Document ID: EPA-HQ-OPPT-2007-0094-0012
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-18T05:00Z

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:   0574.14	OMB Control No.: 	2070-0014

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) Chemical Substance 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 (NOC).  After processing the NOC, EPA will place
the substance on the TSCA Chemical Substance Inventory (“the
Inventory”).  

In order to determine whether a substance would be considered “new
chemical” and subject to TSCA section 5 premanufacture notice
requirements, a company may inquire of EPA whether their substance is
included on the TSCA Inventory Master File.  Reporting provisions
require specific information from the submitter so as to encourage only
bona fide requests reflecting legitimate intent to manufacture or import
a chemical substance.  After reviewing the information provided in a
bona fide request, EPA will notify the submitter of the Inventory status
of the substance in question.  

If at any time a submitter determines that the chemical identity of a
substance placed on the TSCA Inventory was misidentified, a correction
request may be initiated by the submitter by filing a TSCA Chemical
Substance Inventory Reporting Form C for substances reported to the
initial Inventory or by filing the appropriate amended pages of the PMN
form for substances reported to the Inventory via a PMN and NOC, along
with the pertinent information to justify the request.  The correction
mechanism allows the submitter to add the correct substance to the TSCA
Inventory without having to file another PMN under TSCA section 5.

This information collection request addresses the TSCA section 5
reporting and recordkeeping and Inventory reporting and maintenance
requirements associated with the new chemicals review and regulatory
program, as briefly outlined above.  Additionally and more specifically,
this information collection request addresses the respondent burden and
cost associated with the implementation of electronic submission of
reports require by this information collection.  (See related
discussions below at section 5(b), “Collection Methodology and
Management,” and section 6(b), “Burden Associated with
Reporting.”)  Finally, this information collection request serves to
incorporate the respondent burden associated with corrections made from
time to time to the original TSCA Inventory.  The latter burden to this
point has been addressed by OMB Control No. 2070-0145 (EPA ICR No. 1741)
titled “Correction of Misreported Chemical Substances on the TSCA
Inventory.”

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 (inter-generic) 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.

  SEQ CHAPTER \h \r 1 TSCA section 8(b) requires EPA to compile and keep
current a complete list of chemical substances that are manufactured or
processed in, or imported into, the United States.    SEQ CHAPTER \h \r
1 The purpose of the TSCA Inventory, therefore, is to define, for the
purpose of TSCA, what chemical substances exist in U.S. commerce. 
Substances on the Inventory are considered to be existing chemical
substances.  Substances not included on the Inventory are considered to
be new chemical substances and are subject to the PMN requirements
stipulated under TSCA section 5(a)(1).  EPA requires that companies
inform EPA when non-exempt commercial manufacture, processing or
importation of a substance actually begins by submitting a NOC.  After
processing the NOC, EPA will place the substance on the Inventory.  

A company that has a legitimate, bona fide intent to manufacture or
import a chemical substance may inquire of EPA whether the substance is
included on the TSCA Inventory Master File (i.e., determine whether the
substance would be considered new and therefore subject to TSCA section
5(a)(1) PMN requirements).  Reporting provisions found at 40 CFR 720.25
and 40 CFR 725.15 require specific information from the company to
encourage submission of only bona fide requests that reflect legitimate
intent to manufacture or import.  After reviewing the information
provided in a bona fide request, EPA will notify the requesting company
of the TSCA Inventory status of the substance in question.  

If at any time a company determines that the chemical identity of a
substance placed on the TSCA Inventory was misreported, a correction
request may be initiated by the submitter of the substance by filing a
Chemical Substance Inventory Report Form C (EPA Form 7710-3C, see
Attachment J) for substances reported to the initial Inventory or by
filing the appropriate amended pages of the PMN form for substances
reported to the Inventory via a PMN and NOC.  EPA reviews the
information provided in the Form C or amended PMN pages to evaluate the
correction request.  If EPA grants a correction request, the Agency will
correct the chemical identity of the substance in question on the TSCA
Inventory.

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, 710, 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 Inventory of chemicals imported, 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 PMN 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 and 40 CFR 725.15 require specific information from the
company to encourage the submission of only bona fides that reflect
legitimate intent to manufacture or import.

