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Sustainable Futures -- Voluntary Pilot Project Under the TSCA New



Thought this would be of interest to the list members...


[Federal Register: December 11, 2002 (Volume 67, Number 238)]
[Notices]
[Page 76281-76292]
>From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de02-73]

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ENVIRONMENTAL PROTECTION AGENCY
[OPPT-2002-0011; FRL-7198-6]
RIN 2070-AD60

Sustainable Futures -- Voluntary Pilot Project Under the TSCA New
Chemicals Program; Notice

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.

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SUMMARY: This notice announces a voluntary pilot project by EPA,
entitled Sustainable Futures, to encourage the application of pollution
prevention principles during the development of new chemicals submitted
as premanufacture notices (PMNs) under section 5 of the Toxic
Substances Control Act (TSCA). Certain expedited review under section 5
of TSCA is proposed as an incentive to PMN submitters. The goal of this
pilot project is to encourage pollution prevention and the development
of inherently low hazard chemicals. Furthermore, the Agency seeks to
gain additional data and experience regarding the pollution prevention,
risk reduction, and source reduction benefits of use of hazard,
exposure, and risk screening methodologies such as EPA's Pollution
Prevention Framework in new product development efforts.

DATES: Comments are solicited on or before June 9, 2003.

ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: For general information contact:
Barbara Cunningham, Acting Director, 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: TSCA-
<A HREF="mailto:Hotline@epa.gov";>Hotline@epa.gov</A>.
    For technical information contact: For New Chemicals Program
regulatory information: Kenneth T. Moss, Chemical Control Division
(7405M), Office Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-9232; e-mail address:
<A HREF="mailto:moss.kenneth@epa.gov";>moss.kenneth@epa.gov</A>. For
information about P2 Framework and Training
or Workshops: Bill Waugh or Maggie Wilson, Risk Assessment Division
(7403M), Office of Pollution Prevention and Toxics, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone numbers: (202) 564-7657 or 564-8924; e-mail addresses:
<A HREF="mailto:waugh.bill@epa.gov";>waugh.bill@epa.gov</A> or <A HREF="
mailto:wilson.maggie@epa.gov.";>wilson.maggie@epa.gov.</A>

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are or may in
the future be a submitter of a PMN under TSCA. Potentially affected
entities may include, but are not limited to:
    ? Chemical manufacturers or importers (NAICS 325, 32411, 28,
2911). Anyone who plans to manufacture or import a new chemical
substance (as defined in TSCA section 3) for a non-exempt commercial
purpose is required to provide the EPA with a PMN at least 90 days
prior to the activity. Any TSCA Chemical substance that is not on the
TSCA Inventory is classified as a new chemical.
    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. 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 Get Copies of This Document and Other Related Information?

    1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPPT-2002-0011. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the EPA Docket Center, Rm.
B102-Reading Room, EPA West, 1301 Constitution Ave., NW., Washington,
DC. The EPA Docket Center 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 EPA Docket Center, is (202) 566-
0280.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at <A HREF="http://www.epa.gov/fedrgstr/
">http://www.epa.gov/fedrgstr/</A>.
    An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at <A HREF="http://www.epa.gov/edocket/
">http://www.epa.gov/edocket/</A> to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
    Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
    For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the

[[Page 76283]]

version of the comment that is placed in EPA's electronic public
docket. The entire printed comment, including the copyrighted material,
will be available in the public docket.
    Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.

C. How and To Whom Do I Submit Comments?

    You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
    1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. 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.
    i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at <A HREF="
http://www.epa.gov/edocket";>http://www.epa.gov/edocket</A>
, and follow the online instructions for submitting comments.
Once in the system, select ``search,'' and then key in docket ID number
OPPT-2002-0011. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
    ii. E-mail. Comments may be sent by e-mail to <A HREF="
mailto:oppt.ncic@epa.gov";>oppt.ncic@epa.gov</A>,
Attention: Docket ID Number OPPT-2002-0011. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
    iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
    2. By mail. Send your comments to: Document Control Office (7407M),
Office of Pollution Prevention and Toxics (OPPT), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
    3. By hand delivery or courier. Deliver your comments to: OPPT
Document Control Office (DCO) in EPA East Building Rm. 6428, 1201
Constitution Ave., NW., Washington, DC. Attention: Docket ID Number
OPPT-2002-0011. 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.

D. How Should I Submit CBI To the Agency?

    Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
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 CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    In addition to one complete version of the comment that includes
any 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 and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the technical person listed under FOR FURTHER INFORMATION CONTACT.

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

    We invite you to provide your views on the various options we
propose, new approaches we have not considered, the potential impacts
of the various options (including possible unintended consequences),
and any data or information that you would like the Agency to consider
during the development of the final action. You may find the following
suggestions helpful for preparing your comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice or collection
activity.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

II. Background

    Under section 5(a) of TSCA, persons must notify EPA at least 90
days before manufacturing or importing a new chemical substance for
non-exempt purposes. A new chemical substance, as defined in section
3(9) of TSCA, is any chemical substance (as defined in section 3(2) of
TSCA) that is not included on the Inventory compiled under section 8(b)
of TSCA. EPA requires that submissions be made on EPA Form 7710-25-
Premanufacture

[[Page 76284]]

Notice (PMN). The Agency encourages chemical manufacturers to
incorporate health and environmental issues into product decisionmaking
during the development of new chemical substances. EPA has several
ongoing initiatives intended to help stakeholders better assess risk
issues during the early stages of chemical development efforts.
Examples include the Design for Environment Program, the Green
Chemistry Program, and the Pollution Prevention Framework (P2
Framework), among other programs. Of specific relevance to today's
notice is the P2 Framework as utilized in the development of safer new
chemicals submitted as PMNs under section 5 of TSCA.

A. What Action is the Agency Taking?

    The Agency seeks to gain additional data and experience regarding
the pollution prevention, safer chemicals, risk reduction, and source
reduction benefits of use of hazard, exposure, and risk screening
methodologies such as the P2 Framework in new product development
efforts. To help build this knowledge base the Agency has established
this pilot project, entitled Sustainable Futures, to encourage
application of pollution prevention principles during the development
of new chemicals under TSCA, known hereafter as the ``pilot project.''
While EPA's major goal is development of safer new chemicals, for
purposes of the pilot it will also consider low-moderate hazard
chemicals for which exposure assessment indicates potentially low risk.
This pilot project is entirely voluntary and will enable the Agency to
develop information to support a possible future exemption under
section 5(h)(4) of TSCA based on experience gained in Sustainable
Futures. Under this initiative, pilot project participants would be
encouraged to become proficient with and to apply the Pollution
Prevention Framework (P2 Framework) or other scientifically acceptable
hazard, exposure, and risk screening methods in new chemical
development efforts. To encourage industry participation in this
voluntary pilot project, the Agency will consider providing certain
expedited review to participants in the pilot project. This notice
provides additional detail relating to the expedited review available
under this pilot project and discusses criteria or factors EPA will
consider to determine eligibility for the pilot project and associated
expedited review.

