[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)]
[Notices]
[Pages 29781-29782]
[FR Doc No: 2018-13663]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP16-1299-004.
    Applicants: Kinetica Energy Express, LLC.
    Description: Compliance filing Compliance Filing to be effective 4/
12/2017.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5054.
    Comments Due: 5 p.m. ET 7/2/18.

    Docket Numbers: RP18-899-000.
    Applicants: Equitrans, L.P.

    Description: Sec.  4(d) Rate Filing: Negotiated Rate Service
Agreement--EQT Energy, LLC 6-19-2018 to be effective 6/19/2018.
    Filed Date: 6/18/18.
    Accession Number: 20180618-5038.
    Comments Due: 5 p.m. ET 7/2/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 20, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-13663 Filed 6-25-18; 8:45 am]
 BILLING CODE 6717-01-P


SCIENCE AND TECHNOLOGY FOR SUSTAINABILITY MID-CYCLE SUBCOMMITTEE

DRAFT TELECONFERENCE AGENDA

Thursday, February 12, 2009

7:30 p.m. – 10:00 p.m. Eastern Time

Participation by Teleconference Only

866-299-3188

code:<PHONE_NUMBER>#

ADMINISTRATIVE CALL

7:30 pm	Welcome	Dr. John Giesy

	- Introduction of Subcommittee Members	Subcommittee Chair

	- Overview of Subcommittee Objectives

7:45 pm	Administrative Procedures	Greg Susanke

FACA Refresher	Subcommittee DFO,

What to Expect	Office of Research and

Roles and Responsibilities	Development

PUBLIC CALL

8:00-8:10 pm	Welcome	Dr. John Giesy

	-  Roll Call	Subcommittee Chair

	- Overview of Agenda

8:10-8:15 pm	Administrative Procedures	Greg Susanke

		Subcommittee DFO

8:15-8:35 pm	Overview of Charge/	Dr. John Giesy

	Rating Program Performance	Subcommittee Chair &

Phillip Juengst, Office of Research and Development

8:35-8:45 pm	Overview of Material	Dr. Alan Hecht, Director for
Sustainable Development,

Office of Research and Development

8:45-9:15 pm	Overview of Program	Dr. Alan Hecht, Director for
Sustainable Development

9:15-9:35 pm	Summary of Multi-Year Plan	Dr. Alan Hecht, Director for
Sustainable Development

9:35-9:40 pm	Public Comment

9:40-10:00 pm 	Preparation for Face-to-Face 	Dr. John Giesy,

	Meeting	Subcommittee Chair

	- Discuss Writing Assignments

	- Identify Additional Information Needs

10:00 pm	Adjourn

            A Federal Advisory Committee for the U.S. Environmental
Protection Agency’s Office of Research and Development


[Federal Register: February 11, 2008 (Volume 73, Number 28)]
[Notices]
[Page 7803-7804]
[DOCID:fr11fe08-115]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2008-0008 Notice 1]

NHTSA's Activities Under the United Nations Economic Commission
for Europe 1998 Global Agreement: Glazing

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Request for comments.

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SUMMARY: NHTSA is publishing this notice to inform the public that
there may be a vote to adopt the Global Technical Regulation (GTR) on
Glazing at the March 2008 session of the World Forum for Harmonization
of Vehicle Regulations (WP.29). In anticipation of this vote, NHTSA is
requesting comments on this GTR to inform its decision for the vote.
Publication of this information is in accordance with NHTSA's Statement
of Policy regarding Agency Policy Goals and Public Participation in the
Implementation of the 1998 Global Agreement on Global Technical
Regulations.

DATES: Written comments may be submitted to this agency by March 6,
2008.

ADDRESSES: You may submit comments [identified by DOT Docket No. NHTSA-
2008-0008, Notice 1] by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov.
 Follow the online instructions for submitting

comments.
     Mail: Docket Management Facility: U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC, 20590-0001.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue S.E., between 9 a.m. and 5 p.m. ET,
Monday through Friday, except Federal holidays. Telephone: 1-800-647-
5527.
     Fax:<PHONE_NUMBER>
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://www.regulations.gov
 including any personal information provided. Please

see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketInfo.dot.gov
.

    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and follow the

online instructions, or visit the Docket Management Facility at the
street address listed above.

FOR FURTHER INFORMATION CONTACT: Mr. Ezana Wondimneh, Division Chief,
International Policy and Harmonization (NVS-133), National Highway
Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington,
DC, 20590-0001; Phone<PHONE_NUMBER>, Fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: At the March 2004 session of WP.29 the
formal proposal to develop a GTR on safety glazing, sponsored by
Germany, was adopted with a modification to restrict the scope of the
GTR to glass-based safety glazing. An informal working group chaired by
Germany was subsequently established to develop the GTR. In October
2004, NHTSA docketed the draft GTR proposed by Germany (69 FR 60460,
60462; October 8, 2004), but received no comments. At the November 2005
session of WP.29 AC.3 further agreed that the GTR would not include
installation provisions and that the informal working group could
consider possible approaches to including certification markings in the
GTR. However, it was later decided by WP.29 that a separate informal
working group would be tasked with examining the issue of markings for
all GTRs. Therefore, the glazing GTR only specifies the required
markings to identify the type of glazing material without reference to
certification type markings. Contracting parties to the 1998 Agreement
will be able to require additional markings for identification of
manufacturer and the regulation(s) the glazing is manufactured to
comply with.
    On October 10, 2006, NHTSA published a new notice that described
the progress made on the agency's GTR activities including the glazing
GTR (docket number NHTSA-2003-14395). The notice included the draft
GTR, provided discussions on several key issues, and requested public
comments. A comment with regard to the GTR was submitted by Pilkington
North America that sought to clarify an incorrect citing of the test
procedures concerning light transmittance and optical distortion, which
has since been addressed.
    The latest draft of the GTR specifies performance requirements for
various types of glazing (i.e., laminated and toughened glass) intended
for installation in Category 1 and 2 vehicles as defined in Special
Resolution No. 1. The requirements apply to glazing as an item of
equipment, and do not include installation requirements for vehicles.
Performance requirements for some of the materials vary depending on
whether the material is intended for installation as a windscreen or a
pane. The draft includes requirements and tests to ensure the
mechanical strength, optical qualities and environmental resistance of
glazing.
    Four sets of tests and requirements for mechanical properties are
under consideration in the GTR: a fragmentation test, a 227g steel ball
impact test, a 2.26kg steel ball impact test and a 10kg headform impact
test. Each of the first three of these tests was adopted from widely
used procedures currently in effect, with small differences, in all
three national regulations examined for this GTR (European, Japanese
and U.S. safety regulations). The fragmentation test proposed in the
draft GTR is based on the current European approach, except that it was
modified to use two different impact forces depending on the design of
glazing being evaluated. The 227g and 2.26kg steel ball impact tests
are also very similar to the existing national regulations examined--
with the exception of the drop height for the small ball test. Based
upon analysis conducted by Japan, which determined that the force from
a drop height of 2.0m replicated the force of a typical object that
impacts a pane, it was decided that a drop height of 2.0m could be
specified. The headform test (which is currently in the European and
Japanese national regulations, but not in the U.S.) under consideration
for the GTR specifies one drop height (1.5m), instead of retaining the
two separate drop heights currently found in the European and Japanese
regulations because the purpose of the second height drop was already
addressed in other tests specified in the GTR. Also, the headform test
is an optional requirement in the GTR. Each contracting party to the
1998 Agreement can decide whether or not to apply this provision in
national/regional law.
    Three types of optical qualities are addressed in the GTR: light
transmission, optical distortion and double imaging. The minimum light
transmittance level for glazing requisite

