Document ID: EPA-HQ-OPPT-2007-0272-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-09-21T04:00Z

SEQ CHAPTER \h \r 1 Supporting Statement for a Request for OMB Review
under

the Paperwork Reduction Act

IDENTIFICATION OF THE INFORMATION COLLECTION

	l(a)  	Title and Number of the Information Collection

	TITLE:	Correction of Misreported Chemical Substances on the Toxic
Substances Control Act (TSCA) Chemical Substance Inventory

	EPA ICR No.:  1741.05	OMB Control No.:  2070-0145

	l(b)	Short Characterization

	Section 8(b) of the Toxic Substances Control Act (TSCA), requires the
Environmental Protection Agency (EPA) to compile and keep current an
Inventory of Chemical Substances in Commerce (hereinafter “the
Inventory”), which is a listing of chemical substances manufactured,
imported and processed for commercial purposes in the United States. 
Individual plant or factory sites producing chemicals submit the
required information.

	This information collection request pertains to the use of the TSCA
Chemical Substance Inventory Reporting Form C (EPA Form 7710-3C; see
Attachment 4 below), which the chemical industry uses exclusively in
submitting requests to EPA’s Office of Pollution Prevention and Toxics
(OPPT) for correcting misreported chemical identities of substances
listed on the Inventory.  Such requests pertain only to errors
discovered in the original submissions to the Inventory when the
Inventory was first established in 1979.

	Each year, OPPT receives a small number of such correction requests
from chemical companies or their legal representatives.  In almost all
cases, a submitter who wishes to correct the chemical identity of a
substance that was previously misreported for the Inventory initiates
these requests for correction.  The correction mechanism allows the
submitter to add the correct substance to the Inventory without having
to file a Premanufacture Notice (PMN) under TSCA section 5.

	In submitting a request for correction, the submitter provides certain
basic information to EPA on Form C.  This information is stored in one
of EPA’s mainframe computers.  This information allows OPPT to
establish a correct chemical identity that accurately reflects the
substance the submitter manufactures.  Since the Inventory performs a
regulatory function by distinguishing between an existing chemical and a
new chemical, it is imperative that the Inventory be accurate.  A
correct Inventory also ensures the accuracy of EPA’s chemical
screening and risk assessment activities.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

	TSCA requires EPA to identify, assess and control risks of injury to
human health and the environment posed by commercial chemicals.  TSCA
section 8(b) requires EPA to compile and keep current a complete list of
chemical substances manufactured or processed in, or imported into, the
United States.  Under TSCA section 8(a) the Administrator of EPA
promulgates rules to provide for the maintenance and collection of
records from manufacturers, importers and processors of commercial
chemicals.  The Inventory Update Rule (IUR), which EPA uses periodically
to update the TSCA section 8(b) Inventory, is codified at 40 CFR 710. 
Copies of the relevant sections of TSCA and of the Code of Federal
Regulations are attached below (see Attachments 1 and 2, respectively).

	The purpose of the Inventory is to define, for the purpose of TSCA,
what chemical substances exist in U.S. commerce.  Substances not
included on the Inventory are considered to be new substances that are
subject to the Premanufacture Notification (PMN) requirements stipulated
under section 5(a) of TSCA.

	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 in the initial Inventory could be, for various reasons,
incorrectly described by reporting companies.  EPA determined that
reported substances may have been unintentionally misidentified as a
result of simple typographical errors, the misidentification of
substances, or the lack of sufficient technical or analytical
capabilities fully to characterize the exact chemical substances. 
Although not required to do so under TSCA, EPA developed guidelines, at
the request of industry, under which industry could correct the chemical
identities of incorrectly described substances listed in the Inventory. 
EPA published these guidelines in the Federal Register on July 29, 1980
(45 FR 50544); see Attachment 3.

	For the Inventory to perform its regulatory function, it must
accurately identify those substances that exist in U.S. commerce. 
Otherwise the Inventory will not be able to provide reliable information
that EPA needs in performing chemical screening and risk assessment
activities under TSCA.  The submitter, on the other hand, must be
certain that the substance he/she manufactures or imports is correctly
identified on the Inventory, so that he/she will be 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.  Without the Inventory correction mechanism, a
submitter would have to file a PMN to place the correct chemical
substance on the Inventory whenever finding that the previously reported
substance was misidentified.  This would impose a much greater burden on
both EPA and the submitter than the existing correction mechanism.

2(b)	Practical Utility/Users of the Data

	OPPT will use the data contained in the correction request to alter the
incorrect chemical identities in the Inventory so that the information
is complete and accurate.  Many branches of the Agency rely on the
Inventory when making regulatory decisions.  Within OPPT, the Chemical
Control Division (CCD) and the Interagency Testing Committee (ITC)
frequently use the Inventory.  Both CCD and the ITC rely on the accuracy
of the Inventory for screening chemical substances for further attention
or testing.  If the Inventory data were inaccurate, CCD or the ITC could
inadvertently screen a fictitious chemical, i.e., a misreported
substance not yet corrected on the Inventory.

	As well as providing vital government service, the Inventory provides
information necessary to members of industry.  Correspondence between
the private and public sectors of the U.S. concerning the Inventory is
ceaseless.  OPPT receives hundreds of inquiries regarding the Inventory
each year.  These letters are primarily requests for Chemical Abstracts
Service (CAS) Registry Numbers or Accession Numbers assigned to a
substance, although the Agency also receives a variety of other requests
regarding TSCA.

	One such request expresses a bona fide intent to manufacture a chemical
substance.  A “bona fide” letter requests a formal search of the
Inventory for a particular chemical substance.  If the substance is
included on the Inventory, the potential manufacturer need not submit a
PMN.  Since failure to submit a PMN for a substance not included on the
Inventory, i.e., a new chemical, would constitute a violation of TSCA,
the Inventory must be correct to ensure that only substances that are
actually manufactured are included.  An Inventory correction letter
requests a change in the Inventory to correct a previously misreported
substance.  This correction mechanism allows the Inventory to be kept
accurately, thus ensuring that the Agency’s responses to industry
inquiries, e.g., bona fide, Accession Number and CAS Registry Number
requests, are accurate.  Furthermore, an accurate Inventory also ensures
that the Agency performs risk assessments on the correct chemical
substance and that industry will not need to submit unnecessary PMNs.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Non-Duplication

	Not applicable: the required data can only be provided by the submitter
and no other government agency collects such information.

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

	Prior to submission to OMB, EPA will make this ICR available to the
public for comment through a Federal Register notice.  The public will
have 60 days to provide comments.  EPA will give consideration to any
comments received when completing the supporting statement that EPA
submits to OMB.

	3(c)	Consultations

	EPA will pursue additional consultations with interested parties during
the development of the renewal of this collection.

3(d)	Effects of Less Frequent Collection

	Not applicable, since the frequency of correction depends wholly on
industry.

3(e)	General Guidelines

	To the best of EPA’s knowledge, this collection does not exceed any
of the Paperwork Reduction Act guidelines at 5 CFR 1320.6.

