[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]
=======================================================================
-----------------------------------------------------------------------
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).
-----------------------------------------------------------------------
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:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: http://www.epa.gov/edocket/. EDOCKET,
EPA's electronic public docket and
[[Page 65566]]
comment system, is EPA's preferred method for receiving comments.
Follow the on-line instructions for submitting comments.
E-mail: [email protected].
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.
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: [email protected].
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: [email protected].
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:
Chemical manufacturers (NAICS 325), e.g., persons
manufacturing, importing, processing, or using chemicals for commercial
purposes.
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.
[[Page 65567]]
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:
BILLING CODE 6560-50-S
[[Page 65569]]
[GRAPHIC] [TIFF OMITTED] TP15NO04A.055
BILLING CODE 6560-50-C
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.
[[Page 65570]]
Dated: November 1, 2004.
Michael O. Leavitt,
Administrator.
[FR Doc. 04-25307 Filed 11-12-04; 8:45 am]
BILLING CODE 6560-50-S