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

    This pilot project is entirely voluntary and will enable the Agency
to develop information to support a possible future exemption to the
PMN reporting requirements of section 5 of TSCA, under section 5(h)(4)
of TSCA and based on experience gained in Sustainable Futures. See
below for a further explanation of these requirements and general
information on the New Chemicals Program.

C. Overview of the PMN Process

    Under section 5(a) of TSCA, persons must notify EPA at least 90
days before manufacturing or importing a new chemical substance for
non-exempt purposes. EPA requires that submissions be made on EPA Form
7710-25 - Premanufacture Notice (PMN). Along with the PMN submitters
must send in all available data on chemical identity, production
volume, byproducts, use, environmental release, disposal practices, and
human exposure. In addition, submitters must send in all existing
health and environmental data in the possession of the submitter,
parent company, or affiliates. All of this information is considered by
Agency risk assessors to determine whether manufacture, processing,
distribution in commerce, use, or disposal of such substance, or any
combination of such activities, presents an unreasonable risk of injury
to health or the environment. In some cases, EPA can require submission
of any additional data, including development of data through testing,
when the information included with the PMN, coupled with that available
to its risk reviewers from internal archives is not adequate to allow
EPA to make this determination. The Instruction Manual for
Premanufacture Notification of New Chemical Substances explains all
reporting requirements.
    EPA has limited or no reporting requirements for new chemical
substances in the following cases:
    ? Low Volume Exemption (LVE) -- 10,000 kilograms or less of
the substance will be manufactured or imported each year under the
requirements at (40 CFR 723.50). Notification required, using EPA Form
7710-25 (the PMN Form).
    ? Research and Development (R&D) -- the substance is
manufactured in small quantities for research and development, and
special procedural and recordkeeping requirements are met (40 CFR
720.36 and 720.78). Notification not required.
    ? Low Releases and Low Exposures (LoREX) Exemptions -- the
substance is expected to have low release and exposure under the
requirements at 40 CFR 723.50. Notification required, using the PMN
Form.
    ? Test Marketing Exemption (TME) -- the substance is being
manufactured or imported for TME, under the requirements at 40 CFR
720.38. Notification required, using the PMN Form.
    ? Polymer Exemption -- the substance is a polymer that meets
certain specified criteria where the substance is not considered
chemically active or bioavailable under the requirements at 40 CFR
723.250. Annual report to the Agency is required for those exempt
polymers commenced for the first time in the preceding calendar year.
    Section 5 of TSCA gives EPA 90 days to review a PMN (also referred
to as a ``section 5 notice''). The PMN program has evolved into an
efficient mechanism to identify new chemicals which are of greatest
concern during the early stages of the 90-day review process and focus
detailed analysis on these cases with the ultimate goal of identifying
and controlling unreasonable risks. EPA utilizes an integrated approach
that draws on knowledge and experience across scientific and
organizational lines to identify and evaluate concerns regarding health
and environmental effects, exposure and release and economic impacts.
PMNs and exemption notices share the early stages of the 90-day PMN
review process; LVE and LoREX applications conclude review by day 30
and TME applications by day 45.
    A large majority of PMN submissions are reviewed, evaluated and
dropped from further consideration during the early stages, i.e., first
30 days, of the PMN review period. The early stages of the PMN review
period include:
    1. The Chemical Review and Search Strategy Meeting;
    2. The Structure Activity Team Meeting;
    3. Development of the Exposure and Release Profile; and
    4. The Focus Meeting.
    The Chemical Review and Search Strategy (CRSS) meeting (day 8-12)
examines chemical identity; structure/chemical nomenclature; structural
analogs/TSCA Inventory Status; synthesis (including byproducts and
impurities); use/TSCA jurisdiction as provided by the PMN submitter,
open literature, or as identified by EPA for similar chemical
substances; physical/chemical properties (physical state, molecular
weight, melting and boiling point, vapor pressure, solubility, octanol
water partition co-efficient, pH); and

[[Page 76285]]

pollution prevention aspects, using information provided by the PMN
submitter. EPA also may make suggestions for alternate synthetic
pathways. Decisions at this meeting include notice completeness,
validity, reportability, eligibility for exemption, candidacy for
exposure-based review (PMN has potential for substantial production
volume and substantial or significant human exposure or substantial
environmental release), and whether the notice meets certain CRSS drop
criteria.
    The Structure Activity Team meeting (day 9-13) is an
interdisciplinary meeting of scientists, including chemists,
biologists, toxicologists, and information specialists, which evaluates
potential environmental fate, health effects and environmental hazard
through the use of structure activity relationships (SAR), test data on
the new chemical substance, data on structural analogs, and expert
judgment.
    The Initial Exposure and Release Assessments are developed by Day
10-19 and examine occupational exposure, environmental releases, and
environmental, general population and consumer exposures.
    The Focus meeting (Day 15-20) is the earliest risk management
meeting in the section 5 notice review period; representatives from all
PMN technical disciplines are involved in this assessment. Initial
decisions are developed at this meeting. For Exemption notices, the
initial decisions are to grant or deny the notice, with or without
certain conditions of use specified in the notice, to which the
submitter is legally bound. Focus meeting decisions for PMNs can range
from identifying the need to consider a ban or section 5(e) of TSCA
regulation of the new chemical to a ``drop'' from further Agency
review. A PMN can also continue on to a more detailed review which
occupies much of the remainder of the 90-day period. Regardless of
whether the Agency drops a PMN submission during the early stages of
review at the Focus meeting or near the end of the statutorily mandated
90-day PMN review period, the PMN submitter is nonetheless not allowed
to commence manufacture before day 90 of the review period.
    The review period can be extended under section 5(c) of TSCA for
good cause; it may also be suspended voluntarily by the mutual consent
of EPA and the PMN submitter. During the review period for PMNs, EPA
may take action under section 5(e) or (f) of TSCA to prohibit or limit
the production, processing, distribution in commerce, use, and disposal
of new chemical substances that raise health or environmental concerns.
If EPA has not taken action under section 5(e) or (f) of TSCA, the PMN
submitter may manufacture or import the new chemical substance when the
review period expires (i.e., day 90) and need merely notify the agency
of commencement of manufacture or import. Similarly, during the review
period for PMN exemption notices, EPA may take action to prohibit or
limit the production, processing, distribution in commerce, use, and
disposal of new chemical substances that raise health or environmental
concerns. If EPA has not taken action to deny the exemption
application, under section 5(h)(1) for TMEs or section 5(h)(4) of TSCA
for LVE and LoREX notices, the notice submitter may manufacture or
import the new chemical substance when the respective review period for
those notices expires (i.e., day 45 for TME or day 30 LVE and LoREX).
    No later than 30 days after the PMN submitter initiates manufacture
or import of the PMN substance, it must provide EPA with a notice of
commencement of manufacture or import (NOC). Section 8(b) of TSCA
provides that, upon receipt of such a notice, EPA must add the
substance to the TSCA Inventory. Thereafter, other manufacturers and
importers may engage in activities involving the new substance without
submitting a PMN, unless the Agency has used its Significant New Use
Rule (SNUR) authority under section 5(a)(2) of TSCA to designate a use
of a chemical substance as a ``significant new use.'' Section
5(a)(1)(B) of TSCA would then require persons to submit a Significant
New Use Notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the substance for the use designated as significant.
The required SNUN provides EPA with the opportunity to evaluate the
intended use, and if necessary, to prohibit or limit that activity
before it occurs.

