[Federal Register Volume 69, Number 219 (Monday, November 15, 2004)]
[Proposed Rules]
[Pages 65565-65570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-25307]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 720

[OPPT-2003-0058; FRL-7342-2]
RIN 2070-AJ04


TSCA Inventory Nomenclature for Enzymes and Proteins

AGENCY: Environmental Protection Agency (EPA).

ACTION: Advance Notice of Proposed Rulemaking (ANPRM).

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SUMMARY: This ANPRM alerts interested parties that EPA is considering 
new procedures and regulations for naming enzymes and proteins when 
listing such substances on the Toxic Substances Control Act (TSCA) 
Chemical Substances Inventory (Inventory). More specifically, this 
ANPRM outlines four identification elements that EPA currently believes 
are appropriate for use in developing unique TSCA Inventory 
nomenclature for proteinaceous enzymes. This ANPRM also solicits public 
comment on several specific questions relating to this initiative.

DATES: Comments must be received on or before December 15, 2004.

ADDRESSES: Submit your comments, identified by docket ID number OPPT-
2003-0058, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov/. 
Follow the on-line instructions for submitting comments.
    <bullet> Agency Website: http://www.epa.gov/edocket/. EDOCKET, 
EPA's electronic public docket and

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comment system, is EPA's preferred method for receiving comments. 
Follow the on-line instructions for submitting comments.
    <bullet> E-mail: <a href="/cdn-cgi/l/email-protection#315e4141451f5f525852715441501f565e47"><span class="__cf_email__" data-cfemail="ff908f8f8bd1919c969cbf9a8f9ed1989089">[email protected]</span></a>.
    <bullet> Mail: Document Control Office (7407M), Office of Pollution 
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 
Pennsylvania Ave., NW., Washington, DC 20460-0001.
    <bullet> Hand delivery/courier: OPPT Document Control Office (DCO), 
EPA East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC, 
Attention: Docket ID number OPPT-2003-0058. The DCO is open from 8 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the DCO is (202) 564-8930. Such deliveries are 
only accepted during the Docket's normal hours of operation, and 
special arrangements should be made for deliveries of boxed 
information.
    Instructions: Direct your comments to docket ID number OPPT-2003-
0058. EPA's policy is that all comments received will be included in 
the public docket without change and may be made available on-line at 
http://www.epa.gov/edocket/, including any personal information 
provided, unless the comment includes information claimed to be 
Confidential Business Information (CBI) or other information whose 
disclosure is restricted by statute. Do not submit information that you 
consider to be CBI or otherwise protected through EDOCKET, 
regulations.gov, or e-mail. The EPA EDOCKET and the Federal 
regulations.gov websites are ``anonymous access'' systems, which means 
EPA will not know your identity or contact information unless you 
provide it in the body of your comment. If you send an e-mail comment 
directly to EPA without going through EDOCKET or regulations.gov, your 
e-mail address will be automatically captured and included as part of 
the comment that is placed in the public docket and made available on 
the Internet. If you submit an electronic comment, EPA recommends that 
you include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. Electronic 
files should avoid the use of special characters, any form of 
encryption, and be free of any defects or viruses. For additional 
information about EPA's public docket visit EDOCKET on-line or see the 
Federal Register of May 31, 2002 (67 FR 38102) (FRL-7181-7).
    Docket: All documents in the docket are listed in the EDOCKET index 
at http://www.epa.gov/edocket/. Although listed in the index, some 
information is not publicly available, i.e., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, is not placed on the Internet and will be 
publicly available only in hard copy form. Publicly available docket 
materials are available either electronically in EDOCKET or in hard 
copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Rm. 
B102, 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 EPA Docket Center Reading Room telephone 
number is (202) 566-1744, and the telephone number for the OPPT Docket, 
which is located in the EPA Docket Center, is (202) 566-0280.

