Procedures for Rulemaking Under Section 6 of the Toxic Substances Control Act; Amendment, 93633-93636 [2016-30055]
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93633
Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations
classifications, Intergovernmental
relations, Nitrogen oxides, Ozone,
Reporting and recordkeeping
requirements, Volatile organic
compounds.
2. Section 52.1885 is amended by
adding paragraph (pp)(2) to read as
follows:
■
§ 52.1885
Control strategy: Ozone.
*
Dated: December 5, 2016.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
Parts 52 and 81, chapter I, title 40 of
the Code of Federal Regulations is
amended as follows:
PART 52—APPROVAL AND
PROMULGATION OF
IMPLEMENTATION PLANS
1. The authority citation for part 52
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
*
*
*
*
(pp) * * *
(2) Approval—On June 16, 2016, the
Ohio Environmental Protection Agency
submitted a request to redesignate the
Columbus area to attainment of the 2008
ozone NAAQS. As part of the
redesignation request, the State
submitted a maintenance plan as
required by section 175A of the Clean
Air Act. Elements of the section 175
maintenance plan include a contingency
plan and an obligation to submit a
subsequent maintenance plan revision
in eight years as required by the Clean
Air Act. The 2020 motor vehicle
emissions budgets for the Columbus
area are 50.66 tons per summer day
(TPSD) for VOC and 90.54 TPSD for
NOX. The 2030 motor vehicle emissions
budgets for the Columbus area are 44.31
TPSD for VOC and 85.13 TPSD for NOX.
PART 81—DESIGNATION OF AREAS
FOR AIR QUALITY PLANNING
PURPOSES
3. The authority citation for part 81
continues to read as follows:
■
Authority: 42 U.S.C. 7401 et seq.
4. Section 81.336 is amended by
revising the entry for Columbus, OH in
the table entitled ‘‘Ohio—2008 8-Hour
Ozone NAAQS (Primary and
secondary)’’ to read as follows:
■
§ 81.336
*
*
Ohio.
*
*
*
OHIO—2008—8-HOUR OZONE NAAQS
[Primary and secondary]
Designation
Classification
Designated area
Date 1
*
*
Columbus, OH: 2 Delaware County, Fairfield
County, Franklin County, Knox County,
Licking County, Madison County.
*
1 This
*
Type
*
*
December 21, 2016 ... Attainment.
*
Date 1
Type
*
*
*
*
*
*
*
date is July 20, 2012, unless otherwise noted.
Indian country located in each area, unless otherwise noted.
2 Excludes
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[FR Doc. 2016–30470 Filed 12–20–16; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 750
[HQ–OPPT–2016–0525; FRL–9955–15]
RIN 2070–AK28
Procedures for Rulemaking Under
Section 6 of the Toxic Substances
Control Act; Amendment
Environmental Protection
Agency (EPA).
ACTION: Final rule.
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AGENCY:
Section 6 of the Toxic
Substances Control Act (TSCA) provides
EPA with several authorities for
addressing risks from chemical
substances and includes procedures that
EPA must follow in doing so. EPA
promulgated regulations shortly after
TSCA was enacted to implement the
procedural requirements for rulemaking
SUMMARY:
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under TSCA section 6 as they existed at
that time. TSCA was recently amended
by the Frank R. Lautenberg Chemical
Safety for the 21st Century Act. This
final rule removes the regulations
specifying certain procedural
requirements for rulemaking under
TSCA section 6, including the
requirement for a hearing, because
TSCA, as amended, no longer mandates
those procedures.
DATES: This final rule is effective
December 21, 2016.
FOR FURTHER INFORMATION CONTACT:
Cindy Wheeler, Chemical Control
Division, Office of Pollution Prevention
and Toxics, Environmental Protection
Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460–0001; telephone
number: (202) 566–0484; email address:
wheeler.cindy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What is the agency’s authority for
taking this action?
The authority for this action is TSCA
section 6, as amended by the Frank R.
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Lautenberg Chemical Safety for the 21st
Century Act (15 U.S.C. 2605).
Section 553 of the Administrative
Procedure Act (APA), 5 U.S.C.
553(b)(3)(A), provides that ‘‘rules of
agency organization, procedure, or
practice’’ are exempt from notice and
comment requirements. This action
involves revisions to the rules that set
out the general rulemaking procedure
for EPA under the prior version of
TSCA, and the action does not affect the
substance of any determinations EPA
will make under the amended TSCA
section 6. Accordingly, these revisions
fall under the exemption provided in
APA section 553(b)(3)(A), and the EPA
is not taking comment on this action.
B. Does this action apply to me?
This action affects only Agency
procedure in future rulemakings under
TSCA section 6 and has no particular
applicability to the public. If you have
any questions regarding the
applicability of this action, consult the
person listed under FOR FURTHER
INFORMATION CONTACT.