for the driver's forward field of vision is 70 percent, per U.S. and
Japanese regulations, rather than 75 percent required in European
regulations. This is supported through a cost-benefit analysis, which
shows no perceptible difference in light transmission and savings in
energy usage. The light transmission test procedure used in the GTR was
adopted from the European and Japanese test procedures, because they
are based on the driver's field of view and thus better approximate
normal driving conditions. For the other optical quality tests, the
main differences between the standards and regulations examined were
not the requirements but just the test procedures. These differences
were resolved by selecting the European and Japanese test procedures
for the same reasons mentioned above.
    The GTR also includes environmental resistance requirements related
to temperature change, fire, chemical resistance, abrasion, radiation,
high temperature and humidity. The first four of these were common to
all the examined regulations. The remaining three requirements had
minor differences, which the GTR resolved by selecting the best
alternatives. For example, in the case of resistance to radiation, the
major difference between the American and European approaches is that
the former specifies 100 hours exposure, using a specified radiation
source, while the later specifies 100 hours of exposure at 1400 W/m\2\.
Since the European procedure ensures a constant level of exposure and
allows for alternative sources of UV radiation during testing, it was
deemed more flexible and was thus selected for the GTR.
    In July 2007, NHTSA received comments on the draft GTR from the
Society of Automotive Engineers (SAE) Glazing Committee. In October,
the agency made recommendations to the informal working group to
implement some of the SAE comments into the GTR. The comments accepted
in the GTR included editorial corrections, clarifications to Part A of
the draft GTR (the technical rationale and justifications section),
adding a definition for ``Uniformly toughened-glass'', and clarifying
what would be considered a sharp edge for the fragmentation test.
Several other points were not incorporated since they fell outside the
scope of the GTR, were not relevant or already addressed in previous
notices, or could not reasonably be pursued without conducting lengthy
additional research and validation testing that is not supported by the
majority of the Contracting Parties to the 1998 Agreement. SAE's
comments can be found in the docket of this notice.
    The informal working group submitted the draft GTR to the Working
Party on General Safety Provisions (GRSG) for consideration at the
October 2007 session. The October 2007 session of GRSG voted to
recommend the GTR to WP.29. The GTR is expected to be voted on at the
March 2008 session of WP.29. In anticipation of this vote, NHTSA
requests comments on the draft GTR. The draft GTR that will be
considered can be found in the docket for this notice.
    Once the GTR is established through consensus voting at WP.29,
NHTSA will initiate domestic rulemaking to amend its existing FMVSS to
incorporate approved provisions of the GTR. This will allow for further
opportunity to consider comments from interested parties through the
usual rulemaking process. If NHTSA's rulemaking process leads it to
either not adopt or to modify aspects of the GTR, the agency will seek
to amend the GTR in accordance with established procedures under the
1998 Global Agreement and WP.29, as it recently did with the door lock
GTR.

    Issued on: February 5, 2008.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
 [FR Doc. E8-2474 Filed 2-8-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)]
[Proposed Rules]
[Pages 16261-16262]
[FR Doc No: 2018-07664]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2018-0139; Airspace Docket No. 18-ACE-1]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Lyons, KS

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify Class E airspace extending
upward from 700 feet above the surface at Lyons-Rice County Municipal
Airport, Lyons, KS. This action is necessary due to the decommissioning
of the Lyons non-directional radio beacon (NDB), and cancellation of
the NDB approach, and would enhance the safety and management of
standard instrument approach procedures for instrument flight rules
(IFR) operations at this airport. Additionally, the geographic
coordinates are being updated to coincide with the FAA's aeronautical
database.

DATES: Comments must be received on or before May 31, 2018.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone
(202) 366-9826, or 1-800-647-5527. You must identify FAA Docket No.
FAA-2018-0139; Airspace Docket No. 18-ACE-1, at the beginning of your
comments. You may also submit comments through the internet at http://www.regulations.gov. You may review the public docket containing the
proposal, any comments received, and any final disposition in person in
the Dockets Office between 9:00 a.m. and 5:00 p.m., Monday through
Friday, except Federal holidays.
    FAA Order 7400.11B, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC, 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to http://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: Rebecca Shelby, Federal Aviation
Administration, Contract Support, Operations Support Group, Central
Service Center, 10101 Hillwood Parkway, Fort Worth, TX, 76177;
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would amend Class E airspace extending upward from 700 feet above
the surface at Lyons-Rice County Municipal Airport, Lyons, KS.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Commenters wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2018-0139;
Airspace Docket No. 18-ACE-1.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive public contact
with FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at http://www.faa.gov//air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Federal Aviation Administration, Air Traffic
Organization, Central Service Center, Operations Support Group, 10101
Hillwood Parkway, Fort Worth, TX, 76177.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11B, Airspace

Designations and Reporting Points, dated August 3, 2017, and effective
September 15, 2017. FAA Order 7400.11B is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11B lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 by modifying Class E airspace extending
upward from 700 feet above the surface at Lyons-Rice County Municipal
Airport, Lyons, KS, and the geographic coordinates to coincide with the
FAA's aeronautical database.
    Airspace reconfiguration is necessary due to the decommissioning
and cancellation of the Lyons NDB, and NDB approach, which would
enhance the safety and management of the standard instrument approach
procedures for IFR operations at the airport.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11B, dated August 3, 2017, and effective September 15,
2017, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the Federal
Aviation Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B,
Airspace Designations and Reporting Points, dated August 3, 2017, and
effective September 15, 2017, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ACE KS E5 Lyons, KS [Amended]

Lyons-Rice County Municipal Airport, KS
    (Lat. 38[deg]20'31'' N, long. 98[deg]13'38'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Lyons-Rice County Municipal Airport.

    Issued in Fort Worth, TX, on April 5, 2018.
Christopher L. Southerland,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2018-07664 Filed 4-13-18; 8:45 am]
 BILLING CODE 4910-13-P


\* MERGEFORMAT
                 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
                            WASHINGTON, D.C.  20460

                                                  OFFICE OF CHEMICAL SAFETY AND
                                                                                POLLUTION PREVENTION

MEMORANDUM

Date:  February 2, 2016

SUBJECT: Response to Public Comments: Process for Establishing and Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies

PC Code:  NA
DP Barcode:  xxx
Decision No.:  NA
Registration No.:  NA
Petition No.:  NA
Regulatory Action:  NA
Risk Assessment Type:  NA
Case No.:  NA
TXR No.:  NA
CAS No.:  NA
MRID No.: NA
40 CFR:  40 CFR§180.342

FROM:		Evisabel Craig
			Chris Schlosser
			Health Effects Division (7509P)

THROUGH:		Anna Lowit, Senior Scientist
			Health Effects Division (7509P)

TO:			Jennifer McLain, Deputy Director
			Antimicrobials Division (xxx)

In early 2015, the EPA published a draft document delineating the proposed process for establishing and implementing alternative approaches to traditional in vivo acute toxicity studies. Members of the private sector, non-governmental organizations and the general public had the opportunity to provide comments to further strengthen and improve the draft document. The EPA has taken into consideration all comments received and made appropriate changes to the revised document.  The following memorandum constitutes a formal response to the aforementioned comments.
Overall Positive Comments

During the public comment period, EPA received an array of comments from the private sector, non-governmental organizations and private individuals. Overall, the majority of comments received by EPA were positive and supportive of the proposed guidance along with the direction that the agency is headed with respect to expanding the implementation of alternative approaches. A few comments asked for clarifications or revisions of the document, and responses to these are summarized below. Comments have been summarized and responses organized based on the section of the document they pertain to.

