81 FR 1365 - TSCA Inventory Equivalency Determinations for Certain Class 2 Substances; TSCA Section 21 Petition; Reasons for Agency Response

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 7 (January 12, 2016)

Page Range		1365-1368
FR Document		2016-00435
This document announces the availability of EPA's response to a petition it received under the Toxic Substances Control Act (TSCA). The TSCA section 21 petition was received from the Biobased and Renewable Products Advocacy Group (BRAG) on October 7, 2015. The petitioner requested EPA to promulgate a rule pursuant to TSCA section 8 that would ``establish a process to amend the list of natural sources of oil and fat in the `Soap and Detergent Association' (SDA) nomenclature system by considering the chemical equivalency of additional natural sources.'' After careful consideration, EPA denied the TSCA section 21 petition for the reasons discussed in this document.
Federal Register, Volume 81 Issue 7 (Tuesday, January 12, 2016)
[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Proposed Rules]
[Pages 1365-1368]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-00435]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2015-0823; FRL-9940-61]


TSCA Inventory Equivalency Determinations for Certain Class 2 
Substances; TSCA Section 21 Petition; Reasons for Agency Response

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This document announces the availability of EPA's response to 
a petition it received under the Toxic Substances Control Act (TSCA). 
The TSCA section 21 petition was received from the Biobased and 
Renewable Products Advocacy Group (BRAG) on October 7, 2015. The 
petitioner requested EPA to promulgate a rule pursuant to TSCA section 
8 that would ``establish a process to amend the list of natural sources 
of oil and fat in the `Soap and Detergent Association' (SDA) 
nomenclature system by considering the chemical equivalency of 
additional natural sources.'' After careful consideration, EPA denied 
the TSCA section 21 petition for the reasons discussed in this 
document.

DATES: EPA's response to this TSCA section 21 petition was signed 
December 31, 2015.

FOR FURTHER INFORMATION CONTACT: 
    For technical information contact: Kent Anapolle, Chemistry, 
Economics, and Sustainable Strategies Division (7406M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(202) 564-8578; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may, 
however, be of interest to those persons who are or may manufacture or 
import biobased chemicals similar to fats and oils described by the SDA 
nomenclature system. Since other entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action.

B. How can I access information about this petition?

    The docket for this TSCA section 21 petition, identified by docket 
identification (ID) number EPA-HQ-OPPT-2015-0823, is available at 
http://www.regulations.gov or at the Office of Pollution Prevention and 
Toxics Docket (OPPT Docket), Environmental Protection Agency Docket 
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 
Constitution Ave. NW., Washington, DC. The Public Reading Room is open 
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal 
holidays. The telephone number for the Public Reading Room is (202) 
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280. Please review the visitor instructions and additional information 
about the docket available at http://www.epa.gov/dockets.

II. TSCA Section 21

A. What is a TSCA section 21 petition?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA 
to initiate a rulemaking proceeding for the issuance, amendment, or 
repeal of a rule under TSCA section 4, 6, or 8 or an order under TSCA 
section 5(e) or 6(b)(2). A TSCA section 21 petition must set forth the 
facts that are claimed to establish the necessity for the action 
requested. EPA is required to grant or deny the petition within 90 days 
of its

[[Page 1366]]

filing. If EPA grants the petition, the Agency must promptly commence 
an appropriate proceeding. If EPA denies the petition, the Agency must 
publish its reasons for the denial in the Federal Register. A 
petitioner may commence a civil action in a U.S. district court to 
compel initiation of the requested rulemaking proceeding within 60 days 
of either a denial or the expiration of the 90-day period.

B. What criteria apply to a decision on a TSCA section 21 petition?

    Section 21(b)(1) of TSCA requires that the petition ``set forth the 
facts which it is claimed establish that it is necessary'' to issue the 
rule or order requested, 15 U.S.C. 2620(b)(1). Thus, TSCA section 21 
implicitly incorporates the statutory standards that apply to the 
requested actions. In addition, TSCA section 21 establishes standards a 
court must use to decide whether to order EPA to initiate rulemaking in 
the event of a lawsuit filed by the petitioner after denial of a TSCA 
section 21 petition, 15 U.S.C. 2620(b)(4)(B). Accordingly, EPA has 
relied on the standards in TSCA section 21 and in the provisions under 
which actions have been requested to evaluate this TSCA section 21 
petition.

III. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On October 7, 2015, EPA received a petition from the Biobased and 
Renewable Products Advocacy Group (BRAG) requesting the Agency to 
address the ``disproportionate regulatory burden'' imposed on companies 
in the bio-based chemical sector, noting that a ``limitation of source 
categories in the SDA system results in inequitable regulatory 
treatment for chemical substances that are functionally the same and 
chemically nearly identical.'' Specifically, the petition asks EPA to 
commence a rulemaking process under TSCA section 8, the objective of 
which would be to ``establish a procedure by which EPA can add new 
sources of fats and oils to the SDA-eligible list.''
    The petition states that the SDA-eligible list is part of a broader 
``nomenclature system developed by SDA when the TSCA Inventory was 
initially compiled.'' The term ``SDA-eligible list'' refers to a list 
found in the 1978 Candidate List of Chemical Substances on the TSCA 
Inventory, in ``Addendum III: Chemical Substances of Unknown or 
Variable Composition, Complex Reaction Products and Biological 
Materials'' (Ref. 2). In Section I of that document, EPA described a 
chemical substance naming convention, attributed to the SDA that was 
available for ``identifying and reporting certain multicomponent Class 
2 chemical substances derived from natural fats and oils and synthetic 
long-chain alkyl substitutes.'' The identification and reporting in 
question was the identification and reporting of chemical manufacture 
and processing to EPA, pursuant to a past reporting obligation under 
TSCA section 8(a), to inform EPA's original compilation of the TSCA 
Inventory under TSCA section 8(b). The document listed 35 ``natural 
fats and oils,'' as potential alkyl group sources. It provided that the 
particular chemical substances named under the SDA convention would not 
be identified ``in terms of source.'' However, chemical substances with 
alkyl groups derived from unlisted natural sources were beyond the 
scope of the naming convention. Thus, each time that a particular 
chemical substance was identified, reported, and entered into EPA's 
original compilation of the TSCA Inventory based on the SDA naming 
convention, the definition of that particular substance inherited a 
certain characterization from the SDA naming convention: Specifically, 
that the chemical substance in question was derived either from one or 
more of the 35 listed natural fats and oils or from synthetic long-
chain alkyl substitutes.
    The procedure that the petition asks EPA to establish by a TSCA 
section 8 rule is a procedure for submitting further requests to EPA. 
Specifically, it would be a regulation governing how the public would 
submit requests to amend the SDA-eligible list and how EPA would 
respond to such requests. The procedure would detail how EPA would 
review a request to include an additional source material of a fat or 
oil substance, ``following a premanufacture notice or other appropriate 
notification to EPA,'' in order to determine if it is ``sufficiently 
similar'' to sources of fat or oil substances with the same alkyl range 
that are already built into the SDA naming convention. After review, if 
EPA found ``such similarity'' between the requested additional source 
material and already-listed source materials, the contemplated rule 
would direct the Agency to add the requested source material to the 
SDA-eligible list in the SDA naming convention.
    The petition explains that the outcome sought (in the event EPA 
granted a request under the procedure that petitioners now ask EPA to 
establish by section 8 rule) would be to authorize manufacturers of 
various chemical substances derived from the additional source material 
to ``rely on the appropriate SDA alkyl range identity for purposes of 
Inventory listing and TSCA nomenclature.'' The petition elsewhere 
clarifies what it means by ``rely on,'' when it notes that without 
``access to the alkyl range names,'' the manufacturers would need to 
submit premanufacture notifications to EPA. The petition makes clear 
that the intended effect of enlarging the definitions of existing 
chemical substance listings in this fashion would be to limit the 
circumstances in which manufacturers would be deemed to be 
manufacturing a new chemical substance, and thus be subject to the 
requirements of TSCA section 5(a)(1)(A).

B. What support does the petitioner offer?

    While the petition includes no specific request to add a particular 
natural fat or oil to the ``SDA-eligible'' list, the bulk of the 
petition is concerned with giving, by way of background, the 
petitioners' general reasons to believe that such requests would have 
merit if submitted to EPA. The petition asserts, in general terms, that 
chemical substances derived from other natural sources ``may be 
chemically indistinguishable from,'' are ``nearly identical'' to, or 
are ``substantially similar,'' to chemical substances synthesized from 
one of the 35 listed natural sources. The petition also asserts that 
while such substances address ``critical needs for sustainability,'' 
there is a ``key hindrance'' to their commercialization. Specifically, 
the ``key hindrance'' is that certain of these chemical substances (or 
derivatives thereof) would be subject to EPA's pre-manufacture review 
under section 5 of TSCA, while assertedly similar chemical substances 
derived from one of the 35 listed natural sources would be existing 
chemical substances and therefore would not need to undergo such 
review. The petition claims that continuing to treat chemical 
substances derived from ``these novel sources,'' as new chemical 
substances ``creates a disincentive for customers to switch from 
traditional oils.''
    The specific action requested in the petition is that EPA 
``initiate a rulemaking under TSCA section 8 that would establish a 
process to amend the list of natural sources of oil and fat [the SDA-
eligible list] . . . by considering the chemical equivalency of 
additional natural sources.'' The petition supplies two reasons for the 
specific action requested. First, that EPA ``should allow for new 
sources to be added,'' to the list and second, that issuing such a 
regulatory proposal would not require a

[[Page 1367]]

``significant expenditure of time and resources.''