3(f)	Confidentiality

	Respondents may claim information submitted to EPA on the correction
form as confidential if release of such information would reveal the
submitter’s trade secrets or proprietary information, as defined by
TSCA section 14.  A respondent may claim as confidential any information
submitted on the reporting form, except the identity of a chemical
substance that the respondent has not claimed as confidential in the
existing Inventory data base.  Respondents must assert claims of
confidentiality at the time they submit the information to EPA and only
in the manner specified by EPA.

	EPA has established procedures for handling, storing, processing, and
disposing of TSCA confidential business information (CBI), in accordance
with stipulations set forth at 40 CFR Part 2, subpart B.  In general,
EPA houses confidential information in secured areas, and only persons
specifically authorized by EPA may access such information.  EPA further
restricts access to computer systems containing TSCA CBI to those who
have a need for access.  Such systems may be accessed only via special
computer terminals in restricted areas.  Furthermore, the procedures set
forth in 40 CFR Part 2, subpart B, strictly govern any transfer of TSCA
CBI from EPA to another agency, and the Agency receiving such
information must agree to comply fully with EPA procedures.

	Furthermore, this information collection fully complies with the
requirements of the Privacy Act of 1974 and OMB Circular A-108.

3(g)	Sensitive Questions

	Not applicable; this information collection does not include questions
of a sensitive nature.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAICS Codes

	

	The respondent community consists of persons manufacturing or importing
chemicals listed on the Inventory and regulated under TSCA section 8. 
In general, the industry segments that compose the respondent community
for this information collection are those that produce or import organic
chemicals, who have already reported to the initial Inventory effort,
and who need to make a correction to that submission.  Using North
American Industry Classification System (NAICS) codes, these persons are
typically classified under Chemical Manufacturing (NAICS 325) and
Petroleum and Coal Product Manufacturing (NAICS 324).

4(b)	Information Requested

		(i) 	Data Items

	The correction request form requires the submitter to include
information concerning the chemical substance’s identity, plant site,
production volume, site limitations, and import/export of the substance,
if applicable.

		(ii) 	Respondent Activities

	Most of the information contained on the Form C reporting form is
readily accessible to the submitter as “customary business
practices,” such as production and site-limitation data.  The
remaining information is equally apparent, e.g., plant site location and
whether the submitter imports or manufactures.

	With regard to the chemical substance identity requirement, such data
should be predetermined before the time of an Inventory correction
submission.  Since industry almost exclusively initiates corrections to
the Inventory, the submitter presumably has already determined the new
chemical substance identity before he/she is able to conclude that the
substance was previously misidentified.  Therefore, the information
required to submit a correction request is readily available to the
submitter, who needs only to transpose the data to the form the Agency
provides.

	Furthermore, if, for whatever reason, the submitter is unable to
produce a suitable technical name for the corrected substance, he/she
need only provide the Agency with information concerning the reaction
mechanism, including all reactants.  In such a case, EPA will devise an
appropriate name for the chemical substance.

	It is significant to note that in almost all cases it is industry, not
EPA, that initiates correction requests.  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 correction mechanism exists at the request of industry and
the EPA form is used because it reduces the burden on both the Agency
and industry by providing a clear format for the data.  Because the Form
C has been in use since the initial Inventory reporting period,
submitters are generally familiar with the format and with the
information needed to complete the form.  Furthermore, use of the form
guards against delays due to incomplete submissions, as the form clearly
outlines the required information.

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

5(a) 	Agency Activities

	As a result of the correction mechanism, the Agency must review the
original submissions to determine whether a correction is needed.  Once
EPA confirms the validity of the correction, the Agency will process the
correction information.  EPA will maintain the confidentiality of the
information at the request of the submitter, and will forward the
results to the Chemical Abstracts Service (CAS) where the data are
stored.  EPA will add the corrected chemical substance to the Inventory
while the incorrectly reported substance will become a candidate for
deletion from the Inventory, if no other person has reported the same
substance, through notice and comment rulemaking.

5(b) 	Collection Methodology and Management

	EPA sends all of the submitted information, after processing, to an EPA
contractor, Chemical Abstracts Service (CAS), whereupon the contractor
enters the information to a computerized system.  The public is able to
access non-confidential data through commercial on-line systems, or on
compact discs (CDs) available from the National Technical Information
Service (NTIS).

5(c) 	Small Entity Flexibility

	No small entity exemption exists.  A small entity exemption would be
meaningless or counterproductive to the interests of small entities who
may wish to submit corrections.  In addition, the amount of information
required to complete a correction request is minimal.  Furthermore, the
correction cannot be processed without each piece of information
requested, as only essential data are solicited.  Any small entity
simplification of the correction process would fail to provide the
Agency with the pertinent information needed to make a correction.

5(d) 	Collection Schedule

	Not applicable since industry, not EPA, initiates the corrections as
necessary.

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a) 	Estimating Respondent Burden

	This ICR addresses an information collection effort that has been
undertaken in the same manner since 1980.  As time goes by, the need for
correcting the initial Inventory entries diminishes as most of the
corrections needed presumably would have been discovered and made by
now, after 27 years and several Inventory Update Rule (IUR) reporting
cycles.  At this time EPA estimates the number of respondents to be no
more than nine per year, based on recent experience.  It is anticipated
that these respondents will incur a minimal reporting burden in
providing information to the Agency, estimated at 2.0 hours per report,
and a recordkeeping burden estimated at 0.25 hours per report, for a
total estimated burden of 2.25 hours per report.  Worksheet 1, below,
illustrates the estimated burden per respondent for responding to this
information collection.

	6(b) 	Estimating Respondent Cost 

	Worksheet 1 illustrates the estimated costs per respondent for
responding to this information collection.  This information is derived
from information provided by submitters, individuals involved in the
processing of the forms received, and previous experience.  

The assumptions for wages and fringe benefits for managerial,
professional/technical and clerical employee categories are based on
information published by the Bureau of Labor Statistics (BLS),
specifically Employer Costs for Employee Compensation (ECEC) data, for
December 2005 for manufacturing industries.  

WORKSHEET 1: ANNUAL RESPONDENT BURDEN/COST ESTIMATES

Burden Hours and Costs per Respondent by Employee Category  SEQ CHAPTER
\h \r 1 

	Managerial

@ $63.61	Technical

@ $53.02	Clerical

@$26.37	Total Hours	Total Costs

Create and gather information

1.50

1.50	 $79.53

Review and report information	0.50

	0.50	 $31.81

Recordkeeping

	0.25	0.25	      $  6.59

Subtotal	0.50	1.50	0.25	2.25	$117.93

	6(c)	Estimating Agency Burden and Cost

	Costs associated with this collection include the printing and
distributing of reporting forms, providing reporting assistance,
reviewing and processing of the report forms and entry of data into the
Inventory databases.  The time to review a correction request by an EPA
employee is estimated from experience at two hours.  Assuming salary and
benefits costs of $67.43 per hour (based on salary scales for a GS-13,
step 5 employee) and the receipt of approximately nine reports, the cost
for EPA review is $1,215.54.  Processing of the forms and entry of the
data into EPA computer systems is estimated at $271.50 per form (based
on contractor’s fee and estimate of 0.5 hours non-exempt time and 1.5
hours of exempt time), for a total of $2,443.50.  The total Agency cost
would be $3,659.04.  The total burden found in reviewing and processing
the forms, based on two hours of review and two hours of processing
time, would be 36 hours.

