MEMORANDUM 10 August 2001 SUBJECT: Diuron. Results of the Health Effects Division ( HED) Metabolism Assessment Review Committee ( MARC) Meeting Held on 03 JULY 2001.

Reregistration Case No.: 0046 PC Code: 035505 DP Barcode No.: D275688 FROM: John S. Punzi, Ph. D., Chemist Reregistration Branch II Health Effects Division [ 7509C]

THROUGH: Alan Nielsen, Branch Senior Scientist Reregistration Branch II Health Effects Division [ 7509C]

Christine Olinger, MARC Chair Health Effects Division [ 7509C]

TO: Yan W. Donovan, MARC Executive Secretary Health Effects Division [ 7509C]

1. Attendance MARC Members:

Alberto Protzel, Richard Loranger, Yan Donovan, Sheila Piper, Abdallah Khasawinah, Christine Olinger, David Nixon.

Non members attended:

Rich Griffin, Ibrahim Abdel Saheb, James Jim Breithaupt, Sherrie Kinard, Carol Christensen, Diana Locke, John Punzi. 2 MARC Members Absent:

William Wassell.

MARC Members Absent but providing comments:

John Doherty 2. Summary of Deliberations The metabolism of diuron in plants and animals from results of wheat, corn, orange, ruminant, and poultry studies together with the environmental fate studies conducted for diuron was presented to the HED MARC on 03/ July/ 2001.

The 14C containing residues that were identified in oranges were: diuron, 3,4 dichlorophenylurea ( DCPU), and 3( 3,4 dichlorophenyl) 1 methylurea ( DCPMU) ( Figure 1). These compounds were detected only in trace quantities (< 0.01 0.03 ppm) in pulp and peels. No other dichloroanilinecontaining metabolites were identified. The majority of radioactivity in the aqueous/ organic fractions was characterized as polar unknowns.

The 14C containing residues that were identified in corn plants were: Following postemergence treatment, diuron was found at 13.2 95.2% of TRR ( 0.62 1.21 ppm) in whole plants, 4.1 13.1% of TRR ( 0.20 0.37 ppm) in foliage, and 57.1 70.4% of TRR ( 0.04 0.22 ppm) in cobs; very minor amounts of diuron were observed in kernels ( 2.4% of TRR, < 0.01 ppm). Following preemergence treatment, diuron was detected at 22.0 48.4% of TRR ( 0.22 1.15 ppm) in whole plants and at 11% of TRR ( 0.35 ppm) in foliage; diuron was not detected in corn cobs or kernels. Other residues identified in corn matrices were DCPMU at 1.4 46.4% of TRR (< 0.01 1.60 ppm) and DCPU at 2.1 50.0% of TRR ( 0.02 2.22 ppm) from both types of treatments. No other metabolites were identified. Polar unknowns accounting for 0.5 23.6% of TRR ( 0.01 1.44 ppm) in whole plants, foliage, cobs, and kernels from both treatments were observed.

The 14C containing residues that were identified in wheat were: diuron, at 34.2 98.5% TRR ( 0.12 80.79 ppm) in wheat forage harvested 0 71 days posttreatment, and at 11.2% TRR ( 0.002 ppm) and 5.2% TRR ( 0.051 ppm) in mature wheat grain and straw, respectively. The diuron metabolite DCPMU was identified at 7.7 25.6% TRR ( 0.002 0.24 ppm) in all wheat commodities except forage harvested on the day of treatment, and DCPU was identified at 1.2 34.5% TRR ( 0.02 1.01 ppm) in all wheat commodities except mature grain. No other metabolites were identified. Two polar unknowns accounting for 2.4 34.9% TRR ( 0.007 0.023 ppm) were detected in wheat forage harvested 71 days posttreatment and in mature grain and straw. 3 NH N O Cl Cl CH 3 CH 3 NH NH O Cl Cl CH 3 NH NH 2 O Cl Cl Diuron: 3( 3,4 dichlorophenyl) 1,1 dimethylurea DCPMU; IN 15654: 3( 3,4 dichlorophenyl) 1 methylurea DCPU; IN R915: 3,4 dichlorophenylurea Figure 1.

Livestock Commodities:

The 14C containing residues that were identified in lactating goats were: The principal residue identified was DCPU which comprised 10% of TRR in milk, 27% of TRR in fat, 35% of TRR in kidney, 23% of TRR in liver, and 22% of TRR in muscle. The parent and other dichloroaniline containing metabolites ( i. e., 3,4 DCA and DCPMU) were detected in trace quantities ( # 0.01 ppm each) except in liver ( 0.12 ppm). Four minor ( each # 6% of TRR) hydroxylated metabolites ( 2 OH DCA; 2 OH DCPU; 2 OHDCPMU and N acetyl 2 OH DCA) were also detected; these metabolites were not observed in plants and would not be determined by the enforcement method.

The major portion of radioactive residues in milk was comprised of several conjugated polar components which collectively accounted for 56% of TRR. These polar components also accounted for substantial portions of the total radioactivity in liver ( collectively 25% of TRR ) and kidney ( collectively 23% of TRR). Attempts to further elucidate the nature of these polar materials using various techniques ( e. g., enzyme digestions, heat treatment) were not successful.

Poultry:

The 14C containing residues that were identified in laying hens were: DCPU, which comprised - 45% of TRR in liver, - 67 75% of TRR in muscle, - 47% of TRR in skin with fat, - 57% of TRR in egg yolk, and - 54% of TRR in egg white. The parent, other dichloroaniline containing metabolites ( i. e., DCPMU), and hydroxylated metabolites ( 2 OH diuron, 2 OH DCA, 2 OH DCPU, 2 OHDCPMU and N acetyl 2 OH DCA) were identified only in trace quantities ( mostly at # 0.01 ppm each).

Adequate radiovalidation data were submitted for the proposed enforcement method for animal commodities. The GC method recovered - 86 to > 100% of the TRR in liver, kidney, and muscle; however, the method recovered only 10% of the TRR in milk and 25% of the TRR in fat. The low 4 recovery in milk was previously addressed ( DP Barcodes D195058 and D195068, 11/ 30/ 93, R. Perfetti). It was concluded that because the major portion of radioactive residues in milk appear to be hydroxy metabolites which cannot be converted to DCA and do need not be quantitated, a new method would not be required for milk. Instead, it was determined that the levels of diuron residues in milk identified in the ruminant feeding study would be multiplied by 10 to account for all of the exposure in the risk assessment. The low recovery in fat was most likely due to the low residue levels present in fat. In a separate radiovalidation study, the GC method recovered - 62 to 77% of the TRR in poultry liver and muscle, and 58 to 65% of the TRR in egg whites and yolks.

Dietary Water The environmental data base is complete, diuron is persistent in the environment and has potential for leaching to ground and surface water. The metabolism studies of diuron in a variety of environmental conditions demonstrate that monochlorinated methylphenyl urea ( MCMPU) and monochlorinated dimethylphenyl urea ( MCDMPU) can be formed under some conditions and that MCDMPU is a major degredate in aquatic aeobic and anerobic studies. DCPMU was identified as a major degradate in several studies and 3,4 DCA, DCMU, PDMU were identified as minor metabolites.

The MARC raised concerns for MCPDMU based on an analogous compound, monuron. With the exception of the position of the chlorine, the structures are identical. There are cancer concerns for monuron but the target organs are different than those effected by diuron. The MARC recommended that a separate cancer assessment be conducted for MCPDMU..

