[Federal Register Volume 64, Number 165 (Thursday, August 26, 1999)]
[Proposed Rules]
[Pages 46772-46812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22243]



[[Page 46771]]

_______________________________________________________________________

Part III





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 710



TSCA Inventory Update Rule Amendments; Proposed Rule

  Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / 
Proposed Rules  

[[Page 46772]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 710

[OPPTS-82053; FRL-6097-4]
RIN 2070-AC61


TSCA Inventory Update Rule Amendments

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The TSCA Inventory Update Rule (IUR) Amendments will help both 
EPA and the public better identify and mitigate potential exposures and 
risks associated with TSCA chemicals. Under section 8(a) of the Toxic 
Substances Control Act (TSCA), EPA currently requires manufacturers 
(including importers) of certain chemical substances and mixtures on 
the TSCA Chemical Substances Inventory to report current data regarding 
production volume, plant site information, and site-limited status. EPA 
is proposing to require the reporting of additional data that would 
assist EPA in evaluating potential exposures and risks resulting from 
industrial chemical operations and commercial and consumer uses of 
chemical substances. EPA is also proposing to modify reporting and 
recordkeeping requirements, to remove one reporting exemption and to 
create others, and to modify its Confidential Business Information 
(CBI) reporting procedures.

DATES: Comments on this proposed rule must be received no later than 
October 25, 1999. A public meeting to allow the opportunity for oral 
comment on this proposed rule will be held on Monday, October 4, 1999, 
from 9 a.m. to noon at the EPA Auditorium, 401 M St., SW., Washington, 
DC 20460.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the ``SUPPLEMENTARY INFORMATION'' section of 
this document.

FOR FURTHER INFORMATION CONTACT: For technical information contact: 
Susan Krueger, Project Manager, Economics, Exposure and Technology 
Division (7406), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; 
telephone: (202) 260-1713, fax: (202) 260-1661; e-mail: 
[email protected].
    For general information contact: Christine M. Augustyniak, 
Associate Director, Environmental Assistance Division (7408), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 401 M 
St., SW., Washington, DC 20460; telephone: (202)554-1404, TDD: (202) 
554-0551; e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Notice Apply to Me?

    You may be potentially affected by this notice if you manufacture 
or import chemical substances and mixtures currently subject to 
reporting under the Inventory Update Rule (IUR) at 40 CFR part 710 or 
manufacture or import inorganic chemical substances. In the past, 
processors of chemical substances have not been required to comply with 
the requirements at 40 CFR part 710. These proposed amendments do not 
change the status of processors under the regulations at 40 CFR part 
710. Potentially affected categories and entities may include, but are 
not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
            Category                     NAICS            Potentially
                                                       Regulated Persons
------------------------------------------------------------------------
Chemical manufacturers and        325, 32411          Chemical
 importers                                             manufacturers
                                                       (including
                                                       importers)
                                                       currently subject
                                                       to IUR reporting
 
                                                      Chemical
                                                       manufacturers
                                                       (including
                                                       importers) of
                                                       inorganic
                                                       chemical
                                                       substances
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be regulated by this 
action. Other types of entities not listed above could also be 
regulated. To determine whether you or your business is affected by 
this action, carefully examine the applicability provisions in title 40 
of the Code of Federal Regulations (CFR), part 710. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the technical person listed in the preceding ``FOR 
FURTHER INFORMATION CONTACT'' section.

B. How Can I Get Additional Information or Copies of this Document or 
Other Documents?

    1. Electronically. You may obtain electronic copies of this 
document and various support documents from the EPA Internet Home Page 
at http://www.epa.gov/. On the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the ``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPPTS-82053. The official 
record consists of the documents specifically referenced in this 
action, any public comments received during an applicable comment 
period, and other information related to this action, including any 
information claimed as confidential business information (CBI). This 
official record includes the documents that are physically located in 
the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period, is available 
for inspection in the TSCA Nonconfidential Information Center, Rm. NE-
B607, Waterside Mall, 401 M St., SW., Washington, DC, from noon to 4 
p.m., Monday through Friday, excluding legal holidays. The TSCA 
Nonconfidential Information Center telephone number is (202) 260-7099.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropiate docket number (i.e., 
OPPTS-82053) in your correspondence.
    1. By mail. Submit your comments to: Document Control Office (DCO) 
(7407), Office of Pollution Prevention and Toxics (OPPT), Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: OPPT Document 
Control Office (DCO) in the East Tower Rm. G-099, Waterside Mall, 401 M 
St., SW., Washington, DC 20460. The DCO is open from 8 a.m. to 4 p.m., 
Monday through Friday, excluding legal holidays. The telephone number 
for the DCO is 202-260-7099.
    3. Electronically. You may submit your comments electronically by 
e-mail

[[Page 46773]]

to: ``[email protected],'' or mail your computer disk to the address 
identified above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 5.1/
6.1 or ASCII file format. All comments in electronic form must be 
identified by the docket control number OPPTS-82053. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    You may claim information that you submit in response to this 
document as CBI by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the comment that does 
not contain CBI must be submitted for inclusion in the public record. 
Information not marked confidential will be included in the public 
docket by EPA without prior notice. If you have any questions about CBI 
or the procedures for claiming CBI, please consult with the technical 
person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.

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

    EPA invites you to provide your views on the various options 
proposed, new approaches EPA has not considered, the potential impacts 
of the various options (including possible unintended consequences), 
and any data or information that you would like the Agency to consider 
during the development of the final action. You may find the following 
suggestions helpful for preparing your comments:
      Explain your views as clearly as possible.
      Describe any assumptions that you used.
      Provide solid technical information and/or data to 
support your views.
      If you estimate potential burden or costs, explain how 
you arrived at the estimate.
      Tell us what you support, as well as what you disagree 
with.
      Provide specific examples to illustrate your concerns.
      Offer alternative ways to improve the rule or collection 
activity.
      Make sure to submit your comments by the deadline in this 
proposal.
      At the beginning of your comments (e.g., as part of the 
``Subject'' heading), you must properly identify the document you are 
commenting on by providing the docket control number assigned to the 
proposal. You may also provide the name, date, and Federal Register 
citation, and the appropriate EPA or OMB ICR number.

II. Authority

    EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to 
compile and keep current an inventory of chemical substances in 
commerce. In 1977, EPA promulgated a rule (42 FR 64572, December 23, 
1977) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an 
inventory of chemical substances. In 1986, EPA promulgated the IUR (51 
FR 21447, June 12, 1986), also under TSCA section 8(a), to facilitate 
the periodic updating of the inventory and to support activities 
associated with the implementation of TSCA.
    This document proposes amendments to 40 CFR part 710, which 
currently contains the Inventory Update Reporting Regulations. Failure 
to comply fully with any provision of a final rule would be a violation 
of TSCA section 15 and would subject the violator to the penalties of 
TSCA sections 16 and 17.
    TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate 
rules under which manufacturers (including importers) and processors of 
chemical substances and mixtures (referred to hereafter as ``chemical 
substances'') must maintain such records and submit such information as 
the Administrator may reasonably require. Under TSCA section 8(a), the 
Agency may collect information, insofar as it is known to, or 
reasonably ascertainable by the submitter, on the manufacture 
(including import) and processing of chemical substances. EPA possesses 
broad discretion in determining the information to be reported under 
TSCA section 8(a). Some of the types of information which can be 
required under TSCA section 8(a)(2) include: categories of use for each 
chemical substance, estimates of the amount manufactured or processed 
for each category of use, a description of the byproducts resulting 
from the manufacture, processing, use, or disposal of each chemical 
substance, an estimate of the number of individuals exposed, and the 
duration of such exposure. TSCA section 8(a) excludes, with certain 
exceptions, small manufacturers (including small importers), and 
processors of chemical substances from reporting requirements 
established in TSCA section 8(a). However, EPA is authorized by TSCA 
section 8(a)(3) to require TSCA section 8(a) reporting from small 
manufacturers (including importers) and processors with respect to any 
chemical substance that is the subject of a rule proposed or 
promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject 
of an order under TSCA section 5(e), or that is the subject of relief 
that has been granted pursuant to a civil action under TSCA sections 5 
or 7. For purposes of the IUR, the standards for determining whether a 
business qualifies as a ``small manufacturer or importer'' are defined 
at 40 CFR 704.3. For additional information, see TSCA sections 2 and 8; 
H. Rep. 1341, 94th Cong., 2d Sess. 6-7 (July 14, 1976); Sen. Rep. 698, 
94th Cong. 2d Sess. 3-5 (March 16, 1976).

III. Summary of the Amendments

    In this document, EPA is proposing several changes to the current 
IUR reporting requirements. First, EPA is proposing to amend 40 CFR 
710.32 in order to add exposure-related information to the reporting 
requirements for chemical substances covered by the IUR. Specifically, 
the Agency is proposing that manufacturers (including importers) 
subject to the proposed rule report, in ranges, the number of workers 
reasonably likely to be exposed to the chemical substance at the site 
of manufacture or import, and the physical form, average concentration, 
and maximum concentration of the chemical substance as it leaves the 
submitter's possession.
    Second, EPA is proposing to amend 40 CFR 710.32 in order to require 
chemical manufacturers (including importers) (``submitters'') of 
larger-volume chemical substances to report information concerning the 
processing and use of each reportable chemical substance that is 
conducted at sites controlled by the submitter and at ``downstream'' 
sites that receive the reportable chemical substance from the submitter 
directly or indirectly (including through a broker/distributor, from a 
customer of the submitter, etc.). Specifically, manufacturers 
(including importers) of these larger-volume chemical substances would 
be required to report:
    1. The type of industrial processing or use operation at each site, 
including downstream sites.
    2. The five-digit North American Industrial Classification System 
(``NAICS'') codes that best describe the industrial activities 
conducted by the facilities that use or process the substance.
    3. The ``industrial functions'' of the chemical substances.
    4. The approximate number of processing and use sites.

[[Page 46774]]

    5. The estimated number of workers reasonably likely to be exposed 
to each chemical substance at each site at which the chemical is used 
or processed.
    6. The commercial and consumer uses of reportable chemical 
substances.
    7. The estimated percentages of the submitter's production volume 
in each industrial function category and commercial and consumer 
product category.
    8. The maximum concentration of the reportable chemical substance 
in each commercial and consumer product category.
    Third, EPA is proposing to revoke the current full exemption from 
IUR reporting at 40 CFR 710.26(a) for inorganic chemical substances, 
and instead require partial reporting for these substances. EPA is also 
proposing to amend 40 CFR 710.26 to create a partial reporting 
exemption for petroleum process streams.
    Fourth, EPA is proposing to amend 40 CFR 710.26 to provide an 
exemption from IUR reporting for certain forms of natural gas.
    Fifth, EPA is proposing to amend 40 CFR 710.32 to require the 
reporting of additional information to assist in the identification of 
plant sites reporting under IUR.
    Sixth, EPA is proposing to amend 40 CFR 710.28, 710.32, and 710.33 
to change the period for which reporting is required from a corporate 
fiscal year to a calendar year basis.
    Seventh, EPA is proposing to amend 40 CFR 710.32 to include two 
separate confidentiality boxes on the reporting form (Form U) for 
production volume in exact amounts and in ranges (see Unit VI. of this 
preamble for a copy of the proposed reporting form). These 
confidentiality boxes would enable submitters to assert a 
confidentiality claim for specific production volume information while 
releasing the more general production volume range as public 
information.
    Eighth, EPA is proposing to amend 40 CFR 710.38 to require upfront 
substantiation of plant site confidentiality claims made in IUR 
submissions to EPA.
    Ninth, EPA is proposing to add a new section, 40 CFR 710.39, to 
require submitters to reassert CBI claims made in past IUR reports 
during each reporting cycle.
    Finally, EPA is proposing to amend 40 CFR 710.28 and 710.32 to 
raise the production volume reporting threshold from the current 10,000 
pounds (lbs.) per year threshold to 25,000 lbs. per year, and to add a 
new larger-volume reporting threshold of 300,000 lbs. per year for the 
reporting of processing and use information.
    Units VI. through VIII. of this preamble provide a discussion 
regarding changes to the current IUR that would occur upon promulgation 
of these proposed amendments. The discussion includes the current 
reporting requirements only to the extent that they would be modified 
in this proposal. EPA is not reopening the existing requirements for 
comment where they would not be modified in this proposal. CBI issues 
are discussed in Unit VIII. of this preamble, although certain of these 
issues are mentioned briefly in Unit VI. of this preamble.

IV. Background

A. Establishment of the Inventory Update Rule

    In the Federal Register of June 12, 1986 (51 FR 21447), EPA 
published the Inventory Update Rule (IUR), which requires chemical 
manufacturers (including importers) to report to EPA every 4 years the 
identity of chemical substances manufactured (including imported) 
annually in quantities over 10,000 lbs. per year at each plant site 
they own or control. The current IUR excludes several categories of 
substances, including polymers, inorganic substances, microorganisms, 
and naturally occurring chemical substances. Plant sites subject to the 
rule are currently required to report information such as company name, 
plant site location, plant site Dun and Bradstreet number(s), identity 
of the reportable chemical substance, and production volume of the 
reportable chemical substance.
    The data reported under IUR are used to update the information 
collected on the TSCA Inventory, which is a listing of chemical 
substances in commerce. EPA uses the TSCA Inventory and data reported 
under the IUR to support many TSCA-related activities and to provide 
overall support for a number of EPA and other Federal health, safety, 
and environmental protection activities (See Unit IV.B. of this 
preamble for further explanation of some of these activities).

B. EPA's TSCA-Related Chemical Screening and Assessment Activities

    Congress enacted TSCA to establish a number of new requirements and 
authorities for identifying and controlling toxic chemical risks to 
human health and the environment (See TSCA section 2). To implement its 
responsibilities under TSCA, EPA must identify potential chemical 
risks, assess the magnitude of the identified risks and, where 
necessary, manage risks determined to be unreasonable. TSCA provides 
EPA with the authority to gather data, such as chemical toxicity data, 
chemical exposure data, and other related data, to determine whether a 
chemical substance may present an unreasonable risk of injury to human 
health or the environment, and to institute control actions when risks 
are determined to be unreasonable. As part of the implementation of 
this authority, EPA has established the IUR and other regulations to 
collect information on chemical substances.
    Identification of chemical substances, plant sites, and exposures 
of greatest potential concern and setting priorities for more detailed 
risk assessment and potential risk management actions are important 
elements in a successful chemical risk management program. The TSCA 
Inventory includes more than 75,000 chemical substances. Approximately 
8,300 of these chemical substances are non-polymer organic chemical 
substances manufactured or imported in quantities of 10,000 lbs. per 
year, as reported under the 1994 IUR data collection. See ``Economic 
Analysis of Proposed Amendments to the TSCA Section 8 Inventory Update 
Rule,'' available in the public record for this proposal and listed at 
Unit X.A.2.f. of this preamble.
    Once a chemical substance has been identified for risk screening 
under EPA's Existing Chemicals Program, EPA completes an initial review 
of the chemical. This initial review is designed to select the chemical 
substances that raise particular concern regarding the risks they 
present to human health and the environment. At the close of the 
initial review, three possible outcomes may occur: a testing 
recommendation, a recommendation for further evaluation, or closure. 
``Closure'' may include referrals to other programs or agencies, 
dissemination of initial review results, or a decision to discontinue 
further review based on the chemical's low hazard, low risk potential, 
or because it will be considered for regulatory control as part of a 
broader cluster of chemical substances. This process is described in 
more detail in the document entitled, ``Economic Analysis of Proposed 
Amendments to the TSCA Section 8 Inventory Update Rule,'' which is 
available in the public record for this rulemaking and listed at Unit 
X.A.2.f. of this preamble.
    Between 1990 and 1994, 1,924 chemical substances were screened for 
inclusion in the risk management (RM) program. Of these candidate 
chemical substances, 561 were selected for more detailed review based 
on potential risks. Of the 561 chemicals evaluated, 125

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(22%) were recommended for testing; 156 (28%) were recommended for 
further risk management; and 280 (50%) were recommended for closure. 
The Existing Chemicals Program represents a significant outlay in EPA 
resources, and is an important component in EPA's ability to manage 
unreasonable risks presented by chemical substances in commerce.
    Effective risk screening and risk management are dependent upon 
both exposure information and hazard information. The exposure-related 
information reported under the IUR amendments, in combination with 
hazard information such as that developed under TSCA section 4 test 
rules, would allow the Agency to effectively screen and prioritize 
chemicals. In order to meet the directives put forth by Vice President 
Gore in his April 21, 1998 announcement (Ref. 1), EPA recently 
undertook the drafting of a significant proposed test rule for certain 
high production volume chemicals. The test rule would collect baseline 
hazard information which, in conjunction with the exposure-related 
information that would be reported under these IUR amendments, would be 
critical for chemical screening purposes.
    EPA's Existing Chemicals Program is currently evaluating risks from 
indoor air pollutants, high release chemical substances listed on the 
Toxics Release Inventory (TRI) (established under section 313 of the 
Emergency Planning and Community Right-to-Know Act (EPCRA), 42 U.S.C. 
sections 11001 to 11050), persistent bioaccumulators, and high 
production volume chemicals. While past approaches to priority setting 
have been primarily based on relative chemical hazards and production 
volume as a simple surrogate for exposure, EPA has increased its 
emphasis on the exposure component of risk screening and assessment. An 
example of this increased emphasis is reflected in the voluntary effort 
within EPA called the Use and Exposure Information Project (UEIP), 
undertaken by EPA and the Chemical Manufacturers Association (CMA), the 
Chemical Specialty Manufacturers Association (CSMA), the Synthetic 
Organic Chemical Manufacturers Association (SOCMA), and the American 
Petroleum Institute (API) (Ref. 2). The UEIP was undertaken 
cooperatively by government and industry in recognition of the 
difficulties encountered in obtaining current exposure information on 
TSCA chemicals. The UEIP, however, provided one-time reporting of 
information on a small number of selected high production volume 
chemicals. Given these efforts, the limitations of the data available 
from past and current information collections that are described in 
detail in Unit IV.B. of this preamble, and the amount of time it would 
take to acquire screening-level data for all of the chemical substances 
on the Inventory otherwise, EPA believes it is appropriate to develop a 
more systematic and comprehensive approach to the prioritization 
process. The new exposure-related information that would be reported 
under this proposed rule is necessary to allow more efficient and 
effective chemical risk screening.

V. Development of this Proposed Rule

A. Need for Change in the Inventory Update Rule

    EPA is proposing to amend the Inventory Update Rule (IUR) for three 
primary reasons: (1) To tailor the chemical substance reporting 
requirements to more closely match the Agency's overall information 
needs; (2) to obtain new and updated information relating to potential 
exposures to a subset of chemical substances listed on the TSCA 
Chemical Substances Inventory (``the TSCA Inventory''); and (3) to 
improve the utility of the information reported. Changes to the 
information collected through the IUR, the chemicals covered by the 
rule, and CBI requirements accomplish these three goals.
    These goals are supported by a primary policy underlying TSCA, 
which is that ``adequate data should be developed with respect to the 
effect of chemical substances and mixtures on health and the 
environment and that the development of such data should be the 
responsibility of those who manufacture and those who process such 
chemical substances and mixtures'' (TSCA section 2(b)(1)). EPA believes 
that, for basic risk screening purposes, the data currently available 
are inadequate (See Unit IV.B. of this preamble). TSCA section 8(a)(2) 
authorizes EPA to require manufacturers and processors of chemical 
substances to report a wide variety of data, including the exposure-
related information which would be reported under these amendments to 
IUR. These amendments would remove certain reporting requirements and 
add others in an effort by EPA to focus the information reported under 
IUR on information that is most needed so that EPA and other Federal 
agencies are better able to screen for risk, and consequently assess 
and manage risk, and so that public awareness of basic information 
about a large number of chemical substances is improved.
    As discussed in Unit IV.B. of this preamble, any determination of 
``risk'' is based on some amount of hazard information in combination 
with some amount of exposure information. EPA relies on risk screening 
to indicate which chemical substances may present a risk, and thus 
warrant a resource-intensive risk assessment. The EPA Science Advisory 
Board's ``Reducing Risk: Setting Priorities and Strategies for 
Environmental Protection'' report (Ref. 3) and the National Academy of 
Public Administration's ``Setting Priorities, Getting Results, A New 
Direction for EPA'' report (Ref. 4) recognize that EPA's ability to set 
priorities through risk screening and EPA's ability to allocate its 
limited resources has been significantly impeded by a lack of exposure 
data. Screening the potential risks posed by the chemical substances 
included in the Inventory and setting priorities for more detailed risk 
assessment and possible risk management is an enormous challenge. The 
manufacturing, processing, and use of Inventory chemicals result in a 
wide array of exposure scenarios. By collecting the exposure-related 
data included in this proposed amendment to the IUR, the Agency would 
acquire information that would greatly improve EPA's ability to 
identify, through risk screening, the chemical substances that could 
pose a risk to human health and to the environment.
    1. Exposure-related data needed for chemical risk screening. As 
discussed in Unit IV. of this preamble, EPA must screen thousands of 
chemical substances for potential risk to determine priorities for 
follow-up risk assessment and management among the chemical substances 
included on the TSCA Inventory. Because so many chemical substances and 
exposure scenarios are involved, it is not practical to devote the 
extensive resources that would be required to develop more precise 
exposure data, such as occupational and environmental monitoring data. 
Instead, EPA must identify and rely on exposure-related data that are 
more accessible and that are reasonably accurate and useful for 
identifying potential chemical risks.
    EPA has had access to certain types of exposure-related information 
which it has found to be extremely useful. For example, EPA's New 
Chemicals Program requires the submission of exposure-related 
information in Premanufacture Notice (PMN) submissions. This 
information is used in developing risk estimates to determine the 
status of the chemical