D. History

    EPA has over 20 years experience in reviewing PMNs and exemption
notices under TSCA on a wide variety of classes or categories of
chemicals. During this period the Agency has reviewed over 38,000 PMNs
and section 5 of TSCA exemption notices.
    Historically, it has been EPA's policy to not allow simultaneous
submission of section 5 exemption notices and PMNs for the same
substance. For LVEs, EPA restricts submission of a PMN until nine
months after the date on which a LVE is approved by EPA (i.e., 90 days
before termination of the one year low volume period) and restricts a
LVE when a pending PMN estimates a production volume greater than
10,000 kilograms per year. This policy, in interpreting the intent of
the rule, places emphasis on the rule's use of the words 10,000
kilograms ``per year,'' rather than per any lesser time period.
Accordingly, EPA has denied a LVE because a PMN simultaneously
submitted by the same company on the same chemical estimated the
production volume to be over 10,000 kilograms per year.
    Test Market Exemption (TME) applications have been allowed in
combination with Premanufacture Notices (PMNs) only if the submitter's
description clearly distinguishes the test marketing activity from
full-scale commercial production or research and development. EPA's New
Chemical Information Bulletin Exemptions for Research and Development
and Test Marketing (USEPA, 1986, see Unit XV.1.) describes how the
Agency, in order to discourage the use of simultaneous submissions to
simply obtain PMN review of a chemical substance in 45 days, closely
examines such submissions to determine if genuine test marketing
activity is involved; if it is not, the application has been denied.
The suggested mechanism for such a combination submission has been
that, following the submission of a TME application, the same company
may not submit a PMN for the same chemical until 90 days before the end
of the test marketing period specified by the company in its TME
application pursuant to 40 CFR 720.38(b)(5).

III. What is the P2 Framework?

    The P2 Framework (USEPA, 2000, see Unit XV.2.) is a set of computer
models that predict hazards and exposures of chemicals using structure
activity relationships (SARs), exposure assessment models and
databases, and standard (default) scenarios. These models have been
developed over a 20-year period by EPA's Office of Pollution Prevention
and Toxics, and others in the scientific and technical community, to
screen new chemicals in the presence of limited data. Annually, EPA
evaluates over 2,000 new chemicals submitted under section 5 of TSCA.
TSCA requires that EPA evaluate the chemicals within 90 days. Although
the law does not generally require that the submitter conduct
laboratory tests to evaluate potential hazards of the chemicals, PMN
submissions must include all available existing information on exposure
and environmental release on new chemicals and the Agency will use this
information or, in absence of supplied information, professional
judgment to

[[Page 76286]]

evaluated exposures and releases. Operating under this time limitation,
and often a lack of data, EPA developed methods to quickly screen
chemicals to assess human and environmental hazards, physical/chemical
properties, environmental fate, human and environmental exposures, and
risks.
    The P2 Framework models listed in the table in this unit, capture
the expertise of multiple EPA scientists, grantees, support
contractors, and others in the scientific community working for over 20
years screening chemicals in the presence of limited data. The P2
Framework project presents these models to industry with the hope that
the models will be useful in identifying potential problem chemicals
and processes early in the research and development process. EPA
believes that application of hazard screening methodologies early in
new chemicals research and development will lead to commercialization
of safer new chemical substances. In other instances where chemicals
are projected to present a low-moderate hazard concern, exposure and
risk screening methodologies can be used early in the research and
development process to identify lower risk chemical alternatives. The
table also provides information regarding the availability of the
models.

                                               P2 Framework Models
----------------------------------------------------------------------------------------------------------------

                Model                    Endpoints addressed         Inputs
needed             Availability
----------------------------------------------------------------------------------------------------------------

                                 Models to Estimate Physical-Chemical
Properties
----------------------------------------------------------------------------------------------------------------

EPI Suite\TM\                          Melting and Boiling      Chemical
Abstract        Download at no cost
                                        Points, Vapor            Service
Registry         from <A HREF="http://Pressure";>http://Pressure</A>
; Octanol/       Number (CAS RN), if in   www.epa.gov/oppt/
                                        water partition          Smilecas
database -      exposure/docs/
                                        coefficient (Kow);       CAS
database of          episuitedl.htm
                                        Water solubility from    Simplified
Molecular
                                        log Kow; Soil organic    Input Line
Entry
                                        carbon partition         System
(SMILES) - or
                                        coefficient (Koc);       Chemical
Structure in

                                        Henry's law constant:    SMILES
notation
                                        vapor pressure/water
                                        solubility; Fish
                                        bioconcentration
                                        factor
--------------------------------------
                                      Models to Estimate Environmental Fate
----------------------------------------------------------------------------------------------------------------

EPI Suite\TM\                          Atmospheric oxidation    Chemical
Abstract        Download at no cost
                                        potential;               Service
Registry         from
                                    http://Biodegradation
 rate;     Number (CAS RN), if in   www.epa.gov/oppt/
                                        Hydrolysis rate;         Smilecas
database -      exposure/docs/
                                        Percent removal in       CAS
database of          episuitedl.htm
                                        POTW (Publicly Owned     Simplified
Molecular
                                        Treatment Works)         Input Line
Entry
                                                                 System
(SMILES) - or
                                                                 Chemical
Structure in
                                                                 SMILES
notation
--------------------------------------
                            Models to Estimate Human Health and
Environmental Hazards
----------------------------------------------------------------------------------------------------------------