MARC Decisions & Rationale Plants: The MARC concluded that for tolerance expression and risk assessment purposes, the residues of concern in/ on plants are diuron and its metabolites convertible to 3,4 dichloroaniline. This decision was based on the assumption that the metabolites DCPMU, and DCPU would not be any more or less toxic than the parent and in consideration of the analytical methods used to collect field trial data which are not capable of measuring each metabolite individually. 3,4 Dichloroaniline is not of toxicological concern for the endpoints regulated for diuron, but methods specific for diuron, DCPMU, and DCPU are not widely employed. . Livestock Commodities:

The MARC concluded that for the tolerance expression and risk assessment purposes, the residues of concern in/ on livestock and poultry are diuron and its metabolites convertible to 3, 4 dichloroaniline. This decision was based on the 5 assumption that the metabolites DCPMU and DCPU would not be any more or less toxic than the parent and in consideration the analytical methods used to collect field trial data which are not capable of measuring each metabolite individually. To account for the poor recovery of hydroxylated metabolites from milk, it was determined that the levels of diuron residues in milk identified in the ruminant feeding study would be multiplied by 10 to account for all of the exposure to diuron related residues in the risk assessment.

Drinking Water: The MARC concluded that for risk assessment purposes, the residues of concern in drinking water are parent, DCPMU, and MCPDMU. Based on a structural analogy to monuron, the MARC recommended that a separate cancer assessment be conducted for MCPDMU.

cc: JSPunzi ( RRB2), D. Locke ( RRB2), Diuron Reg. Std. File, Diuron SF, RF, LAN. RD/ I: RRB2 Chem Review Team ( 07/ 11/ 2001), Alan Nielsen ( 08/ 31/ 2001), MARC Chair ( 07/ 11/ 2001). John S. Punzi: 7509C: RRB2: CM2: Rm 712M: 703 305 7727: 07/ 11/ 2001.


[Federal Register Volume 87, Number 22 (Wednesday, February 2, 2022)]
[Rules and Regulations]
[Pages 5709-5711]
[FR Doc No: 2022-02099]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0139; FRL-9253-01-OCSPP]

Saccharomyces cerevisiae Strain LAS02; Exemption From the
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of Saccharomyces cerevisiae strain LAS02 in
or on all food commodities when used in accordance with label
directions and good agricultural practices. Lesaffre Yeast Corporation
(c/o Wagner Regulatory Associates, Inc.) 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 Saccharomyces cerevisiae strain LAS02 under FFDCA when used
in accordance with this exemption.

DATES: This regulation is effective February 2, 2022. Objections and
requests for hearings must be received on or before April 4, 2022 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-2021-0139, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Reading Room is closed to visitors with
limited exceptions. The staff continues to provide remote customer
service via email, phone, and webform. For the latest status
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Charles Smith, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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 Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2021-0139 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
April 4, 2022. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b), although EPA
strongly encourages those interested in submitting objections or a
hearing request, to submit objections and hearing requests
electronically. See Order Urging Electronic Service and Filing (April
10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf.
At this time, because of the COVID-19 pandemic, the judges and staff of
the Office of Administrative Law Judges are working remotely and not
able to accept filings or correspondence by courier, personal delivery,
or commercial delivery, and the ability to receive filings or
correspondence by U.S. Mail is similarly limited. When submitting
documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a
person should utilize the OALJ e-filing system, at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.
    Although EPA's regulations require submission via U.S. Mail or hand
delivery, EPA intends to treat submissions filed via electronic means
as properly filed submissions during this time that the Agency
continues to maximize telework due to the pandemic; therefore, EPA
believes the preference for submission via electronic means will not be
prejudicial. If it is impossible for a person to submit documents
electronically or receive service electronically, e.g., the person does
not have any access to a computer, the person shall so advise OALJ by
contacting the Hearing Clerk at<PHONE_NUMBER>. If a person is without
access to a computer and must file documents by U.S. Mail, the person
shall notify the Hearing Clerk every time it files a document in such a
manner. The address for mailing documents is U.S. Environmental
Protection Agency, Office of Administrative Law Judges, Mail Code
1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.
    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-2021-0139 by one of
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/where-send-comments-epa-dockets.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

II. Background

    In the Federal Register of September 22, 2021 (86 FR 52624) (FRL-
8792-03), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
exemption petition (PP 0F8841) by Lesaffre Yeast Corporation (c/o
Wagner Regulatory Associates, Inc.,) P.O. Box 640, 7217 Lancaster Pike,
Suite A, Hockessin, DE 19707. The petition requested that 40 CFR part
180 be amended by establishing an exemption from the requirement of a
tolerance for residues of the bactericide and fungicide Saccharomyces
cerevisiae strain LAS02 in or on all food commodities. That notice
referenced a summary of the petition prepared by the petitioner
Lesaffre Yeast Corporation and available in the docket via https://www.regulations.gov. No comments were received on the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement of 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 in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption 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. . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicological and exposure data on
Saccharomyces cerevisiae strain LAS02 and considered their validity,
completeness, and reliability, as well as the relationship of this
information to human risk. A full explanation of the data upon which
EPA relied and its risk assessment based on those data can be found
within the document entitled ``Human Health Risk Assessment of the New
Active Ingredient Saccharomyces cerevisiae strain LAS02 in the Proposed
End-use Product EPA File Symbol 91810-G with an Associated Tolerance
Exemption Petition'' (Saccharomyces cerevisiae strain LAS02 Human
Health Assessment). This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
    The available data and rationale supported by existing scientific
literature on Saccharomyces cerevisiae strain LAS02 and related
Saccharomyces cerevisiae species demonstrate that, with regard to
humans, Saccharomyces cerevisiae strain LAS02 is not toxic, pathogenic,
or infective via any reasonably foreseeable route of exposure. Humans,
including infants and children, are naturally exposed to Saccharomyces
cerevisiae as this microorganism is commonly found in many habitats
including soil, water, and plant surfaces. Furthermore, humans,
including infants and children, have a long history of safe dietary
exposure to strains of Saccharomyces cerevisiae through their use in
food production, nutritional supplements, and bio-therapeutics.
Saccharomyces cerevisiae strain LAS02 is expected to be non-toxic, non-
pathogenic, and non-infective based on its genetic similarity to other
food-use Saccharomyces cerevisiae strains and its lack of genetic
modification.
    Although there may be some dietary and non-occupational exposures
to pesticide residues of Saccharomyces cerevisiae strain LAS02 when
used in accordance with label directions and good agricultural
practices, there is not a concern due to the lack of potential for
adverse effects. Humans have a long history of dietary exposure of
Saccharomyces cerevisiae through its use in food and supplement
products and natural exposure through its presence in the environment
with no reported significant adverse effects attributable to dietary or
non-occupational exposure based on the proposed pesticide uses. Because
there are no threshold levels of concern with the toxicity,
pathogenicity, or infectivity of Saccharomyces cerevisiae strain LAS02,
EPA determined that no additional margin of safety is necessary to
protect infants and children as part of the qualitative assessment
conducted. Based upon its evaluation in the Saccharomyces cerevisiae
strain LAS02 Human Health Assessment, which concludes that there are no
risks of concern from aggregate exposure to Saccharomyces cerevisiae
strain LAS02, EPA concludes that there is a reasonable certainty that
no harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of Saccharomyces
cerevisiae strain LAS02.

B. Analytical Enforcement Methodology

    An analytical method is not required for Saccharomyces cerevisiae
strain LAS02 because EPA is establishing an exemption from the
requirement of a tolerance without any numerical limitation.

