and promotional
materials for ASRs include the identity and purity of the ASR and the
identity of the analyte.
    Recordkeeping Burden
    Section 801.150(a)(2) establishes recordkeeping requirements for
re-processors, re-labelers, or re-packagers to retain a copy of the
agreement containing the specifications for the processing, labeling,
or repacking of the device for 2 years after the shipment or delivery
of the device. Section 801.150(a)(2) also requires that the subject
respondents make copies of this agreement available for inspection at
any reasonable hour to any officer or employee of the Department of
Health and Human Services (DHHS), upon their request.
    Section 801.421(d) establishes requirements for hearing aid
dispensers to retain copies of all physician statements or any waivers
of medical evaluation for 3 years after dispensing the hearing aid.
    Section 801.410(e) requires copies of invoices, shipping documents,
and records of sale or distribution of all impact resistant lenses,
including finished eyeglasses and sunglasses, be maintained for 3 years
by the retailer and made available upon request by any officer or
employee of FDA or by any other officer or employee acting on behalf of
the Secretary of Health and Human Services.
    Section 801.410(f) requires that the results of impact tests and
description of the test method and apparatus be retained for a period
of 3 years.
    Section 801.421(d) requires hearing aid dispensers to retain a copy
of any written statement from a physician required under Sec.
801.421(a)(1), or any written statement waiving medical evaluation
required under Sec.  801.421(a)(2)(iii) for 3 years after the
dispensing the hearing aid.
    Section 801.435(g) requires latex condom manufacturers to document
and provide, upon request, an appropriate justification for the
application of the testing data from one product on any variation of
that product to support expiration dating in the user labeling.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                 No. of        Annual Frequency     Total Annual        Hours per
                      21 CFR Section                          Respondents       per  Response        Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.10(a)(3) and 800.12(c)                                                 4                 10                 40                  1                 40
--------------------------------------------------------------------------------------------------------------------------------------------------------
800.10(b)(2)                                                               4                 10                 40                 40              1,600
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.1                                                                 30,000                3.5            105,000                0.1             10,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.5                                                                  5,000                3.5             17,500              22.35            391,125
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.61                                                                 5,000                3.5             17,500                  1             17,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.62                                                                 1,000                  5              5,000                  1              5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.109                                                               18,000                3.5             63,000              17.77          1,119,510
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.110                                                               10,000                 50            500,000               0.25            125,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(e)                                                                 2                  1                  2               0.50                  1
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.405(b)(1)                                                             40                  1                 40                  4                160
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.405(c)                                                                40                  1                 40                  4                160
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.420(c)(1)                                                            275                  5              1,375                 40             55,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.420(c)(4)                                                            275                  5              1,375                 80            110,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.421(b)                                                            10,000                160          1,600,000               0.30            480,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.421(c)                                                            10,000                  5             50,000               0.17              8,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.430(d)                                                                 8                  5                 40                  2                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.430(e)(2)                                                              8                  5                 40                  2                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------

