[Federal Register: September 11, 2009 (Volume 74, Number 175)]
[Proposed Rules]
[Page 46707-46714]
[DOCID:fr11se09-9]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2008-0483; FRL-8432-3]
RIN 2070-AJ36

Elemental Mercury Used in Flow Meters, Natural Gas Manometers,
and Pyrometers; Proposed Significant New Use Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY:  EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) for
elemental mercury (CAS No. 7439-97-6) for use in flow meters, natural
gas manometers, and pyrometers, except for use in these articles when
they are in service as of the effective date of the final rule. This
action would require persons who intend to manufacture (including
import) or process elemental mercury for an activity that is designated
as a significant new use by this proposed rule to notify EPA at least
90 days before commencing that activity. Persons subject to the
provisions of this proposed rule would not be exempt from significant
new use reporting if they import into the United States or process
elemental mercury as part of an article. The required notification
would provide EPA with the opportunity to evaluate the intended use
and, if necessary, to prohibit or limit that activity before it occurs.

DATES: Comments must be received on or before November 10, 2009.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2008-0483, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID Number EPA-HQ-OPPT-2008-0483. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2008-0483. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute.

Do not submit information that you consider to be CBI or otherwise
protected through regulations.gov or e-mail. The regulations.gov
website is an ``anonymous access'' system, which means EPA will not
know your identity or contact information unless you provide it in the
body of your comment. If you send an e-mail comment directly to EPA
without going through regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the docket and made available on the Internet. If you submit
an electronic comment, EPA recommends that you include your name and
other contact information in the body of your comment and with any disk
or CD-ROM you submit. If EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, EPA may not be
able to consider your comment. Electronic files should avoid the use of
special characters, any form of encryption, and be free of any defects
or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, will be publicly available only
in hard copy. Publicly available docket materials are available
electronically at http://www.regulations.gov, or, if only available in
hard copy, at the OPPT Docket. The OPPT Docket is located in the EPA
Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC Public Reading Room hours of
operation are 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding
legal holidays. The telephone number of the EPA/DC Public Reading Room
is<PHONE_NUMBER>, and the telephone number for the OPPT Docket is
(202) 566-0280. Docket visitors are required to show photographic
identification, pass through a metal detector, and sign the EPA visitor
log. All visitor bags are processed through an X-ray machine and
subject to search. Visitors will be provided an EPA/DC badge that must
be visible at all times in the building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby
Lintner, Regulatory Coordinator, Environmental Assistance Division
(7408M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address: TSCA-
<EMAIL_ADDRESS>     For technical information contact: Peter Gimlin, National Program
Chemicals Division, Office of Pollution Prevention and Toxics, Office
of Pollution Prevention and Toxics, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture
(defined by statute to include import) or process elemental mercury
used in flow meters, natural gas manometers, or pyrometers. Potentially
affected entities may include, but are not limited to, manufacturers of
instruments and related products for measuring, displaying, and
controlling industrial process variables (North American Industrial
Classification System (NAICS) code 334513). This listing is not
intended to be exhaustive, but rather provides a guide for readers
regarding entities likely to be affected by this action. Other types of
entities not listed in this unit could also be affected. The NAICS
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in 40 CFR 721.5 for
SNUR-related obligations. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.
    This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Persons
who import any chemical substance governed by a final SNUR are subject
to the TSCA section 13 (15 U.S.C. 2612) import certification
requirements and the corresponding regulations at 19 CFR 12.118 through
12.127 and 19 CFR 127.28. Those persons must certify that the shipment
of the chemical substance complies with all applicable rules and orders
under TSCA, including any SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after October
13, 2009 are subject to the export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)), (see 40 CFR 721.20), and must comply
with the export notification requirements in 40 CFR part 707, subpart
D.

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

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

II. Background

A. What Action is the Agency Taking?

    This proposed SNUR would require persons to notify EPA at least 90
days before commencing the manufacture, import, or processing of
elemental

mercury for any of the following significant new uses: Flow meters,
natural gas manometers, or pyrometers. This proposed rule does not
affect the manufacturing and processing of elemental mercury for use in
these articles when they are in service as of the effective date of the
final rule. EPA believes this proposed SNUR is necessary because
manufacturing, processing, use, or disposal of mercury associated with
these uses may produce significant changes in human and environmental
exposures. The rationale and objectives for this proposed SNUR are
explained in Unit IV.

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

    Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including those listed in TSCA section 5(a)(2). Once
EPA determines that a use of a chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires persons to submit a significant
new use notice (SNUN) to EPA at least 90 days before they manufacture
or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)). As described in Unit II.C., the general SNUR provisions
are found at 40 CFR part 721, subpart A.

C. Applicability of General Provisions

    General provisions for SNURs appear under 40 CFR part 721, subpart
A. These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the final
rule. However, 40 CFR 721.45(f) does not apply to this SNUR. As a
result, persons subject to the provisions of this proposed rule would
not be exempt from significant new use reporting if they import or
process elemental mercury as part of an article (see 40 CFR 721.5).
Conversely, the exemption from notification requirements for exported
articles (see 40 CFR 707.60(b)) remains in force. Thus, persons who
export elemental mercury as part of an article are not required to
provide export notification.
    Provisions relating to user fees appear at 40 CFR part 700.
According to 40 CFR 721.1(c), persons subject to SNURs must comply with
the same notice requirements and EPA regulatory procedures as
submitters of Premanufacture Notices (PMNs) under TSCA section
5(a)(1)(A). In particular, these requirements include the information
submission requirements of TSCA section 5(b) and 5(d)(1), the
exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and
(h)(5), and the regulations at 40 CFR part 720. Once EPA receives a
SNUN, EPA may take regulatory action under TSCA section 5(e), 5(f), 6,
or 7 to control the activities on which it has received the SNUN. If
EPA does not take action, EPA is required under TSCA section 5(g) to
explain in the Federal Register its reasons for not taking action.
    Persons who export or intend to export a chemical substance
identified in a proposed or final SNUR are subject to the export
notification provisions of TSCA section 12(b). The regulations that
interpret TSCA section 12(b) appear at 40 CFR part 707, subpart D.
Persons who import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements,
codified at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Such
persons must certify that the shipment of the chemical substance
complies with all applicable rules and orders under TSCA, including any
SNUR requirements. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B.