C. Conclusion

    Therefore, an exemption from the requirement of a tolerance is
established for residues of Saccharomyces cerevisiae strain LAS02 in or
on all food commodities when used in accordance with label directions
and good agricultural practices.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action 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 action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq., nor does it 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).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA 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. Thus, EPA 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 action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (15 U.S.C. 272 note).

V. 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: January 14, 2022.
Edward Messina,
Director, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

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. Add Sec.  180.1391 to subpart D to read as follows:

Sec.  180.1391  Saccharomyces cerevisiae strain LAS02; exemption from
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for
residues of Saccharomyces cerevisiae strain LAS02 in or on all food
commodities when used in accordance with label directions and good
agricultural practices.

[FR Doc. 2022-02099 Filed 2-1-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Page 15142]
[FR Doc No: 2018-07136]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1966-000]

Notice of Authorization for Continued Project Operation;
Wisconsin Public Service Corporation

    On September 28, 2012, Wisconsin Public Service Corporation,
licensee for the Grandfather Falls Hydroelectric Project, filed an
Application for a New License pursuant to the Federal Power Act (FPA)
and the Commission's regulations thereunder. The Grandfather Falls
Hydroelectric Project facility is located on the Wisconsin River in
Lincoln County, Wisconsin.
    The license for Project No. 1966 was issued for a period ending
March 31, 2018. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1),
requires the Commission, at the expiration of a license term, to issue
from year-to-year an annual license to the then licensee under the
terms and conditions of the prior license until a new license is
issued, or the project is otherwise disposed of as provided in section
15 or any other applicable section of the FPA. If the project's prior
license waived the applicability of section 15 of the FPA, then, based
on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c),
and as set forth at 18 CFR 16.21(a), if the licensee of such project
has filed an application for a subsequent license, the licensee may
continue to operate the project in accordance with the terms and
conditions of the license after the minor or minor part license
expires, until the Commission acts on its application. If the licensee
of such a project has not filed an application for a subsequent
license, then it may be required, pursuant to 18 CFR 16.21(b), to
continue project operations until the Commission issues someone else a
license for the project or otherwise orders disposition of the project.
    If the project is subject to section 15 of the FPA, notice is
hereby given that an annual license for Project No. 1966 is issued to
the licensee for a period effective April 1, 2018 through March 31,
2019 or until the issuance of a new license for the project or other
disposition under the FPA, whichever comes first. If issuance of a new
license (or other disposition) does not take place on or before March
31, 2019, notice is hereby given that, pursuant to 18 CFR 16.18(c), an
annual license under section 15(a)(1) of the FPA is renewed
automatically without further order or notice by the Commission, unless
the Commission orders otherwise.
    If the project is not subject to section 15 of the FPA, notice is
hereby given that the licensee, Wisconsin Public Service Corporation,
is authorized to continue operation of the Grandfather Falls
Hydroelectric Project, until such time as the Commission acts on its
application for a subsequent license.

    Dated: April 3, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-07136 Filed 4-6-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 237 (Tuesday, December 14, 2021)]
[Notices]
[Pages 71069-71071]
[FR Doc No: 2021-26990]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3758]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Expanded Access to Investigational Drugs for Treatment
Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
associated with expanded access to investigational drugs for treatment
use.

DATES: Submit either electronic or written comments on the collection
of information by February 14, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 14, 2022. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 14, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3758 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Expanded Access Applications.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal

Agencies to provide a 60-day notice in the Federal Register concerning
each proposed collection of information, including each proposed
extension of an existing collection of information, before submitting
the collection to OMB for approval. To comply with this requirement,
FDA is publishing notice of the proposed collection of information set
forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Expanded Access to Investigational Drugs for Treatment Use

OMB Control Number 0910-0814--Revision

    This information collection supports Agency regulations in 21 CFR
part 312, subpart I, Expanded Access to Investigational Drugs for
Treatment Use; associated guidance; and Form FDA 3926, Individual
Patient Expanded Access Investigational New Drug Application (IND). The
regulations govern the use of investigational new drugs, biologics, and
approved drugs if availability is limited by a risk evaluation and
mitigation strategy, when the primary purpose is to diagnose, monitor,
or treat a patient's disease or condition. The goal of the expanded
access program is to facilitate the availability of such products to
patients with serious diseases or conditions when there is no
comparable or satisfactory alternative therapy to diagnose, monitor, or
treat the patient's disease or condition. The regulations provide that
certain criteria be met, establish content and format requirements for
associated reporting, and require that submissions include a cover
sheet.
    Although we continue to account for burden associated with the
submission of expanded access requests for individual patients, we are
revising the information collection to also account for burden
attendant to other expanded access submissions, including commercial
investigational new drug applications (INDs) that involve large groups
of patients enrolled for treatment use of the investigational drug
(Sec. Sec.  312.300 through 312.320 (21 CFR 312.300 through 312.320)),
currently approved under OMB control number 0910-0014. Because of FDA's
long history of facilitating expanded access to investigational drugs
for treatment use for patients with serious or immediately life-
threatening diseases or conditions, our efforts in this regard are
ongoing.
    Form FDA 3926 was developed to assist respondents to the
information collection. Form FDA 3926 requires the completion of data
fields that enable us to uniformly collect the minimum information
necessary from licensed physicians who want to request expanded access
as prescribed in the applicable regulations. To supplement the form
instructions, we issued guidance, most recently updated in October
2017, entitled ``Individual Patient Expanded Access Applications: Form
FDA 3926,'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/individual-patient-expanded-access-applications-form-fda-3926. As discussed in the guidance, Sec.
312.310(b) contains additional submission requirements for individual
patient expanded access requests. These respondents may continue to use
either Form FDA 3926 or Form FDA 1571, Investigational New Drug
Application (IND), for all types of IND submissions to satisfy
requirements in 21 CFR 312.23(a) (approved under OMB control number
0910-0014). FDA considers a completed Form FDA 3926 signed by the
physician and checked in the box in Field 10.a (Request for
Authorization to use Form FDA 3926) to be a waiver request in
accordance with 21 CFR 312.10.
    We are proposing the following revisions to data elements in Form
FDA 3926 and will make corresponding revisions to the form
instructions:
     Reorder Field 8, ``Physician Name, Address, and Contact
Information'' to Field 1, and renumber remaining data fields
accordingly;
     Add ``Race and Ethnicity'' as an optional item under the
``Clinical Information/Brief Clinical History'' field;
     Add ``Request for Withdrawal'' under the ``Contents of
Submission'' field;
     Add technological enhancements to the electronic version
of Form FDA 3926 that utilize user-based selections to prompt required
data field entries. Currently, certain fields become grayed out if not
required for the submission type selected.
    Data elements in Sec. Sec.  312.315 and 312.320 continue to be
reported in Forms FDA 1571 and 1572, Statement of Investigator,
(approved under OMB control number 0910-0014).
    We estimate the burden of the information collection as follows:

             Table 1--Estimated Annual Reporting Burden--Center for Drug Evaluation and Research \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   21 CFR part 312, subpart I;       Number of     responses per   Total annual   Average burden    Total hours
 information collection activity    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   312.310(b) and                1,204          2.4958           3,005          * 0.75           2,254
 312.305(b); submissions related
 to expanded access and
 treatment of an individual
 patient: Form FDA 3926.........
Sec.   312.310(d); submissions             1,265           2.843           3,596              16          57,536
 related to emergency use of an
 investigational new drug: Form
 FDA 3926.......................
Sec.  Sec.   312.315(c) and                   88            3.64             320             120          38,400
 312.305(b); submissions related
 to expanded access and
 treatment of an intermediate-
 size patient population \2\....
Sec.   312.320(b); submissions                20               7             140             300          42,000
 related to a treatment IND or
 treatment protocol \2\.........
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           7,061  ..............         140,190
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910-0014.
* (45 minutes).