IV. Disposition of TSCA Section 21 Petition

A. What is EPA's response?

    After careful consideration, EPA denied the petitioner's request to 
initiate a TSCA section 8 rulemaking. EPA denied the request because 
the petition neither justified the petitioners' claim (that the 
initiation of a TSCA section 8 rulemaking proceeding is necessary) nor 
explained how petitioners believe EPA's actual rulemaking authorities 
under section 8 could be used to accomplish the objectives that 
petitioners are seeking. To the extent the petition was actually 
seeking an Agency order under TSCA section 8(b) (e.g., effectuating the 
alteration of certain entries on the TSCA Inventory), EPA notes that a 
request for an order under TSCA section 8(b) is not cognizable in a 
petition that is submitted pursuant to TSCA section 21 (15 U.S.C. 
2620(b)(1)). A copy of the Agency's response, which consists of a 
letter to the petitioner, is available in the docket for this TSCA 
section 21 petition.

B. What is EPA's reason for this response?

    1. Background on TSCA Section 8 Rules. TSCA section 8 provides 
express rulemaking authority in three distinct subsections: First, TSCA 
section 8(a) (15 U.S.C. 2607(a)) authorizes EPA to promulgate rules 
under which current or prospective manufacturers (including importers) 
and processors of chemical substances must maintain records and submit 
such information as the EPA Administrator may reasonably require. TSCA 
section 8(a) also authorizes EPA to promulgate rules under which 
current or prospective manufacturers and processors of mixtures must 
maintain records and submit information to the extent the EPA 
Administrator determines the maintenance of records or submission of 
reports, or both, is necessary for the effective enforcement of TSCA. 
Second, TSCA section 8(c) (15 U.S.C. 2607(c)) authorizes EPA to 
promulgate rules that ``determine'' certain obligations to ``maintain 
records of significant adverse reactions to health or the 
environment.'' Third, TSCA section 8(d) (15 U.S.C. 2607(d) authorizes 
rules for the submission to the Administrator of lists and copies of 
certain health and safety studies. If the Agency denies a petition 
submitted under TSCA section 21, judicial review in the case of a 
petition to initiate a proceeding for the issuance of a rule under TSCA 
section 8 requires the petitioner to show by a ``preponderance of the 
evidence that . . . there is a reasonable basis to conclude that the 
issuance of such a rule . . . is necessary to protect health or the 
environment against an unreasonable risk of injury'' (15 U.S.C. 
2620(b)(4)(B)).
    2. Background on the TSCA Inventory. EPA's authority to manage the 
TSCA Inventory is pursuant to TSCA section 8(b) (15 U.S.C. 2607(b)), 
which directs the Agency to ``compile, keep current, and publish a list 
of each chemical substance which is manufactured or processed in the 
United States.'' Although EPA was directed to promulgate a data 
collection rule under TSCA section 8(a), ``not later than 180 days 
after January 1, 1977,'' to gather data ``[f]or purposes of the 
compilation of the list . . . under subsection (b),'' rules under TSCA 
section 8(a) do not themselves effectuate changes to the contents of 
the TSCA Inventory. The initial compilation process under TSCA section 
8(b) was completed long ago, with the Agency noting in 1980 that 
henceforth ``premanufacture notification requirements of section 5 will 
apply to all chemical substances manufactured and imported in bulk or 
as part of a mixture which has not been reported for the Inventory.'' 
45 FR 50544 (July 29, 1980). Today, it remains EPA's practice to add 
entries to the TSCA Inventory on the basis of notices of commencement 
that are submitted ``in accordance with [TSCA] section 5.'' See 15 
U.S.C. 2607(b) and 40 CFR 720.102. From time to time, EPA has also made 
corrections to the TSCA Inventory. EPA has consistently done so without 
rulemaking. See 66 FR 34193, 34197 (June 27, 2001) (making clear that 
the action in question was a ``correction to TSCA Inventory 
nomenclature,'' and ``not a rule.'') and 75 FR 8266, 8272 (February 24, 
2010) (again, ``not a rule'')
3. Necessity of Establishing a Regulatory Procedure for Requesting and 
Effectuating Changes to SDA Naming Conventions
    The petition asserts that a new regulatory procedure is necessary, 
to govern public requests for changes to the SDA naming convention and 
EPA response to those requests. The reason given for why such a 
procedure is necessary is that the SDA naming convention ``should allow 
for new sources to be added.'' Yet the petition supplies no evidence of 
any current impediment to any party in making requests along these 
lines, or to EPA in considering such requests, which would be addressed 
if EPA were to promulgate a regulatory procedure governing the manner 
and method of making and responding to such requests. Part of the 
difficulty in following the petition's reasoning stems from the 
petition's conflation of two distinct issues: (1) Whether a chemical 
substance derived from an unlisted natural fat or oil can currently be 
treated as identical to another substance that is derived consistent 
with the SDA naming convention; and (2) whether alteration of the SDA 
naming convention, to encompass new sources of fats and oils, is 
currently ``allowed.''
    The petition correctly recognizes the current limitations of 
certain TSCA Inventory listings (i.e., those listings that incorporate 
particular assumptions about the natural sources of fats or oils from 
which the listed substance is derived, because they were named 
according to the SDA naming convention). Manufacturers of a new 
chemical substance that clearly falls outside the definitional scope of 
an existing chemical substance are not allowed to determine that the 
new chemical substance is nonetheless sufficiently ``similar'' to the 
existing chemical substance, and simply deem the new chemical substance 
to be an existing substance on the basis of that similarity. Nor would 
EPA grant such a request, which would be inconsistent with TSCA section 
3(9): A new chemical substance is ``any chemical substance which is not 
included in the chemical substance list compiled and published under 
[TSCA section 8(b)].''
    But the petition presumes, without justification, that until a 
certain preliminary EPA rulemaking has been completed, those same 
manufacturers lack a meaningful opportunity to request that EPA enlarge 
the definitional scope of one or more existing chemical substances 
named according to the SDA naming convention. The petition's failure to 
explain that a particular impediment exists (either to manufacturers in 
making these sorts of requests or to EPA in adjudicating them) is 
sufficient grounds to deny the request to commence a rulemaking 
proceeding intended to remove the unspecified impediment.
    Thus, the petition does not demonstrate that the requested rule is 
necessary in any respect, much less that it is necessary to protect 
health or the environment against an unreasonable risk of injury.