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 a 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.

	6(d)	Bottom Line Burden Hours and Cost

	(i)	Respondent Burden

		The simple collection (see Worksheet 1)

		Burden: 2.25 hours/report x 9 reports = 20 hours

		Costs:  $117.93/report x 9 reports = $1,061.37

	(ii)	Agency Burden

		The total Agency burden is estimated to be 36 hours.

		The total Agency cost is estimated to be $3,659.04.



	(iii)	The complex collection - Not applicable.

	(iv)	Variations in the annual bottom line - Not applicable.

6(e)	Reasons for Change in Burden

	This request reflects no change in the total estimated respondent
burden from that currently in the OMB inventory.

	6(f)	Burden Statement

	The annual public burden for this collection of information, which is
approved under OMB Control No. 2070-0145, is estimated to be 2.25 hour
per response.  According to the Paperwork Reduction Act, “burden”
means the total time, effort, or financial resources expended by persons
to generate, maintain, retain, or disclose or provide information to or
for a Federal agency.  For this collection it includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control number for this information collection
appears above.  The OMB control numbers for EPA’s regulations in title
40 of the CFR, after appearing in the Federal Register, are listed in 40
CFR part 9 and included on the related collection instrument or form, if
applicable.

	  SEQ CHAPTER \h \r 1 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-2007-0272.  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-2007-0272 and OMB control number
2070-0145 in any correspondence.

EPA ICR No.  1741.05; OMB Control No.  2070-0145

ATTACHMENT 1

Toxic Substances Control Act Section 8

15 USC 2607

US Code as of: 01/23/00

Sec. 2607. Reporting and retention of information 

(a) Reports 

	(1) The Administrator shall promulgate rules under which - 

(A) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process a
chemical substance (other than a chemical substance described in
subparagraph (B)(ii)) shall maintain such records, and shall submit to
the Administrator such reports, as the Administrator may reasonably
require, and 

		(B) each person (other than a small manufacturer or processor) who
manufactures or processes or proposes to manufacture or process - 

(i) a mixture, or 

(ii) a chemical substance in small quantities (as defined by the
Administrator by rule) solely for purposes of scientific experimentation
or analysis or chemical research on, or analysis of, such substance or
another substance, including any such research or analysis for the
development of a product, shall maintain records and submit to the
Administrator reports but only to the extent the Administrator
determines the maintenance of records or submission of reports, or both,
is necessary for the effective enforcement of this chapter. The
Administrator may not require in a rule promulgated under this paragraph
the maintenance of records or the submission of reports with respect to
changes in the proportions of the components of a mixture unless the
Administrator finds that the maintenance of such records or the
submission of such reports, or both, is necessary for the effective
enforcement of this chapter. For purposes of the compilation of the list
of chemical substances required under subsection (b) of this section,
the Administrator shall promulgate rules pursuant to this subsection not
later than 180 days after January 1, 1977. 

(2) The Administrator may require under paragraph (1) maintenance of
records and reporting with respect to the following insofar as known to
the person making the report or insofar as reasonably ascertainable: 

(A) The common or trade name, the chemical identity, and the molecular
structure of each chemical substance or mixture for which such a report
is required. 

(B) The categories or proposed categories of use of each such substance
or mixture. 

(C) The total amount of each such substance and mixture manufactured or
processed, reasonable estimates of the total amount to be manufactured
or processed, the amount manufactured or processed for each of its
categories of use, and reasonable estimates of the amount to be
manufactured or processed for each of its categories of use or proposed
categories of use. 

(D) A description of the byproducts resulting from the manufacture,
processing, use, or disposal of each such substance or mixture. 

(E) All existing data concerning the environmental and health effects of
such substance or mixture. 

(F) The number of individuals exposed, and reasonable estimates of the
number who will be exposed, to such substance or mixture in their places
of employment and the duration of such exposure. 

(G) In the initial report under paragraph (1) on such substance or
mixture, the manner or method of its disposal, and in any subsequent
report on such substance or mixture, any change in such manner or
method. To the extent feasible, the Administrator shall not require
under paragraph (1), any reporting which is unnecessary or duplicative. 

	(3) 

		(A) 

(i) The Administrator may by rule require a small manufacturer or
processor of a chemical substance to submit to the Administrator such
information respecting the chemical substance as the Administrator may
require for publication of the first list of chemical substances
required by subsection (b) of this section. 

(ii) The Administrator may by rule require a small manufacturer or
processor of a chemical substance or mixture - 

(I) subject to a rule proposed or promulgated under section 2603,
2604(b)(4), or 2605 of this title, or an order in effect under section
2604(e) of this title, or 

(II) with respect to which relief has been granted pursuant to a civil
action brought under section 2604 or 2606 of this title, to maintain
such records on such substance or mixture, and to submit to the
Administrator such reports on such substance or mixture, as the
Administrator may reasonably require. A rule under this clause requiring
reporting may require reporting with respect to the matters referred to
in paragraph (2). 

(B) The Administrator, after consultation with the Administrator of the
Small Business Administration, shall by rule prescribe standards for
determining the manufacturers and processors which qualify as small
manufacturers and processors for purposes of this paragraph and
paragraph (1). 

(b) Inventory 

(1) The Administrator shall compile, keep current, and publish a list of
each chemical substance which is manufactured or processed in the United
States. Such list shall at least include each chemical substance which
any person reports, under section 2604 of this title or subsection (a)
of this section, is manufactured or processed in the United States. Such
list may not include any chemical substance which was not manufactured
or processed in the United States within three years before the
effective date of the rules promulgated pursuant to the last sentence of
subsection (a)(1) of this section. In the case of a chemical substance
for which a notice is submitted in accordance with section 2604 of this
title, such chemical substance shall be included in such list as of the
earliest date (as determined by the Administrator) on which such
substance was manufactured or processed in the United States. The
Administrator shall first publish such a list not later than 315 days
after January 1, 1977. The Administrator shall not include in such list
any chemical substance which is manufactured or processed only in small
quantities (as defined by the Administrator by rule) solely for purposes
of scientific experimentation or analysis or chemical research on, or
analysis of, such substance or another substance, including such
research or analysis for the development of a product. 

(2) To the extent consistent with the purposes of this chapter, the
Administrator may, in lieu of listing, pursuant to paragraph (1), a
chemical substance individually, list a category of chemical substances
in which such substance is included. 