          Table 2--Estimated Annual Reporting Burden--Center for Biologics Evaluation and Research \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
   21 CFR part 312, subpart I;       Number of     responses per   Total annual   Average burden    Total hours
 information collection activity    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
Sec.  Sec.   312.310(b) and                  118           1.305             154               8           1,232
 312.305(b); number of
 submissions related to expanded
 access and treatment of an
 individual patient: Form FDA
 3926...........................
Sec.   312.310(d); number of               1,591          4.2137           6,704              16         107,264
 submissions related to
 emergency use of an
 investigational new drug: Form
 FDA 3926.......................
Sec.  Sec.   312.315(c) and                   28               1              28             120           3,360
 312.305(b); number of
 submissions related to expanded
 access and treatment of an
 intermediate-size patient
 population \2\.................
Sec.   312.320(b); number of                  15               1              15             300           4,500
 submissions related to a
 treatment IND or treatment
 protocol \2\...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............           6,901  ..............         116,356
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Data elements are reported in Forms FDA 1571 and 1572, approved under OMB control number 0910-0014.

    The information collection reflects an increase in 254,750 burden
hours and 11,568 responses annually since the last OMB review and
approval of the information collection. We attribute this to an
increase in the number of submission.

    Dated: December 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26990 Filed 12-13-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33758-33759]
[FR Doc No: 2014-13641]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0725]

Draft Guidance for Industry on Abbreviated New Drug Application
Submissions; Content and Format of Abbreviated New Drug Applications;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``ANDA
Submissions--Content and Format of Abbreviated New Drug Applications.''
The guidance document is intended to assist applicants in preparing
complete and high-quality original abbreviated new drug applications
(ANDAs) for submission to FDA under the Federal Food, Drug, and
Cosmetic Act. The guidance summarizes the statutory and regulatory
requirements for ANDAs, references existing guidance documents, and
incorporates additional recommendations on the content and format of
ANDA submissions. This guidance describes the Common Technical Document
format for human pharmaceutical product applications and specifies the
information to be submitted in each section of the application.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by August 11, 2014.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240-
402-7930, email<EMAIL_ADDRESS>or Stephen Ripley,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``ANDA Submissions--Content and Format of Abbreviated New Drug
Applications.'' On July 9, 2012, the Generic Drug User Fee Amendments
(GDUFA) was signed into law by the President to speed the delivery of
safe and effective generic drugs to the public and reduce costs to
industry. Under GDUFA, FDA agreed to certain obligations as laid out in
the GDUFA Commitment Letter. Among these obligations is FDA's
commitment to performance metrics for the review of original ANDAs. For
example, FDA has committed to review and act on 90 percent of original
ANDA submissions within 10 months from the date of submission in Year 5
of the program, which begins on October 1, 2016.
    In an effort to increase the number of original ANDAs that the
Agency can receive upon initial submission and to decrease the number
of review cycles required to approve an application for marketing, FDA
prepared this guidance on improving the quality of original ANDA
submissions. FDA is committed to providing comprehensive assistance in
the early stages of the application process to ensure that an original
ANDA contains all information necessary for FDA to complete its review
in one review cycle.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on ``ANDA
Submissions--Content and Format of Abbreviated New Drug Applications.''
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 314.94 have been approved under
0910-0001. The collection of information in Form FDA 356h has been
approved under 0910-0338. The collection of information for Form FDA
3674 has been approved under 0910-0616. The collection of information
for Form FDA 3794 has been approved under 0910-0727. The collection of
information for Form FDA 3454 has been approved under 0910-0393. The
collection of information for Form FDA 3455 has been approved under
0910-0396. The collection information for 21 CFR part 11, Electronic
Records, has been approved under 0910-0303.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: June 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13641 Filed 6-11-14; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: April 10, 2008 (Volume 73, Number 70)]
[Notices]
[Page 19524]
[DOCID:fr10ap08-79]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1731-DR]

California; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster for the
State of California (FEMA-1731-DR), dated October 24, 2007, and related
determinations.

DATES: Effective Date: March 31, 2008.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance
Directorate, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective March 31, 2008.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidential Declared Disaster Areas; 97.049, Presidential Declared
Disaster Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidential Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.)

R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-7593 Filed 4-9-08; 8:45 am]

BILLING CODE 9110-10-P


[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Page 18024]
[FR Doc No: 2014-07093]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER14-1569-000]

Dynegy Energy Services, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Dynegy Energy Services, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 14, 2014.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 25, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-07093 Filed 3-28-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: April 16, 2008 (Volume 73, Number 74)]
[Proposed Rules]
[Page 20774-20778]
[DOCID:fr16ap08-18]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 209

[FRA-2007-28573]
RIN 2130-AB87

Railroad Safety Enforcement Procedures; Enforcement, Appeal and
Hearing Procedures for Rail Routing Decisions

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

ACTION: Notice of proposed rulemaking.

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

SUMMARY: In a separate document published today, the Pipeline and
Hazardous Materials Safety Administration is requiring railroad
carriers to compile annual data on specified shipments of hazardous
materials (security-sensitive materials), use the data to analyze
safety and security risks along rail transportation routes where those
materials are transported, assess alternative routing options, and make
routing decisions based on those assessments. This document proposes
procedures to enable railroad carriers to challenge rail routing
decisions made by the FRA Associate Administrator for Safety in
accordance with PHMSA's requirements.

DATES: Submit comments by June 16, 2008. To the extent possible, we
will consider late-filed comments as we develop a final rule.

ADDRESSES: You may submit comments identified by the docket number FRA
2007-28573 by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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.
    Instructions: You must include the agency name and docket number
FRA-2007-28573 for this notice at the beginning of your comment.
Internet users may access comments received by DOT at http://
www.regulations.gov. Note that comments received may be posted without
change to http://www.regulations.gov including any personal information
provided. Please see the Privacy Act section of this document.
    Comments or those portions of comments FRA determines to include
trade secrets, confidential commercial information, or sensitive
security information (SSI) will not be placed in the public docket and
will be handled separately. If you believe your comments contain trade
secrets, confidential commercial information, or SSI, those comments or
the relevant portions of those comments should be appropriately marked
so that DOT may make a determination. FRA procedures in 49 CFR 209.11
establish a mechanism by which commenters may request confidentiality.
    In accordance with 49 CFR 209.11, you may ask FRA to keep
information confidential using the following procedures: (1) Mark the
document or portions of the document ``CONFIDENTIAL'' or ``CONTAINS
CONFIDENTIAL INFORMATION''; (2) send DMS both the original document and
a second copy of the original document with the confidential
information deleted; and (3) include a separate, detailed statement
justifying nondisclosure, explaining why the information is
confidential (such as a trade secret, confidential commercial
information, or SSI), and referring to the specific legal authority
claimed. In your explanation, you should provide enough information to
enable FRA to determine whether the information provided is protected
by law and must be handled separately.
    In addition, for comments or portions of comments that you believe
contain SSI as defined in 49 CFR 15.7, you should comply with Federal
regulations governing restrictions on the disclosure of SSI. See 49 CFR
1520.9 and 49 CFR 15.9. For example, these sections restrict the
sharing of SSI to those with a need to know, set out the requirement to
mark the information as SSI, and address how the information should be
disposed. Note also when mailing in or using a special delivery service
to send comments containing SSI, comments should be wrapped in a manner
to prevent the information from being read. FRA and the Transportation
Security Administration (TSA) may perform concurrent reviews on
requests for designations as SSI.
    After reviewing your request for confidentiality and the
information provided, FRA will analyze applicable laws and regulations
to decide whether to treat the information as confidential. FRA will
notify you of the decision to grant or deny confidentiality. If FRA
denies confidentiality, you will be provided an opportunity to respond
to the denial before the information is publicly disclosed. FRA will
reconsider its decision to deny confidentiality based on your response.
    Regarding comments not marked as confidential, prior to posting
comments received in response to this notice in the public docket, FRA
will review all comments, whether or not they are identified as
confidential, to determine if the submission or portions of the
submission contain information that should not be made available to the
general public. FRA will notify you if the agencies make such a
determination relative to your comment. If, prior to submitting your
comment, you have any questions concerning the procedures for
determining confidentiality or security sensitivity, you may call the
individual listed below under FOR FURTHER INFORMATION CONTACT for more
information.