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II. Background
A. What action is the agency taking?
This action removes 40 CFR part 750,
subpart A (the general procedural
requirements for rulemaking under
TSCA section 6, including the
requirement for a hearing). Subpart A
detailed hearing-related procedures as
well as the content and timing of EPA’s
notices and the Agency’s record. This
action also removes the similar
provisions from the procedural rules in
subparts B and C for exemptions from
the prohibitions in TSCA section 6(e)
applicable to polychlorinated biphenyls.
TSCA, enacted in 1976, was intended
to provide EPA with the tools necessary
to develop information and manage
risks associated with chemicals in
commerce. TSCA section 6(a) requires
EPA to take action to address
unreasonable risks that EPA determines
are presented by chemical substances or
mixtures. Under TSCA section 6 as
enacted in 1976, if EPA had a
reasonable basis to conclude that the
manufacture (including import),
processing, distribution in commerce,
use, or disposal of a chemical substance
or mixture presented an unreasonable
risk of injury to health or the
environment, EPA would have to by
rule apply requirements to the
substance or mixture to the extent
necessary to address the unreasonable
risk using the least burdensome
requirement. These requirements could
include prohibitions or limitations on
manufacturing processing, distribution
in commerce, commercial use, or
disposal; marking (labeling)
requirements; and recordkeeping
requirements. This section of TSCA also
established certain procedures that EPA
would have to follow in promulgating
such rules. As enacted in 1976, TSCA
section 6(c) required, among other
things, that EPA provide the
opportunity for an informal hearing and
that EPA make certain findings and
publish certain statements.
EPA published final procedural
regulations to implement the TSCA
section 6 procedural requirements
shortly thereafter in the Federal
Register of December 2, 1977, (42 FR
61259). These procedural regulations,
codified as 40 CFR part 750, are quite
detailed with respect to the contents of
Notices of Proposed Rulemaking,
hearing procedures, the handling of
public comments, and docketing of
comments and other supporting
materials. These procedural
requirements for rulemaking under
TSCA section 6 have been amended
several times, most notably in 1978 to
add interim procedural rules for filing
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and processing petitions for exemptions
from the TSCA section 6(e) ban on the
manufacture of polychlorinated
biphenyls (PCBs) (43 FR 50905,
November 1, 1978), and in 1979 to add
similar rules for petitions for
exemptions from the TSCA section 6(e)
bans on PCB processing and distribution
in commerce (44 FR 31558, May 31,
1979).
On June 22, 2016, the President
signed the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act into law. This legislation amends
many sections of TSCA, including
TSCA section 6. While the new law still
directs EPA to take action against
unreasonable risks presented by
chemical substances or mixtures, EPA’s
duties under TSCA section 6 have been
significantly modified to include
specific deadlines and procedures for
prioritizing chemicals for risk
evaluations, conducting the risk
evaluations and promulgating
regulations to address unreasonable
risks that are identified. Notably, once
unreasonable risks have been identified
through a risk evaluation, TSCA section
6(c)(1) now requires EPA to issue a
proposed rule to address the risks no
later than one year after the final risk
evaluation is published, and the final
rule must be issued no later than two
years after the final risk evaluation is
published, subject to the limited
extension authorized by TSCA section
6(c)(1)(C).
After reviewing 40 CFR part 750 in
light of the amendments to TSCA, EPA
has determined that the procedural
regulations in subpart A do not facilitate
the efficient administrative process
envisioned by the Frank R. Lautenberg
Chemical Safety for the 21st Century
Act. Subpart A was principally
promulgated to provide further details
related to the informal hearing process
under TSCA as originally enacted.
However, with the statutory
amendments’ removal of the informal
hearing requirement and addition of
ambitious deadlines for action under
section 6, subpart A is particularly
outdated and no longer designed for
effective implementation of section 6.
To the extent subpart A simply reflected
administrative requirements of TSCA
and the Administrative Procedure Act,
the current version of TSCA and the
Administrative Procedure Act will
continue to apply on their own terms,
and section 6 of TSCA as amended
prescribes considerably more procedure
than the previous version of TSCA. To
the extent subpart A goes beyond the
current statutory requirements of such
law, EPA believes that the layering of
additional procedural requirements by
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regulation is both unnecessary to ensure
a transparent rulemaking process with
robust public participation and not
well-suited to the rapid throughput
required by the law. EPA also believes
the requirements are in some respects
outdated with respect to current
technology. The remainder of this notice
elaborates on these points.
First, regarding the hearing-related
provisions of 40 CFR part 750, TSCA
section 6, as amended, no longer
requires EPA to provide an opportunity
for an informal hearing on a proposed
rule. After TSCA was amended on June
22, 2016 and before this final rule, 40
CFR part 750 inaccurately referred to
‘‘the informal hearing required by
section 6(c)(2)(C) of TSCA’’ when, in
fact, TSCA section 6 no longer requires
EPA to provide an opportunity for
informal hearing and TSCA section
6(c)(2)(C) in particular now refers to
another topic. Given that EPA is no
longer required to provide an
opportunity for an informal hearing on
a proposed rule under TSCA section 6,
and that the statutory citations in the
hearing-related regulations are no longer
correct, much of 40 CFR part 750 is no
longer needed or appropriate.