OncoLogic                              Cancer hazard potential  Chemical
structure       Developed by USEPA,
OPPT and LogiChem
under a cooperative
agreement. Information
http://logichem.com/___________________ECOSAR
\TM\                             Acute and chronic        CAS RN (if in
Smilecas   Download at no cost
                                        toxicity to fish,        db) or
Chemical          from
                                     http://invertebrates
, algae     Structure in SMILES      www.epa.gov/oppt/
                                                                 notation
newchems/21ecosar.htm
--------------------------------------
                                           Models to Estimate Exposure
----------------------------------------------------------------------------------------------------------------

E-FAST                                 Surface water
Physical/chem            Download at no cost
                                        ingestion, fish
properties, fate         from
                                         http://ingestion
, ground        properties, release      www.epa.gov/oppt/
                                        water ingestion,         amounts,
release         exposure/docs/
                                        ambient air              medium,
release          efast.htm
                                        inhalation, indoor air   location,
aquatic
                                        inhalation, dermal
concentration of
                                        exposure, aquatic        concern,
National
                                        environment exposure/    Pollutant
Discharge
                                        risk
Elimination System
                                                                 (NPDES)
number.
--------------------------------------
ReachScan                              Impact of surface water  Facility
location        EPA is updating
                                        discharges on drinking   (NPDES),
release data    ReachScan and will
                                        water facilities,
make information
                                        chemical concentration
available on its use
                                        downstream at drinking
in this and other
                                        water intake point
programs at
                                       http://www.epa.gov/oppt/
                              Occupational inhalation  Molecular weight,
vapor  Download at no cost
                                        and dermal exposure      pressure,
density;       from
                                            http://during
 industrial and    production or use        www.epa.gov/oppt/
                                        commercial               volume,
fractions        exposure/docs/
                                        manufacturing,           devoted to
multiple      chemsteer.htm
                                        processing, and use      uses;
weight
                                        operations; industrial   fractions,
physical
                                        & commercial             state.
Numbers of
                                        manufacturing, &         sites &
workers, batch
                                        processing releases to   amounts &
times,
                                        air, water, and land     release
sources,
                                                                 worker
activities;
                                                                 workplace

concentrations,
                                                                 release
amounts &
                                                                 media.
----------------------------------------------------------------------------------------------------------------


[[Page 76287]]

IV. How Has the Agency Worked to Educate Industry About the P2
Framework?

    Over the last several years the Agency has gained considerable
experience in working with stakeholders (e.g., chemical manufacturers,
formulators, users, consulting firms, etc.) in the application of the
P2 Framework during new product development. EPA has conducted detailed
P2 Framework workshops and training exercises, including workshops in
California, Texas, Illinois, New Hampshire, and Virginia. These
workshops were designed to introduce stakeholders to the P2 Framework
and to help stakeholders develop experience in the use, interpretation,
limitations and applicability of the P2 Framework methodologies in
chemical hazard and exposure screening. The workshops also discussed
use of the P2 Framework outputs in risk screening analyses.
Approximately 100 companies, among other stakeholders, have
participated in the P2 Framework workshops and training. In addition to
providing workshops and training sessions, the Agency has worked with
individual companies, and other stakeholders, regarding opportunities
to apply the P2 Framework in the development of environmentally
preferable new chemical products and other activities designed to
identify and implement pollution prevention opportunities.

V. What Is the Potential Benefit Derived from Use of the P2 Framework?

    Companies that develop new chemical substances often have
alternative chemical structures that could become the subject of a PMN.
Chemical manufacturers and users often lack hazard- and exposure-
related information on new chemical alternatives and, as a result,
sometimes choose among new chemical product alternatives without an
understanding of the potential hazard and risk trade-offs of product
alternatives under consideration. Many companies that have used the P2
Framework indicate that the P2 Framework generates screening-level
information about human and environmental hazards and exposures, and
that this information helps further differentiate among product
alternatives, leading to identification of alternatives which are
potentially safer or present lower potential risks or, in other cases,
the development of environmentally preferable products and processes
and other pollution prevention outcomes. It is hoped that the P2
Framework will enable PMN submitters to design safer products and
conduct an analysis similar to that done by EPA for each new chemical
submitted, and to identify and develop products and processes that can
be sustained both environmentally and economically.
    Chemical companies, consultants, research and development
laboratories, etc. which have applied the P2 Framework during new
chemical and product development activities have indicated that the P2
Framework:
    1. Generates chemical specific hazard and exposure related
information previously unavailable;
    2. Helps compare new chemical product alternatives based on hazard,
exposure, and risk considerations early in the product development
process, when change is most cost effective;
    3. Helps identify environmentally preferable new products and
processes;
    4. Reduces the generation of hazardous waste that typically occurs
during product development; and
    5. Results in potentially significant financial and business
benefits, among other benefits (Tellus Institute, 1999, see Unit XV.3;
Eastman Kodak, 1996, see Unit XV.4).

VI. What Is the Regulatory Incentive for Chemical Manufacturers under
this Sustainable Futures Pilot Project?

    For purposes of this voluntary pilot project, EPA will implement a
program leading to the opportunity for simultaneous submissions of TME
applications and PMNs on chemical substances for which the submitter
demonstrates the application and use of the P2 Framework or other
scientifically acceptable hazard and exposure screening methodologies.
While EPA's major goal is the development of safer chemicals, it will
also consider, for the purposes of this pilot, low-moderate hazard
chemicals for which exposure assessment indicates potentially low risk.
Thus, under the pilot, the submitter, following approval of the TME by
the Agency, can begin manufacture of the chemical substance for test
marketing purposes, in accordance with the TME after 45 days. They must
continue to meet the exemption requirements for an additional 45 days,
at which time the 90-day PMN review may be satisfactorily completed and
they may then submit the NOC and begin manufacture for PMN purposes.
    Under the voluntary pilot project, qualifying simultaneous PMN/TME
submitters may begin manufacture of those chemical substances at 45
days in accordance with the TME. As described in Unit II.A., most
decisions on PMNs or TMEs are made before day 30 of their review
periods, which in the case of simultaneous submissions would run
concurrently. Chemicals qualifying for this option will be restricted
to those PMN/TME chemical substances that the Agency, in the case of a
PMN, drops from review and, in the case of a TME, grants by the Focus
meeting which occurs by day 30 of the 90- or 45-day review period,
respectively, and which satisfy certain criteria described below (see
Unit IX.). In granting a TME, the chemical substance (and its
associated uses and exposures) must be judged by EPA to meet the
requirement that it ``will not present an unreasonable risk of injury
to human health and the environment,'' after which the submitter can
commence TME activities at 45 days. EPA will also review the
simultaneously submitted PMN and, provided the TME is granted and the
PMN is dropped during the first 30 days of the 90-day review period,
the submitter may then commence full commercialization on or after day
90 of PMN review and file the NOC. All TME requirements must, however,
be met until such time as commencement of manufacture occurs and the
NOC is filed, at which point the substance becomes an existing chemical
and is placed on the TSCA Inventory. If EPA grants the TME, but does
not drop the PMN during the first 30 days of review, the submitter will
be notified that the submitter must choose, by letter within 15 days of
being notified of the Agency's decision, to continue only one of the
two notification procedures (i.e., withdraw the TME and continue with
the PMN, or continue with the TME and withdraw the PMN).

