[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Rules and Regulations]
[Pages 57285-57289]
[FR Doc No: 2013-22601]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0383; FRL-9398-4]

2,5-Furandione, Polymer With Ethenylbenzene, Hydrolyzed, 3-
(Dimethylamino)propyl Imide, Imide With Polyethylene-Polypropylene
Glycol 2-Aminopropyl Me Ether, 2,2'-(1,2-Diazenediyl)bis[2-
Methylbutanenitrile]-Initiated; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of 2,5-furandione, polymer with
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated (CAS Reg. No. 1062609-
13-5) when used as an inert ingredient in a pesticide formulation.
Evonik Goldschmidt Corporation (Evonik) submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-

(dimethylamino)propyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated on food or feed commodities.

DATES: This regulation is effective September 18, 2013. Objections and
requests for hearings must be received on or before November 18, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0383, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER> email 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 are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. Can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0383 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 18, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0383, by one of
the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at  http://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of July 19, 2013 (78 FR 43115) (FRL-9392-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the receipt of a pesticide petition (IN-10559) filed
by Evonik Goldschmidt Corporation, P.O. Box 1299, 914 East Randolph Rd.
Hopewell, VA 23860. The petition requested that 40 CFR 180.960 be
amended by establishing an exemption from the requirement of a
tolerance for residues of 2,5-furandione, polymer with ethenylbenzene,
hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-
polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated; CAS Reg. No. 1062609-
13-5. That document included a summary of the petition prepared by the
petitioner and solicited comments on the petitioner's request. The
Agency received one comment.
    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and use in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing an exemption from the
requirement of a tolerance and to ``ensure that there is a reasonable
certainty that no harm will result to infants and children from
aggregate exposure to the pesticide chemical residue. . . .'' and
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be shown that the risks from aggregate
exposure to pesticide chemical residues under reasonably foreseeable
circumstances will pose no appreciable risks to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no

harm will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children. In the case of certain chemical substances that
are defined as polymers, the Agency has established a set of criteria
to identify categories of polymers expected to present minimal or no
risk. The definition of a polymer is given in 40 CFR 723.250(b) and the
exclusion criteria for identifying these low-risk polymers are
described in 40 CFR 723.250(d) for 2,5-furandione, polymer with
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated conforms to the
definition of a polymer given in 40 CFR 723.250(b) and meets the
following criteria that are used to identify low-risk polymers.
    1. The polymer is not a cationic polymer nor is it reasonably
anticipated to become a cationic polymer in a natural aquatic
environment.
    2. The polymer does contain as an integral part of its composition
the atomic elements carbon, hydrogen, and oxygen.
    3. The polymer does not contain as an integral part of its
composition, except as impurities, any element other than those listed
in 40 CFR 723.250(d)(2)(ii).
    4. The polymer is neither designed nor can it be reasonably
anticipated to substantially degrade, decompose, or depolymerize.
    5. The polymer is manufactured or imported from monomers and/or
reactants that are already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
    6. The polymer is not a water absorbing polymer with a number
average molecular weight (MW) greater than or equal to 10,000 daltons.
    7. The polymer does not contain certain perfluoroalkyl moieties
consisting of a CF3- or longer chain length as specified in 40 CFR
723.250(d)(6).
    Additionally, the polymer also meets as required the following
exemption criteria specified in 40 CFR 723.250(e).
    8. The polymer's number average MW of 5,816 is greater than 1,000
and less than 10,000 daltons. The polymer contains less than 10%
oligomeric material below MW 500 and less than 25% oligomeric material
below MW 1,000, and the polymer does not contain any reactive
functional groups.
    Thus, 2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-
(dimethylamino)propyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated meets the criteria for a polymer to be
considered low risk under 40 CFR 723.250. Based on its conformance to
the criteria in this unit, no mammalian toxicity is anticipated from
dietary, inhalation, or dermal exposure to 2,5-furandione, polymer with
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this
exemption, EPA considered that 2,5-furandione, polymer with
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated could be present in
all raw and processed agricultural commodities and drinking water, and
that non-occupational non-dietary exposure was possible. The number
average MW of 2,5-furandione, polymer with ethenylbenzene, hydrolyzed,
3-(dimethylamino)propyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated is 5,816 daltons. Generally, a polymer
of this size would be poorly absorbed through the intact
gastrointestinal tract or through intact human skin. Since 2,5-
furandione, polymer with ethenylbenzene, hydrolyzed, 3-
(dimethylamino)propyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated conform to the criteria that identify a
low-risk polymer, there are no concerns for risks associated with any
potential exposure scenarios that are reasonably foreseeable. The
Agency has determined that a tolerance is not necessary to protect the
public health.

V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity

    Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
    EPA has not found 2,5-furandione, polymer with ethenylbenzene,
hydrolyzed, 3-(dimethylamino)propyl imide, imide with polyethylene-
polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated to share a common
mechanism of toxicity with any other substances, and 2,5-furandione,
polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl iide,
imide with polyethylene-polypropylene glycol 2-aminopropyl me ether,
2,2'-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
2,5-furandione, polymer with ethenylbenzene, hydrolyzed, 3-
(dimethylamino)propyl imide, imide with polyethylene-polypropylene
glycol 2-aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
methylbutanenitrile]-initiated does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at http://www.epa.gov/pesticides/cumulative.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold margin of safety for infants and children in the
case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Due to the expected low toxicity of 2,5-furandione, polymer
with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide
with polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-
(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated, EPA has not used
a safety factor analysis to assess the risk. For the same reasons the
additional tenfold safety factor is unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no
harm to the U.S. population, including infants and children, from
aggregate exposure to residues of 2,5-furandione, polymer with
ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide with
polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-(1,2-
diazenediyl)bis[2-methylbutanenitrile]-initiated.