Collaboration

ACC, CLA and NC3R  -  suggest that EPA work with other federal agencies (FDA, CPSC, etc.) and OECD in the development of test guidelines for any specific alternative method being proposed to ensure consistency and harmonization.

EPA is already working with other federal, state and international agencies and will continue to do so to ensure consistency and harmonization of test guidelines, and has included language to that effect on page 7 of the Process guidance.

Syngenta  -  state that the proposed approach needs to be part of the NAFTA regulatory cooperation process to be successful.

The Agency is aware of the importance of international cooperation. OPP has already been collaborating with PMRA on the use of alternative approaches for the acute 6-pack battery.  However, this guidance is drafted in the context of FIFRA section 6(a)(2), which is a US-specific statute. Interested parties are encouraged to contact Canada PMRA regarding their efforts on alternative methods to in vivo toxicity testing.

Other Alternative Methods

Biocides Panel - Acknowledge that there are existing alternative approaches to the six studies requirement including waiving and bridging, as discussed in EPA's Guidance for Waiving or Bridging of Mammalian Acute Toxicity Tests for Pesticides and Pesticide Products (Acute Oral, Acute Dermal, Acute Inhalation, Primary Eye, Primary Dermal, and Dermal Sensitization) (dated March 1, 2012).

A citation of the aforementioned bridging guidance document has been added.

CLA, PETA/PCRM  -  -  would like to have in silico methods included, not just in vitro.

A reference to in silico methods has been included.

Evaluation Phase

ARDF and Syngenta  -  Text places too much emphasis on comparing new alternative methods to current "in vivo" standards.  The draft guidance should do more to: 1. move away from apical endpoints and towards pathways-based approaches; 2. incorporate more guidance on integrated testing strategies-how they could be developed and applied to the chemicals under consideration.

As guidelines for in vivo studies are referenced in the current data regulations at 40 CFR part 158, any developed alternative approaches will most often be compared to these standards already in place to determine the suitability of the alternative approach in replacing the required studies, except in cases where the alternative approach has been shown to be more predictive of human effects than the in vivo laboratory animal study.  These comparisons do not preclude use of adverse outcome pathways as scientific foundation for developing or evaluating alternative approaches for use as stand-alone replacements or as part of an integrated approach on testing and assessment (IATA) process or integrated testing strategy (ITS).

With respect to developing integrated testing strategies, the agency expects IATAs/ITS to be developed on a case-by-case basis for various endpoints or effects; this level of detail is beyond the scope of the  "Process For Evaluating & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use" document.

Syngenta  -  Provide clarification on who is responsible for data generation, is it voluntary? Also, it is not clear in the current document how something is determined to be useful for regulatory purposes.

In the near future, the Agency's expectation is that data to be used will likely come from existing sources of data (e.g. industry or in-house research and development).  Data may come from any source and participation in this initiative is voluntary. However, the Agency notes that limited participation by industry may lead to slower adoption of alternatives methods and/or narrow adoption with respect to chemical space of applicability.  Considerations to determine whether data are useful for regulatory purposes are discussed in section IIA (e.g. the degree to which a method has been validated by an international validation process).

CLA - suggest EPA consider test methods which have been vetted through an international validation process (i.e., OECD) in order to ensure consistency in test methods and data interpretation, particularly when conducting any evaluation correlating in vitro to in vivo results.

The Agency notes that OECD does not validate methods, per se.  The role of the OECD is develop guidelines from well-established methods.  There are validation organizations around the world who work collaboratively to achieve validation (https://ntp.niehs.nih.gov/pubhealth/evalatm/iccvam/international-partnerships/index.html).  The issue identified in this comment is addressed in point 1 under "considerations during the evaluation phase" in the draft guidance. The Agency concurs that well-established methods will be the focus during the evaluation phase.

PETA/PCRM - suggest the EPA add language stating that the agency should be consulted prior to the data being generated to ensure the study is conducted in a manner that meets any applicable standards for evaluating the method. Add language clarifying suitability of methods for all classes vs. class-specific methods, and if class-specific methods are acceptable.

The Agency expects to use data that has already been generated.  For new data generation, EPA encourages and welcome open dialogue.  The Agency often reviews study protocols and invites the submission of protocols. The suitability of a method, whether class-specific or across many classes, will be assessed during the evaluation phase as stipulated in point 3 of the evaluation phase section.

Transition Phase

ARDF  -  Do not extend public comments into the transition phase, work with state and international regulators early in the process. Discourage use of "in vivo" studies as early as possible.

The previously titled transition phase has been renamed "the proposal and public comment phase". As discussed in IIA, throughout the course of an evaluation, the Agency will engage diverse stakeholders including states, NGOs, international partners and other federal agencies.

Syngenta and PETA/PCRM - No length of time or volume of data required was identified for the transition phase. Concerns were raised regarding cost for potential registrants who must utilize more than one test method for one endpoint for an indeterminate period of time. Suggestions include that methods that already have been substantially evaluated (for example at OECD) and/or undergone peer review, be subject to an abbreviated transition phase. Also, it is suggested that the EPA set up some form of outreach (ideally including incentives such as fast-track review) that would encourage companies to submit data so that, with a greater volume of submittals, the transition period could hopefully be shortened.

The previously titled transition phase has been renamed "the proposal and public comment phase". The Agency will work diligently after the public comment period closes to issue a revised policy in a timely manner to ensure rapid application. Typical comment periods are 30-90 days but extensions may be granted whenever appropriate. Upon finalization of the policy, it will be the choice of the submitter to use the alternative approach or the traditional in vivo test. The statement encouraging data submission during the comment period seemed to confuse readers so it has been removed. However, consistent with EPA's regulations, companies may submit data generated with an alternative method at any time.

EPA appreciates the suggestion of incentives and encourages the commenters to provide specific ideas to the agency.

Implementation Phase

PETA/PCRM  -  Provide discussion on the phase-out of in vivo methods in the event that one or more acute in vitro methods are deemed acceptable by the agency. We would hope that a "test on animals only as a last resort" policy could be developed.

Our 2013 document, Guiding Principles for Data Requirements, states that "The goal is to ensure there is sufficient information to reliably support registration decisions that are protective of public health and the environment while avoiding the generation and evaluation of data that do not materially influence the scientific certainty of a regulatory decision. It is important to only require data that adequately inform regulatory decision making and thereby avoid unnecessary use of time and resources, data generation costs, and animal testing."

6a2

CLA - Clarity is also sought regarding the timing of if and when FIFRA §6(a)(2) reporting will be required for a new method, and whether the requirement for reporting would apply to specific individual methods or to multiple approaches combined in an integrated fashion.