VII. How Could EPA Decide to Approve a TME but Identify Concerns with a
PMN on the Same Chemical?

    As mentioned in Unit II.B., a TME submitter's description must
clearly distinguish the test marketing activity from full-scale
commercial production or research and development. When EPA approves
the TME, it has determined that test marketing the new chemical
substance, under terms and conditions set out in the TME application
and any additional controls stipulated in an accompanying Federal
Register notice announcing Agency approval of the TME, will not present
an unreasonable risk of injury to health or the environment. Such
specific conditions of approval include the test market time period,
production volume, number of customers, and use. Upon review of the
same chemical when submitted as a PMN, the Agency could determine that
a higher production volume or distribution and use of the

[[Page 76288]]

chemical without the limitations imposed under the TME may present an
unreasonable risk to human health or the environment, and therefore
take regulatory action under section 5(e) of TSCA. The Agency also
reserves the right to rescind approval or modify the conditions and
restrictions of a TME during the TME period should any new information
that comes to its attention cast significant doubt on its finding that
the test marketing activities will not present an unreasonable risk of
injury to human health or the environment.

VIII. How Will Accepting Simultaneous PMN/TME Submissions for P2
Screened Chemicals Benefit the Agency and the Public?

    This voluntary pilot project to accept simultaneous PMN/TME
submissions will enable the Agency to develop information to support a
possible future exemption under section 5(h)(4) of TSCA based on
experience gained in Sustainable Futures. This would include
information on the adequacy and effectiveness of companies' use of
Agency tools and models to improve the environmental health and safety
attributes of the new chemicals notified to EPA under section 5 of
TSCA. It is hoped that this modification in the Agency's policy under
section 5 of TSCA ultimately results in fewer section 5 notices
requiring extensive Agency review or negotiation of necessary risk
controls with submitters, and in safer chemicals being introduced to
market.

IX. What Are EPA's Suggested Approach and Criteria for Participation in
the Voluntary Sustainable Futures Pilot Project?

    The Agency solicits participation on the part of chemical
companies, and other stakeholders, in this voluntary pilot project. In
order to qualify for this pilot project, and associated expedited
review, companies subject to section 5 of TSCA reporting requirements
must demonstrate experience and competence with the P2 Framework or
other scientifically acceptable approaches to chemical risk screening.
Typically, EPA expects that the following will be necessary:

A. Training

    Companies interested in participating in this pilot project must
demonstrate an understanding of the scope, applicability,
interpretation, and limitations of pollution prevention and chemical
hazard and exposure screening tools, such as the P2 Framework, that can
be used to conduct screening level assessments of chemicals based on an
analysis of chemical structure or other considerations. EPA will offer
P2 Framework risk screening software to participating companies and
other interested stakeholders. The Agency will also offer detailed
training workshops to those interested in learning more about the P2
Framework models. EPA conducts workshops and presentations that provide
an overview of the P2 Framework models to industry and other
stakeholders (see Unit IV.). P2 Framework workshops are 2-3 days in
length, involve hands-on training in the use, interpretation, and
limitations of P2 Framework methodologies. Attendees of the P2
Framework workshops are encouraged to bring to the workshop the CAS
Registry Numbers or structures of the types of chemicals of specific
interest to them so that the attendee may use these as examples when
that attendee runs the models during the workshop. Attendees should not
bring any CBI chemicals to the workshops. P2 Framework workshops are
particularly well suited for participants with a strong background in
chemistry and familiarity with issues associated with human health and
environmental hazard, exposure, and risk assessment. Those interested
in learning about dates and times for upcoming training, whether given
by EPA or other qualified individuals, should contact the persons
listed under FOR FURTHER INFORMATION CONTACT or check the New Chemicals
Program web site <A HREF="http://www.epa.gov/oppt/newchems/
">www.epa.gov/oppt/newchems/</A>.

B. Apply Hazard and Exposure Screening Tools

    Companies must apply hazard and exposure screening tools to gain
hazard-, exposure-, and risk-related information on chemical
alternatives under consideration in the R&D and product development
stages and demonstrate to EPA that this information has been used to
inform decisionmaking to select safer new chemical alternatives to
submit as the subject of a new chemical notification, and, where
appropriate, to identify opportunities to eliminate or control
exposures through process controls.
    The Agency is interested in learning if, how, and when hazard and
exposure screening tools are of value to participants in the pilot as
they choose among chemical alternatives that may become the subject of
a PMN notice. This type of information will be considered in the
development, if deemed appropriate, of a new exemption under section
5(h)(4) of TSCA based on experience gained in Sustainable Futures. In
order to help determine if a new exemption is appropriate, participants
in this pilot project may be asked to provide either summary or
detailed information to EPA, described below, that demonstrates that
the submitter has used information gained using the hazard and exposure
screening tools to inform their decisionmaking to select safer new
chemical alternatives that became the subject of the submission. Pilot
project participants should provide this information on or as an
attachment to page 11 (``Optional Pollution Prevention Information'')
of the PMN form. Submitters should be aware that EPA may request
additional information where warranted in support of the goal of this
pilot project. The goal of this project is to encourage pollution
prevention and the development of inherently low hazard chemicals. The
Agency solicits comments on the type of information to submit to EPA
that (a) captures an increase in proficiency in a company's use of
these assessment tools or (b) discusses hazard or risk reduction in
PMNs ultimately submitted to the Agency, in contrast to those chemicals
not submitted because of concerns raised through the use of the tools.
    Summary level information should include:
    1. The number of chemical alternatives (if more than one)
evaluated,
    2. The screening models used,
    3. Factors on which decisions were based, such as vapor pressure,
PBT characteristics, aquatic toxicity, potential human exposure, etc.,
and
    4. The submitter's perspective on the extent to which the P2
Framework, or similar methodologies, helped in the understanding of
hazard-, exposure-, and risk-related issues of the PMN chemical. In
addition, information is solicited regarding the extent to which the
methodologies helped the submitter compare or contrast product or
process alternatives based on hazard-, exposure-, and risk-related
information.
    Three different examples of summary level information are provided
below:
    ? Due to a number of factors, only one chemical substance was
identified as having necessary product performance characteristics. As
a result, there were no product alternatives to evaluate. Our company
used the P2 Framework models on the single chemical meeting product
performance characteristics. This analysis indicated low hazard
potential for both human health and ecological effects. In addition,
the material showed low persistence and low bioconcentration potential.
As a result, we concluded the material presents low hazard/low risk.
    ? Five alternatives were evaluated for environmental fate and
persistence,