[[Page 46776]]

under evaluation within the New Chemicals Program. Under section 5 of 
TSCA, companies must submit a PMN to EPA at least 90 days before 
initiating the manufacture for commercial purposes (including import) 
of chemical substances that are not included on the TSCA Inventory. 
Chemical substances included on the TSCA Inventory are often referred 
to as ``existing chemicals'' and those not included on the TSCA 
Inventory are often referred to as ``new chemicals.'' EPA reviews the 
potential risks of new chemicals for which it has received a PMN and 
may act to restrict certain aspects of the chemicals' manufacture, 
processing or use. For example, for chemical substances that pose 
potential risks to workers based on estimates of inhalation exposures, 
the Agency often requires the use of respiratory protection by workers. 
EPA requires companies to include information in their PMN submissions 
that will provide an accurate review of potential exposures and risks. 
Exposure-related data included in the PMN include estimates of 
production volume, categories of use, percent production volume in 
categories of use, releases during manufacture, processing and use, 
maximum number of workers exposed, and physical form of the chemical. 
Since the creation of the New Chemicals Program, EPA has successfully 
reviewed the potential risks of approximately 32,000 chemicals.
    The exposure-related information submitted in PMNs is typically 
developed prior to the manufacture of the chemical and prior to the 
addition of the chemical to the TSCA Inventory; information submitted 
through the New Chemicals Program is not sufficient for the future 
screening of new chemicals once they have been added to the TSCA 
Inventory (i.e., once they have become existing chemicals). The 
exposure-related information submitted in a PMN is not necessarily 
reflective of exposures once a chemical substance is added to the 
Inventory and is produced commercially by the company that originally 
submitted the PMN and/or any number of additional companies. Production 
volume information, for example, is provided only once during the PMN 
process, whereas production volume information is tracked over time 
under the IUR. EPA's analysis of the PMN data base is provided in a 
document entitled, ``Inventory Update Rule (IUR) Amendment Technical 
Support Document: Exposure-Related Data Useful for Chemical Risk 
Screening,'' found in the record for this proposal and listed at Unit 
X.A.2.a. of this preamble.
    Another example of EPA's use of available exposure-related 
information is in the evaluation of chemical risks and establishment of 
hazard testing priorities in the Agency's New Chemicals and Chemical 
Testing Programs. These programs rely upon data that are similar to 
data that would be collected under this proposal. EPA's New Chemicals 
Program, under the authority of TSCA section 5(e)(1)(A)(ii)(II), has 
established an exposure-based policy which utilizes various exposure 
criteria to guide its decisions regarding the issuance of consent 
orders. These criteria include estimates of production volume, 
releases, potential dose rates, numbers of potentially exposed workers 
and consumers, and the size of the potentially exposed general 
population and are used to determine whether an exposure concern exists 
(Ref. 5). These decisions are based on the expected use of the new 
chemical.
    Similarly, the Chemical Testing Program relies upon exposure-
related information to require testing under TSCA section 4. In order 
to require testing, EPA must initially make either risk-based findings 
under TSCA section 4(a)(1)(A) or exposure-based findings under TSCA 
section 4(a)(1)(B). Risk-based findings are partially based on 
exposure-related information. Because exposure is a component of risk 
(see Unit IV.B. of this preamble), risk-based findings require a 
demonstration that there is some possibility of exposure to a chemical 
substance. The possibility of exposure must be based on more than 
theoretical scenarios; some amount of factual information must be 
demonstrated by EPA. Chemical Manufacturers Association v. EPA, 859 
F.2d 977, 991 (D.C. Cir. 1988). Exposure-based findings, on the other 
hand, are based entirely on exposure-related information. Generally, 
EPA relies upon production volume information in addition to chemical 
release information or human exposure information (i.e., for general 
population exposure, consumer exposure, or worker exposure) to make 
exposure-based findings. EPA's interpretation of its legal authority to 
make the findings necessary to require testing under TSCA section 
4(a)(1)(B) is articulated in a Statement of Policy (``B Policy'') (58 
FR 28736, May 14, 1993). Many of the exposure data elements included in 
these proposed amendments to IUR are specifically relevant to the 
exposure-related findings contained in the B Policy. As a result, the 
exposure information submitted under the IUR amendments would be 
integral to the identification of candidate chemicals for inclusion in 
test rules. For example, the use information reported under the IUR 
amendments would assist in the selection of chemicals for inclusion in 
a planned test rule that would collect hazard information on chemicals 
to which children may be exposed, many of which are present in consumer 
products.
    Other organizations recognize that exposure-related data is useful 
for screening chemical risks. The Chemical Manufacturers Association 
(CMA), in a letter to EPA (Ref. 6), noted that data on chemical use 
volumes, numbers of exposed workers, magnitudes of chemical usage per 
worker, number of use sites, and environmental releases can supplement 
production volume data in chemical risk screening. In addition, the 
exposure-related information that would be reported under these 
amendments to IUR would support chemical screening by the Consumer 
Product Safety Commission (CPSC). CPSC has stated that, ``[a]t present, 
there is no comprehensive source of information on the ingredients of 
household chemicals and CPSC does not have the authority to obtain this 
information. The [IUR amendments] would be a first step in obtaining 
information on product ingredients and provide a more efficient means 
of screening household chemicals for emerging hazards under the 
Chemical Hazard Program'' (Ref. 7).
    Certain international organizations collect and utilize exposure-
related information. The European Union (EU), in a regulation enacted 
in 1993 regarding the evaluation and control of existing substances 
(Ref. 8), requires chemical manufacturers and importers to report a 
variety of hazard and exposure information for the chemical substances 
they manufacture or import so that the EU can undertake preliminary 
risk evaluations and identify lists of priority substances which 
require special attention. Information on reasonably foreseeable uses 
of chemical substances is included in these reports. The types of use 
data collected under the EU regulation are similar to the types of use 
data that would be reported under this proposed rule.
    The Organization for Economic Cooperation and Development (OECD) 
also recognizes the utility of exposure-related information. OECD 
sponsors an international cooperative effort designed to share the 
costs of chemical testing among its more than 20 member countries. This 
effort, called the Screening Information Data Set (SIDS) Program, has 
focused on securing

[[Page 46777]]

ecological and human hazard data for high production volume chemical 
substances. As this Program has evolved, the member countries have 
become more aware of the need to consider the contribution of exposure 
to estimates of potential chemical risks. At times, decisions to pursue 
followup risk management have been delayed until exposure information 
could be developed. Without exposure information for use in risk 
screening and risk assessment, sufficient information did not exist to 
determine potential risk. To ensure a consistent and accurate 
evaluation of potential exposures by the various member countries, OECD 
organized a meeting of designated national experts in occupational and 
environmental exposure assessment, including experts from the chemical 
industry and international agencies, to define the exposure-related 
data needed to support screening level prioritization decisions for 
chemical testing and risk assessment. The exposure data that are 
recognized as needed for SIDS screening-level determinations are very 
similar to the exposure data that would be reported under these 
amendments to the existing IUR (Ref. 9).
    The successful use of exposure-related information in the 
development of risk estimates in EPA's New Chemicals Program (described 
in this unit) illustrates that the data reported under this proposed 
amendment to IUR would support EPA's risk screening of existing 
chemicals in commerce. EPA is proposing to collect readily obtainable 
exposure-related data that can be used to better establish priorities 
for its Existing Chemicals Program. The new IUR data elements included 
in this proposed rule are related to or are indicative of three 
components of exposure: The number of ecosystems or size of human 
populations potentially exposed (for example, data elements regarding 
number of sites, number of workers, and use in consumer products); the 
potential routes, magnitudes, and concentrations of exposures 
experienced by the environment or by humans (for example, data elements 
regarding function of chemical substances in industrial processes, 
physical form of chemical substances, industrial sectors where chemical 
substances are manufactured and used, average concentration, and 
maximum concentration); and the frequency and duration of potential 
exposures (for example, data elements regarding industrial function 
categories and commercial and consumer use categories). EPA intends to 
supplement the current data collected under IUR with additional data 
elements that would improve the Agency's ability to evaluate each of 
these components of exposure.
    2. Need to screen risks of inorganic chemical substances. In this 
action, EPA is proposing to remove the IUR reporting exemption for 
inorganic chemical substances which currently exists at 40 CFR 
710.26(a). The exemption exists because EPA believed in the past that 
the hazard potential of many inorganics was ``relatively well-
established'' (50 FR 9944, 9947, March 12, 1985) and that information 
about these hazards was a sufficient basis for prioritization within 
inorganic chemical substance risk assessment. EPA now intends to 
increase the consideration given to exposure, another component of 
risk, in screening chemicals and in setting priorities for risk 
assessment and risk management activities due to its belief that 
chemical hazard information alone is an insufficient basis for 
prioritization for these purposes. EPA therefore believes that the 
basis for this exemption is no longer applicable. However, during 
interagency review it was suggested that EPA first collect the IUR 
information in Parts I., II., and IV. of the revised Form U on these 
substances before collecting processing and use information in Part 
III. of the revised Form U.
    The need for additional basic information regarding production 
volume and other exposure-related data on the ongoing uses of inorganic 
chemical substances has been shown in a variety of ways. For example, 
the use of asbestos building materials led to the exposure of workers 
and other building occupants to asbestos. EPA has worked toward 
controlling and mitigating this exposure to asbestos. However, there is 
evidence that builders have unknowingly been incorporating new 
materials containing asbestos into buildings (Ref. 10). By including 
inorganic chemicals under the IUR, information needed to control 
exposure to asbestos in buildings would be made available to EPA. Such 
examples highlight the importance not only of production volume data, 
but of the use and other exposure-related data EPA may propose to 
collect through the IUR in the future.
    At this time, EPA is proposing that inorganic chemicals would be 
subject to only partial IUR reporting. Partial reporting consists of 
the information in Parts I, II, and IV of revised reporting Form U, 
whereas full reporting consists of all information on the reporting 
form (see Unit VI. of this preamble). EPA is choosing to only require 
partial reporting on inorganic chemicals to allow the Agency to become 
familiar with information on inorganics; EPA does not generally require 
reporting of information on inorganics under the existing IUR. Partial 
reporting would identify inorganic chemicals that are produced in 
quantities large enough to report to IUR, and would allow EPA to 
generally become familiar with the production volumes of inorganic 
chemicals. In addition, limiting IUR reporting for inorganic chemicals 
to a partial report would allow manufacturers (including importers) of 
these chemicals, who may never have reported to IUR before, to 
familiarize themselves with the most basic IUR reporting requirements.
    Because EPA and other IUR data users have a need for processing and 
use information on inorganic substances, EPA will review the need for 
full IUR reporting, i.e., all parts of revised reporting Form U, from 
manufacturers (including importers) of inorganic chemicals in the 
future. Based on EPA's review of the information submitted on inorganic 
chemicals in the first reporting period under these IUR amendments, EPA 
may propose to require full IUR reporting on inorganic chemicals by the 
second reporting period.
    3. Need for procedural reforms to IUR--a. Linking IUR data to other 
reporting. EPA is undertaking a comprehensive facility identification 
initiative to improve coordination and comparability among different 
information reporting mechanisms. To facilitate this effort, EPA is 
establishing the Facility Registry System (FRS) as a central 
information resource of definitive facility information, which will 
link all facilities represented in EPA program data bases through 
common facility identification data elements. As part of the program, 
the FRS will include implementation of a new facility numbering system 
identifying each facility with a unique Facility Registration 
Identifier (FRI) which will be used for electronic and integrated 
reporting and central receiving. EPA and the States will develop the 
business rules for assigning the FRI to each facility and will 
determine how the number will be used in reporting. EPA anticipates 
releasing the first version of the FRS and the new numbering system in 
the fall of 1999.
    In line with the FRS initiative, EPA is proposing to amend IUR so 
that future data collections include the reporting of the submitting 
plant site's FRI, as well as the county in which the plant site is 
located. Use of the new FRI number is

[[Page 46778]]

important to EPA and others in linking IUR information with information 
from other data bases, such as the Toxics Release Inventory (TRI).
    In the alternative, should the FRS initiative not be underway at 
the time this proposed rule becomes final, EPA will require submitters 
to report the plant site's EPA identification number (ID), if it has 
one. The EPA ID is the 12-character number assigned to sites covered by 
the hazardous waste regulations under RCRA (40 CFR 262.12). For sites 
that have not been assigned an EPA ID, submitters would report this 
item as ``not applicable.'' Section 262.12 states that plant sites that 
generate hazardous waste can obtain an EPA ID by applying to the EPA 
Administrator using Form 8700-12 ``Notification of Regulated 
Activity.'' Upon receipt of such a request, the Administrator assigns 
an EPA ID number. Plant sites are required to report the EPA ID on RCRA 
manifests and biennial reports.
    EPA also is proposing to amend the reporting basis from a corporate 
fiscal year basis to a calendar year basis. This amendment would make 
the information submitted under these amendments more consistent than 
the information submitted under the existing IUR because all submitters 
would refer to the same period of time when gathering reportable 
information. In addition, this amendment would make the IUR reporting 
schedule more comparable with other EPA reporting requirements, such as 
TRI, thereby increasing EPA's ability to link information from various 
data bases.
    b. Improving the process by which CBI claims are made. IUR 
submitters currently have the ability to claim much of the information 
they report under the IUR as CBI. The ability to make CBI claims would 
continue under these amendments; however, EPA is proposing certain 
modifications to existing CBI policies in order to ensure that CBI 
claims are justified, and to facilitate the submission and subsequent 
release of non-confidential data.
    TSCA section 14 provides that certain information may be claimed as 
confidential. The impact of a confidentiality claim on information is 
that the information may only be made available to properly trained 
Federal government employees and contractor employees. Accordingly, 
under most circumstances, non-Federal entities cannot be authorized for 
access to CBI data for independent assessment or other purposes. In 
addition to significantly increasing transaction costs, CBI claims can 
impact EPA's ability to use IUR data, because it is more difficult to 
justify risk screening, assessment and management decisions when data 
driving those decisions are CBI and cannot be publicly shared. While 
legitimate CBI claims protect valuable proprietary information, invalid 
claims thwart the Agency's goal of using TSCA data to support a wide 
variety of chemical management activities as intended by Congress.
    Since the enactment of TSCA in 1976, the Agency has grappled with 
its related, but somewhat conflicting, obligations to protect CBI but 
also to make information available to the public. In 1990, the Agency 
initiated a program by which industry's TSCA CBI claims practices were 
examined and assessed (Refs. 11 and 12). The program revealed that the 
Agency's transaction costs are increased with CBI claims, the Agency's 
ability to use CBI data is limited, and CBI claims make it difficult to 
describe with specificity the facts necessary to justify chemical risk 
assessment and management decisions. The program also demonstrated that 
CBI claims prevent state governments engaging in chemical management 
activities from benefiting from access to TSCA CBI information (Ref. 
13).
    EPA's review of CBI claims practices also revealed that some CBI 
claims appeared to be unjustified. In some cases, certain information 
was claimed as confidential when the same information was available in 
a variety of publicly available sources such as newspapers, 
advertisements, and Internet websites. For example, site identity was 
at times claimed as CBI in IUR filings when that information was 
available in a variety of public documents. While it was widely 
accepted that the need for CBI protection for certain information 
expired over time, there was no mechanism which ensured that older CBI 
claims would be reviewed by the information submitter. The public 
increasingly questioned the validity of CBI claims over time as the 
overall credibility of industry's initial CBI claims was diminished.
    One of the purposes of the CBI-specific IUR amendments is to ensure 
that CBI claims are valid at the time they are filed. Another purpose 
is to ensure that certain critical information, such as production 
volume information, is submitted in a way that generally enables the 
Agency to characterize industry-wide production volume, but that 
protects the specific CBI information involved. Finally, the new CBI 
amendments are intended to act as a mechanism that ensures that 
submitters periodically review older CBI claims and declassify 
information as their need for confidentiality ends.
    Specifically, in an effort to increase the public availability of 
data and reduce transaction costs, EPA is proposing requirements in 
addition to those currently in place to require that submitters assert 
a separate CBI claim for production volume data reported in ranges; 
submitters substantiate CBI claims for plant site identity at the time 
the claims are made; and submitters reassert CBI claims for information 
claimed as CBI in past IUR filings. A detailed discussion of 
confidentiality issues is included in Unit VIII. of this preamble.
    4. Creating an exemption from IUR reporting for certain forms of 
natural gas. EPA is proposing to add an exemption from IUR reporting to 
40 CFR 710.26 for certain forms of natural gas. The six chemical 
substances that would be subject to this exemption are as follows: CAS 
No. 64741-48-6, Natural gas (petroleum), raw liquid mix; CAS No. 68919-
39-1, Natural gas condensates; CAS No. 8006-61-9, Gasoline natural; CAS 
No. 68425-31-0, Gasoline (natural gas), natural; CAS No. 8006-14-2, 
Natural gas; and CAS No. 68410-63-9, Natural gas, dried.
    EPA currently believes that additional IUR information on these 
chemical substances would be of limited value in the execution of 
various assessment and testing programs because EPA believes that 
adequate IUR information on these chemical substances is available to 
fulfill EPA's current needs, and the current needs of other IUR 
information users.

B. Consideration of Alternative Data Sources

    TSCA section 8(a)(2) states that, to the extent feasible, the 
Administrator of EPA shall not impose reporting requirements under TSCA 
section 8(a)(1) which are unnecessary or duplicative. In order to 
ensure that the reporting requirements proposed in these amendments are 
not unnecessary or duplicative, EPA considered the extent to which the 
data that would be gathered as a result of this rulemaking are 
available to EPA through existing public data collections.
    The data collections considered by EPA include EPA sources such as 
the current IUR, the TSCA Preliminary Assessment Information Reporting 
(PAIR) rule (40 CFR part 712), the TRI, and the Use and Exposure 
Information Project (UEIP), as well as other Federal sources such as 
the National Occupational Exposure Survey (NOES). EPA has used these 
sources to support its chemical review program. Although

[[Page 46779]]

the sources can provide useful information, EPA has been unable to 
perform the large-scale screening necessary to screen the chemicals on 
the TSCA Inventory based on risk because of limitations in the existing 
data. Some sources are dated, others are narrow in coverage of data 
elements or limited to certain chemical substances, while others entail 
procedural complications which limit their effectiveness in meeting 
EPA's needs. Based on this review, EPA has concluded that these 
information sources, considered individually or in the aggregate, do 
not adequately substitute for the information EPA is proposing to 
collect in this rulemaking. A detailed description of the basis for 
this conclusion is provided in the several documents provided in the 
public record for this proposal. These documents are: ``Inventory 
Update Rule (IUR) Amendment Technical Support Document: Exposure-
Related Data Useful for Chemical Risk Screening,'' ``Economic Analysis 
of Proposed Amendments to the TSCA Section 8 Inventory Update Rule,'' 
and ``A Review of Existing Exposure-Related Data Sources and Approaches 
to Screening Chemicals: A Response to CMA.'' These documents are listed 
at Unit X.A.2.a., Unit X.A.2.f., and Unit X.A.2.i. of this preamble 
respectively.
    The following is a brief description of the extent to which each of 
these data collections includes exposure-related information (e.g., 
number of plant sites and workers, industrial and consumer uses, etc.), 
and whether they are sufficient for the risk-based screening of 
chemical substances listed on the TSCA Inventory. The documents 
mentioned in the preceding paragraph provide a more comprehensive and 
detailed discussion of existing exposure information data sources.
    1. The current IUR. Although certain provisions in the current IUR 
would be amended by this action, many of its requirements would remain 
unchanged under these amendments. The existing IUR requires chemical 
manufacturers (including importers) to provide to EPA every four years 
the identity of chemical substances manufactured (including imported) 
in annual quantities of 10,000 lbs. or more at each plant site they own 
or control. The information required includes company name, plant site 
location, plant site Dun and Bradstreet number, the identity of the 
chemical substance, and the production volume of the chemical 
substance. The IUR has been a reliable source of production volume and 
site location data for organic chemical substances. Inorganic chemical 
substances are currently excluded from reporting.
    Past approaches to the risk screening of chemical substances have 
been primarily based on relative chemical substance hazard, coupled 
with IUR production volume data. EPA has determined that production 
volume information alone is not typically adequate as a proxy for 
exposure information for purposes of risk assessment and risk screening 
(Ref. 14). In the past, the absence in IUR of exposure-related data 
beyond production volume data has severely limited the utility of IUR 
in a comprehensive screening program for chemicals in commerce.
    2. PAIR rule. PAIR, which was promulgated under TSCA section 8(a), 
requires any person who manufactures (including imports) a particular 
chemical substance during the indicated reporting year to complete and 
submit a form that requests a variety of information pertaining to the 
manufacture and processing of TSCA chemicals. In some ways this 
information is similar to the information that would be reported under 
these amendments to IUR, while in other ways the information reported 
under PAIR is different.
    Information reported under PAIR includes, but is not limited to, 
the following: chemical and company identity, plant site location, 
annual volume manufactured (including imported), plant site and 
customer activities (i.e., whether the substance is manufactured or 
used as a reactant or nonreactant, and whether operations are enclosed, 
controlled release or open), workers and worker hours, and types of 
industrial products (i.e., whether the substance is produced in pure 
form or incorporated into a mixture or article), and whether 
environmental releases occur (see 40 CFR 712.28). This information, on 
a per report basis, is both broader and narrower than the proposed IUR 
amendments information. For instance, release information is collected 
under PAIR, but would not be collected under the proposed IUR 
amendments. At the same time, PAIR reporting does not include 
information which can identify uses by specific consumer groups or 
NAICS codes, whereas the proposed IUR amendments would require the 
reporting of such information by certain entities. Duplicative 
reporting under both PAIR and IUR is avoided under the existing IUR 
regulations at 40 CFR 710.35, and would be avoided under the proposed 
IUR amendments as well.
    The TSCA Interagency Testing Committee (ITC) determines which 
chemical substances are included on the TSCA section 4(e) Priority 
Testing List. PAIR rules are primarily used to collect information on 
those chemicals the ITC is considering designating for testing under 
TSCA section 4 (40 CFR 712.30). PAIR reporting is done on a one-time 
basis in response to the publication of a chemical-specific rule 
amendment, as opposed to the IUR which, in a single rule, requires 
recurring reporting for a large group of chemicals. About 458 chemicals 
have been subject to PAIR reporting as of September 1996, and 360 
companies have submitted 1,668 reports (See ``Preliminary Assessment 
Information Rule (PAIR) Database, Manufacturing Process Type/Release 
Analysis and Number of Workers/Production Quantity Analysis,'' 
available in the public record for this proposal, and listed at Unit 
X.A.2.b. of this preamble). Other features of PAIR include a reporting 
threshold of 500 kg/yr/site and reporting based on a corporate fiscal 
year.
    Both PAIR and IUR could potentially be utilized to require the 
reporting of data regarding a greater number of chemical substances 
than the IUR currently covers. For example, the current IUR exemption 
for polymers and low volume chemicals could be eliminated, or a PAIR 
rule could be used to collect information for these exempted chemicals.
    There are two major differences between reporting under IUR and 
PAIR other than differences in specific data elements. One of the 
differences is that IUR requires the reporting of information every 4 
years, while PAIR requires the reporting of information on a one-time 
basis. However, the chemical industry is dynamic, and 30% of the 
chemicals for which IUR information was reported in 1990 were not 
reported in 1994. Because the industry is dynamic, the information it 
would report under the IUR amendments could change from reporting year 
to reporting year. Therefore, the information collected under these 
amendments would present a view of exposure to chemical substances that 
recognizes chemical industry dynamics which PAIR rules are not able to 
reveal. The other major difference between IUR and PAIR is that IUR 
requires the reporting of information on a large number of chemical 
substances during each reporting period, whereas each PAIR rule 
typically covers only one or a much more limited group of chemical 
substances. As discussed above, information on a large number of 
chemicals is necessary for the effective implementation of a chemical 
screening program.