(c) Records 

Any person who manufactures, processes, or distributes in commerce any
chemical substance or mixture shall maintain records of significant
adverse reactions to health or the environment, as determined by the
Administrator by rule, alleged to have been caused by the substance or
mixture. Records of such adverse reactions to the health of employees
shall be retained for a period of 30 years from the date such reactions
were first reported to or known by the person maintaining such records.
Any other record of such adverse reactions shall be retained for a
period of five years from the date the information contained in the
record was first reported to or known by the person maintaining the
record. Records required to be maintained under this subsection shall
include records of consumer allegations of personal injury or harm to
health, reports of occupational disease or injury, and reports or
complaints of injury to the environment submitted to the manufacturer,
processor, or distributor in commerce from any source. Upon request of
any duly designated representative of the Administrator, each person who
is required to maintain records under this subsection shall permit the
inspection of such records and shall submit copies of such records. 

(d) Health and safety studies 

The Administrator shall promulgate rules under which the Administrator
shall require any person who manufactures, processes, or distributes in
commerce or who proposes to manufacture, process, or distribute in
commerce any chemical substance or mixture (or with respect to paragraph
(2), any person who has possession of a study) to submit to the
Administrator - 

(1) lists of health and safety studies (A) conducted or initiated by or
for such person with respect to such substance or mixture at any time,
(B) known to such person, or (C) reasonably ascertainable by such
person, except that the Administrator may exclude certain types or
categories of studies from the requirements of this subsection if the
Administrator finds that submission of lists of such studies are
unnecessary to carry out the purposes of this chapter; and 

(2) copies of any study contained on a list submitted pursuant to
paragraph (1) or otherwise known by such person. 

(e) Notice to Administrator of substantial risks 

Any person who manufactures, processes, or distributes in commerce as
chemical substance or mixture and who obtains information which
reasonably supports the conclusion that such substance or mixture
presents a substantial risk of injury to health or the environment shall
immediately inform the Administrator of such information unless such
person has actual knowledge that the Administrator has been adequately
informed of such information. 

(f) ''Manufacture'' and ''process'' defined 

For purposes of this section, the terms ''manufacture'' and ''process''
mean manufacture or process for commercial purposes. 

EPA ICR No.  1741.05; OMB Control No.  2070-0145

ATTACHMENT 2

40 CFR 710

TITLE 40--PROTECTION OF ENVIRONMENT

 

CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY

 

PART 710--INVENTORY REPORTING REGULATIONS

 

Sec. 710.1  Scope and compliance.

    (a) This part establishes regulations governing reporting by certain
persons who manufacture, import, or process chemical substances for
commercial purposes under section 8(a) of the Toxic Substances Control
Act (15 U.S.C. 2607(a)). Section 8(a) authorizes the Administrator to
require reporting of information necessary for administration of the Act
and requires EPA to issue regulations for the purpose of compiling an
inventory of chemical substances manufactured or processed for a
commercial purpose, as required by section 8(b) of the Act. Following an
initial reporting period, EPA published an initial inventory of chemical
substances manufactured, processed or imported for commercial purposes.
In accordance with section 8(b), EPA periodically amends the inventory
to include new chemical substances which are manufactured or imported
for a commercial purpose and reported under section 5(a)(1) of the Act.
EPA also revises the categories of chemical substances and makes other
amendments as appropriate.

    (b) Section 15(3) of TSCA makes it unlawful for any person to fail
or refuse to submit information required under these reporting
regulations. In addition, section 15(3) makes it unlawful for any person
to fail to keep, and permit access to, records required by these
regulations. Section 16 provides that any person who violates a
provision of section 15 is liable to the United States for a civil
penalty and may be criminally prosecuted. Pursuant to section 17, the
Government may seek judicial relief to compel submission of section 8(a)
information and to otherwise restrain any violation of section 15.

    Note: As a matter of traditional Agency policy, EPA does not intend
to concentrate its enforcement efforts on insignificant clerical errors
in reporting.

    (c) Each person who reports under these regulations shall maintain
records that document information reported under these regulations and,
in accordance with the Act, permit access to, and the copying of, such
records by EPA officials.

[42 FR 64572, Dec. 23, 1977, as amended at 45 FR 18375, Mar. 21, 1980;
60 FR 31921, June 19, 1995]

Sec. 710.2  Definitions.

    In addition to the definitions in Sec. 704.3 in this chapter, the
following definitions also apply to this part:

    (a) The following terms shall have the meaning contained in the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., and the
regulations issued under such Act: Cosmetic, device, drug, food, and
food additive. In addition, the term food includes poultry and poultry 

products, as defined in the Poultry Products Inspection Act, 21 U.S.C.
453 et seq.; meats and meat food products, as defined in the Federal
Meat Inspection Act, 21 U.S.C. 60 et seq.; and eggs and egg products, as
defined in the Egg Products Inspection Act, 21 U.S.C. 1033 et seq.

    (b) The term pesticide shall have the meaning contained in the
Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136 et
seq., and the regulations issued thereunder.

    (c) The following terms shall have the meaning contained in the
Atomic Energy Act of 1954, 42 U.S.C. 2014 et seq., and the regulations
issued thereunder: byproduct material, source material, and special
nuclear material.

    (d) Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et
seq.

    (e) Administrator means the Administrator of the U.S. Environmental
Protection Agency, any employee or authorized representative of the
Agency to whom the Administrator may either herein or by order delegate
his authority to carry out his functions, or any other person who shall 

by operation of law be authorized to carry out such functions.

    (f) An article is a manufactured item: (1) Which is formed to a
specific shape or design during manufacture, (2) which has end use
function(s) dependent in whole or in part upon its shape or design
during end use, and (3) which has either no change of chemical
composition during its end use or only those changes of composition
which have no commercial purpose separate from that of the article and
that may occur as described in Sec. 710.4(d)(5); except that fluids and
particles are not considered articles regardless of shape or design.

    (g) Byproduct means a chemical substance produced without separate
commercial intent during the manufacture or processing of another
chemical substance(s) or mixture(s).

    (h) Chemical substance means any organic or inorganic substance of a
particular molecular identity, including any combination of such
substances occurring in whole or in part as a result of a chemical
reaction or occurring in nature, and any chemical element or uncombined
radical; except that ``chemical substance'' does not include:

    (1) Any mixture,

    (2) Any pesticide when manufactured, processed, or distributed in
commerce for use as a pesticide,

    (3) Tobacco or any tobacco product, but not including any derivative
products,

    (4) Any source material, special nuclear material, or byproduct
material,

    (5) Any pistol, firearm, revolver, shells, and cartridges, and

    (6) Any food, food additive, drug, cosmetic, or device, when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device.

    (i) Commerce means trade, traffic, transportation, or other
commerce: (1) Between a place in a State and any place outside of such
State, or (2) which affects trade, traffic, transportation, or commerce
described in paragraph (i)(1) of this section.

    (j) Distribute in commerce and distribution in commerce when used to
describe an action taken with respect to a chemical substance or mixture
or article containing a substance or mixture, mean to sell or the sale
of, the substance, mixture, or article in commerce; to introduce or
deliver for introduction into commerce, or the introduction or delivery
for introduction into commerce of, the substance, mixture, or article;
or to hold, or the holding of, the substance, mixture, or article after
its introduction into commerce.

    (k) EPA means the U.S. Environmental Protection Agency.