[[Page 76289]]

bioconcentration potential, aquatic toxicity, and health effects using
XYZ methodologies (e.g., the P2 Framework). While the aquatic toxicity
and human health hazard profiles of all five were equivalent (i.e.,
low), two compounds were seen as persistent and with bioconcentration
potential much higher than the other three alternatives. The PMN
substance was selected from among these three alternatives having lower
persistence and bioconcentration potential. In addition, application of
exposure models indicated that exposure controls on specific areas,
e.g., environmental release, occupational etc., were warranted. These
controls have been identified and their effectiveness has been
sufficiently described in the PMN submission.
    ? The results of the P2 Framework model runs helped to
differentiate among product alternatives based on hazard and exposure
issues. It helped our company identify a product that is the most
environmentally preferable based on its hazard (e.g., low aquatic
toxicity and low concern for adverse effects to human health) and
exposure (e.g., less persistent) properties. The P2 Framework software
package helped us think about chemical design options and exposure
issues, including manufacturing controls to choose among product
alternatives. These controls have been identified and their
effectiveness has been sufficiently described in the PMN submission.
    More detailed information may also be provided, for example, the
actual outputs from the methodologies used, or screening level hazard
assessments for low hazard chemicals and, for low-moderate hazard
chemicals, submission of a screening-level exposure and risk
assessment. EPA's P2 Framework, as well as other hazard, exposure, and
risk screening methods, can be used to assist in many, although not
all, components of such an assessment. This screening level assessment
could include:
    1. Physical/chemical properties, potential environmental transport,
and environmental fate;
    2. Human health effects such as cancer hazard potential, organ
toxicity, reproductive and/or developmental toxicity, neurotoxicity or
other health endpoints of potential concern;
    3. Toxicity to the aquatic environment, i.e., aquatic vertebrates,
invertebrates and plants;
    4. As appropriate, environmental releases, exposure to the general
population, consumer exposure, occupational exposure, and environmental
exposure;
    5. Descriptions of exposure and release mitigation steps, such as
personal protective equipment and engineering controls information; and
    6. Summary conclusions regarding the hazards, exposure, and risks
of product alternatives including a determination if alternatives under
consideration exceed EPA new chemicals program criteria for PBT
(Persistent, Bioaccumulative and Toxic) chemical substances (64 FR
60194, November 4, 1999), or ecotoxicity concern levels described in
the P2 Framework Manual (see http://www.epa.gov/pbt/P2 -- Manual --6-
00.pdf - ``ECOSAR to Estimate Aquatic Toxicity'').
    Assessments need not include every factor listed in this unit,
depending on the specific chemical submitted, intended uses, etc. For
example, toxicity to aquatic organisms would not need to be evaluated
if no environmental releases are anticipated under expected conditions
of manufacture, processing, and use of the new chemical. Additional
guidance regarding preparation of screening-level assessments,
including examples of screening-level assessments, and other technical
assistance, will be provided during P2 Framework training workshops,
discussed above.

C. Submit 5-10 Successful PMNs or PMN Exemption Notices

    Companies will need to submit 5-10 successful (i.e., not regulated
by EPA) PMNs or PMN exemption notices which have been developed using
chemical hazard and exposure screening tools, and which had, as part of
the submission, documentation (summary or detailed) of chemicals
evaluated, models used, endpoints on which decisions were based, and
the submitter's perspectives on the extent to which the screening tools
provided useful information to compare alternatives and select safer
chemicals.
    Pilot project participants' PMN submissions will be evaluated by
EPA consistent with the normal PMN review process. Participants will
typically be eligible for the expedited review described in Unit VI. of
this notice after 5-10 new chemical cases (PMNs or PMN exemption
notices) have been successfully screened by the company, as described
above, submitted to EPA, and determined to be low hazard and/or low
risk by EPA. The Agency will, at its discretion, consider requests for
expedited review before completion of this 5-10 case experience base.
Participants requesting relief before completion of the 5-10 case
experience base will need to demonstrate that their approach to hazard,
exposure, and risk screening is the functional equivalent of a 5-10
case experience base. The Agency may also make an exception with
regards to the definition of ``successful'' for PMNs regulated only
under TSCA section 5 exposure-based authority.
    The Agency considered several factors when determining the number
of successful new chemical cases needed to qualify for expedited review
under this pilot project. Some stakeholders submit relatively few PMNs
or exemption notices, e.g., some stakeholders submit one PMN every two
to three years. Setting the number of successful new chemical cases at
a level greater than 5-10 would mean that infrequent submittters of
PMNs might take many years to reach the 5-10 PMN or exemption notice
experience base. Some stakeholders submit many PMNs annually, e.g. 20
PMNs per year or more. In this case of a stakeholder submitting 20 PMNs
or exemption notices per year, the experience base could be achieved in
approximately six months. The Agency believes that 5-10 successful PMNs
or exemption notices, or the functional equivalent, is a reasonable
experience base to qualify for expedited review under this pilot
project. The Agency will use its discretion when determining if and
when a company has sufficient experience. For example, for a company
whose PMN submissions have historically been limited in scope, e.g.,
PMNs submissions only for surfactants, 5 successful PMN submissions
might be considered adequate for the Agency to judge that the submitter
has effectively used the screening methodologies. On the other hand, a
company with PMNs covering a wide spectrum of industrial chemistry
might need to submit 10 successful PMNs to qualify. The Agency solicits
comment on this issue.
    If a pilot project participant's PMN or exemption submission is
determined by EPA to be low hazard or low risk (meaning the submission
is dropped from further review during the early stages of the PMN
review process, i.e., first 30 days), and the participant submits
descriptive information to demonstrate that chemical hazard and
exposure screening models contributed to their decisions regarding the
new chemical substance, this will likely be judged sufficient to
demonstrate an ability (for that particular PMN or exemption
submission) to effectively use the screening methodologies. All such
decisions under the pilot are within the sole discretion of the Agency
and no rights are extended by this pilot.