VIII. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for 2,5-furandione, polymer
with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide, imide
with polyethylene-polypropylene glycol 2-aminopropyl me ether, 2,2'-
(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated.

C. Response to Comments

    The one comment received was an anonymous public comment regarding
the acceptability of the polymer under 40 CFR 180.960 and whether it
met the 40 CFR 723.250 low risk polymer exemption. The comment stated,
``When DMAPA (dimentylaminopropyl amine) is reacted into the polymer to
form the imide, that leaves a tertiary amine (dimethylpropyl amine)
that can be protonated to become cationic when dispersed in water. If
there are more than one of these DMAPAs per polymer molecule the
equivalent weight will be below the 5,000 amu required to meet 40 CFR
723.250 low risk polymer exemption from both TSCA and to get approval
on 40 CFR 180.960.'' While this polymer does contain a tertiary amine
functional group, the functional group equivalent weight is greater
than 5,000 daltons. Therefore, this polymer is a cationic polymer of
low cationic density and not excluded from the polymer exemption
criteria given at 40 CFR 723.250(d).

IX. Conclusion

    Accordingly, EPA finds that exempting residues of 2,5-furandione,
polymer with ethenylbenzene, hydrolyzed, 3-(dimethylamino)propyl imide,
imide with polyethylene-polypropylene glycol 2-aminopropyl me ether,
2,2'-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated from the
requirement of a tolerance will be safe.

X. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these rules from review under
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993). Because this final rule has been exempted
from review under Executive Order 12866, this final 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) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it involve any
technical standards that would require Agency consideration of
voluntary consensus standards pursuant to section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272
note).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes, or otherwise have any unique
impacts on local governments. Thus, the Agency has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999) and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000) do not apply to this final rule. In addition, this final rule
does not impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
    Although this action does not require any special considerations
under Executive Order 12898, entitled ``Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations'' (59 FR 7629, February 16, 1994), EPA seeks to achieve
environmental justice, the fair treatment and meaningful involvement of
any group, including minority and/or low-income populations, in the
development, implementation, and enforcement of environmental laws,
regulations, and policies. As such, to the extent that information is
publicly available or was submitted in comments to EPA, the Agency
considered whether groups or segments of the population, as a result of
their location, cultural practices, or other factors, may have atypical
or disproportionately high and adverse human health impacts or
environmental effects from exposure to the pesticide discussed in this
document, compared to the general population.

XI. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal

Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 9, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.960, alphabetically add the following polymer to the
table to read as follows:

Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a
tolerance.

* * * * *

------------------------------------------------------------------------
                       Polymer                             CAS No.
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                              * * * * * * *
2,5-Furandione, polymer with ethenylbenzene,              1062609-13-5
 hydrolyzed, 3-(dimethylamino)propyl imide, imide
 with polyethylene-polypropylene glycol 2-
 aminopropyl me ether, 2,2'-(1,2-diazenediyl)bis[2-
 methylbutanenitrile]-initiated, minimum number
 average molecular weight (in amu), 5,816...........

                              * * * * * * *
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[FR Doc. 2013-22601 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 14 (Monday, January 23, 2012)]
[Rules and Regulations]
[Pages 3115-3118]
[FR Doc No: 2012-1171]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-1069]
RIN 1625-AA00

Safety Zone; Grain-Shipment Vessels, Columbia and Snake Rivers

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule; request for comments.

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SUMMARY: The Coast Guard is establishing a temporary safety zone around
all inbound and outbound grain-shipment vessels involved in commerce
with Export Grain Terminal, Longview, WA, while they are located on the
Columbia and Snake Rivers. This safety zone extends to waters 500 yards
ahead of these vessels and 200 yards abeam and astern of these vessels.
This safety zone is being implemented to ensure that protest activities
associated with the opening of the Export Grain Terminal to maritime
traffic does not prevent safe navigation of grain shipment vessels and
other vessels using the waterway during grain-shipment vessel transits
to and from the terminal.

