Document ID: EPA-HQ-OPPT-2007-0094-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-05-09T04:00Z

Supporting Statement for a Request for OMB Review under

The Paperwork Reduction Act

1	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

TITLE:	Premanufacture Review Reporting and Exemption Requirements for
New Chemical Substances and Significant New Use Reporting Requirements
for Chemical Substances

EPA ICR No: 	0574.13	OMB Control No.: 	2070-0012 

1(b)	Short Characterization

The Environmental Protection Agency (EPA) administers the New Chemicals
Program under section 5 of the Toxic Substances Control Act (TSCA). 
TSCA section 5 requires that any person who proposes to manufacture or
import a “new chemical,” (i.e., a chemical not listed on the TSCA
section 8(b) Inventory), must provide a premanufacture notice (PMN) to
EPA at least 90 days prior to commencing manufacture or import of that
chemical.  Similarly, TSCA section 5 requires a significant new use
notice (SNUN) from any person who proposes to manufacture, import or
process a chemical for a use that is determined to be a “significant
new use.”  EPA considers genetically engineered microorganisms to be
chemical substances for purposes of the notification requirements found
in TSCA section 5; the 90-day notice for microorganisms is a Microbial
Commercial Activity Notice (MCAN).

Furthermore, TSCA section 5 authorizes EPA to regulate the manufacture,
processing, distribution in commerce, use or disposal of new chemical
substances.  Using the notice information submitted to the Agency, EPA
evaluates the health and environmental effects of new chemical
substances.  On the basis of its review, EPA may take regulatory action
with respect to the manufacture or importation of a new chemical
substance or with respect to a substance(s proposed new use.  If EPA
takes no action within the 90-day review period, the submitter is free
to manufacture or import the new substance, or to manufacture, import or
process the substance for a new use.  EPA requires that the submitter
inform EPA when non-exempt commercial manufacture, processing or
importation of the substance in question actually begins by submitting a
Notice of Commencement.

This information collection request addresses the TSCA section 5
reporting and recordkeeping requirements associated with the new
chemicals review and regulatory program, as briefly outlined above.

               

2	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

TSCA section 5(a)(1), 15 U.S.C. 2604, requires manufacturers and
importers of new chemical substances to submit to the Administrator of
EPA a premanufacture notice (PMN) of intent to manufacture or import a
new chemical substance at least 90 days before manufacture or import
begins.  TSCA section 5(a)(1) also requires notification from any person
who proposes to manufacture, import or process a chemical substance for
a use that EPA has by rule determined to be  a significant new use.  The
notice must include, insofar as known to or is reasonably ascertainable
by the submitter, information described in TSCA section 8(a)(2) (e.g.,
chemical identity, use and exposure data), plus test data and
descriptions of other data related to the effects on health and the
environment of the manufacture, processing, use, distribution in
commerce and disposal of the new chemical substance.  EPA reviews the
information to evaluate the health and environmental effects of the new
chemical substance.  On the basis of the review, EPA can take further
regulatory action under TSCA sections 5(e) and 5(f), if warranted.  If
EPA takes no action at the end of 90 days, the submitter is free to
manufacture or import the new chemical substance.

TSCA section 5, as interpreted in EPA(s Microbial Products of
Biotechnology; Final Regulation under the Toxic Substances Control Act;
final rule published at 62 FR 17910 (April 11, 1997), authorizes EPA to
regulate “new” genetically engineered microorganisms.  According to
the 1997 final rule, “new” microorganisms are those that, through
deliberate human intervention, contain genetic material from dissimilar
source organisms.  For the purposes of this policy, all microorganisms
of different genera (intergeneric) are considered “new.” 
Manufacturers and importers of these new microorganisms must submit to
EPA a microbial commercial activity notice (MCAN) at least 90 days
before manufacturing or import begins.  These microorganisms are subject
to the same potential regulatory controls as new chemical substances.

Significant New Use Rules (SNURs) are authorized under TSCA section
5(a)(2).  Regulations providing details on EPA’s SNUR authority were
promulgated at 40 CFR Part 721 on July 27, 1989 and at 40 CFR Part 725
subparts H-K on April 11, 1997.  EPA uses this authority to take follow
up action on new or existing chemicals that may not present an
unreasonable risk in their original uses but may present an unreasonable
risk should other uses occur that may result in different and/or higher
exposures to human beings or the environment.  EPA determines that a new
use is significant by examining the specific circumstances of each case.

A SNUR allows EPA to receive reporting on such uses, review them and, if
necessary, regulate the uses before they occur.  Once a use is
determined to be a “significant new use,”  a person must submit a
SNUN to EPA at least 90 days before that person may manufacture, process
or import a chemical substance for that use.  The same reporting
requirements that apply to PMNs also apply to SNUNs, and EPA has the
same authorities under TSCA section 5(e) and 5(f) to regulate the SNUR
chemical during the notice review period.

TSCA section 5(d)(1)(B) requires notices to include all test data in the
submitter’s possession or control and TSCA section 5(d)(1)(C) requires
submitters to provide other data on environmental or health effects that
are known to or reasonably ascertainable by the submitter.  These
requirements are described in 40 CFR 720.50.

TSCA section 5(e) authorizes EPA to regulate the manufacture,
processing, distribution in commerce, use or disposal of a new substance
pending development of data sufficient to evaluate the health and
environmental effects of the substance.  EPA may take action under TSCA
section 5(e) if the Agency determines that the information available is
insufficient to evaluate the substance and that the substance either (1)
may present an unreasonable risk of injury to health or the environment
or (2) will be produced in substantial quantities and there may be
significant or substantial human or environmental exposure to the
chemical.

Under TSCA section 5(f), EPA may regulate a new chemical substance if
there is a reasonable basis to conclude that the manufacture,
processing, distribution in commerce, use or disposal of the new
substance will present an unreasonable risk of injury to health or the
environment before EPA can promulgate a rule to regulate the chemical
under TSCA section 6.

EPA may also grant certain exemptions from the PMN, SNUN, and MCAN
requirements of TSCA section 5, including the following.  These
exemption rules reduce reporting requirements, thereby providing relief
to submitters from the burdens of the full PMN reporting requirements.

(i)	Test-Marketing Exemption (TME)

Under TSCA section 5(h)(1), persons may apply for an exemption from the
requirements of TSCA section 5 for test-marketing purposes.  EPA may
grant the exemption if it finds that the test-marketing activities
described by the applicant will not present an unreasonable risk of
injury to health or the environment.  The applicant must provide the
information necessary to make this finding and EPA must grant or deny
the exemption within 45 days.  If EPA grants the exemption, it may
impose appropriate restrictions on the test-marketing activities.  See
40 CFR 720.38 and 725.370.

(ii)	Research and Development Exemption (R&D)

TSCA section 5(h)(3) exempts from PMN reporting small quantities of
chemical substances manufactured or imported only for research and
development purposes.  Persons using this exemption must have their
research overseen by a technically qualified individual and must notify
any person involved in the research of any risk.  See 40 CFR 720.36. 
Small quantities of genetically modified microorganisms manufactured
solely for research and developmental purposes are also exempt when
additional criteria are met as described in 40 CFR 725.235, activities
conducted inside a structure, and 40 CFR 725.238 and 239, activities
conducted outside a structure. 

(iii)	TSCA Section 5(h)(4) Exemptions

TSCA section 5(h)(4) authorizes EPA to exempt any person from the
provisions of TSCA section 5 if EPA determines that the chemical
substance will not present an unreasonable risk of injury to health or
the environment when manufactured, processed, distributed, used or
disposed of under the exemption.  To date EPA has promulgated four rules
under this section for chemical substances and three exemptions for
microbial products of biotechnology:

Low Volume Exemption (LVE) - This exemption applies to substances
manufactured in quantities of 10,000 kilograms or less per year;
submitters may request that EPA evaluate their exemption at a lower
production volume level, to which the submitter would be legally bound. 
See 40 CFR 723.50.

