81 FR 93633 - Procedures for Rulemaking Under Section 6 of the Toxic Substances Control Act; Amendment

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 245 (December 21, 2016)

Page Range		93633-93636
FR Document		2016-30055
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.
Federal Register, Volume 81 Issue 245 (Wednesday, December 21, 2016)
[Federal Register Volume 81, Number 245 (Wednesday, December 21, 2016)]
[Rules and Regulations]
[Pages 93633-93636]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-30055]


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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.

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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: 
[email protected].

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 http://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]
BILLING CODE 6560-50-P
Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations 93633

classifications, Intergovernmental ■ 2. Section 52.1885 is amended by area are 50.66 tons per summer day
relations, Nitrogen oxides, Ozone, adding paragraph (pp)(2) to read as (TPSD) for VOC and 90.54 TPSD for
Reporting and recordkeeping follows: NOX. The 2030 motor vehicle emissions
requirements, Volatile organic budgets for the Columbus area are 44.31
§ 52.1885 Control strategy: Ozone.
compounds. TPSD for VOC and 85.13 TPSD for NOX.
* * * * *
Dated: December 5, 2016. (pp) * * * PART 81—DESIGNATION OF AREAS
Robert A. Kaplan, (2) Approval—On June 16, 2016, the FOR AIR QUALITY PLANNING
Acting Regional Administrator, Region 5. Ohio Environmental Protection Agency PURPOSES
submitted a request to redesignate the
Parts 52 and 81, chapter I, title 40 of Columbus area to attainment of the 2008 ■ 3. The authority citation for part 81
the Code of Federal Regulations is ozone NAAQS. As part of the continues to read as follows:
amended as follows: redesignation request, the State
submitted a maintenance plan as Authority: 42 U.S.C. 7401 et seq.
PART 52—APPROVAL AND required by section 175A of the Clean ■ 4. Section 81.336 is amended by
PROMULGATION OF Air Act. Elements of the section 175 revising the entry for Columbus, OH in
IMPLEMENTATION PLANS maintenance plan include a contingency the table entitled ‘‘Ohio—2008 8-Hour
plan and an obligation to submit a Ozone NAAQS (Primary and
■ 1. The authority citation for part 52 subsequent maintenance plan revision secondary)’’ to read as follows:
continues to read as follows: in eight years as required by the Clean
Air Act. The 2020 motor vehicle § 81.336 Ohio.
Authority: 42 U.S.C. 7401 et seq.
emissions budgets for the Columbus * * * * *

OHIO—2008—8-HOUR OZONE NAAQS
[Primary and secondary]

Designation Classification
Designated area
Date 1 Type Date 1 Type

* * * * * * *
Columbus, OH: 2 Delaware County, Fairfield December 21, 2016 ... Attainment.
County, Franklin County, Knox County,
Licking County, Madison County.

* * * * * * *
1 This date is July 20, 2012, unless otherwise noted.
2 Excludes Indian country located in each area, unless otherwise noted.

* * * * * under TSCA section 6 as they existed at Lautenberg Chemical Safety for the 21st
[FR Doc. 2016–30470 Filed 12–20–16; 8:45 am] that time. TSCA was recently amended Century Act (15 U.S.C. 2605).
BILLING CODE 6560–50–P by the Frank R. Lautenberg Chemical Section 553 of the Administrative
Safety for the 21st Century Act. This Procedure Act (APA), 5 U.S.C.
final rule removes the regulations 553(b)(3)(A), provides that ‘‘rules of
ENVIRONMENTAL PROTECTION specifying certain procedural
AGENCY agency organization, procedure, or
requirements for rulemaking under practice’’ are exempt from notice and
TSCA section 6, including the
40 CFR Part 750 comment requirements. This action
requirement for a hearing, because
involves revisions to the rules that set
[HQ–OPPT–2016–0525; FRL–9955–15] TSCA, as amended, no longer mandates
out the general rulemaking procedure
those procedures.
RIN 2070–AK28 for EPA under the prior version of
DATES: This final rule is effective TSCA, and the action does not affect the
Procedures for Rulemaking Under December 21, 2016. substance of any determinations EPA
Section 6 of the Toxic Substances FOR FURTHER INFORMATION CONTACT: will make under the amended TSCA
Control Act; Amendment Cindy Wheeler, Chemical Control section 6. Accordingly, these revisions
Division, Office of Pollution Prevention fall under the exemption provided in
AGENCY: Environmental Protection and Toxics, Environmental Protection APA section 553(b)(3)(A), and the EPA
Agency (EPA). Agency, 1200 Pennsylvania Ave. NW., is not taking comment on this action.
ACTION: Final rule. Washington, DC 20460–0001; telephone
number: (202) 566–0484; email address: B. Does this action apply to me?
SUMMARY: Section 6 of the Toxic wheeler.cindy@epa.gov.
asabaliauskas on DSK3SPTVN1PROD with RULES