As stated in section C (implementation phase) and section III (page 7), data generated with an alternative method for which the Agency has issued a final policy detailing how the data generated with the method (or a set of methods) should be interpreted with respect to EPA labeling requirements will be reportable under section 6(a)(2). In the evaluation phase of the process, the results of the alternative testing methods are unlikely to be of interest to EPA, because the degree to which those results correspond to EPA's regulatory criteria is unknown.  Through its evaluation process, the Agency will determine whether the alternative method(s) may meet OPP's regulatory needs. Whether the requirement for reporting would apply to specific individual methods or to multiple approaches combined in an integrated fashion will depend on the particular policy at hand. The critical factor is whether the Agency has determined how to interpret the data with respect to EPA's regulatory criteria. If the interpretation is dependent on using results from a set of methods combined in an integrated fashion, only such data are reportable. However, if the Agency issues criteria for interpreting data from individual methods with respect to EPA's regulatory criteria, whether or not those individual methods may also be combined in an integrated fashion, data from the individual methods would be reportable.

Syngenta - Should an agreement of not changing already approved label/registration, like EDSP program used, be included for participants evaluating alternative assays? We're interested in the comments on PRF of effects. Currently, our criteria state that, when used as a screen, in vitro results are not referable. In this case referability is entirely dependent on the in vivo data. When used as a stand-alone assay an in vitro test would be referable. We need to understand exactly how the EPA's comments would affect this.

FIFRA section 6(a)(2) provides that "if at any time after the registration of a pesticide the registrant has additional factual information regarding unreasonable adverse effects on the environment of the pesticide, he shall submit such information to the Administrator."  This is required irrespective of whether the study is in vitro, in vivo, used as a screen or as a stand-alone assay. The 2009 "Endocrine Disruptor Screening Program; Policies and Procedures for Initial Screening" document, section K states that "Under FIFRA section 6(a)(2), pesticide product registrants are required to submit adverse effects information about their products to the EPA", which corresponds to the discussion in "Process for Evaluating & Implementing Alternative Approaches to Traditional In Vivo Acute Toxicity Studies for FIFRA Regulatory Use."

ARDF  -  Establish a framework for "systematic review" instead of a "weight-of-evidence" approach in order to provide a scientific method for data integration.

In recent years, the National Academy of Sciences has encouraged the Agency to move towards systematic review processes to enhance the transparency of scientific literature reviews that support chemical-specific risk assessments to inform regulatory decision making.  According to the National Research Council, systematic reviews "have several common elements: transparent and explicitly documented methods, consistent and critical evaluation of all relevant literature, application of a standardized approach for grading the strength of evidence, and clear and consistent summative language. "  EPA's Office of Chemical Safety and Pollution Prevention is currently developing systematic review policies and procedures. Weight of evidence analysis is the Agency's process for evaluating the strength of the scientific evidence along with integrating such evidence as a component of systematic review.

ARDF and NC3R  -  Is a safe harbor from 6A2 possible?  Is it possible to elaborate on how this will be done - are there plans to establish a framework? (In considering data for 6a2).

EPA believes that it would be inconsistent with its FIFRA mandate to create a "safe harbor" that would allow registrants to withhold information "if the registrant knows, or reasonably should know, that if the information should prove to be correct, EPA might regard the information alone or in conjunction with other information about the pesticide as raising concerns about the continued registration of a product or about the appropriate terms and conditions of registration of a product prevent unreasonable adverse effects of pesticides." (§ 159.195(a)). However, EPA emphasizes that information submitted pursuant to section 6(a)(2) will not necessarily dictate regulatory decisions or label amendments. EPA will consider reported data in the context of the full range of data previously submitted in support of the registration, applying a weight of the evidence approach.

General Comments

PETA/PCRM  -  On page 3, footnote 5 indicates that the document does not apply to in vitro or alternative methods used to develop adverse outcome pathways. We are not sure what this refers to as the assays involved in evaluating skin sensitization, for example, i.e., DPRA, KeratinoSens, and hCLAT, all measure events along the AOP for this endpoint. We would ask that the OPP provide more clarification on this footnote.

Footnote 5 has been removed.


United States Prevention, Pesticides EPA 738 F 05 XX Environmental Protection and Toxic Substances August 2005 Agency ( 7508C)

Maneb Facts Pesticide Reregistration All pesticides sold or distributed in the United States must be registered by EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides which were first registered before November 1, 1984, be reregistered to ensure that they meet today's more stringent standards.

In evaluating pesticides for reregistration, EPA obtains and reviews a complete set of studies from pesticide producers, describing the human health and environmental effects of each pesticide. To implement provisions of the Food Quality Protection Act of 1996, EPA considers the special sensitivity of infants and children to pesticides, as well as aggregate exposure of the public to pesticide residues from all sources, and the cumulative effects of pesticides and other compounds with common mechanisms of toxicity. The Agency develops any mitigation measures or regulatory controls needed to effectively reduce each pesticide's risks. EPA then reregisters pesticides that meet the safety standard of the FQPA and can be used without posing unreasonable risks to human health or the environment.

When a pesticide is eligible for reregistration, EPA explains the basis for its decision in a Reregistration Eligibility Decision ( RED) document. This fact sheet summarizes the information in the RED document for the pesticide maneb, case number 0642.

Regulatory History Maneb was first registered in the United States in 1962 for use on food and ornamental crops to prevent crop damage in the field and to protect harvested crops from deterioration in storage or transport. Maneb is a member of the ethylene bisdithiocarbamate ( EBDC) group of fungicides, which includes the related active ingredients mancozeb and metiram. The EBDCs share the common degradate ethylenethiourea ( ETU). EPA has considered aggregate risk from ETU from all sources as a part of the RED.

The EBDCs have been the subject of two Special Reviews. In 1977, the Agency initiated a Special Review for products containing EBDCs based on evidence suggesting that the EBDCs and ETU, a contaminant, metabolite and degradation product of these pesticides, posed potential risks to human health and the environment. In 1982, the Agency concluded this Special Review by issuing a Final Determination ( PD 4) which required risk reduction measures to prevent unreasonable adverse effects pending development and submission of additional data needed for improved risk assessment. 2 In 1987, EPA issued a second Notice of Initiation of Special Review of the EBDC pesticides because of health concerns caused by ETU, including potential carcinogenic, developmental and thyroid effects. The Special Review's Preliminary Determination ( PD 2/ 3) was published on December 20, 1989 ( 54 FR 52158) and the Final Determination ( PD 4) on March 2, 1992 ( 57 FR 7484). The Agency concluded that the dietary risks of EBDCs exceeded the benefits for the following food/ feed uses for which one or more of the EBDC pesticides were registered: apricots, carrots, celery, collards, mustard greens, nectarines, peaches, rhubarb, spinach, succulent beans, and turnips. Accordingly, EPA canceled all maneb and other EBDC products registered on the above listed food/ feed crops.

The Maneb Registration Standard dated August 22, 1986 required additional product chemistry data. Addendum No. 1 to the Maneb Registration Standard dated March 31, 1987 included a review of data not available at the time of the original registration standard and required additional product chemistry data. A comprehensive Data Call In ( DCI) was issued April 1, 1987 to all registrants of maneb addressing product chemistry data requirements. The Product Chemistry Chapter of the Maneb Registration Standard Update dated May 13, 1988 included a review of data submitted in response to the April 1987 DCI with regard to adequacy in fulfilling product chemistry requirements. A Guidance Document for maneb was issued in October 1988. Product chemistry data submitted in response to the Guidance Document were reviewed in the Maneb Registration Standard Update dated August 11, 1992, and additional data were required for the registration of maneb.

Uses ° Maneb is used on a wide variety of food/ feed crops, including fruit and nut crops, vegetable crops, field and forage crops, grapes, field crop seeds, and others; ornamental plants in nurseries and greenhouses; and sod farms. There are no residential uses, and no agricultural uses that could result in exposure to maneb in residential settings.