Low Release/Low Exposure (LoREX) - This exemption applies to certain
chemical substances that meet strict human exposure and environmental
release criteria to ensure that these substances will not present an
unreasonable risk.  See 40 CFR 723.50.

Polymer Exemption - This exemption applies to polymers that comply with
certain chemical characterizations and that therefore will not present
an unreasonable risk of injury to health or the environment.  See 40 CFR
723.250.

Instant Photographic Film Articles Exemption - This exemption applies to
chemical substances used in or for the manufacture or processing of
instant photographic and peel-apart film articles.  See 40 CFR 723.175.

TSCA Experimental Release Application (TERA) - This exemption applies to
research and development activities that result in intentional
environmental releases of microorganisms.  EPA may grant the exemption
if it finds that the activities described by the applicant will not
present an unreasonable risk of injury to health or the environment. 
The applicant must provide the information necessary to make this
finding and EPA must grant or deny the exemption within 60 days.  If EPA
grants the exemption, it may impose appropriate restrictions on the
activities described in the notice.  See 40 CFR 725.250.

Tier I Exemption - This exemption applies to certain microorganisms
subject to physical containment and control technologies.  EPA has
developed specific criteria for the host microorganism, introduced
genetic material, and containment technology to ensure that the
microorganism will not present an unreasonable risk.  See 40 CFR
725.400.

Tier II Exemption - This exemption applies to the same microorganisms
subject to a Tier I exemption without specified physical containment and
control technologies.   EPA may grant the exemption if it finds that the
physical containment and control technologies activities described by
the applicant will not present an unreasonable risk of injury to health
or the environment.  The applicant must provide the information
necessary to make this finding and EPA must grant or deny the exemption
within 45 days.  If EPA grants the exemption, it may impose appropriate
restrictions on the activities described in the notice.  See 40 CFR
725.428.

Finally, under TSCA section 26(b), EPA requires manufacturers, importers
and processors to pay fees for PMNs, MCANs, certain PMN exemption
applications and notices, and Significant New Use Notices (SNUNs)
submitted under TSCA sections 5(a) and (h) to help defray the cost of
administering TSCA.  EPA must take into account a submitter(s ability to
pay the fee and the cost of reviewing the submitted data.  TSCA section
26(b) provides for maximum fees of $100 for small business concerns and
$2,500 for other PMN submitters.  The rule requires a limited amount of
additional information to be submitted with the PMN or MCAN form.  See
40 CFR 700.

Copies of TSCA section 5 and of 40 CFR Parts 700, 720, 721 (excepting
Subpart E), 723 and 725 are attached.  40 CFR Part 721, Subpart E,
Significant New Uses for Specific Chemical Substances, which consumes
nearly 200 pages in the Code of Federal Regulations, is not attached due
to its volume.  However, Subpart E (40 CFR 721.225 through 40 CFR
721.9973) can be viewed at or downloaded from the Internet at
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=7c22bc6f9d5d641
7b6075c757b8736b0&rgn=div6&view=text&node=40:28.0.1.1.10.5&idno=40

2(b)	Use/Users of the Data

TSCA gives EPA authority to regulate the manufacture or import of
chemical substances that may present an unreasonable risk of injury to
health or the environment from their manufacture, processing,
distribution in commerce, use or disposal.  To make a reasoned
evaluation of the risk associated with such chemicals, EPA needs data on
each chemical’s structure and properties, manufacturing process,
worker exposure, environmental release, production volume, potential
industrial, commercial, and consumer use, and test data related to the
substance.  EPA needs sufficient information so as to identify
substances with analogous chemical structures and properties, with
similar manufacturing processes and with similar uses.  The Agency
reviews available data to evaluate the toxicity of the chemical and the
potential risk resulting from human and environmental exposure to the
substance.  If EPA is considering regulation of the chemical, the Agency
also evaluates the benefits of the substance to determine what
regulatory action, if any, to take.

On the basis of its initial review, EPA eliminates the vast majority of
new chemical substances from further review.  EPA may (1) identify a
number of chemical substances for more detailed evaluation for which
additional exposure or toxicological data may be needed; (2) identify
some substances for follow-up reporting on their commercial development;
and (3) select a limited number for immediate regulatory action. 
Through this process EPA minimizes the burden on both the Agency and
industry by requiring detailed information only on those substances that
may present unreasonable risk or injury to health or the environment.

A chemical is considered to be a “new” chemical if it is not listed
in the TSCA section 8(b) Inventory of chemicals manufactured or
processed in the United States.  The Inventory includes both public and
confidential information.  Chemicals appear in the public portion of the
Inventory by name if the company manufacturing the chemical does not
claim the name of the chemical to be confidential.  Chemicals whose
names are claimed confidential are identified in the public portion of
the Inventory by an accession number and a generic name.  The specific
chemical name of a confidential chemical appears only in the
confidential portion of the Inventory, which is not available to the
public.

A company that intends to manufacture or import a chemical substance
that does not appear by a specific name in the public portion of the
Inventory may inquire of EPA whether the substance is included in the
confidential portion of the Inventory (i.e., to determine whether the
substance would be considered new and therefore subject to the TSCA
section 5 notice requirements).  EPA will respond to such an inquiry
only if the Agency determines that the company has a “bona fide”
intent to manufacture or import the substance.  Reporting provisions
found at 40 CFR 720.25 or 40 CFR 725.15 require additional information
from a submitter so as to encourage the submission only of bona fides
that reflect serious intent.

EPA requires submitters of PMNs and bona fides to provide a specific
chemical identity for the substance for which a notice is made, based on
a Chemical Abstracts (CA) Index name or a CA preferred name.  This
requirement reduces delays caused by incorrect or ambiguous chemical
identity, expedites the Agency’s ability to perform Inventory searches
and saves Agency resources spent on naming submitters’ substances.

Since a company’s initial intention to manufacture or import a
substance or microorganism may change after making a PMN or MCAN
submission, EPA requires companies to notify the Agency when manufacture
or importation begins by submitting a Notice of Commencement (NOC)  (see
40 CFR 720.102 and 725.190).  Submitters specify in the NOC whether
commencement occurred via manufacture or importation and the address of
the site(s) of first manufacture.  This information is essential to the
Agency as a compliance mechanism.  The information requirements for NOC
reporting also assist in identifying cases in which submitters have
mistakenly reported the wrong case number in the NOC, or erroneously
listed a substance that is very different from that which they intended
to commence manufacture.  In addition, the reporting requirements
provide submitters an opportunity to update information that may no
longer be correct or appropriate as reported in the notice.  Finally,
the Notice of Commencement results in EPA adding that substance to the
TSCA Inventory.

EPA requires the use of a specific form (EPA Form No. 7710-56) for
Notices of Commencement of chemical substances.  The form is not
required for microorganisms.  The use of a standard form leads to
greater efficiency by assisting EPA in readily identifying the type of
notice, providing uniformity in recording responses in EPA databases,
and providing manufacturers a format to assure that important
information is not inadvertently omitted in their submissions.  Before
EPA required the use of a standard NOC form, a significant number of
NOCs created difficulty because they were not recognized by the Agency
as a NOC or they contained confusing, missing or unnecessary
information.  These problems resulted in a waste of time and resources
for both submitters and EPA personnel who must prepare or review these
notices.  The required use of a standard reporting form also reduces EPA
processing time for NOCs.