[[Page 1368]]

4. Capacity of a Rule Under TSCA 8(a), 8(c), or 8(d) To Alter the 
Identification of New and Existing Chemical Substances Under the SDA 
Naming Convention
    Even if the petition had established that a rulemaking proceeding 
is necessary, the petition would still be deficient. While the petition 
states in very general terms that it is seeking a change to the legal 
status quo (i.e., establish some regulatory process ``to allow'' 
certain chemical substances derived from new sources of natural fats 
and oils to be nonetheless deemed existing chemicals), the petition 
still fails to explain how a rule under TSCA section 8 could be crafted 
to accomplish that objective. Rules under 8(c) and 8(d) only cover 
reporting and retention of certain health and safety related documents; 
they are inapposite to the stated objective. Nor does the petition 
suggest any plan to make specific use of EPA's rulemaking authorities 
under sections 8(c) or 8(d). Rules under section 8(a) are somewhat 
broader in potential scope, but once again, the rulemaking authority at 
issue here is inapposite; it is to require current or prospective 
manufacturers or processors of a chemical substance to supply existing 
information relating to that chemical substance. While, historically, 
information collected using a TSCA section 8(a) rule provided the 
factual basis for EPA's assembly of the TSCA Inventory, TSCA section 
8(a) does not itself govern or authorize EPA's management of the TSCA 
Inventory. That is instead authorized under TSCA section 8(b). Yet TSCA 
section 8(b) does not contain an express grant of rulemaking authority, 
and EPA has never used rulemaking to establish or make additions or 
changes to the Inventory. For its part, the petition merely makes a 
blanket assertion that ``EPA is authorized under TSCA section 8 to 
commence a rulemaking.'' Especially since the text of TSCA section 8(b) 
does not itself refer to rulemaking authority, and the petitioners are 
seeking a change in legal requirements to ``allow for new sources to be 
added,'' the absence of any particular explanation in the petition 
describing how petitioners believe EPA could issue an appropriate rule 
(under any subsection of TSCA section 8) is a critical deficiency of 
the petition. Finally, to the extent that petitioners are actually 
seeking an order under TSCA section 8(b), EPA notes that such petitions 
are not cognizable under TSCA section 8, 15 U.S.C. 2620(b)(1).

V. 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 that are 
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. Biobased and Renewable Products Advocacy Group. Petition to 
Promulgate Rule Pursuant to Section 8 of the Toxic Substances Control 
Act, 15 U.S.C. 2620, Concerning Equivalency Determinations for Class 2 
Substances. October 5, 2015.
2. United States Environmental Protection Agency. Toxic Substances 
Control Act Pl 94-469, Candidate List of Chemical Substances, Addendum 
III: Chemical Substances of Unknown or Variable Composition, Complex 
Reaction Products and Biological Materials. Washington, DC, March 1978.

List of Subjects in 40 CFR Chapter I

    Environmental protection, Natural sources of oil and fat, SDA 
nomenclature system, TSCA Inventory.