DATES: This rule is effective from 12:01 a.m. on January 23, 2012 until
12:01 a.m. on April 1, 2012. Comments must be received on or before
March 1, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2011-1069 and are available online
by going to http://www.regulations.gov, inserting USCG-2011-1069 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
temporary rule, call or email BM1 Sylvestre Suga, Waterways Management
Division, Coast Guard Marine Safety Unit Portland; telephone (503) 240-
9319, email<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary interim rule without
prior notice and opportunity to comment pursuant to authority under
section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C.
553(b)). This provision authorizes an agency to issue a rule without
prior notice and opportunity to comment when the agency for good cause
finds that those procedures are ``impracticable, unnecessary, or
contrary to the public interest.''
    Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause
exists for not publishing a notice of proposed rulemaking (NPRM) with
respect to this rule because to do so would be contrary to public
interest because delayed promulgation may result in injury or damage to
the maritime public, vessel crews, the vessels themselves, and law
enforcement personnel from protest activities that could occur prior to
conclusion of a notice and comment period.
    On September 8, 2011, a large protest occurred at Export Grain
Terminal (EGT) in which over 200 protestors were arrested for criminal
offenses including assault. These protest activities resulted in damage
to rail cars and the cargo they were carrying. The Longview local
International Longshore and Warehouse Union (ILWU) has also been
subject to fines for contempt of court for engaging in activity that
violated a temporary restraining order. Subsequent protest activities
aimed at blocking rail access to EGT on September 21, 2011 led to
further arrests.
    These protest activities arose from a labor dispute between the
ILWU, the Port of Longview, and EGT. The dispute is ongoing and
picketing activity occurs daily at the EGT facility in Longview, WA.
EGT has not yet opened for vessel traffic; however, as recently as
November 5, 2011, the president of the ILWU's Local 21 has threatened
that protest activities will be mounted when the first vessel arrives
to load at EGT's facility.
    The schedule of vessel arrivals at EGT is controlled by a number of
factors over which the Coast Guard has no control. Additionally, these
vessels may be arriving at EGT from foreign ports. Consequently, it is
impracticable for grain-shipment vessel arrival schedules to be changed
or delayed in order to accommodate a notice of proposed rulemaking and
subsequent comment period.
    Due to past protest events, threats of similar protest activity in
the future, and the significant difficulty and impracticality of
changing vessel arrival schedules, the Coast Guard finds it is contrary
to the public interest to delay implementation of this safety zone
during a notice and comment period. Postponing the promulgation creates
a very likely risk that protest activities will threaten safe
navigation and the safety of persons and property on the Columbia and
Snake rivers when vessels begin arriving at EGT, Longview, WA.
    Under 5 U.S.C. 553(d)(3), the Coast Guard also finds that good
cause exists for making this rule effective less than 30 days after
publication in the Federal Register because to do otherwise would be
contrary to the public interest since the protest activities associated
with EGT are unpredictable and potentially volatile and may result in
injury to persons and property. Delaying the effective date until 30
days after publication may mean that grain-shipment vessels will have
arrived or departed the Columbia and Snake Rivers before the end of a
30 day period. This delay would eliminate the safety zone's
effectiveness and usefulness in protecting persons, property, and the
safe navigation of maritime traffic during the transit of grain-
shipment vessels that may arrive or depart before 30 days have elapsed.
    Although the Coast Guard has good cause to issue this temporary
rule without first publishing a proposed rule, you are invited to
submit post-promulgation comments and related material regarding this
rule through March 1, 2012. All comments will be reviewed as they are
received. Your comments will assist us in drafting future rules should
they be necessary, and may result in changes to this temporary interim
rule before it expires. All comments received will be posted, without
change, to http://www.regulations.gov and will include any personal
information you have provided. We have an agreement with the Department
of Transportation (DOT) for their Docket Management Facility to process
online submissions to Coast Guard dockets. You may review the
Department of Transportation's Privacy Act Statement in the Federal
Register published on April 11, 2000 (65 FR 19477), or you may visit
http://DocketsInfo.dot.gov.

Background and Purpose

    The ILWU, the Port of Longview, WA, and EGT have been engaged in a
labor dispute related to the newly-constructed facility. In addition to
picketing, ILWU members have engaged in protest activities that have
resulted in personal injury and property damage. In particular, a
large-scale protest on

September 8, 2011 led to arrests for criminal offenses. Additionally,
protesters blocked the arrival of the first rail delivery of cargo to
the facility. Although the focus of these protests was ashore, there
were some waterborne protest activities on the waters adjacent to the
EGT piers.
    The labor dispute continues, as do the protest efforts. As recently
as November 5, 2011, the president of the ILWU's Local 21 threatened
that protest activities, similar to those that occurred upon the
arrival of the first rail shipment, will be mounted when the first
vessel arrives to load at EGT's facility. Once EGT opens for vessel
traffic, grain-shipment vessels will be transiting the Columbia and
Snake Rivers with cargos of various grain products bound for and
departing from EGT at Longview, WA. Based on the past violent protest
activities and the ILWU's stated intent to interfere with the inaugural
vessel arrival at EGT, Longview, WA, the Coast Guard has determined
that a temporary safety zone is required around vessels bound for and
departing from that facility.
    This safety zone is being implemented to help ensure the safe
navigation of maritime traffic on the Columbia River while grain-
shipment vessels transit to and from EGT at Longview, WA. This safety
zone applies equally to all waterway users and is intended to allow
maximal use of the waterway consistent with safe navigation and to
ensure that protestors are not injured by deep-draft vessels with
maneuvering characteristics with which protesters afloat may be
unfamiliar.