FOR FURTHER INFORMATION CONTACT: Roberta Stewart, Trial Attorney,
Office of Chief Counsel, RCC-12, Mail Stop 10, FRA, 1120 Vermont Ave.,
NW., Washington, DC 20590 (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2006, the Pipeline and Hazardous Materials Safety
Administration (PHMSA) issued a notice of proposed rulemaking (PHMSA's
NPRM), 71 FR 76834, proposing revisions to the requirements in the
hazardous materials regulations (HMR) applicable to the safe and secure
transportation of hazardous materials transported in commerce by rail.
In today's edition of the Federal Register, PHMSA issued an interim
final rule (IFR) on this subject. Specifically, PHMSA is requiring
railroad carriers to compile annual data on specified shipments of
hazardous materials (security-sensitive materials), use the data to
analyze safety and security risks along rail transportation routes
where those materials are transported, assess alternative routing
options, and make routing decisions based on those assessments. In that
IFR, PHMSA also issued clarifications of the current security plan
requirements to address en route storage, delays in transit, delivery
notification, and additional security inspection requirements for
hazardous materials shipments.
    The Federal hazardous materials transportation law (Federal hazmat
law), 49 U.S.C. 5101 et seq., authorizes the Secretary of the
Department of

Transportation (Secretary) to ``prescribe regulations for the safe
transportation, including security, of hazardous material in
intrastate, interstate, and foreign commerce.'' The Secretary has
delegated this authority to PHMSA (formerly the Research and Special
Programs Administration).
    The HMR (49 CFR parts 171-180), promulgated by PHMSA under the
mandate in 49 U.S.C. 5103(b) govern safety aspects, including security,
of the transportation of hazardous material the Secretary considers
appropriate. Consistent with this security authority, in March 2003,
PHMSA adopted new transportation security requirements for offerors and
transporters of certain classes and quantities of hazardous materials
and new security training requirements for hazardous materials
employees. The security regulations, which are explained in more detail
below, require offerors and carriers to develop and implement security
plans and to train their employees to recognize and respond to possible
security threats.
    When PHMSA adopted its security regulations, shippers and railroad
carriers were informed these regulations were ``the first step in what
may be a series of rulemakings to address the security of hazardous
materials shipments.'' 68 FR 14509, 14511 (March 25, 2003). PHMSA also
noted that ``TSA is developing regulations that are likely to impose
additional requirements beyond those established in this final rule,''
and stated it would ``consult and coordinate with TSA concerning
security-related hazardous materials transportation regulations * * *''
68 FR 14511.
    Enforcement of the HMR has been delegated by the Secretary to modal
administrations within DOT. Specifically, FRA is authorized to ``carry
out the functions vested in the Secretary by 49 U.S.C. 5121(a), (b),
(c) and (d), 5122, 5123, and 5124, with particular emphasis on the
transportation or shipment of hazardous materials by railroad.'' 49 CFR
1.49(s).
    FRA is the agency within DOT responsible for railroad safety, and
is the primary enforcer of safety and security requirements in the HMR
pertaining to rail shippers and carriers. FRA inspectors routinely
review hazardous materials security plans required by the HMR during
site visits to railroad carrier and shipper facilities and may offer
suggestions for improving the security plans, as appropriate. If an
inspector's recommendations are not implemented, FRA may compel a rail
shipper or carrier to make changes to its security plan through its
normal enforcement process. FRA consults with TSA concerning railroad
security issues in accordance with the FRA-TSA annex to the DOT-
Department of Homeland Security Memorandum of Understanding (DOT-DHS
MOU) on transportation security.
    PHMSA's NPRM and IFR provide that a railroad carrier may be
required to revise its analysis or make changes to a route selected by
the carrier to move covered hazardous materials if the route selection
documentation or underlying analysis is found to be deficient. In
addition, both PHMSA's NPRM and IFR provide that if the carrier's
chosen route is found not to be the safest and most secure commercially
practicable route available, the FRA Associate Administrator for Safety
(Associate Administrator), in consultation with TSA, may require the
use of an alternative route until such time as identified deficiencies
are satisfactorily addressed. PHMSA's NPRM stated that FRA would
establish procedures for railroad carriers to appeal a decision by the
Associate Administrator to require the use of an alternative route.
    Several comments were submitted regarding the PHMSA NPRM and the
possibility that the FRA Associate Administrator could require
rerouting. The Association of American Railroads (AAR) questioned
whether FRA properly had the authority to require rerouting. The Dow
Chemical Company and the Institute of Makers of Explosives suggested
that, consistent with fundamental concepts of due process, PHMSA should
provide an immediate procedure to appeal an FRA determination to
require the use of an alternative route. The Surface Transportation
Board (STB) suggested that prior to making a determination requiring
the use of an alternative route, FRA and TSA obtain the comments of the
STB as to whether the contemplated alternative route(s) would be
commercially practicable.
    FRA's authority to require the use of an alternative route derives
from Sec.  5121(a) of the Federal hazmat law. The Secretary is
authorized to issue an order, after notice and an opportunity for a
hearing, requiring compliance with the Federal hazmat law or a
regulation, order, special permit, or approval issued under Federal
hazmat law. The authority provided in 49 U.S.C. 5121(a) has been
delegated to FRA ``with particular emphasis on the transportation or
shipment of hazardous materials by railroad'' (49 CFR 1.49(s)), as well
as to PHMSA, the Federal Aviation Administration, the Federal Motor
Carrier Safety Administration and the United States Coast Guard (with
``particular emphasis'' on the respective authority of these agencies).