FOR FURTHER INFORMATION CONTACT: For general information contact: Colby 
Lintner, Regulatory Coordinator, Environmental Assistance Division 
(7408M), Office of Pollution Prevention and Toxics, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 554-1404; e-mail address: <a href="/cdn-cgi/l/email-protection#683c3b2b294520071c0401060d280d1809460f071e"><span class="__cf_email__" data-cfemail="5d090e1e1c70153229313433381d382d3c733a322b">[email protected]</span></a>.
    For technical information contact: James Alwood, Chemical Control 
Division, (7405M), Office Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (202) 564-8974; e-mail 
address: <a href="/cdn-cgi/l/email-protection#1f7e736870707b317576725f7a6f7e31787069"><span class="__cf_email__" data-cfemail="0a6b667d65656e246063674a6f7a6b246d657c">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture, 
import, process, or use chemical substances which are subject to TSCA 
jurisdiction. Potentially affected entities may include, but are not 
limited to:

    <bullet> Chemical manufacturers (NAICS 325), e.g., persons 
manufacturing, importing, processing, or using chemicals for commercial 
purposes.
    <bullet> Petroleum and coal product industries (NAICS 324), e.g., 
persons manufacturing, importing, processing, or using chemicals for 
commercial purposes.

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. To determine 
whether you or your business may be affected by this action, you should 
carefully examine the applicability provisions in title 40 of the Code 
of Federal Regulations (CFR) at 40 CFR 720.22. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document and Other 
Related Information?

    In addition to EDOCKET (http://www.epa.gov/edocket/), you may 
access this Federal Register document electronically through the EPA 
Internet under the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 720 
is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.

C. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of 
the information that you claim to be CBI. For CBI information in a disk 
or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM 
as CBI and then identify electronically within the disk or CD ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the rulemaking by docket ID number and other 
identifying information (subject heading, Federal Register date and 
page number).
    ii. Follow directions--The Agency may ask you to respond to 
specific questions or organize comments by referencing a CFR part or 
section number.

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    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
reproduced.
    vi. Provide specific examples to illustrate your concerns, and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. Background

A. What Action is the Agency Taking?

    This ANPRM is alerting stakeholders that EPA is considering 
changing procedures and requirements for naming enzymes and proteins 
for the purpose of listing those substances on the TSCA Inventory. 
Specifically, EPA has identified four elements that it currently 
believes are appropriate for use in creating unique and unambiguous 
identities for proteinaceous enzymes on the TSCA Inventory. Through 
this ANPRM, EPA is also soliciting public comment on the scientific 
appropriateness and technical feasibility of using the identification 
elements summarized herein.

B. What is the Agency's Authority for Taking this Action?

    Section 8(b) of TSCA requires EPA to ``compile, keep current, and 
publish a list of each chemical substance which is manufactured or 
processed in the United States'' (the TSCA Inventory). In order to 
fulfill this requirement, EPA must continuously update and keep current 
various types of information, including, but not limited to, the 
information used to identify any new chemical substance that is 
reported to be manufactured or processed in the United States. EPA also 
makes corrections, when necessary, of previously reported information 
on the TSCA Inventory.

C. TSCA Inventory Background

    As stated above, TSCA section 8(b) requires EPA to compile, keep 
current, and publish a list of chemical substances which are 
manufactured (including imported) or processed in the United States. 
This listing, known as the ``TSCA Inventory,'' informs the public of 
which chemical substances are being manufactured, imported, or 
processed in the United States for commercial purposes. For the TSCA 
Inventory to accurately inform the public, it must be continuously and 
accurately updated as new information becomes available. The updating 
process includes adding to the Inventory the identities of new chemical 
substances that are being introduced into U.S. commerce and corrections 
when necessary of the identities of previously reported substances. The 
Agency has developed policies regarding the identification of chemical 
substances for the purpose of assigning a unique description of each 
substance on the TSCA Inventory. Published nomenclature guidance is 
currently available for polymeric substances, substances containing 
varying carbon chain lengths, complex reaction products, mixtures, and 
chemical substances of unknown or variable compositions. Approximately 
81,500 chemical substances, as defined in section 3 of TSCA, are on the 
TSCA Inventory at this time.
    In its implementation of TSCA, EPA defines chemical substances as 
either ``existing'' chemicals or ``new'' chemicals. The only way to 
determine if a substance is new or existing is by consulting the TSCA 
Inventory. Any substance that is listed on the TSCA Inventory is an 
existing chemical, otherwise it is a new chemical. If a substance is a 
new chemical, generally it can be manufactured or imported for non-
exempt commercial purposes only when a Premanufacture Notice (PMN) is 
submitted at least 90 days before the manufacture or import of such 
substance begins (see section 5(a) of TSCA and 40 CFR part 720). During 
this 90-day review period EPA will evaluate the proposed manufacture, 
processing, use, distribution in commerce, and disposal of the 
substance, and if necessary, prohibit or limit any activity that may 
result in an unreasonable risk of injury to human health or the 
environment. A new chemical substance also can be manufactured or 
imported if it is subject to an exemption from full premanufacture 
reporting, for example a Low Volume Exemption or a Test Marketing 
Exemption (see 40 CFR part 723 and 40 CFR 720.38). In addition a new 
chemical substance is excluded from premanufacture reporting under 
certain conditions such as manufacture or import of small quantities 
for research and development or if the substance does not meet the TSCA 
definition of chemical substance as defined in 40 CFR part 720.3(e) 
(see 40 CFR 720.30).