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 (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.  The NOC
results in EPA adding that substance to the TSCA Inventory.

EPA requires the use of a specific form (EPA Form No. 7710-56) for NOCs.
 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.

If at any time EPA or a company determines that the chemical identity of
the substance on the TSCA Inventory is incorrect, a correction request
may be initiated by EPA or the original submitter of the substance.   
SEQ CHAPTER \h \r 1 The need for correcting chemical identities listed
on the Inventory arose following the initial Inventory reporting period,
when both EPA and the chemical industry recognized that substances
submitted for inclusion on the initial TSCA Inventory were incorrectly
described by reporting companies for various reasons, including simple
typographical errors, unintentional misidentification of substances, or
the lack of sufficient technical or analytical capabilities to fully
characterize the exact chemical substances.  

	  SEQ CHAPTER \h \r 1 The TSCA Inventory supports EPA’s TSCA
regulatory functions, and as such, it must accurately identify those
substances that exist in commerce in the United States.  Companies also
must be certain that the substances they manufacture or import are
correctly identified on the Inventory so that they are in full
compliance with TSCA reporting requirements.  The correction mechanism
ensures the accuracy of the Inventory without imposing an unreasonable
burden on the chemical industry, and, in fact, may be initiated by
industry.  Without the Inventory correction mechanism, a submitter would
have to file a PMN to place the correct chemical substance on the
Inventory whenever the previously reported substance is found to be
incorrect.  This would impose a much greater burden on both EPA and
industry than the existing correction mechanism.

Although not required to do so under TSCA, EPA developed guidelines, at
the request of industry, under which the chemical identities of
incorrectly described substances listed in the TSCA Inventory could be
corrected.  These guidelines were published July 29, 1980.  See 45 FR
50544.  EPA requires submitters to file the TSCA Chemical Substance
Inventory Reporting Form C for requests to correct substances reported
to the initial Inventory.  EPA requires submitters to file the
appropriate amended pages of the PMN form to correct substances reported
to the Inventory via a PMN and NOC.    SEQ CHAPTER \h \r 1  EPA reviews
the information provided in the Form C or amended PMN pages to evaluate
the correction request.  If EPA grants a correction request, the Agency
will correct the chemical identity of the substance in question on the
TSCA inventory.

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., 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 members of the New
Chemicals Program 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 has
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
will also contact potential respondents to request review and comments.

Finally, when proposing previously to renew this ICR, EPA provided a
60-day public notice and comment period that ended on February 13, 2004
(68 FR 69677, December 15, 2003). EPA received no comments during the
comment period.

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 (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 EPA by submitting a Notice of Commencement (NOC)
when non-exempt commercial manufacture or importation of a new chemical
begins.  Required reporting information includes specific chemical
identity of the chemical and a generic chemical name if the specific
name is considered confidential, PMN 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, NOCs must be
submitted to EPA using the standard NOC 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 a 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, infrared spectrum data
to identify the substance, a signed statement that the submitter intends
to manufacture or import that substance, the address of the facility
where manufacturing or processing will occur, a description of the
manufacturing process, a description of the research and development
activity conducted on that substance, a description of the intended use
of the substance, the estimated date on which the company intends to
submit a PMN, and a clear indication what information, if any, is to be
considered confidential.

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.

TSCA Inventory correction requests – Per TSCA Inventory guidelines
published July 29, 1980 (45 FR 50544), EPA requires submitters to file
the TSCA Chemical Substance Inventory Reporting Form C for requests to
correct substances reported to the initial Inventory.  EPA requires
submitters to file the appropriate amended pages of the PMN form to
correct substances reported to the Inventory via a PMN and NOC.    SEQ
CHAPTER \h \r 1  Required reporting information includes the specific
chemical identity of the corrected chemical, PMN number assigned by EPA
(if applicable), production volume, address of the facility where
manufacturing or processing occurs, name and address of the requesting
company, name of the authorized official signing the correction request,
the name and telephone number of a technical contact person, and a clear
indication what information, if any, is to be considered confidential.