° Approximately 2.5 million pounds of maneb are used annually, mostly on almonds, lettuce, peppers, and walnuts.

° Maneb is not a Restricted Use Pesticide ( RUP) .

Health Effects ° Similar to other EBDCs and ETU, the thyroid is the target organ for maneb. Thyroid effects observed in multiple studies across species include changes in clinical chemistry parameters indicative of thyroid toxicity, increased thyroid weight, follicular ( thyroid) cell hyperplasia, decreased T 4 ( serum thyroxin), and increased incidence of diffuse follicular epithelial hypertrophy/ hyperplasia. Risks 3 ° Acute, chronic, and cancer dietary ( food only) risk from maneb, maneb derived ETU, and ETU from all sources are low and below the Agency's level of concern.

° The drinking water exposure assessment for maneb addresses concentrations of ETU only, since maneb is not expected to remain in drinking water long enough to reach a location that would supply water for human consumption, whether from surface or groundwater sources. Estimated concentrations of ETU, for both surface and ground water sources of drinking water, are low and not of concern.

° There are no currently registered residential uses of maneb. The only potential residential exposure to maneb is from residues remaining on transplanted turf from sod farms. The reduced application rate and/ or extended PHI, combined with the logistics of transplanting turf and installation restrictions, effectively reduced the potential contribution from this use pattern to a level not of concern to the Agency.

° Acute, short term, and chronic ( non cancer) aggregate risks are low and not of concern. Aggregate cancer risk estimates are within a negligible risk range.

° EPA has risk concerns for some workers who mix, load, and/ or apply maneb to agricultural sites and workers who enter treated areas.

° Acute and chronic risks exceed the Agency's level of concern for some terrestrial and aquatic species. Also, there is potential concern for acute and chronic effects on listed terrestrial and aquatic endangered species, should exposure actually occur.

Risk Mitigation To address assessed risks of concern, the following mitigation measures will be implemented:

Maneb All Formulations ° Sweet Corn  Cancel Use ° Grapes  Cancel Use ° Apples  Cancel Use ° Kadota Figs  Cancel Use ° Seed Treatment to Rice and Peanuts  Cancel Use ° Oats Seed Treatment  Reduce maximum application rate from 0.0031lb ai/ lb seed to 0.0021 lb ai/ lb seed ° Almonds Reduce maximum seasonal rate from 25.6 to 19.2 lbs ai/ acre/ season and retain maximum application rate of 6.4 lbs ai/ acre ° Sod Farm Turf  Reduce maximum application rate from 17.4 lbs ai/ acre to 8.7 lbs ai/ acre, limit maximum seasonal rate to 34.8 lbs ai/ acre/ season and add a 3 day preharvest interval. Handlers mixing/ loading of dry flowables and liquids for aerial or chemigation application, add a PF5 Respirator. 4 ° Cut Flowers  Limit number of applications per year to 20 ° Commercial Potato Seed Piece Treatment ( dust)  require engineering controls ( e. g. dust collector equipment)

Maneb Wettable Powder Formulation Only ° Sod Farm Turf  Cancel Use ° Chemigation/ Aerial Applications  Delete Application Method ° For mixing/ loading all remaining uses add PF 5 Respirator.

Regulatory Conclusion The Agency has determined that maneb containing products are eligible for reregistration provided that the risk mitigation measures are adopted and labels are amended to reflect these measures. The following uses of maneb are not eligible for reregistration and are being voluntarily canceled by registrants and deleted from all maneb labels: sweet corn, grapes, apples, kadota figs, and seed treatment use for peanuts and rice.

For More Information Electronic copies of the Maneb RED and all supporting documents are available in the public docket OPP 2005 0178 located on line in the Federal Docket Management System ( FDMS) at http:// www. regulations. gov.

For more information about EPA's pesticide reregistration program, the Maneb RED, or reregistration of individual products containing maneb, please contact the Special Review and Reregistration Division ( 7508C), Office of Pesticide Programs, US EPA, Washington, DC 20460, telephone 703 308 8000.

For information about the health effects of pesticides, or for assistance in recognizing and managing pesticide poisoning symptoms, please contact the National Pesticide Information Center ( NPIC). Call toll free 1 800 858 7378, from 6: 30 am to 4: 30 am Pacific Time, or 9: 30 am to 7: 30 pm Eastern Standard Time, seven days a week. The NPIC internet address is http:// npic. orst. edu.


[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Notices]
[Pages 90843-90848]
[FR Doc No: 2016-30177]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2016-0597; FRL-9954-68]

Chemical Data Reporting; Requirements for Inorganic Byproduct
Chemical Substances; Notice of Intent To Negotiate

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Intent to Establish Negotiated Rulemaking Committee
and Negotiate a Proposed Rule.

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SUMMARY: EPA is giving notice that it intends to establish a Negotiated
Rulemaking Committee under the Federal Advisory Committee Act

(FACA) and the Negotiated Rulemaking Act (NRA). The objective of the
Negotiated Rulemaking Committee will be to negotiate a proposed rule
that would limit chemical data reporting requirements under section
8(a) of the Toxic Substances Control Act (TSCA), as amended by the
Frank. R. Lautenberg Chemical Safety for the 21st Century Act, for
manufacturers of any inorganic byproduct chemical substances, when such
byproduct chemical substances are subsequently recycled, reused, or
reprocessed. The purpose of the Negotiated Rulemaking Committee will be
to conduct discussions in a good faith attempt to reach consensus on
proposed regulatory language. This negotiation process is required by
section 8(a)(6) of TSCA. The Negotiated Rulemaking Committee will
consist of representatives of parties with a definable stake in the
outcome of the proposed requirements.

DATES: Comments must be received on or before January 17, 2017.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2016-0597, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Susan Sharkey, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
(202) 564-8789; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you manufacture
(including manufacture as a byproduct chemical substance) or import
chemical substances listed on the TSCA Inventory. The following list of
North American Industrial Classification System (NAICS) codes are not
intended to be exhaustive, but rather provides a guide to help readers
determine whether this action may apply to them:
     Chemical manufacturers and importers (NAICS codes 325 and
324110; e.g., chemical manufacturing and processing and petroleum
refineries).
     Chemical users and processors who may manufacture a
byproduct chemical substance (NAICS codes 22, 322, 331, and 3344; e.g.,
utilities, paper manufacturing, primary metal manufacturing, and
semiconductor and other electronic component manufacturing).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the technical person listed
under FOR FURTHER INFORMATION CONTACT.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or email. Clearly mark the part or all of
the information that you claim to be CBI. For CBI information in a disk
or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM
as CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

II. Background

A. What action is the Agency taking?

    As required by the Negotiated Rulemaking Act of 1996 (NRA), EPA is
giving notice that the Agency intends to establish a Negotiated
Rulemaking Committee. The objective of this Negotiated Rulemaking
Committee will be to develop a proposed rule providing for limiting
chemical data reporting requirements, under TSCA section 8(a), for
manufacturers of any inorganic byproduct chemical substances, when such
byproduct chemical substances are subsequently recycled, reused, or
reprocessed. This negotiation process, which includes the establishment
of a federal advisory committee, is required by section 8(a)(6) of the
Toxic Substances Control Act (TSCA), as amended by the Frank. R.
Lautenberg Chemical Safety for the 21st Century Act (``Lautenberg
Act'').

