[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Proposed Rules]
[Pages 1365-1368]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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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]
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