III. Summary of the Proposed Rule

A. Overview of Mercury and Mercury Uses

    1. Mercury. This proposed rule applies to elemental mercury (CAS
No. 7439-97-6), which is a naturally occurring element. Because of its
unique properties (e.g., exists as a liquid at room temperature and
forms amalgams with many metals), elemental mercury has been used in
many industrial processes and consumer products. In addition to its
useful characteristics, mercury also is known to cause adverse health
effects in humans and wildlife. These effects can vary depending on the
form of mercury to which a person or animal is exposed, as well as the
magnitude, length, and frequency of exposure.
    The most prevalent human and wildlife exposure to mercury results
from ingesting fish contaminated with methylmercury. Methylmercury is
an organo-metallic compound that is formed via the conversion of
elemental or inorganic mercury compounds by certain microorganisms and
other natural processes. For example, elemental mercury may evaporate
and be emitted into the atmosphere. Atmospheric mercury can be
deposited directly into water bodies or watersheds, where it can be
washed into surface waters via overland run-off. Once deposited in
sediments, certain microorganisms and other natural processes can
convert elemental mercury into methylmercury. Methylmercury
bioaccumulates, which means that it is taken up and concentrated in the
tissues of aquatic, mammalian, avian, and other wildlife. Methylmercury
is a highly toxic substance; a number of adverse health effects
associated with exposure to it have been identified in humans and in
animal studies. Most extensive are the data on neurotoxicity,
particularly in developing organisms. Fetuses, infants, and young
children generally are more sensitive to methylmercury's neurological
effects than adults.
    In 2004, EPA and the Food and Drug Administration (FDA) issued a
national consumption advisory concerning mercury in fish. The advisory
contains recommended limits on the amount of certain types of fish and
shellfish that pregnant women and young children can safely consume. By
2005, all 50 states had issued fish consumption advisories for fish
from certain water bodies known to be contaminated by methylmercury,
see http://www.epa.gov/mercury/advisories.htm.
    In addition to methylmercury, exposure to elemental mercury can
also pose health risks. Elemental mercury primarily causes health
effects when it is breathed as a vapor that can be absorbed through the
lungs. These exposures can occur when elemental mercury is spilled or
products that contain elemental mercury break, resulting in release of
mercury to the air, particularly in warm or poorly-ventilated indoor
spaces.
    For a more detailed summary of background information (e.g.,
chemistry, environmental fate, exposure pathways, and health and
environmental effects), as well as references pertaining to elemental
mercury that EPA considered before proposing this rule, please refer to
EPA's proposed SNUR for mercury switches in motor vehicles, issued in
the Federal Register of July 11, 2006 (71 FR 39035)(FRL-7733-9), or in
the docket for the 2006 proposal under docket ID number EPA-HQ-OPPT-
2005-0036. All documents in the docket are listed in the docket's index
which is available at http://www.regulations.gov.
    2. Mercury uses. Elemental mercury has been used in thousands of
products and applications. Over the past two decades, there has been a
dramatic drop in elemental mercury use by industries in the United
States. In response to increased concerns about exposure to
anthropogenic sources of mercury in the environment and also because of
the availability of suitable mercury-free

products, Federal and State governments have made efforts to limit the
use of elemental mercury in certain products. Various states have
banned or restricted the manufacture or sale of products containing
mercury, see http://www.epa.gov/epawaste/hazard/tsd/mercury/laws.htm.
On October 7, 2007, EPA issued a final SNUR for elemental mercury used
in convenience light switches, anti-lock braking system switches, and
active ride control system switches in certain motor vehicles (72 FR
56903).
    In the past, elemental mercury was used in the manufacture of flow
meters, natural gas manometers, and pyrometers. The latest information
available to EPA indicates that the manufacture of these mercury-
containing articles has ceased (Ref. 1). EPA requests comments on
whether elemental mercury continues to be used in manufacturing
(including importing into the United States) flow meters, natural gas
manometers, or pyrometers. EPA also requests comment on whether
elementary mercury is being used in the remanufacturing of any of these
articles that remain in use.
    3. Flow meters containing elemental mercury. Flow meters are
instruments which measure the flow rate of liquids or gases.
Historically, they have been used in civil service applications, e.g.,
water treatment plants, sewage plants, and power stations. Flow meters
contained up to 5 kilograms (kg) of elemental mercury. At present, the
sale of mercury-containing flow meters is banned in six states:
California, Maine, Massachusetts, New Hampshire, New York, and Vermont
(Ref. 4). Many mercury-free alternatives exist, including differential
pressure meters, positive displacement meters, velocity meters, and
mass meters. EPA found sufficient information to conclude that mercury-
containing flow meters are no longer manufactured in or imported into
the United States (Ref. 1).
    4. Natural gas manometers containing elemental mercury. A manometer
is an instrument used to measure the pressure of gases or liquids. For
purposes of this proposed rule, a natural gas manometer means a
mercury-containing instrument used in the natural gas industry to
measure the pressure differential of natural gas in a pipeline. Mercury
manometers have been used in the natural gas industry on individual
wells, pipeline junctions, pipeline manifolds, compressor stations, and
distribution points. The manometers contain between 3.2 and 54.5 kg of
mercury. A common design for manometers is a U-shaped tube with one end
opened to the atmosphere and the other connected to a process.
Contained in the tube is a liquid (mercury, in the past). Pressure
differential is measured by comparing the liquid levels in each of the
two vertical sections of the tube. Seven states have enacted broad bans
on the sale of mercury manometers (Ref. 4), and Louisiana prohibits the
sale of mercury-containing natural gas manometers (Ref. 2). Available
information indicates that bellows orifice meters have replaced mercury
meters in the natural gas industry. EPA found sufficient information to
conclude that mercury-containing manometers are no longer manufactured
in or imported into the United States (Ref. 1).
    5. Pyrometers containing elemental mercury. A pyrometer is an
instrument that is similar to a thermometer but is typically used to
measure extremely high temperatures in industrial processes such as in
foundries, for pottery and ceramic kiln work, and in automotive
applications. Historically, pyrometers contained mercury in sensing
units in amounts ranging between 5 and 10 grams of mercury. In recent
years, California, Maine, Massachusetts, New Hampshire, New York, and
Vermont have banned the sale of mercury-containing pyrometers (Ref. 4).
EPA found sufficient information to conclude that mercury-containing
pyrometers are no longer manufactured, or imported into the U.S. (Ref.
1).
    6. Potential exposure and release. The typical lifecycle of flow
meters, natural gas manometers, and pyrometers includes several stages:
Manufacture, distribution in commerce, use, and waste management
(landfilling or recycling). At any point in the lifecycle, there is
potential for mercury to be released as liquid or vapor. Workers and
others can be exposed to the mercury and it can be released into water,
air, or onto land as the mercury is transported, stored, and handled
during manufacturing. While the flow meters, manometers, and pyrometers
are in use, the mercury can vaporize or spill due to breakage during
transport, installation, maintenance, refilling, or repair. Beginning
in the 1920s, mercury-containing manometers were used in the Louisiana
natural gas industry. Mercury from these manometers has been identified
as a source of soil contamination. (Ref. 3). Other opportunities for
release can occur at the end of the lifecycle of flow meters,
manometers, and pyrometers, as the devices are removed from equipment
and facilities, and handled during waste management.