    (l) Importer means any person who imports any chemical substance or
any chemical substance as part of a mixture or article into the customs
territory of the U.S. and includes:

    (1) The person primarily liable for the payment of any duties on the
merchandise, or

    (2) An authorized agent acting on his behalf (as defined in 19 CFR
1.11).

    (m) Impurity means a chemical substance which is unintentionally
present with another chemical substance.

    (n) Intermediate means any chemical substance:

    (1) Which is intentionally removed from the equipment in which it is
manufactured, and (2) which either is consumed in whole or in part in
chemical reaction(s) used for the intentional manufacture of other
chemical substance(s) or mixture(s), or is intentionally present for the

purpose of altering the rate of such chemical reaction(s).

    Note: The equipment in which it was manufactured includes the
reaction vessel in which the chemical substance was manufactured and
other equipment which is strictly ancillary to the reaction vessel, and
any other equipment through which the chemical substance may flow during
a continuous flow process, but does not include tanks or other vessels
in which the chemical substance is stored after its manufacture.

    (o) Manufacture means to produce or manufacture in the United States
or import into the customs territory of the United States.

    (p) Manufacture or import ``for commercial purposes'' means to
manufacture or import:

    (1) For distribution in commerce, including for test marketing
purposes, or

    (2) For use by the manufacturer, including for use as an
intermediate.

    (q) Mixture means any combination of two or more chemical substances
if the combination does not occur in nature and is not, in whole or in
part, the result of a chemical reaction; except that ``mixture'' does
include:

    (1) Any combination which occurs, in whole or in part, as a result
of a chemical reaction if the combination could have been manufactured
for commercial purposes without a chemical reaction at the time the
chemical substances comprising the combination were combined and if,
after the effective date or premanufacture notification requirements,
none of the chemical substances comprising the combination is a new
chemical substance, and

    (2) Hydrates of a chemical substance or hydrated ions formed by
association of a chemical substance with water.

    (r) New chemical substance means any chemical substance which is not
included in the inventory compiled and published under subsection 8(b)
of the Act.

    (s) Person means any natural or juridicial person including any
individual, corporation, partnership, or association, any State or
political subdivision thereof, or any municipality, any interstate body
and any department, agency, or instrumentality of the Federal
Government.

    (t) Process means the preparation of a chemical substance or
mixture, after its manufacture, for distribution in commerce (1) in the
same form or physical state as, or in a different form or physical state
from, that in which it was received by the person so preparing such
substance or mixture, or (2) as part of a mixture or article containing
the chemical substance or mixture.

    (u) Process for ``commercial purposes'' means to process (1) for
distribution in commerce, including for test marketing purposes, or (2)
for use as an intermediate.

    (v) Processor means any person who processes a chemical substance or
mixture.

    (w) Site means a contiguous property unit. Property divided only by
a public right-of-way shall be considered one site. There may be more
than one manufacturing plant on a single site. For the purposes of
imported chemical substances, the site shall be the business address of
the importer.

    (x) Small manufacturer or importer means a manufacturer or importer
whose total annual sales are less than $5,000,000, based upon the
manufacturer's or importer's latest complete fiscal year as of January
1, 1978, except that no manufacturer or importer is a ``small
manufacturer or importer'' with respect to any chemical substance which
such person manufactured at one site or imported in quantities greater
than 100,000 pounds during calendar year 1977. In the case of a company
which is owned or controlled by another company, total annual sales
shall be based on the total annual sales of the owned or controlled
company, the parent company, and all companies owned or controlled by
the parent company taken together.

    Note: The purpose of the exception to the definition is to ensure
that manufacturing and importers report production volumes for all
chemical substances which they manufactured at one site or imported in
quantities equal to or greater than 100,000 pounds during calendar year
1977.

    (y) Small quantities for purposes of scientific experimentation or
analysis or chemical research on, or analysis of, such substance or
another substance, including any such research or analysis for the
development of a product (hereinafter sometimes shortened to small
quantities for research and development) means quantities of a chemical
substance manufactured, imported, or processed or proposed to be
manufactured, imported, or processed that (1) are no greater than
reasonably necessary for such purposes and (2) after the publication of
the revised inventory, are used by, or directly under the supervision
of, a technically qualified individual(s).

    Note: Any chemical substances manufactured, imported or processed in
quantities less than 1,000 pounds annually shall be presumed to be
manufactured, imported or processed for research and development
purposes.

No person may report for the inventory any chemical substance in such
quantities unless that person can certify, that the substance was not
manufactured, imported, or processed solely in small quantities for
research and development, as defined in this section.

    (z) State means any State of the United States, the District of
Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, the
Canal Zone, American Samoa, the Northern Mariana Islands, or any other
territory or possession of the United States.

    (aa) Technically qualified individual means a person: (1) Who
because of his education, training, or experience, or a combination of
these factors, is capable of appreciating the health and environmental
risks associated with the chemical substance which is used under his
supervision, (2) who is responsible for enforcing appropriated methods
of conducting scientific experimentation, analysis, or chemical research
in order to minimize such risks, and (3) who is responsible for the
safety assessments and clearances related to the procurement, storage,
use, and disposal of the chemical substance as may be appropriate or
required within the scope of conducting the research and development
activity. The responsibilities in paragraph (aa)(3) of this section may
be delegated to another individual, or other individuals, as long as
each meets the criteria in paragraph (aa)(1) of this section.

    (bb) Test marketing means the distribution in commerce of no more
than a predetermined amount of a chemical substance, mixture, or article
containing that chemical substance or mixture, by a manufacturer or
processor to no more than a defined number of potential customers to
explore market capability in a competitive situation during a
predetermined testing period prior to the broader distribution of that
chemical substance, mixture or article in commerce.

    (cc) United States, when used in the geographic sense, means all of
the States, territories, and possessions of the United States.

    (dd) Master Inventory File means EPA's comprehensive list of
chemical substances which constitute the Chemical Substances Inventory
compiled under section 8(b) of the Act. It includes substances reported
under subpart A of this part and substances reported under part 720 of 

this chapter for which a Notice of Commencement of Manufacture or Import
has been received under Sec. 720.120 of this chapter.

    (ee) Nonisolated intermediate means any intermediate that is not
intentionally removed from the equipment in which it is manufactured,
including the reaction vessel in which it is manufactured, equipment
which is ancillary to the reaction vessel, and any equipment through
which the substance passes during a continuous flow process, but not
including tanks or other vessels in which the substance is stored after
its manufacture.

    (ff) Site-limited means a chemical substance is manufactured and
processed only within a site and is not distributed for commercial
purposes as a substance or as part of a mixture or article outside the
site. Imported substances are never site-limited.

[42 FR 64572, Dec. 23, 1977, as amended at 60 FR 31921, June 19, 1995]

Sec. 710.4  Scope of the inventory.

    (a) Chemical substances subject to these regulations. Only chemical
substances which are manufactured, imported, or processed ``for a
commercial purpose,'' as defined in Sec. 710.2, are subject to these
regulations.