  SEQ CHAPTER \h \r 1 The Agency does not require industry to provide
correction information, nor does EPA have an obligation to provide a
correction mechanism or to specify a reporting format.  The mechanism
exists at the request of industry and the EPA form is used because it
reduces the burden on both EPA and industry by providing a clear format
for the data.  

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 strongly encourages but does not require the submission of PMNs and
other submissions by electronic means (see 40 CFR 720.40).  EPA believes
an 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 data.  An electronic
submission tool may also improve data quality because it facilitates
correcting data and it highlights fields with omitted data prior to
submission. 

Respondents presently are able to create TSCA section 5 notices
electronically using the PMN form available at the EPA New Chemicals
Program website (https://cdx.epa.gov/ssl/pmn/download.asp).  The form
uses Adobe Acrobat software, which must be purchased, that allows
submitters to complete and save the form electronically, and then print
out and mail it to EPA as hard copy, as they have always done.  About
20% of TSCA section 5 notices presently are submitted using this
software to create the PMN form. 

The Agency now has developed a data entry tool using technology that
will allow electronic submittal of TSCA section 5 data over the
Internet, called the electronic PMN or e-PMN.  This technology will work
with Windows and UNIX-based computers, using XML technology for more
efficient data transmittal.  Data may also be submitted to the Agency
using portable media, such as a CD-ROM; however, the preferred way will
be submission via the Internet.  This information will be transmitted
using secure technologies to protect CBI.   Submitters also will be able
to submit supporting documents and amendments electronically following
the submission of a PMN.  In the same manner, the Agency will be able to
communicate electronically with the submitter.  For the most part, these
transactions have taken place through the standard paper mail process
for both submitters and the Agency.  Having the means of communicating
electronically should provide significant time and resource savings for
both parties.

The software for this e-form will be available on the Internet and will
be free to download and use.  Regardless of the technologies being
implemented, paper submissions will always be accepted; however, the
Agency has learned from its experience with Inventory Update Reporting
(IUR) that paper submissions will slow down entry of the data into an
Agency database and is therefore encouraging submitters to submit PMNs
over the Internet.  To this end, the Agency is considering various
incentives to encourage this means of transmittal, including lowering
the User Fee for electronically submitted PMNs and SNUNs.

A submission sent to the Agency over the Internet will necessitate an
electronic signature. The Cross-Media Electronic Reporting Regulation
(CROMERR) (October 13, 2005; 70 FR 59848) gives the Agency the authority
to accept such signatures.  Once the new e-PMN tool is in place, senior
company officials and registrants submitting section 5 notices will only
need to register once for all future submissions.  However, changes to
authorized officials in a company will necessitate re-registration. 

If a submitter prefers to enter the data onto a PMN electronically,
print it out, and submit it to the Agency via traditional paper mail,
the printed version of the new e-PMN form will have the look of the
original (current) paper PMN form.  Questions on the new form will be
the same as on the old form. The pagination will stay true to the old
form.  Fields have been expanded to make more room for submitter
information which will result in the total number of running pages being
greater.  Fields on the form have been realigned to make the form easier
to scan.  As a consequence of creating this new scannable form, the
Agency expects to phase out the old or existing version of the paper PMN
form with the implementation of the new system.

	The major difference between the old and new methods of data entry is
the user interface. Data now will be entered through a series of pages
or screens on the computer as opposed to being entered on the form
itself.  Users will have the option to go back and forth between the
screens and the printed version of the form to affirm that the
information entered in the screens is what is actually captured on the
form.  Most screens will represent a page of the printed PMN form.

	Other changes to the e-PMN form will be the addition of a new required
field, a User Fee Payment Identity Number, to help EPA better connect a
user fee with a particular submission.  The number may be a check
number, a wire number, or an “e-gov” transaction number used to
transmit the user fee.  This information is presently already in the
submitter’s possession.  Further, EPA will request e-mail addresses
for the principals listed on the Submitter Identification section
(currently page 3) of the PMN form. 