    Dated: December 31, 2015.
James Jones,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2016-00435 Filed 1-11-16; 8:45 am]
BILLING CODE 6560-50-P
Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Proposed Rules 1365

ACTION:Notice of public hearing on comments. After the deadline for For technical information contact:
proposed rulemaking. receiving outlines has passed, the IRS Kent Anapolle, Chemistry, Economics,
will prepare an agenda containing the and Sustainable Strategies Division
SUMMARY: This document provides schedule of speakers. Copies of the (7406M), Office of Pollution Prevention
notice of public hearing on proposed agenda will be made available, free of and Toxics, Environmental Protection
regulations relating to the holdings of charge, at the hearing or in the Freedom Agency, 1200 Pennsylvania Ave. NW.,
Obergefell v. Hodges, 2015, Windsor v. of Information Reading Room (FOIA RR) Washington, DC 20460–0001; telephone
United States, 2013, and a revenue (Room 1621) which is located at the number: (202) 564–8578; email address:
ruling that define terms in the Internal 11th and Pennsylvania Avenue NW., anapolle.kent@epa.gov.
Revenue Code (Code) describing the entrance, 1111 Constitution Avenue For general information contact: The
marital status of taxpayers. NW., Washington, DC. TSCA-Hotline, ABVI-Goodwill, 422
DATES: The public hearing is being held Because of access restrictions, the IRS South Clinton Ave., Rochester, NY
on Wednesday, January 27, 2016, at will not admit visitors beyond the 14620; telephone number: (202) 554–
10:00 a.m. The IRS must receive immediate entrance area more than 30 1404; email address: TSCA-Hotline@
outlines of the topics to be discussed at minutes before the hearing starts. For epa.gov.
the public hearing by Friday, January information about having your name SUPPLEMENTARY INFORMATION:
15, 2016. placed on the building access list to
ADDRESSES: The public hearing is being attend the hearing, see the FOR FURTHER I. General Information
held in the Chief Counsel NYU INFORMATION CONTACT section of this A. Does this action apply to me?
conference room 2615, Internal Revenue document. This action is directed to the public
Service Building, 1111 Constitution in general. This action may, however, be
Martin V. Franks,
Avenue NW., Washington, DC 20224. of interest to those persons who are or
Send Submissions to CC:PA:LPD:PR Chief, Publications and Regulations Branch,
Legal Processing Division, Associate Chief may manufacture or import biobased
(REG–148998–13), Room 5205, Internal chemicals similar to fats and oils
Counsel, (Procedure and Administration).
Revenue Service, P.O. Box 7604, Ben described by the SDA nomenclature
[FR Doc. 2016–00386 Filed 1–11–16; 8:45 am]
Franklin Station, Washington, DC system. Since other entities may also be
BILLING CODE 4830–01–P
20044. Submissions may be hand- interested, the Agency has not
delivered Monday through Friday to attempted to describe all the specific
CC:PA:LPD:PR (REG–148998–13), entities that may be affected by this
Couriers Desk, Internal Revenue ENVIRONMENTAL PROTECTION action.
Service, 1111 Constitution Avenue NW., AGENCY
Washington, DC 20224 or sent B. How can I access information about
electronically via the Federal 40 CFR Chapter I this petition?
eRulemaking Portal at The docket for this TSCA section 21
[EPA–HQ–OPPT–2015–0823; FRL–9940–61]
www.regulations.gov (IRS–2015–0032). petition, identified by docket
FOR FURTHER INFORMATION CONTACT: TSCA Inventory Equivalency identification (ID) number EPA–HQ–
Concerning the regulations, Mark Determinations for Certain Class 2 OPPT–2015–0823, is available at
Shurtliff at (202) 317–3400; concerning Substances; TSCA Section 21 Petition; http://www.regulations.gov or at the
submissions of comments, the hearing Reasons for Agency Response Office of Pollution Prevention and
and/or to be placed on the building Toxics Docket (OPPT Docket),
access list to attend the hearing Regina AGENCY: Environmental Protection Environmental Protection Agency
Johnson at (202) 317–6901 (not toll-free Agency (EPA). Docket Center (EPA/DC), West William
numbers). ACTION: Petition; reasons for Agency Jefferson Clinton Bldg., Rm. 3334, 1301
SUPPLEMENTARY INFORMATION: The response. Constitution Ave. NW., Washington,
subject of the public hearing is the DC. The Public Reading Room is open
notice of proposed rulemaking (REG– SUMMARY: This document announces the from 8:30 a.m. to 4:30 p.m., Monday
148998–13) that was published in the availability of EPA’s response to a through Friday, excluding legal
Federal Register on Friday, October 23, petition it received under the Toxic holidays. The telephone number for the
2015 (80 FR 64378) relating to the Substances Control Act (TSCA). The Public Reading Room is (202) 566–1744,
holdings of Obergefell v. Hodges, 575 TSCA section 21 petition was received and the telephone number for the OPPT
U.S.lll, 135 S. Ct. 2584 (2015), from the Biobased and Renewable Docket is (202) 566–0280. Please review
Windsor v. United States, 570 Products Advocacy Group (BRAG) on the visitor instructions and additional
U.S. lll, 133 S. Ct. 2675 (2013), and October 7, 2015. The petitioner information about the docket available
Revenue Ruling 2013–17 (2013–38 IRB requested EPA to promulgate a rule at http://www.epa.gov/dockets.
201), and that define terms in the pursuant to TSCA section 8 that would
‘‘establish a process to amend the list of II. TSCA Section 21
Internal Revenue Code (Code)
describing the marital status of natural sources of oil and fat in the A. What is a TSCA section 21 petition?
taxpayers. The rules of 26 CFR ‘Soap and Detergent Association’ (SDA) Under TSCA section 21 (15 U.S.C.
601.601(a)(3) apply to the hearing. nomenclature system by considering the 2620), any person can petition EPA to
Persons who wish to present oral chemical equivalency of additional initiate a rulemaking proceeding for the
natural sources.’’ After careful
tkelley on DSK3SPTVN1PROD with PROPOSALS