Discussion of Rule

    This rule establishes a temporary safety zone around grain-shipment
vessels while they are located in the Columbia and Snake Rivers. This
safety zone extends to waters 500 yards ahead of grain-shipment vessels
and 200 yards abeam and astern of these vessels. No person or vessel
may enter or remain in the safety zone without authorization from the
Captain of the Port Columbia River or his designated representatives.
    This rule is effective from 12:01 a.m. on January 23, 2012 until
12:01 a.m. on April 1, 2012.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Executive Order 12866. The
Office of Management and Budget has not reviewed it under that Order.
It is not ``significant'' under the regulatory policies and procedures
of the Department of Homeland Security (DHS). Although this rule will
restrict access to the regulated area, the effect of this rule will not
be significant because: (i) Individual grain-shipment vessel safety
zones are limited in size; (ii) the official on-scene patrol may
authorize access to the grain-shipment vessel safety zone; (iii) the
grain-shipment vessel safety zone will only be effective for a limited
geographical location over a limited duration while grain-shipment
vessels transit to berth; and (iv) the Coast Guard will make
notifications via maritime advisories so mariners can adjust their
plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities some of which may
be small entities: The owners and operators of vessels intending to
operate in the area covered by the safety zone created in this rule.
    This rule will not have a significant economic impact on a
substantial number of small entities for the following reasons: (i)
Individual grain-shipment vessel safety zones are limited in size; (ii)
the official on-scene patrol may authorize access to the grain-shipment
vessel safety zone; (iii) the grain-shipment vessel safety zone for any
given transiting grain-shipment vessel will effect a limited
geographical location for a limited time; and (iv) the Coast Guard will
make notifications via maritime advisories so mariners can adjust their
plans accordingly.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-(888) 734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them.
    We believe that this rule and the process by which it was drafted
adhere to the federalism principles outlined in Executive Order 13132.
The Coast Guard has coordinated with the officials from the states of
Oregon and Washington in drafting this rule. By allowing state
enforcement of this rule, it is in accord with paragraph (h) of section
2 of the Executive Order, which encourages recognition of
responsibility of localities and their sub-units to pursue objectives
through their own means. This rule puts no obligation on state or
municipal governments, but simply allows for their participation in
enforcement activities.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a

State, local, or tribal government, in the aggregate, or by the private
sector of $100,000,000 (adjusted for inflation) or more in any one
year. Though this rule will not result in such an expenditure, we do
discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule is categorically excluded, under figure 2-1,
paragraph (34)(g), of the Instruction. This rule involves the
establishment of a temporary safety zone. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703;
50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T13-200 to read as follows:

Sec.  165.T13-200  Safety Zone; Grain-Shipment Vessels, Columbia and
Snake Rivers

    (a) Definitions. As used in this section:
    (1) Federal Law Enforcement Officer means any employee or agent of
the United States government who has the authority to carry firearms
and make warrantless arrests and whose duties involve the enforcement
of criminal laws of the United States.
    (2) Grain-Shipment Vessel means any vessel bound for or departing
from Export Grain Terminal (EGT), Longview, WA, or any vessel assisting
such a vessel to moor or maneuver.
    (3) Navigable waters of the United States means those waters
defined as such in 33 CFR part 2.
    (4) Navigation Rules means the Navigation Rules, International-
Inland.
    (5) Official Patrol means those persons designated by the Captain
of the Port to monitor a grain-shipment vessel safety zone, permit
entry into the zone, give legally enforceable orders to persons or
vessels within the zone and take other actions authorized by the
Captain of the Port. Federal Law Enforcement Officers authorized to
enforce this section are designated as the Official Patrol.
    (6) Public vessel means vessels owned, chartered, or operated by
the United States, or by a State or political subdivision thereof.
    (7) Oregon Law Enforcement Officer means any Oregon Peace Officer
as defined in Oregon Revised Statutes section 161.015.
    (8) Washington Law Enforcement Officer means any General Authority
Washington Peace Officer, Limited Authority Washington Peace Officer,
or Specially Commissioned Washington Peace Officer as defined in
Revised Code of Washington section 10.93.020.
    (b) Location. The following areas are safety zones: All navigable
waters of the United States within the Columbia River Captain of the
Port Zone, between the Columbia Bar ``CR'' buoy and extending eastward
on the Columbia River to Kennewick, WA and upriver through Lewiston, ID
on the Snake River, extending from the surface to the sea floor, that
are:
    (1) Not more than 500 yards ahead of any grain-shipment vessel that
is underway and 200 yards abeam and astern of any grain-shipment vessel
underway, or
    (2) Within a maximum 200-yard radius of any grain-shipment vessel
that is anchored, at any berth, moored, or in the process of mooring.
    (c) Effective Period. The safety zone created in this section will
be in effect