[[Page 76290]]

X. How Can Chemical Manufacturers Demonstrate Their Proficiency in
Effective Use of Hazard and Exposure Screening Tools and Thereby
Qualify for Expedited Review Under Section 5 of TSCA?

    As mentioned in the previous section, in order to demonstrate
proficiency in the use of the P2 Framework or other comparable hazard
and exposure screening tools, companies would, following formal
training, submit 5-10 PMNs, or functional equivalent, which were
developed via application of these tools, and that EPA determines to be
low hazard and/or low risk. This number of PMN cases are considered a
sufficient sample to judge the adequacy and effectiveness of a
company's use of the P2 Framework in the evaluation of PMNs prior to
their submission to the Agency. Companies submitting PMNs under this
pilot project (either as part of the initial qualifying process or in
conjunction with TMEs upon successful completion of that process) may
be asked to supplement their submissions, using page 11 (``Optional
Pollution Prevention Information'') of the PMN form, with additional
information which demonstrates the application of the P2 Framework and
provide a basis for EPA to judge the application of the P2 Framework.
See Unit IX. for more details on training and ``additional
information.''
    A chemical manufacturer, formulator, or import who has submitted 5-
10 successful (i.e., not regulated by EPA) PMNs that EPA determines to
be low hazard and/or low risk, or the functional equivalent and who is
interested in participating in the pilot project should approach the
Agency to request the expedited review under section 5 of TSCA
described in Unit VI. This should be done by submitting in writing to
the Director of the Chemical Control Division (address below),
documentation of the following:
    ? The date of training completed in accordance with Unit
IX.A.,
    ? A list of the PMNs which were submitted and the outcome of
Agency review, i.e., the chemicals were not regulated,
    ? A summary table presenting the hazard and exposure
screening tools used to evaluate each PMN substance, including
identification of methods and models/tools used in the assessment, and
    ? An overall qualitative or quantitative assessment of the
value of the use of hazard and exposure screening tools to evaluate
these PMN substances (see Unit IX.B.).
    Submitters are encouraged to submit nonconfidential reports to the
extent possible. If necessary, check
http://www.epa.gov/oppt/newchems/cbi.html
 for information on properly transmitting CBI material to EPA.
A non-CBI or sanitized version of the information described above
should be submitted to: Charles M. Auer, Acting Director, Chemical
Control Division (7405M), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave, NW., Washington, DC 20460-0001.
    Upon review of this information, EPA will respond in writing to
notify candidates of their eligibility for expedited review (i.e.,
being allowed to submit simultaneous TMEs and PMNs). Following EPA
review of the PMNs submitted under the pilot during an approximately 2
year period starting from the date of this notice, the Agency can at
its discretion extend the time period of this pilot project to gain
additional experience, or conclude the pilot. EPA solicits comments on
this overall approach.

XI. Will EPA Allow the Use of Other Hazard and Risk Screening Tools
Besides the P2 Framework?

    EPA understands that the P2 Framework is just one example of
pollution prevention and chemical hazard, exposure, and risk screening
tools that could be used to evaluate chemicals, in general and under
this pilot project in particular. Although the Agency is aware that
other assessment methodologies are widely available and that use of
these other methods may be of value in identifying less risky or
environmentally preferable alternatives, the Agency lacks experience
with their use. The Agency will consider the applicability of other
pollution prevention and chemical hazard, exposure, and risk screening
tools, but PMN submissions for consideration under this pilot project
should describe the alternate methodology used and the results
obtained. To assist and improve EPA's understanding of other tools, the
Agency may ask, where evaluations resulting from the P2 Framework and
alternative methodologies differ in conclusions, that additional detail
on the basis and underlying assumptions for these conclusions be
provided.

XII. How Will the Agency Incorporate Other Information on Risk
Reduction, Such as Control Technology, into this Pilot Project?


    Although the Agency's primary goal in this pilot project is
encouraging the use of chemical hazard identification and risk
screening methods at R&D and the development of inherently low hazard
chemicals, it is expected that for low-moderate hazard chemicals the
information generated through use of the P2 Framework, and other
methods, can also contribute to identification of exposure and risk
reduction steps, through use of control technologies or other measures
that can mitigate potential risks. Pilot project participants could
apply the hazard and exposure screening tools and demonstrate the
ability to use the information generated by the P2 Framework to
identify opportunities to eliminate or control exposures through
process controls, recycling, or reuse. Companies are encouraged under
the pilot project to identify and apply control technology or other
mitigation steps which results in low risk outcomes and to include
discussion of this aspect in their PMN submissions.

XIII. What is the Relationship of Sustainable Futures to Project XL?

    On September 14, 2000, the Agency signed Final Project Agreements
(FPAs) with Eastman Kodak (Kodak, 2000; see Unit XV.5.) and PPG
Industries (PPG 2000; see Unit XV.6.) under the Agency's XL Program,
based on application of hazard and exposure screening tools in new
product development. Project XL, which stands for ``eXcellence and
Leadership,'' is a national program that allows state and local
governments, businesses and federal facilities to develop with EPA
innovative strategies to test better or more cost-effective ways of
achieving environmental and public health protection. Under the FPAs,
the Agency allows Kodak and PPG to simultaneously submit a TME and a
PMN on a new chemical substance, thus enabling each company to begin
manufacture of that new chemical substance in accordance with the TME
after 45 days, provided the TME is granted and the PMN is dropped from
further review during the first 30 days of the review period. Under
both FPAs the companies propose to take other actions that go beyond
compliance. See the Kodak or PPG FPAs at the Project XL web site for
additional details: <A HREF="http://www.epa.gov/projectxl/
">http://www.epa.gov/projectxl/</A>. The Agency has
worked very closely with both Kodak and PPG regarding use and
interpretation of the P2 Framework in new product development. Both
Kodak and PPG have participated in P2 Framework workshops, seminars and
other training and outreach efforts. Both Kodak and PPG have used the
P2 Framework to evaluate product alternatives and to inform their
judgement regarding commercialization of environmentally preferable
products.

[[Page 76291]]

 Both PPG and Kodak have submitted well over 10 PMNs or PMN exemption
notices that were developed using the P2 Framework. The Agency has
dropped these PMNs because they either present a low inherent human
health and environmental hazard, or in those cases where potential
risks were identified, the companies were able to develop mitigation
strategies which adequately reduced those potential risks. Because of
these companies' demonstrated experience in the use of the P2 Framework
in new product development, and their contribution to advancing
excellence in environmental protection, as evidenced by their project
XL proposals, Kodak and PPG will not need to submit the minimum ten
PMNs (see Unit IX.) for review under the pilot project. Kodak and PPG
have been eligible for the requested expedited review with the first
complying new chemical submission received after signature of their
respective FPAs.