B. Proposed Action

    EPA is proposing to designate as significant new uses use of
elemental mercury in flow meters, natural gas manometers, or
pyrometers. However, use of elemental mercury in these articles when
they are in service as of the effective date of the final rule would
not be covered as a significant new use under this proposed SNUR.
Proposed definitions of ``flow meter,'' ``natural gas manometer,'' and
``pyrometer'' can be found at 40 CFR 721.10068 of the regulatory text
for this proposal.
    This action would amend 40 CFR 721.10068 and require persons who
intend to manufacture or process elemental mercury for a use designated
by this proposed rule as a significant new use to notify EPA at least
90 days before commencing the manufacturing or processing of elemental
mercury for such significant new use. The required notification would
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit that activity before it occurs.
    For this SNUR, EPA is proposing not to include the general
``article'' exemption at 40 CFR 721.45(f). Thus, persons importing or
processing elemental mercury (including when part of an article) for a
significant new use would be subject to the notification requirements
of 40 CFR 721.25. EPA proposes not to include this exemption because
flow meters, natural gas manometers, and pyrometers are articles, and a
primary concern associated with this SNUR is potential exposures
associated with the lifecycle of these uses. Further, it is possible to
reclaim elemental mercury from certain articles, which could be used to
produce flow meters, natural gas manometers, and pyrometers. EPA notes
that, in accordance with TSCA section 12(a) and 40 CFR 721.45(g),
persons who manufacture or process elemental mercury solely for export
would be exempt from the notification requirements of 40 CFR 721.25, if
when distributing the substance in commerce, it is labeled in
accordance with TSCA section 12(a)(1)(B). Further, EPA notes that the
exemption from the TSCA section 12(b) notification requirements for
exported articles (see 40 CFR 707.60(b)) would remain in force. Thus,
persons who export elemental mercury as part of an article would not be
required to provide export notification.
    EPA believes elemental mercury is no longer used to manufacture
flow meters, natural gas manometers, or pyrometers, but some of these
articles may remain in service in the United States. EPA believes the
ongoing use of such

articles, including some maintenance and servicing activities, falls
outside the regulation of significant new uses, and EPA has clarified
this in the proposed rule text. Thus, the manufacturing and processing
of elemental mercury for use in these articles, provided they are in
service as of the effective date of the final rule, would not be
covered by the rule. For example, if an article that is in service as
of the effective date of the final rule is removed from service for
maintenance or servicing, including the addition of new mercury, and
then placed back into service, any manufacturing or processing of
mercury associated with that maintenance or servicing would not be
covered by the rule. Otherwise, the addition of new mercury to these
existing articles after the effective date of the final rule could
potentially trigger a significant new use notice under this proposed
rule (e.g., if it involved processing of the mercury), which is not
EPA's intent.

IV. Rationale and Objectives

A. Rationale

    As summarized in Unit III.A., EPA has concerns regarding the
environmental fate and the exposure pathways that lead to the presence
of methylmercury in fish and the consumption of mercury-contaminated
fish by humans and wildlife. EPA is encouraged by the discontinuation
of the use of elemental mercury in the manufacturing of flow meters,
natural gas manometers, and pyrometers. However, EPA is concerned that
the manufacturing or processing of elemental mercury for use in flow
meters, natural gas manometers, or pyrometers could be reinitiated in
the future. Accordingly, EPA wants the opportunity to evaluate and
control, where appropriate, activities associated with those uses, if
such manufacturing or remanufacturing were to occur again. The required
notification provided by a SNUN would provide EPA with the opportunity
to evaluate activities associated with a significant new use and an
opportunity to protect against unreasonable risks, if any, from
exposure to mercury.

B. Objectives

    Based on the considerations in Unit IV.A., EPA has the following
objectives with regard to the significant new uses that are designated
in this proposed rule:
    1. EPA would receive notice of any person's intent to manufacture
or process elemental mercury for any of the described significant new
uses before that activity begins.
    2. EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing of elemental mercury for any of the described significant
new uses.
    3. EPA would be able to regulate prospective manufacturers or
processors of elemental mercury before the described significant new
uses of the chemical substance occur, provided that regulation is
warranted pursuant to TSCA sections 5(e), 5(f), 6 or 7.

V. Significant New Use Determination

    Section 5(a)(2) of TSCA states that EPA's determination that a use
of a chemical substance is a significant new use must be made after
consideration of all relevant factors including:
     The projected volume of manufacturing and processing of a
chemical substance.
     The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
     The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
     The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
    In addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorizes EPA to consider any other relevant factors.
    To determine what would constitute a significant new use of
elemental mercury, EPA considered the four factors listed in section
5(a)(2) of TSCA. The latest information available to EPA indicates that
there is no ongoing use of elemental mercury in the manufacture or
remanufacture of flow meters, natural gas manometers, or pyrometers.
Resumption of these uses of elemental mercury could result in a
significant increase in the magnitude and duration of exposure to
workers and the surrounding environment at facilities of all types in
the lifecycle, as well as an increase in releases which could
contribute additional mercury to the atmosphere for long-range
transport. Resumption of these uses could also result in exposures to
workers who had not previously worked in these facilities when
elemental mercury was commonly used, as well as exposures to workers
who are not currently being exposed to mercury in the manufacture of
flow meters, natural gas manometers, or pyrometers. Increases in
mercury releases could lead to increases in mercury concentrations in
the environment and reduction in overall ecosystem and human health
from consumption of mercury-contaminated fish.
    EPA believes that any of these renewed uses of elemental mercury
would increase the magnitude and duration of exposure to humans and the
environment over that which would otherwise exist. Based upon the
relevant factors as discussed in this Unit, EPA has determined that any
manufacturing or processing of elemental mercury for use in flow
meters, natural gas manometers, or pyrometers is a significant new use.

VI. Alternatives

    Before proposing this SNUR, EPA considered the following
alternative regulatory actions:

A. Promulgate a TSCA Section 8(a) Reporting Rule

    Under a TSCA section 8(a) rule, EPA could, among other things,
generally require persons to report information to the Agency when they
intend to manufacture or process a listed chemical for a specific use
or any use. However, for elemental mercury used in flow meters, natural
gas manometers, and pyrometers, the use of TSCA section 8(a) rather
than SNUR authority would have several limitations. First, if EPA were
to require reporting under TSCA section 8(a) instead of TSCA section
5(a), EPA would not have the opportunity to review human and
environmental hazards and exposures associated with the proposed
significant new use and, if necessary, take immediate follow-up
regulatory action under TSCA sections 5(e) or 5(f) to prohibit or limit
the activity before it begins. In addition, EPA may not receive
important information from small businesses, because such firms
generally are exempt from TSCA section 8(a) reporting requirements. In
view of the level of health and environmental concerns about elemental
mercury, if used for the proposed significant new use, EPA believes
that a TSCA section 8(a) rule for this substance would not meet EPA's
regulatory objectives.