[[Page 46780]]

    3. Toxics Release Inventory (TRI). EPCRA section 313 and section 
6607 of the Pollution Prevention Act (42 U.S.C. 13106(b)) require 
certain facilities that manufacture, import, process, or ``otherwise 
use'' EPCRA section 313 listed toxic chemicals at or above specified 
thresholds to annually report their releases and other waste management 
activities regarding such substances. The reporting thresholds are 
generally 25,000 lbs. per year for chemicals that are manufactured 
(including imported) and processed, and 10,000 lbs. per year for 
chemicals that are otherwise used. Included in the report is the 
following information: Chemical identity, facility identity, parent 
company identity, certain general activities and uses of the chemical 
at the reporting facility, the maximum amount on-site, releases on-site 
and quantities sent off-site for disposal, quantities combusted for 
energy recovery and recycled both on-site and off-site, and on-site 
waste treatment methods and efficiencies.
    Only about 650 chemicals and chemical categories are currently 
reportable, including chemicals excluded from TSCA jurisdiction such as 
pesticides, and chemicals currently exempt from the IUR, such as 
inorganics. This list consists of fewer than 1% of the chemicals listed 
on the TSCA Inventory. In addition, facilities subject to the reporting 
requirements of EPCRA section 313 are limited to specific SIC codes and 
Federal facilities. Only facilities with 10 or more full-time employees 
are currently required to report. About 22,000 facilities report to 
TRI.
    TRI data are useful for screening and assessing releases from 
industrial facilities for site-specific assessments of potential 
general population or environmental exposures to populations near 
facilities that manufacture, process or use EPCRA section 313 listed 
toxic chemicals. However, the TRI universe of chemicals is limited to a 
small portion of the chemicals on the TSCA Inventory. Also, TRI does 
not contain worker exposure and use data. These data, along with a 
larger universe of chemicals than is included in the TRI, are needed to 
accomplish the type of broad based chemical screening process that 
would be possible under the proposed IUR amendments.
    4. National Occupational Exposure Survey (NOES). In 1983, NIOSH 
completed a systematic effort to collect data on potential occupational 
chemical, physical, and biological exposure agents in a representative 
sample of businesses. The sample was designed to be representative of 
virtually all of the non-agricultural, non-mining, and non-governmental 
businesses covered under the Occupational Safety and Health Act (OSH 
Act) of 1970. The survey consisted of observational data collected at 
4,490 establishments by NIOSH surveyors through field visits, which 
included walk-through surveys and interviews of employees at the 
establishments. To develop nationwide samples from the data, the survey 
results were multiplied by a weighting factor. A description of the 
survey and the data base can be found in the public record for this 
proposal (Ref. 15).
    The NOES data base includes information on plant site location, 
plant site SIC code, plant site occupational safety and health 
programs, occupational titles of workers potentially exposed, number of 
employees per occupational title, process steps, and product trade 
names. EPA has frequently used the NOES survey to estimate the total 
number of workers potentially exposed per chemical per SIC code; to 
estimate the number of chemical manufacturing, processing, and use 
sites; to rank potential exposures; and to develop exposure 
assessments.
    Now over 15 years old, the NOES data have become progressively 
dated, and as a consequence, less representative of current exposure 
situations. In light of this shortcoming, EPA believes that the NOES 
data base cannot substitute for the up-to-date data base that EPA would 
develop with the proposed IUR amendments.
    5. Use and Exposure Information Project (UEIP). The UEIP is a 
program developed jointly by EPA and chemical manufacturers. It 
provides a method for chemical manufacturers to voluntarily send 
readily obtainable use and exposure information to EPA for chemical 
substances entering the Existing Chemicals Program's screening 
assessment process. A sample UEIP data submittal package is included in 
the public record for this rulemaking (Ref. 2). The program started in 
the fall of 1992 and was developed after CMA and SOCMA asked EPA what 
the chemical industry could do to help strengthen EPA's Existing 
Chemicals Program. EPA explained that accurate use and exposure 
information was not available and that better information in this area 
was a key need. A joint industry/EPA workgroup was formed to address 
this need, to define relevant exposure data, and to develop a data 
transfer process for industry to effectively transmit data to EPA. More 
recently, the API and CSMA have endorsed and participated in further 
development of this project.
    In the UEIP, manufacturers (including importers) voluntarily report 
production volume, site location, environmental releases, number of 
potentially exposed workers, monitoring data, industrial and consumer 
uses, and percent of production volume attributed to a given use. For 
any given chemical substance, the data transmitted to EPA via UEIP are 
more detailed than the data EPA would receive as a result of these IUR 
amendments. Upon receipt of UEIP data from manufacturers and importers, 
EPA prepares an exposure profile. The UEIP program is limited by 
agreement among the parties to obtaining data on no more than 40 
chemical substances per year. The screening information that would be 
generated by this proposal would assist with the selection of chemical 
substances for inclusion in the UEIP program.
    The UEIP program has yielded important advances for EPA's risk 
assessment and risk management efforts for several chemical substances. 
For example, exposure assessments based on the UEIP data have in some 
instances obviated the need for additional testing or followup risk 
management action for certain chemical substances under the SIDS 
program. However, the proposed amendments to IUR would include a wider 
range of chemicals than the UEIP and therefore would address the need 
for exposure-related data from across a wider segment of the chemical 
industry.
    6. Use Cluster Scoring System (UCSS). EPA has developed the UCSS to 
identify potential risks of, and to establish regulatory review 
priorities for, chemical substances used in similar applications, or 
``use clusters'' (Ref. 16). For example, instead of evaluating a single 
chemical used as a paint stripper, the UCSS evaluates the exposures and 
risks posed by the entire set of chemical substances that are used as 
paint strippers.
    The UCSS evaluates exposure based on information from several 
sources. Although the UCSS has proven to be a valuable tool in 
conducting screening level exposure assessments, some of the sources of 
UCSS data are dated and some of the methods used to further develop the 
data are not yet validated for accuracy. Some of these data are 
discussed briefly below.
    Use volume estimates are obtained from past EPA studies and 
commercial market reports. These sources are very limited in the number 
of uses covered and the detail of use information. Only large volume 
uses (100,000 kilograms/year or more) of chemical substances are 
usually captured in commercial market studies. These studies are 
further discussed in the document entitled, ``A

[[Page 46781]]

Review of Existing Exposure-Related Data Sources and Approaches to 
Screening Chemicals: A Response to CMA,'' available in the public 
record for this rulemaking and listed at Unit X.A.2.i. of this 
preamble.
    Consumer use data are obtained from internal data bases (such as 
EPA's Indoor Air Chemical Database) and the Hazardous Substances Data 
Bank (HSDB), a database of Department of Transportation (DOT) 
information compiled by the National Library of Medicine. Each of these 
data bases, however, contains limited consumer use information for a 
small number of chemicals. These data bases are further discussed in 
the document entitled, ``Economic Analysis of Proposed Amendments to 
the TSCA Section 8 Inventory Update Rule,'' and in ``A Review of 
Existing Exposure-Related Data Sources and Approaches to Screening 
Chemicals: A Response to CMA,'' both of which can be found in the 
public record for this proposal and which are listed at Unit X.A.2.f. 
and Unit X.A.2.i. of this preamble.
    Environmental release estimates are obtained from the TRI. The UCSS 
is not limited to TRI chemicals; however, no comprehensive sources of 
release data are available for non-TRI chemical substances. While the 
UCSS contains data from the Biennial Reporting System (BRS), these data 
are not used by UCSS to rank potential exposures. BRS, a data base 
maintained by EPA's Office of Solid Waste, is a collection of 
information on the quantity, management, and minimization of hazardous 
solid or liquid wastes from facilities that generate and/or manage 
these wastes. Information is identified by the RCRA waste codes. These 
waste codes identify the type of waste and frequently describe mixtures 
of chemicals; they do not provide information on the waste stream 
composition. This lack of composition information makes it difficult to 
determine the quantity of an individual chemical substance in the 
waste. Therefore, there is little information to use to determine 
potential exposures.
    Estimates of the number of potentially exposed workers and the 
number of chemical processing and use sites are obtained from the NOES 
and the Bureau of Census' Census of Manufacturers. As in Unit V.B.4. of 
this preamble, the NOES data (developed by NIOSH) are over 15 years old 
and contain uncertainties due to the age of the data as well as 
sampling errors and systematic biases. The Census of Manufacturers data 
are not chemical-specific; chemical-specific or use-specific 
conclusions are therefore based upon data provided by four-and six-
digit SIC codes when Census of Manufacturers data are used.
    A recent review of the UCSS by EPA's Science Advisory Board (Ref. 
17) found that ``the cluster scoring system heavily weights exposure 
data. . . Unfortunately, there are no easily accessible data on 
exposure.'' The proposed amendments to the IUR would create a data 
source that would be used to augment the information in the UCSS, 
giving EPA a tool for use in prioritizing chemical clusters in a way 
that is consistent with the Science Advisory Board's suggestions (Ref. 
16). Because the exposure information sources used to support many of 
EPA's existing chemical assessments are essentially the same as those 
relied upon by the UCSS, this comment is generally applicable to most 
of EPA's efforts to assess exposure to existing chemical substances.
    7. Other data sources. Other data sources that have been considered 
are listed in the ``Inventory of Exposure-Related Data Systems 
Sponsored by Federal Agencies'' (Ref. 18). This document is a 
compilation of information on federally managed data systems that 
contain exposure information. These systems access collections of 
analytical results that assess environmental media such as air, soil, 
or water as well as analytical results from food, human samples, or 
bulk chemicals.
    Each of the data bases described in the document is of limited 
utility due to a small or specialized sample size, the limited number 
of chemicals, or the age of the data. None of the data bases, either 
alone or combined, provide the Agency with the full array of screening 
level data on chemical substances that would be collected by the 
proposed amendments to IUR.
    The information in available data systems does not provide a 
sufficiently clear picture of the potential for chemical exposure. Some 
of the systems are regional, rather than national in scope. Several 
systems cover only a very limited set of chemical substances, or a 
limited number of chemical uses, or only specific industry sectors. 
Several systems collect information on categories of pollutants or on 
waste streams rather than on specific chemical substances, making it 
difficult to use the data in chemical risk screening. Many of these 
systems collect monitoring data which are frequently media-specific 
(e.g., air or water), but do not collect information on the potential 
sources of chemical releases to the environment. This proposed rule 
would provide the exposure information needed for screening the 
chemical substances included on the TSCA Inventory for potential risk.

VI. Amendments Affecting All Manufacturers (Including Importers)

    As discussed in detail in Unit VI.B. of this preamble, plant sites 
that manufacture (including import) a chemical substance in annual 
quantities of 25,000 lbs. or more would be required to report the 
information in Parts I., II., and IV. of Revised Reporting Form U. This 
information relates to basic site identification, manufacturing 
information, and CBI reassertion. Sites that manufacture (including 
import) a chemical substance in annual quantities of 300,000 lbs. or 
more would be required to report the information in Part III. of 
Reporting Form U in addition to the information in Parts I., II., and 
IV. This additional information relates to the processing and use of 
chemical substances.
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    EPA will make available detailed instructions for completing the 
reporting form before the effective date of the final rule. EPA also 
intends to encourage electronic submissions of the final form. The 
procedures for electronic submissions will be made available before the 
effective date of the final reporting rule.

A. Amendments to Substances Covered by IUR

    1. Inorganics. EPA is proposing to require partial reporting for 
inorganic chemical substances (i.e., Parts I., II., and IV. of revised 
Reporting Form U, but not Part III.), most of which are presently 
excluded under the current IUR regulations at 40 CFR 710.26(a). As 
discussed in Unit V.A.2. of this preamble, EPA intends to screen 
potential risks associated with inorganic chemical substances to set 
priorities for testing, more detailed risk assessment and potential 
risk management. The removal of the IUR reporting exemption for 
inorganic chemical substances would allow EPA to gather information 
important for effective risk screening and priority setting.
    2. Petroleum process streams. EPA is proposing to exempt as a class 
certain chemical substances termed ``petroleum process streams'' from a 
portion of the amended IUR's reporting requirements. For purposes of 
this proposed rule, the petroleum process streams included in the 
exemption would be the multi-component complex chemical substances 
listed by Chemical Abstracts Service (CAS) Registry Number in the 
proposed regulatory text at Sec. 710.26(d). The reporting excluded by 
this exemption would be the exposure-related data contained in Part 
III. of Revised Reporting Form U. The chemical substances listed as 
petroleum process streams in the proposed regulatory text were derived 
from the 1983 publication of the API entitled ``Petroleum Process 
Stream Terms Included in the Chemical Substances Inventory Under the 
Toxic Substances Control Act (TSCA)'' (Ref. 19). Chemical substances 
listed in the API document consisting of a single component chemical, 
except for water, would not be considered petroleum process streams for 
IUR reporting purposes.
    This exemption is not being proposed because these streams are of 
known low toxicity. In fact, EPA believes that several petroleum 
process streams are toxicologically active; however, EPA believes that 
it, as well as other IUR information users, will not have a need in the 
near future for full IUR reporting on petroleum process streams. EPA 
will take action to revoke this exemption if its needs change. About 
5,850 of the about 24,000 IUR reports submitted to EPA during the 1994 
reporting period were for chemical substances that fit the definition 
of petroleum process streams. Therefore, this proposed exemption is 
expected to significantly reduce submitters' reporting burdens from the 
burden that would exist without the exemption.
    3. Natural gas. EPA is proposing to exempt certain forms of natural 
gas from IUR reporting. The chemical substances that would be covered 
by this exemption are the following: CAS No. 64741-48-6, Natural gas 
(petroleum), raw liquid mix; CAS No. 68919-39-1, Natural gas 
condensates; CAS No. 8006-61-9, Gasoline natural; CAS No. 68425-31-0, 
Gasoline (natural gas), natural; CAS No. 8006-14-2, Natural gas; and 
CAS No. 68410-63-9, Natural gas, dried.
    EPA believes that adequate IUR information collected on these 
chemical substances to date is available to fulfill EPA's current 
needs, and the current needs of other IUR information users. EPA 
specifically requests comment on whether IUR reporting for these six 
natural gas substances should be required in upcoming reporting 
periods, and whether the six CAS numbers identified are the appropriate 
natural gas substances for inclusion in this exemption. EPA will take 
action to revoke this exemption if its needs change in the future. 
Approximately 1,225 of the 24,000 IUR reports submitted to EPA during 
the 1994 reporting period were for the six chemical substances included 
in this proposed exemption. Therefore, this proposed exemption would 
likely result in a beneficial burden reduction for IUR submitters.

B. Amendments to Reporting Thresholds

    EPA is proposing to raise the IUR reporting threshold from a 
production volume of 10,000 lbs. per year to 25,000 lbs. per year. 
Every person manufacturing (including importing) a non-excluded 
substance at or above the threshold would be required to report the 
information in Parts I., II., and IV. of Revised Reporting Form U. The 
increased IUR reporting threshold would make the IUR and TRI reporting 
thresholds equivalent at 25,000 lbs. per year for manufacturers 
(including importers). These thresholds are also approximately equal to 
the recently amended PMN low volume exemption threshold of 10,000 kg 
(approximately 22,000 lbs.). EPA is proposing to raise this reporting 
threshold in order to reduce the number of reports filed, thus reducing 
industry burden. The new reporting threshold does not represent a 
finding of low exposure or low risk.
    EPA is also proposing a second, higher-volume threshold of 300,000 
lbs. per year. Persons who manufacture (including import) a non-
excluded substance at or above this level would be required to report 
the information in Part III. of Revised Reporting Form U in addition to 
the information in Parts I., II., and IV. The information reported 
under Part III. relates to the processing and use of chemical 
substances. EPA recognizes that the requirement that processing and use 
information be reported would impose a burden on industry. EPA 
originally considered proposing a higher-volume threshold of 100,000 
lbs. per year; however, in the interest of further reducing the 
paperwork burden imposed on industry, EPA is proposing a higher-volume 
threshold of 300,000 lbs. per year. EPA is proposing this separate 
threshold to limit exposure data reporting to a subset of a few 
thousand IUR reportable chemicals.
    The new, higher thresholds proposed in this action are consistent 
with a report from the General Accounting Office (Ref. 20), which 
recommended that, ``. . .the inventory could be more useful to EPA and 
other interested parties if it initially focused on a smaller number of 
the highest-priority chemicals known to present risks to health and the 
environment and was expanded as necessary.'' EPA considered a number of 
different thresholds between 10,000 lbs. and 50,000 lbs. for basic IUR 
information and between 10,000 lbs. and 10,000,000 lbs. for processing 
and use information (See ``Economic Analysis of Proposed Amendments to 
the TSCA Section 8 Inventory Update Rule,'' available in the public 
record for this rulemaking and listed in this preamble at Unit 
X.A.2.f.). EPA examined each of these options in light of the benefits 
that would be obtained from the information collected, EPA's ability to 
utilize that information, and the burden imposed on the public to 
provide the information. EPA concluded that processing and use 
information would be highly valuable (see Ref. 14), but that EPA would 
likely focus initially on larger volume chemical substances.
    In order to retain information on potential substitutes for the 
larger volume chemical substances, but at the same time reduce the 
public reporting burden, EPA initially considered proposing a 100,000 
lb. higher-volume reporting threshold for processing and use 
information to reduce the paperwork burden on industry. Although EPA 
believes a 100,000 lbs.

[[Page 46786]]

higher-volume threshold would provide valuable information, EPA is 
proposing that this threshold be set at 300,000 lbs. in an attempt to 
further reduce paperwork burden on submitters. EPA believes that this 
effort to further reduce the paperwork burden, as well as the Agency's 
other efforts to minimize burden in this proposed rule, is consistent 
with the Paperwork Reduction Act. EPA seeks public comment on the 
proposed threshold and on the other alternative thresholds analyzed in 
the Economic Analysis (listed in Unit X.A.2.f. of this preamble).
    EPA still believes that information concerning lower production 
volume chemical substances is valuable, especially for identifying 
trends and additional substitute chemicals, but EPA also recognizes the 
importance of limiting the reporting burden when the need for the data 
is generally less great. In the future, EPA may find it necessary to 
collect information on chemicals at reporting thresholds below the 
thresholds proposed in this action. Although both proposed thresholds 
are significantly higher than the current IUR 10,000 lbs. threshold, 
EPA believes that the enhanced information it would receive under this 
rule at the proposed thresholds would enable the Agency to more 
efficiently identify those chemical substances warranting further, more 
in-depth regulatory review (see Ref. 14).
    The new, higher reporting thresholds would result in a reduction in 
the number of currently reportable chemicals. However, this reduction 
would be partially offset by the elimination of the exemption for 
inorganic chemical substances. Under the current IUR, EPA receives 
reports on about 8,900 chemical substances. The Agency estimates that 
raising the reporting threshold from 10,000 lbs. to 25,000 lbs. reduces 
the number of reportable chemicals to about 7,800, while deleting the 
exemption for inorganic chemical substances would increase the number 
of reportable chemicals by about 1,200. Of the approximately 8,900 
reportable chemical substances expected under the IUR amendments, about 
4,050 would likely be produced in volumes of 300,000 lbs. or more and 
would require the completion of the entire revised reporting form.

C. Amendments to Reporting Period and Frequency

    Under the current IUR regulations at 40 CFR 710.33(b), submitters 
are required to report on a recurring basis between August 25 and 
December 23 every 4 years (``the reporting period''). EPA is not 
proposing to change this requirement. However, the current IUR 
regulations indicate that the information reported during each 
reporting period is from the submitter's latest complete corporate 
fiscal year prior to the reporting period. In order to standardize 
reporting time frames across IUR submitters and across various other 
reporting programs, such as the TRI program, the Agency is proposing to 
change this IUR reporting scheme from a fiscal year reporting basis to 
a calendar year reporting basis. This would mean, for example, that the 
information that would be reported during the reporting period from 
August 25 to December 23 in the year 2002 would be from calendar year 
2001.

D. Amendments to Recordkeeping Requirements

    Currently, the Inventory regulations at 40 CFR 710.37 require 
submitters to retain records on IUR reports for 4 years. In these 
amendments to IUR, EPA is proposing that persons subject to the rule be 
required to retain records that document information reported for 5 
years after the end of the relevant reporting period. For example, if a 
person submits an IUR report in the reporting year 2002, that person 
would be required to retain the records on which the report is based 
until December 31, 2007. This change, which would assist EPA's 
enforcement of the IUR, would result in the requirement that submitters 
maintain records that span successive reporting periods, which would 
continue to occur every 4 years as under the existing IUR.
    Persons who are not required to report under the existing IUR 
because they manufacture less than the 10,000 lb. reporting threshold 
are required to retain volume records as evidence to support a decision 
not to submit a report. In this rulemaking, EPA is proposing that this 
provision be eliminated because EPA believes that this information is 
of the type that companies would routinely retain in the normal course 
of business.