comments at the hearing that submitted issuance, amendment, or repeal of a rule
written comments by January 14, 2016 consideration, EPA denied the TSCA under TSCA section 4, 6, or 8 or an
must submit an outline of the topics to section 21 petition for the reasons order under TSCA section 5(e) or
be addressed and the amount of time to discussed in this document. 6(b)(2). A TSCA section 21 petition
be devoted to each topic by Friday, DATES: EPA’s response to this TSCA must set forth the facts that are claimed
January 15, 2016. section 21 petition was signed to establish the necessity for the action
A period of 10 minutes is allotted to December 31, 2015. requested. EPA is required to grant or
each person for presenting oral FOR FURTHER INFORMATION CONTACT: deny the petition within 90 days of its

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1366 Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Proposed Rules

filing. If EPA grants the petition, the attributed to the SDA that was available for purposes of Inventory listing and
Agency must promptly commence an for ‘‘identifying and reporting certain TSCA nomenclature.’’ The petition
appropriate proceeding. If EPA denies multicomponent Class 2 chemical elsewhere clarifies what it means by
the petition, the Agency must publish substances derived from natural fats and ‘‘rely on,’’ when it notes that without
its reasons for the denial in the Federal oils and synthetic long-chain alkyl ‘‘access to the alkyl range names,’’ the
Register. A petitioner may commence a substitutes.’’ The identification and manufacturers would need to submit
civil action in a U.S. district court to reporting in question was the premanufacture notifications to EPA.
compel initiation of the requested identification and reporting of chemical The petition makes clear that the
rulemaking proceeding within 60 days manufacture and processing to EPA, intended effect of enlarging the
of either a denial or the expiration of the pursuant to a past reporting obligation definitions of existing chemical
90-day period. under TSCA section 8(a), to inform substance listings in this fashion would
EPA’s original compilation of the TSCA be to limit the circumstances in which
B. What criteria apply to a decision on Inventory under TSCA section 8(b). The manufacturers would be deemed to be
a TSCA section 21 petition? document listed 35 ‘‘natural fats and manufacturing a new chemical
Section 21(b)(1) of TSCA requires that oils,’’ as potential alkyl group sources. substance, and thus be subject to the
the petition ‘‘set forth the facts which it It provided that the particular chemical requirements of TSCA section
is claimed establish that it is necessary’’ substances named under the SDA 5(a)(1)(A).
to issue the rule or order requested, 15 convention would not be identified ‘‘in
U.S.C. 2620(b)(1). Thus, TSCA section terms of source.’’ However, chemical B. What support does the petitioner
21 implicitly incorporates the statutory substances with alkyl groups derived offer?
standards that apply to the requested from unlisted natural sources were While the petition includes no
actions. In addition, TSCA section 21 beyond the scope of the naming specific request to add a particular
establishes standards a court must use convention. Thus, each time that a natural fat or oil to the ‘‘SDA-eligible’’
to decide whether to order EPA to particular chemical substance was list, the bulk of the petition is concerned
initiate rulemaking in the event of a identified, reported, and entered into with giving, by way of background, the
lawsuit filed by the petitioner after EPA’s original compilation of the TSCA petitioners’ general reasons to believe
denial of a TSCA section 21 petition, 15 Inventory based on the SDA naming that such requests would have merit if
U.S.C. 2620(b)(4)(B). Accordingly, EPA convention, the definition of that submitted to EPA. The petition asserts,
has relied on the standards in TSCA particular substance inherited a certain in general terms, that chemical
section 21 and in the provisions under characterization from the SDA naming substances derived from other natural
which actions have been requested to convention: Specifically, that the sources ‘‘may be chemically