XIV. What's Next After Completion of this Pilot Program?

    As mentioned in Unit II., EPA will use the data and experience
gained though this Sustainable Futures pilot project, and through
related Project XL initiatives, to improve Agency understanding of how
early hazard, exposure, and risk screening can lead to development of
environmentally preferable products and processes, among other
pollution prevention outcomes. Based on this experience, EPA may
develop an exemption under section 5(h)(4) of TSCA to provide expedited
review for low hazard/low risk PMNs that have been the subject of early
hazard, exposure, and risk screening. Section 5(h)(4) of TSCA
authorizes EPA, upon application and by rule to exempt the manufacturer
or importer of new chemical substance from some or all of the
provisions of section 5 of TSCA, if the Agency determines that the
manufacture, processing, distribution in commerce, use, or disposal of
the substance will not present an unreasonable risk of injury to health
or the environment. As described in Unit II., EPA has implemented other
exemptions under section 5(h)(4) of TSCA and these may provide a model
for any such future exemption.

XV. References

    1. USEPA. 1986. New Chemical Information Bulletin: Exemptions for
Research and Development and Test Marketing. Office of Toxic
Substances, U.S. Environmental Protection Agency. (November, 1986) and
at http://www.epa.gov/oppt/newchems/tmeranddbulletin.pdf.
    2. USEPA. 2000. Pollution Prevention (P2) Framework. Office of
Pollution Prevention and Toxics, U.S. Environmental Protection Agency
(EPA-748-B-00-001; June, 2000) and at <A HREF="
http://www.epa.gov/opptintr/p2framework/
">http://www.epa.gov/opptintr/p2framework/</A>
    3. Tellus Institute. 1999. Design for Competitive Advantage: The
Business Benefits of the EPA Pollution Prevention Assessment Framework
in New Product Development, by Thomas J. Votta and Allen L. White,
Ph.D. Boston, MA; <A HREF="http://www.tellus.org";>http://www.tellus.org</A>
(September 28, 1999).
    4. Eastman Kodak Company. 1996. EPA-Developed Methodologies for
Assessing the Fate and Hazards of Industrial Chemicals: A Summary of
Eastman Kodak Company's Experience with Their Use and Applicability in
Risk Assessment. Kodak Technology Transfer Team, Health and Environment
Laboratories, Rochester, NY. (May 13, 1996).
    5. Eastman Kodak Company. 2000. Kodak Pollution Prevention
Framework Final Project Agreement (Draft, July, 2000) <A HREF="
http://www.epa.gov/ProjectXL/kodak/fpakd7-21.pdf";>http://www.epa.gov/
ProjectXL/kodak/fpakd7-21.pdf</A> (http://www.epa.gov/
ProjectXL/groupfrn.pdf for Federal Register notice of September 14,
2000 signing).
    6. PPG Industries, Inc. 2000. PPG Industries, Inc. Pollution
Prevention Framework Final Project Agreement, Project XL, September 14,
2000 <A HREF="http://www.epa.gov/ProjectXL/ppg/913fpa.pdf
">http://www.epa.gov/ProjectXL/ppg/913fpa.pdf</A> (<A HREF="
http://www.epa.gov/ProjectXL/groupfrn.pdf";>http://www.epa.gov/
ProjectXL/groupfrn.pdf</A> for Federal Register notice of September 14,
ProjectXL/groupfrn.pdf for Federal Register notice of September 14,
2000 signing).

XVI. Statutory and Executive Order Reviews

    This notice announces a voluntary pilot project to encourage the
application of Pollution Prevention principles during the development
of new chemicals under TSCA. Since this voluntary project does not
include a regulation or otherwise require notice and comment and does
not impose any new binding requirements, it is not subject to review by
the Office of Management and Budget (OMB) under Executive Order 12866,
entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993),
Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997), or Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001). For the same reason, the requirements
of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not
apply.
    Pursuant to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et
seq., an agency may not conduct or sponsor, and a person is not
required to respond to, an information collection request as defined by
the PRA, unless it displays a currently valid OMB control number. The
OMB control numbers for EPA's regulations, after appearing in the
Federal Register, are listed in 40 CFR part 9, and included on the
related collection instrument or form, if applicable.
    This document does not contain any new information collection
requirements that would require additional OMB review and approval
under the PRA. The information collection activities related to the
submission of information pursuant to TSCA section 5 are already
approved by OMB under OMB control number 2070-0012 (EPA ICR No. 574).
The hours for respondent reporting burden for a full PMN submission is
estimated to range between 95 and 114 hours, with an average respondent
burden of 105 hours. This burden applies also to the submission of
SNUN, LVE, and LoREX submissions since each of these notices requires
the submission of a complete PMN form. The respondent burden for
submission of a test market exemption is estimated to average 98 hours.
    As defined by the PRA and 5 CFR 1320.3(b), ``burden'' means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or
for a Federal agency. This includes the time needed to review
instructions; develop, acquire, install, and utilize technology and
systems for the purposes of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; adjust the existing ways to comply with any
previously applicable instructions and requirements; train personnel to
be able to respond to a collection of information; search data sources;
complete and review the collection of information; and transmit or
otherwise disclose the information.
    This action will not have substantial direct effects on State or
tribal governments, on the relationship between the Federal government
and States or Indian tribes, or on the distribution of power and
responsibilities between the Federal government and States or Indian
tribes. As a result, no action is required under Executive Order 13132,
entitled Federalism(64 FR 43255, August 10, 1999), or under Executive
Order 13175,

[[Page 76292]]

entitled Consultation and Coordination with Indian Tribal Governments
(65 FR 67249, November 6, 2000). Nor does it impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
    Nor does it require special considerations under Executive Order
12898, entitled Federal Actions to Address Environmental Justice in
Minority Populations and Low-Income Populations (59 FR 7629, February
16, 1994); or Executive Order 12630, entitled Governmental Actions and
Interference with Constitutionally Protected Property Rights (53 FR
8859, March 15, 1988).
    This action does not involve any technical standards that would
require Agency consideration of 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).

List of Subjects

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

    Dated: November 27, 2002.
Stephen L. Johnson,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.

[FR Doc. 02-31243 Filed 12-10-02; 8:45 am]
BILLING CODE 6560-50-S






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