from 12:01 a.m. on January 23, 2012 until 12:01 a.m. on April 1, 2012.
It will be activated for enforcement as described in paragraph (d) of
this section.
    (d) Enforcement Periods. The Captain of the Port Columbia River
will cause notice of the enforcement of the grain-shipment vessel
safety zone to be made by all appropriate means to effect the widest
publicity among the affected segments of the public as practicable, in
accordance with 33 CFR 165.7. This notification of enforcement will
identify the grain-shipment vessel by name and IMO number. Such means
of notification may include, but are not limited to, Broadcast Notices
to Mariners or Local Notices to Mariners. The Captain of the Port
Columbia River will issue a Broadcast Notice to Mariners and Local
Notice to Mariners notifying the public when enforcement of the grain-
shipment vessel safety zone is suspended. Upon notice of enforcement by
the Captain of the Port Columbia River, the Coast Guard will enforce
the grain-shipment vessel safety zone in accordance with rules set out
in this section. Upon notice of suspension of enforcement by the
Captain of the Port Columbia River, all persons and vessels are
authorized to enter, transit, and exit the grain-shipment vessel safety
zone, consistent with the Navigation Rules.
    (e) Regulation. (1) In accordance with the general regulations in
Sec.  165.23 of this part, entry into or movement within these zones is
prohibited unless authorized by the Captain of the Port Columbia River,
the official patrol, or other designated representatives of the Captain
of the Port.
    (2) To request authorization to enter or operate within a grain-
shipment vessel safety zone contact the on-scene official patrol on
VHF-FM channel 16 or 13. Authorization will be granted based on the
necessity of access and consistent with safe navigation.
    (3) Vessels authorized to enter or operate within a grain-shipment
vessel safety zone shall operate at the minimum speed necessary to
maintain a safe course and shall proceed as directed by the on-scene
official patrol. The Navigation Rules shall apply at all times within a
grain-shipment vessel safety zone.
    (4) Maneuver-restricted vessels. When conditions permit, the on-
scene official patrol should:
    (i) Permit vessels constrained by their navigational draft or
restricted in their ability to maneuver to enter or operate within a
grain-shipment vessel safety zone in order to ensure a safe passage in
accordance with the Navigation Rules; and
    (ii) Permit commercial vessels anchored in a designated anchorage
area to remain at anchor within a grain-shipment vessel safety zone;
and
    (iii) Permit vessels that must transit via a navigable channel or
waterway to enter or operate within a grain-shipment vessel safety zone
in order to do so.
    (f) Exemption. Public vessels as defined in paragraph (a) of this
section are exempt from complying with paragraph (e) of this section.
    (g) Enforcement. Any Coast Guard commissioned, warrant or petty
officer may enforce the rules in this section. In the navigable waters
of the United States to which this section applies, when immediate
action is required and representatives of the Coast Guard are not
present or are not present in sufficient force to provide effective
enforcement of this section, any Federal Law Enforcement Officer,
Oregon Law Enforcement Officer, or Washington Law Enforcement Officer
may enforce the rules contained in this section pursuant to 46 U.S.C.
70118. In addition, the Captain of the Port may be assisted by other
federal, state or local agencies in enforcing this section.
    (h) Waiver. The Captain of the Port Columbia River may waive any of
the requirements of this section for any vessel or class of vessels
upon finding that operational conditions or other circumstances are
such that application of this section is unnecessary or impractical for
the purpose of port safety or environmental safety.

    Dated: January 6, 2012.
B. C. Jones,
Captain, U.S. Coast Guard, Captain of the Port, Columbia River.
[FR Doc. 2012-1171 Filed 1-20-12; 8:45 am]
BILLING CODE 9110-04-P


TABLE 1 AVERAGE ANNUAL EPA RESOURCE REQUIREMENT NEW SOURCE PERFORMANCE STANDARD ( NSPS) SUBPART L  SECONDARY LEAD SMELTERS REPORTING/ RECORDKEEPING REQUIREMENT EPA Hours/

Occurence ( A ) Occurences/

Plant/ Year ( B) EPA Hours/

Year ( C= A* B)

( C) Plants/ Year ( D) EPA Hours/

Year ( E= C* D)

( E)

INITIAL PERFORMANCE TESTS New Plant 24 1 24 0 0 REPEAT PERFORMANCE TEST New Plant 24 0.2 4.8 0 0 REPORT REVIEW New Plant Notification of Construction 2 1 2 0 0 Notification of Initial Startup 0.5 1 0.5 0 0 Notification of Actual Startup 0.5 1 0.5 0 0 Notification of Initial Test 0.5 1.2 0.6 0 0 Review Test Results 8 1.2 9.6 0 0 TOTAL ANNUAL HOURS 0 ANNUAL TRAVEL EXPENSES 0 SALARY BURDEN ( per year)

1 person x 2100 h/ yr x $ 34.69/ h = $ 0.00 TOTAL ANNUAL BURDEN $ 0.00 Assumptions Number of new plants ( per year) 0 Rate of failed performance tests 20%

Time required to participate with performance test ( hours per plant) 24 Time require to review construction notification ( hours) 2 Time required to review startup and initial test notifications ( hours) 0.5 Time required to review performance test results ( hours) 8 EPA labor rate ( GS 10 Step 1 + 110% overhead) $ 34.69 Percentage of new plant visits 10%

Round trip airfare to visit plant $ 250


[Federal Register Volume 86, Number 15 (Tuesday, January 26, 2021)]
[Notices]
[Pages 7084-7086]
[FR Doc No: 2021-01556]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP21-21-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization and Establishing Intervention and Protest Deadline

    Take notice that on January 6, 2021, Columbia Gas Transmission, LLC
(Columbia), 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700,
filed in the above referenced docket a prior notice pursuant to Section
157.205 and 157.216(b) of the Federal Energy Regulatory Commission's
regulations under the Natural Gas Act and the blanket certificate
issued to Columbia by the Commission in Docket No. CP83-76-000,\1\
seeking authorization to abandon ten injection/withdrawal wells and
associated pipelines and appurtenances, located in its Benton,
Crawford1, Laurel and McArthur Storage Fields in Hocking, and Vinton
Counties, Ohio (2021 Southcentral Ohio Well Abandonments Project).
Columbia states that there will be no change to the existing boundary,
total inventory, reservoir pressure, reservoir and buffer boundaries,
or the certificated capacity of the Benton, Crawford, Laurel and
McArthur Storage Fields as a result of these abandonments. Further,
Columbia avers that the proposed abandonments will not affect any other
Columbia storage fields, operations, or service, all as more fully set
forth in the request which is on file with the Commission and open to
public inspection.
---------------------------------------------------------------------------