D. Inventory Listings of Enzymes

    When EPA promulgated the TSCA Inventory Reporting Regulations of 
1977 (42 FR 64572, December 23, 1977), the Agency did not provide 
specific guidance regarding how complex biological compounds should be 
identified. However, EPA did publish the TSCA Candidates List to 
provide examples of the types of substances that would be reportable 
for the Inventory. That list included enzymes. As a result, 
approximately 150 enzymes were reported and listed on the TSCA 
Inventory without specific agency guidance regarding how they should be 
unambiguously identified. The original Inventory listings for non-
enzymatic proteins and other complex biological compounds are based on 
information originally reported to EPA that varies widely in the type 
and specificity of information included.
    The enzymes currently on the TSCA Inventory are identified by a 
Chemical Abstract Services (CAS) Registry Number and Chemical Abstracts 
9\th\ Collective Index Name. The names assigned to these enzymes by EPA 
vary in the type and specificity of information included due to wide 
variation in the type and amount of information originally reported to 
EPA. For some enzymes, the name is broad, defining only the most 
generic catalytic activity of the enzyme (e.g., proteinase).
    As a result of the existing broad and generic TSCA Inventory enzyme 
listings, it has been difficult for EPA to determine whether enzyme 
substances are new and distinct, or covered under existing listings. In 
most cases, newly developed enzymes appear to be subsumed under one of 
the current broad and generic TSCA Inventory enzyme listings, which 
means that, although they are newly developed, they appear to be 
existing chemicals. This, in turn, means that EPA is reviewing very few 
new enzymes under section 5 of TSCA, despite the ongoing innovation in 
this field as to the specificity and functions of commercially 
available enzymes. Under the existing nomenclature system, therefore, 
EPA may not be addressing all of the newly developed enzymes and 
considering the potential risks that may be associated with these 
substances under section 5 of TSCA. A more specific nomenclature system 
would allow EPA to assess newly developed enzymes and take actions 
needed to prevent potential unreasonable risks to health and the 
environment that may be associated with these substances under section 
5 of TSCA before they occur.

[[Page 65568]]

    In addition, the broad TSCA Inventory enzyme listings, the lack of 
clear reporting guidelines, and the absence of policy concerning what 
structural variation or changes trigger reporting, also make it 
difficult for manufacturers to determine whether enzyme substances are 
new or covered under existing listings. Recognizing that enzyme 
listings on the Inventory were broad, EPA developed an interim policy 
that manufacturers of enzymes should contact EPA regarding submission 
of a bona fide intent to manufacture before producing any enzyme. EPA 
also routinely advised submitters of a Notice of Bona Fide Intent to 
Manufacture that the Agency may modify the method of listing enzymes on 
the Inventory and that this could require reporting at a higher level 
of detail than is required at present. This case-by-case determination 
creates uncertainty and an unnecessary burden for both the Agency and 
PMN submitters. More specific guidelines for identifying enzymes on the 
TSCA Inventory would make the process of deciding whether an enzyme is 
new or existing more predictable and transparent.
    In order to more effectively meet its statutory obligation under 
TSCA to prevent unreasonable risk to human health and the environment 
and to maintain a complete and accurate list of all chemical substances 
manufactured, imported, or processed, EPA believes it is necessary to 
refine its policies with regard to enzyme identification reporting 
requirements. The timely development of identification reporting 
guidelines for enzymes is essential, given the increasing use of 
enzymes in commerce, the wide variety of enzymes that are being 
produced, and the development of new and different manufacturing 
techniques.