To facilitate EPA’s ability to regulate new substances efficiently and
expeditiously, EPA considers essential the capability to promulgate
Significant New Use Rules (SNURs) for new chemical substances without
first issuing a TSCA section 5(e) consent order for the substance. 
Since the reporting requirements and provisions of a non-section 5(e)
SNUR apply also to the original PMN submitter, only one EPA action is
required instead of two; fewer EPA resources are necessary and
efficiency is gained as a non-section 5(e) SNUR is more efficient than a
combination of consent order and SNUR to regulate new chemical
substances.

EPA publishes in the Federal Register information summarizing the
content of each notice, including the generic class of the chemical
substance, the proposed uses and certain test data submitted with the
notice, as required by TSCA section 5(d)(2).  EPA publishes at the
beginning of each month a list of PMN notices and polymer exemption
applications that have been received, those that are still under review
and those for which the review period has ended.  This publication is
mandated by TSCA section 5(d)(3).  TSCA also requires EPA to publish a
notice of receipt of a test-marketing application so that the public may
comment, and another notice stating whether the application was granted
or denied.

Periodically EPA compiles certain information such as the number of
notices submitted and their disposition.  This information may be
published in various EPA documents or other publications, e.g.,
Chemicals-in-Progress Bulletin, support documents for TSCA section 5
rulemakings.

The recordkeeping requirements for PMNs, MCANs, and SNURs are necessary
for EPA enforcement purposes.  As part of its enforcement program, EPA
conducts inspections to review the records of TSCA section 5 submitters
to ensure that the information submitted in the notice was correct, that
the submitter did not begin manufacture, importation or processing
before the review period expired, and that, for PMN chemicals or MCAN
microorganisms, the notice of commencement was submitted when
manufacture or import began.  The Agency also inspects manufacturers’
or processors’ chemical substances subject to SNURs to ensure that
they are not doing so in violation of the SNUR.  The recordkeeping
requirements for exemptions are necessary for enforcement purposes as
well.  EPA conducts inspections to ensure that the information submitted
in the aforementioned applications is true and that the person holding
the exemption is complying with any restrictions EPA imposed when it
granted the exemption.

Users of these data are EPA employees located primarily in the Office of
Pollution Prevention and Toxics (OPPT), within the Office of Prevention,
Pesticides and Toxic Substances (OPPTS), and in the Office of
Enforcement and Compliance Assurance (OECA), and Core TSCA Regional
Coordinator Inspectors.  In particular, staff of the New Chemicals
Program of the Chemical Control Division within OPPT use this
information to review and evaluate the health and environmental effects
of new chemicals and significant new uses of chemicals, and to recommend
and implement regulatory actions if warranted.  OPPTS employees in the
Regional Offices and OECA employees in Headquarters and in the Regions
use TSCA section 5 data for compliance monitoring and enforcement
purposes.

3	NON-DUPLICATION, CONSULTATIONS AND OTHER COLLECTION CRITERIA

3(a)	Non-Duplication

EPA is the only federal agency that regularly collects information on
new chemical substances used for purely industrial applications. (In
instances where chemical substances with industrial applications also
have drug or cosmetic uses, the Food and Drug Administration would have
concurrent jurisdiction.)  Therefore, the information submitters provide
in a PMN or MCAN cannot be obtained elsewhere.  However, data previously
submitted to EPA need not be resubmitted if the following conditions are
met: the data were submitted with no claims of confidentiality and the
PMN (or other TSCA section 5 notice) identifies the office or person to
whom the data were submitted and the date of the submission.

3(b)	Public Notice Required Prior to ICR Submission to OMB

Prior to submission to OMB, this ICR will be made available to the
public for comment through a Federal Register notice.  The public will
have 60 days to provide comments.  The comments received will be given
consideration when completing the supporting statement that is submitted
to OMB.

3(c)	Consultations

Since 1983, EPA has received hundreds of public comments from industry,
public interest groups, trade unions and other governmental agencies on
various aspects of the TSCA section 5 rules.  Early in the Program,
persons commented on the final PMN rule and notice form, and the
clarification of polymers and revisions to four stayed provisions of the
PMN regulation, particularly the R&D exemption.  Industry comments to
the PMN rule led to staying of various sections of the PMN rule and
clarification of other sections.  All these issues were resolved with
the issuance of final revisions in April 1986.

The Agency reviewed and modified its standard recordkeeping requirements
associated with various SNUR reporting triggers when issuing the final
General Provisions for New Chemical Follow-up (Generic SNUR) in July
1989.  These more flexible recordkeeping provisions resulted from
comments received by the Agency during public meetings with
representatives of the Conservation Foundation, the Natural Resources
Defense Council, the Chemical Manufacturers Association, the Chemical
Specialties Manufacturers Association, the Synthetic Organic Chemicals
Manufacturer(s Association and individual chemical companies.  In 1993
and 1995, EPA held several public meetings for the general public to
discuss in detail the four PMN Rule Amendments that were published in
March 1995.  In December 1989 and June 1993 the biotechnology rule was
discussed in public meetings of the Biotechnology Science Advisory
Committee before the final biotechnology rule was published in 1997.

In addition, EPA has held various public meetings with interested
parties.  In June 1983, EPA officials held a two-day seminar attended by
450 industry representatives.  Discussions centered on PMN review
procedures and clarification of PMN requirements.  EPA has also held
several seminars that included sessions on TSCA section 5 in February
and May 1986 and May 1987, and participated in industry-sponsored
seminars (e.g., American Chemistry Council and the Synthetic Organic
Chemicals Manufacturers Association, “Living With TSCA” seminar
series in April 1989, October 1990, October 1992, April 1994, October
1995, April 1997, November 1998, March 2001, March 2002, and April
2003).   

EPA has arranged or actively participated in a number of scientific
meetings and symposia of immediate relevance to the PMN program.  Among
the programs for which EPA has made substantial contributions (often in
collaboration with others) are the following: “Safer Chemicals Through
Molecular Design,” EPA-sponsored, Crystal City, VA, 1983; “SAR and
Toxicity Assessment,” American Chemical Society, Gaithersburg, MD,
1984; workshop on “The Application of the Techniques of Computational
Biological Chemistry to Environmental Problems,” EPA Office of
Research and Development, Research Triangle Park, NC, 1984; symposium on
“Assessment for Potential Developmental Toxicants,” EPA-sponsored,
at the 1985 Teratology Society Meeting in Calloway Gardens, GA.

For several years EPA has been engaged in a continuing series of joint
EPA/industry/public interest group meetings to facilitate the
identification and exchange of critical information or to arrange for
the generation of data that otherwise are not available to the PMN
program.  These meetings have involved issues of hazard assessment
(health and environmental), exposure analysis (occupational,
environmental, consumer) and economics.  Industry groups that have
established an ongoing dialogue with EPA over the past several years
include DETO/ETAD (an association of dyestuff manufacturers), acrylate
manufacturers and pyridine manufacturers/ users.  A workshop in April
1990 discussed the chemical category of epoxides with the Chemical
Manufacturers Association and other industry, environmental and trade
union organization representatives.

In renewing the previous information collection, EPA contacted nine
organizations to request their review of and comments on basic elements
of the ICR.  Except for one response, no other persons contacted chose
to respond to EPA’s solicitation for comments.  The response was
simply to inform EPA that, since his organization was not a respondent
to the information collection but rather a user of information that
resulted from the information collection, he declined to offer any
substantive comments on the information collection.  For this ICR, EPA
has also contacted nine organizations to request review and comments.

Finally,   SEQ CHAPTER \h \r 1 EPA will pursue additional consultations
with interested parties during the development of the renewal of this
collection.