B. What is the Agency's authority for this action?

    This notice announcing EPA's intent to establish a Negotiated
Rulemaking Committee to negotiate a proposed regulation was developed
under the authority of sections 563 and 564 of the Negotiated
Rulemaking Act (NRA) (5 U.S.C. 561, Pub. L. 104-320). This Negotiated
Rulemaking Committee will be a statutory committee under the Federal
Advisory Committee Act (FACA) (5 U.S.C. App. 2, section 9(a)(1)). Any
proposed regulation resulting from the negotiation process would be
developed under the authority of TSCA section 8 (15 U.S.C. 2607), as
amended by the Lautenberg Act (Pub. L. 114-182).

III. Negotiated Rulemaking

A. Why is the Agency pursuing a negotiated rulemaking?

    In the Lautenberg Act, Congress mandated that EPA undertake a
negotiation process, pursuant to the NRA, aimed at developing a rule to
limit TSCA section 8(a) chemical data reporting requirements for
manufacturers of any inorganic byproduct chemical substances, when such
byproduct chemical substances are subsequently recycled, reused, or
reprocessed.
    EPA sees potential benefits from undertaking this negotiated
rulemaking process. A regulatory negotiation process will allow EPA to
engage directly with informed, interested, and affected parties, all of
whom are working together to resolve their differences. Because a
negotiating committee includes representatives from the major
stakeholder groups affected by or interested in the rule, the number of
public comments on any proposed rule may be reduced and those comments
that are received may be more moderate. EPA anticipates that few
substantive changes would be

needed to any proposed rule resulting from the negotiated rulemaking
process. Finally, EPA recognizes an observation of the Administrative
Conference of the United States: ``Experience indicates that if the
parties in interest were to work together to negotiate the text of a
proposed rule, they might be able in some circumstances to identify the
major issues, gauge their importance to the respective parties,
identify the information and data necessary to resolve the issues, and
develop a rule that is acceptable to the respective interests, all
within the contours of the substantive statute.'' ACUS Recommendation
82-4.

B. What is the concept of negotiated rulemaking?

    Negotiated rulemaking is a process in which a proposed rule is
developed by a committee composed of representatives of all those
interests that will be significantly affected by the rule. Decisions
are made by consensus, which the NRA defines as the unanimous
concurrence among interests represented on a Negotiated Rulemaking
Committee, unless the Negotiated Rulemaking Committee itself
unanimously agrees to use a different definition. To start the process,
the Agency identifies all interests potentially affected by the
rulemaking under consideration. To help in this identification process,
the Agency publishes a notice in the Federal Register, such as this
one, which identifies a preliminary list of interests and requests
public comment on that list. Following receipt of the comments, the
Agency establishes a committee representing these various interests to
negotiate a consensus on the terms of a proposed rule. Representation
on the Negotiated Rulemaking Committee may be direct, that is, each
member represents a specific interest, or may be indirect, through
coalitions of parties formed for this purpose. The Agency is a member
of the Negotiated Rulemaking Committee representing the Federal
government's own set of interests. The Negotiated Rulemaking Committee
is facilitated by a trained mediator, who facilitates the negotiation
process. The role of this mediator, or facilitator, is to apply proven
consensus building techniques to the advisory committee setting.
    If a regulatory negotiation advisory committee reaches consensus on
the provisions of a proposed rule, the Agency, consistent with its
legal obligations, would use such consensus as the basis of a proposed
rule, to be published in the Federal Register. This provides the
required public notice and allows for a public comment period. All
participants and interested parties would retain their rights to
comment and to seek judicial review. EPA anticipates, however, that any
preproposal consensus agreed upon by this Negotiated Rulemaking
Committee would effectively address all major issues prior to
publication of a proposed rulemaking.

C. What is the Agency commitment?

    In initiating this regulatory negotiation process, EPA is making a
commitment to provide adequate resources to ensure timely and
successful completion of the process. This commitment includes making
the process a priority activity for all representatives, components,
officials, and personnel of the Agency who need to be involved in the
rulemaking, from the time of initiation until such time as a final rule
is issued or the process is expressly terminated. EPA will provide
administrative support for the process and will take steps to ensure
that the Negotiated Rulemaking Committee has the dedicated resources it
requires to complete its work in a timely fashion. These include the
provision or procurement of such support services as: Properly equipped
space adequate for public meetings and caucuses; logistical support;
distribution of background information; the service of a facilitator;
and such additional research and other technical assistance as may be
necessary. If there is consensus within the Negotiated Rulemaking
Committee, EPA will use the consensus to the maximum extent possible,
consistent with the legal obligations of the Agency, as the basis for a
rule proposed by the Agency for public notice and comment. The Agency
is committed to working in good faith to seek consensus on a proposal
that is consistent with the legal mandate of TSCA.

D. What is the negotiating consensus?

    A key principle of negotiated rulemaking is that agreement is by
consensus of all the interests. Thus, no one interest or group of
interests is able to control the process. Again, the NRA defines
consensus as the unanimous concurrence among interests represented on a
Negotiated Rulemaking Committee, unless the Negotiated Rulemaking
Committee itself unanimously agrees to use a different definition. In
addition, experience has demonstrated that using a trained mediator to
facilitate this process will assist all potential parties, including
EPA, to identify their interests in the rule and so to be able to
reevaluate previously stated positions on issues involved in this
rulemaking effort.

IV. Chemical Data Reporting for Inorganic Byproduct Chemical Substances

A. Chemical Data Reporting (CDR) Framework

    Under TSCA, EPA regulates the manufacture, processing,
distribution, use, and disposal of chemical substances in the United
States. The TSCA Inventory of Chemical Substances (TSCA Inventory)
lists the chemical substances which are manufactured or processed in
the United States (also called ``existing chemical substances'').
Chemical substances not on the TSCA Inventory are known as ``new
chemical substances'' and are required to be reviewed through EPA's new
chemical program (under TSCA section 5) prior to the commencement of
manufacture or processing. There are over 85,000 chemical substances
listed on the TSCA Inventory.
    In 1986, EPA created the Inventory Update Reporting (IUR)
regulation under TSCA section 8 to collect, every four years, limited
information on the manufacture (which includes import) of organic
chemical substances listed on the TSCA Inventory, thereby providing
more up-to-date production volume information on the chemical
substances in U.S. commerce. In 2005, EPA amended the IUR to require
the reporting of information on inorganic chemical substances and to
collect additional manufacturing, processing, and use information. EPA
has since made additional changes to the reporting requirements, and in
2011 changed the name of the reporting rule to Chemical Data Reporting.
CDR regulations are currently codified at 40 CFR part 711. EPA believes
CDR is the only current reporting obligation under TSCA section 8(a)
that is likely to affect the manufacturers of inorganic byproduct
chemical substances. Information collected under CDR is used to support
Agency programs, providing exposure-related data for chemical
substances subject to TSCA in U.S. commerce. This information is also
made publicly available, to the extent possible while continuing to
protect submitted information claimed as confidential business
information.
    Manufacturers of inorganic chemical substances first reported under
the IUR in 2006. They also reported under the CDR in 2012 and 2016.
Specific reporting requirements for these manufacturers were phased in,
to allow for the industry to better understand the reporting
requirements and for EPA to

gain a better understanding of the industry. In recent years, the
regulatory requirement to report byproduct chemical substances (and the
availability of exemptions from that requirement) has been a frequent
topic of discussion.