The electronic tool will include invaluable features for PMN
preparation.  One feature is a built-in validation mechanism which will
alert users that information, required by regulation, is missing.  This
should help industry users submit fewer incomplete notices which
ultimately will save EPA and industry processing resources.  Also,
similar to the existing Adobe e-PMN form, the new electronic tool will
allow for the creation of a sanitized non-CBI version from the initial
submission that contains CBI.  It also will allow submitters to share a
draft notice within their company during the creation of a notice and to
save a copy of the final file for future use.

	As added features, the e-PMN tool will allow for the electronic
submission of PMN support documents such as amendments, correspondence
and test data. However, the Agency will only accept these electronic
documents for those PMNs that are submitted after the e-PMN tool is
officially in place. Also, submitters can now fill out and submit the
NOC form electronically through CDX. 

The Agency envisions that after two years submitters will have gained
experience using the tool and will submit a high percentage of their
notifications electronically. At that time, the Agency will no longer
accept paper submissions for notifications, and support documents and
NOCs submitted for PMNs after the tool was officially in place. Rather,
EPA will then require that those submissions be sent through the
Internet via CDX or by delivery of a CD-ROM (or acceptable electronic
media) by courier.

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  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.  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

	This section presents burden and costs estimates associated with
submissions of PMNs, SNUNs, MCANs, and the following related exemption
applications: test-marketing exemptions (TMEs), low volume exemptions
(LVEs), low exposure/low release exemptions (LoREXs), TSCA Experimental
Release Applications (TERAs), and Tier I and II, R&D and instant
photographic film articles exemption applications.  It also presents
burden and cost estimates associated with submissions of Bona Fide
claims, notices of commencement (NOCs), correction requests, and
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 an average of 2,206 TSCA Section 5 notices each year.  This
estimate is derived by averaging the number of notices received in 2004,
2005 and 2006 for each of the submission types listed in the paragraph
above and then summing these averages (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 2,267 in FY 1994, to 839 in FY 2006.  

6(a)	Estimating Respondent Burden

	The burden to respondents includes: 1) reporting burden for submission
of PMNs, SNUNs, MCANs, exemption notices, NOCs, correction requests, 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 149,235 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 submission
received over the past three years (2004, 2005 and 2006) according to
data provided in the OPPT New Chemicals Annual Report (OPPT, 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 5 SNUNs annually.

	

	The amendments also placed stricter control on bona fide claims,
intended to establish bona fide intent on the part of the submitter to
manufacture or import a chemical substance.  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 116 bona fide notices
are expected to be submitted annually.

On average, LVE and LoREX exemptions are expected to account for
approximately 453 notices annually.  TMEs are expected to average 6
applications per year, or less than 1% of all TSCA Section 5 notices. 
NOCs are expected to account for 497 notices annually, while correction
requests are expected to account for 9 notices annually, or less than 1%
of all TSCA Section 5 notices. (OPPT, 2006.) 

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 (OPPT, 2002).  Based on historical data,
EPA estimates 29 cases would be subject to TSCA Section 5(e) consent
order restrictions burden, with 14 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 (RIA, 1994).  This burden also applies to the
submission of SNUN, LVE, and LoREX submissions because 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, or 302 hours on average.  (RIA, 1997).

The respondent burden for submission of a TME is estimated to average 98
hours (RIA, 1994).

The respondent burden for a TERA is estimated to range between 91 and
950 hours, or 521 hours on average.  (RIA, 1997).

The respondent burden for a Tier I or Tier II exemption is estimated to
range between 13 and 215 hours, or 114 hours on average (RIA, 1997).

Users of the R&D exemption are not required to notify EPA when utilizing
this exemption.  Although having no supporting data, the Agency assumes
for purposes of this discussion 200 R&D exemptions per year with an
estimated burden of 2.5 hours per exemption for reporting and 0.5 hours
per exemption for recordkeeping.  EPA projects this burden only to
inform potential users of this exemption of a reporting and
recordkeeping burden.

Submissions of instant photographic film articles exemption notices are
incredibly rare.  EPA has not received any such notifications in many
years and does not expect to receive any such notices during the next
several years.  Therefore, EPA does not expect that any associated
burden will be imposed upon ICR respondents.  For purposes of this
discussion EPA projects a minimal burden per response (times zero
responses) only to inform potential users of this exemption of a
reporting and recordkeeping burden.  Since EPA has no data on the
associated burden, the per-response burden projection is strictly a best
estimate.