E. Amendments to Reportable Data Elements

    The new and revised data elements that would be reported under the 
rule are discussed in this section. Data elements that are currently 
reported under IUR but that would not be revised by these amendments 
(such as company information, Part I., Section II. of Revised Reporting 
Form U; site-limited activity, Part II., Section II.; and manufacturer/
importer activity, Part II., Section II.) are not generally discussed 
because EPA is not reopening these data elements for comment. Although 
certain CBI issues are mentioned in this section (see Unit VI.E.3. of 
this preamble, for example), changes to CBI procedures are discussed 
more completely in Unit VIII. of this preamble.
    1. Plant site identification (Part I., Section III. of Revised 
Reporting Form U). EPA currently requires the following information to 
be reported for each plant site at which a reportable chemical 
substance is manufactured (including imported) in amounts greater than 
the reporting threshold: the plant site name, Dun and Bradstreet 
number, street address, city, state, and zip code. The site for a 
chemical substance importer is the site of the operating unit within 
the importer's organization that is directly responsible for importing 
the substance and that controls the import transaction, and may in some 
cases be the organization's headquarters office in the U.S.
    EPA believes additional plant site identifiers would allow for full 
integration of IUR data with other ``place-based'' environmental data 
collected by EPA or states under other regulatory authorities into 
multi-source and function data bases. By facilitating this integration, 
the Agency would be better able to address its obligations under TSCA 
section 10, and would thereby achieve the intended TSCA goal that 
information collected under the Act be made easily accessible to a wide 
variety of governmental and nongovernmental entities. With data 
integrations, TSCA data could be fully utilized as a ``feedstock'' for 
a wide variety of chemical management activities.
    Providing linkages and achieving integration for environmental data 
across various data bases are important EPA goals under TSCA. While it 
was always intended that TSCA data be made available to chemical 
managers, until relatively recently, the primary user of TSCA data has 
been OPPT and the TSCA data systems were designed with this user in 
mind. Over the last several years, however, TSCA data has been sought 
by a wide variety of Federal, State and private organizations. For 
example, several States routinely contact the Agency to gain access to 
TSCA data that might be useful for their implementation of both State 
laws and Federally delegated laws. As demand has increased, EPA has 
recognized that the existing TSCA data systems do not always 
efficiently address the needs of the non-OPPT user.
    Another benefit associated with fully integrating TSCA data into 
multi-source and function data bases is that duplicative information 
collections would be more easily identified and

[[Page 46787]]

eliminated. Finally, improved linkages among data bases would provide 
the public with access to additional information at little or no burden 
to the regulated community.
    EPA is proposing to require the reporting of two identifiers for 
each plant site reporting under IUR:
    a. The Facility Registration Identifier (FRI) (if the plant site 
has one).
    b. The county or parish (or other jurisdictional indicator) in 
which the plant site is located.
    EPA is establishing the Facility Registry System (FRS) as a central 
resource of facility information, which will link all facilities 
represented in EPA program data bases through common facility 
identification data elements. The FRS will include a new facility 
numbering system identifying each facility with a unique Facility 
Registration Identifier (FRI) which will be used for electronic and 
integrated reporting and central receiving. The business rules for 
assigning an FRI to each facility will be developed by EPA and the 
States. EPA anticipates releasing the first version of the FRS and the 
new numbering system in the fall of 1999. The first reporting year 
under the final IUR amendments should occur after this system is in 
effect. For sites that have not been assigned an FRI, submitters would 
report this item as ``not applicable.''
    In the alternative, should the FRS initiative not be underway at 
the time this rule becomes final, EPA will require submitters to report 
the plant site's EPA identification number (ID), if it has one. The EPA 
ID is described by the 12-character number assigned to sites covered by 
the hazardous waste regulations under RCRA (40 CFR 262.12). This number 
is further described in Unit V.A.3.a. of this preamble. For sites that 
have not been assigned an EPA ID, submitters would report this item as 
``not applicable.''
    The TRI program has demonstrated that many public and private 
sector organizations find it useful to aggregate release data by county 
or parish of reporting plant sites when evaluating chemical risks. EPA 
believes that there is merit to including similar geographic 
identifiers in future IUR reporting so that similar aggregations of IUR 
data can be generated. The two proposed plant site identifiers will 
facilitate improved linkages of the IUR information to other data 
bases, enabling the Agency to perform more comprehensive risk 
screening, assessment, and management activities.
    2. Chemical identification (Part II., Section I. of Revised 
Reporting Form U). The IUR currently requires manufacturers (including 
importers) to report both the specific chemical substance name and the 
Chemical Abstracts Service (CAS) Registry Number of each reportable 
chemical substance manufactured (including imported) in amounts over 
10,000 lbs. per year. EPA is proposing to require that chemicals be 
identified only by EPA Accession Number, PMN case number or Inventory 
reporting form number when the CAS Registry Number is unknown to the 
submitter. Other previously used substitute identifying numbers (such 
as EPA-assigned numbers for Test Market Exemption applications) would 
not be allowed because they cannot be efficiently cross-referenced to 
CAS Registry Numbers.
    3. Confidentiality of production volume range. In addition to the 
requirement that specific production volume be reported, EPA is 
proposing to amend the IUR to allow submitters to claim a pre-
determined production volume range corresponding to the reported 
production volume number as CBI. This claim would be separate from a 
CBI claim for the specific production volume. Production volume range 
reporting is included in these amendments because EPA believes that the 
availability of range information is less likely to raise CBI concerns 
than the availability of specific production volume figures. 
Accordingly, EPA expects that the confidentiality claim rates will be 
roughly 50% lower for the reporting of volume ranges than for the 
reporting of specific volumes. EPA's expectation of reduced CBI claims 
for production volume ranges is based on the CBI claim statistics 
associated with the development of the original TSCA Inventory (See 
``Inventory Update Rule (IUR) Technical Support Document: Evaluation of 
Likelihood of Confidential Business Information Claims for Production 
Volume Information,'' available in the public record for this 
rulemaking and listed at Unit X.A.2.g. of this preamble) as well as 
comments received from industry (Ref. 21). If this expectation is 
correct, the public would have greater access to data on chemical 
production volumes, and the Agency would be better equipped to publicly 
release more data relevant to its risk screening decisions.
    EPA is proposing to use the following production volume ranges for 
future CBI determinations:
      At least 25,000 but less than 100,000 lbs.
      At least 100,000 but less than 1,000,000 lbs.
      At least 1,000,000 but less than 10,000,000 lbs.
      At least 10,000,000 but less than 50,000,000 lbs.
      At least 50,000,000 but less than 100,000,000 lbs.
      At least 100,000,000 but less than 500,000,000 lbs.
      At least 500,000,000 but less than 1,000,000,000 lbs.
      At least 1,000,000,000 lbs.
    These ranges were first used in the development of the original 
TSCA Inventory, except that the proposed ranges start at the proposed 
IUR reporting threshold of 25,000 lbs. rather than the existing 10,000 
lb. threshold.
    4. Number of potentially exposed workers (Part II., Section III. of 
Revised Reporting Form U). Workers involved in chemical manufacturing 
(including importing), processing and use are a subpopulation of 
concern to EPA, the Occupational Safety and Health Administration 
(OSHA) (Ref. 22), the National Institute of Occupational Safety and 
Health (NIOSH) (Ref. 23), and other organizations. Workers may often be 
exposed to chemical substances in higher doses and with greater 
frequency than the general population, and so are potentially at 
greater risk of adverse health effects. Accordingly, EPA and other 
organizations believe that it is important to be able to estimate the 
number of workers potentially exposed to specific chemical substances 
when developing priorities for testing, more detailed risk assessment, 
and risk management.
    EPA is proposing to use ranges for the reporting of certain 
quantitative estimates, including number of workers and number of 
processing sites (see Unit VII.A. of this preamble), instead of 
requiring the reporting of specific values. In general, EPA believes 
that reporting these estimates in ranges has two advantages over 
requiring the reporting of specific values:
    a. Range reporting would reduce the potential burden to submitters 
of developing a precise point estimate for the data element.
    b. Range reporting should reduce CBI claims because ranges tend to 
reveal less sensitive information than specific estimates while still 
conveying information useful to more effectively screen chemical risks.
Submitters would be permitted to claim the reported ranges as 
confidential if even revealing this general information would disclose 
CBI.
    EPA is proposing to require reporting of the range code that 
corresponds to the submitter's estimate of the total number of workers 
reasonably likely to be exposed to each reportable chemical substance 
at each reporting plant site. EPA is proposing to define ``reasonably

[[Page 46788]]

likely to be exposed'' as an exposure to a chemical substance which, 
under foreseeable conditions of manufacture (including import), 
processing, distribution in commerce, or use of the chemical substance, 
is more likely to occur than to not occur. Such exposures would 
normally include, but not be limited to, exposure during activities 
such as charging reactor vessels; drumming; bulk loading; cleaning 
equipment; maintenance operations; materials handling and transfers; 
and analytical operations. Covered exposures include exposures through 
any route of entry (inhalation, ingestion, skin contact or absorption, 
contact with personal protective equipment, etc.), but excludes 
accidental or theoretical exposures. The use of protective equipment or 
engineering controls to minimize worker exposures cannot be used by 
submitters as a rationale for lowering their estimates of the total 
number of exposed workers.
    EPA has considered using the OSHA hazard communication standard's 
(29 CFR 1910.1200) definition of exposed worker for amended IUR 
reporting. The Hazard Communication Standard defines ``employee'' as a 
worker who may be exposed to hazardous chemicals under normal operating 
conditions or in foreseeable emergencies. Workers such as office 
workers or bank tellers who encounter hazardous chemicals only in non-
routine, isolated instances are not covered. The Standard also defines 
``exposure'' or ``exposed'' as the subjection of an employee to a 
hazardous chemical in the course of employment through any route of 
entry (inhalation, ingestion, skin contact or absorption, etc.) and 
includes potential (e.g. accidental or possible) exposure. In EPA's 
view, this definition is overly broad for IUR purposes and for use in 
exposure assessments. The definition, for OSHA's purposes, was intended 
to be protective in order to ensure that all workers that could 
conceivably be exposed to a chemical substance would receive hazard 
communication. EPA solicits comment on the definition of ``reasonably 
likely to be exposed'' that the Agency has selected for this proposed 
rule.
    The proposed ranges for reporting the estimated number of 
potentially exposed workers are as follows:
     Less than 10.
      At least 10 but less than 25.
      At least 25 but less than 50.
      At least 50 but less than 100.
      At least 100 but less than 250.
      At least 250 but less than 500.
      At least 500 but less than 1,000.
      At least 1,000 but less than 10,000
      At least 10,000.
    5. Physical Form (Part II., Section III. of Revised Reporting Form 
U). EPA is proposing to require submitters to report the physical form 
of each reportable chemical substance as it leaves their sites. EPA 
believes that the physical form of a chemical is an important factor to 
consider when estimating magnitudes and concentrations of potential 
exposures. Two technical documents that support this proposed rule, 
entitled, ``Inventory Update Rule (IUR) Amendment Technical Support 
Document: Exposure-Related Data Useful for Chemical Risk Screening,'' 
and ``Preliminary Assessment Information Rule (PAIR) Database, 
Manufacturing Process Type/Release Analysis and Number of Workers/
Production Quantity Analysis,'' both available in the public record for 
this proposal (listed at Unit X.A.2.a. and Unit X.A.2.b. of this 
preamble), state that an EPA data analysis demonstrated that 
information regarding the physical form of chemical substances provides 
an indication of potential chemical exposures to the environment or to 
humans. EPA is proposing that submitters would select the category that 
best describes the physical form of the chemical as it leaves their 
site. In the event the submitter ships a chemical in more than one 
physical form, the submitter must report the code corresponding to the 
physical form of the majority of the chemical manufactured (including 
imported). The proposed categories for reporting the physical form are 
as follows:
      Dry powder.
      Pellets or large crystals.
      Water- or solvent-wet solid.
      Other solid.
      Gas or vapor.
      Liquid.
    The Agency recognizes that, for some chemical substances, the 
physical form of the substance at the time it leaves the submitter's 
site may not be the same physical form of the substance during 
processing and use; the Agency believes that such substances constitute 
a minority of all reportable chemical substances, and that it can, 
based on its knowledge of work practices in many industrial sectors, 
successfully identify many of the substances that undergo changes in 
physical form during processing and use. Therefore, to limit 
submitters' reporting burdens, EPA is proposing that physical form 
reporting be limited to the physical form of the substance at the time 
it leaves a submitter's site. Comments are invited on this proposed 
approach.
    6. Average and maximum concentration in commercial products (Part 
II., Section III. of Revised Reporting Form U). EPA is proposing to 
require submitters to report the average and maximum concentration, 
measured by weight, of the reportable chemical substance as it leaves 
their sites in a commercial product. EPA believes that concentration is 
an important factor to consider when estimating magnitudes of potential 
exposures. Information related to average concentration is valuable 
when estimating the potential for concerns due to chronic exposures, 
while information related to maximum concentration is useful when 
estimating the potential for concerns due to acute exposures. EPA 
frequently uses models to estimate potential human inhalation and 
dermal exposures (Ref. 24). In the absence of concentration data, EPA 
often assumes that human inhalation and dermal exposures are the result 
of exposures to undiluted chemicals. Chemical substance concentration 
data would allow EPA to generate less conservative exposure estimates 
for chemicals that are diluted prior to processing or use.
    Information about the average and maximum concentration of a 
chemical substance present at processing and use sites is used in 
chemical risk screening in EPA's New Chemicals Program. Estimates of 
maximum concentration assist EPA in establishing the maximum 
concentrations to which the environment and workers might be exposed by 
releases from industrial settings. For example, EPA has developed 
standard methods to estimate dermal exposures that workers may 
experience while performing common industrial operations such as 
sampling and loading chemicals into drums. If EPA is aware that a 
chemical substance is not processed or used at concentrations above a 
certain level, exposure estimates may be adjusted accordingly.
    The following is the list of proposed concentration codes for use 
in IUR reporting under the proposed rule:
      Less than 1% by weight.
      1 - 30% by weight.
      31 - 60% by weight.
      61 - 90% by weight.
      Greater than 90% by weight.
    The Agency is proposing that reporting on concentrations be limited 
to concentrations at the time the chemical substance leaves the 
submitter's site, for the reasons discussed in Unit V.E.6. of this 
preamble.

VII. Amendments Affecting Larger Volume Manufacturers (Including 
Larger Volume Importers)

    As discussed in Unit VI.B. of this preamble, EPA is proposing to 
replace

[[Page 46789]]

the current IUR reporting threshold of 10,000 lbs. per year with two 
new reporting thresholds of 25,000 lbs. per year and 300,000 lbs. per 
year. Every person manufacturing (including importing) a reportable 
substance at or above the 25,000 lbs. threshold would be required to 
report the information in Parts I., II., and IV. of Revised Reporting 
Form U. Persons who manufacture (including import) a reportable 
substance at or above the 300,000 lbs. threshold would be required to 
report the information in Part III. of Revised Reporting Form U in 
addition to the information in Parts I., II., and IV. Part III. relates 
to the processing and use of chemical substances.
    Process is defined in 40 CFR 710.2 as ``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.''
    Process for commercial purposes means ``to process (1) for 
distribution in commerce, including for test marketing purposes, or (2) 
for use as an intermediate.''
    Based on these definitions, processing includes incorporating a 
reportable chemical substance into a formulation, an article, or a 
product. EPA is proposing to define ``use'' as ``any utilization of a 
chemical substance or mixture that is not otherwise covered by the 
terms manufacture or process. Relabeling or redistributing a container 
holding a chemical substance or mixture where no repackaging of the 
chemical substance or mixture occurs does not constitute use or 
processing of the chemical substance or mixture.''
    TSCA section 8(a) authorizes EPA to require persons to report 
information that is ``known to or reasonably ascertainable by'' them 
(see proposed regulatory text Sec. 710.2). Under the proposed 
amendment, the submitter would be required to report processing and use 
information only to the extent that such information is ``readily 
obtainable'' by the submitter's management and supervisory employees 
responsible for manufacturing, processing, distributing, technical 
services, and marketing (see proposed regulatory text Sec. 710.2). 
Extensive file searches would not be required. The ``readily 
obtainable'' standard proposed for processing and use information 
requires less effort on the part of the submitter than the ``known to 
or reasonably ascertainable by'' standard that applies to all other IUR 
reporting. The Agency believes that the ``readily obtainable'' 
reporting standard would provide processing and use information of a 
sufficient precision for use in screening level reviews. Reducing the 
precision to ``readily obtainable'' from ``known to or reasonably 
ascertainable by'' for processing and use information also lowers the 
reporting burdens for many submitters. Moreover, the proposed reporting 
standard for processing and use information under these IUR amendments 
is the same standard currently in effect under PAIR (See 40 CFR 712.7).
    Much of the additional information required under Part III. of 
Revised Reporting Form U would be provided in ranges, rather than 
discrete values, as described in more detail in this unit. EPA 
preliminarily determined that the planned use of information such as 
percent production volume, number of sites, number of potentially 
exposed workers, average concentration, and maximum concentration does 
not warrant the reporting of discrete values. In addition, the use of 
ranges for certain data elements would reduce reporting burdens, yet 
provide sufficient information for screening level analyses. EPA also 
believes that the use of ranges would greatly diminish CBI claims for 
information reported.
    EPA considered the option of requiring processing and use reporting 
by larger volume manufacturers (i.e., those manufacturers that reach 
the 300,000 lbs. threshold) based upon submitter owned or controlled 
sites alone versus customer owned or controlled sites in addition to 
submitter owned or controlled sites. EPA preliminarily determined that 
manufacture, processing, and end use of the chemical substance were 
important to examining the potential exposure scenarios for a chemical 
substance, but that it did not matter if the processing or use site was 
submitter controlled or not. In addition, restricting the reporting of 
this information to submitter owned or controlled sites alone would not 
capture much of the information needed regarding the processing and use 
of reportable chemicals. Therefore, EPA decided to require the 
reporting of processing and use information readily obtainable by the 
submitter, including information based upon submitters' sites as well 
as their customers' sites.
    The two general types of information that would be reported under 
Part III. of Revised Reporting Form U are industrial processing and use 
information and commercial and consumer use information.

A. Processing and Use Information (Part III. of Revised Reporting Form 
U)

    EPA is proposing to require submitters to report the information 
described in Unit VII.A.1-5. of this preamble concerning the processing 
and use of each reportable chemical substance that are conducted both 
at sites the submitter controls and at sites that receive a reportable 
chemical substance from the submitter either directly or indirectly 
(including through a broker/distributor, from a customer of the 
submitter, etc.).
    1. Industrial process or use code (Part III., Section I.a. of 
Revised Reporting Form U). The first item of reportable information 
under this proposed section is the industrial process or use code. The 
proposed categories for reporting the industrial processing and use 
are:
      Processing - as a reactant.
      Processing - incorporation into a formulation or mixture.
      Processing - incorporation into an article.
      Processing - repackaging.
      Use - non-incorporative activities.
    Repackaging would be defined for purposes of IUR reporting under 
the proposed rule as the physical transfer of a chemical substance or 
mixture, as is, from one container to another container or containers 
in preparation for distribution of the chemical substance or mixture in 
commerce. This definition, therefore, would not include sites which 
only relabel or redistribute the reportable chemical substance without 
removing the chemical substance from the container in which it is 
received or purchased.
    2. The North American Industrial Classification System (NAICS) Code 
and Industrial Function Category (Part III., Section I.b. and c. of 
Revised Reporting Form U). EPA is proposing to require submitters to 
report the five-digit NAICS code(s) that best describe(s) the 
industrial activities at the sites under the control of the submitter, 
as well as at the sites that receive a reportable chemical substance 
from the submitter either directly or indirectly (including through a 
broker/distributor, from a customer of the submitter, etc.), and that 
process and use the reportable chemical substance (Ref. 25). The NAICS 
codes, published by the Office of Management and Budget (OMB), have 
superseded OMB's prior system of Standard Industrial Classification 
(SIC) Codes. EPA is proposing that, to the extent the information is 
readily obtainable, submitters will report on industrial processing and 
use of chemical substances they manufacture after the chemical 
substances have passed