801.430(f)                                                                 8                  5                 40                 80              3,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.435(b), (c), and (h)                                                 135                  1                135                 96             12,960
--------------------------------------------------------------------------------------------------------------------------------------------------------
809.10(a) and (b)                                                      1,700                  6             10,200                 80            816,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
809.10(d)(1)                                                             300                  2                600                 40             24,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
809.10(e)                                                                300                 25              7,500                  1              7,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
809.10(f)                                                                 20                  1                 20                100              2,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
809.30(d)                                                                300                 25              7,500                  1              7,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                3,197,416
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Annual Frequency
                      21 CFR Section                             No. of              per            Total Annual    Hours per  Record     Total Hours
                                                             Recordkeepers      Recordkeeping         Records
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.150(a)(2)                                                             57                  1                 57               0.50                 28
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.410(e)                                                                30            769,000         23,070,000               0.25          5,767,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.410(f)                                                                30            769,000         23,070,000               0.25          5,767,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
801.421(d)                                                            10,000                160          1,600,000               0.25            400,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Hours                                                                                11,935,028
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    This regulation also refers to previously approved collections of
information found in FDA regulations. The collections of information
under Sec. Sec.  800.12(d) and 801.437(i) have been approved under OMB
control number 0910-0183; the collections of information under Sec.
800.12(e) have been approved under OMB control number 0910-0231; and
the collections of information under Sec.  801.435(g) have been
approved under OMB control number 0910-0073.
    Further, FDA concludes that labeling statements under Sec. Sec.
801.63, 801.405(b)(2) and (b)(3), 801.420(c)(2) and (c)(3), 801.430(c)
and (e)(1), 801.433, 801.437(d) through (g), 809.30(d)(2) and (d)(3),
and 809.30(e) do not constitute a ``collection of information'' under
the PRA. Rather, these labeling statements are ``public disclosure'' of
information originally supplied by the Federal Government to the
recipient for the purpose of ``disclosure to the public'' (5 CFR
1320.3(c)(2)).
    Reporting
    These estimates are based on FDA's registration and listing
database for medical device establishments, agency communications with
industry, and FDA's knowledge of and experience with device labeling.
    Recordkeeping
    These estimates are based on FDA's registration and listing
database for medical device establishments, agency communications with
industry, and FDA's knowledge of and experience with device labeling.
In addition, the Vision Council of America provided the growth rate
used to estimate the burden under Sec.  801.410(e) through (f).
    This regulation also refers to previously approved collections of
information found in FDA regulations. The collections of information
under Sec. Sec.  800.12(d) and 801.437(i) have been approved under OMB
control number 0910-0183; and the collections of information under
Sec.  800.12(e) have been approved under OMB control number 0910-0231.
    The information collection requirements under Sec. Sec.  801.22,
801.63, 801.405(b)(2) and (b)(3), 801.420(c)(2) and (c)(3), 801.430(c)
and (e)(1), 801.433, 801.437(d) through (g), 809.30(d)(2) and (d)(3),
and 809.30(e) are not considered information collection because the
public information is originally supplied by the Federal Government to
the recipient for the purpose of disclosure to the public (5 CFR
1320.3(c)(2)).
    We have not estimated a burden for information that is disclosed to
third parties, because it is a ``usual and customary'' part of a
medical device manufacturer, distributor, or importer's normal business
activities. Nor have we estimated a burden for time that is spent
designing labels to improve the format or presentation.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: April 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-8710 Filed 4-22-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Page 37058]
[FR Doc No: 2023-11934]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PL03-3-012]

Argus Media Inc.; Notice of Filing

    Take notice that on May 30, 2023, Argus Media Inc. filed a formal
application to the Federal Energy Regulatory Commission (Commission)
for re-approval as a price index developer fully or substantially in
compliance with the Commission's April 2022 Actions Regarding the
Commission's Policy on Price Index Formation and Transparency, and
Indices Referenced in Natural Gas and Electric Tariffs (Revised Policy
Statement).\1\
---------------------------------------------------------------------------

    \1\ 179 FERC ] 61,036 (2022).
---------------------------------------------------------------------------

    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.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on June 12, 2023.

    Dated: May 30, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-11934 Filed 6-5-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 225 (Thursday, November 21, 2019)]
[Notices]
[Pages 64401-64403]
[FR Doc No: 2019-25339]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0106]

Hours of Service of Drivers: Kimble Recycling & Disposal, Inc.;
Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to grant Kimble Recycling &
Disposal, Inc.'s (KRD) request for an exemption from the 12-hour limit
of the hours-of-service (HOS) short-haul exception. The exemption
enables all KRD's drivers who operate commercial motor vehicles (CMVs)
to collect waste and recycling materials to use the short-haul
exception but return to their work-reporting location within 14 hours
instead of the usual 12 hours without losing their short-haul status.
FMCSA has analyzed the application and the public comments and has
determined that the exemption, subject to the terms and conditions
imposed, will likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption.

DATES: This exemption is effective November 21, 2019 and expires
November 21, 2024.

ADDRESSES:
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov at any time or visit Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday,
except Federal holidays. The on-line FDMS is available 24 hours each
day, 365 days each year.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

FOR FURTHER INFORMATION CONTACT: Ms. Pearlie Robinson, FMCSA Driver and
Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>If you
have questions on viewing or submitting material to the docket, contact
Docket Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to www.regulations.gov and insert
the docket number, ``FMCSA-2019-0106 in the ``Keyword'' box and click
``Search.'' Next, click the ``Open Docket Folder'' button and choose
the document to review. If you do not have access to the internet, you
may view the docket online by visiting the Docket Management Facility
in Room W12-140 on the ground floor of the DOT West Building, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
E.T., Monday through Friday, except Federal holidays.