    \1\ Columbia Gas Transmission Corporation (predecessor to
Columbia Gas Transmission, LLC), 22 FERC ] 62,029 (1983).
---------------------------------------------------------------------------

    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://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_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    Any questions concerning this application should be directed to
Dave Hammel, Director, Commercial & Regulatory Law, Columbia Gas
Transmission, LLC, 700 Louisiana Street, Suite 700, Houston, Texas
77002-2700, by telephone<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
Public Participation

    There are three ways to become involved in the Commission's review
of this project: You can file a protest to the project, you can file a
motion to intervene in the proceeding, and you can file comments on the
project. There is no fee or cost for filing protests, motions to
intervene, or comments. The deadline for filing protests, motions to
intervene, and comments is 5:00 p.m. Eastern Time on March 15, 2021.
How to file protests, motions to intervene, and comments is explained
below.

Protests

    Pursuant to section 157.205 of the Commission's regulations under
the NGA,\2\ any person \3\ or the Commission's staff may file a protest
to the request. If no protest is filed within the time allowed or if a
protest is filed and then withdrawn within 30 days after the allowed
time for filing a protest, the proposed activity shall be deemed to be
authorized effective the day after the time allowed for protest. If a
protest is filed and not withdrawn within 30 days after the time
allowed for filing a protest, the instant request for authorization
will be considered by the Commission.
---------------------------------------------------------------------------

    \2\ 18 CFR 157.205.
    \3\ Persons include individuals, organizations, businesses,
municipalities, and other entities. 18 CFR 385.102(d).
---------------------------------------------------------------------------

    Protests must comply with the requirements specified in section
157.205(e) of the Commission's regulations,\4\ and must be submitted by
the protest deadline, which is March 15, 2021. A protest may also serve
as a motion to intervene so long as the protestor states it also seeks
to be an intervenor.
---------------------------------------------------------------------------

    \4\ 18 CFR 157.205(e).
---------------------------------------------------------------------------

Interventions

    Any person has the option to file a motion to intervene in this
proceeding. Only intervenors have the right to request rehearing of
Commission orders issued in this proceeding and to subsequently
challenge the Commission's orders in the U.S. Circuit Courts of Appeal.
    To intervene, you must submit a motion to intervene to the
Commission in accordance with Rule 214 of the Commission's Rules of
Practice and Procedure \5\ and the regulations under the NGA \6\ by the
intervention deadline for the project, which is March 15, 2021. As
described further in Rule 214, your motion to intervene must state, to
the extent known, your position regarding the proceeding, as well as
your interest in the proceeding. For an individual, this could include
your status as a landowner, ratepayer, resident of an impacted
community, or recreationist. You do not need to have property directly
impacted by the project in order to intervene. For more information
about motions to intervene, refer to the FERC website at https://www.ferc.gov/resources/guides/how-to/intervene.asp.
---------------------------------------------------------------------------

    \5\ 18 CFR 385.214.
    \6\ 18 CFR 157.10.
---------------------------------------------------------------------------

    All timely, unopposed motions to intervene are automatically
granted by operation of Rule 214(c)(1). Motions to intervene that are
filed after the intervention deadline are untimely and may be denied.
Any late-filed motion to intervene must show good cause for being late
and must explain why the time limitation should be waived and provide
justification by reference to factors set forth in Rule 214(d) of the
Commission's Rules and Regulations. A person obtaining party status
will be placed on the service list maintained by the Secretary of the
Commission and will receive copies (paper or electronic) of all
documents filed by the applicant and by all other parties.

Comments

    Any person wishing to comment on the project may do so. The
Commission considers all comments received about the project in
determining the appropriate action to be taken. To ensure that your
comments are timely and properly recorded, please submit your comments
on or before March 15, 2021. The filing of a comment alone will not
serve to make the filer a party to the proceeding. To become a party,
you must intervene in the proceeding.

How To File Protests, Interventions, and Comments

    There are two ways to submit protests, motions to intervene, and
comments. In both instances, please reference the Project docket number
CP21-21-000 in your submission.
    (1) You may file your protest, motion to intervene, and comments by
using the Commission's eFiling feature, which is located on the
Commission's website (www.ferc.gov) under the link to Documents and
Filings. New eFiling users must first create an account by clicking on
``eRegister.'' You will be asked to select the type of filing you are
making; first select General'' and then select ``Protest'',
``Intervention'', or ``Comment on a Filing''; or \7\
---------------------------------------------------------------------------

    \7\ Additionally, you may file your comments electronically by
using the eComment feature, which is located on the Commission's
website at www.ferc.gov under the link to Documents and Filings.
Using eComment is an easy method for interested persons to submit
brief, text-only comments on a project.
---------------------------------------------------------------------------

    (2) You can file a paper copy of your submission by mailing it to
the address below.\8\ Your submission must reference the Project docket
number CP21-21-000.
---------------------------------------------------------------------------

    \8\ Hand-delivered submissions in docketed proceedings should be
delivered to Health and Human Services, 12225 Wilkins Avenue,
Rockville, Maryland 20852.