    (b) Naturally occurring chemical substances automatically included.
Any chemical substance which is naturally occurring and:

    (1) Which is (i) unprocessed or (ii) processed only by manual,
mechanical, or gravitational means; by dissolution in water; by
flotation; or by heating solely to remove water; or

    (2) Which is extracted from air by any means, shall automatically be
included in the inventory under the category ``Naturally Occurring
Chemical Substances.'' Examples of such substances are: raw agricultural
commodities; water, air, natural gas, and crude oil; and rocks, ores,
and minerals.

    (c) Substances excluded by definition or section 8(b) of TSCA. The
following substances are excluded from the inventory:

    (1) Any substance which is not considered a ``chemical substance''
as provided in subsection 3(2)(B) of the Act and in the definition of
``chemical substance'' in Sec. 710.2(h);

    (2) Any mixture as defined in Sec. 710.2(q);

    Note: A chemical substance that is manufactured as part of a mixture
is subject to these reporting regulations. This exclusion applies only
to the mixture and not to the chemical substances of which the mixture
is comprised. The term ``mixture'' includes alloys, inorganic glasses,
ceramics, frits, and cements, including Portland cement.

    (3) Any chemical substance which is manufactured, imported, or
processed solely in small quantities for research and development, as
defined in Sec. 710.2(y); and

    (4) Any chemical substance not manufactured, processed or imported
for a commercial purpose since January 1, 1975.

    (d) Chemical substances excluded from the inventory. The following
chemical substances are excluded from the inventory. Although they are
considered to be manufactured or processed for a commercial purpose for
the purpose of section 8 of the Act, they are not manufactured or
processed for distribution in commerce as chemical substances per se and
have no commercial purpose separate from the substance, mixture, or
article of which they may be a part.

    Note: In addition, chemical substances excluded here will not be
subject to premanufacture notification under section 5 of the Act.

    (1) Any impurity.

    (2) Any byproduct which has no commercial purpose.

    Note: A byproduct which has commercial value only to municipal or
private organizations who (i) burn it as a fuel, (ii) dispose of it as a
waste, including in a landfill or for enriching soil, or (iii) extract
component chemical substances which have commercial value, may be
reported for the inventory, but will not be subject to premanufacturing
notification under section 5 of the Act if not included.

    (3) Any chemical substance which results from a chemical reaction
that occurs incidental to exposure of another chemical substance,
mixture, or article to environmental factors such as air, moisture,
microbial organisms, or sunlight.

    (4) Any chemical substance which results from a chemical reaction
that occurs incidental to storage of another chemical substance,
mixture, or article.

    (5) Any chemical substance which results from a chemical reaction
that occurs upon end use of other chemical substances, mixtures, or
articles such as adhesives, paints, miscellaneous cleansers or other
housekeeping products, fuels and fuel additives, water softening and
treatment agents, photographic, films, batteries, matches, and safety
flares, and which is not itself manufactured for distribution in
commerce or for use as an intermediate.

    (6) Any chemical substance which results from a chemical reaction
that occurs upon use of curable plastic or rubber molding compounds,
inks, drying oils, metal finishing compounds, adhesives, or paints; or
other chemical substances formed during manufacture of an article 

destined for the marketplace without further chemical change of the
chemical substance except for those chemical changes that may occur as
described elsewhere in this Sec. 710.4(d).

    (7) Any chemical substance which results from a chemical reaction
that occurs when (i) a stabilizer, colorant, odorant, antioxidant,
filler, solvent, carrier, surfactant, plasticizer, corrosion inhibitor,
antifoamer or de-foamer, dispersant, precipitation inhibitor, binder,
emulsifier, de-emulsifier, dewatering agent, agglomerating agent,
adhesion promoter, flow modifier, pH neutralizer, sequesterant,
coagulant, flocculant, fire retardant, lubricant, chelating agent, or
quality control reagent functions as intended or (ii) a chemical
substance, solely intended to impart a specific physicochemical
characteristic, functions as intended.

    (8) Chemical substances which are not intentionally removed from the
equipment in which they were manufactured.

    Note: See note to definition of ``intermediate'' at Sec. 710.2(n)
for explanation of ``equipment in which it was manufactured.''

[42 FR 64572, Dec. 23, 1977]

Sec. 710.25  Chemical substances for which information must be reported.

    Any chemical substance which is in the Master Inventory File at the
beginning of a reporting period described in Sec. 710.33, unless the
chemical substance is specifically excluded by Sec. 710.26.

[51 FR 21447, June 12, 1986]

Sec. 710.26  Chemical substances for which information is not required.

    The following categories of chemical substances are excluded from
the reporting requirements of this subpart. However, a chemical
substance described in paragraphs (a), (b), or (c) of this section is
not excluded from the reporting requirements of this subpart if that
substance is the subject of a rule proposed or promulgated under section
4, 5(a)(2), 5(b)(4), or 6 of the Act, or is the subject of an order
issued under section 5(e) or 5(f) of the Act, or is the subject of
relief that has been granted under a civil action under section 5 or 7
of the Act.

    (a) Inorganic chemical substances. Any chemical substance which does
not contain carbon or contains carbon only in the form of carbonato
[=CO<INF>3</INF>], cyano [-CN], cyanato [-OCN], isocyano [-NC], or
isocyanato [-NCO] groups, or the chalcogen analogues of such groups.

    (b) Polymers. (1) Any chemical substance described with the word
fragments ``*polym*'', ``*alkyd'', or ``*oxylated'' in the Chemical
Abstracts Service Index or Preferred Nomenclature in the Chemical
Substance Identities section of the 1985 edition of the Inventory or in
the Master Inventory File, where the asterisk (*) indicates that any
sets of characters may precede, or follow, the character string defined.

    (2) Any chemical substance which is identified in the 1985 edition
of the Inventory or the Master Inventory File as siloxane and silicone,
silsesquioxane, a protein (albumin, casein, gelatin, gluten,
hemoglobin), an enzyme, a polysaccharide (starch, cellulose, gum),
rubber, or lignin. This exclusion, however, does not apply to a chemical
substance which has been hydrolyzed, depolymerized, or chemically
modified to the extent that the final product is no longer polymeric in
structure.

    (c) Microorganisms. Any combination of chemical substances that is a
living organism, such as bacteria, eimeria, fungi, and yeasts. Any
chemical substance produced from such a living organism is reportable
unless otherwise excluded.

    (d) Naturally occurring chemical substances. Any naturally occurring
chemical substance, as described in Sec. 710.4(b). The applicability of
this exclusion is determined in each case by the specific activities of
the person who manufactures the substance in question. Some chemical
substances can be manufactured both as described in Sec. 710.4(b) and by
means other than those described in Sec. 710.4(b). If a person described
in Sec. 710.28 manufactures a chemical substance by means other than
those described in Sec. 710.4(b), the person must report regardless of
whether the substance also could have been produced as described in Sec.
710.4(b). Any chemical substance that is produced from such a naturally
occurring chemical substance described in Sec. 710.4(b) is reportable
unless otherwise excluded.

[51 FR 21447, June 12, 1986]

Sec. 710.28  Persons who must report.

    Except as provided in Secs. 710.29 and 710.30, the following persons
are subject to the requirements of this subpart. Persons must determine
whether they must report under this Sec. 710.28 for each chemical
substance that they manufacture at an individual site.