II. Legal Basis

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain Federal Motor Carrier Safety Regulations
(FMCSRs). FMCSA must publish a notice of each exemption request in the
Federal Register (49 CFR 381.315(a)). The Agency must provide the
public an opportunity to inspect the information relevant to the
application, including any safety analyses that have been conducted.
The Agency must provide an opportunity for public comment on the
request.
    The Agency reviews safety analyses and public comments submitted
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The Agency's
decision of the Agency must be published in the Federal Register (49
CFR 381.315(b)) with the reasons for denying or granting the
application and, if granted, the name of the person or class of persons
receiving the exemption, and the regulatory provision from which the
exemption is granted. The notice must specify the effective period (up
to 5 years) and explain the terms and conditions of the exemption. The
exemption may be renewed (49 CFR 381.300(b)).

III. Request for Exemption

    KRD seeks an exemption for approximately 320 drivers who operate
CMVs to collect waste and recycling materials. These drivers qualify
routinely for the short-haul exception in 49 CFR 395.1(e)(1); however,
occasionally they cannot complete their duty day within 12 hours. KRD
seeks an exemption to allow its drivers to continue to qualify for the
short-haul exception up to the 14th hour after coming on duty.
    KRD states that ELDs delay and distract its drivers working to
collect waste and recycling materials because they require excessive
interaction. The exemption application states that, because of frequent
stops to pick up trash, its drivers are required to interact with the
ELD ``hundreds if not thousands of times a day.'' KRD asserts that ELDs
are not designed to accommodate operations such as theirs.
    KRD notes that certain short-haul CMV drivers already operate up to
14 hours without forfeiting short-haul status. Drivers in the ready-
mixed concrete industry enjoy a statutory exemption [49 CFR
395.1(e)(1)(ii)(B)], and FMCSA has granted an exemption for the
asphalt-paving business [83 FR 3864, Jan. 26, 2018]. KRD asserts that
its operations are similar to these industries as its drivers spend a
significant portion of their days conducting non-driving duties.

IV. Method To Ensure an Equivalent or Greater Level of Safety

    In its application, KRD lists the following fatigue management
programs and processes it would implement were the exemption granted:
Observation Program; Routeware DriveCam Video Event Recorder Program;
and the KRD Fatigued Driver Process. KRD noted that it incorporated
elements of the North American Fatigue Management Program into its
Fatigued Driver Process. Details of these plans are provided in KRD's
application for exemption, available for review in the docket for this
notice.

V. Public Comments

    On May 28, 2019, FMCSA published notice of this application and
requested public comment [84 FR 24592]. The Agency received six
comments. One commenter, Mr. Chuck Simmons, supported the exemption,
writing that ``First and foremost, this is a company that takes Safety,
and specifically fatigue management, very seriously. In fact, they `get
it' far more than many other motor carriers that I've encountered in my
17 years in this industry. It seems readily apparent that there would
be no adverse safety impact by granting the requested exemption.''
    Three commenters opposed the exemption; KRD wrote responses to
those commenters. Mr. Michael Millard wrote, ``As local 100-air-mile
radius drivers Kimble Recycling and Disposal, Inc., has no SMS data to
determine HOS compliance.'' Mr. Millard asserted that KRD operated
wholly in intrastate commerce and was not subject to the hours of
service rules for interstate commerce. Mr. Millard concluded his
comments by saying, ``Based on roadside inspection data I do not
believe it is warranted for the FMCSA to issue an exemption as
requested.''
    In response to Mr. Millard's comments, KRD explained that it
operates in interstate commerce and serves customers in both West
Virginia and Ohio and that its SMS data is available on the internet.
KRD indicated that it has no HOS violations.
    The Commercial Vehicle Safety Alliance (CVSA) neither opposed nor
supported the application. CVSA wrote that ``When considering this
exemption request, FMCSA should consider its impacts on safety and the
enforcement process.'' CVSA explained that exemptions have the
potential to undermine safety while complicating the enforcement
process. Additionally, CVSA said, ``If this exemption is granted, all
drivers, managers, dispatchers and relevant staff should be required to
complete the North American Fatigue Management Program training
developed in partnership by FMCSA, Transport Canada and industry
stakeholders as a comprehensive approach for managing fatigue. Required
participation in the program will aid in mitigating any impact on
safety additional exposure to fatigue causes.''