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
---------------------------------------------------------------------------
First Street NE, Washington, DC 20426

    The Commission encourages electronic filing of submissions (option
1 above) and has eFiling staff available to assist you at (202) 502-
8258 or [email protected]
    Protests and motions to intervene must be served on the applicant
either by mail or email (with a link to the document) at:
<EMAIL_ADDRESS>or 700 Louisiana Street, Suite 700, Houston,
Texas 77002-2700. Any subsequent submissions by an intervenor must be
served on the applicant and all other parties to the proceeding.
Contact information for parties can be downloaded from the service list
at the eService link on FERC Online.

Tracking the Proceeding

    Throughout the proceeding, additional information about the project
will be available from the Commission's Office of External Affairs, at
(866) 208-FERC, or on the FERC website at

www.ferc.gov using the ``eLibrary'' link as described above. The
eLibrary link also provides access to the texts of all formal documents
issued by the Commission, such as orders, notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. For more information and to register, go to
www.ferc.gov/docs-filing/esubscription.asp.

    Dated: January 12, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-01556 Filed 1-25-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 180 (Tuesday, September 19, 2023)]
[Notices]
[Pages 64515-64516]
[FR Doc No: 2023-20234]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2000-7257, Notice No. 94]

Railroad Safety Advisory Committee; Notice of Meeting

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice of public meeting.

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

SUMMARY: FRA announces the sixty-fifth meeting of the Railroad Safety
Advisory Committee (RSAC), a Federal advisory committee that provides
advice and recommendations to FRA on railroad safety matters through a
consensus process. This meeting of the RSAC will focus on efforts made
regarding potential safety improvements related to the February 3,
2023, Norfolk Southern freight train derailment in East Palestine,
Ohio.

DATES: The RSAC meeting is scheduled for Thursday, October 26, 2023.
The meeting will commence at 9:30 a.m. and will adjourn by 4:30 p.m.
(all times Eastern Daylight Time). Requests to submit written materials
to be reviewed during the meeting must be received by October 16, 2023.
Requests for accommodations because of a disability must be received by
October 16, 2023.

ADDRESSES: The RSAC meeting will be held at the National Association of
Home Builders, located at 1201 15th Street NW, Washington, DC 20005. A
final agenda will be posted on the RSAC

internet website at https://rsac.fra.dot.gov/ at least one week in
advance of the meeting. Please see the RSAC website for additional
information on the committee at https://rsac.fra.dot.gov/.

FOR FURTHER INFORMATION CONTACT: Kenton Kilgore, RSAC Designated
Federal Officer/RSAC Coordinator, FRA Office of Railroad Safety, (202)
365-3724 or [email protected]. Any committee-related request
should be sent to Mr. Kilgore.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FRA is giving notice of a
meeting of the RSAC.
    The RSAC is composed of 56 voting representatives from 30 member
organizations, representing various rail industry perspectives. The
diversity of the Committee ensures the requisite range of views and
expertise necessary to discharge its responsibilities.
    Public Participation: The meeting is open to the public. Attendance
is on a first-come, first served, basis, and is accessible to
individuals with disabilities. DOT and FRA are committed to providing
equal access to this meeting for all participants. If you need
alternative formats or services because of a disability, please contact
Mr. Kenton Kilgore as listed in the FOR FURTHER INFORMATION CONTACT
section, and submit your request by October 16, 2023.
    Any member of the public may submit a written statement to the
committee at any time; however, submissions for committee review during
the meeting must be received by October 16, 2023.
    Agenda Summary: This meeting of the RSAC will include updates from
the working groups for: train braking modernization; wayside detectors;
and enhancement of hazardous trains designations. These working groups
were formed in response to the February 3, 2023, Norfolk Southern
Railway Co. freight train derailment in East Palestine, Ohio. Working
groups for Confidential Close Call Reporting (C3RS) and roadway worker
protection will also report to the committee on their activity. FRA
will also announce the renewal of the RSAC charter for the period of
October 2023-October 2025, and discuss changes made to the charter. A
detailed agenda for the meeting will be posted on the RSAC internet
website at least one week in advance of the meeting. Copies of the
minutes of past meetings, along with general information about the
committee, are also available on the RSAC internet website at https://rsac.fra.dot.gov/.