B. Regulate Elemental Mercury for Use in Flow Meters, Natural Gas
Manometers, and Pyrometers Under TSCA Section 6

    EPA may regulate under TSCA section 6 if ``the Administrator finds
that there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use or disposal of a chemical
substance or mixture . . . presents or will present an unreasonable
risk of injury to health or the environment.'' (TSCA section

6(a)) Given that elemental mercury is no longer being used in the
manufacture of flow meters, natural gas manometers, or pyrometers, EPA
concluded that risk management action under TSCA section 6 is not
necessary at this time. This proposed SNUR would allow the Agency to
address the potential risks associated with the proposed significant
new use.

C. Allow the Exemption for Persons Who Import or Process Elemental
Mercury as Part of Articles That Could be Subject to the SNUR

    Under the SNUR exemption provision at 40 CFR 721.45(f), a person
who imports or processes a substance covered by a SNUR identified in
subpart E of part 721 as part of an article is not generally subject to
the notification requirements of Sec. 721.25 for that substance.
However, EPA is concerned that exempting articles would render the SNUR
less effective because of the possibility that flow meters, natural gas
manometers, or pyrometers containing elemental mercury could be
imported or processed for uses subject to this proposed SNUR without
the submission of a SNUN. Because mercury-containing flow meters,
natural gas manometers and pyrometers are the primary concerns in this
SNUR, EPA wishes to include not only bulk elemental mercury but also
these and other articles when they contain elemental mercury imported
or processed for a significant new use. Thus, EPA is proposing to
promulgate this rule without the exemption generally provided for in
Sec. 721.45(f).

VII. Applicability of Rule to Uses Occurring Before Effective Date of
the Final Rule

    As discussed in the Federal Register of April 24, 1990 (55 FR
17376), EPA has decided that the intent of section 5(a)(1)(B) of TSCA
is best served by designating a use as a significant new use as of the
date of publication of the proposed rule rather than as of the
effective date of the final rule. If uses begun after publication of
the proposed rule were considered ongoing rather than new, it would be
difficult for EPA to establish SNUR notice requirements, because a
person could defeat the SNUR by initiating the proposed significant new
use before the rule became final, and then argue that the use was
ongoing as of the effective date of the final rule. Thus, persons who
begin commercial manufacture or processing of the chemical substance
that would be regulated through this proposed rule, if finalized, would
have to cease any such activity before the effective date of the rule
if and when finalized. To resume their activities, these persons would
have to comply with all applicable SNUR notice requirements and wait
until the notice review period, including all extensions, expires. EPA
has promulgated provisions to allow persons to comply with this SNUR
before the effective date. If a person were to meet the conditions of
advance compliance under Sec.  721.45(h), that person would be
considered to have met the requirements of the final SNUR for those
activities.

VIII. Test Data and Other Information

    EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. Persons are required
only to submit test data in their possession or control and to describe
any other data known to or reasonably ascertainable by them (15 U.S.C.
2604(d); 40 CFR 721.25). However, as a general matter, EPA recommends
that SNUN submitters include data that would permit a reasoned
evaluation of risks posed by the chemical substance during its
manufacture, processing, use, distribution in commerce, or disposal.
EPA encourages persons to consult with the Agency before submitting a
SNUN. As part of this optional pre-notice consultation, EPA would
discuss specific data it believes may be useful in evaluating a
significant new use. SNUNs submitted for significant new uses without
any test data may increase the likelihood that EPA will take action
under TSCA section 5(e) to prohibit or limit activities associated with
this chemical.
    SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs that provide detailed information on:
    1. Human exposure and environmental releases that may result from
the significant new uses of the chemical substance.
    2. Potential benefits of the chemical substance.
    3. Information on risks posed by the chemical substances compared
to risks posed by potential substitutes.

IX. SNUN Submissions

    SNUNs must be mailed to the Environmental Protection Agency, OPPT
Document Control Office (7407M), 1200 Pennsylvania Avenue, NW.,
Washington, D.C. 20460-0001. Information must be submitted in the form
and manner set forth in EPA Form No. 7710-25. This form is available
from the Environmental Assistance Division (7408M), 1200 Pennsylvania
Avenue, NW., Washington, D.C. 20460-0001 (see 40 CFR 721.25 and
720.40). Forms and information are also available electronically at
http://www.epa.gov/opptintr/newchems/pubs/pmnforms.htm.

X. Economic Analysis

    EPA has evaluated the potential costs of establishing SNUR
reporting requirements for potential manufacturers and processors of
the chemical substance included in this proposed rule (Ref. 1). EPA's
economic analysis (Ref. 1), which is briefly summarized here, is
available in the docket for this proposed rule.
    The costs of submission of a SNUN will not be incurred by any
company until a company decides to pursue a significant new use as
defined in this proposed SNUR. In the event that a SNUN is submitted,
costs are estimated at approximately $8,000 per SNUN submission, and
includes the cost for preparing and submitting the SNUN, and the
payment of a user fee. Businesses that submit a SNUN are either subject
to a $2,500 user fee required by 40 CFR 700.45(b)(2)(iii), or, if they
are a small business with annual sales of less than $40 million when
combined with those of the parent company (if any), a reduced user fee
of $100 (40 CFR 700.45(b)(1)). In its evaluation of this rule, EPA also
considered the potential costs a company might incur by avoiding or
delaying the significant new use in the future, but these costs have
not been quantified.
    In addition to comments on all aspects of this proposal, the Agency
is specifically interested in comments and supporting information on
the following questions related to assumptions used in the Agency's
analysis:
    Do you know of any current domestic production of mercury flow
meters for the uses defined as significant in this rule that EPA
missed? If yes, please provide detailed information.
    Are mercury flow meters currently available in the market place for
the uses defined as significant in this rule? If yes, please provide
detailed information.
     Does the analysis capture the lost option value of mercury flow
meters? If no, please provide specific information that you believe
should be included.
    Are the costs for preparing and submitting a SNUN comparable to the
costs for preparing and submitting a PMN? If not, in what ways is it
different?
    Providing supporting and detailed information for comments on these
points will be used by EPA to review

related assumptions in the economic analysis as it prepares the final
rule.