Moreover, by establishing a two-year
deadline for final rules after
unreasonable risks are identified
through risk evaluation, Congress
expressed an intention for EPA to move
relatively quickly to address
unreasonable risks. Although Congress
also established a limited process by
which EPA could extend this deadline,
EPA does not believe that Congress
intended for extended deadlines to be a
routine occurrence. The cumbersome
nature of the informal hearing-related
provisions established in 40 CFR part
750 would make it difficult for EPA to
meet the newly-established rulemaking
deadlines.
Yet EPA does not interpret the
removal of the hearing requirement as
an indication that reduced public input
is desired. To the contrary, the amended
TSCA section 6 specifically requires
public comment periods at several
stages during the chemical
prioritization, risk evaluation, and risk
management processes. EPA interprets
the removal of the informal hearing
requirement as being motivated by
Congressional intent to simplify and
thereby quicken the pace of TSCA
section 6 rulemaking, considering the
establishment of new rulemaking
deadlines and the manner in which the
tools for managing EPA’s administrative
rulemaking process have evolved over
the 40 years since TSCA was enacted
(e.g., the advent of electronic
commenting). Under the Administrative
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Procedure Act (5 U.S.C. 553), EPA must
give interested persons an opportunity
to participate in a legislative rulemaking
by submitting written comments. In
addition, for existing chemicals under
TSCA, EPA often holds public meetings
in order to solicit oral comments as well
as written comments.
Next, while EPA must still consider
and publish a statement on certain
factors when promulgating a rule under
TSCA section 6(a), the factors have
changed. For example, TSCA section
6(c) as originally enacted required EPA
to consider and publish a statement
with respect to the availability of
substitutes for various uses of a
chemical substance or mixture. TSCA
section 6(c) as amended requires EPA
to, in deciding whether to prohibit or
restrict a chemical substance or mixture
in a manner that substantially prevents
a specific condition of use, and in
setting an appropriate transition period
for such chemical substance or mixture,
consider, to the extent practicable,
whether technically and economically
feasible alternatives that benefit health
or the environment will be reasonably
available as a substitute when the
proposed prohibition or other restriction
takes effect. Therefore, EPA is removing
the outdated specification of the content
and timing of EPA notices in 40 CFR
part 750, subpart A, and instead EPA’s
notices in future section 6 rulemakings
will conform to TSCA as amended.
As EPA noted in 1987 (52 FR 23054),
the initiation of a section 6 proceeding
could be by proposed rule, advance
notice of proposed rulemaking, or notice
of other appropriate action. The agency
is not changing its position on this
matter by removing 40 CFR 750.2(a). As
the agency stated previously, ‘‘Federal
courts have acknowledged that
rulemaking commences before the
publication of a notice of proposed
rulemaking. See, for example, Natural
Resources Defense Council v. EPA, 595
F. Supp. 1255 (S.D.N.Y. 1984), where
the court found that EPA may use an
ANPR to initiate a rulemaking
proceeding under section 4 of TSCA.’’
Therefore, the provision regarding when
a proceeding begins does not need to be
codified in the CFR.
Lastly, modern electronic tools and
remote conferencing were not available
when TSCA was enacted nor when
procedural requirements under 40 CFR
part 750 regarding Agency records were
promulgated by EPA. EPA believes that
it is now reasonable and prudent to use
its information resources, including
information technology, to establish an
electronic record to contain rulemaking
documents being considered and public
comments submitted, a possibility not
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anticipated by the outdated record
provisions. Consistent with TSCA
section 2’s expression of Congressional
intent that EPA carry out TSCA in a
reasonable and prudent manner, and in
consideration of the environmental,
economic, and social impacts that any
action taken under TSCA may have, (15
U.S.C. 2601), electronic correspondence
can reduce burden and costs for the
regulated entities by eliminating the
costs associated with printing and
mailing documents, and traveling to
hearings, while at the same time
improving EPA’s efficiency in reviewing
public comments, making decisions,
and disseminating information to the
public.
Therefore, after considering the points
discussed earlier in this notice, EPA is
removing the general TSCA section 6
procedural requirements contained in
subpart A of 40 CFR part 750. EPA is
not making any changes to the
procedures contained in subparts B and
C of 40 CFR part 750 for petitions for
exemptions from the prohibitions in
TSCA section 6(e), other than to remove
references to the informal hearingrelated procedures as well as the
content and timing of EPA’s notices and
the Agency’s record corresponding to
the removal of subpart A.
III. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www2.epa.gov/lawsregulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulation and
Regulatory Review
This action is not a significant
regulatory action and was therefore not
submitted to the Office of Management
and Budget (OMB) for review under
Executive Orders 12866 (58 FR 51735,
October 4, 1993) and 13563 (76 FR 3821,
January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not contain any
information collection activities that
require approval under the PRA, 44
U.S.C. 3501 et seq. This rulemaking
removes unnecessary internal EPA
procedures and does not impose any
requirements on the public.
C. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA,
5 U.S.C. 601 et seq. The RFA applies
only to rules subject to notice and
comment rulemaking requirements
under the APA, 5 U.S.C. 553, or any
other statute.
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93635
D. Unfunded Mandates Reform Act
This action does not contain any
unfunded mandate as described in
UMRA, 2 U.S.C. 1531–1538, and does
not significantly or uniquely affect small
governments. This action imposes no
enforceable duty on any state, local or
tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism
implications as specified in Executive
Order 13132 (64 FR 43255, August 10,
1999). It will not have substantial direct
effects on the states, on the relationship
between the national government and
the states, or on the distribution of
power and responsibilities among the
various levels of government.
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action does not have tribal
implications as specified in Executive
Order 13175 (65 FR 67249, November 9,
2000), because it merely removes
procedural requirements that the
Agency must follow when conducting
rulemaking under TSCA section 6.
Thus, Executive Order 13175 does not
apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
EPA interprets Executive Order 13045
(62 FR 19885, April 23, 1997), as
applying only to those regulatory
actions that concern environmental
health or safety risks that the EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not
subject to Executive Order 13045
because it does not concern an
environmental health risk or safety risk.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because it is not a significant
regulatory action under Executive Order
12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
This rulemaking does not involve any
technical standards, and is therefore not
subject to considerations under NTTAA
section 12(d), 15 U.S.C. 272 note.
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EPA proposes to take on the exemption
petitions.
apply the two standards enunciated in
TSCA section 6(e)(3)(B).
§§ 750.14 and 750.15
J. Executive Order 12898: Federal
Actions To Address Environmental
Justice in Minority Populations and
Low-Income Populations
[FR Doc. 2016–30055 Filed 12–20–16; 8:45 am]
[Removed]
5. Remove §§ 750.14 and 750.15.
This action does not establish an
environmental health or safety standard,
and is therefore not is not subject to
environmental justice considerations
under Executive Order 12898 (59 FR
7629, February 16, 1994), because it
does not establish an environmental
health or safety standard. This
regulatory action is a procedural change
and does not have any impact on human
health or the environment.
■
K. Congressional Review Act (CRA)
§ 750.15
This rule is exempt from the CRA (5
U.S.C. 801 et seq.) because it is a rule
of agency organization, procedure or
practice that does not substantially
affect the rights or obligations of nonagency parties.
(a) [Reserved]
(b) EPA will grant or deny petitions
under TSCA section 6(e)(3)(B)
submitted pursuant to § 750.11.
(c) In determining whether to grant an
exemption to the PCB ban, the Agency
shall apply the two standards
enunciated in TSCA section 6(e)(3)(B).
■ 9. Revise § 750.30 to read as follows:
List of Subjects in 40 CFR Part 750
Administrative practice and
procedure, Chemicals, Environmental
protection, Hazardous substances.
§ 750.16
■
6. Redesignate § 750.16 as § 750.14.
§§ 750.17 through 750.20
■
Therefore, 40 CFR chapter I is
amended as follows:
PART 750—PROCEDURES FOR
RULEMAKING UNDER SECTION 6 OF
THE TOXIC SUBSTANCES CONTROL
ACT [AMENDED]
§§ 750.21
Authority: 15 U.S.C. 2605.
Subpart A—[Removed and Reserved]
2. Subpart A, consisting of §§ 750.1
through 750.9 and an appendix, is
removed and reserved.
■ 3. Revise § 750.10 to read as follows:
■
§ 750.10
8. Redesignate § 750.21 as § 750.15,
and revise it to read as follows:
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Notice of proposed rulemaking.
Rulemaking for PCB exemptions filed
pursuant to § 750.11(a) shall begin with
the publication of a notice of proposed
rulemaking in the Federal Register. The
notice shall state in summary form the
required information described in
§ 750.11(c). Due to time constraints, the
notice need not indicate what action
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Applicability
Sections 750.30 through 750.35 apply
to all rulemakings under authority of
section 6(e)(3)(B) of the Toxic
Substances Control Act (TSCA), 15
U.S.C. 2605(e)(3)(B) with respect to
petitions for PCB processing and
distribution in commerce exemptions
filed pursuant to § 750.31(a).
■ 10. Revise § 750.33 to read as follows:
Notice of proposed rulemaking.
Rulemaking for PCB exemptions filed
pursuant to § 750.31(a) shall begin with
the publication of a notice of proposed
rulemaking in the Federal Register. The
notice shall state in summary form the
required information described in
§ 750.31(c).
■
Applicability
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Final rule.
§§ 750.34 and 750.35
Sections 750.10–750.15 apply to all
rulemakings under authority of section
6(e)(3)(B) of the Toxic Substances
Control Act (TSCA), 15 U.S.C.
2605(e)(3)(B) with respect to petitions
filed pursuant to § 750.11(a).
■ 4. Revise § 750.13 to read as follows:
§ 750.13
[Redesignated as § 750.15]
■
§ 750.33
1. The authority citation for part 750
continues to read as follows:
■
[Removed]
7. Remove §§ 750.17 through 750.20.
§ 750.30
Dated: December 8, 2016.