    Issued in Washington, DC.
Amitabha Bose,
Administrator.
[FR Doc. 2023-20234 Filed 9-18-23; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43143-43144]
[FR Doc No: 2019-17874]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-P-0466]

Determination That Dextrose, 20 Grams/100 Milliliters, and
Dextrose, 50 Grams/100 Milliliters, in Plastic Containers, Were Not
Withdrawn From Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that Dextrose, 20 grams (g)/100 milliliters (mL), and
Dextrose, 50 g/100 mL, in plastic containers, were not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic
containers, if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Heather A. Dorsey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
348-3946<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price
Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417)
(the 1984 amendments), which authorized the approval of duplicate
versions of drug products under an ANDA procedure. ANDA applicants
must, with certain exceptions, show that the drug for which they are
seeking approval contains the same active ingredient in the same
strength and dosage form as the ``listed drug,'' which is a version of
the drug that was previously approved. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    The 1984 amendments include what is now section 505(j)(7) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which
requires FDA to publish a list of all approved drugs. FDA publishes
this list as part of the ``Approved Drug Products With Therapeutic
Equivalence Evaluations,'' which is known generally as the ``Orange
Book.'' Under FDA regulations, drugs are removed from the list if the
Agency withdraws or suspends approval of the drug's NDA or ANDA for
reasons of safety or effectiveness or if FDA determines that the listed
drug was withdrawn from sale for reasons of safety or effectiveness (21
CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic
containers, are the subject of NDA 017521, held by Baxter Healthcare
Corporation and initially approved on August 28, 1979. Dextrose, 20 g/
100 mL, and Dextrose, 50 g/100 mL, in plastic containers, are indicated
as a source of calories when mixed with amino acids or other compatible
intravenous fluids for patients requiring parenteral nutrition when
oral or enteral nutrition is not

possible, insufficient, or contraindicated.
    Dextrose, 20 g/100 mL, and Dextrose, 50 g/100 mL, in plastic
containers (NDA 017521), are currently listed in the ``Discontinued
Drug Product List'' section of the Orange Book.
    Fresenius Kabi USA, LLC, submitted a citizen petition dated January
29, 2019 (Docket No. FDA-2019-P-0466), under 21 CFR 10.30, requesting
that the Agency determine whether Dextrose, 20 g/100 mL, and Dextrose,
50 g/100 mL, in plastic containers (NDA 017521), were withdrawn from
sale for reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that Dextrose, 20 g/100 mL, and Dextrose, 50 g/100
mL, in plastic containers (NDA 017521), were not withdrawn for reasons
of safety or effectiveness. The petitioner has identified no data or
other information suggesting that Dextrose, 20 g/100 mL, and Dextrose,
50 g/100 mL, in plastic containers, were withdrawn for reasons of
safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of Dextrose, 20 g/100 mL, and
Dextrose, 50 g/100 mL, in plastic containers, from sale. We have also
independently evaluated relevant literature and data for possible
postmarketing adverse events. We have found no information that would
indicate that these drug products were withdrawn from sale for reasons
of safety or effectiveness.
    Accordingly, the Agency will continue to list Dextrose, 20 g/100
mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), in
the ``Discontinued Drug Product List'' section of the Orange Book. The
``Discontinued Drug Product List'' delineates, among other items, drug
products that have been discontinued from marketing for reasons other
than safety or effectiveness. ANDAs that refer to Dextrose, 20 g/100
mL, and Dextrose, 50 g/100 mL, in plastic containers (NDA 017521), may
be approved by the Agency as long as they meet all other legal and
regulatory requirements for the approval of ANDAs. If FDA determines
that labeling for this drug product should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.

    Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17874 Filed 8-19-19; 8:45 am]
 BILLING CODE 4164-01-P


Comment Info: =================

General Comment: May 12th, 2014

Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to.  And to do so accurately when time is limited is hard. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life.  I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request.


Endothall Occupational Exposure Discussion with the Army Corp of Engineers Meeting Minutes July 27, 2005 On July 27, 2005 EPA met with Kurt Getsinger of the Army Corp of Engineers to discuss the aquatic herbicide endothall. Endothall is commonly used by the Army Corp for exotic weed management, and is also the subject of ongoing research conducted by the Army Corp and Kurt Getsinger. The Agency requested the meeting with the Army Corp to better understand endothall use patterns and occupational exposures.

Currently several hand held application scenarios are of concern to the Agency. The exposure scenarios that the Agency used in the occupational assessment are derived from agricultural application scenarios because aquatic data is not available. The technical registrant, Cerexagri, commented that the exposure scenarios used are not indicative of typical endothall applications, particularly the amount of area treated. The Army Corp was able to describe typical applications for the Agency to use in refining their application exposure estimates.

To assess applications to lakes, the Agency assumed that a depth of 5 feet and an area up to 30 acres per day could be treated by an applicator making an application with hand held equipment. Both the registrant and the Army Corp commented that it is unlikely an area this large would be treated by hand. The Army Corp commented that this was likely a 2 to 4 fold exaggeration of typical application scenarios. The Agency commented that for 2,4 D surface treatments, 10 acres per day was the assumption used to assess hand held applications. In addition, the Army Corp agreed that it was unlikely that a depth of 5 feet would be treated, especially because handheld applications are primarily used to spot treat heavy infestations of aquatic vegetation that is commonly close to the surface.

To assess hand held applications to canals, the Agency assumed that an area of 40 miles per day could be treated. Both the Army Corp and the registrant commented that this area was too large to be treated by hand in a single day, and that it was not typical practice to make such a large application using hand held equipment. Mr. Getsinger commented that 40 miles per day was likely a 2 to 4 fold exaggeration of typical scenarios.

Due to the characterization of applications by the Army Corp, and the Agency's understanding the hand held applications are typically made to limited areas as spottreatments the Human Health Division is exploring the use of the smaller areas treated in the occupational risk assessment. It has been recommended by the Agency and the Army Corp that the hand held exposure scenarios are similar to those used in the 2,4 D occupational risk assessment, incorporating reduced areas of treatment.