B. Inorganic Byproduct Chemical Substances Under CDR

    A byproduct chemical substance is a chemical substance produced
without a separate commercial intent during the manufacture,
processing, use, or disposal of another chemical substance or mixture.
Such byproduct chemical substances may, or may not, in themselves have
commercial value. They are nonetheless produced for the purpose of
obtaining a commercial advantage. Because byproduct chemical substances
are manufactured for a commercial purpose, such manufacturing is
reportable under CDR unless covered by a specific reporting exemption.
CDR contains a specific reporting exemption for the manufacture of
byproduct chemical substances, limited to cases where those byproduct
chemical substances are not used for any commercial purposes (or are
only used for certain limited commercial purposes) after they are
manufactured. 40 CFR 711.10(c). Inorganic byproduct chemical substances
are often recycled. The recycling of a byproduct chemical substance may
qualify as a commercial purpose beyond the limited commercial purposes
encompassed by 40 CFR 711.10(c). If so, then the CDR exemption for the
manufacturer of a byproduct chemical substance is unavailable.
    Beginning in 2006, EPA became aware of a variety of questions
raised by the manufacturers of inorganic byproduct chemical substances
about their obligations to report their manufacture of those byproduct
chemical substances. EPA has since provided detailed guidance to
address a variety of questions that have been raised. See 75 FR 49675-6
(2010); 76 FR 50832-3, 50849-50851 (2011). In 2011, EPA also stated
that it would examine CDR information related to byproduct chemical
substances to identify whether there are segments of byproduct chemical
substance manufacturing for which EPA can determine that there is no
need for the CDR information to continue to be collected, either for
2016 or for future reporting cycles. 76 FR 50832-3 (2011). EPA did not
amend the CDR requirements for the 2016 reporting cycle. Documents
providing information to assist inorganic byproduct chemical substance
manufacturers with reporting under CDR requirements include:
Instructions for the 2016 TSCA CDR (Ref. 1); CDR Byproduct and
Recycling Scenarios (Ref. 2); TSCA CDR Fact Sheet for the Printed
Circuit Board Industry (Ref. 3); and TSCA CDR Fact Sheet for Reporting
Manufactured Chemical Substances from Metal Mining and Related
Activities (Ref. 4).
    On June 22, 2016, TSCA was amended by the Lautenberg Act. TSCA now
includes a requirement that EPA enter into a negotiated rulemaking,
pursuant to the NRA, to develop and publish a proposed rule to limit
the reporting requirements under TSCA section 8(a), for manufacturers
of any inorganic byproduct chemical substances, when such byproduct
chemical substances, whether by the byproduct chemical substance
manufacturer or by any other person, are subsequently recycled, reused,
or reprocessed. The objective of the negotiated rulemaking process is
to develop and publish a proposed rule by June 22, 2019. In the event a
proposed rule is developed through the negotiated rulemaking process, a
final rule ``resulting from such negotiated rulemaking'' must be issued
by December 22, 2019. 15 U.S.C. 2607(a)(6).
    EPA construes its obligation to propose and finalize a rule under
TSCA section 8(a)(6) as being contingent on the Negotiated Rulemaking
Committee reaching a consensus. EPA's interpretation is based on
several factors. First, TSCA section 8(a)(6)(A) does not give any
direction on how CDR reporting requirements for the specified byproduct
chemical substance manufacturers should be limited, other than
directing that the particular limitations should be negotiated. Second,
EPA's obligation to finalize a rule under TSCA section 8(a)(6)(B)
presupposes that such rule would be one ``resulting from such
negotiated rulemaking.'' While EPA would have authority to issue an
amendment to the CDR even if negotiation failed to achieve a consensus,
such a rule would not be a rule resulting from the negotiated
rulemaking. Accordingly, TSCA section 8(a)(6)(B) presupposes that the
negotiated rulemaking process reached a consensus in directing EPA to
issue a final rule. If the obligation to issue a final rule is so
contingent, then it stands to reason that the prior obligation to issue
a proposal is similarly contingent. Third, the time allotted for
issuing a final rule (i.e., six months) is relatively short, consistent
with a presupposition that the proposal in question would be the
product of a successful negotiation. As noted in Unit III., the process
of responding to comment on a proposal would likely be simplified if
that proposal is itself the result of a previously negotiated
consensus. For the reasons described above, if consensus cannot be
reached, and there is no agreement upon which to base a proposal, then
there is no further statutory obligation to issue a proposal or a final
rule.

V. Proposed Negotiating Procedures

A. Interests Involved

    Section 562 of the NRA defines the term ``interest'' as one of
``multiple parties which have a similar point of view or which are
likely to be affected in a similar manner.'' We anticipate that the
following key interests are likely to be significantly affected by the
rule to be addressed by the Negotiated Rulemaking Committee while
negotiating how to limit CDR requirements for manufacturers of any
inorganic byproduct chemical substances, when such byproduct chemical
substances are subsequently recycled, reused, or reprocessed:
    [ssquf] Inorganic chemical manufacturers and processors, including
metal mining and related activities;
    [ssquf] Recyclers, including scrap recyclers;
    [ssquf] Industry advocacy groups;
    [ssquf] Environmental advocacy groups;
    [ssquf] Federal, State, or Tribal governments; and
    [ssquf] Employee advocacy groups, such as labor unions.

B. Negotiated Rulemaking Committee Formation

    The Negotiated Rulemaking Committee will be formed and operated in
full compliance with the requirements of FACA in a manner consistent
with the requirements of the NRA.

C. Negotiated Rulemaking Committee Membership

    The Agency intends to conduct the negotiated rulemaking proceedings
with particular attention to ensuring full and adequate representation
of those interests that may be significantly affected by a rule
providing for limiting CDR requirements for inorganic byproduct
chemical substances. We have listed those interests likely to be
significantly affected by a rule in Unit V.A., and the following list
identifies the parties that the Agency has initially identified as
representing interests likely to be significantly affected by a rule:

 Aluminum Association
 American Chemistry Council
 American Coal Ash Association

 Environmental Defense Fund
 Institute of Scrap Recycling Industries
 IPC--Association Connecting Electronics Industries
 North American Metals Council
 National Mining Association
 U.S. Environmental Protection Agency
 Utility Solid Waste Activities Group