evaluate this TSCA section 21 petition. chemical substance in question was indistinguishable from,’’ are ‘‘nearly
derived either from one or more of the identical’’ to, or are ‘‘substantially
III. Summary of the TSCA Section 21 35 listed natural fats and oils or from
Petition similar,’’ to chemical substances
synthetic long-chain alkyl substitutes. synthesized from one of the 35 listed
A. What action was requested? The procedure that the petition asks
natural sources. The petition also asserts
EPA to establish by a TSCA section 8
On October 7, 2015, EPA received a that while such substances address
rule is a procedure for submitting
petition from the Biobased and ‘‘critical needs for sustainability,’’ there
further requests to EPA. Specifically, it
Renewable Products Advocacy Group is a ‘‘key hindrance’’ to their
would be a regulation governing how
(BRAG) requesting the Agency to commercialization. Specifically, the
the public would submit requests to
address the ‘‘disproportionate regulatory ‘‘key hindrance’’ is that certain of these
amend the SDA-eligible list and how
burden’’ imposed on companies in the chemical substances (or derivatives
EPA would respond to such requests.
bio-based chemical sector, noting that a thereof) would be subject to EPA’s pre-
The procedure would detail how EPA
‘‘limitation of source categories in the would review a request to include an manufacture review under section 5 of
SDA system results in inequitable additional source material of a fat or oil TSCA, while assertedly similar
regulatory treatment for chemical substance, ‘‘following a premanufacture chemical substances derived from one
substances that are functionally the notice or other appropriate notification of the 35 listed natural sources would be
same and chemically nearly identical.’’ to EPA,’’ in order to determine if it is existing chemical substances and
Specifically, the petition asks EPA to ‘‘sufficiently similar’’ to sources of fat or therefore would not need to undergo
commence a rulemaking process under oil substances with the same alkyl range such review. The petition claims that
TSCA section 8, the objective of which that are already built into the SDA continuing to treat chemical substances
would be to ‘‘establish a procedure by naming convention. After review, if EPA derived from ‘‘these novel sources,’’ as
which EPA can add new sources of fats found ‘‘such similarity’’ between the new chemical substances ‘‘creates a
and oils to the SDA-eligible list.’’ requested additional source material disincentive for customers to switch
The petition states that the SDA- and already-listed source materials, the from traditional oils.’’
eligible list is part of a broader contemplated rule would direct the The specific action requested in the
‘‘nomenclature system developed by Agency to add the requested source petition is that EPA ‘‘initiate a
SDA when the TSCA Inventory was material to the SDA-eligible list in the rulemaking under TSCA section 8 that
initially compiled.’’ The term ‘‘SDA- SDA naming convention. would establish a process to amend the
eligible list’’ refers to a list found in the The petition explains that the list of natural sources of oil and fat [the
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1978 Candidate List of Chemical outcome sought (in the event EPA SDA-eligible list] . . . by considering
Substances on the TSCA Inventory, in granted a request under the procedure the chemical equivalency of additional
‘‘Addendum III: Chemical Substances of that petitioners now ask EPA to natural sources.’’ The petition supplies
Unknown or Variable Composition, establish by section 8 rule) would be to two reasons for the specific action
Complex Reaction Products and authorize manufacturers of various requested. First, that EPA ‘‘should allow
Biological Materials’’ (Ref. 2). In Section chemical substances derived from the for new sources to be added,’’ to the list
I of that document, EPA described a additional source material to ‘‘rely on and second, that issuing such a
chemical substance naming convention, the appropriate SDA alkyl range identity regulatory proposal would not require a