Gina McCarthy,
Administrator.
[Redesignated as § 750.14]
§ 750.36
■
[Removed]
11. Remove §§ 750.34 and 750.35.
[Redesignated as § 750.34]
12. Redesignate § 750.36 as § 750.34.
§§ 750.37 through 750.40
■
[Removed]
13. Remove §§ 750.37 through 750.40.
§ 750.41
[Redesignated as § 750.35]
14. Redesignate § 750.41 as § 750.35,
and revise it to read as follows:
■
§ 750.35
Final rule.
(a) [Reserved]
(b) EPA will grant or deny petitions
under TSCA section 6(e)(3)(B)
submitted pursuant to § 750.31.
(c) In determining whether to grant an
exemption to the PCB ban, EPA will
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BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Part 414
[CMS–6072–N]
Medicare Program; Implementation of
Prior Authorization Process for Certain
Durable Medical Equipment,
Prosthetics, Orthotics, and Supplies
(DMEPOS) Items and Publication of the
Initial Required Prior Authorization List
of DMEPOS Items That Require Prior
Authorization as a Condition of
Payment
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Implementation of list and
phases.
AGENCY:
This document announces the
implementation of the prior
authorization program for certain
durable medical equipment, prosthetics,
orthotics, and supplies (DMEPOS) items
in two phases and the issuance of the
initial Required Prior Authorization List
of DMEPOS items that require prior
authorization as a condition of payment.
DATES: Phase one of implementation is
effective on March 20, 2017. Phase two
of implementation is effective on July
17, 2017.
FOR FURTHER INFORMATION CONTACT:
Jennifer Phillips, (410) 786–1023.
Linda O’Hara (410) 786–8347.
Scott Lawrence (410) 786–4313.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Sections 1832, 1834, and 1861 of the
Social Security Act (the Act) establish
that the provision of durable medical
equipment, prosthetic, orthotics, and
supplies (DMEPOS) is a covered benefit
under Part B of the Medicare program.
Section 1834(a)(15) of the Act
authorizes the Secretary to develop and
periodically update a list of DMEPOS
items that the Secretary determines, on
the basis of prior payment experience,
are frequently subject to unnecessary
utilization and to develop a prior
authorization process for these items.
In the December 30, 2015 final rule
(80 FR 81674), titled ‘‘Medicare
Program; Prior Authorization Process for
Certain Durable Medical Equipment,
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Agencies
[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Rules and Regulations]
[Pages 93633-93636]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30055]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 750
[HQ-OPPT-2016-0525; FRL-9955-15]
RIN 2070-AK28
Procedures for Rulemaking Under Section 6 of the Toxic Substances
Control Act; Amendment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Section 6 of the Toxic Substances Control Act (TSCA) provides
EPA with several authorities for addressing risks from chemical
substances and includes procedures that EPA must follow in doing so.
EPA promulgated regulations shortly after TSCA was enacted to implement
the procedural requirements for rulemaking under TSCA section 6 as they
existed at that time. TSCA was recently amended by the Frank R.
Lautenberg Chemical Safety for the 21st Century Act. This final rule
removes the regulations specifying certain procedural requirements for
rulemaking under TSCA section 6, including the requirement for a
hearing, because TSCA, as amended, no longer mandates those procedures.
DATES: This final rule is effective December 21, 2016.
FOR FURTHER INFORMATION CONTACT: Cindy Wheeler, Chemical Control
Division, Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (202) 566-0484; email address:
wheeler.cindy@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. What is the agency's authority for taking this action?
The authority for this action is TSCA section 6, as amended by the
Frank R. Lautenberg Chemical Safety for the 21st Century Act (15 U.S.C.
2605).
Section 553 of the Administrative Procedure Act (APA), 5 U.S.C.
553(b)(3)(A), provides that ``rules of agency organization, procedure,
or practice'' are exempt from notice and comment requirements. This
action involves revisions to the rules that set out the general
rulemaking procedure for EPA under the prior version of TSCA, and the
action does not affect the substance of any determinations EPA will
make under the amended TSCA section 6. Accordingly, these revisions
fall under the exemption provided in APA section 553(b)(3)(A), and the
EPA is not taking comment on this action.
B. Does this action apply to me?
This action affects only Agency procedure in future rulemakings
under TSCA section 6 and has no particular applicability to the public.
If you have any questions regarding the applicability of this action,
consult the person listed under FOR FURTHER INFORMATION CONTACT.
[[Page 93634]]
II. Background
A. What action is the agency taking?
This action removes 40 CFR part 750, subpart A (the general
procedural requirements for rulemaking under TSCA section 6, including
the requirement for a hearing). Subpart A detailed hearing-related
procedures as well as the content and timing of EPA's notices and the
Agency's record. This action also removes the similar provisions from
the procedural rules in subparts B and C for exemptions from the
prohibitions in TSCA section 6(e) applicable to polychlorinated
biphenyls.