II. Proposals in This NPRM

    As previously noted, in its rail security NPRM, PHMSA stated that
FRA would provide a procedure for administrative due process so that a
railroad carrier may seek redress of decision by the Associate
Administrator that the carrier's routing analysis is deficient and
directing a carrier to use a route while the deficiencies are
corrected. 71 FR at 76844. This NPRM proposes procedures governing the
review of rail routing decisions, including appeal, and these
procedures are summarized below. FRA notes in this regard that the
procedures are carefully designed so that a carrier is fully informed
of deficiencies found by FRA in a carrier's safety and security routing
analysis, and that the carrier is permitted to work with FRA to correct
those deficiencies. FRA will only require the use of an alternate route
if it concludes the carrier's analysis did not satisfy the minimum
criteria for performing a safety and security risk analysis, as
established by Sec.  172.820 and appendix D to part 172, and that an
alternative route poses the least safety and security risks based on
the information available to the agency. Moreover, FRA expects to
mandate temporary route changes only for the most exigent
circumstances.
    Section 209.501 provides that if the Associate Administrator
determines that a carrier's route selection documentation and
underlying analysis are deficient and fail to establish that the route
chosen by the carrier is the safest and most secure route, the
Associate Administrator will issue a written notice of review
(``Notice'') to the railroad carrier. The Notice will specifically
address each deficiency found in the railroad carrier's route analysis,
and may also include suggested mitigation measures that may be taken to
remedy the deficiencies, including selection and use of an alternative
commercially practicable route. After issuing the Notice, the Associate
Administrator will conference with the railroad carrier for a 30-day
period (or longer, if necessary, as determined by the Associate
Administrator) to resolve the deficiencies. The Associate Administrator
will keep a record of all written correspondence with the railroad
carrier, as well as written summaries of each meeting and telephone
conversation with the carrier pertaining to the Notice.
    If, after the close of the 30-day period, the Associate
Administrator concludes

that the identified deficiencies have not been satisfactorily resolved,
the Associate Administrator will:
    (1) Consult with TSA and PHMSA regarding the safety and security of
the route proposed by the railroad carrier and any alternative route(s)
over which the carrier is authorized to operate that are being
considered by the Associate Administrator. A written summary of the
recommendations from TSA and PHMSA will be prepared;
    (2) Obtain the comments of the STB regarding whether the
alternative route(s) under consideration by the Associate Administrator
would be commercially practicable; and
    (3) After fully considering the input of TSA, PHMSA and STB, render
a decision.
    In section 209.501(d), there are two possible outcomes of a
decision by the Associate Administrator. First, the Associate
Administrator may find that the route analysis and documentation
provided by the railroad carrier are sufficient to support the route
selected by the carrier or that commercial practicability issues
preclude the use of an alternative route. In either of those
circumstances, the Associate Administrator would conclude the route
review without further action, and notify the railroad carrier of the
decision in writing.
    Alternately, the Associate Administrator may conclude that the
railroad carrier's route analysis does not support the railroad
carrier's original selected route, that safety and security
considerations establish a significant preference for an alternative
route, and that the alternative route is commercially practicable. The
Associate Administrator would then issue a second written notice (2nd
Notice) to the railroad carrier that specifically identifies
deficiencies in the route analysis, including a clear description of
the risks that have not been satisfactorily mitigated; explains why the
available data and reasonable inferences support an alternative route;
and directs the railroad carrier to temporarily use the alternative
route determined by the Associate Administrator to be the safest and
most secure route. The railroad carrier would be required to start
using the alternative route selected by the Associate Administrator
within 20 days after the issuance date of the 2nd Notice. The railroad
carrier shall use the alternative route until such time as the carrier
has adequately mitigated the risks identified by the Associate
Administrator on the original route selected by the carrier.
    When the Associate Administrator issues a 2nd Notice directing the
use of an alternative route pursuant to section 209.501(d)(2), the
Associate Administrator shall make available to the railroad carrier
the administrative record relied upon in issuing the 2nd Notice,
including the recommendations of TSA, PHMSA and the STB to FRA.
    Within 20 days after the issuance date of the 2nd Notice, the
railroad carrier may: (1) Comply with the Associate Administrator's
directive to use an alternative route while addressing deficiencies in
its route analysis identified by the Associate Administrator; or (2)
file a petition for judicial review of the Associate Administrator's
2nd Notice. Judicial review would be available in an appropriate United
States court of appeals as provided in 49 U.S.C. 5127. The filing of a
petition for judicial review will not stay or modify the force and
effect of final agency action unless otherwise ordered by the Associate
Administrator or the court of appeals.
    With respect to enforcement of the new rail security requirements
established in PHMSA's IFR, FRA plans to work closely with TSA to
develop a coordinated enforcement strategy to include both FRA and TSA
inspection personnel. We note in this regard that TSA does not have the
authority to enforce safety or security requirements established in the
HMR. If in the course of an inspection of a railroad carrier, TSA
identifies evidence of non-compliance with a DOT security regulation,
TSA will provide the information to FRA and PHMSA for appropriate
action. TSA will not directly enforce DOT security rules, and will not
initiate safety inspections. Consistent with the PHMSA-TSA and FRA-TSA
annexes to the DOT-DHS MOU, all the involved agencies will cooperate to
ensure coordinated, consistent, and effective activities related to
rail security issues.

III. Rulemaking Analyses and Notices

A. Statutory/Legal Authority for This Rulemaking

    This NPRM is published under authority of the Federal hazmat law
(49 U.S.C. 5101 et seq.) Section 5103(b) of Federal hazmat law
authorizes the Secretary to prescribe regulations for the safe
transportation, including security, of hazardous materials in
intrastate, interstate, and foreign commerce. The HMR are issued by
PHMSA. 49 CFR 1.53(b). Responsibility for the enforcement of the
hazardous materials transportation law and regulations primarily in
instances where violations involve railroads and those entities which
ship by rail has been delegated to FRA. 49 CFR 1.49(s).

B. Executive Order 12866 and DOT Regulatory Policies and Procedures

    This NPRM is not considered a significant regulatory action under
section 3(f) of Executive Order 12866 and, therefore, was not reviewed
by the Office of Management and Budget. This NPRM is not significant
under the Regulatory Policies and Procedures of DOT (44 FR 11034). The
economic impact of this proposed rule is minimal to the extent that
preparation of a regulatory evaluation is not warranted.

C. Executive Order 13132

    This NPRM has been analyzed in accordance with the principles and
criteria contained in Executive Order 13132 (``Federalism''). This
proposed rule would not have any direct effect on the States or their
political subdivisions; it would not impose any compliance costs; and
it would not affect the relationships between the national government
and the States or their political subdivisions, or the distribution of
power and responsibilities among the various levels of government.

D. Regulatory Flexibility Act and Executive Order 13272

    FRA certifies that this proposed rule will not have a significant
economic impact on a substantial number of small entities. This
proposed rule would apply to carriers of hazardous materials by rail.
Some of these entities are classified as small entities; however, there
is no economic impact on any person that complies with Federal
hazardous materials law and the regulations and orders issued under
that law.

E. Paperwork Reduction Act

    There are no new information requirements in this proposed rule.

F. Unfunded Mandates Reform Act of 1995

    This proposed rule does not impose unfunded mandates under the
Unfunded Mandates Act of 1995. It does not result in annual costs of
$128,100,000 or more, in the aggregate, to any of the following: State,
local, or Indian tribal governments, or the private sector, and is the
least burdensome alternative to achieve the objective of the rule.

G. Environmental Assessment

    There are no significant environmental impacts associated with this
proposed rule.

H. Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement of Energy Effects for any ``significant energy action.'' 66
FR 28355 (May 22, 2001). Under the Executive Order, a ``significant
energy action'' is defined as any action by an agency (normally
published in the Federal Register) that promulgates or is expected to
lead to the promulgation of a final rule or regulation, including
notices of inquiry, advance notices of proposed rulemaking, and notices
of proposed rulemaking, that: (1)(i) Is a significant regulatory action
under Executive Order 12866 or any successor order, and (ii) is likely
to have a significant adverse effect on the supply, distribution, or
use of energy; or (2) is designated by the Administrator of the Office
of Information and Regulatory Affairs as a significant energy action.
We have evaluated this proposed rule in accordance with Executive Order
13211, and we have determined that this NPRM is not likely to have a
significant adverse effect on the supply, distribution, or use of
energy. Consequently, we have determined that this regulatory action is
not a ``significant energy action'' within the meaning of Executive
Order 13211.