VI. FMCSA Response and Decision

    FMCSA has evaluated KRD's application and the public comments and
decided to grant the exemption. The Agency believes that KRD's CMV
drivers collecting waste and recycling materials who are exempted will
likely achieve a level of safety that is equivalent to or greater than
the level of safety achieved without the exemption [49 CFR 381.305(a)].
The exemption will allow KRD's drivers to use the short-haul RODS
exception, but with a 14-hour duty period instead of 12 hours. The
Agency has granted similar exemptions to the National Asphalt Pavement
Association, Inc. [83 FR 3864, Jan. 26, 2018] and Waste Management
Holdings, Inc. [83 FR 53940, Oct. 25, 2018]. FMCSA has no evidence that
the safety of their operations has deteriorated.
    Regarding the recommendation from CVSA for KRD's relevant staff to
complete the North American Fatigue Management Program training, KRD
reported in its application that it has reviewed and incorporated
elements of the program into its Fatigued Driver Process.
    The Agency emphasizes that this exemption does not allow any
additional driving time during the work shift nor does it allow driving
after the

14th hour from the beginning of the work shift. Drivers remain limited
by the weekly limits and the employer must maintain accurate time
records concerning the time the driver reports for work each day, the
total number of hours the driver is on duty each day, and the time the
driver is released from duty each day. As KRD explained, drivers
usually return to the work reporting location within 12 hours but the
demands during certain periods necessitate work shifts going beyond 12
hours. Therefore, the exemption application should not be construed as
a mechanism for the applicant to implement a new business model with
all its drivers routinely extending their maximum work shifts from 12
to 14 hours. The exemption provides limited relief to the recordkeeping
requirements for HOS for short-haul drivers who find it necessary to
exceed the 12-hour limit, which impacts the type of HOS records
required.

VII. Terms and Conditions for the Exemption

     KRD drivers must have a copy of this notice in their
possession while operating under the terms of the exemption. This
notice serves as the exemption document and must be presented to law
enforcement officials upon request.
     KRD drivers must return to the work reporting location and
be released from work within 14 consecutive hours.

Extent of the Exemption

    This exemption is limited to the provisions of 49 CFR
395.1(e)(1)(ii)(A). KRD drivers must comply will all other applicable
provisions of the FMCSRs.

Preemption

    In accordance with 49 U.S.C. 31315(d), during the period this
exemption is in effect, no State shall enforce any law or regulation
that conflicts with or is inconsistent with this exemption with respect
to a firm or person operating under the exemption.

Notification to FMCSA

    Any motor carrier utilizing this exemption must notify FMCSA within
5 business days of any accident (as defined in 49 CFR 390.5), involving
any of the motor carrier's CMVs operating under the terms of this
exemption. The notification must include the following information:
    (a) Identity of the exemption: ``Kimble Recycling & Disposal,
Inc;''
    (b) Name of operating motor carrier;
    (c) Date of the accident;
    (d) City or town, and State, in which the accident occurred, or
closest to the accident scene;
    (e) Driver's name and license number;
    (f) Vehicle number and State license number;
    (g) Number of individuals suffering physical injury;
    (h) Number of fatalities;
    (i) The police-reported cause of the accident;
    (j) Whether the driver was cited for violation of any traffic laws,
motor carrier safety regulations; and
    (k) The driver's total driving time and total on-duty time period
prior to the accident.
    Reports filed under this provision shall be emailed to
[email protected]

VIII. Termination

    FMCSA does not believe the drivers covered by this exemption will
experience any deterioration of their safety record. Interested parties
or organizations possessing information that would otherwise show that
this motor carrier is not achieving the requisite statutory level of
safety should immediately notify FMCSA. FMCSA will take all steps
necessary to protect the public interest, including revocation of the
exemption. The FMCSA will revoke the exemption immediately for failure
to comply with its terms and conditions.

    Issued on: November 14, 2019.
 Jim Mullen,
 Deputy Administrator.
[FR Doc. 2019-25339 Filed 11-20-19; 8:45 am]
BILLING CODE 4910-EX-P