3(d)	Effects of Less Frequent Collection

The frequency of the submission of information under TSCA section 5 is
not under the Agency(s control.  Manufacturers of new chemical
substances typically submit a PMN, SNUN, or MCAN at least 90 days prior
to anticipated manufacturing or distribution of the substance for
non-exempt commercial use.  Submission of information thus is on an
as-needed, on-occasion basis, initiated by respondents.  Subsequent
reporting would only be required if EPA determined that a specific use
of a substance constituted a significant new use.  Less frequent
collection would mean respondents not being required to submit data at
all.  However, without such data, EPA would be unable to administer the
new chemical review requirements found in TSCA and would be unable to
carry out its mandate to protect the public from unreasonable risks to
health and the environment.

3(e)	General Guidelines

This collection of information is consistent with all OMB guidelines
under 5 CFR 1320.6 except with respect to the maintenance of records by
respondents for more than three years.  EPA believes a five-year
recordkeeping requirement is needed to carry out an effective program. 
The five-year recordkeeping requirement is consistent with the five-year
statute of limitations under 28 U.S.C. 2462 held applicable to all EPA
enforcement actions, including administrative proceedings under TSCA. 
3M Company v. Carol Browner and EPA, 17F.3d (DC Cir.1994) In addition, a
five-year retention period comports with certain recordkeeping
requirements imposed by the Occupational Safety and Health
Administration and helps to keep these requirements consistent with one
another, thereby avoiding different reporting obligations.  Therefore,
the Agency requires respondents to retain records for more than three
years.

3(f)	Confidentiality

Much of the required premanufacture information may be considered by the
submitter to be a trade secret, proprietary, or “confidential business
information” (CBI).  However, TSCA mandates that EPA require the
submission of such information because it is essential for providing a
basis to determine unreasonable risk.  EPA cannot draw conclusions or
make assumptions concerning toxicological effects and potential risks
without examining physicochemical structure, methods of production,
byproducts, potential uses, exposure data, etc. The Agency is required
by TSCA section 5(d)(2) to publish a Federal Register notice that
identifies the chemical substance, lists its uses or intended uses and
describes test data.  Congress included these provisions to allow active
public participation in the review process.

The Agency’s policies allow public involvement while preserving
confidentiality.  TSCA section 14(a) prohibits, except in limited
circumstances, the disclosure of trade secret information.  TSCA section
14(d) allows disclosure of health and safety studies, including
underlying data, unless these studies disclose confidential process or
mixture information.  Under 40 CFR 720.85 and 720.87(See also 40 CFR
Part 2), when the specific chemical identity or use data are claimed
confidential, the Agency requires the submitter to provide generic
descriptions for inclusion in Federal Register notices and the public
file.  Additionally, the submitter must provide a “sanitized” copy
of all health and environmental effects data, with confidential
information deleted, for placement in the public docket.  Within the
Agency, only personnel with the required clearance may handle CBI.

Based on its experience, EPA expects that most information included in
TSCA section 5 notices will be CBI.  EPA has developed an elaborate
system to prevent unauthorized disclosure of CBI.  This system includes
procedures for logging material in and out of the Confidential Business
Information Center (CBIC) at EPA headquarters and procedures for
photocopying and transmitting CBI.  These procedures apply to CBI
submitted by manufacturers as well as CBI generated by EPA staff in the
course of their review.  Access to CBI is restricted to persons who need
the information for their work.  No one is allowed access to CBI without
first undergoing instruction on procedures for handling CBI.  Special
procedures have been instituted to restrict access to computerized CBI. 
These procedures are detailed in the “TSCA CBI Protection Manual,”
October 2003.  EPA believes these procedures protect confidential
information while providing the public with as much information as
possible.

3(g)	Sensitive Questions

Information requirements under TSCA section 5 do not include questions
of a sensitive nature.

4	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAIC Codes

This information collection affects companies that manufacture, process
or import chemical substances.  These companies are typically found in
NAIC major groups 325 (Chemical Manufacture) and 324 (Petroleum and Coal
Products).

4(b)	Information Requested

(i) 	Data Items - Reporting Requirements

Premanufacture Notices - Premanufacture notices required by TSCA section
5 must include certain information to the extent known to or is
reasonably ascertainable by the submitter.  This information is defined
in TSCA section 8(a)(2) and 40 CFR 720.45.  Specific information
includes the following:

Common or trade name, chemical identity and molecular structure of the
chemical in question;

Categories or proposed categories of use of the chemical;

Estimate of the total amount of such chemical to be manufactured or
processed, including the amount to be manufactured or processed for each
use category;

Description of the byproducts resulting from the manufacture,
processing, use or disposal of the chemical;

Estimate of the total number of individuals who will be exposed to the
chemical in their places of employment, and the duration of such
exposure; and

Manner or method of the disposal of the chemical.

In addition, the submitter must provide any test data in the
submitter’s possession that indicates the environmental or health
effects of the chemical, and a description of any other data known to
the submitter concerning the environmental or health effects of the
chemical.  The specific information requirements are spelled out in 40
CFR part 720, on the PMN reporting form itself, and in the Instruction
Manual.

To facilitate the review of chemicals, EPA has developed a PMN reporting
form (EPA Form 7710-25, copy attached).  This form is required for
reporting new chemicals under TSCA section 5(a)(1) and is also required
for submitting Significant New Use Notices (SNUNs).  By supplying the
information specified in the form, submitters do not incur the burden of
providing information unnecessary for EPA’s review.  Therefore, use of
the form lessens the burden on companies by reducing uncertainty,
minimizing the need for additional contact with EPA, and allowing
companies to establish procedures for meeting reporting requirements.

EPA has limited the level of detail of information required in the PMN
form to that necessary for EPA to conduct an initial review of a
chemical.  However, submitters may include additional or optional
information in their notices that they believe EPA should consider in
its review.  For example, submitters may identify pollution prevention
techniques being employed by the submitter that may be relevant to the
Agency(s risk assessment.  EPA encourages submitters to provide
information on the benefits of the new substance in comparison to
existing chemical substances, information on the substitutes, and any
additional information available to them on waste management techniques.

The existing PMN form is not appropriate for reporting of new
microorganisms in MCANs since the form was designed with traditional
chemical substances in mind.  EPA has developed a “Points to
Consider” guidance document to assist submitters in providing to EPA
the information necessary for EPA to make assessments of new
microorganisms under TSCA section 5.  The submitter will be able to
provide information in a format of his or her own choosing.

Exemption Applications - Applications for exemptions from premanufacture
or microbial commercial activity notice requirements have additional
information requirements, as follows:

Test-Marketing Exemption (TME) (40 CFR 720.38)

Test-marketing exemption applicants are not currently required to use
the PMN form or any other prescribed reporting form.  However, the
test-marking exemption rule states that applicants should provide the
following information: (1) all existing health and environmental effects
data on the chemical or a discussion of toxicity based on
structure-activity relationships and relevant data on chemical
analogues; (2) the maximum quantity of the chemical substance that the
applicant will manufacture or import for test-marketing purposes; (3)
the maximum number of persons who may be provided the chemical substance
during test-marketing; (4) the maximum number of persons who may be
exposed to the chemical substance as a result of test-marketing,
including information regarding the duration and route of such exposure;
and (5) a description of the test-marketing activity, including its
length and how it can be distinguished from full-scale commercial
production and research and development.  The Agency retains the right
to declare that an application contains insufficient information to make
an evaluation.  Any person who receives a test-marketing exemption must
retain documentation of any information in the exemption application and
documentation of their compliance with any restrictions imposed by EPA
when it granted the application.  This information must be retained for
five years from the final date of manufacture or import under the
exemption.

Research and Development Exemption (R&D) (40 CFR 720.36)

A manufacturer or importer using this exemption must notify all persons
in its employ or to whom it distributes the chemical substance and who
are involved in any way in the research, of any risk to health
associated with the chemical substance.

TSCA section 5(h)(4) Exemptions

1.  For the low volume exemption (LVE) (40 CFR 723.50(1)), submitters
are required to submit their exemption on the PMN form to ensure that
the Agency has adequate information to make a determination that these
substances will not present an unreasonable risk.  Statements describing
exposure and release controls, site, and use in an exemption application
are legally binding and enforceable.

