[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
[[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]
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