III. Identification Elements

A. Description of Identification Elements

    EPA has identified four elements that it currently believes are 
appropriate to use in combination to create unambiguous listings for 
proteinaceous enzymes on the TSCA Inventory:
    1. Function.
    2. Source.
    3. Processing.
    4. Amino acid sequence.
EPA believes that no individual element provides sufficient 
identification information by itself. Rather, EPA anticipates that all 
four elements will provide useful and necessary information for the 
unambiguous identification of proteinaceous enzymes and that some 
combination of these and/or additional identification elements may be 
appropriate for other enzymes and proteins.
    The function of an enzyme refers to its catalytic activity. The 
internationally accepted nomenclature conventions of the Nomenclature 
Committee of the International Union of Biochemistry and Molecular 
Biology (NC-IUBMB) describe and differentiate enzymes based on 
catalytic activity. Function, or catalytic activity, could be 
incorporated as an element of chemical identity of an enzyme on the 
TSCA Inventory using this standard enzyme nomenclature.
    Source refers to the organism from which the gene encoding the 
enzyme was derived and the organism or manufacturing platform (e.g., 
tissue culture) in which the enzyme is produced. The two sources may be 
the same or differ when the enzyme gene from one organism is introduced 
through genetic engineering into a different organism or through the 
use of a synthetic sequence.
    Processing refers to procedures used to isolate the enzyme from the 
production organism or manufacturing platform, procedures used to 
purify it, or any chemical reactions to which the enzyme is subjected 
to produce the final product.
    The amino acid sequence of an enzyme or protein is known as its 
primary structure. The amino acid sequence is a systematic 
representation of the linear chain of amino acids connected via amide 
bonds that produce a polypeptide.
An example of enzyme nomenclature using these identification elements 
would be neopullulanase (Enzyme Commission 3.2.1.135), produced by 
Bacillus stearothermophilus, treated with acetic acid, with amino acid 
sequence:
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This is one version of enzyme nomenclature using these four 
identification elements. Actual nomenclature would vary widely 
depending on use of all four elements, nomenclature used for each 
element, and the level of detail ultimately used for each element.

B. Issues for Public Comment

    EPA is soliciting comments on all aspects of the discussion 
presented in this document regarding nomenclature issues for enzymes 
and proteins, for purposes of listing these chemical substances on the 
TSCA Inventory. EPA is particularly interested in receiving comments on 
the following topics.
    EPA has identified four elements (listed in Unit III.A.), that it 
currently believes are appropriate to derive unique nomenclature for 
the purpose of unambiguously listing proteinaceous enzymes on the TSCA 
Inventory. EPA is seeking comments on the scientific appropriateness of 
using these identification elements, the level of detail necessary to 
create specific, unambiguous TSCA Inventory listings, the technical 
feasibility of providing such information, and any additional or 
alternative elements that could be used to identify proteinaceous 
enzymes on the TSCA Inventory.
    Are the identification elements proposed for proteinaceous enzymes 
scientifically appropriate and sufficiently comprehensive for non-
proteinaceous enzymes and non-enzymatic proteins? Are there additional 
or alternative identification elements that should be used in creating 
TSCA Inventory listings for non-proteinaceous enzymes and non-enzymatic 
proteins?If so, what are these alternatives, and why is it believed 
that these alternatives are preferable.

IV. Do Any Statutory or Executive Order Reviews Apply to this Action?

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993), it has been determined that this 
ANPRM is a ``significant regulatory action'' under section 3(f) of the 
Executive order. The Agency therefore submitted this document to OMB 
for the 10-day review period afforded under this Executive order. Any 
changes made in response to OMB comments during that review have been 
documented in the docket as required by the Executive order.
    Since this ANPRM does not impose or propose any requirements, and 
instead seeks comments and suggestions for the Agency to consider in 
developing a subsequent notice of proposed rulemaking, the various 
other review requirements that apply when an agency imposes 
requirements do not apply to this action.
    As part of your comments on this ANPRM you may include any comments 
or information that you have regarding these requirements. In 
particular, any comments or information that would help the Agency to 
assess the potential impact of a rule on small entities pursuant to the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.); to consider 
voluntary consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note); or to consider 
environmental health or safety effects on children pursuant to 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997). The Agency will consider such comments during the development of 
any subsequent notice of proposed rulemaking as it takes appropriate 
steps to address any applicable requirements.

List of Subjects in 40 CFR Part 720

    Environmental protection, Chemicals, Hazardous substances, 
Reporting and recordkeeping requirements.



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    Dated: November 1, 2004.
Michael O. Leavitt,
Administrator.

[FR Doc. 04-25307 Filed 11-12-04; 8:45 am]
BILLING CODE 6560-50-S


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