XI. References

    The following documents are specifically referenced in the preamble
for this rulemaking. In addition to these documents, other materials
may be available in the docket established for this rulemaking under
Docket ID No. EPA-HQ-OPPT-2008-0483, which you can access through
www.regulations.gov. Those interested in the information considered by
EPA in developing this proposed rule, should also consult documents
that are referenced in the documents that EPA has placed in the docket,
regardless of whether the other documents are physically located in the
docket.
    1. EPA, 2008b. Economic Analysis for the Proposed Significant New
Use Rule for Mercury-Containing Flow Meters, Nanometers, and
Pyrometers. Washington, D.C. OPPT/EETD/EPAB, July 21, 2009.
    2. La. Sess. Law Serv. Act 126 (S.B. 615)
    3. State of Louisiana Mercury Risk Reduction Plan, prepared by the
Louisiana Department of Environmental Quality, 2007. Available as of
September 1, 2008 at http://www.ldeq.org/portal/Portals/0/organization/
MercuryReportforweb.pdf
    4. Mercury Reduction & Education Legislation in the IMERC-Member
States, prepared by Terri Goldberg and Adam Wienert, NEWMOA, June 2008.
Available as of January 8, 2009 at http://www.newmoa.org/prevention/
mercury/imerc/legislation-2008.htm

XII. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

     Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), the Office of Management and
Budget (OMB) has determined that this proposed SNUR is a ``significant
regulatory action,'' because it meets the criteria in section 3(f) of
the Executive Order. Accordingly, this action was submitted to the OMB
for review under Executive Order 12866 and any changes made based on
OMB recommendations have been documented in the public docket for this
rulemaking as required by section 6(a)(3)(E) of the Executive Order.

B. Paperwork Reduction Act

    According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in Title 40 of the CFR, after appearing in the Federal
Register, are listed in 40 CFR, part 9, and included on the related
collection instrument, or form, if applicable.
    The information collection requirements related to this action have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0038 (EPA ICR No. 1188). This action does not impose any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average 110 hours
per response. This burden estimate includes the time needed to review
instructions, search existing data sources, gather and maintain the
data needed, and complete, review, and submit the required SNUN.
    Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection techniques, to the Director,
Collection Strategies Division, Office of Environmental Information
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, D.C. 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.

C. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency hereby certifies that promulgation
of this SNUR would not have a significant adverse economic impact on a
substantial number of small entities. The rationale supporting this
conclusion is as follows. A SNUR applies to any person (including small
or large entities) who intends to engage in any activity described in
the rule as a ``significant new use.'' By definition of the word
``new,'' and based on all information currently available to EPA, it
appears that no small or large entities presently engage in such
activity. Since this proposed SNUR would require a person who intends
to engage in such activity in the future to first notify EPA by
submitting a SNUN, no economic impact will occur unless someone files a
SNUN to pursue a significant new use in the future or forgoes profits
by avoiding or delaying the significant new use. Although some small
entities may decide to conduct such activities in the future, EPA
cannot presently determine how many, if any, there may be. However,
EPA's experience to date is that, in response to the promulgation of
over 1,000 SNURs, the Agency receives on average only 5 notices per
year. Of those SNUNs submitted, only one appears to be from a small
entity in response to any SNUR. Therefore, EPA believes that the
potential economic impact of complying with this SNUR is not expected
to be significant or adversely impact a substantial number of small
entities. In a SNUR that published as a final rule on August 8, 1997
(62 FR 42690)(FRL-5735-4), the Agency presented its general
determination that proposed and final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.

D. Unfunded Mandates Reform Act

    Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reason to believe that any
State, local, or Tribal government would be impacted by this
rulemaking. As such, EPA has determined that this regulatory action
would not impose any enforceable duty, contain any unfunded mandate, or
otherwise have any effect on small governments subject to the
requirements of sections 202, 203, 204, or 205 of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Public Law 104-4).

E. Executive Order 13132: Federalism

    This action would not have a substantial direct effect on 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, entitled
Federalism (64 FR 43255, August 10, 1999).

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

    This proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly or uniquely affect the
communities of Indian Tribal governments, nor would it involve or
impose any requirements that affect Indian Tribes. Accordingly, the

requirements of Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000), do not apply to this proposed rule.

G. Executive Order 13045: Protection of Children from Environmental
Health Risks and Safety Risks

    This action is not subject to Executive Order 13045, entitled
Protection of Children from Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997), because this is not an economically
significant regulatory action as defined by Executive Order 12866, and
this action does not address environmental health or safety risks
disproportionately affecting children.

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

    This proposed rule is not subject to Executive Order 13211,
entitled Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001),
because this action is not expected to affect energy supply,
distribution, or use.

I. National Technology Transfer Advancement Act

    Since this action does not involve any technical standards; section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note), does
not apply to this action.

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

    This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements

    Dated: August 25, 2009.
Wendy C. Hamnett,
Acting Director, Office of Pollution Prevention and Toxics.
    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 721--[AMENDED]

0
1. The authority citation for part 721 continues to read as follows:

    Authority: 15 U.S.C. 2604, 2607, 2625(c).

0
2. Section 721.10068 is amended by revising paragraph (a) and adding a
new paragraph (b)(2)(vii) to read as follows:

Sec.  721.10068  Elemental mercury.

    (a) Definitions. The definitions in Sec. 721.3 apply to this
section. In addition, the following definition applies:
    (1) Motor vehicle has the meaning found at 40 CFR 85.1703.
    (2) Flow meter means an instrument used in various applications to
measure the flow rate of liquids or gases.
    (3) Natural gas manometer means an instrument used in the natural
gas industry to measure gas pressure.
    (4) Pyrometer means an instrument used in various applications to
measure extremely high temperatures.
    (b)* * *
    (2)* * *
    (vii) Manufacturing or processing of elemental mercury for use in
flow meters, natural gas manometers, and pyrometers except for use in
these articles when they are in service as of September 11, 2009.
* * * * *

[FR Doc. E9-21894 Filed 9-10-09; 8:45 am]

BILLING CODE 6560-50-S


32493 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices nominated should have expertise in one or more of the following areas: Toxicology, in vitro test methods, biostatistics. Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the issues for this meeting. Nominees should be identified by name, occupation, position, address, and telephone number. Nominations should be provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before June 9, 2003. The criteria for selecting scientists to serve on the FIFRA SAP are that these persons be recognized scientists   experts in their fields; that they be as impartial and objective as possible; that they represent an array of backgrounds and perspectives ( within their disciplines); have no financial conflict of interest; have not previously been involved with the scientific peer review of the issue( s) presented; and that they be available to participate fully in the review, which will be conducted over a relatively short time frame. Nominees will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. Finally, they will be asked to review and to help finalize the meeting minutes. If a FIFRA SAP nominee is considered to assist in a review by the FIFRA SAP for a particular session, the nominee is subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. As such, the FIFRA SAP nominee is required to submit a Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the Environmental Protection Agency ( EPA Form 3110   485   02) which shall fully disclose, among other financial interests, the nominee's employment, stocks, and bonds, and where applicable, sources of research support. The EPA will evaluate the nominee's financial disclosure form to assess that there are no formal conflicts of interest before the nominee is considered to serve on the FIFRA SAP. Selected FIFRA SAP members will be hired as Special Government Employees. The Agency will review all nominations. FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP web site or may be obtained by contacting the PIRIB at the address or telephone number listed in Unit I. II. Background A. Purpose of the FIFRA SAP Amendments to FIFRA enacted November 28, 1975 ( 7 U. S. C. 136w( d)), include a requirement under section 25( d) of FIFRA that notices of intent to cancel or reclassify pesticide regulations pursuant to section 6( b)( 2) of FIFRA, as well as proposed and final forms of rulemaking pursuant to section 25( a) of FIFRA, be submitted to a SAP prior to being made public or issued to a registrant. In accordance with section 25( d) of FIFRA, the FIFRA SAP is to have an opportunity to comment on the health and environmental impact of such actions. The FIFRA SAP also shall make comments, evaluations, and recommendations for operating guidelines to improve the effectiveness and quality of analyses made by Agency scientists. Members are scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments as to the impact on health and the environment of regulatory actions under sections 6( b) and 25( a) of FIFRA. The Deputy Administrator appoints seven individuals to serve on the FIFRA SAP for staggered terms of 4 years, based on recommendations from the National Institutes of Health and the National Science Foundation. Section 104 of FQPA ( Public Law 104   170) established the FQPA Science Review Board ( SRB). These scientists shall be available to the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the FIFRA SAP.