2.  The low exposure/low release exemption (LoREX) (40 CFR 723.50(2))
encourages the use of pollution prevention practices through the
development of manufacturing, processing and use techniques that
minimize exposure to workers, consumers, the general public and the
environment.  As with the low volume exemption, site, use, exposure and
release controls identified in the notice are binding.

3.  The polymer exemption rule (40 CFR 723.250) requires the submission
of a post-manufacture report to EPA.  A simple one-page annual report is
required to be submitted to the Agency no later than January 31 of the
year subsequent to initial manufacture under the terms of the exemption.
 The report must include company identity information including the name
and telephone number of a technical contact and the number of exempt
substances for which manufacture commenced during the preceding year.

4.  Instant photographic film articles exemption notices (under 40 CFR
723.175) must, at a minimum, identify the manufacturer and the new
chemical substance.  Applicants must submit an exemption notice when
manufacture begins and comply with certain requirements to limit
exposure to the chemical. Applicants must retain certain records for 30
years from the final date of manufacture.

5. A TSCA experimental release application (TERA)(under 40 CFR 725.250)
applies to research and development activities that result in
intentional environmental releases of microorganisms.  Applicants are
required to include adequate information in their exemption so that the
Agency can make a determination that the microorganism will not present
an unreasonable risk.  Submitters must follow the conditions described
in the TERA as well as any conditions of EPA(s TERA approval.

6. Tier I exemption (40 CFR 725.424) - This exemption applies to certain
microorganisms subject to physical containment and control technologies.
 EPA has developed specific criteria for the host microorganism,
introduced genetic material, and containment technology to ensure that
the microorganism will not present an unreasonable risk.  Applicants
must notify EPA 10 days before manufacture or import, certifying
compliance with the exemption criteria and include the site of
manufacture or import.

7. Tier II exemption (40 CFR 725.428) - This exemption applies to the
same microorganisms subject to a Tier I exemption, however, the
applicant must provide adequate information on its proposed physical
containment and control technologies in order for EPA to evaluate the
exemption.  If EPA grants the exemption, it may impose appropriate
restrictions on the activities described in the notice.

Notices of Commencement - Under 40 CFR 720.102 and 725.190, EPA requires
companies to notify the Agency by submitting a Notice of Commencement
(NOC) when non-exempt commercial manufacture or importation of a new
chemical begins.  Required reporting information includes the following:

Specific chemical identity of the chemical, and a generic chemical name
if the specific name is considered confidential;

Premanufacture notice number assigned by EPA;

Date manufacture or importation commenced;

Address of the site where manufacture commenced;

Name and address of the submitting company, the name of the authorized
official signing the NOC, the name and telephone number of a technical
contact person; and

Clear indication what information, if any, is to be considered
confidential.

For traditional chemicals regulated under 40 CFR part 720, Notices of
Commencement must be submitted to EPA using the standard Notice of
Commencement form (EPA Form 7710-56).  The submitter must provide the
NOC to EPA on, or no later than 30 calendar days after, the day
manufacture or importation began.  The existing NOC form is not
appropriate for reporting of new microorganisms since the form was
designed with traditional chemical substances in mind.  Thus, under 40
CFR 725.190 the submitter may provide information in a format of his or
her own choosing when reporting an NOC for a new microorganism.

Bona Fides - To determine whether a chemical substance is on the
confidential portion of the TSCA Inventory, submitters of bona fide
inquiries under 40 CFR 720.25 are required to provide the specific
chemical identity of the substance in question, a signed statement that
the submitter intends to manufacture or import that substance, a
description of the research and development activity conducted on that
substance, a description of the intended use of the substance, infrared
spectrum data to identify the substance, the estimated date on which the
company intends to submit a PMN, the address of the facility where
manufacturing or processing will occur, and a description of the
manufacturing process.

To determine whether a microorganism is on the confidential portion of
the TSCA Inventory, submitters of bona fide inquiries under 40 CFR
725.15 are required to provide the taxonomic designations, pertinent
genotypic and phenotypic information, a signed statement that the
submitter intends to manufacture or import that microorganism, a
description of the research and development activity conducted on that
substance, a description of the intended use of the substance,  and an
indication of whether a related microorganism was previously reviewed by
EPA to the extent known by the submitter.

User Fees - The TSCA section 26(b) rule (at 40 CFR part 700) that
requires manufacturers, importers and processors to pay fees for PMNs,
MCANs, certain PMN exemption application  notices, and SNUNs submitted
under TSCA sections 5(a) and (h), requires a limited amount of
additional information to be submitted with the section 5 notice.  This
information includes certification that the firm is a “small business
concern,” (if applicable) a certification statement that the submitter
remitted the appropriate fee, and the placement of corresponding
identifying numbers both on the PMN form and the fee remittance.

(ii)	Data Items - Recordkeeping Requirements

Under 40 CFR 720.78(a), notice submitters must keep the following data
for five years from the date of commencement of manufacture, import, or
processing: documentation of information in the notice (e.g., sources of
information provided in the notice); production volume for the first
three years of production; the date of commencement, plus documentation
of this information; and “other data” described in the notice, as
required by 40 CFR 720.50(b).

Recordkeeping requirements under SNURs require persons who manufacture
or process a substance subject to significant new use reporting to
maintain records indicating their compliance with certain methods of
manufacture or processing.   Some Significant New Use Rules do not
require recordkeeping.  Rather, recordkeeping requirements apply only to
those SNURs for which compliance can only be monitored by recordkeeping
or SNUR notice submission under TSCA section 5(a)(2).  For example, upon
occasion EPA will determine that a specific set of exposure controls
will adequately mitigate risks to workers by a specific chemical
substance.  In such cases EPA may determine, by rule, that the failure
to utilize such controls constitutes a significant new use.  However,
those persons employing the controls identified in the SNUR are not
required to report to EPA.  In order to demonstrate to EPA inspectors or
to purchasers of the chemical substance that they are properly employing
worker exposure controls (to avoid SNUR notification requirements),
manufacturers or processors will likely maintain some record of their
compliance.  In instances such as those described above, EPA would
request that records be kept documenting the establishment and
implementation of procedures to ensure that employees use applicable
personal protective equipment, and that employees are informed of the
hazards associated with the chemical substance and are trained in the
use of protective equipment.  These records aid inspectors in EPA’s
compliance monitoring program during their visits to plants where
substances subject to SNUR requirements are manufactured or processed.
EPA does not consider recordkeeping that indicates compliance with a
SNUR to be burdensome.  Information contained in these records is not
submitted to EPA.  Therefore, the costs of keeping such records should
be minimal.

There are also recordkeeping requirements for persons subject to consent
orders containing exposure controls.  Depending on the facts of each
case, submitters must keep records in connection with the use of the
exposure controls including one or more of the following: (1)
documentation of manufacture and importation volumes of the PMN
substance, with associated dates of manufacture or importation; (2)
documentation of the names and addresses of all persons outside the site
of manufacture or import to whom the submitter directly sells or
transfers the substance, with associated dates of transfer; (3)
documentation of the establishment and implementation of personal
protective equipment program; (4) documentation of chemical protective
clothing imperviousness testing; (5) documentation of the hazard
communication program; (6) copies of labels; (7) copies of material
safety data sheets; (8) documentation of compliance with industrial,
commercial and consumer use limitations; and (9) documentation of
compliance with disposal and release to water limitations.

(iii)	Respondent Activities

In responding to the reporting and recordkeeping requirements outlined
in this document, respondents will engage in the following activities:

Read regulatory requirements and provisions;

Determine which provisions are applicable to their activities;

Gather information necessary to meet the requirements;

Substantiate any claims of confidential business information;

Submit information to EPA, as necessary;

Comply with any restrictions EPA may impose upon completion of review of
their submission; and

Maintain any necessary records.