Substances Control Act (TSCA) provides This action affects only Agency
SUPPLEMENTARY INFORMATION: procedure in future rulemakings under
EPA with several authorities for
addressing risks from chemical I. General Information TSCA section 6 and has no particular
substances and includes procedures that applicability to the public. If you have
EPA must follow in doing so. EPA A. What is the agency’s authority for any questions regarding the
promulgated regulations shortly after taking this action? applicability of this action, consult the
TSCA was enacted to implement the The authority for this action is TSCA person listed under FOR FURTHER
procedural requirements for rulemaking section 6, as amended by the Frank R. INFORMATION CONTACT.

VerDate Sep<11>2014 17:05 Dec 20, 2016 Jkt 241001 PO 00000 Frm 00063 Fmt 4700 Sfmt 4700 E:\FR\FM\21DER1.SGM 21DER1
93634 Federal Register / Vol. 81, No. 245 / Wednesday, December 21, 2016 / Rules and Regulations

II. Background and processing petitions for exemptions regulation is both unnecessary to ensure
from the TSCA section 6(e) ban on the a transparent rulemaking process with
A. What action is the agency taking?
manufacture of polychlorinated robust public participation and not
This action removes 40 CFR part 750, biphenyls (PCBs) (43 FR 50905, well-suited to the rapid throughput
subpart A (the general procedural November 1, 1978), and in 1979 to add required by the law. EPA also believes
requirements for rulemaking under similar rules for petitions for the requirements are in some respects
TSCA section 6, including the exemptions from the TSCA section 6(e) outdated with respect to current
requirement for a hearing). Subpart A bans on PCB processing and distribution technology. The remainder of this notice
detailed hearing-related procedures as in commerce (44 FR 31558, May 31, elaborates on these points.
well as the content and timing of EPA’s 1979). First, regarding the hearing-related
notices and the Agency’s record. This On June 22, 2016, the President provisions of 40 CFR part 750, TSCA
action also removes the similar signed the Frank R. Lautenberg section 6, as amended, no longer
provisions from the procedural rules in Chemical Safety for the 21st Century requires EPA to provide an opportunity
subparts B and C for exemptions from Act into law. This legislation amends for an informal hearing on a proposed
the prohibitions in TSCA section 6(e) many sections of TSCA, including rule. After TSCA was amended on June
applicable to polychlorinated biphenyls. TSCA section 6. While the new law still 22, 2016 and before this final rule, 40
TSCA, enacted in 1976, was intended directs EPA to take action against CFR part 750 inaccurately referred to
to provide EPA with the tools necessary unreasonable risks presented by ‘‘the informal hearing required by
to develop information and manage chemical substances or mixtures, EPA’s section 6(c)(2)(C) of TSCA’’ when, in
risks associated with chemicals in duties under TSCA section 6 have been fact, TSCA section 6 no longer requires
commerce. TSCA section 6(a) requires significantly modified to include EPA to provide an opportunity for
EPA to take action to address specific deadlines and procedures for informal hearing and TSCA section
unreasonable risks that EPA determines prioritizing chemicals for risk 6(c)(2)(C) in particular now refers to
are presented by chemical substances or evaluations, conducting the risk another topic. Given that EPA is no
mixtures. Under TSCA section 6 as evaluations and promulgating longer required to provide an
enacted in 1976, if EPA had a regulations to address unreasonable opportunity for an informal hearing on
reasonable basis to conclude that the risks that are identified. Notably, once a proposed rule under TSCA section 6,
manufacture (including import), unreasonable risks have been identified and that the statutory citations in the
processing, distribution in commerce, through a risk evaluation, TSCA section hearing-related regulations are no longer
use, or disposal of a chemical substance 6(c)(1) now requires EPA to issue a correct, much of 40 CFR part 750 is no
or mixture presented an unreasonable proposed rule to address the risks no longer needed or appropriate.
risk of injury to health or the later than one year after the final risk Moreover, by establishing a two-year