    The listed parties have been preliminarily identified by EPA as
being either a potential member of the Negotiated Rulemaking Committee,
or a potential member of a coalition that would in turn nominate a
candidate to represent one of the significantly affected interests
listed in Unit V.A. This list is not presented as a complete or
exclusive list from which Negotiated Rulemaking Committee members will
be selected, nor does inclusion on the list mean that a party on the
list has agreed to participate as a member of the Negotiated Rulemaking
Committee or as a member of a coalition. This list merely indicates
those parties that represent interests that EPA has tentatively
identified as being significantly affected by a rule providing for
limiting CDR requirements for inorganic byproduct chemical substances.
    EPA anticipates that the Negotiated Rulemaking Committee will be
comprised of approximately 10-25 members representing significantly
affected interests. The EPA Administrator will select members carefully
to ensure that there is a balanced representation of such interests on
the Negotiated Rulemaking Committee. EPA anticipates that the
Negotiated Rulemaking Committee will contain representatives from
industry, environmental groups, and state, local, and tribal
governments.
    One purpose of this document is to determine whether the negotiated
rulemaking will significantly affect interests that are not listed in
Unit V.A., as well as whether the list of parties the Agency has listed
identifies accurately and comprehensively a group of stakeholders
representing the significantly affected interests listed in Unit V.A.
EPA requests comment and suggestions on the list of significantly
affected interests, as well as the list of proposed representatives of
those interests. EPA recognizes that any regulatory actions it takes
under this program may at times affect various segments of society in
different ways, and that this may in some cases produce unique
interests in a rule based on demographic factors. Particular attention
will be given by the Agency to ensure that any unique interests that
have been identified in this regard, and that may be significantly
affected by any rule resulting from the negotiation, are represented.
    This document affords potential participants the opportunity to
request representation in the negotiations. Request such representation
by submitting a comment as described under ADDRESSES in this notice.
    Section 565(b) of the NRA requires the Agency to limit membership
on a Negotiated Rulemaking Committee to 25 members, unless the Agency
determines that more members are necessary in order for the Negotiated
Rulemaking Committee to function or to achieve balanced membership. The
Agency believes that the negotiating group should not exceed 25
members, which would make it difficult to conduct effective
negotiations. EPA is aware that there are many more than 25 potential
participants to consider for the Negotiated Rulemaking Committee. The
Agency does not believe, nor does the NRA contemplate, that each
significantly affected interest must participate directly in the
negotiations; however, each significantly affected interest can be
adequately represented. To have a successful negotiation, it is
important for significantly affected interests to identify and form
coalitions that adequately represent those interests. These coalitions,
to provide adequate representation, must agree to support, both
financially and technically, a member to the Negotiated Rulemaking
Committee whom they will choose to represent their interest. The Agency
believes it is very important to recognize that interested parties who
are not selected to membership on the Negotiated Rulemaking Committee
can still make valuable contributions to this negotiated rulemaking
effort in any of several ways:
     The party could request to be placed on the Negotiated
Rulemaking Committee mailing list, submitting written comments, as
appropriate;
     The party could attend the Negotiated Rulemaking Committee
meetings, which are open to the public, caucus with his or her
interest's member on the Negotiated Rulemaking Committee, or even
address the Negotiated Rulemaking Committee (usually allowed at the end
of an issue's discussion or the end of the session, as time permits);
or
     The party could assist a workgroup that might be
established by the Negotiated Rulemaking Committee.
    An advisory committee may convene informal workgroups to assist the
Negotiated Rulemaking Committee in ``staffing'' various discrete and
technical matters (e.g., researching or preparing summaries of the
technical literature or comments on particular matters such as economic
issues) so as to facilitate Negotiated Rulemaking Committee
deliberations. They also might assist in estimating costs and drafting
regulatory text on issues associated with the analysis of the
affordability and benefits addressed, and formulating drafts of the
various provisions and their justification previously developed by the
Negotiated Rulemaking Committee. Given their staffing function,
workgroups usually consist of participants who have expertise or
particular interest in the technical matter(s) being studied. Because
it recognizes the importance of this staffing work for the Negotiated
Rulemaking Committee, EPA will provide appropriate administrative and
technical expertise for such workgroups.
    EPA requests comment regarding particular appointments to
membership on the Negotiated Rulemaking Committee. Members can be
individuals or organizations. If the effort is to be successful,
participants should be able to fully and adequately represent the
viewpoints of their respective interests. Those who wish to be
appointed as members of the Negotiated Rulemaking Committee should
submit a request to EPA by submitting a comment as described under
ADDRESSES in this notice. The list of potential Negotiated Rulemaking
Committee members provided earlier in this document includes those who
have been initially identified by EPA as being either a potential
member of the Negotiated Rulemaking Committee, or a potential member of
a coalition that would in turn nominate a candidate to represent one of
the significantly affected interests on the Negotiated Rulemaking
Committee.
    EPA values and welcomes diversity. In an effort to obtain
nominations of diverse candidates, EPA encourages nominations of women
and men of all racial and ethnic groups.

D. Good Faith Negotiation

    Negotiated Rulemaking Committee members should be willing to
negotiate in good faith and have the authority, from her or his
constituency, to do so. The first step is to ensure that each member
has good communications with her or his constituencies. An intra-
interest network of communication should be established to bring
information from the support organization to the member at the table,
and to take information from the table back to the support
organization. Second, each organization or coalition should, therefore,
designate as its

representative an official with credibility and authority to insure
that needed information is provided and decisions are made in a timely
fashion.
    Negotiated rulemaking efforts can require a very significant
contribution of time by the appointed members. The convening meeting of
the Negotiated Rulemaking Committee is expected to be held in March
2017, and the work of the Negotiated Rulemaking Committee is expected
to conclude approximately in September 2017.
    Other qualities that can be very helpful are negotiating experience
and skills, as well as sufficient technical knowledge to participate in
substantive negotiations. Certain concepts are central to negotiating
in good faith. One is the willingness to bring key issues to the
bargaining table in an attempt to reach a consensus, instead of keeping
issues in reserve. The second is a willingness to keep the issues at
the table and not take them to other forums. Finally, good faith
includes a willingness to move away from the type of positions usually
taken in a more traditional rulemaking process, and instead explore
openly with other parties all ideas that may emerge from the
discussions of the Negotiated Rulemaking Committee.

E. Facilitator

    The facilitator will not be involved with the substantive
development of any proposed rule. Rather, the facilitator's role
generally includes facilitating the meetings of the Negotiated
Rulemaking Committee in an impartial manner and impartially assisting
the members of the Negotiated Rulemaking Committee in conducting
discussions and negotiations.

F. EPA Representative

    The EPA representative will be a full and active participant in the
consensus building negotiations. The Agency's representative will meet
regularly with various senior Agency officials, briefing them on the
negotiations and receiving their suggestions and advice, in order to
effectively represent the Agency's views regarding the issues before
the Negotiated Rulemaking Committee. EPA's representative also will
ensure that the entire spectrum of federal governmental interests
affected by the rulemaking, including the Office of Management and
Budget (OMB) and other Departments and agencies, are kept informed of
the negotiations and encouraged to make their concerns known in a
timely fashion.

VI. Comments Requested

    EPA requests comment on the extent to which the issues, interests,
Negotiated Rulemaking Committee representatives, and procedures
described in this document are adequate and appropriate.

VII. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents referenced
within the documents that are included in the docket, even if the
referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. EPA (2016). Instructions for Reporting 2016 TSCA CDR, https://www.epa.gov/sites/production/files/2016-05/documents/instructions_for_reporting_2016_tsca_cdr_13may2016.pdf. Retrieved
October 21, 2016.
2. EPA (2012). CDR Byproduct and Recycling Scenarios, https://www.epa.gov/sites/production/files/documents/2012_cdr_byproducts_scenaros_0.pdf. Retrieved October 21, 2016.
3. EPA (2016). TSCA CDR Fact Sheet: Byproducts Reporting for the
Printed Circuit Board Industry, https://www.epa.gov/sites/production/files/2016-02/documents/final_cdr_fact_sheet_printed_circuit_board_2_22_16.pdf. Retrieved
October 21, 2016.
4. EPA (2016). TSCA CDR Fact Sheet: Reporting Manufactured Chemical
Substances from Metal Mining and Related Activities, https://www.epa.gov/sites/production/files/2016-05/documents/cdr_fact_sheet_metal_mining_5may2016.pdf. Retrieved October 21,
2016.

    Authority:  15 U.S.C. 2601 et seq.

    Dated: December 7, 2016.
Jim Jones,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2016-30177 Filed 12-14-16; 8:45 am]
 BILLING CODE 6560-50-P