5	THE INFORMATION COLLECTED--AGENCY ACTIVITIES, COLLECTION METHODOLOGY
AND INFORMATION MANAGEMENT

5(a)	Agency Activities

In connection with administering the TSCA section 5 new chemical review
and regulatory program, EPA performs the following activities:

Reviews PMN/MCAN submissions;

Analyzes submissions for confidentiality and provides appropriate
protection for confidential data;

Files and stores submissions;

Proposes and implements regulatory action as appropriate; and

Conducts site and record inspections and performs related compliance
monitoring functions.

5(b)	Collection Methodology and Management

EPA encourages but does not require the submission of premanufacture
notices and other submissions by electronic means (see 40 CFR 720.40). 
EPA believes electronic submission potentially reduces the reporting
burden on industry, because it is intended to reduce both the cost and
the time required to enter, review, edit and transmit the data. 
Electronic submission may also improve data quality because it
facilitates correcting incorrect data or adding omitted data.

Respondents are able to submit TSCA section 5 notices electronically,
using the “e-PMN” form available at the New Chemicals website
(https://cdx.epa.gov/ssl/pmn/download.asp).  The form uses Adobe Acrobat
software that allows submitters to complete and save the form
electronically, but then print it and mail it to EPA as hard copy as
they have always done.  About 15-20% of TSCA section 5 notices are
submitted on this form.  This was the first phase of an e-PMN project
that is to be followed with submitters being able to submit the form
electronically via diskettes with a hard copy signature page.

The Agency is currently developing a data entry tool using technology
that will allow pure electronic submittal of TSCA section 5 data.  This
technology will work with DOS- as well as UNIX-based computers and uses
XML technology for more efficient data transmittal.  This approach will
be designed so that data can be submitted using portable media, such as
a CD ROM.  However the proposed solution can easily be scaled to enable
eventual submission of data over the Internet.  The Agency contemplates
in time receiving electronic TSCA section 5 notices via the Internet
once security issues have been resolved and industry(s preferences have
been determined.  No matter what electronic media the Agency decides
upon, however, paper submissions will always be accepted.

Additionally, to aid persons subject to this information collection,
OPPT has set up a TSCA Hotline that provides information regarding TSCA
regulatory requirements.  When TSCA Hotline staff members are unable to
answer questions regarding TSCA section 5, the questions are referred to
OPPT staff for appropriate resolution.

5(c)	Small Entity Flexibility

The reporting and recordkeeping requirements associated with TSCA
section 5 are applicable to all affected entities, regardless of size of
business.  However, EPA provides specialized assistance to respondents,
particularly to small entities.  TSCA section 26(d) established the TSCA
Assistance Office, now known as the Environmental Assistance Division
(EAD), to provide technical and other non-financial assistance to
manufacturers, importers and processors of chemical substances.  This
office has established a hotline to assist small businesses complying
with TSCA rules.  It provides material such as copies of Federal
Register notices, advisories, and other information on request.  It also
publishes the bi-monthly Chemicals-in-Progress bulletin that identifies
activities in EPA.  In addition, “small business concerns” submit a
reduced fee of $100 (rather than $2,500) for each TSCA section 5 notice
submitted pursuant to the user fee regulation at 40 CFR 700.45(a)(1).

Moreover, EPA has taken certain steps to minimize for all respondents
the reporting burden associated with complying with this collection. 
For example, the information technology used by EPA includes
bibliographic data bases that reference scientific literature and data
bases containing previously submitted chemical information.  These data
bases allow EPA to exempt submitters from needlessly providing
already-published data or resubmitting previously submitted information
(unless the previously submitted information was claimed confidential).

Also, as discussed above, EPA has issued several TSCA section 5
exemption rules that reduce PMN reporting requirements thereby providing
relief to submitters from the burden of responding to the full PMN/MCAN
requirements.

Finally, EPA provides the services of pre-notice communications
coordinators and other personnel to assist persons in a comprehensive
manner for purposes of notice preparation prior to submission.  For
instance, for new chemical substances a PMN submitter may, upon
consultation with the pre-notice communication coordinator, prepare one
“consolidated notice” for two or more chemical substances if they
are similar in physicochemical structure and use and share common test
data or other information.  Pre-notice communication coordinators
respond to other pre-notice inquiries that may pertain to the full scope
of the TSCA section 5 regulations. 

5(d)	Collection Schedule

Does not apply.  Submission of information under this collection is on
an as-needed, on-occasion basis, initiated by the respondents.

6	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	The analysis covers submissions of PMNs, SNUNs, MCANs, and associated
exemption applications: test-marketing exemption (TME), low volume
exemption (LVE), low exposure/low release exemption (LoREX), TSCA
Experimental Release Applications (TERAs), and Tier I and II exemption
applications.  It also covers submission of Bona Fide claims, and the
burden associated with implementation of TSCA section 5(e) consent order
restrictions. Since the 1995 amendments, polymer exemptions are no
longer submitted, and so are not included in this analysis.  

	Burden and cost calculations are based on the assumption that EPA will
receive approximately 1,455 TSCA section 5 notices each year, based on
the average number of notices received for years 2003, 2004, and 2005
(see Table 1).  Amendments to the PMN rule in 1995 eliminated the PMN
requirement for eligible polymers, broadened the low volume exemption,
and introduced the low release/low exposure exemption.  The overall
effect of these amendments has been a significant decline in the
submission of notices in general and of full PMNs in particular, from
2,645 in FY 1994, to 772 in FY 2005. 

6(a)	Estimating Respondent Burden

	The burden to respondents includes: (1) reporting burden for submission
of PMNs, SNUNs, MCANs, exemption notices, and implementation of TSCA
section 5(e) consent order restrictions such as the use of exposure
controls and/or performing toxicity testing; and (2) recordkeeping
burden associated with notice submissions, consent orders, exposure
controls and toxicity testing.

6(b)	Burden Associated with Reporting

	As shown in Table 1, the total respondent reporting burden associated
with this information collection is estimated to total 142,351 hours. 
This burden estimate is calculated by multiplying the hours of reporting
burden by the number of each type of notice that EPA expects to receive
and summing across the notice types.   

Number of Notices.  The number of notices expected to be submitted
annually is estimated by averaging the number of each type of
submissions received over the past three years (2003, 2004, and 2005),
according to data provided in the OPPT New Chemicals Annual Report
(2006). 

Prior to the 1995 amendments to the PMN rule, 70% to 80% of all TSCA
section 5 notices were full PMN submissions. Since the amendments of
1995, the increase in exemptions has not significantly changed this
distribution.  EPA expects few persons to submit significant new use
notices (SNUNs).  The number of SNUNs submitted is a function of the
number of chemicals regulated under Significant New Use Rules, which are
relatively few.  Current data suggest the Agency expects to receive
approximately 7 SNUNs annually.

	

	The amendments also placed stricter control on bona fide claims,
intended to establish bona fide intent.  This was done in response to
the steadily increasing number of bona fide notices submitted to EPA. 
The result of the amendments has been a significant reduction in bona
fide submissions.  Current EPA data suggests that 133 bona fide notices
are expected to be submitted annually.

	On average, LVE and LoREX exemptions are expected to account for about
470 notices annually.  Further, TME are expected to average 5
applications per year, or less than 1% of all TSCA section 5 notices.	