TSCA, enacted in 1976, was intended to provide EPA with the tools
necessary to develop information and manage risks associated with
chemicals in commerce. TSCA section 6(a) requires EPA to take action to
address unreasonable risks that EPA determines are presented by
chemical substances or mixtures. Under TSCA section 6 as enacted in
1976, if EPA had a reasonable basis to conclude that the manufacture
(including import), processing, distribution in commerce, use, or
disposal of a chemical substance or mixture presented an unreasonable
risk of injury to health or the environment, EPA would have to by rule
apply requirements to the substance or mixture to the extent necessary
to address the unreasonable risk using the least burdensome
requirement. These requirements could include prohibitions or
limitations on manufacturing processing, distribution in commerce,
commercial use, or disposal; marking (labeling) requirements; and
recordkeeping requirements. This section of TSCA also established
certain procedures that EPA would have to follow in promulgating such
rules. As enacted in 1976, TSCA section 6(c) required, among other
things, that EPA provide the opportunity for an informal hearing and
that EPA make certain findings and publish certain statements.
EPA published final procedural regulations to implement the TSCA
section 6 procedural requirements shortly thereafter in the Federal
Register of December 2, 1977, (42 FR 61259). These procedural
regulations, codified as 40 CFR part 750, are quite detailed with
respect to the contents of Notices of Proposed Rulemaking, hearing
procedures, the handling of public comments, and docketing of comments
and other supporting materials. These procedural requirements for
rulemaking under TSCA section 6 have been amended several times, most
notably in 1978 to add interim procedural rules for filing and
processing petitions for exemptions from the TSCA section 6(e) ban on
the manufacture of polychlorinated biphenyls (PCBs) (43 FR 50905,
November 1, 1978), and in 1979 to add similar rules for petitions for
exemptions from the TSCA section 6(e) bans on PCB processing and
distribution in commerce (44 FR 31558, May 31, 1979).
On June 22, 2016, the President signed the Frank R. Lautenberg
Chemical Safety for the 21st Century Act into law. This legislation
amends many sections of TSCA, including TSCA section 6. While the new
law still directs EPA to take action against unreasonable risks
presented by chemical substances or mixtures, EPA's duties under TSCA
section 6 have been significantly modified to include specific
deadlines and procedures for prioritizing chemicals for risk
evaluations, conducting the risk evaluations and promulgating
regulations to address unreasonable risks that are identified. Notably,
once unreasonable risks have been identified through a risk evaluation,
TSCA section 6(c)(1) now requires EPA to issue a proposed rule to
address the risks no later than one year after the final risk
evaluation is published, and the final rule must be issued no later
than two years after the final risk evaluation is published, subject to
the limited extension authorized by TSCA section 6(c)(1)(C).
After reviewing 40 CFR part 750 in light of the amendments to TSCA,
EPA has determined that the procedural regulations in subpart A do not
facilitate the efficient administrative process envisioned by the Frank
R. Lautenberg Chemical Safety for the 21st Century Act. Subpart A was
principally promulgated to provide further details related to the
informal hearing process under TSCA as originally enacted. However,
with the statutory amendments' removal of the informal hearing
requirement and addition of ambitious deadlines for action under
section 6, subpart A is particularly outdated and no longer designed
for effective implementation of section 6. To the extent subpart A
simply reflected administrative requirements of TSCA and the
Administrative Procedure Act, the current version of TSCA and the
Administrative Procedure Act will continue to apply on their own terms,
and section 6 of TSCA as amended prescribes considerably more procedure
than the previous version of TSCA. To the extent subpart A goes beyond
the current statutory requirements of such law, EPA believes that the
layering of additional procedural requirements by regulation is both
unnecessary to ensure a transparent rulemaking process with robust
public participation and not well-suited to the rapid throughput
required by the law. EPA also believes the requirements are in some
respects outdated with respect to current technology. The remainder of
this notice elaborates on these points.
First, regarding the hearing-related provisions of 40 CFR part 750,
TSCA section 6, as amended, no longer requires EPA to provide an
opportunity for an informal hearing on a proposed rule. After TSCA was
amended on June 22, 2016 and before this final rule, 40 CFR part 750
inaccurately referred to ``the informal hearing required by section
6(c)(2)(C) of TSCA'' when, in fact, TSCA section 6 no longer requires
EPA to provide an opportunity for informal hearing and TSCA section
6(c)(2)(C) in particular now refers to another topic. Given that EPA is
no longer required to provide an opportunity for an informal hearing on
a proposed rule under TSCA section 6, and that the statutory citations
in the hearing-related regulations are no longer correct, much of 40
CFR part 750 is no longer needed or appropriate.
Moreover, by establishing a two-year deadline for final rules after
unreasonable risks are identified through risk evaluation, Congress
expressed an intention for EPA to move relatively quickly to address
unreasonable risks. Although Congress also established a limited
process by which EPA could extend this deadline, EPA does not believe
that Congress intended for extended deadlines to be a routine
occurrence. The cumbersome nature of the informal hearing-related
provisions established in 40 CFR part 750 would make it difficult for
EPA to meet the newly-established rulemaking deadlines.