[[Page 46790]]

through distributors or other distribution or shipping systems. EPA 
does not intend for manufacturers (including importers) to survey their 
customers or distributors to precisely identify the appropriate NAICS 
codes at their ``downstream'' sites.
    The NAICS code classification system is being used in this 
application solely to describe the industrial setting in which there 
may be chemical exposures associated with the industrial processing or 
use of a chemical substance. The submitter would be required to report 
all known and readily obtainable NAICS codes for the reportable 
chemical substances it manufactures (including imports). If the 
submitter is aware of more than 10 NAICS codes that describe the 
industrial activities at sites that process and use the reportable 
chemical substance, the submitter would be required under this proposed 
rule to report only the 10 NAICS codes that cumulatively represent the 
largest percentage of production volume, measured by weight. This 
limitation on reporting is intended to minimize submitters' reporting 
burdens.
    EPA is also proposing to require submitters to report the 
industrial function categories associated with each NAICS code for each 
reportable chemical substance that is processed or used for industrial 
purposes. EPA believes that a NAICS code and industrial function 
category combination sufficiently define a potential exposure scenario 
for risk screening and priority-setting purposes. Two technical 
documents that support this proposed rule, entitled ``Inventory Update 
Rule (IUR) Amendment Technical Support Document: Exposure-Related Data 
Useful for Chemical Risk Screening,'' and ``Preliminary Assessment 
Information Rule (PAIR) Database, Manufacturing Process Type/Release 
Analysis and Number of Workers/Production Quantity Analysis,'' both 
found in the public record for this rulemaking (listed at Unit X.A.2.a 
and X.A.2.b. of this preamble), describe studies that demonstrate that 
information regarding the industrial sectors where a chemical substance 
is produced and used and information regarding the function that a 
chemical substance performs within industrial processes provide 
indications of the route, magnitude, and concentration of potential 
chemical exposures to the environment and to humans.
    Industrial function categories are helpful in estimating the 
frequency and duration of chemical substance exposures. For example, 
EPA has found that the relationship between industrial function 
categories and the frequency and duration of exposure to chemical 
substances is particularly useful in developing exposure assessments 
for the New Chemicals Program. Similarly, data elements such as the 
number of sites and the number of workers enable the Agency to better 
estimate the scope of potential exposure. These data elements are 
important pieces in developing the most accurate exposure scenarios 
possible. In the absence of this data, EPA often assumes, for chemical 
risk screening purposes, that workers are exposed to chemical 
substances for full 8-hour work days for the duration of their careers. 
The data that would be obtained under these proposed amendments to IUR 
would enable EPA to make more realistic characterizations of exposure, 
instead of ``worst case'' assumptions.
    Industrial function categories would be reported by selecting from 
the following list of proposed industrial function category codes for 
chemical processing and use:
      Adhesives and binding agents.
      Adsorbents and absorbents.
      Aerosol propellants.
      Agricultural chemicals (non-pesticidal).
      Anti-adhesive agents.
      Bleaching agents.
      Coloring agents, dyes.
      Coloring agents, pigments.
      Corrosion inhibitors and anti-scaling agents.
      Fillers.
      Fixing agents.
      Flame retardants.
      Flotation agents.
      Fuels.
      Functional fluids.
      Intermediates.
      Lubricants.
      Odor agents.
      Oxidizing agents.
      pH-regulating agents.
      Photosensitive chemicals.
      Plating agents and metal surface treating agents.
      Process regulators, used in vulcanization or 
polymerization processes.
      Process regulators, other than polymerization or 
vulcanization processes.
      Processing aid, not otherwise listed.
      Reducing agents.
      Solvents (for chemical manufacture and processing and are 
not part of the end product at greater than one percent by weight).
      Solvents (for cleaning or degreasing).
      Solvents (that become part of product formulation or 
mixture).
      Stabilizers.
      Surface active agents.
      Viscosity adjustors.
      Other.
    As described in the document entitled, ``Inventory Update Rule 
(IUR) Amendment Technical Support Document: Exposure-Related Data 
Useful for Chemical Risk Screening'' (listed at Unit X.A.2.a. of this 
preamble), these industrial function categories have been developed and 
defined based on a review of different chemical function classification 
systems (including the systems used in the Premanufacture Notification, 
UCSS, UEIP, and EU programs), as well as development of data pertinent 
to the potential media of releases, potential quantities released, 
potential worker exposures, and potential incorporation into commercial 
and consumer products for each industrial function category. This list 
of specific categories is not meant to be exhaustive, therefore, an 
``other'' category is provided for miscellaneous uses not captured in 
the listed categories. These categories address a wide range of 
industrial chemical processing and use functions, and are likely to be 
revised as analysis of reported IUR data is further refined over time.
    3. Percentage of production volume attributable to each combination 
of NAICS code and industrial function category (Part III., Section I.d. 
of Revised Reporting Form U). EPA is proposing to require submitters to 
estimate the percentage of production volume that is attributable to 
each reported combination of NAICS code estimate and industrial 
function category, to the extent that such information is readily 
obtainable. Estimates must be rounded off to the nearest 10% of 
production volume. However, under the proposed rule, a particular NAICS 
code/industrial function category (NAICS/IFC) combination which 
accounts for 5% or less of the total production volume of a reportable 
chemical substance would not be permitted to be rounded off to zero if 
the production volume attributable to that NAICS/IFC combination is 
greater than or equal to 300,000 lbs. In such cases, submitters must 
report the percentage of production volume attributable to that NAICS/
IFC combination to the nearest 1% of production volume. This exception 
to the general rounding off rule is being proposed to ensure that 
adequate use information is reported for the very large production 
volume chemical substances. The 300,000 lbs. level was selected for 
consistency with the proposed threshold for reporting exposure and use 
data.

[[Page 46791]]

    4. Number of sites (Part III., Section I.e. of Revised Reporting 
Form U). For risk screening purposes, the number of sites at which 
chemical substances are manufactured (including imported), processed 
and used is a useful indicator of the number of ecosystems and the size 
of the general population potentially exposed to the chemical 
substances. EPA is proposing to require submitters to report an 
estimate of the total number of industrial sites, including those 
beyond the submitter's control, that process or use each reported 
chemical substance manufactured (including imported) by the submitter, 
as described by each combination of NAICS code estimate and industrial 
function category.
    The ranges that would be used for reporting the number of sites are 
as follows:
      Less than 10.
      At least 10 but less than 25.
      At least 25 but less than 100.
      At least 100 but less than 250.
      At least 250 but less than 1,000.
      At least 1,000 but less than 10,000.
      At least 10,000.
    EPA recognizes that there is a possibility of double-counting 
sites, for example, where two or more submitters manufacture (including 
import) the same reportable chemical substance and each sends the 
chemical substance to the same industrial processing or use site. 
However, because the Agency is proposing that the number of sites be 
reported in the specified ranges, it believes the impact of double-
counting sites will not significantly affect the use of these estimates 
for screening purposes. In the event a submitter both manufactures 
(including imports) and processes or uses the same reportable chemical 
substance at the reporting plant site, the site should be counted as 
both a manufacturing site in Part II. of Revised Reporting Form U, and 
as a processing or use site reported in Part III. of Revised Reporting 
Form U.
    5. Number of workers (Part III., Section I.f. of Revised Reporting 
Form U). As discussed in Unit V.A. of this preamble, information 
related to the exposure of workers to chemical substances is of 
particular interest to EPA and other organizations. EPA is proposing to 
require submitters to report an estimate of the total number of workers 
reasonably likely to be exposed while processing or using the 
reportable chemical substance as described by each combination of NAICS 
code estimate and industrial function category. These combinations 
relate to sites under the control of the submitter as well as sites 
that receive a reportable chemical substance from the submitter either 
directly or indirectly (see Unit VII.A.2. of this preamble). The 
approximate number of workers reasonably likely to be exposed during 
processing and use would be reported using the same definitions and 
codes described under Unit VI.E.4. of this preamble. The only 
difference in reporting worker exposure information under this section 
is that such information need be reported only to the extent that it is 
readily obtainable.
    EPA recognizes that there is also a possibility of double-counting 
workers at industrial processing and use sites, for example, when two 
or more submitters manufacture the same reportable chemical substance 
and each ships the chemical substance to the same processing or use 
site. Because EPA is proposing that the number of workers be reported 
through the use of broad ranges, EPA believes the impact of double-
counting workers will not significantly affect the use of the estimates 
for risk screening purposes. In addition, it will be possible to 
estimate the maximum potential magnitude of double counted workers at 
processing and use sites because the total number of manufacturers 
(including importers) will be known to EPA.

B. Commercial and Consumer Use Information (Part III., Section II. of 
Revised Reporting Form U)

    EPA is proposing to require submitters to report the information 
described in Unit VII.B.1-3. of this preamble concerning the commercial 
and consumer uses of each reportable chemical substance that is 
manufactured (including imported) at sites the submitter controls and 
at sites controlled by persons to whom the submitter has either 
directly or indirectly (including through a broker/distributor or from 
a customer of the submitter, etc.) distributed the reportable chemical 
substance. As with the industrial processing and use information 
described in Unit VII.A. of this preamble, this requirement would apply 
only to each chemical substance manufactured (including imported) in 
annual quantities of 300,000 lbs. or more and submitters would only be 
required to report information to the extent that it is readily 
obtainable.
    For purposes of IUR reporting, a commercial use means the use of a 
chemical substance or mixture in a commercial enterprise providing 
saleable goods or a service, such as painting contractors using paint 
products. A consumer use, on the other hand, means the use of a 
chemical substance that is directly, or as part of a mixture, sold to 
or made available to consumers for their use in or around a permanent 
or temporary household or residence, in or around a school, or in or 
around recreational areas. Exposures to commercial and consumer 
products are similar for risk screening purposes because existing 
assessment methods are not sophisticated enough to distinguish between 
these exposures.
    Consumers comprise a subpopulation of particular concern to EPA, 
the Consumer Products Safety Commission (CPSC), and other 
organizations. Information from submitters on whether the chemical 
substances they manufacture (including import) are used in consumer 
products is useful in estimating the potential risks to consumers that 
result from chemical exposures. EPA often assumes, for risk screening 
purposes, that large, unprotected populations may potentially be 
exposed to the chemical substances in consumer products. EPA plans to 
propose a test rule to develop hazard data regarding chemicals in 
consumer products to which children are exposed. The consumer product 
information that would be reported under these IUR amendments would be 
used by EPA in the identification of chemicals that might be included 
in the test rule.
    1. Commercial and consumer product categories (Part III., Section 
II.a. of Revised Reporting Form U). Commercial and consumer product 
categories are helpful in estimating the frequency and duration of 
chemical substance exposures. In the absence of other information, 
consumers are often assumed to experience less controlled, but less 
frequent exposures than workers. The data that would be obtained under 
these proposed amendments to IUR would enable EPA to make more 
realistic characterizations of exposure, instead of ``worst case,'' 
overly conservative assumptions.
    The proposed commercial and consumer product categories were 
developed based on a review of various data sources including national 
usage surveys of consumer products, product emissions testing, and 
exposure monitoring data (See ``Technical Support Document: Technical 
Approach for the Selection of Consumer End-Use Categories for the 
Inventory Update Rule,'' available in the public record for this 
proposal and listed at Unit X.A.2.h. of this preamble). This review 
identified an extensive list of consumer products and provided 
subsequent categorization of these products by common characteristics, 
such as use scenarios, into major groupings of commercial and consumer 
products. The list is not meant to be comprehensive, therefore, an 
``other'' category is provided for

[[Page 46792]]

miscellaneous commercial and consumer products not captured in the 
categorization system. Further details about the categories, including 
their development and definitions, are provided in the technical 
support document described in this paragraph.
    The proposed categories for reporting commercial and consumer 
products are:
      Adhesives and sealants.
      Artists' supplies.
      Automotive care products.
      Electrical and electronic products.
      Fabrics, textiles and apparel.
      Glass and ceramic products.
      Lawn and garden products (non-pesticidal).
      Leather products.
      Lubricants, greases and fuel additives.
      Metal products.
      Paints and coatings.
      Paper products.
      Photographic chemicals.
      Polishes and sanitation goods.
      Rubber and plastic products.
      Soaps and detergents.
      Transportation products.
      Wood and wood furniture.
      Other.
    2. Percentage of production volume attributable to each commercial 
and consumer product category (Part III., Section II.b. of Revised 
Reporting Form U). EPA is proposing to require submitters to estimate 
the percentage of their production volume for each reportable chemical 
substance that is attributable to each specific commercial and consumer 
end-use carried out at sites under the control of the submitter, as 
well as at sites that receive a reportable chemical substance from the 
submitter either directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.), to the extent 
that such information is readily obtainable. Estimates must be rounded 
off to the nearest 10% of production volume. However, under the 
proposed rule, a commercial and consumer product (CCP) category which 
accounts for 5% or less of the total production volume of a reportable 
chemical substance would not be permitted to be rounded off to zero if 
the production volume attributable to that CCP category is greater than 
or equal to 300,000 lbs. In such cases, submitters must report the 
percentage of production volume attributable to that CCP category to 
the nearest 1% of production volume. This exception to the general 
rounding off rule is being proposed to ensure that adequate use 
information is reported for the very large production volume chemical 
substances. The 300,000 lbs. level was selected for consistency with 
the proposed threshold for reporting processing and use data (see Unit 
VI.B. of this preamble).
    3. Maximum concentration, measured by weight in commercial and 
consumer products (Part III., Section II.c. of Revised Reporting Form 
U). EPA is proposing to require each submitter to report estimates, in 
ranges, of the maximum concentration (measured by weight) of each 
reportable chemical substance likely to be present in commercial and 
consumer products manufactured (including imported) at sites under the 
submitter's control and at sites where the submitter's commercial and 
consumer products are distributed directly or indirectly (including 
through a broker/distributor, from a customer of the submitter, etc.). 
As with the other information in this section, such information would 
be required only to the extent that it is readily obtainable by the 
submitter. The proposed reporting range codes are the same as those 
listed in Unit VI.E.6. of this preamble.

VIII. Confidentiality

A. Asserting Claims

    Submitters are able to claim certain information submitted to EPA 
under this proposed rule as confidential if they have reason to believe 
that release of the information would reveal trade secrets or 
confidential commercial or financial information, as provided by 
section 14 of TSCA and 40 CFR part 2. Claims of confidentiality must be 
asserted at the time information is submitted to EPA. EPA's procedures 
for processing and reviewing confidentiality claims are set forth at 40 
CFR part 2, subpart B. EPA strongly encourages submitters to review 
confidentiality claims carefully to ensure that the information in 
question falls within the protection of TSCA section 14 and to limit 
confidentiality claims as much as possible.
    To claim information as confidential, a submitter must check the 
appropriate box and sign the certification statement on the reporting 
form. If a submitter failed to do so, EPA could release the information 
to the public without further notice to the submitter. As in the last 
three TSCA Inventory Update collections and the initial TSCA Inventory 
collection and as reflected in the regulations, by signing the 
certification statement the submitter certifies that its claims of 
confidentiality are made in good faith. Procedures for claiming 
information submitted electronically (such as a submission on diskette) 
as confidential will be specified in the reporting rule instruction 
manual. CBI should not be submitted by e-mail. A discussion on proposed 
procedures and policies for making CBI claims in the context of this 
proposed rule is provided in this unit.

B. Chemical Identity

    Under the existing IUR, confidentiality claims for chemical 
identity can only be made for those chemicals listed on the 
confidential portion of the Inventory. A submitter must currently 
assert a separate claim of confidentiality for specific chemical 
identity when submitting an IUR report. To assert a claim of 
confidentiality for the identity of a chemical substance which is 
confidential on the TSCA Inventory, submitters are currently, and would 
continue to be, required to indicate the claim on the IUR reporting 
form and provide a detailed substantiation of the claim as specified in 
40 CFR 710.38. If a submitter fails to substantiate the chemical 
identity CBI claims in accordance with the applicable regulations, EPA 
may make the information available to the public without further notice 
to the submitter. EPA is not proposing to change these requirements.

C. Manufacturing Plant and Plant Site Information

    Under IUR, a submitter may assert a claim of confidentiality for 
the specific manufacturing plant and plant site information if it is 
believed that release of that identity would reveal trade secrets or 
confidential commercial or financial information as provided by TSCA 
section 14. In past IUR information collections, in excess of 15% of 
IUR information submitters have claimed plant site name as CBI. While 
the Agency does not question the occasional need for this claim, it 
believes that these claims should be limited to only those 
circumstances in which it is absolutely necessary. The Agency has 
identified instances in which submitters have claimed plant site name 
as confidential yet this same information was found in such public 
filings as material safety data sheets and State and Federal permits. 
Overall, approximately 20% of the 1994 IUR reports contained CBI claims 
for plant site information. The IUR does not currently require upfront 
substantiation of CBI claims for plant site information. In these 
amendments to IUR, EPA is proposing a new upfront substantiation 
requirement for CBI claims for plant site information.
    EPA has observed that, on occasion, plant site information has been 
claimed as confidential even though it was revealed in filings required 
under

[[Page 46793]]

sections 311, 312 and 313 of EPCRA. EPA believes that many of these CBI 
claims are inappropriate and that the new substantiation requirement 
would reduce the occurrence of inappropriate claims. A decrease in the 
number of CBI claims under the new substantiation requirement would 
facilitate EPA's ability to make current plant site information 
available to other Federal agencies and the public because more 
information submitted under IUR could be released publicly.
    Under this proposed rule, in order to assert a claim of 
confidentiality for plant site information, the submitter would be 
required to both check the appropriate box on the reporting form 
indicating a confidentiality claim for plant site information, and to 
substantiate the claim in writing by answering certain questions 
provided in Sec. 710.38(d)(1) of the proposed rule. If a submitter 
fails to substantiate the plant site CBI claim in accordance with the 
applicable regulations, EPA may make the information available to the 
public without further notice to the submitter.

D. Chemical Production Volume Information

    Under IUR, a submitter may assert a claim of confidentiality for 
production volume information if the release of that information would 
reveal trade secrets or confidential commercial or financial 
information as provided by section 14 of TSCA. EPA is not proposing to 
change this.
    EPA observed that, in the last three IUR reporting periods when EPA 
sought actual production volume information, over 65% of the 
information was claimed as confidential. In contrast, overall CBI 
claims for production volume information in the original TSCA Inventory 
collection were 35%; this information, however, was collected in 
ranges. This high proportion of CBI claims in IUR reports has limited 
EPA's ability to convey to the public plant site production volume 
information. Because over 95% of the chemicals reported under IUR are 
manufactured at three plant sites or less, these CBI claims also 
greatly hinder EPA's ability to create national aggregate statistics on 
overall chemical production for specific chemical substances. For 
example, if EPA publishes a national aggregate production volume for a 
chemical substance that is manufactured at three plant sites and one 
site claims its production volume CBI and the other two do not, it 
might be possible to calculate the CBI production volume by difference. 
In such a case, EPA would not release aggregate data because of its 
responsibility to protect the CBI claim of the one submitter. However, 
EPA needs to be able to convey chemical substance production volume 
information to the public to explain its chemical risk assessment and 
risk management decisions. Effective communication of this information 
is vital to EPA's overall mission. To address this problem and yet 
acknowledge industry's legitimate concerns about this data element, EPA 
is proposing to require submitters to report both actual plant site 
chemical production volume information and a corresponding production 
volume range. Separate CBI claims could be made for each.
    EPA is proposing to use the production volume ranges that are 
similar to those that were successfully used in the implementation of 
the original TSCA Inventory collection. Proposed production volume 
ranges for use in this action are listed in Unit VI.E.3. of this 
preamble. EPA anticipates that the CBI claim rates will be around 50% 
lower for the reporting of volume ranges than for the reporting of 
specific claims (See ``Inventory Update Rule (IUR) Technical Support 
Document: Evaluation of Likelihood of Confidential Business Information 
Claims for Production Volume Information,'' available in the public 
record for this proposal and listed at Unit X.A.2.g. of this preamble).
    EPA is seeking to develop and use ranged chemical production volume 
information at the suggestion of industry representatives following a 
dialogue with the public about TSCA CBI claims. In correspondence, an 
industry representative noted that manufacturers were less sensitive 
about ranged production volume information than specific numbers (Ref. 
21). The representative suggested that collecting information on ranges 
similar to those used under the original TSCA Inventory might reduce 
the incidence of CBI claims for production volume information and 
facilitate EPA information dissemination goals. In this proposed rule, 
EPA would seek chemical production volume information and would use 
that information to make a production volume range assignment. EPA 
intends to use the production volume information in the creation of 
national statistics, whereas the ranged production volume data may be 
most useful in the creation of information products conveying site-
specific chemical information.

E. Reasserting Claims

    Submitters would use Part IV. of Revised Reporting Form U to 
reassert CBI claims made in their previous IUR reporting. CBI claims 
made in IUR submissions prior to 2002 (the first IUR reporting year 
under these amendments) would be not be subject to this reassertion 
requirement.
    Since 1990, EPA has been engaged in a dialogue with the public on 
issues associated with TSCA CBI. During this dialogue, industry has 
confirmed EPA understanding that the need for certain confidentiality 
claims is reduced or eliminated over time. What was considered CBI to a 
submitter during one reporting cycle may not be considered CBI in 
subsequent years. Some information submitted to EPA with CBI claims is 
subsequently released by the submitter to the public because the 
submitter no longer believes that the claims are necessary. The result 
is that some information submitted to EPA is withheld by EPA from the 
public for long periods, at additional cost to the Agency and with no 
appreciable advantage to the submitter. This situation complicates 
EPA's efforts to make information available to potential users, 
including other Federal agencies, State and local chemical management 
authorities and local communities, secure the participation of the 
public in EPA's chemical management efforts, and in other ways allow 
for the effective EPA implementation of TSCA.
    EPA is proposing new procedures to ensure that there is an ongoing 
need by the submitter for continued CBI protection. Under the proposed 
procedures, manufacturers (including importers) would be required, in 
subsequent reporting periods, to affirmatively represent the need for 
the continued CBI protection of the claims made in previous IUR 
reporting periods. To illustrate, for data submitted to EPA in the year 
2010, a manufacturer (including importer) would be required to 
affirmatively represent on the reporting form that: (1) The specific 
CBI claims made for the first time in reporting year 2006 and (2) the 
specific CBI claims reasserted in reporting year 2006 continue to be 
necessary in order to protect trade secrets or confidential commercial 
or financial information as provided by TSCA section 14. The CBI 
certification statements would be contained in Part IV. of Revised 
Reporting Form U for the convenience of the submitter. If either 
certification is not provided by the submitter, EPA would assume that 
the submitter is waiving those claims of confidentiality to the 
underlying information contained in the earlier filings and the 
information would be subject to public disclosure without further 
notice.