I. Regulation Identifier Number (RIN)

    A regulation identifier number (RIN) is assigned to each regulatory
action listed in the Unified Agenda of Federal Regulations. The
Regulatory Information Service Center publishes the Unified Agenda in
spring and fall of each year. The RIN contained in the heading of this
document can be used to cross-reference this action with the Unified
Agenda.

List of Subjects in 49 CFR Part 209

    Administrative practice and procedure, Hazardous materials
transportation, Penalties, Railroad safety, Railroad safety enforcement
procedures, Reporting and recordkeeping requirements.

    Therefore, in consideration of the foregoing, chapter II, subtitle
B of title 49 of the Code of Federal Regulations is amended as follows:

PART 209--[AMENDED]

    1. The authority citation for part 209 continues to read as
follows:

    Authority: 49 U.S.C. 5123, 5124, 20103, 20107, 20111, 20112,
20114; 28 U.S.C. 2461, note; and 49 CFR 1.49.

    2. Amend Sec.  209.3 by adding the following new definitions:
* * * * *
    Associate Administrator means the Associate Administrator for
Safety, Federal Railroad Administration, or that person's delegate as
designated in writing.
* * * * *
    Railroad carrier means a person providing railroad transportation.
* * * * *
    3. Add new Subpart F to read as follows:

Subpart F--Enforcement, Appeal and Hearing Procedures for Rail
Routing Decisions Pursuant to 49 CFR 172.820

Sec.  209.501  Review of rail transportation safety and security route
analysis.

    (a) Review of route analysis. If the Associate Administrator for
Safety determines that a railroad carrier's route selection, analysis
and documentation pursuant to Sec.  172.820 of chapter I of this title
is deficient and fails to establish that the route chosen by the
carrier is the safest and most secure route, the Associate
Administrator shall issue a written notice of review (``Notice'') to
the railroad carrier. The Notice shall specifically address each
deficiency found in the railroad carrier's route analysis. The Notice
may also include suggested mitigation measures that the railroad
carrier may take to remedy the deficiencies found, including selection
of an alternative commercially feasible routing.
    (b) Conference to resolve deficiencies. After issuing the Notice,
the Associate Administrator conferences with the railroad carrier for a
thirty (30)-day period, or such longer period as provided by the
Associate Administrator, to resolve the deficiencies as identified in
the Notice. The Associate Administrator keeps a record of all written
correspondence with the railroad carrier and a summary of each meeting
and telephone conversation with the railroad carrier that pertains to
the Notice.
    (c) Consultation with and comment from other agencies. If, after
the close of the conference period, the Associate Administrator
concludes that the issues identified have not been satisfactorily
resolved, the Associate Administrator:
    (1) Consults with the Transportation Security Administration
(``TSA'') and the Pipeline and Hazardous Materials Safety
Administration (PHMSA) regarding the safety and security of the route
proposed by the railroad carrier and any alternative route(s) over
which the carrier is authorized to operate that are being considered by
the Associate Administrator and prepares a written summary of the
recommendations from TSA and PHMSA;
    (2) Obtains the comments of the Surface Transportation Board
(``STB'') regarding whether the alternative route(s) being considered
by the Associate Administrator would be commercially practicable; and
    (3) Fully considers the input of TSA, PHMSA and the STB and renders
a decision pursuant to paragraph (d) of this section which shall be
administratively final.
    (d) Decision. (1) If the Associate Administrator finds that the
route analysis and documentation provided by the railroad carrier are
sufficient to support the route selected by the carrier or that valid
issues of commercial practicability preclude an alternative route, the
Associate Administrator concludes the review without further action and
so notifies the railroad carrier in writing.
    (2) If the Associate Administrator concludes that the railroad
carrier's route analysis does not support the railroad carrier's
original selected route, that safety and security considerations
establish a significant preference for an alternative route, and that
the alternative route is commercially practicable, the Associate
Administrator issues a second written notice (2nd Notice) to the
railroad carrier that:
    (i) Specifically identifies deficiencies found in the railroad
carrier's route analysis, including a clear description of the risks on
the selected route that have not been satisfactorily mitigated;
    (ii) Explains why the available data and reasonable inferences
indicate that a commercially practicable alternative route poses less
safety and security risks than the route selected by the railroad
carrier; and
    (iii) Directs the railroad carrier, beginning within twenty (20)
days of the issuance date of the 2nd Notice on the railroad carrier, to
temporarily use the alternative route that the Associate Administrator
determines is the safest and most secure route until such time as the
railroad carrier has adequately mitigated the risks identified by the
Associate Administrator on the original route selected by the carrier.
    (e) Actions following 2nd Notice and re-routing directive. When
issuing a 2nd Notice that directs the use of an alternative route, the
Associate Administrator shall make available to the railroad carrier
the administrative record relied upon by the Associate Administrator in
issuing the 2nd Notice, including the recommendations of TSA, PHMSA and
STB to FRA made pursuant to paragraphs (c)(1) and (2) of this section.
Within twenty (20) days of the issuance date of the Associate

Administrator's 2nd Notice, the railroad carrier may:
    (1) Comply with the Associate Administrator's directive to use an
alternative route while the carrier works to address the deficiencies
in its route analysis identified by the Associate Administrator; or
    (2) File a petition for judicial review of the Associate
Administrator's 2nd Notice, pursuant to paragraph (f) of this section.
    (f) Review and decision by Associate Administrator on revised route
analysis submitted in response to 2nd Notice. Upon submission of a
revised route analysis containing an adequate showing by the railroad
carrier that its original selected route is the safest and most secure
route, the Associate Administrator notifies the carrier in writing that
the carrier may use its original selected route.
    (g) Appellate review. If a railroad carrier is aggrieved by final
agency action, it may petition for review of the final decision in the
appropriate United States court of appeals as provided in 49 U.S.C.
5127. The filing of the petition for review does not stay or modify the
force and effect of the final agency action unless the Associate
Administrator or the Court orders otherwise.
    (h) Time. In computing any period of time prescribed by this part,
the day of any act, event, or default from which the designated period
of time begins to run shall not be included. The last day of the period
so computed shall be included, unless it is a Saturday, Sunday, or
Federal holiday, in which event the period runs until the end of the
next day which is not one of the aforementioned days.
    4. In appendix B to part 209, amend the civil penalty guideline
table by adding the following entries:

Appendix B to Part 209--Federal Railroad Administration Guidelines for
Initial Hazardous Material Assessments