The respondent burden for submission of a NOC is estimated to average
0.5 hours.

The respondent burden for submission of correction requests is estimated
to average 2 hours. (OPPT, 2004).

In response to e-government initiatives, and to simplify and improve the
submission process for industry, EPA has developed 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 that will be available for free on the
Internet, submitters will be able to upload their electronic data
securely and efficiently over the Internet and transmit to EPA for
processing.  If they choose, submitters will also continue to be able to
submit PMN forms in hard copy or on CD-ROM; however, EPA expects to
phase out the old or existing version of the paper PMN form and replace
it with the new scanner-friendly version of the e-PMN form for those who
want to submit on paper.

EPA expects that the electronic submission option will reduce burden
associated with reporting for PMN, SNUN, LVE, and LoREX submissions. 
The burden estimation of 95-114 hours to complete this form includes the
time spent reading and becoming familiar with the form, gathering the
required information and preparing the report, producing sanitized
responses for items claimed as CBI, and maintaining a file of the
submission (RIA, 1994).  The convenience of an automated electronic form
may reduce the time required to read and become familiar with the form.
The electronic tool will also allow for the creation of a sanitized
version of the form containing CBI, decreasing the effort to do this
manually.  Maintaining electronic files may also be less burdensome than
hardcopy files.  In addition, burden reduction may result from some of
the unquantified costs associated with submission, such as printing,
photocopying, and mailing paper notices.  Furthermore, when data is
submitted electronically, this may reduce the time required for EPA
staff to review the information, as any need for manual data entry or
processing is eliminated.

Because use of the e-PMN electronic submission approach is optional, it
is uncertain how many submitters will choose to take advantage of this
tool, and cost savings cannot be quantified here.  Therefore, estimated
costs presented in this analysis for submitters (reporting burden) and
the Agency (time required for manual processing of data) will be
overestimates of actual costs to the extent that submitters are able to
use the electronic submission tool.

Table 1

Reporting Burden

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

PMN	882	105	92,610

SNUN			5	105	525

MCAN	3	302	906

Exemptions:

	     TME	6	98	588

     LVE/LoREX	453	105	47,565

     TERA	2	521	1,042

     Tier I and II	3	114	342

     R&D	200	2.5	500

     Instant photographic	0	0.5	0

Bona Fide	116	20	2,320

5(e) Test	14	155	2,170

Non-Testing 5(e) Burden	16	25	400

NOC	497	0.5	249

Correction Request	9	2	18

Total	2,206

149,235

1Average Annual Responses computed as the average of the number of
notices filed over 2004, 2005, and 2006 based on OPPT, 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 4,056
hours.  This burden estimate is calculated by multiplying the estimated
recordkeeping burden associated with each type of submission (as
estimated in RIA, 1994) by the estimated number of submissions for each
notice and then 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 (RIA, 1994). 

	Table 2 summarizes the overall respondent recordkeeping burden.

Table 2

Respondent Recordkeeping Burden

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

PMN	882	2	1,764

SNUN	    5	2	     10

MCAN	    3	2	       6

Exemptions:

	     TME	    6	2	      12

     LVE/LoREX	453	2	    906

     TERA	    2	2	       4

     Tier I and II	    3	2	       6

     R&D	200	0.5	   100

     Instant photographic	    0	0.25	       0

Bona Fide	116	2	   232

5(e) Test	 14	35	   490

Non-Testing 5(e) Burden	  16	25	   400

NOC	497	0.25	   124

Correction Request	    9	0.25	       2

Total                                                        2,206	4,056

1Average Annual Responses computed as the average number of notices
filed over 2004, 2005, and 2006 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
$37,737,821, 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 (Rice, 2002), and the Revised Economic Analysis for
the Amended Inventory Update Rule: Final Report (EPAB, 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 1994 RIA, and inflated
to 2006 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 153,291 (149,235
reporting hours plus 4,056 recordkeeping hours).  As noted above, total
respondent costs based on the expected number of TSCA Section 5 notice
submissions are $37,737,821.