[[Page 46794]]

    This policy would be applied even if the submitter is not required 
to report in the present reporting period due to low production volume 
or other applicable exclusions. In other words, if a submitter who 
asserts a CBI claim in a prior reporting period is not required to 
report under the current IUR reporting period, that submitter must file 
a certification regarding its prior CBI claim during the current 
reporting period if it wishes to retain the claim. Again, CBI claims 
made in IUR submissions prior to 2002 (the first IUR reporting year 
under these amendments) would not be subject to this reassertion 
requirement.
    EPA will undertake certain precautions in order to ensure that 
persons that make CBI claims in IUR submissions in the 2002 reporting 
period and subsequent reporting periods are aware of the requirement 
that these claims be reasserted, as appropriate, in subsequent 
reporting periods in order to retain CBI protections. Prior to each IUR 
reporting period, EPA will send an IUR reporting package to each person 
who submitted an IUR report or CBI reassertion in the previous 
reporting period. This package will contain a cover letter which will: 
(1) Remind the submitters of the reassertion requirements and (2) 
advise that failure to affirmatively reassert prior CBI claims will 
result in the removal of CBI protections for this information. The 
package will also contain a reporting form and reporting instructions 
which will reiterate these reminders. In addition, EPA will publish a 
Federal Register notice at least 2 weeks before the end of each 
reporting period which will remind members of the public who have not 
reasserted their prior CBI claims of the pending declassification of 
these claims if they do not reassert by the end of the reporting 
period.
    In addition to the reminders related to CBI reassertion that are 
specifically proposed in this document, EPA also intends to publicize 
the need to reexamine and reassert past CBI claims via the EPA/OPPT 
Homepage on the Internet, and in communications with trade association 
publications.
    It has been suggested that EPA additionally send a followup 
certified letter to persons who were sent IUR reporting packages, but 
who fail to indicate their intention to reassert/not reassert previous 
CBI claims by the end of the reporting period. The intent of the letter 
would be to further notify submitters that they need to reevaluate 
their past CBI claims and reassert them, as appropriate. EPA believes 
that this additional step would be costly and would result in an 
inefficient use of Agency resources. For example, if a submitter does 
not receive the reporting package mailed by EPA because the submitter's 
address was changed between the last IUR reporting period and the 
current reporting period (EPA sends packages to the addresses submitted 
during the previous reporting period), the submitter likewise would not 
receive a followup letter from EPA sent to the same incorrect address. 
As discussed above, before each reporting period ends, EPA is proposing 
to publish a Federal Register notice which EPA believes would reach a 
far broader audience than individual letters would. EPA seeks comment 
on the issue of whether means beyond those proposed in this action are 
needed to better inform submitters of the requirement that they 
reexamine their past CBI claims and reassert them, as appropriate, in 
order to retain CBI protections.

IX. Request for Comment and Notice of Public Meeting

    The comment period for this proposed rule will extend until October 
25, 1999. EPA will hold a public meeting on Monday, October 4, 1999, 
from 9 a.m. to noon at the EPA Auditorium, 401 M St., SW., Washington, 
DC 20460 to provide an opportunity for the public to present oral 
comments.
    The following is a list of issues on which the Agency is 
specifically requesting public comment. EPA encourages all interested 
persons to submit comments on these issues, and to identify any other 
relevant issues as well. This input will assist the Agency in 
developing a rule that successfully addresses information needs while 
minimizing potential reporting burdens associated with the rule. EPA 
requests that commenters making specific recommendations include 
supporting documentation where appropriate.
    1. What (if any) specific mechanisms or sources of data could EPA 
use to acquire the exposure-related information sought in this proposed 
rule with greater ease and less burden to industry?
    2. EPA initially considered proposing a larger-volume threshold for 
the reporting of processing and use information of 100,000 lbs. per 
year per site, rather than the 300,000 lbs. per year per site threshold 
proposed in this document. EPA analyzed a number of alternative 
thresholds in the Economic Analysis (listed in Unit X.A.2.f. of this 
preamble). EPA is specifically seeking comment on the question of 
whether this threshold should be modified.
    3. During the interagency review process, it was suggested that EPA 
consider proposing a partial reporting exemption for ``low priority'' 
chemicals. Manufacturers of these chemicals could be exempt from 
reporting the exposure-related data contained in Part III. of the 
reporting form. At one point during the development of this proposal, 
EPA considered developing such an exemption, but was unable to develop 
a satisfactory rationale for the exemption. Therefore, EPA seeks 
comment on the criteria the Agency might use to establish such an 
exemption. EPA also solicits comment on the specific chemicals that 
would qualify for such an exemption.
    During the interagency review process, various lists of chemicals 
were suggested as candidates for such a ``low priority'' partial 
exemption. EPA would be interested in comments on the alternative lists 
described below, as well as any other suggested set of chemicals.
    One set consists of those chemical substances that: (1) EPA has 
previously determined to be of low concern under the Existing Chemicals 
Program and (2) for which EPA has a minimum set of hazard and exposure 
data. This could include chemicals for which the following exist: (1) A 
complete set of basic test data as specified in the OECD's Screening 
Information Data Set (SIDS) Manual; (2) the UEIP data set (submitted by 
at least two-thirds of the manufacturers of the subject chemical 
substance based on the most recent IUR report); and (3) a determination 
by EPA's Existing Chemicals Program that the chemical substance is a 
``low priority.''
    An alternative set is the list of chemical substances that the 
European Union exempted from its reporting requirements for existing 
substances (Ref. 8, Annex II).
    A third option for a ``low priority substances'' partial exemption 
is the list of high production volume chemical substances that are not 
considered candidates for testing under the HPV Challenge Program (Ref. 
26). This list currently consists of the following 41 chemicals:

[[Page 46795]]



 
------------------------------------------------------------------------
                CAS Number                         Chemical Name
------------------------------------------------------------------------
50-70-4                                    Glucitol, D-
50-99-7                                    D-Glucose
56-81-5                                    Glycerol
57-50-1                                    Sucrose
69-65-8                                    Mannitol, D-
124-38-9                                   Carbon dioxide
1592-23-0                                  Stearic acid, calcium salt
7440-44-0                                  Carbon
8001-21-6                                   Sunflower oil
8001-22-7                                  Soybean oil
8001-26-1                                  Linseed oil
8001-29-4                                  Cottonseed oil
8001-30-7                                  Corn oil
8001-31-8                                  Coconut oil
8001-78-3                                  Castor oil, hydrogenated
8001-79-4                                  Castor oil
8002-03-7                                  Peanut oil
8002-75-3                                  Palm oil
8006-54-0                                  Lanolin
8016-28-2                                  Lard oil
8016-70-4                                  Soybean oil, hydrogenated
8021-99-6                                  Charcoal, bone
8029-43-4                                  Syrups, hydrolyzed starch
9050-36-6                                  Maltodextrin
16291-96-6                                 Charcoal
61788-61-2                                 Fatty acids, tallow, Me
                                            esters
61789-97-7                                 Tallow
61789-99-9                                 Lard
64147-40-6                                 Castor oil, dehydrated
64755-01-7                                 Fatty acids, tallow, calcium
                                            salts
68188-81-8                                 Grease, poultry
68334-00-9                                 Cottonseed oil, hydrogenated
68409-76-7                                 Bone meal, steamed
68425-17-2                                 Syrups, hydrolyzed starch,
                                            hydrogenated
68439-86-1                                 Bone, ash
68476-78-8                                 Molasses
68514-27-2                                 Grease, catch basin
68514-74-9                                 Palm oil, hydrogenated
68525-87-1                                 Corn oil, hydrogenated
68952-94-3                                 Soaps, stocks, vegetable-oil
73138-67-7                                 Lard, hydrogenated
------------------------------------------------------------------------

    Alternatively, it was suggested that EPA create a ``low priority 
chemicals'' list by identifying chemicals that are present on both the 
European Union list and the HPV Challenge Program list. Currently, the 
following chemicals are included on both of these lists:

 
------------------------------------------------------------------------
                CAS Number                         Chemical Name
------------------------------------------------------------------------
50-70-4                                    Glucitol, D-
50-99-7                                    D-Glucose
57-50-1                                    Sucrose
69-65-8                                    Mannitol, D-
124-38-9                                   Carbon dioxide
1592-23-0                                  Stearic acid, calcium salt
7440-44-0                                  Carbon
8001-21-6                                  Sunflower oil
8001-22-7                                  Soybean oil
8001-26-1                                  Linseed oil
8001-30-7                                  Corn oil
8001-79-4                                  Castor oil

[[Page 46796]]

 
9050-36-6                                  Maltodextrin
61788-61-2                                 Fatty acids, tallow, Me
                                            esters
------------------------------------------------------------------------

    4. During the interagency review process, it was suggested that the 
information the Agency would collect under the IUR amendments might be 
duplicative of existing reporting for manufacturers and importers of 
petroleum chemicals, who may also be required to report to the 
Department of Energy's (DOE) Energy Information Administration. Under 
the existing IUR 4 year reporting cycle, if a manufacturer or importer 
of a petroleum chemical meets the 10,000 lbs. reporting threshold, they 
must complete EPA Form U to report to EPA. Under the proposed IUR 
amendments, if a manufacturer or importer of a petroleum chemical meets 
the proposed 25,000 lbs. reporting threshold, they must complete Parts 
I., II., and IV. of Revised Reporting Form U. The proposed IUR 
amendments exempt these entities from reporting the proposed processing 
and use information in Part III. of revised reporting Form U (see Unit 
VI.A.2. of this preamble). In addition, EPA is proposing to fully 
exempt certain forms of natural gas from IUR reporting (see Unit 
VI.A.3. of this preamble).
    It has been suggested that information provided to DOE in forms EIA 
810, EIA 816, and EIA 64A might duplicate the information that would be 
provided to EPA under the proposed IUR amendments. Operators of 
domestic natural gas processing plants must complete form EIA 64A to 
provide an annual report of the origin of natural gas liquids 
production to DOE. Operators of all operating and idle petroleum 
refineries, blending plants or blending terminals must complete form 
EIA 810 to provide a monthly refinery report on their operations to 
DOE. Operators that extract liquid hydrocarbons from a natural gas 
stream and/or separate a liquid hydrocarbon stream into its component 
products must complete form EIA 816 to provide a monthly natural gas 
liquids report to DOE.
    EPA is concerned about potential reporting duplication and is 
specifically requesting comments on whether such duplication exists, 
what specific information may be duplicated, and whether the 
information collected by DOE would satisfy the proposed IUR reporting 
requirements. EPA will also work with DOE to identify potential 
duplication, and investigate the potential utility of the information 
reporting to DOE in fulfilling EPA's statutory obligations under TSCA. 
Your comments will further inform EPA's evaluation of this issue.
    5. EPA is proposing to require only partial IUR reporting for 
inorganic chemicals, i.e. only the information in Parts I., II., and 
IV. of Form U would be reported by manufacturers of inorganic 
chemicals. Full IUR reporting for inorganic chemicals, i.e. all parts 
of Form U, including the processing and use-related data elements in 
Part III., would be considered for a future amendments to the IUR 
regulations. Alternatively, EPA could adopt a phased-in approach to 
full reporting for inorganics, e.g., partial reporting for inorganic 
chemicals could be required in the first reporting year, followed by 
full reporting in subsequent reporting years. EPA solicits public 
comment on the proposed and alternate approaches.
    6. During the interagency review process, it was suggested that the 
Agency limit the reporting of processing and use information on Part 
III. of Revised Reporting Form U to manufacturers and importers of high 
production volume (HPV) chemicals in the U.S. (i.e., are produced in 
amounts equal to or greater than 1 million pounds), chemicals that are 
currently subject to testing under TSCA section 4 (i.e., test rules and 
enforceable consent agreements (ECAs)), chemicals identified for 
voluntary testing, chemicals designated for testing by the ITC, and 
chemicals listed in the Agency's Master Testing List (the current 
edition is available at http://www.epa.gov/opptintr/chemtest/mtl.htm). 
This would mean that, for example, in order to determine whether or not 
a chemical is an HPV chemical, a manufacturer or importer would not 
only need to know their own production volume, but also whether the 
chemical is produced nationally in amounts equal to or greater than 1 
million pounds. In order to determine whether a chemical is subject to 
testing under TSCA section 4, identified for voluntary testing, or 
designated for testing by the ITC during a particular reporting period, 
a manufacturer or importer would be required to review the regulations 
and the most recent Master Testing List. Therefore, EPA is specifically 
requesting comment on whether manufacturers and importers will be able 
to make these determinations for the universe of chemicals potentially 
subject to IUR reporting, including any suggestions for ways in which 
to make these determinations.
    EPA believes that for an HPV determination procedure to be 
effective, it must be able to accommodate the frequency with which 
individual chemicals may rise above or fall below the HPV threshold 
criteria of a U.S. aggregate production volume of 1 million lbs. or 
more per year. For example, 17% of the chemicals which were HPVs 
according to data submitted under the 1990 IUR were not HPVs according 
to data submitted under the 1994 IUR. To address this issue, EPA is 
proposing in these IUR amendments to use a submitter-specific 
processing and use production volume threshold of 300,000 lbs. or more 
per site per year to ensure that reporting is captured for a great 
majority of HPVs (as defined on the basis of national aggregate 
production volume). EPA seeks comments on alternative approaches for 
identifying HPVs for IUR reporting purposes that similarly account for 
the dynamic nature of the set of HPV chemicals.
    EPA is also specifically interested in receiving comments on the 
additional burden imposed on manufacturers and importers associated 
with the reporting of processing and use information under the IUR 
amendments to manufacturers and imports of HPV chemicals. Under EPA's 
current proposal, in order to determine whether a chemical is subject 
to IUR reporting during a particular reporting period, a manufacturer 
or importer would first determine the production volume of the 
chemicals they produced during the year for which reporting is required 
(i.e., was the chemical produced in an amount of 25,000 lbs. or more, 
or in an amount of 300,000 lbs. or more for processing and use 
information). They would then determine if the chemical is otherwise 
exempt from IUR reporting. The Agency is concerned that limiting 
reporting to the HPV chemicals would require a manufacturer or importer 
to make additional determinations, as described in the beginning of 
this request for

[[Page 46797]]

comment, in order to ascertain whether they must report under IUR.
    In addition, EPA is interested in receiving comment on whether this 
suggestion would limit the utility of the information that would be 
collected, because it would change the focus and purpose of the 
proposed IUR amendments related to the collection of processing and use 
information. As discussed previously, EPA believes that the basic 
processing and use information that EPA is proposing to collect on less 
than 3,500 of the 76,000 chemicals on the TSCA Inventory, is critical 
for EPA to more effectively and efficiently fulfill its obligations 
under TSCA, e.g., to assess the risks of chemicals in commerce, and to 
promote pollution prevention by encouraging the development of safer 
substitutes and alternatives. In developing its proposal, the Agency 
has taken steps to minimize burden and costs, and believes that the 
information that the Agency is proposing to collect is essential to the 
Agency's chemical screening process. The basic processing and use 
information that EPA is proposing to collect will allow the Agency and 
other users of IUR information to better prioritize their efforts based 
on a chemical's potential risks. The Agency therefore believes that the 
burden and costs associated with providing the information proposed in 
this document will assist the Agency and others to avoid the imposition 
of additional burden and costs related to further actions, such as more 
in-depth assessments and regulations.
    7. Are the industrial function categories listed in this proposed 
rule the most appropriate ones?
    8. Are the commercial and consumer product categories in this 
proposed rule the most appropriate ones?
    9. Are there better alternatives to the definition of ``potentially 
exposed worker'' contained in this proposed rule (i.e., Sec. 710.2), 
``reasonably likely to be exposed'')? Is the OSHA hazard communication 
standard's definition (i.e., 29 CFR 1910.1200(c), ``employee'') more 
appropriate for this proposed rule?
    10. Should EPA require the reporting of TRI facility identification 
numbers, where available?
    11. Is the reporting of production volume ranges, as proposed, 
likely to result in fewer confidentiality claims than when specific 
production volumes are reported? What else could be done to the 
reporting process and data elements included in the final rule to 
reduce CBI claims of submitters to allow better public access to data?
    12. Should the Agency collect information on the use of personal 
protective equipment during the manufacture or import of chemicals 
reported on the IUR? During the interagency review process, it was 
suggested that the Agency consider collecting information on the use of 
personal protective equipment (PPE). Generic PPE recommendations exist 
from Material Safety Data Sheets (MSDS), and may be available from 
other sources. As described in this preamble, EPA plans to use the 
information collected through these proposed amendments mainly for 
initial screening level assessments. EPA is interested in receiving 
comment on whether the Agency should collect information on PPE, what 
kind of specific PPE information should be collected, and whether such 
additional data reporting requirements would result in a significant 
burden increase to industry.
    13. Are the data sought in this proposed rule related to industrial 
processing and use and commercial and consumer products ``readily 
obtainable'' by those who are required to report?
    14. What alternatives are available to the procedures proposed in 
this document that will protect submitters' right to reassert their CBI 
claims? Can you identify means other than those discussed in this 
proposed rule which the Agency might use to better inform submitters of 
the requirement to reexamine past CBI claims and to reassert CBI 
claims, as appropriate, in order to retain CBI protections?
    15. Should EPA require data to be reported using the metric system?

X. Materials in the Public Docket

    The official record for this rulemaking has been established under 
docket control number OPPTS-82053. The following is a listing of the 
documents that have already been placed in the official record for this 
proposal.

A. Supporting Documentation

    1. Federal Register notices/EPA documents/court opinions pertaining 
to this proposed rule consisting of:
    a. ``TSCA Section 4(a)(1)(B) Final Statement of Policy; Criteria 
for Evaluating Substantial Production, Substantial Release, and 
Substantial or Significant Human Exposure,'' (58 FR 28736, May 14, 
1993).
    b. 29 CFR 1910.1200 (OSHA hazard communication standards for toxic 
and hazardous substances).
    c. Chemical Manufacturers Association v. EPA, 859 F.2d 977, 991 
(D.C. Cir. 1988).
    2. Technical support documents and studies consisting of:
    a. EPA/OPPT, ``Inventory Update Rule (IUR) Amendment Technical 
Support Document: Exposure-Related Data Useful for Chemical Risk 
Screening,'' Volumes 1 and 2, July 19, 1996.
    b. Eastern Research Group, Inc., ``Preliminary Assessment 
Information Rule (PAIR) Database, Manufacturing Process Type/Release 
Analysis and Number of Workers/Production Quantity Analysis,'' prepared 
for EPA/OPPT, September 26, 1996.
    c. Environmental Business Strategies, ``U.S. Chemical Production, 
Use, and Exposure Data: A Study of Existing Information Sources,'' on 
behalf of Chemical Manufacturers Association, October 1997.
    d. GE Plastics, ``IUR Reporting Frequency and EPA's Existing 
Chemicals Program,'' 1996.
    e. NIOSH, National Occupational Exposure Survey (NOES), 1981.
    f. EPA/OPPT/EETD/EPAB, ``Economic Analysis of Proposed Amendments 
to the TSCA Section 8 Inventory Update Rule,'' March 1, 1999.
    g. EPA/OPPT, ``Inventory Update Rule (IUR) Technical Support 
Document: Evaluation of Likelihood of Confidential Business Information 
Claims for Production Volume Information,'' Final Draft, August 26, 
1996.
    h. EPA/OPPT, ``Technical Support Document: Technical Approach for 
the Selection of Consumer End-Use Categories for the Inventory Update 
Rule,'' 1996.
    i. EPA/OPPT, ``A Review of Existing Exposure-Related Data Sources 
and Approaches to Screening Chemicals: A Response to CMA,'' March 1999.
    3. Minutes or summaries of public meetings:
    a. American Chemical Society Roundtable Forum, ``A Pollution 
Prevention Strategy for Toxic Chemicals,'' July 28, 1993.
    b. EPA, ``Chemical Use Inventory (CUI) Meeting With Environmental 
and Right-to-Know Groups,'' September 29, 1993.
    c. EPA, ``The EPA Office of Pollution Prevention and Toxics (OPPT) 
Meeting on the Chemical Use Inventory,''' October 6, 1993.
    d. EPA, ``Chemical Use Inventory (CUI) Meeting With Industry,'' 
October 12, 1993.
    e. EPA, ``OPPT's Chemical Use Inventory Project: Presentation to 
FOSTTA Chemical Management and Chemical Information Project Members,'' 
October 19, 1993.
    f. EPA, ``Meeting with Labor Constituents,'' November 10, 1993.
    g. EPA, ``CUI Multi-stakeholder Meeting,'' January 5, 1994.
    h. EPA, ``Statement of Lynn R. Goldman, M.D. Before the

[[Page 46798]]