Yet EPA does not interpret the removal of the hearing requirement
as an indication that reduced public input is desired. To the contrary,
the amended TSCA section 6 specifically requires public comment periods
at several stages during the chemical prioritization, risk evaluation,
and risk management processes. EPA interprets the removal of the
informal hearing requirement as being motivated by Congressional intent
to simplify and thereby quicken the pace of TSCA section 6 rulemaking,
considering the establishment of new rulemaking deadlines and the
manner in which the tools for managing EPA's administrative rulemaking
process have evolved over the 40 years since TSCA was enacted (e.g.,
the advent of electronic commenting). Under the Administrative
[[Page 93635]]
Procedure Act (5 U.S.C. 553), EPA must give interested persons an
opportunity to participate in a legislative rulemaking by submitting
written comments. In addition, for existing chemicals under TSCA, EPA
often holds public meetings in order to solicit oral comments as well
as written comments.
Next, while EPA must still consider and publish a statement on
certain factors when promulgating a rule under TSCA section 6(a), the
factors have changed. For example, TSCA section 6(c) as originally
enacted required EPA to consider and publish a statement with respect
to the availability of substitutes for various uses of a chemical
substance or mixture. TSCA section 6(c) as amended requires EPA to, in
deciding whether to prohibit or restrict a chemical substance or
mixture in a manner that substantially prevents a specific condition of
use, and in setting an appropriate transition period for such chemical
substance or mixture, consider, to the extent practicable, whether
technically and economically feasible alternatives that benefit health
or the environment will be reasonably available as a substitute when
the proposed prohibition or other restriction takes effect. Therefore,
EPA is removing the outdated specification of the content and timing of
EPA notices in 40 CFR part 750, subpart A, and instead EPA's notices in
future section 6 rulemakings will conform to TSCA as amended.
As EPA noted in 1987 (52 FR 23054), the initiation of a section 6
proceeding could be by proposed rule, advance notice of proposed
rulemaking, or notice of other appropriate action. The agency is not
changing its position on this matter by removing 40 CFR 750.2(a). As
the agency stated previously, ``Federal courts have acknowledged that
rulemaking commences before the publication of a notice of proposed
rulemaking. See, for example, Natural Resources Defense Council v. EPA,
595 F. Supp. 1255 (S.D.N.Y. 1984), where the court found that EPA may
use an ANPR to initiate a rulemaking proceeding under section 4 of
TSCA.'' Therefore, the provision regarding when a proceeding begins
does not need to be codified in the CFR.
Lastly, modern electronic tools and remote conferencing were not
available when TSCA was enacted nor when procedural requirements under
40 CFR part 750 regarding Agency records were promulgated by EPA. EPA
believes that it is now reasonable and prudent to use its information
resources, including information technology, to establish an electronic
record to contain rulemaking documents being considered and public
comments submitted, a possibility not anticipated by the outdated
record provisions. Consistent with TSCA section 2's expression of
Congressional intent that EPA carry out TSCA in a reasonable and
prudent manner, and in consideration of the environmental, economic,
and social impacts that any action taken under TSCA may have, (15
U.S.C. 2601), electronic correspondence can reduce burden and costs for
the regulated entities by eliminating the costs associated with
printing and mailing documents, and traveling to hearings, while at the
same time improving EPA's efficiency in reviewing public comments,
making decisions, and disseminating information to the public.
Therefore, after considering the points discussed earlier in this
notice, EPA is removing the general TSCA section 6 procedural
requirements contained in subpart A of 40 CFR part 750. EPA is not
making any changes to the procedures contained in subparts B and C of
40 CFR part 750 for petitions for exemptions from the prohibitions in
TSCA section 6(e), other than to remove references to the informal
hearing-related procedures as well as the content and timing of EPA's
notices and the Agency's record corresponding to the removal of subpart
A.
III. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www2.epa.gov/laws-regulations/laws-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review
This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review under Executive Orders 12866 (58 FR 51735, October 4, 1993)
and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
This action does not contain any information collection activities
that require approval under the PRA, 44 U.S.C. 3501 et seq. This
rulemaking removes unnecessary internal EPA procedures and does not
impose any requirements on the public.
C. Regulatory Flexibility Act (RFA)
This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA
applies only to rules subject to notice and comment rulemaking
requirements under the APA, 5 U.S.C. 553, or any other statute.
D. Unfunded Mandates Reform Act
This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. This action imposes no enforceable duty on any
state, local or tribal governments or the private sector.
E. Executive Order 13132: Federalism
This action does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have
substantial direct effects on the states, on the relationship between
the national government and the states, or on the distribution of power
and responsibilities among the various levels of government.
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action does not have tribal implications as specified in
Executive Order 13175 (65 FR 67249, November 9, 2000), because it
merely removes procedural requirements that the Agency must follow when
conducting rulemaking under TSCA section 6. Thus, Executive Order 13175
does not apply to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997),
as applying only to those regulatory actions that concern environmental
health or safety risks that the EPA has reason to believe may
disproportionately affect children, per the definition of ``covered
regulatory action'' in section 2-202 of the Executive Order. This
action is not subject to Executive Order 13045 because it does not
concern an environmental health risk or safety risk.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because it is not a significant regulatory action under
Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
This rulemaking does not involve any technical standards, and is
therefore not subject to considerations under NTTAA section 12(d), 15
U.S.C. 272 note.