environment, EPA would have to by evaluation is published, and the final deadline for final rules after
rule apply requirements to the rule must be issued no later than two unreasonable risks are identified
substance or mixture to the extent years after the final risk evaluation is through risk evaluation, Congress
necessary to address the unreasonable published, subject to the limited expressed an intention for EPA to move
risk using the least burdensome extension authorized by TSCA section relatively quickly to address
requirement. These requirements could 6(c)(1)(C). unreasonable risks. Although Congress
include prohibitions or limitations on After reviewing 40 CFR part 750 in also established a limited process by
manufacturing processing, distribution light of the amendments to TSCA, EPA which EPA could extend this deadline,
in commerce, commercial use, or has determined that the procedural EPA does not believe that Congress
disposal; marking (labeling) regulations in subpart A do not facilitate intended for extended deadlines to be a
requirements; and recordkeeping the efficient administrative process routine occurrence. The cumbersome
requirements. This section of TSCA also envisioned by the Frank R. Lautenberg nature of the informal hearing-related
established certain procedures that EPA Chemical Safety for the 21st Century provisions established in 40 CFR part
would have to follow in promulgating Act. Subpart A was principally 750 would make it difficult for EPA to
such rules. As enacted in 1976, TSCA promulgated to provide further details meet the newly-established rulemaking
section 6(c) required, among other related to the informal hearing process deadlines.
things, that EPA provide the under TSCA as originally enacted. Yet EPA does not interpret the
opportunity for an informal hearing and However, with the statutory removal of the hearing requirement as
that EPA make certain findings and amendments’ removal of the informal an indication that reduced public input
publish certain statements. hearing requirement and addition of is desired. To the contrary, the amended
EPA published final procedural ambitious deadlines for action under TSCA section 6 specifically requires
regulations to implement the TSCA section 6, subpart A is particularly public comment periods at several
section 6 procedural requirements outdated and no longer designed for stages during the chemical
shortly thereafter in the Federal effective implementation of section 6. prioritization, risk evaluation, and risk
Register of December 2, 1977, (42 FR To the extent subpart A simply reflected management processes. EPA interprets
61259). These procedural regulations, administrative requirements of TSCA the removal of the informal hearing
codified as 40 CFR part 750, are quite and the Administrative Procedure Act, requirement as being motivated by
detailed with respect to the contents of the current version of TSCA and the Congressional intent to simplify and
Notices of Proposed Rulemaking, Administrative Procedure Act will thereby quicken the pace of TSCA
asabaliauskas on DSK3SPTVN1PROD with RULES

hearing procedures, the handling of continue to apply on their own terms, section 6 rulemaking, considering the
public comments, and docketing of and section 6 of TSCA as amended establishment of new rulemaking
comments and other supporting prescribes considerably more procedure deadlines and the manner in which the
materials. These procedural than the previous version of TSCA. To tools for managing EPA’s administrative
requirements for rulemaking under the extent subpart A goes beyond the rulemaking process have evolved over
TSCA section 6 have been amended current statutory requirements of such the 40 years since TSCA was enacted
several times, most notably in 1978 to law, EPA believes that the layering of (e.g., the advent of electronic
add interim procedural rules for filing additional procedural requirements by commenting). Under the Administrative

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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This final rule is effective December 21, 2016.
Contact		Cindy Wheeler, Chemical Control Division, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation		81 FR 93633
RIN Number		2070-AK28
CFR Associated		Administrative Practice and Procedure; Chemicals; Environmental Protection and Hazardous Substances