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	882	18	63.61	75	53.02	14	26.37	5,491	23,378	2,500	31,368	27,666,923

SNUN	5	18	63.61	75	53.02	14	26.37	5,491	23,378	2,500	31,368	156,842

MCAN	3	65	63.61	224	53.02	15	26.37	16,407	23,378	2,500	42,284	126,853

Exemptions:	0

	     TME	6	17	63.61	70	53.02	13	26.37	5,136	0	0	5,136	30,813

     LVE/LoREX	453	18	63.61	75	53.02	14	26.37	5,491	11,767	0	17,258
7,817,773

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

     Tier I and II	3	23	63.61	88	53.02	5	26.37	6,261	0	0	6,261	18,782

     R&D	200	0	63.61	2.5	53.02	0.5	26.37	146	0	0	146	29,147

     Instant photographic	0	0	63.61	0	53.02	0	26.37	0	0	0	0	0

Bona Fide	116	5	63.61	12	53.02	5	26.37	1,086	0	0	1,086	125,992

5(e) Test	14	38	63.61	130	53.02	22	26.37	9,890	0	108,108	117,998
1,651,971

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

NOCs	497	0	63.61	0.5	53.02	0.25	26.37	33	0	0	33	16,452

Correction Requests	9	0.5	63.61	1.5	53.02	0.25	26.37	118	0	0	118	1,061

Total	2,206	341.5

1,159

133

86,656	81,900	115,608

$37,737,821

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 RIA, 1994, updated to 2006$ using Bureau of Labor Statistics (BLS)
Producer Price Index (PPI)  data for the chemical manufacturing industry
(BLS Series 325).  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 $7,776,117 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), 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).  Because EPA does not receive R&D exemption
submissions, and does not expect to receive any instant photographic
film articles exemptions in the foreseeable future, no Agency costs are
associated with these types of exemptions.

	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($)	Labor Costs($)6	Extramural Costs($)7	Total Avg. Costs($)8
Total Agency Costs($)

PMN	882	641	67.43	4,316	999	5,315	4,687,552

SNUN	5	641	67.43	4,316	944	5,260	26,299

MCAN	3	1,0672	67.43	71,952	0	71,952	215,856

Exemptions:

	     TME	6	1093	67.43	7,350	0	7,350	44,102

     LVE/LoREX	453	221	67.43	1,484	712	2,195	994,368

     TERA	2	1,4762	67.43	99,532	0	99,532	199,065

     Tier I and II	3	1872	67.43	12,610	0	12,610	37,830

     R&D	0	0	0	0	0	0	0

     Instant photographic film articles	0	0	0	0	0	0	0

Bona Fide	116	21	67.43	135	81	215	24,991

5(e) Test	14	1,5004	67.43	101,151	0	101,151	1,416,111

Non-Testing 5(e) Burden 	16	655	67.43	4,383	0	4,383	70,131

NOCs	497	19	67.43	67	0	67	33,515

Correction Requests	9	210	67.43	135	2,787	2,922	26,298

Total	2,006	4,559

307,431	5,522	312,953	7,776,117

1 RIA, 1994.

2 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 OPPT, 2003, and Correction Request
value, taken from OPPT, 2004) and, updated to 2006$ using Bureau of
Labor Statistics (BLS) Producer Price Index (PPI) data for the chemical
manufacturing industry (BLS Series 325).

8 Agency labor costs plus extramural costs.

9 Based on Agency expert opinion.

10 OPPT, 2004.

	6(f)	Reasons for Change in Burden

	This request reflects a net decrease in the total estimated respondent
burden of 10,500 hours (from 163,791 hours to 153,291 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 respondent burden and cost associated with the implementation
of electronic submission of reports require by this information
collection, and adjustments associated with including corrections to the
TSCA Inventory in this analysis.  The decrease is an adjustment.

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 is estimated
to average about 67.6 hours per response for reporting and to require
about 1.8 hours per response for recordkeeping, or a total of about 69.5
hours per response overall.  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.



References

BLS, 2006a.  U.S. Bureau of Labor Statistics, Employer Costs for
Employee Compensation: Changes to NAICS and SOC, Table 2. ECEC
Occupational Comparability between SOC and OCS.  Downloaded February
2006 from   HYPERLINK "http://www.bls.gov/ncs/ect/sp/ecsm0003.htm" 
http://www.bls.gov/ncs/ect/sp/ecsm0003.htm .