[[Page 93636]]
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not establish an environmental health or safety
standard, and is therefore not is not subject to environmental justice
considerations under Executive Order 12898 (59 FR 7629, February 16,
1994), because it does not establish an environmental health or safety
standard. This regulatory action is a procedural change and does not
have any impact on human health or the environment.
K. Congressional Review Act (CRA)
This rule is exempt from the CRA (5 U.S.C. 801 et seq.) because it
is a rule of agency organization, procedure or practice that does not
substantially affect the rights or obligations of non-agency parties.
List of Subjects in 40 CFR Part 750
Administrative practice and procedure, Chemicals, Environmental
protection, Hazardous substances.
Dated: December 8, 2016.
Gina McCarthy,
Administrator.
Therefore, 40 CFR chapter I is amended as follows:
PART 750--PROCEDURES FOR RULEMAKING UNDER SECTION 6 OF THE TOXIC
SUBSTANCES CONTROL ACT [AMENDED]
0
1. The authority citation for part 750 continues to read as follows:
Authority: 15 U.S.C. 2605.
Subpart A--[Removed and Reserved]
0
2. Subpart A, consisting of Sec. Sec. 750.1 through 750.9 and an
appendix, is removed and reserved.
0
3. Revise Sec. 750.10 to read as follows:
Sec. 750.10 Applicability
Sections 750.10-750.15 apply to all rulemakings under authority of
section 6(e)(3)(B) of the Toxic Substances Control Act (TSCA), 15
U.S.C. 2605(e)(3)(B) with respect to petitions filed pursuant to Sec.
750.11(a).
0
4. Revise Sec. 750.13 to read as follows:
Sec. 750.13 Notice of proposed rulemaking.
Rulemaking for PCB exemptions filed pursuant to Sec. 750.11(a)
shall begin with the publication of a notice of proposed rulemaking in
the Federal Register. The notice shall state in summary form the
required information described in Sec. 750.11(c). Due to time
constraints, the notice need not indicate what action EPA proposes to
take on the exemption petitions.
Sec. Sec. 750.14 and 750.15 [Removed]
0
5. Remove Sec. Sec. 750.14 and 750.15.
Sec. 750.16 [Redesignated as Sec. 750.14]
0
6. Redesignate Sec. 750.16 as Sec. 750.14.
Sec. Sec. 750.17 through 750.20 [Removed]
0
7. Remove Sec. Sec. 750.17 through 750.20.
Sec. Sec. 750.21 [Redesignated as Sec. 750.15]
0
8. Redesignate Sec. 750.21 as Sec. 750.15, and revise it to read as
follows:
Sec. 750.15 Final rule.
(a) [Reserved]
(b) EPA will grant or deny petitions under TSCA section 6(e)(3)(B)
submitted pursuant to Sec. 750.11.
(c) In determining whether to grant an exemption to the PCB ban,
the Agency shall apply the two standards enunciated in TSCA section
6(e)(3)(B).
0
9. Revise Sec. 750.30 to read as follows:
Sec. 750.30 Applicability
Sections 750.30 through 750.35 apply to all rulemakings under
authority of section 6(e)(3)(B) of the Toxic Substances Control Act
(TSCA), 15 U.S.C. 2605(e)(3)(B) with respect to petitions for PCB
processing and distribution in commerce exemptions filed pursuant to
Sec. 750.31(a).
0
10. Revise Sec. 750.33 to read as follows:
Sec. 750.33 Notice of proposed rulemaking.
Rulemaking for PCB exemptions filed pursuant to Sec. 750.31(a)
shall begin with the publication of a notice of proposed rulemaking in
the Federal Register. The notice shall state in summary form the
required information described in Sec. 750.31(c).
Sec. Sec. 750.34 and 750.35 [Removed]
0
11. Remove Sec. Sec. 750.34 and 750.35.
Sec. 750.36 [Redesignated as Sec. 750.34]
0
12. Redesignate Sec. 750.36 as Sec. 750.34.
Sec. Sec. 750.37 through 750.40 [Removed]
0
13. Remove Sec. Sec. 750.37 through 750.40.
Sec. 750.41 [Redesignated as Sec. 750.35]
0
14. Redesignate Sec. 750.41 as Sec. 750.35, and revise it to read as
follows:
Sec. 750.35 Final rule.
(a) [Reserved]
(b) EPA will grant or deny petitions under TSCA section 6(e)(3)(B)
submitted pursuant to Sec. 750.31.
(c) In determining whether to grant an exemption to the PCB ban,
EPA will apply the two standards enunciated in TSCA section 6(e)(3)(B).
[FR Doc. 2016-30055 Filed 12-20-16; 8:45 am]
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