B. Face to Face Public Meeting The FIFRA SAP will meet to consider and review issues concerned with ensuring data quality for in vitro tests used as alternatives to animal studies for regulatory purposes. Many in vitro methods have been developed or are under development to replace animal tests. Organizations may develop in vitro methods using ex vivo tissues or biological constructs as the target tissue and fully disclose their test design and the scientific principles of the test. In other cases, in vitro methods may be developed by commercial sponsors for commercial marketing as Proprietary Test Methods ( PTM). In vitro alternatives to animal testing pose unique issues regarding quality and performance. Once a new in vitro method is validated and accepted for regulatory use to characterize human health and environmental effects, a process is needed to provide assurance that it will continue to perform in a manner consistent with the test system as it was originally validated. Consistency of the in vitro assay system is needed with: Time, any change in ingredients or manufacturing process in the test system to be marketed, or variations in interpretation of a method described only generically in a test guideline. In addition, a process should be developed to allow `` Me too'' methods to qualify for regulatory use, based on the validation originally performed for the PTM. For this meeting, the FIFRA SAP will consider and review test guideline approaches to address performance and quality of in vitro methods when used as alternatives to animal studies. In addition, the panel will consider core guideline elements, and minimum performance and procedural standards for three new in vitro corrosivity assays.

C. FIFRA SAP Meeting Minutes The FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency in approximately 60 days. The meeting minutes will be posted on the FIFRA SAP web site or may be obtained by contacting the PIRIB at the address or telephone number listed in Unit I.

List of Subjects Environmental protection, Pesticides and pests.

Dated: May 22, 2003. Joseph J. Merenda, Director, Office of Science Coordination and Policy. [ FR Doc. 03   13434 Filed 5   29   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0160; FRL   7307   1]

Pesticide Products; Registration Approvals AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: This notice announces Agency approval of applications to register the following four pesticide products Nut GuardV/ Fruit GuardV, Novozymes Biofungicide Green ReleafTM 710 140, GB34 Concentrate Biological Fungicide, and GB34 Technical Biological Fungicide containing active ingredients not included in any previously registered products pursuant to the provisions of section 3( c)( 5) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended.

VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1 32494 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices FOR FURTHER INFORMATION CONTACT: Regulatory Action Leader, listed in the table below:

Regulatory Action Leader Telephone number/ e mail address Mailing address EPA Registration No.

Leonard Cole ( 703) 305   5412; cole. leonard@ epa. gov Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001 73176   1 Susanne Cerrelli ( 703) 308   8077; cerrelli. susanne@ epa. gov Do. 70127   2 Anne Ball ( 703) 308   8717; ball. anne@ epa. gov Do. 7501   191 7501   192 SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0160. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. In accordance with section 3( c)( 2) of FIFRA, a copy of the approved label, the list of data references, the data and other scientific information used to support registration, except for material specifically protected by section 10 of FIFRA, are also available for public inspection. Requests for data must be made in accordance with the provisions of the Freedom of Information Act and must be addressed to the Freedom of Information Office ( A   101), 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. The request should: Identify the product name and registration number and specify the data or information desired. A paper copy of the fact sheet, which provides more detail on this registration, may be obtained from the National Technical Information Service ( NTIS), 5285 Port Royal Rd., Springfield, VA 22161. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number. II. Did EPA Approve the Applications? The Agency approved the applications after considering all required data on risks associated with the proposed uses of Indian Meal Moth Granulosis Virus; Bacillus licheniformis strain SB3086; Bacillus pumilus strain GB34, and information on social, economic, and environmental benefits to be derived from use. Specifically, the Agency has considered the nature of the chemical and its pattern of use, application methods and rates, and level and extent of potential exposure. Based on these reviews, the Agency was able to make basic health and safety determinations which show that use of Indian Meal Moth Granulosis Virus; Bacillus licheniformis strain SB3086; Bacillus pumilus strain GB34 when used in accordance with widespread and commonly recognized practice, will not generally cause unreasonable adverse effects to the environment.

III. Approved Applications 1. EPA issued a notice, published in the Federal Register of August 31, 2001 ( 66 FR 45987) ( FRL   6760   5), which announced that AgriVir LLC, 1625 K Street, NW, Suite 1000, Washington, DC 20006, had submitted an application to register the pesticide product, Nut GuardV/ Fruit GuardV, as a moth larvicide ( EPA File Symbol 73176   R), containing 96.4% Indian Meal Moth Granulosis Virus and larval parts on milled wheat bran carrier. This product was not previously registered. The application was approved on December 21, 2001, as Nut GuardV/ Fruit GuardV ( EPA Registration Number 73176   1) for controlling Indian Meal moth larvae on dried fruit, shelled and unshelled nuts, and in cracks and crevices in processing, packing, and storage areas. 2. EPA issued a notice, published in the Federal Register of June 26, 2002 ( 67 FR 43114) ( FRL   7182   9), which announced that Novozymes Biologicals,

VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1 32495 Federal Register / Vol. 68, No. 104 / Friday, May 30, 2003 / Notices Inc., 111 Kelser Mill Road, Salem, VA 24153, had submitted an application to register the pesticide product, Novozymes Biofungicide Green Releaf TM 710 140, a biological fungicide ( EPA File Symbol 70127   E), containing Bacillus licheniformis Strain SB3086 at 0.14%. This product was not previously registered. The application was approved on February 4, 2003, as Novozymes Biofungicide Green ReleafTM 710 140 ( EPA Registration Number 70127   2) for fungicidal treatment of ornamental turf, lawns, golf courses, ornamental plants, conifers and tree seedlings in outdoor, greenhouse, and nursery sites. The active ingredients registered for this product are Bacillus licheniformis Strain SB3086 at 0.14% and Indole 3 butyric Acid at 0.00096%. 3. EPA issued a notice, published in the Federal Register of December 31, 2001 ( 66 FR 67520) ( FRL   6813   7), which announced that Gustafson LLC, 1400 Preston Road, Suite 400, Plano, TX 75093, had submitted applications to register the following two pesticide products GB34 Concentrate Biological Fungicide, fungicide ( EPA File Symbol 7501   ROR) and GB34 Technical Biological Fungicide ( EPA File Symbol 7501   ROE), containing Bacillus pumilus GB34 at 0.28% and 13.8%, respectively. These products were not previously registered. The applications were approved on March 13, 2003, as GB34 Concentrate Biological Fungicide ( EPA Registration Number 7501   191); for use as a treatment for soybeans for suppression of root diseases caused by Rhizoctonia and Fusarium and GB34 Technical Biological Fungicide ( EPA Registration Number 7501   192) for reformulating into end use fungicide products.