EPAB, 2002.  U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Revised Economic Analysis for the
Amended Inventory Update Rule: Final Report.  Washington, DC.  August
2002.

EPAB, 2006. U.S. EPA, Office of Pollution Prevention and Toxics,
Economic and Policy Analysis Branch. Economic Analysis of Expedited
Significant New Use Rules for 66 Chemical Substances; December 2006.

OPPT, 2003.   SEQ CHAPTER \h \r 1 Burden Cost Analysis Supporting the
Information Collection Request Renewal for TSCA Section 5 Premanufacture
Notifications. U.S. EPA/OPPT,   SEQ CHAPTER \h \r 1 Economics, Exposure
and Technology Division; August 15, 2003.

OPPT, 2004.  Supporting Statement for An Information Collection Request:
  SEQ CHAPTER \h \r 1 Correction of Misreported Chemical Substances on
the Toxic Substances Control Act (TSCA) Chemical Substance Inventory,
OMB Control Number 2070-0145, 2004.

OPPT, 2006.  “OPPT New Chemicals Annual Report.”  U.S. EPA/OPPT.

RIA, 1994. “Regulatory Impact Analysis of Amendments to Regulations
for TSCA Section 5 Premanufacture Notifications;” U.S.
EPA/OPPT/Economics, Exposure and Technology Division/ Regulatory Impacts
Branch; September 9, 1994.

RIA, 1997. “Regulatory Impact Analysis of Regulations on Microbial
Products of Biotechnology;” U.S.EPA/OPPT/Economics, Exposure and
Technology Division; January 21, 1997.

Rice, 2002.  Cody Rice. Wage Rates for Economic Analysis of the Toxics
Release Inventory Program.  Washington, DC: U.S.EPA, Office of Pollution
Prevention and Toxics, Economic and Policy Analysis Branch, June 10,
2002.

 These types of submissions are also referred to as “notices” in
this analysis.

 The estimate of respondent burden hours for NOC submission is based on
Agency expert opinion.

 This follows the approach in Economic Analysis of Expedited Significant
New Use Rules for 66 Chemical Substances (EPAB, 2006) and is a change
from the method used in earlier PMN SNUR economic reports such as EPAB,
2003.  Previously, wage rates for production workers came from the BLS
National Employment, Hours, and Earnings, Average Hourly Earnings of
Production Workers, while fringe benefits were taken from the ECEC data.
 Here, as in EPAB, 2006, both wages and fringes for production workers
come from ECEC data, for better consistency with the method of
estimating labor costs for other labor categories.

 Employer Costs for Employee Compensation, Private Manufacturing
Industry by Occupation, unpublished BLS data (BLS, 2006a).  This follows
the approach in EPAB, 2006.  Past economic analyses used ECEC data for
“All Goods Producing” sectors (manufacturing, mining, and
construction).  However, the manufacturing sector data seem more
relevant since the SNUR mainly affects the chemicals industry.

 This follows the terminology introduced in EPAB, 2006.  Past SNUR
economic analyses have used the term “technical” labor. Here the
category is called “professional/technical” labor, to make clear how
it relates to BLS categories.  In 2004, BLS changed from the
Occupational Classification System, OCS, to the Standard Occupational
Classification system, SOC.  In the process, the “Professional
specialty and technical” category became the “Professional and
related” category.  However, the coverage of the old and new
occupational groups is approximately the same. 

 Using data taken from the BLS Detailed PPI Statistics “Create
Customized Tables” link at   HYPERLINK
"http://www.bls.gov/ppi/home.htm#data" 
http://www.bls.gov/ppi/home.htm#data , for Chemical Mfg (325) industry,
an inflation factor of 1.55 was calculated.  

 U.S. Office of Personnel Management, effective January 2006.  
HYPERLINK "http://www.opm.gov/oca/06tables/pdf/DCB.pdf" 
http://www.opm.gov/oca/06tables/pdf/DCB.pdf .  Accessed November 17,
2006.

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