    (a) Persons subject to initial reportinq. Any person who
manufactured for commercial purposes 10,000 pounds (4,540 kilograms) or
more of a chemical substance described in Sec. 710.25 at any single site
owned or controlled by that person at any time during the person's
latest complete corporate fiscal year before August 25, 1986.

    (b) Persons subject to recurring reporting. Any person who
manufactured for commercial purposes 10,000 pounds (4,540 kilograms) or
more of a chemical substance described in Sec. 710.25 at any single site
owned or controlled by that person at any time during the person's
latest complete corporate fiscal year before August 25, 1990, or before
August 25 at four-year intervals thereafter.

    (c) Special provisions for importers. For purposes of paragraphs (a)
and (b) of this section, the site for a person who imports a chemical
substance described in Sec. 710.25 is the site of the operating unit
within the person's organization which is directly responsible for
importing the substance and which controls the import transaction. The
import site may in some cases be the organization's headquarters in the
U.S. (See also Sec. 710.35(b).)

[51 FR 21447, June 12, 1986]

Sec. 710.29  Persons not subject to this subpart.

    A person described in Sec. 710.2 8 is not subject to the
requirements of this subpart if that person qualifies as a small
manufacturer as that term is defined in Sec. 704.3 of this chapter.
Notwithstanding this exclusion, a person who qualifies as a small
manufacturer is subject to this subpart with respect to any chemical
substance that is the subject of a rule proposed or promulgated under
section 4, 5(b)(4), or 6 of the Act, or is the subject of an order in
effect under section 5(e) of the Act, or is the subject of relief that
has been granted under a civil action under section 5 or 7 of the Act.

[51 FR 21447, June 12, 1986]

Sec. 710.30  Activities for which reporting is not required.

    A person described in Sec. 710.28 is not subject to the requirements
of this subpart with respect to any chemical substance described in Sec.
710.25 that the person manufactured or imported under the following
circumstances:

    (a) The person manufactured or imported the chemical substance
described in Sec. 710.25 solely in small quantities for research and
development,

    (b) The person imported the chemical substance described in Sec.
710.25 as part of an article,

    (c) The person manufactured the chemical substance described in Sec.
710.25 in a manner described in Sec. 720.30(g) or (h) of this chapter.

[51 FR 21447, June 12, 1986]

Sec. 710.32  Reporting information to EPA.

    Any person who must report under this part must submit the
information prescribed in this section for each chemical substance
described in Sec. 710.25 that the person manufactured for commercial
purposes in an amount of 10,000 pounds (4,540 kilograms) or more at a
single site during a corporate fiscal year described in Sec. 710.28.
(The site for a person who imports a chemical substance is the site of
the operating unit within the person's organization which is directly
responsible for importing the substance and which controls the import
transaction, and may in some cases be the organization's headquarters
office in the U.S.). A respondent to this subpart must report
information in writing or by magnetic media as prescribed in this
section, to the extent that such information is known to or reasonably
ascertainable by that person. A respondent to this subpart must report
information that applies to the specific corporate fiscal year for which
the person is required to report.

    (a) Reporting in writing. Any person who chooses to report
information to EPA in writing must do so by completing the reporting
form available from EPA at the address set forth in Sec. 710.39(b). The
form must include all information prescribed in paragraph (c) of this
section. Persons reporting in writing must submit a separate form for
each site for which the person is required to report.

    (b) Reporting by magnetic media. Any person who chooses to report
information to EPA by means of magnetic media must submit the
information prescribed in paragraph (c) of this section. Magnetic media
submitted in response to this subpart must meet EPA specifications, as
described in the instruction booklet available from EPA at the address
set forth in Sec. 710.39(b).

    (c) Information to be reported. Persons reporting information under
this subpart must report the following:

    (1) The name, company, address, city, State, Zip code, and telephone
number of a person who will serve as technical contact for the
respondent company, and will be able to answer questions about the
information submitted by the company to EPA. Persons reporting by means
of magnetic media must submit this information on the reporting form
available from EPA at the 

address set forth in Sec. 710.39.

    (2) A certification statement signed and dated by an authorized
official of the respondent company. Persons reporting by means of
magnetic media must submit this information on the reporting form
available from EPA at the address set forth in Sec. 710.39.

    (3) The specific chemical name and Chemical Abstracts Service (CAS)
Registry Number of each chemical substance for which reporting is
required under this subpart. A respondent to this subpart may use other
chemical identification numbers in lieu of CAS Registry Numbers when a
CAS Registry Number is not known to the respondent as provided in the
instruction booklet identified in Sec. 710.39(b), including
EPA-designated Accession Numbers for confidential substances,
EPA-assigned numbers for bona fide or Premanufacture Notification
submissions, or Test Market Exemption Applications, or original
Inventory form numbers.

    (4) The name, street address, city, State, and Zip code of each site
at which 10,000 pounds (4,540 kilograms) or more of a chemical substance
for which reporting is required under this subpart is manufactured or
imported. (The site for a person who imports a chemical substance is the
site of the operating unit within the person's organization which is
directly responsible for importing the substance and which controls the
import transaction, and may in some cases be the organization's
headquarters office in the U.S.) A respondent to this subpart must
include the appropriate Dun and Bradstreet Number for each plant site
reported.

    (5) A statement for each substance for which information is being
submitted indicating whether the substance is manufactured in the United
States or imported into the United States.

    (6) A statement for each substance for which information is being
submitted indicating whether the substance is site-limited.

    (7) The total volume (in pounds) of each subject chemical substance
manufactured or imported at each site. This amount must be reported to
two significant figures of accuracy provided that the reported figures
are within <plus-minus>10 percent of the actual volume.

[55 FR 39587, Sept. 27, 1990, as amended at 60 FR 31921, June 19, 1995]

Sec. 710.33  When to report.

    All information reported to EPA in response to the requirements of
this subpart must be submitted during an applicable reporting period.
The following reporting periods are prescribed for this subpart.

    (a) Initial reporting period. The first reporting period is from
August 25, 1986 to December 23, 1986. Any person described in Sec.
710.28(a) must report during this period for each chemical substance
described in Sec. 710.25 that the person manufactured during the
corporate fiscal year described in Sec. 710.28(a).

    (b) Recurring reporting periods. The first recurring reporting
period is from August 25, 1990 to December 23, 1990. Subsequent
reporting periods, except as provided in paragraph (c) of this section,
are from August 25 to December 23 at 4-year intervals thereafter. Any
person described in Sec. 710.28(b) must report during the appropriate
reporting period for each chemical substance described in Sec. 710.25
that the person manufactured during the applicable corporate fiscal year

described in Sec. 710.28(b).

    (c) Reporting in 1998. The 1998 reporting period is from August 25,
1998 until January 31, 1999. Any person described in Sec. 710.28(b) must
report during this reporting period for each chemical substance
described in Sec. 710.25 that the person manufactured during the
applicable corporate fiscal year described in Sec. 710.28(b). This
reporting period is applicable to 1998 reporting only.