List of Subjects Environmental protection, Chemicals, Pesticides and pests.

Dated: May 15, 2003.

Phil Hutton,

Acting Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

[ FR Doc. 03   13437 Filed 5   29   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY [ OPP   2003   0122; FRL   7304   6]

Fenthion; Notice of Receipt of Request to Voluntarily Cancel Certain Pesticide Registrations AGENCY: Environmental Protection Agency ( EPA). ACTION: Notice.

SUMMARY: In accordance with section 6( f)( 1) of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA), as amended, EPA is issuing a notice of receipt of request by Bayer Environmental Science to voluntarily cancel the registrations for all of their products containing O, O dimethyl O( 4 methylthio) m tolyl) phosphorothioate ( fenthion). EPA intends to grant this request by issuing a cancellation order at the close of the comment period for this announcement unless the Agency receives substantive comments within the comment period that would merit its further review of this request. It is EPA's intent that the effective date of the cancellation order, as requested by Bayer, will be June 30, 2004. Upon the effective date of the cancellation order, any distribution or sale of products listed in this notice will be prohibited as of June 30, 2004, except for return of unused portions to Bayer or for proper disposal. EPA expects use of products listed in this notice will be permitted until November 30, 2004. Any such use must be in accordance with the label. Bayer has submitted, and EPA intends to approve, label amendments intended to further mitigate the risks of fenthion. Because Bayer has requested cancellation of the registrations of all of its fenthion products, Bayer is not required to satisfy the data requirements in any of the Agency's Data Call Ins, including the Developmental Neurotoxicity Data Call In. DATES: Comments on the requested registration cancellations must be submitted to the address provided below and identified by docket ID number OPP   2003   0122. Comments must be received on or before July 29, 2003. ADDRESSES: Comments may be submitted electronically, by mail, or by hand delivery or courier. Please follow the detailed instructions for each method as provided in Unit I. C. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, it is imperative that you identify docket ID number OPP   2003   0122 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: Susan Jennings, Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 706) 355   8574; e mail address: jennings. susan@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me? This action is directed to the public in general. Although this action may be of particular interest to persons who produce or use pesticides, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the information in this notice, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2003   0122. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. EPA also established two dockets containing documents in support of the fenthion IRED. They are dockets OPP   34145 and OPP   34145A. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public VerDate Jan< 31> 2003 19: 12 May 29, 2003 Jkt 200001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\ FR\ FM\ 30MYN1. SGM 30MYN1


[Federal Register: September 26, 2008 (Volume 73, Number 188)]
[Notices]
[Page 55826-55827]
[DOCID:fr26se08-39]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2634-054]

Great Lakes Hydro America, LLC; Notice of Application for
Amendment of License and Soliciting Comments, Motions To Intervene, and
Protests

September 19, 2008.
    Take notice that the following application has been filed with the
Commission and is available for public inspection.
    a. Application Type: Amendment to Recreation Plan.
    b. Project No.: 2634-054.
    c. Dated Filed: July 14, 2008.
    d. Applicant: Great Lakes Hydro America, LLC.
    e. Name of Project: Storage Hydroelectric Project.
    f. Location: The project is located on the West and South Branch of
the Penobscot River in Piscataquis and Somerset Counties, Maine.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Application Contact: Kevin Bernier, FERC Compliance Specialist,
Great Lakes Hydro America, LLC, 1024 Central Street, Millinocket, Maine
04462, telephone:<PHONE_NUMBER>, fax:<PHONE_NUMBER>.
    i. FERC Contact: Any questions on this notice should be addressed
to Gina Krump at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>    j. Deadline for filing comments and/or motions: October 20, 2008.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    k. Description of Request: The licensee filed an amendment
application to remove the requirement to provide a boat launch and
parking area at the Caucomgomoc Lake from the approved recreation plan,
issued April 19, 2006. The licensee proposes to develop an area at
Harrington Lake, which would be outside the project boundary and not
under the Commission's jurisdiction.
    l. Location of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at 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. You may also
register online at http://www.ferc.gov/docs-filing/esubscription.asp to
be notified via e-mail of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>for TTY, call<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in item
(h) above.
    m. Individuals desiring to be included on the Commission's e-
mailing list should so indicate by writing to the Secretary of the
Commission.
    n. Comments, Protests, or Motions To Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST, or
``MOTION TO INTERVENE'', as applicable, and the Project Number (P-6066-
031) of the particular application to which the filing refers. All
documents (original and eight copies) should be filed with: Honorable
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE.,

Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests, and interventions may be filed
electronically, via the Internet in lieu of paper. See, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-22624 Filed 9-25-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 140 (Thursday, July 21, 2011)]
[Rules and Regulations]
[Pages 43597-43598]
[FR Doc No: 2011-18223]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-0630]

Drawbridge Operation Regulation; Lower Grand River, LA

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Eighth Coast Guard District, has issued a
temporary deviation from the regulation in 33 CFR 117.478(b) governing
the operation of the LA 77 bridge across the

Lower Grand River, mile 47.0 (Alternate Route) at Grosse Tete,
Iberville Parish, Louisiana. This deviation allows the Louisiana
Department of Transportation and Development to maintain the bridge in
the closed-to-navigation position from 7 a.m. until 5 p.m. on
Wednesday, July 20, 2011. At all others times, the bridge will operate
normally for the passage of vessels. This temporary deviation was
issued to allow for the repairs to the main girder of the bridge.