* * * * *

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

------------------------------------------------------------------------
172.820(a)-(e)............  General failure to perform   5,000-10,000
                             safety and security route
                             analysis. Factors to
                             consider are the size of
                             the railroad carrier, and
                             the quantities of hazmat
                             transported.
172.820(a)-(e)............  Partial failure to complete  5,000
                             route analysis; failure to
                             complete a component of
                             the route analysis.
                               --Compilation of
                                security-sensitive
                                commodity data.
                               --Identification of
                                practicable alternative
                                routes.
                               --Consultation with
                                State, local, and
                                tribal officials, as
                                appropriate regarding
                                security risks to high-
                                consequence targets
                                along or in proximity
                                to a route used by the
                                carrier to transport
                                security-sensitive
                                materials.
                               --Safety and security
                                route analysis of route
                                used.
                               --Safety and security
                                altenative route
                                analysis.
172.820(f)................  Failure to complete route    2,000
                             analyses within the
                             prescribed time frame.
172.820(g)................  Failure to include one of    2,000
                             the following components
                             in safety and security
                             plan.
                               --Procedure for
                                consultation with
                                offerors and consignees
                                to minimize storage of
                                security-sensitive
                                materials incidental to
                                movement.
                               --Measures to limit
                                unauthorized access to
                                the materials during
                                storage or delays in
                                transit.
                               --Measures to mitigate
                                risk to population
                                centers associated with
                                in-transit storage of
                                the materials.
                               --Measures to be taken
                                in the event of
                                escalating threat
                                levels for the
                                materials stored in
                                transit (Unit of
                                violation is the
                                component. For a total
                                failure to have a
                                security plan, cite
                                Sec.   172.800 and use
                                the penalties provided
                                for that section.).
172.820(h)................  Failure to maintain records  2,000
                             and make available to DOT
                             and DHS authorized
                             officials.
172.820(i)................  Failure to use route         10,000
                             designated by FRA
                             Associate Administrator
                             for Safety.
------------------------------------------------------------------------

* * * * *

    Issued in Washington, DC, on April 10, 2008.
S. Mark Lindsey,
Chief Counsel, Federal Railroad Administration.

 [FR Doc. E8-8187 Filed 4-15-08; 8:45 am]

BILLING CODE 4910-06-P


  SEQ CHAPTER \h \r 1 U. S. ENVIRONMENTAL PROTECTION AGENCY

Washington, D.C. 20460

									            OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

Date: December 13, 2007

MEMORANDUM

Subject:	Novaluron and Novaluron Degradates (Chlorophenyl urea and Chloroaniline) Drinking Water Assessment in Support of New Use Registration Action for Tomato, Sugarcane, and Increase in Application Rate to Brassica.

	PC Code: 124002

	DP Barcode: D345672, D340579, D340581, and D340583

To:		Dana Vogel, Branch Chief, RAB 1

		Health Effects Division (7509P)

		Susan Stanton, RIMUERB

Registration Division (7505P)

From:	Iwona L. Maher, Chemist, ERBI

		Thuy Nguyen, RAPL, ERB1

		Nancy Andrews, PhD, Branch Chief, ERBI

Environmental Fate and Effects Division (7507P)

The registrant is proposing to add two new uses:  tomato and sugarcane to the RimOn 0.83EC and RimOn 10SC (tomato only) product labels, and increase an application rate to brassica (RimOn 0.83EC).  Based on a review and analysis of the application information provided on the product labels for these two end-use products, drinking water estimated concentrations from these new proposed uses are expected to be lower than those from novaluron current use on apples.  According to HED MARC, beside novaluron, there are two novaluron degradates of concern for drinking water: 1-[3-Chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)phenyl]urea (275-352I; chlorophenyl) and 3-chloro-4-(1,1,2-trifluoro-2-trifluoromethoxyethoxy)aniline (275-309I; chloroaniline).

According to the current label no more than 0.96 lbs a.i. (RimOn 7.5WDG) may be applied to apples per acre per year, with the maximum rate per application of 0.32 lbs a.i., a minimum intervals of 10 to 14 days between applications, and up to 3 applications per year.  The proposed maximum application rates are no more than 0.39 lbs a.i. (RimOn 0.83EC) applied per acre per year (sugarcane).  Table 1 lists in detail the proposed application rates for tomato, sugarcane, and brassica, and the currently registered maximum application rate to apples.

Table 1.  Novaluron application rates for the proposed and registered1 uses.

Crop	Maximum application rate (lbs ai/A)	Maximum number of applications per year	Minimum interval between applications

	Single	Annual

Apples 1

0.32

0.96

3

10

Brassica 	0.078	0.233	3	7

Tomato	0.078	0.233	3	7

Sugarcane	0.078	0.39	5	n/a2

1 – It shows only the maximum registered application rate for novaluron registered uses.

2 – According to the proposed label the consequent applications to sugarcane should be made in intervals depending on a pest pressure.

Because the proposed application rate for tomato, sugarcane, and increased application rate for brassica uses are lower than the application rate for apples (annually 0.96 lb a.i./acre), the drinking water concentrations estimated for apples at the maximum application rate are applicable to the new proposed uses on tomato, sugarcane, and increased application to brassica.  At the maximum application rate on apples, Tier II novaluron acute (peak) estimated drinking water concentration is 11.4 μg/L, and exceeds the solubility of the compound (3 μg/L), which is expected to be an upper bound environmental concentration.  Novaluron estimated 1 in 10-year annual mean concentration in drinking water is 1.8 μg/L (apples).  The 30-year annual mean concentration is 1.2 μg/L (apples; Maher et. al., February 11, 2004, D285477).  Tier I chlorophenyl urea estimated peak drinking water concentration from surface water sources is 4.6 μg/L, and chloroaniline is 11.4 μg/L, based on novaluron’s maximum application rate of 0.32 lb ai/acre applied 3 times a season (0.96 lbs ai/year; apples).  Chlorophenyl urea scenario was based on assuming 26.6% (MRID 44961009) conversion from parent to chlorophenyl urea and using molecular weight conversion to adjust from parent application rate to chlorophenyl urea application rate.  Because non of the laboratory studies submitted for novaluron were conducted long enough to establish the pattern of formation and decline of chloroaniline the maximum formation rate is unknown.  Therefore, chloroaniline scenario was based on assuming 100% conversion from parent to chloroaniline and using molecular weight conversion to adjust from parent application rate to chloroaniline application rate.  An estimated annual average concentration of chlorophenyl urea is 0.86 μg/L and chloroaniline is 2.6 μg/L from the same maximum novaluron application rate to apples (I. Maher, February 11, 2004).

Based on laboratory and field studies, novaluron appears to be immobile and ranges from moderately persistent to persistent in the field.  It biodegrades in soil under aerobic conditions with half-lives of 7 to14.5 days, strongly adsorbs to soil and sediment (simple Kd values ranged from 95 to 247), and is stable to hydrolysis and photodegradation.  Due to its high sorptive properties (Koc = 6,680-11,813) on soil, the chemical has low potential for leaching into ground water.  In the field, novaluron appears to degrade with half-lives ranging from 20 to 178 days.  The laboratory and field data suggest that novaluron may be more persistent in colder climates. At 50 oC and pH 9 novaluron hydrolyzes very rapidly with a half-life of 1.2 days. In aerobic soils it degrades slower at 10 oC (i.e., half-life 31.9 days) than at 20 oC (i.e., half-lives from 7 to 14.5 days).  Novaluron has the potential to reach surface water through runoff weeks to months following its application and through spray drift during application.

$

;

?

C

F

J

^

f

€

˜

Î

Ú

Þ

-

"

6

7

A

T

U

 hä

hä

hä

 hä

 in the environment the major degradate chlorophenyl urea is expected to further degrade to form chloroaniline.

The fate and transport data submitted for novaluron were complete.   Fate data submitted for the novaluron degradate chlorophenyl urea (275-352I) was limited to the adsorption/desorption study.  No data was submitted for chloroaniline degradate.  For more detailed information on the drinking water assessment from novaluron use on apples refer to “Novaluron Estimated Drinking Water Concentration for Use in the Human Health Drinking Water Risk Assessment.” memo (Maher et. al., February 11, 2004, D285477).

 PAGE

 PAGE   3