	The various exemptions available to submitters since the 1995
amendments have significantly reduced the need for consent order
development and post-notice data review.  Historical EPA data indicate
that such consent orders and post-notice data reviews will amount to
roughly 2% of the total TSCA section 5 notices.  Based on historical
data, EPA estimates 29 cases would be subject to TSCA section 5(e)
consent order restrictions burden, with 13 cases requiring test data,
and 16 non-testing TSCA section 5(e) cases.  Testing is usually
contracted out to a laboratory, thus the burden associated with testing
requirements represents the time that personnel from the submitting firm
would spend overseeing the testing, assumed to be 25% of the lab burden.

Burden hours.  Burden hours for each type of notice were estimated in
previous analyses, as described below and summarized in Table 1.

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 an MCAN is estimated to range between 71 and
533 hours, with an average of 302 hours.

The respondent burden for submission of a TME is estimated to average 98
hours.

The respondent burden for a TERA is estimated to range between 91 and
950 hours, with an average of 521 hours.

The respondent burden for a Tier I or Tier II exemption is estimated to
range between 13 and 215 hours, with an average of 114 hours.

In response to e-government initiatives and to simplify and improve the
submission process for industry, EPA is developing an option for
industry to submit all section 5(e) premanufacture notifications
electronically, through EPA’s Central Data Exchange (CDX). By using an
electronic submission tool, submitters will be able to upload their
electronic data securely and efficiently over the Web to EPA for
processing.  If they choose, submitters will also continue to be able to
submit forms in hard copy or on CD-ROM.

The electronic submission tool is currently under development, but EPA
expects that it will be available for use within the period of this ICR.
 EPA expects that this streamlined submission process will reduce burden
associated with reporting for all notification types.  Burden reduction
will result from eliminating the time and expense of preparing and
mailing hardcopy notices.  However, because the timeframe for release of
the electronic reporting tool is currently unknown and the complete
details of the electronic submission are not determined, the cost
savings from this option are not quantified here.  To the extent that
submitters are able to use the electronic submission tool, costs both to
submitters (reporting burden) and to the Agency (time required to manual
processing of data) are over-reported in this analysis.

Table 1

Reporting Burden

Type of Notice	Avg. Annual Responses1	Average Reporting Hours per
Response	Avg. Annual Burden

PMN	805	105	84,525

SNUN	7	105	735

MCAN	3	302	906

Exemptions:

	     TME	5	98	490

     LVE/LoREX	470	105	49,350

     TERA	2	521	1,042

     Tier I and II	2	114	228

Bona Fide	133	20	2,660

5(e) Test	13	155	2,015

Non-Testing 5(e) Burden	16	25	400

Total Respondent Reporting Burden Hours	142,351

1Average Annual Responses computed as the average of the number of
notices filed over 2003, 2004, and 2005 based on OPPT New Chemicals
Annual Report, 2006.

6(c)	Burden Associated with Recordkeeping

	As shown in Table 2, the total respondent recordkeeping burden
associated with this information collection is estimated to equal 3,709
hours.  This burden estimate is calculated by multiplying the estimated
recordkeeping burden associated with each type of submission, by the
estimated number of submissions for each notice and summing across
notice types.

	Once a respondent presents information in an initial TSCA section 5
submission, the burden for maintaining or updating these records is
minimal.  The Agency assumes an aggregate annualized recordkeeping
burden of two hours for each PMN, SNUN, MCAN, or exemption submission,
or biotech submission. This is based on the recordkeeping burden
associated with essential technical requirements, such as records that
demonstrate that the first commercial batch of chemical manufactured for
commercial purposes under the exemption met certain eligibility
criteria.  The recordkeeping burden for 5(e) testing and non-testing
burden are 35 and 25 hours, respectively. 

	The overall respondent recordkeeping burden is displayed below in Table
2.

Table 2

Respondent Recordkeeping Burden

Type of Notice	Avg. Annual Responses1	Hours for Recordkeeping	Avg.
Annual Burden

PMN	805	2	1610

SNUN	7	2	14

MCAN	3	2	6

Exemptions:

	     TME	5	2	10

     LVE/LoREX	470	2	940

     TERA	2	2	4

     Tier I and II	2	2	4

Bona Fide	133	2	266

5(e) Test	13	35	455

Non-Testing 5(e) Burden	16	25	400

Total Respondent Recordkeeping Burden Hours	3,709

1Average Annual Responses computed as the average number of notices
filed over 2003, 2004, and 2005 based on OPPT New Chemicals Annual
Report, 2006.

6(d)	Estimating Respondent Cost

	Respondents to TSCA section 5 reporting requirements experience costs
associated with (1) reporting, (2) recordkeeping, and (3) compliance
with exposure controls and testing requirements included in TSCA section
5(e) orders, when EPA takes regulatory action.  The respondent costs
associated with this information collection are estimated to total
$34,298,675, as presented in Table 3 below. 

	Respondent costs for all submissions consist of three components:  (1)
labor costs, calculated by multiplying the estimated burden hours
associated with each submission type by the appropriate labor rate; (2)
delay costs, estimated as the cost of the delayed receipt of profits by
chemical manufactures as a result of the submission review process, and
(3) explicit costs, such as user fees or lab testing fees.

	In order to estimate total respondent cost associated with TSCA section
5 submissions, an average cost was first calculated for each type of
notice.  The cost for each notice type was calculated by summing each of
the associated cost components, and then multiplying by the expected
number of notice submissions.  The total industry cost was calculated by
summing the costs across notice types.  Table 3 below outlines the total
average cost calculations for the various types of notice submissions
and presents the total respondent cost estimate.

Wages and fringe benefits for managerial, professional/technical,
clerical and production labor were taken from the Bureau of Labor
Statistics (BLS) Employer Costs for Employee Compensation (ECEC) data,
for December 2005, for manufacturing industries.   

The cost of fringe benefits such as paid leave and insurance, specific
to each labor category, are taken from the same ECEC series.  Fringe
benefits as a percent of wages are calculated separately for each labor
category.  For example, for December 2005, the average wage rate for
professional/technical labor was $31.02; the average fringe benefit was
$16.73.  Fringe benefits as a percent of wages were $16.73/$31.02, or
approximately 53.9 percent. 

An additional loading factor of 17 percent is applied to wages to
account for overhead.  This approach is used for consistency with Office
of Pollution Prevention and Toxics economic analyses for two major
rulemakings: Wage Rates for Economic Analyses of the Toxics Release
Inventory Program (2002), and the Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report (2002).  This overhead
loading factor is added to the benefits loading factor, and the total is
then applied to the base wage to derive the fully loaded wage.  For
example, the December 2005 fully loaded wage for professional/technical
labor is $31.02 × (1+0.539329 + 0.17) = $53.02. 

	As noted above, delay costs reflect the cost of the delayed receipt of
profits by chemical manufactures as a result of the submission review
process.  Industry delay costs used to calculate the average cost per
submission were computed using the midpoint of the low and high delay
cost estimates (2003 dollars) as presented in the “Regulatory Impact
Analysis of Amendments to Regulations for TSCA section 5 Premanufacture
Notifications (1994), and inflated to 2005 dollars using the Bureau of
Labor Statistics’ Producer Price Index data for the Chemical
Manufacturing industry. 

	The explicit costs or fees used to calculate the average cost per
submission were taken from the 2000 ICR and have not been adjusted.

	

	The total respondent burden hours and costs is the sum of reporting
hours and recordkeeping hours, and the total costs for all expected
notice submissions.  Total respondent burden hours are 146,060 (142,351
reporting hours + 3,709 recordkeeping hours).  As noted above, total
respondent costs based on the expected number of TSCA section 5 notice
submissions are $34,298,675.