[51 FR 21447, June 12, 1986: 51 FR 22521, June 20, 1986, as amended at
63 FR 71600, Dec. 29, 1998]

Sec. 710.35  Duplicative reporting.

    (a) With regard to section 8(a) rules. Any person subject to the
requirements of this part who previously has complied with reporting
requirements of a rule under section 8(a) of the Act by submitting the
information described in Sec. 710.32 for a chemical substance described
in Sec. 710.25 to EPA, and has done so within one year of the start of a
reporting period described in Sec. 710.33, is not required to report
again on the manufacture of that substance at that site during that
reporting period.

    (b) With regard to importers. This part requires that only one
report be submitted on each import transaction involving a chemical
substance described in Sec. 710.25. When two or more persons are
involved in a particular import transaction and each person meets the
Agency's definition of ``importer'' as set forth in Secs. 710.2(l) and
704.3 of this chapter, they may determine among themselves who should
submit the required report; if no report is submitted as required under
this part, EPA will hold each such person liable for failure to report.

[51 FR 21447, June 12, 1986, as amended at 60 FR 31921, June 19, 1995]

Sec. 710.37  Recordkeeping requirements.

    Each person who is subject to the reporting requirements of this
part must maintain records that document any information reported to
EPA. For substances that are manufactured or imported at less than
10,000 pounds annually, volume records must be maintained as evidence to
support a decision not to submit a report. Records relevant to reporting
during a reporting period described in Sec. 710.33 must be retained for
a period of four years beginning with the effective date of that
reporting period.

[51 FR 21447, June 12, 1986, as amended at 58 FR 34204, June 23, 1993;
60 FR 31921, June 19, 1995]

Sec. 710.38  Confidentiality.

    (a) Any person submitting information under this part may assert a
business confidentiality claim for the information. The procedures for
asserting confidentiality claims are described in the instruction
booklet identified in Sec. 710.39. Information claimed as confidential
in accordance with this section and those instructions will be treated
and disclosed in accordance with the procedures in part 2 of this
chapter.

    (b) A person may assert a claim of confidentiality for the chemical
identity of a specific chemical substance only if the identity of that
substance is treated as confidential in the Master Inventory File as of
the time the report is submitted for that substance under this part.

    (c) To assert a claim of confidentiality for the chemical identity
of a specific chemical substance, the person must take the following
steps:

    (1) The person must submit with the report detailed written answers
to the following questions signed and dated by an authorized official.

    (i) What harmful effects to your competitive position, if any, do
you think would result from the identity of the chemical substance being
disclosed in connection with reporting under this part? How could a
competitor use such information? Would the effects of disclosure be
substantial? What is the causal relationship between the disclosure and
the harmful effects?

    (ii) How long should confidential treatment be given? Until a
specific date, the occurrence of a specific event, or permanently? Why?

    (iii) Has the chemical substance been patented? If so, have you
granted licenses to others with respect to the patent as it applies to
the chemical substance? If the chemical substance has been patented and
therefore disclosed through the patent, why should it be treated as
confidential?

    (iv) Has the identity of the chemical substance been kept
confidential to the extent that your competitors do not know it is being
manufactured or imported for a commercial purpose by anyone?

    (v) Is the fact that the chemical substance is being manufactured or
imported for a commercial purpose available to the public, for example
in technical journals, libraries, or State, local, or Federal agency
public files?

    (vi) What measures have you taken to prevent undesired disclosure of
the fact that this chemical substance is being manufactured or imported
for a commercial purpose?

    (vii) To what extent has the fact that this chemical substance is
manufactured or imported for commercial purposes been revealed to
others? What precautions have been taken regarding these disclosures?
Have there been public disclosures or disclosures to competitors?

    (viii) Does this particular chemical substance leave the site of
manufacture in any form, as product, effluent, emission, etc.? If so,
what measures have you taken to guard against discovery of its identity?

    (ix) If the chemical substance leaves the site in a product that is
available to the public or your competitors, can the substance be
identified by analysis of the product?

    (x) For what purpose do you manufacture or import the substance?

    (xi) Has EPA, another Federal agency, or any Federal court made any
pertinent confidentiality determinations regarding this chemical
substance? If so, please attach copies of such determinations.

    (2) If any of the information contained in the answers to the
questions is asserted to contain confidential business information, the
person must mark that information as ``trade secret,'' ``confidential,''
or other appropriate designation.

    (d) If no claim of confidentiality accompanies information at the
time it is submitted to EPA under this part or if substantiation
required under paragraph (c) of this section is not submitted with the 

reporting form, EPA may make the information available to the public
without further notice to the submitter.

[51 FR 21447, June 12, 1986, as amended at 55 FR 39588, Sept. 27, 1990;
60 FR 31921, June 19, 1995]

Sec. 710.39   How do I submit the required information for the 1998
reporting cycle?

    (a) Use the proper EPA form. You must use the EPA form identified as
``Form U'' to submit written information in response to the requirements
of this subpart. Copies of the Form U are available from EPA at the
address set forth in paragraph (c) of this section, from the EPA
Internet Home Page at http://www.epa.gov/opptintr/iur98, or via
Fax-on-Demand by using a faxphone to call (202) 401-0527 and selecting
item 5119.

    (b) Follow the reporting instructions. You should follow the
detailed instructions for completing the reporting form and preparing a
magnetic media report, which are given in the EPA publication entitled
``Instructions for Reporting for Partial Updating of the TSCA Chemical
Inventory Data Base,'' via the Internet or the TSCA Hotline.

    (c) Obtain the reporting package and copies of the form. EPA is
mailing the reporting package to those companies that reported in 1994.
Failure to receive a reporting package does not obviate or otherwise
affect the requirement to submit a timely report. If you did not receive
a reporting package, but are required to report, you may obtain a copy
of the reporting package and the reporting form from EPA by submitting a
request for this information as follows:

    (1) By phone. Call the EPA TSCA Hotline at (202) 554-1404, or TDD
202-554-0551.

    (2) By e-mail. Send an e-mail request for this information to the
EPA TSCA Hotline at TSCA-Hotline@epamail.epa.gov.

    (3) By mail. Send a written request for this information to the
following address: TSCA Hotline, Mail Code 7408, ATTN: Inventory Update
Rule, Office of Pollution Prevention and Toxics, U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460.

    (d) Submit the completed reports. You must submit your completed
reporting form(s) and/or magnetic media to EPA at the following address:
Document Control Officer, Mail Code 7407, ATTN: Inventory Update Rule,
Office of Pollution Prevention and Toxics, U.S. Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460.

[63 FR 45953, Aug. 28, 1998]

EPA ICR No.  1741.05; OMB Control No.  2070-0145

ATTACHMENT 3

Inventory Correction Guidelines

 45 FR 50544, July 29, 1980

(Note: An electronic copy of this attachment is not available.  Please
contact the Environmental Protection Agency at the address noted in the
Federal Register notice for a complete copy of this ICR.)

EPA ICR No.  1741.05; OMB Control No.  2070-0145

ATTACHMENT 4

Inventory Correction Form

EPA Form 7710-3C

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