DATES: This deviation is effective from 7 a.m. through 5 p.m. on
Wednesday July 20, 2011.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2011-0630 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-0252 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail David Frank, Bridge Administration Branch, Coast Guard;
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>If you have
questions on viewing the docket, call Renee V. Wright, Program Manager,
Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The LA 77 bridge across the Lower Grand
River, mile 47.0 (Alternate Route) at Grosse Tete, Iberville Parish,
Louisiana, has a vertical clearance of 2 feet above high water in the
closed-to-navigation position and unlimited clearance in the open-to-
navigation position. Navigation on the waterway consists mainly of tows
with barges and some recreational craft. Coastal Bridge Company, on
behalf of the Louisiana Department of Transportation and Development
requested a temporary deviation from the normal operation of the bridge
in order to effect repairs to the bridge.
    This deviation allows the draw of the LA 77 swing drawbridge across
the Lower Grand River, mile 47.0 (Alternate Route), at Grosse Tete,
Iberville Parish, Louisiana, to remain in the closed-to-navigation
position from 7 a.m. until 5 p.m. on Wednesday, July 20, 2011.
Presently, the draw of the LA 77 bridge, mile 47.0 (Alternate Route) at
Grosse Tete, shall open on signal; except that, from about August 15 to
about June 5 (the school year), the draw need not be opened from 6 a.m.
to 8 a.m. and from 2:30 p.m. to 4:30 p.m., Monday through Friday except
Federal holidays. The draw shall open on signal at any time for an
emergency aboard a vessel.
    The closure is necessary in order to install angles on the main
girder and weld a crack on the bridge. The contractor has indicated
that they may be able to operate the bridge during the closure and may
be able to move their equipment out of the channel but the movement of
the equipment may require several hours to complete immediate work and
move equipment. This maintenance is essential for the continued
operation of the bridge. Notices will be published in the Eighth Coast
Guard District Local Notice to Mariners and will be broadcast via the
Coast Guard Broadcast Notice to Mariners System.
    No alternate routes are available for the passage of vessels;
however, the closure was coordinated with waterway interests who have
indicated that they will be able to adjust their operations around the
proposed work schedule.
    Due to prior experience and coordination with waterway users, it
has been determined that this closure will not have a significant
effect on vessels that use the waterway.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: June 28, 2011.
David M. Frank,
Bridge Administrator.
[FR Doc. 2011-18223 Filed 7-20-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71042-71043]
[FR Doc No: 2011-29538]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0377]

Scott S. Reuben: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is issuing an

order under the Federal Food, Drug, and Cosmetic Act permanently
debarring Scott S. Reuben, M.D. from providing services in any capacity
to a person that has an approved or pending drug product application.
FDA bases this order on a finding that Dr. Reuben was convicted of a
felony under Federal law for conduct relating to the regulation of a
drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben
was given notice of the proposed permanent debarment and an opportunity
to request a hearing within the timeframe prescribed by regulation. Dr.
Reuben failed to respond. Dr. Reuben's failure to respond constitutes a
waiver of his right to a hearing concerning this action.

DATES: This order is effective November 16, 2011.

ADDRESSES: Submit applications for special termination of debarment to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,
(301) 796-4640.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 335a(a)(2)(B)) requires debarment of an individual if FDA
finds that the individual has been convicted of a felony under Federal
law for conduct relating to the regulation of any drug product under
the Federal Food, Drug, and Cosmetic Act.
    On June 24, 2010, the U.S. District Court for the District of
Massachusetts entered judgment against Dr. Reuben for health care fraud
in violation of 18 U.S.C. 1347.
    The FDA's finding that debarment is appropriate is based on the
felony conviction referenced herein for conduct relating to the
regulation of a drug product. The factual basis for this conviction is
as follows: Dr. Reuben was a physician licensed by the State of
Massachusetts working as an anesthesiologist providing anesthesia
services to patients in connection with surgeries, and also treating
patients post-surgery in the District of Massachusetts. Dr. Reuben
served as the chief of acute pain at a hospital in Western
Massachusetts and maintained an office at the hospital for the purpose
of conducting research. Dr. Reuben's interest, from a research
perspective, was in post-operative multimodal analgesia therapy. Dr.
Reuben made proposals for research funding to pharmaceutical companies
that manufactured drugs that he used or proposed to use in multimodal
analgesia therapy. Dr. Reuben represented to the companies that, as the
principal investigator, he would be performing clinical studies with
actual patients to whom he would administer the drug that was the
subject of the research grant.
    Dr. Reuben entered into contracts to perform research studies
funded by the companies from at least as early as 1999. Dr. Reuben
purported to perform the research called for by the contracts, and
published articles in various medical journals based on the purported
results of the research, when in fact those studies had not been
performed, and therefore the research results reported in the medical
journals were false.
    As a result of his convictions, on August 22, 2011, FDA sent Dr.
Reuben a notice by certified mail proposing to permanently debar him
from providing services in any capacity to a person that has an
approved or pending drug product application. The proposal was based on
a finding, under section 306(a)(2)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 335a(a)(2)(B)), that Dr. Reuben was convicted
of a felony under Federal law for conduct relating to the regulation of
a drug product under the Federal Food, Drug, and Cosmetic Act. This
conclusion was based on the fact that FDA regulates clinical trials
related to drug products such as those described previously as part of
the Agency's regulation of drug products. The proposal also offered Dr.
Reuben an opportunity to request a hearing, providing him 30 days from
the date of receipt of the letter in which to file the request, and
advised him that failure to request a hearing constituted a waiver of
the opportunity for a hearing and of any contentions concerning this
action. The proposal was received on August 26, 2011. Dr. Reuben failed
to respond within the timeframe prescribed by regulation and has,
therefore, waived his opportunity for a hearing and has waived any
contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(a)(2)(B) of the (21 U.S.C.
335a(a)(2)(B)) of the Federal Food, Drug, and Cosmetic Act, under
authority delegated to the Director (Staff Manual Guide 1410.35), finds
that Scott S. Reuben has been convicted of a felony under Federal law
for conduct relating to the regulation of a drug product under the
Federal Food, Drug, and Cosmetic Act.
    As a result of the foregoing finding, Dr. Reuben is permanently
debarred from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355,
360b, or 382), or under section 351 of the Public Health Service (42
U.S.C. 262), effective (see DATES) (see section 306(c)(1)(B),
(c)(2)(A)(ii), and 201(dd) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(ii), and 321(dd))). Any person with
an approved or pending drug product application who knowingly employs
or retains as a consultant or contractor, or otherwise uses the
services of Dr. Reuben, in any capacity during Dr. Reuben's debarment,
will be subject to civil money penalties (section 307(a)(6) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)(6))). If Dr.
Reuben provides services in any capacity to a person with an approved
or pending drug product application during his period of debarment he
will be subject to civil money penalties (section 307(a)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335b(a)(7)). In
addition, FDA will not accept or review any abbreviated new drug
applications submitted by or with the assistance of Dr. Reuben during
his period of debarment (section 306(c)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 335a(c)(1)(A))).
    Any application by Dr. Reuben for special termination of debarment
under section 306(d)(4) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 335a(d)(4)) should be identified with Docket No. FDA-2011-N-0377
and sent to the Division of Dockets Management (see ADDRESSES). All
such submissions are to be filed in four copies. The public
availability of information in these submissions is governed by 21 CFR
10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 7, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-29538 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P