Table 3

Total Respondent Cost Calculation

Notice	Average Annual Number of Responses	Total Burden (reporting +
recordkeeping) and Wage Rate by Labor Category	Labor Costs1	Delay Costs2
	Fees3	Total Avg. Costs Per Notice4	Total Respondent Cost 

Managerial	Technical	Clerical

	Hrs	Wage($)	Hrs	Wage($)	Hrs	Wage($)

	PMN	805	18	63.61	75	53.02	14	$26.37	5,491	22,215	2,500	30,206
24,315,842

SNUN	7	18	63.61	75	53.02	14	$26.37	5,491	22,215	2,500	30,206	211,442

MCAN	3	65	63.61	224	53.02	15	$26.37	16,407	22,215	2,500	41,122	123,366

Exemptions:

     TME	5	17	63.61	70	53.02	13	$26.37	5,136	0	0	5,136	25,678

     LVE/LoREX	470	18	63.61	75	53.02	14	$26.37	5,491	11,182	0	16,673
7,836,172

     TERA	2	129	63.61	380	53.02	15	$26.37	28,749	0	0	28,749	57,498

     Tier I and II	2	23	63.61	88	53.02	5	$26.37	6,261	0	0	6,261	12,521

Bona Fide	133	5	63.61	12	53.02	5	$26.37	1,086	0	0	1,086	144,457

5(e) Test	13	38	63.61	130	53.02	22	$26.37	9,890	0	108,1085	117,998
1,533,973

Non-Testing 5(e) Burden	16	10	63.61	25	53.02	15	$26.37	2,357	0	0	2,357
37,714

Total Respondent Costs	$34,298,675

1 Labor costs are calculated by multiplying burden hours by the wage
rate for each labor category and summing across labor categories.

2  Delay costs calculated using the average of low and high estimates
from “Regulatory Impact Analysis of Amendments to Regulations for TSCA
section 5 Premanufacture Notifications” September 9, 1994 (RIA, 1994),
updated to 2005$ using Bureau of Labor Statistics Producer Price Index
data for the chemical manufacturing industry.  MCANs are assumed to have
the same delay costs as PMNs.

3  User fees charged by EPA, except where noted.  These were assumed to
remain constant since ICR, 2000.

4  Total average costs is the sum of labor costs, delay costs and fees.

5  This figure is for a representative testing regimen consisting of
835.3110 (ready biodegradability), 850.1010, 850.1075, 850.5400 (aquatic
base set), and OECD 407 (28-day repeated dose), based on an analysis of
average costs for 277 testing cases.

6  While companies incur costs for control equipment, such costs are
outside the realm of this ICR.



6(e)	Estimating Agency Cost

	The Agency costs associated with this information collection are
estimated to total $7,180,319 as presented in Table 4 below. Costs to
the government include:  (1) initial review of PMN substances (after
which the majority of cases are dropped from further regulatory review),
and (2) comprehensive reviews on a minority of chemicals, during which
the Agency conducts a more through evaluation of the potential risks
associated with manufacturing, processing, use and disposal of PMN
substances including, if necessary, taking regulatory action under TSCA
sections 5(e) or 5(f).

	In order to determine the total cost for the Agency, an average cost
was first computed for each type of notice.  The Agency cost per notice
was computed by multiplying the Agency labor hours for each notice, as
reported in various sources, by the current Agency labor cost per hour
for a fully loaded GS-13, step 5 employee in the Washington D.C. area,
and then adding updated extramural costs for contractor support.  The
average cost per notice was then multiplied by the expected number of
notice submissions and summed across notice types to obtain the Total
Agency Cost.

	Agency wage rate data used to calculate labor costs were gathered from
the U.S. Office of Personnel Management Salary Table 2006-DCB, for a
GS-13, step 5 employee in the Washington, D.C. area.  A loading factor
of 1.6 was applied to the base rate to arrive at the 2006 loaded wage
rate of $140,262 per year.  The hourly wage rate was computed by
dividing the loaded wage by 2,080 hours, the hours associated with a
full time employee.  This loaded hourly wage was used in calculations of
Agency cost.



Table 4

Total Agency Cost Calculation

Type of Notice	Average Annual Number of Responses	Agency Labor Hours
Wage Rate	Labor Costs6	Extramural Costs7	Total Avg. Costs8	Total Agency
Costs

PMN	805	64 1	67.43	4,316	949	5,265	4,238,339

SNUN	7	64 1	67.43	4,316	944	5,260	36,818

MCAN	3	1,067 2	67.43	71,952	0	71,952	215,856

Exemptions:

	     TME	5	109 3	67.43	7,350	0	7,350	36,751

     LVE/LoREX	470	22 1	67.43	1,484	676	2,160	1,015,056

     TERA	2	1,476 2	67.43	99,532	0	99,532	199,065

     Tier I and II	2	187 2	67.43	12,610	0	12,610	25,220

Bona Fide	133	2 1	67.43	135	77	211	28,121

5(e) Test	13	1,500 4	67.43	101,151	0	101,151	1,314,960

Non-Testing 5(e) Burden 	16	65 5	67.43	4,383	0	4,383	70,131

Total Agency Cost	$7,180,319

1“Regulatory Impact Analysis of Amendments to Regulations for TSCA
Section 5 Premanufacture Notifications” September 9, 1994 (RIA, 1994).

2 “Regulatory Impact Analysis of Regulations on Microbial Products of
Biotechnology” January 21, 1997 (RIA, 1997).

3  ICR, 2000.  

4  Estimated to be similar to TERA review.

5  Estimated to be similar to PMN / SNUN review.

6  Labor costs calculated as labor hours multiplied by Agency wage rate.
 Wage rate based on salary taken from Salary Table 2003-DCB, U.S. Office
of Personnel Management.

7  Extramural costs for contractor support.  Values taken from RIA, 1994
(except for SNUN value, taken from “Burden Cost Analysis Supporting
the Information Collection Request Renewal for TSCA Section 5
Premanufacture Notifications,” August 15, 2003) and updated to 2005$
using Bureau of Labor Statistics Producer Price Index data for the
chemical manufacturing industry.

8  Agency labor costs plus extramural costs.

	6(f)	Reasons for Change in Burden

	This request reflects a decrease in the total estimated burden of
17,731 hours (from 163,791 hours to 146,060 hours) in the total
estimated respondent burden from that currently in the OMB inventory. 
This decrease represents an adjustment in the number of annual
submissions to reflect EPA’s experiences since the most recent ICR. 
The decrease in the number of submissions per year is largely associated
with the polymer and other exemptions implemented under the 1995
amendments.

6(g)	Burden Statement

The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0012, is estimated to average 102.1
hours per response, and to require 3.4 hours of recordkeeping per
response.  According to the Paperwork Reduction Act, “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.  For this collection it 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.  An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. 
The OMB control number for this information collection appears above. 
The OMB control numbers for EPA’s regulations in title 40 of the CFR,
after appearing in the Federal Register, are listed in 40 CFR part 9 and
included on the related collection instrument or form, if applicable.

To comment on the Agency’s need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID No.
EPA-HQ-OPPT-2007-0094.  The docket is available for public viewing at
the Pollution Prevention and Toxics Docket in the EPA Docket Center
(EPA/DC).  The EPA/DC Public Reading Room is located in the EPA West
Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC.  The
EPA/DC Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday
through Friday, excluding legal holidays.  The telephone number for the
EPA/DC Public Reading Room is (202) 566-1744, and the telephone number
for the Pollution Prevention and Toxics Docket is (202) 566-0280.  An
electronic version of the public docket is available through the Federal
Docket Management System (FDMS) at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov .  Use FDMS to submit
or view public comments, access the index listing of the contents of the
public docket, and to access those documents in the public docket that
are available electronically.  Once in the system, select “search,”
then key in the docket ID number identified above.  Also, you can send
comments to the Office of Information and Regulatory Affairs, Office of
Management and Budget, 725 17th Street, NW, Washington, DC 20503,
Attention: Desk Office for EPA.  Please include the EPA Docket ID No.
EPA-HQ-OPPT-2007-0094 and OMB control number 2070-0012 in any
correspondence.



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