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Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Proposed Rules 1367

‘‘significant expenditure of time and of a rule under TSCA section 8 requires be addressed if EPA were to promulgate
resources.’’ the petitioner to show by a a regulatory procedure governing the
‘‘preponderance of the evidence that manner and method of making and
IV. Disposition of TSCA Section 21
. . . there is a reasonable basis to responding to such requests. Part of the
Petition
conclude that the issuance of such a difficulty in following the petition’s
A. What is EPA’s response? rule . . . is necessary to protect health reasoning stems from the petition’s
After careful consideration, EPA or the environment against an conflation of two distinct issues: (1)
denied the petitioner’s request to unreasonable risk of injury’’ (15 U.S.C. Whether a chemical substance derived
initiate a TSCA section 8 rulemaking. 2620(b)(4)(B)). from an unlisted natural fat or oil can
2. Background on the TSCA
EPA denied the request because the currently be treated as identical to
Inventory. EPA’s authority to manage
petition neither justified the petitioners’ another substance that is derived
the TSCA Inventory is pursuant to
claim (that the initiation of a TSCA consistent with the SDA naming
TSCA section 8(b) (15 U.S.C. 2607(b)),
section 8 rulemaking proceeding is which directs the Agency to ‘‘compile, convention; and (2) whether alteration
necessary) nor explained how keep current, and publish a list of each of the SDA naming convention, to
petitioners believe EPA’s actual chemical substance which is encompass new sources of fats and oils,
rulemaking authorities under section 8 manufactured or processed in the is currently ‘‘allowed.’’
could be used to accomplish the United States.’’ Although EPA was
objectives that petitioners are seeking. The petition correctly recognizes the
directed to promulgate a data collection current limitations of certain TSCA
To the extent the petition was actually rule under TSCA section 8(a), ‘‘not later
seeking an Agency order under TSCA Inventory listings (i.e., those listings that
than 180 days after January 1, 1977,’’ to incorporate particular assumptions
section 8(b) (e.g., effectuating the gather data ‘‘[f]or purposes of the
alteration of certain entries on the TSCA about the natural sources of fats or oils
compilation of the list . . . under from which the listed substance is
Inventory), EPA notes that a request for subsection (b),’’ rules under TSCA
an order under TSCA section 8(b) is not derived, because they were named
section 8(a) do not themselves effectuate
cognizable in a petition that is according to the SDA naming
changes to the contents of the TSCA
submitted pursuant to TSCA section 21 Inventory. The initial compilation convention). Manufacturers of a new
(15 U.S.C. 2620(b)(1)). A copy of the process under TSCA section 8(b) was chemical substance that clearly falls
Agency’s response, which consists of a completed long ago, with the Agency outside the definitional scope of an
letter to the petitioner, is available in noting in 1980 that henceforth existing chemical substance are not
the docket for this TSCA section 21 ‘‘premanufacture notification allowed to determine that the new
petition. requirements of section 5 will apply to chemical substance is nonetheless
B. What is EPA’s reason for this all chemical substances manufactured sufficiently ‘‘similar’’ to the existing
response? and imported in bulk or as part of a chemical substance, and simply deem
mixture which has not been reported for the new chemical substance to be an
1. Background on TSCA Section 8 the Inventory.’’ 45 FR 50544 (July 29, existing substance on the basis of that
Rules. TSCA section 8 provides express 1980). Today, it remains EPA’s practice similarity. Nor would EPA grant such a
rulemaking authority in three distinct to add entries to the TSCA Inventory on request, which would be inconsistent
subsections: First, TSCA section 8(a) (15 the basis of notices of commencement with TSCA section 3(9): A new
U.S.C. 2607(a)) authorizes EPA to that are submitted ‘‘in accordance with
promulgate rules under which current chemical substance is ‘‘any chemical
[TSCA] section 5.’’ See 15 U.S.C. substance which is not included in the
or prospective manufacturers (including 2607(b) and 40 CFR 720.102. From time
importers) and processors of chemical chemical substance list compiled and
to time, EPA has also made corrections published under [TSCA section 8(b)].’’
substances must maintain records and to the TSCA Inventory. EPA has
submit such information as the EPA consistently done so without But the petition presumes, without
Administrator may reasonably require. rulemaking. See 66 FR 34193, 34197 justification, that until a certain
TSCA section 8(a) also authorizes EPA (June 27, 2001) (making clear that the preliminary EPA rulemaking has been
to promulgate rules under which action in question was a ‘‘correction to completed, those same manufacturers
current or prospective manufacturers TSCA Inventory nomenclature,’’ and lack a meaningful opportunity to
and processors of mixtures must ‘‘not a rule.’’) and 75 FR 8266, 8272 request that EPA enlarge the definitional
maintain records and submit (February 24, 2010) (again, ‘‘not a rule’’) scope of one or more existing chemical
information to the extent the EPA substances named according to the SDA
Administrator determines the 3. Necessity of Establishing a Regulatory
Procedure for Requesting and naming convention. The petition’s
maintenance of records or submission of failure to explain that a particular
reports, or both, is necessary for the Effectuating Changes to SDA Naming
Conventions impediment exists (either to
effective enforcement of TSCA. Second,
manufacturers in making these sorts of
TSCA section 8(c) (15 U.S.C. 2607(c)) The petition asserts that a new
requests or to EPA in adjudicating them)
authorizes EPA to promulgate rules that regulatory procedure is necessary, to
is sufficient grounds to deny the request
‘‘determine’’ certain obligations to govern public requests for changes to
‘‘maintain records of significant adverse the SDA naming convention and EPA to commence a rulemaking proceeding
reactions to health or the environment.’’ response to those requests. The reason intended to remove the unspecified
impediment.
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Third, TSCA section 8(d) (15 U.S.C. given for why such a procedure is
2607(d) authorizes rules for the necessary is that the SDA naming Thus, the petition does not
submission to the Administrator of lists convention ‘‘should allow for new demonstrate that the requested rule is
and copies of certain health and safety sources to be added.’’ Yet the petition necessary in any respect, much less that
studies. If the Agency denies a petition supplies no evidence of any current it is necessary to protect health or the
submitted under TSCA section 21, impediment to any party in making environment against an unreasonable
judicial review in the case of a petition requests along these lines, or to EPA in risk of injury.
to initiate a proceeding for the issuance considering such requests, which would

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Document Created: 2016-01-12 01:23:13
Document Modified: 2016-01-12 01:23:13
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		Proposed Rules
Action		Petition; reasons for Agency response.
Dates		EPA's response to this TSCA section 21 petition was signed December 31, 2015.
Contact		For technical information contact: Kent Anapolle, Chemistry, Economics, and Sustainable Strategies Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number:
FR Citation		81 FR 1365