Subcommittee on Toxic Substances, Research and Development, Committee 
on Environment and Public Works, U.S. Senate,'' May 17, 1994.
    i. U.S. Senate Committee on Environment and Public Works, 
Subcommittee on Toxic Substances, Research and Development, ``Hearing 
to discuss reauthorization of the Toxic Substances and Control Act 
(TSCA),'' July 13, 1994.
    j. Clean Sites, ``CUI/IUR Amendments Workshop, Meeting Summary,'' 
April 13, 1995.
    k. EPA, ``Discussion Paper [for April 13, 1995 meeting], Amendments 
to the TSCA Inventory Update Rule Needed to Create A Chemical Use 
Inventory,'' April 1995.
    l. Mary Ellen Weber, EPA, ``TSCA Chemical Use Inventory, Inventory 
Update Rule Amendments,'' presented to Chemical Manufacturers 
Association, TSCA Information Forum, May 15, 1996.
    m. Mary Ellen Weber, EPA, ``Chemical Use Inventory, TSCA Inventory 
Update Rule Amendments,'' presented to Organization Resources 
Counselors, Inc., Environmental Group, June 26, 1996.
    4. Communications consisting of:
    a. Memorandum from Mark V. Stanga and Patricia A. Franco, 
Electronic Industries Association to EPA, May 5, 1993.
    b. Letter from Claudette M. Cofta, CMA to Mark A. Greenwood, EPA, 
September 8, 1993.
    c. Letter from Albert K. Langley, Jr., Georgia Department of 
Natural Resources to Wardner G. Penberthy, EPA, October 25, 1993.
    d. Letter from Michael A. Babich, Consumer Product Safety 
Commission to Wardner G. Penberthy, EPA, October 26, 1993.
    e. Letter from Stephen S. Kellner, Chemical Specialties 
Manufacturers Association to Mark Greenwood, EPA, October 29, 1993.
    f. Letter from Stephen D. Hanna, California EPA to Mary Ellen 
Weber, EPA, November 8, 1993.
    g. Letter from Public Interest Groups to Mark Greenwood, EPA, 
November 17, 1993 (with attachments).
    h. Letter from Hillel Gray, National Environmental Law Center, to 
Wardner G. Penberthy, EPA, November 22, 1993.
    i. Letter from Roger A. Kanerva, State of Illinois EPA to Wardner 
G. Penberthy, EPA, November 22, 1993.
    j. Letter from F. David Petke, Eastman Chemical Co. to Mary Ellen 
Weber, EPA, November 23, 1993.
    k. Letter from Stephen S. Kellner, Chemical Specialties 
Manufacturers Association to Tim Hunt, OMB, November 30, 1993.
    l. Letter from Andy Opperman, New Jersey Dept. of Environmental 
Protection and Energy to Wardner G. Penberthy, December 6, 1993.
    m. Letter from Claudette M. Cofta, CMA to Mark A. Greenwood, EPA, 
December 7, 1993.
    n. Letter from Cheryl O. Morton, SOCMA to Mark A. Greenwood, EPA, 
December 10, 1993.
    o. Letter from Jeanne Herb, State of New Jersey Department of 
Environmental Protection and Energy, to Wardner G. Penberthy, EPA, 
December 8, 1993.
    p. Letter from Robert D. Bullard, University of California, Los 
Angeles, to Wardner G. Penberthy, EPA, December 14, 1993.
    q. Letter from Stephen R. Sides and H. Allen Irish, National Paint 
Coatings Association to Wardner G. Penberthy, EPA, January 11, 1994.
    r. Letter from Mark V. Stanga, Litton Corporate, to Wardner G. 
Penberthy, EPA, January 17, 1994.
    s. Letter from Stephen S. Kellner, Chemical Specialties 
Manufacturers Association to Lynn R. Goldman, EPA, January 19, 1994.
    t. Letter from Claudette M. Cofta, CMA to Mark A. Greenwood, EPA, 
January 25, 1994.
    u. Letter from Hillel Gray, National Environmental Law Center to 
Lynn R. Goldman, EPA, February 11, 1994.
    v. Letter from Richard I. Sedlak, The Soap and Detergent 
Association to Wardner G. Penberthy, EPA, February 24, 1994.
    w. Letter from Lawrence E. Slimak, American Automobile 
Manufacturers Association to Mark Greenwood, EPA, March 8, 1994.
    x. Letter from Mark A. Greenwood, EPA to Lawrence E. Slimak, 
American Automobile Manufacturers Association, March 28, 1994.
    y. Letter from Sarah Doelp, CMA to Mark Greenwood, EPA, June 20, 
1994.
    z. Report from Ken Geiser, Toxics Use Reduction Institute, 
University of Massachussetts, October 1994.
    aa. Letter from Sarah Doelp, CMA to Wardner G. Penberthy, EPA, 
February 2, 1995.
    bb. Letter from Stephen S. Kellner, Chemical Specialties 
Manufacturers Association to Tim Hunt, OMB, March 23, 1995.
    cc. Letter from Walter L. McLeod, API to Allan Abramson, EPA, April 
21, 1995.
    dd. Letter from Lynn R. Goldman, EPA to Steve Tiber, Office of 
Administration and Resources Management, August 18, 1995.
    ee. Letter from Donald D. Helin, Chemical Manufacturers Association 
to William H. Sanders III, EPA, March 26, 1997.
    ff. Letter from Larry Rampy, Chemical Manufacturers Association to 
Arthur G. Fraas, Office of Management and Budget, May 26, 1999.
    gg. Letter from Pamela Gilbert, Consumer Product Safety Commission, 
to Donald R. Arbuckle, Office of Management and Budget, June 14, 1999.
    hh. Letter from John D. Walter, TSCA Interagency Testing Committee, 
to Mary Ellen Weber, EPA, June 15, 1999.

B. References

    1. Vice President Albert Gore, ``EPA Right-to-Know Announcement,'' 
April 21, 1998.
    2. Chemical Manufacturers Association, Synthetic Organic Chemical 
Manufacturers Association, U.S. EPA, Chemical Specialties Manufacturing 
Association, American Petroleum Institute, ``Round 3 of the UEIP (Use 
and Exposure Information Project),'' June 3, 1996.
    3. U.S. EPA, ``Reducing Risk: Setting Priorities and Strategies for 
Environmental Protection,'' Science Advisory Board, (SAB-EC-90-021), 
1990.
    4. National Academy of Public Administration, ``Setting Priorities, 
Getting Results - A New Direction for EPA,'' 1995.
    5. U.S. EPA, ``Decision Guidelines Manual,'' OPPT/CCD/NCB, December 
1992.
    6. Letter from M.L. Mullins, Chemical Manufacturers Association, to 
EPA, ``Proposed Alternative to Anticipated Rule to Amend TSCA for the 
Creation of a Chemical Use Inventory,'' May 20, 1996.
    7. Letter from Michael A. Babich, U.S. Consumer Product Safety 
Commission, to Wardner G. Penberthy, EPA, June 24, 1996.
    8. Official Journal of the European Communities, ``Council 
Regulation (EEC) No 793/93 of 23 March 1993 on the evaluation and 
control of the risks of existing substances,'' L84, Volume 36, April 5, 
1993.
    9. Organization of Economic Cooperation and Development, ``SIDS 
Manual (Second Revision) Screening Information Data Set Manual of the 
OECD Programme on the Co-operative Investigation of High Production 
Volume Chemicals,'' May 1996.
    10. Memorandum from Norman R. Niedergang, EPA to Dr. Lynn R. 
Goldman, EPA, ``Continuing Sources of Asbestos Exposure,'' June 26, 
1998.
    11. U.S. EPA, ``Influence of CBI Requirements on TSCA 
Implementation,'' OPPT, March 1992.
    12. U.S. EPA, ``Final Action Plan: TSCA Confidential Business

[[Page 46799]]

Information Reform,'' OPPT, June 20, 1994.
    13. U.S. EPA, ``TSCA CBI Reform Program: State Access to TSCA Data, 
Including CBI, Project; Forum on State, Tribal Toxics Action Meeting'' 
OPPT/IMD, June 24, 1996.
    14. U.S. EPA, ``EPA Needs Exposure-Related Data: A Discussion of 
the Justification for Collecting Exposure-Related Data Through the IUR 
Amendments,'' OPPT/EETD/EPAB, 1998.
    15. Griefe, A. et al., ``National Institute for Occupational Safety 
and Health General Industry Occupational Exposure Databases: Their 
Structure, Capabilities and Limitations,'' Applied Occupational and 
Environmental Hygiene 10(4), April 1995.
    16. U.S. EPA, ``Chemical Use Clusters Scoring Methodology,'' Draft 
Report, OPPT/EETD/CEB, July 23, 1994.
    17. U.S. EPA, ``An SAB Report: Improving the Use Cluster Scoring 
System, Recommendations for the Use Cluster Scoring System Prepared by 
the Environmental Engineering Committee,'' Science Advisory Board, SAB-
EEC-95-017, September 1995.
    18. U.S. EPA, ``Inventory of Exposure-Related Data Systems 
Sponsored by Federal Agencies,'' EPA/600/R-92/078, http://www.epa.gov/
ncepihom/nepishom/index.html, 1992.
    19. American Petroleum Institute, ``Petroleum Process Stream Terms 
Included in the Chemical Substances Inventory Under the Toxic 
Substances Control Act (TSCA),'' Health and Safety Regulation Committee 
Task Force on Toxic Substances Control, February 1985.
    20. General Accounting Office, ``EPA Should Focus Its Chemical Use 
Inventory on Suspected Harmful Substances,'' GAO/RCED-95-165, July 7, 
1995.
    21. Letter from Mark N. Duvall, Union Carbide, to EPA, ``Additional 
Comments of Union Carbide Corporation on EPA's Preliminary Actions to 
Reform TSCA Confidential Business Information, Docket No. OPPTS-
00125,'' August 31, 1993.
    22. Letter from Stephen A. Newell, Occupational Safety and Health 
Administration, to Wardner G. Penberthy, EPA, October 15, 1996.
    23. Letter from Paul A. Schulte, National Institute for 
Occupational Safety and Health, to Wardner G. Penberthy, EPA, October 
8, 1996.
    24. U.S. EPA, ``Preparation of Engineering Assessments,'' Vol. 1, 
Ch. 4, pp. 1-33, OPPT/EETD/CEB, February 28, 1991.
    25. U.S. Census Bureau, North American Industrial Classification 
System (NAICS), http://www.census.gov/epcd/www/naics.html, 1999.
    26. U.S. EPA, ``Chemical Right-to-Know Initiative,'' http://
www.epa.gov/chemrtk/index.htm, June 8, 1999.

XI. Regulatory Assessment Requirements

A. Executive Order 12866

    Pursuant to Executive Order 12866 (58 FR 51735, October 4, 1993), 
entitled ``Regulatory Planning and Review,'' the Office of Management 
and Budget (OMB) has determined that this is a ``significant regulatory 
action'' because this action may raise novel policy issues related to 
the collection of information. This action was submitted to OMB for 
review, and any comments or changes made during that review have been 
documented in the public record.
    In addition, the Agency has prepared an economic assessment of the 
estimated costs and benefits attributable to this proposed rule. This 
document, entitled ``Economic Analysis of Proposed Amendments to the 
TSCA Section 8 Inventory Update Rule,'' is available in the public 
version of the official record for this proposal, at the address listed 
in Unit I.B.2. of this preamble. EPA estimates the proposed amendments 
would cost between $36 to $51 million for the first year of reporting 
and $27 to $41 million for future years of reporting, resulting in an 
annualized cost of $10 to $14 million over the next 20 years.
    Under the proposed amendments, approximately 8,900 chemicals would 
be subject to reporting, and the Agency expects that it would receive 
approximately 25,500 submissions during the first reporting cycle. 
Approximately 10,000 of those submissions (providing information on 
about 4,000 chemicals) would be full reports which include information 
found in Part III. of Revised Reporting Form U, with the remainder 
reporting only company, site and chemical identification and 
manufacturing information (Parts I., II., and IV. of Revised Reporting 
Form U). In order to keep the reporting burden as low as possible, EPA 
is proposing to require that certain information be reported in ranges, 
that only the top 10 NAICS codes be accounted for when reporting 
industrial processing and use information, and that only readily 
obtainable information in Part III be reported.
    EPA analyzed the effects of a number of different alternatives for 
the proposed rule, including variations in exemptions, different 
thresholds for both partial- (i.e. Parts I., II., and IV. of Revised 
Reporting Form U) and full-form (i.e. all parts of Revised Reporting 
Form U), and various frequencies of collection. These options are 
explored further in the Economic Analysis.
    In addition to the proposed option, EPA considered continuing the 
exemption from IUR reporting for inorganic chemicals and adding an 
exemption for site-limited petroleum streams. EPA examined the effects 
of keeping the partial-form threshold at 10,000 pounds and considered 
full-form thresholds of 10,000, 25,000, 100,000, 500,000, 1,000,000 and 
10,000,000 pounds, as well as a phased-in 100,000/500,000 full-form 
threshold. EPA also considered changes in the reporting cycle, such as 
a one-time collection, a 2-year cycle, and an option that would have 
collected partial forms every 2 years and full forms every 4 years.
    During the interagency review process, EPA also considered a 50,000 
lb. threshold for the partial form (see Addendum to the economic 
analysis referenced in Unit X.A.2.f. of this preamble). While this 
threshold would indeed reduce industry burden by $2-3 million when 
compared to the proposed 25,000 lb. threshold, EPA feels that the 
benefit of the information obtained on chemicals produced between 
25,000 and 50,000 lbs. yearly, far outweighs the costs. By increasing 
the threshold from 25,000 to 50,000 lbs., EPA would lose data on 
roughly 880 discrete chemicals from roughly 1,750 reports. Forgoing 
this information would exclude a large portion of the chemical industry 
from oversight under TSCA, which requires EPA to regulate the entire 
industry. In addition, EPA feels that the data collected at a 50,000 
lb. threshold would be insufficient to meet the TSCA statutory 
requirement to update and keep current the TSCA Inventory of Chemical 
Substances.
    During the interagency review process, EPA altered its proposal to 
include a natural gas exemption, an inorganics partial exemption, and 
an upper threshold of 300,000 lbs. These options are also analyzed in 
the addendum to the economic analysis referenced in Unit X.A.2.f. of 
this preamble. While the natural gas exemption affects only six 
chemicals, it reduces the number of reports by over 1,200. The 
inorganics partial exemption reduces the number of chemicals requiring 
full reports by about 1,200. The increase in the upper threshold from 
100,000 to 300,000 pounds reduces the number of chemicals reporting 
processing and use information (Part III. of Form U) to about 3,400.

[[Page 46800]]

    The costs of the proposed amendments would be borne by two groups: 
the chemical industry and EPA. Industry costs are associated with 
complying with the regulation, while EPA costs are associated with 
administering the regulation and maintaining the collected data. In 
this rulemaking effort, EPA has made every attempt to balance data 
needs with collection costs and burden. Wherever possible, EPA has used 
exemptions or partial exemptions to reduce the number of reports filed 
by industry. EPA has provided an upper threshold for reporting use 
information required in Part III of Revised Reporting Form U, reducing 
the per report burden for submitters. Recognizing that this information 
would be used for screening-level purposes, EPA has reduced the 
specificity of the information that would be required in three ways:
      By requiring the reporting of only readily obtainable 
information for the use and non-manufacturing exposure-related data.
      By requiring that submitters report much of the 
information in ranges, reducing the need to generate precise estimates.
     By requiring processing and use-related information on 
only the top 10 NAICS codes, as determined by percent of the chemical's 
volume.
These steps limit the amount of information required, reducing the time 
and effort spent by the chemical industry in complying with the 
amendments.
    First-year costs of the proposed rule are estimated to be between 
$36 million and $51 million, with subsequent annual costs in future 
reporting years of $27 to $41 million. This results in an annualized 
cost of between $10 million and $14 million over the first 20 years. 
EPA assumes that the burden associated with reporting under the IUR 
amendments would decrease over time as the industry's familiarity with 
the reporting rule increases and to the extent that the information 
being reported remains somewhat constant from one reporting period to 
the next. Projected costs to EPA are relatively small and are estimated 
to be $525,000 in the first reporting year, and $275,000 in subsequent 
reporting years.
    During the interagency review process, EPA added the collection of 
the data element for average concentration (not included in the 
Economic Analysis) to Part II. of the revised Reporting Form U. EPA 
expects the addition of this data element to result in only a 
negligible increase in burden because similar information is needed in 
order to report both the maximum concentration as well as the average 
concentration. EPA therefore did not find a reason to adjust the 
Economic Analysis to reflect this change.

B. Regulatory Flexibility Act

    Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 
5 U.S.C. 601 et seq., the Agency hereby certifies that this proposed 
rule, if promulgated as proposed, will not have a significant impact on 
a substantial number of small entities. This certification is based on 
the Agency's analysis of potential impacts on small entities, which is 
included in the Economic Analysis summarized in section A. of this 
Unit.
    Small entities include small businesses, small not-for-profit 
organizations, and small governmental jurisdictions (5 U.S.C. 601(6)). 
Because not-for-profit organizations and governmental jurisdictions 
will not be affected by this proposed rule, ``small entity'' for 
purposes of this proposed rule is synonymous with ``small business.''
    Section 601(3) of the RFA establishes as the default definition of 
small business the definition used in section 3 of the Small Business 
Act (15 U.S.C. 632) under which the SBA establishes small business size 
standards (13 CFR 121.201). The RFA recognizes, however, that it may be 
appropriate at times for Federal agencies to use an alternate 
definition of small business. As a result, RFA section 601(3) provides 
that an agency may establish a different definition of small business 
after consultation with the SBA Office of Advocacy and after notice and 
an opportunity for public comment. EPA established a different 
definition of small business, found in the existing IUR at 40 CFR 
704.3, in accordance with these requirements. Manufacturers and 
importers who meet the 40 CFR 704.3 definition of small business are 
generally exempted from IUR reporting in 40 CFR 710.29. This exemption 
is retained under these amendments and is not being reopened for 
comment.
    Despite the fact that small manufacturers and importers that fully 
meet the 40 CFR 704.3 definition of small manufacturers and importers 
are generally exempt from reporting under IUR, and thus are not 
significantly impacted by these amendments to IUR, EPA conducted an 
analysis of the potential impact for submitters that meet only part of 
the 40 CFR 704.3 definition. Specifically, an analysis of the potential 
impact was conducted only for those submitters that meet the first 
criterion in the 40 CFR 704.3 definition of ``small manufacturer or 
importer,'' i.e. total annual sales of less than $40 million, but that 
do not meet the second criterion, i.e. production or import volume of 
less than 100,000 pounds at all sites.
    For small entities manufacturing (including importing) organic 
chemicals subject to reporting, the Agency estimates the impact to be 
0.13% to 0.16% of sales. For small entities manufacturing (including 
importing) inorganic chemicals subject to reporting, the Agency 
estimates the impact to be 0.15% to 0.20% of sales. These estimates are 
based upon the Agency's belief that most small businesses reporting 
will complete the full Form U, unless the business is eligible for one 
of the partial exemptions. These small entity impacts are based on 
EPA's original proposal for the IUR amendments. The revised proposal, 
which has reduced industry cost and burden even further, is expected to 
have even less impact on small entities.
    Information relating to this determination has been provided to the 
Chief Counsel for Advocacy of the Small Business Administration, and is 
included in the docket for this rulemaking. Any comments regarding the 
economic impacts that this proposed regulatory action may impose on 
small entities should be submitted to the Agency according to the 
procedures identified in the ``ADDRESSES'' section at the beginning of 
this preamble.

C. Paperwork Reduction Act

    The information collection requirements contained in this proposed 
rule have been submitted to OMB under the Paperwork Reduction Act 
(PRA), 44 U.S.C. 3501 et seq., and in accordance with the procedures at 
5 CFR 1320.11. An Information Collection Request (ICR) document has 
been prepared by EPA (EPA ICR No. 1884.01), and included in the public 
version of the official record that is described in Unit I.B.3. of this 
preamble. In addition to viewing the ICR document as described in Unit 
I.B.3. of this preamble, you may obtain a copy of the ICR by mail from 
Sandy Farmer, OP Regulatory Information Division; Environmental 
Protection Agency (2137), 401 M St., SW., Washington, DC 20460, by 
calling (202) 260-2740, or by e-mail to ``[email protected].'' An 
electronic copy has also been posted on EPA's World Wide Website 
(http://www.epa.gov/) with other information related to this action.
    The information requirements contained in this proposal are not 
effective until OMB approves them. An Agency may not conduct or 
sponsor,

[[Page 46801]]

and a person is not required to respond to a collection of information 
subject to OMB approval under the PRA unless it displays a currently 
valid OMB control number. The OMB control numbers for EPA's 
regulations, after initial publication in the Federal Register, are 
displayed in a list at 40 CFR part 9.
    The information that would be reported under these amendments to 
IUR would better enable EPA to screen thousands of chemical substances 
for potential risk. Risk screening is necessary in order to conserve 
limited Agency resources by focusing risk assessment work on chemical 
substances for which some level of potential risk has been indicated. 
The new information that would be reported under this rule is critical 
to the risk screening process and is unavailable through other sources. 
Responses to this collection of information would be mandatory, 
pursuant to TSCA section 8(a).
    CBI claims may be made for all of the new information that would be 
reported under these amendments to IUR. This action proposes new 
substantiation procedures for CBI claims regarding plant site identity. 
(See Sec. 710.38(d) of the regulatory text). In addition, a new 
provision for the reassertion of CBI claims would be added. This 
provision states that all CBI claims made in one reporting period would 
be valid only until the beginning of the reporting period immediately 
following the reporting period in which the information was claimed as 
confidential. To maintain the confidential status of information, the 
submitter would need to certify during every reporting period following 
the one in which the original claim of confidentiality was made, that 
the information should continue to be treated as confidential by EPA. 
Reassertions must be made to maintain confidentiality even if the 
submitter is not required to report during a given reporting period. If 
a submitter fails in a reporting period to reassert the confidentiality 
claims made in the previous reporting period, the claims are presumed 
to be waived and EPA will make the information available to the public 
without further notice to the submitter. (See Sec. 710.39 of the 
regulatory text).
    The following annual burden and cost figures represent the cost of 
a 4-year reporting cycle, spread over 4 years. Most or all of the 
burden would fall in the first year of the cycle. The public reporting 
burden for this collection of information is estimated to be 150,000 to 
210,000 hours for each of the 4 years in the first reporting cycle for 
approximately 3,050 respondents. The average annual reporting burden 
per response is 6 to 8 hours, with the average company reporting 8.4 
times per collection and each information collection occurring every 4 
years. The annual public reporting cost burden for operation and 
maintenance expenses is estimated to be $11 to $15 million annually for 
the first four year reporting cycle, and decreasing after that. The 
total capital and start-up costs, as well as the purchase of services, 
are estimated to be zero.
    Under the PRA, ``burden'' means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
or disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; develop, acquire, 
install, and utilize technology and systems for the purposes of 
collecting, validating, and verifying information, processing and 
maintaining information, and disclosing and providing information; 
adjust the existing ways to comply with any previously applicable 
instructions and requirements; train personnel to be able to respond to 
a collection of information; search data sources; complete and review 
the collection of information; and transmit or otherwise disclose the 
information.
    Comments are requested on the Agency's need for this information, 
the accuracy of the provided burden estimates, and any suggested 
methods for minimizing burden, including through the use of automated 
collection techniques. Send comments on the ICR to the EPA according to 
the instructions provided in Unit I.C. of this preamble. Please 
remember to include the docket control number OPPTS-82053, or the ICR 
number in any correspondence. The final rule will respond to any 
comments on the information collection requirements contained in this 
proposal.

D. Unfunded Mandates Reform Act

    Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4), EPA has determined that this proposed regulatory 
action does not contain a Federal mandate that may result in 
expenditures of $100 million or more for State, local, and tribal 
governments, in the aggregate, or for the private sector in any 1 year. 
The analysis of the costs associated with this proposed action are 
described in Unit XI.A. of this preamble. In addition, EPA has 
determined that this proposed rule does not significantly or uniquely 
affect small governments. Accordingly, today's proposed rule is not 
subject to the requirements of sections 202, 203, 204, and 205 of UMRA.

E. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing Intergovernmental 
Partnerships (58 FR 58093, October 28, 1993), EPA may not issue a 
regulation that is not required by statute and that creates a mandate 
upon a State, local or tribal government, unless the Federal government 
provides the funds necessary to pay the direct compliance costs 
incurred by those governments, or EPA consults with those governments. 
If EPA complies by consulting, Executive Order 12857 requires EPA to 
provide to the OMB a description of the extent of EPA's prior 
consultations with representatives of affected State, local and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    Today's notice does not create an unfunded Federal mandate on 
State, local, or tribal governments. The rule does not impose any 
enforceable duties on these entities. Accordingly, the requirements of 
section 1(a) of Executive Order 12875 do not apply to this proposed 
rule. Nevertheless, EPA has sought the active participation of State, 
local and tribal governments who might be interested in this proposal. 
The Agency has had several informal consultations regarding the 
proposed rule with some States through the EPA regional offices and at 
regularly scheduled State meetings. No significant issues or 
information were identified as a result of EPA's discussion with the 
States, who are primarily interested in CBI issues and whether they 
will have access to the information EPA collects under these proposed 
amendments.

F. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communitiies, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments, or EPA 
consults with

[[Page 46802]]

those governments. If EPA complies by consulting, Executive Order 13084 
requires EPA to provide to the OMB, in a separately identified section 
of the preamble to the rule, a description of the extent of EPA's prior 
consultation with representatives of affected tribal governments, a 
summary of the nature of their concerns, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 13084 
requires EPA to develop an effective process permitting elected 
officials and other representatives of Indian tribal governments ``to 
provide meaningful and timely input in the development of regulatory 
policies on matters that significantly or uniquely affect their 
communities.''

G. Executive Order 12898

    Pursuant to Executive Order 12898 (59 FR 7629, February 16, 1994), 
entitled Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations, the Agency has considered 
environmental justice-related issues with regard to the potential 
impacts of this action on the environmental and health conditions in 
low-income and minority communities. The Agency believes that the 
information collected under this proposed rule would assist the Agency 
in determining the risks and exposures associated with these chemicals. 
Although not directly impacting environmental justice-related concerns, 
this information would enable the Agency to protect human health and 
the environment by being better able to prioritize chemical substances 
of concern.

H. Executive Order 13045

    This rulemaking does not require special consideration pursuant to 
the terms of Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997), because it is not likely to have an annual effect on the 
economy of $100 million or more and it does not have a potential effect 
or impact on children. As discussed in this preamble, this proposed 
rule would provide the Agency with information needed to screen and 
prioritize chemical substances. This information will allow the Agency 
and others to determine which chemical substances have potential risks, 
allowing the Agency and others to take appropriate action to 
investigate and mitigate those risks.

I. National Technology Transfer and Advancement Act

    This proposed regulatory action does not involve any technical 
standards that would require Agency consideration of voluntary 
consensus standards pursuant to section 12(d) of the National 
Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 
104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA 
directs EPA to use voluntary consensus standards in its regulatory 
activities unless to do so would be inconsistent with applicable law or 
otherwise impractical. Voluntary consensus standards are technical 
standards (e.g., materials specifications, test methods, sampling 
procedures, business practices, etc.) that are developed or adopted by 
voluntary consensus standards bodies. The NTTAA requires EPA to provide 
Congress, through OMB, explanations when the Agency decides not to use 
available and applicable voluntary consensus standards. EPA invites 
public comment on the Agency's determination that this regulatory 
action does not require the consideration of voluntary consensus 
standards.

List of Subjects in 40 CFR Part 710

    Environmental protection, Chemicals, Hazardous materials, Reporting 
and recordkeeping requirements.

Dated: August 2, 1999.
Susan H. Wayland,
Acting Assistant Administrator, Office of Prevention, Pesticides and 
Toxic Substances.
    Therefore, it is proposed that 40 CFR part 710 be amended as 
follows:

PART 710--[AMENDED]

    1. The authority citation for part 710 would continue to read as 
follows:

    Authority: 15 U.S.C. 2607(a).

    2. By revising Sec. 710.2 to read as follows:


Sec. 710.2   Definitions.

    In addition to the definitions in Sec. 704.3 in this chapter, the 
following definitions 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) The following definitions also apply to this part:
    Act means the Toxic Substances Control Act, 15 U.S.C. 2601 et seq.
    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.
    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.
    Byproduct means a chemical substance produced without separate 
commercial intent during the manufacture or processing of another 
chemical substance(s) or mixture(s).
    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

[[Page 46803]]

manufactured, processed, or distributed in commerce for use as a food, 
food additive, drug, cosmetic, or device.
    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 (1) of this definition.
    Commercial use means the use of a chemical substance or mixture in 
a commercial enterprise providing saleable goods or services (e.g., dry 
cleaning establishment, painting contractor).
    Consumer use means the use of a chemical substance that is 
directly, or as part of a mixture, sold to or made available to 
consumers for their use in or around a permanent or temporary household 
or residence, in or around a school, or in or around recreational 
areas.
    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.
    EPA means the U.S. Environmental Protection Agency.
    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).
    Impurity means a chemical substance which is unintentionally 
present with another chemical substance.
    Industrial use means use at a site at which one or more chemical 
substances or mixtures are manufactured (including imported) or 
processed.
    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.

    Known to or reasonably ascertainable by means all information in a 
person's possession or control, plus all information that a reasonable 
person similarly situated might be expected to possess, control, or 
know.
    Manufacture means to manufacture or import for commercial purposes.
    Manufacture or import ``for commercial purposes'' means: To import, 
produce, or manufacture with the purpose of obtaining an immediate or 
eventual commercial advantage, and includes, for example, the 
manufacture or import of any amount of a chemical substance or mixture:
    (1) For commercial distribution, including for test marketing, or
    (2) For use by the manufacturer, including use for product research 
and development, or as an intermediate.
    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.
    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.
    New chemical substance means any chemical substance which is not 
included in the inventory compiled and published under subsection 8(b) 
of the Act.
    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.
    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.
    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.
    Process for ``commercial purposes'' means to process (1) for 
distribution in commerce, including for test marketing purposes, or (2) 
for use as an intermediate.
    Processor means any person who processes a chemical substance or 
mixture.
    Readily obtainable information means information which is known by 
management and supervisory employees of the submitter company who are 
associated with research, development, distribution, technical 
services, or marketing of the reportable chemical substance. Extensive 
file searches are not required.
    Reasonably likely to be exposed means an exposure to a chemical 
substance which, under foreseeable conditions of manufacture (including 
import), processing, distribution in commerce, or use of the chemical 
substance, is more likely to occur than not to occur. Such exposures 
would normally include, but not be limited to, activities such as 
charging reactor vessels, drumming, bulk loading, cleaning equipment, 
maintenance operations, materials handling, and transfers, and 
analytical operations. Covered exposures include exposures through any 
route of entry (inhalation, ingestion, skin contact, absorption, etc.), 
but excludes accidental or theoretical exposures.

[[Page 46804]]

    Repackaging means the physical transfer of a chemical substance or 
mixture, as is, from one container to another container or containers 
in preparation for distribution of the chemical substance or mixture in 
commerce.
    Reportable chemical substance means a chemical substance described 
in Sec. 710.25.
    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.
    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.
    Small maufacturer 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.

    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.

    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.
    Technically qualified individual means a person:
    (1) Who because of his/her 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 this paragrah may be delegated to another individual, or other 
individuals, as long as each meets the criteria in paragraph (1) of 
this definition.
    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.
    United States, when used in the geographic sense, means all of the 
States, territories, and possessions of the United States.
    Use means any utilization of a chemical substance or mixture that 
is not otherwise covered by the terms manufacture or process. 
Relabeling or redistributing a container holding a chemical substance 
or mixture where no repackaging of the chemical substance or mixture 
occurs does not constitute use or processing of the chemical substance 
or mixture.
    3. In Sec. 710.26, by revising the introductory text and paragraphs 
(a) and (c) and adding paragraph (e) to read as follows:


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 part, with two exceptions: a 
chemical substance described in paragraph (a) only qualifies for a 
partial reporting exemption, as described in paragraph (a), and a 
chemical substance described in paragraph (a), (b), (c), or (e) of this 
section is not excluded from the reporting requirements of this part 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) Petroleum process streams. All chemical substances listed by 
Chemical Abstract Service Registry Number (CAS Number) in this 
paragraph are excluded only from paragraphs (c)(4) and (5) of 
Sec. 710.32. Such chemical substances are not excluded from the other 
reporting requirements under 40 CFR part 710. The chemical substances 
included in the list in this paragraph may be modified and, if 
modified, a new list will be published through direct final rulemaking 
in the Federal Register by EPA prior to the upcoming reporting period. 
If a new list is not published prior to a given reporting period, the 
list in effect for the previous reporting period is still in effect for 
the current reporting period.

CAS Numbers of Partially Exempt Chemical Substances Termed ``Petroleum 
Process Streams''

    63231-60-7
    64741-41-9
    64741-42-0
    64741-43-1
    64741-44-2
    64741-45-3
    64741-46-4
    64741-47-5
    64741-48-6
    64741-49-7
    64741-50-0
    64741-51-1
    64741-52-2
    64741-53-3
    64741-54-4
    64741-55-5

[[Page 46805]]

    64741-56-6
    64741-57-7
    64741-58-8
    64741-59-9
    64741-60-2
    64741-61-3
    64741-62-4
    64741-63-5
    64741-64-6
    64741-65-7
    64741-66-8
    64741-67-9
    64741-68-0
    64741-69-1
    64741-70-4
    64741-71-5
    64741-72-6
    64741-73-7
    64741-74-8
    64741-75-9
    64741-76-0
    64741-77-1
    64741-78-2
    64741-79-3
    64741-80-6
    64741-81-7
    64741-82-8
    64741-83-9
    64741-84-0
    64741-85-1
    64741-86-2
    64741-87-3
    64741-88-4
    64741-89-5
    64741-90-8
    64741-91-9
    64741-92-0
    64741-93-1
    64741-94-2
    64741-95-3
    64741-96-4
    64741-97-5
    64741-98-6
    64741-99-7
    64742-00-3
    64742-01-4
    64742-02-5
    64742-03-6
    64742-04-7
    64742-05-8
    64742-06-9
    64742-07-0
    64742-08-1
    64742-09-2
    64742-10-5
    64742-11-6
    64742-12-7
    64742-13-8
    64742-14-9
    64742-15-0
    64742-16-1
    64742-17-2
    64742-18-2
    64742-19-4
    64742-20-3
    64742-22-9
    64742-23-0
    64742-24-1
    64742-25-2
    64742-27-4
    64742-28-5
    64742-29-6
    64742-30-9
    64742-31-0
    64742-32-1
    64742-33-2
    64742-34-3
    64742-35-4
    64742-36-2
    64742-36-5
    64742-37-6
    64742-38-7
    64742-39-8
    64742-40-1
    64742-41-2
    64742-42-3
    64742-43-4
    64742-44-5
    64742-45-6
    64742-46-7
    64742-47-8
    64742-48-9
    64742-49-0
    64742-50-3
    64742-51-4
    64742-52-5
    64742-53-6
    64742-54-7
    64742-55-8
    64742-56-9
    64742-57-0
    64742-58-1
    64742-59-2
    64742-60-5
    64742-61-6
    64742-62-7
    64742-63-8
    64742-64-9
    64742-65-0
    64742-66-1
    64742-67-2
    64742-68-3
    64742-69-4
    64742-70-7
    64742-71-8
    64742-72-9
    64742-73-0
    64742-74-1
    64742-75-2
    64742-76-3
    64742-78-5
    64742-79-6
    64742-80-9
    64742-81-0
    64742-82-1
    64742-83-2
    64742-84-3
    64742-85-4
    64742-86-5
    64742-87-6
    64742-88-7
    64742-89-8
    64742-90-1
    64742-91-2
    64742-92-3
    64742-93-4
    64742-95-6
    64742-96-7
    64742-97-8
    64742-98-9
    64742-99-0
    64743-00-6
    64743-02-8
    64743-01-7
    64743-03-9
    64743-04-0
    64743-05-1
    64743-06-2
    64743-07-3
    64754-89-8
    64754-96-7
    64771-71-7
    64771-71-7
    64771-72-8
    64771-72-8
    67674-12-8
    67674-13-9
    67674-15-1
    67674-16-2
    67674-17-3
    67674-18-4
    67891-77-4
    67891-79-6
    67891-78-5
    67891-80-9
    67891-82-1
    67891-83-2
    67891-85-4
    68131-05-5
    68131-49-7
    68131-75-9
    68131-77-1
    68131-79-3
    68131-80-6
    68131-81-7
    68131-83-9
    68131-99-7
    68132-00-3
    68153-22-0
    68187-57-5
    68187-58-6
    68187-58-6
    68187-60-9
    68307-98-2
    68307-99-3
    68308-00-9
    68308-01-0
    68308-02-1
    68308-03-2
    68308-04-3
    68308-05-4
    68308-06-5
    68308-07-6
    68308-08-7
    68308-09-8
    68308-10-1
    68308-11-2
    68308-12-3
    68308-27-0
    68333-22-2
    68333-23-3
    68333-24-4
    68333-25-5
    68333-26-6
    68333-27-7
    68333-28-8
    68333-29-9

[[Page 46806]]

    68333-30-2
    68333-81-3
    68333-88-0
    68334-30-5
    68334-31-6
    68409-99-4
    68410-00-4
    68410-01-5
    68410-05-9
    68410-10-6
    68410-12-8
    68410-13-9
    68410-14-0
    68410-16-2
    68410-59-3
    68410-63-9
    68410-71-9
    68410-96-8
    68410-97-9
    68410-98-0
    68411-00-7
    68425-27-4
    68425-28-5
    68425-29-6
    68425-31-0
    68425-31-1
    68425-33-2
    68425-34-3
    68425-35-4
    68425-39-8
    68441-09-8
    68459-79-8
    68475-57-0
    68475-58-1
    68475-59-2
    68475-60-5
    68475-61-6
    68475-70-7
    68475-79-6
    68475-80-9
    68476-26-6
    68476-28-8
    68476-29-9
    68476-30-2
    68476-31-3
    68476-33-5
    68476-34-6
    68476-39-1
    68476-40-4
    68476-42-6
    68476-43-7
    68476-44-8
    68476-45-9
    68476-46-0
    68476-47-1
    68476-49-3
    68476-50-6
    68476-52-8
    68476-53-9
    68476-54-0
    68476-55-1
    68476-56-2
    68476-77-7
    68476-81-3
    68476-84-6
    68476-85-7
    68476-86-8
    68476-87-9
    68477-25-8
    68477-26-9
    68477-29-2
    68477-30-5
    68477-31-6
    68477-33-8
    68477-34-9
    68477-35-0
    68477-36-1
    68477-37-2
    68477-38-3
    68477-39-4
    68477-40-7
    68477-41-8
    68477-42-9
    68477-43-0
    68477-44-1
    68477-45-2
    68477-46-3
    68477-47-4
    68477-48-5
    68477-50-9
    68477-51-0
    68477-52-1
    68477-53-2
    68477-54-3
    68477-55-4
    68477-56-5
    68477-58-7
    68477-59-8
    68477-60-1
    68477-61-2
    68477-62-3
    68477-63-4
    68477-64-5
    68477-65-6
    68477-66-7
    68477-67-8
    68477-68-9
    68477-69-0
    68477-70-3
    68477-71-4
    68477-72-5
    68477-73-6
    68477-74-7
    68477-75-8
    68477-76-9
    68477-77-0
    68477-79-2
    68477-80-5
    68477-81-6
    68477-82-7
    68477-83-8
    68477-84-9
    68477-85-0
    68477-86-1
    68477-87-2
    68477-88-3
    68477-89-4
    68477-90-7
    68477-91-8
    68477-92-9
    68477-93-0
    68477-94-1
    68477-95-2
    68477-96-3
    68477-97-4
    68478-00-2
    68478-01-3
    68478-02-4
    68478-03-5
    68478-04-6
    68478-05-7
    68478-07-9
    68478-08-0
    68478-09-1
    68478-10-4
    68478-12-6
    68478-13-7
    68478-15-9
    68478-16-0
    68478-17-1
    68478-18-2
    68478-19-3
    68478-20-6
    68478-21-7
    68478-22-8
    68478-24-0
    68478-25-1
    68478-26-2
    68478-27-3
    68478-28-4
    68478-29-5
    68478-30-8
    68478-32-0
    68478-33-1
    68478-34-2
    68512-61-8
    68512-62-9
    68512-78-7
    68512-90-3
    68512-91-4
    68513-02-0
    68513-11-1
    68513-12-2
    68513-13-3
    68514-14-4
    68513-15-5
    68513-16-6
    68513-17-7
    68513-18-8
    68512-19-9
    68513-26-8
    68513-62-2
    68513-63-3
    68513-65-5
    68513-66-6
    68513-67-7
    68513-68-8
    68513-69-9
    68513-74-6
    68514-15-8
    68514-29-4
    68514-30-7
    68514-31-8
    68514-32-9
    68514-33-0
    68514-34-1
    68514-35-2
    68514-38-4
    68514-36-3
    68514-37-4
    68514-79-4
    68515-25-3
    68515-26-4
    68515-27-5
    68515-28-6
    68515-30-0
    68515-31-1

[[Page 46807]]

    68515-32-2
    68515-33-3
    68515-34-4
    68515-35-5
    68515-36-6
    68516-20-1
    68516-21-2
    68526-52-3
    68526-53-4
    68526-54-5
    68526-55-6
    68526-56-7
    68526-57-8
    68526-58-9
    68526-77-2
    68526-99-8
    68527-00-4
    68527-11-7
    68527-13-9
    68527-14-0
    68527-15-1
    68527-16-2
    68527-18-4
    68527-19-5
    68527-21-9
    68527-22-0
    68527-23-1
    68527-24-2
    68527-25-3
    68527-26-4
    68527-27-5
    68553-00-4
    68553-14-0
    68602-79-9
    68602-81-3
    68602-82-4
    68602-83-5
    68602-84-6
    68602-96-0
    68602-97-1
    68602-98-2
    68602-99-3
    68603-00-9
    68603-01-0
    68603-02-1
    68603-03-2
    68603-08-7
    68603-09-8
    68603-10-1
    68603-11-2
    68603-12-3
    68603-13-4
    68603-14-5
    68603-31-6
    68603-32-7
    68606-09-7
    68606-10-0
    68606-11-1
    68606-24-6
    68606-25-7
    68606-26-8
    68606-27-9
    68606-28-0
    68606-31-5
    68606-34-8
    68606-35-9
    68606-36-0
    68607-11-4
    68607-30-7
    68608-56-0
    68647-60-9
    68647-61-0
    68647-62-1
    68650-36-2
    68650-37-3
    68650-78-2
    68741-41-9
    68782-97-8
    68782-98-9
    68782-99-0
    68783-00-6
    68783-01-7
    68783-02-8
    68783-04-0
    68783-05-1
    68783-06-2
    68783-07-3
    68783-08-4
    68783-09-5
    68783-10-8
    68783-11-9
    68783-13-1
    68783-15-3
    68783-61-9
    68783-62-0
    68783-61-9
    68783-64-2
    68783-65-3
    68783-66-4
    68814-47-1
    68814-67-5
    68814-89-1
    68814-87-9
    68814-90-4
    68814-91-5
    68855-57-2
    68855-58-3
    68855-59-4
    68855-60-7
    68911-58-0
    68911-59-1
    68915-96-8
    68915-97-9
    68918-69-4
    68918-73-0
    68918-93-4
    68918-99-0
    68919-00-6
    68919-01-7
    68919-02-8
    68919-03-9
    68919-04-0
    68919-05-1
    68919-06-2
    68919-07-3
    68919-08-4
    68919-09-5
    68919-10-8
    68919-11-9
    68919-12-0
    68919-16-4
    68919-17-5
    68919-19-7
    68919-20-0
    68919-37-9
    68919-39-1
    68920-06-9
    68920-07-0
    68920-73-0
    68920-64-9
    68921-07-3
    68921-09-5
    68921-08-4
    68921-67-5
    68952-76-1
    68952-77-2
    68952-78-3
    68952-79-4
    68952-80-7
    68952-81-8
    68952-82-9
    68955-27-1
    68955-28-2
    68955-30-6
    68955-31-7
    68955-32-8
    68955-33-9
    68955-34-0
    68955-35-1
    68955-36-2
    68955-76-0
    68955-96-4
    68956-47-8
    68956-48-9
    68956-52-5
    68956-54-7
    68956-55-8
    68956-70-7
    68988-99-8
    68989-88-8
    68990-35-2
    68991-49-1
    68991-50-4
    68991-51-5
    68991-52-6
    69013-21-4
    69029-75-0
    69430-33-7
    70024-88-3
    70528-71-1
    70528-72-2
    70528-73-3
    70592-76-6
    70592-77-7
    70592-78-8
    70592-79-9
    70693-00-4
    70913-85-8
    70913-86-9
    70955-08-7
    70955-09-8
    70955-10-1
    70955-17-8
    71243-66-8
    71302-82-4
    71329-37-8
    71808-30-5
    72230-71-8
    72623-83-7
    72623-84-8
    72623-85-9
    72623-86-0
    72623-87-1
    7732-18-5
    8002-05-9
    8002-74-2
    8006-14-2

[[Page 46808]]

    8006-20-2
    8006-61-9
    8007-45-2
    8008-20-6
    8008-20-6
    8009-03-8
    8012-95-1
    8030-30-6
    8032-32-4
    8042-47-5
    8052-42-4
    10024-97-2
    *  *  *  *  *
    (c) Microorganisms. Any combination of chemical substances that is 
a living organism, and that meets the definition of ``microorganism'' 
at 40 CFR 725.3 of this chapter. Any chemical substance produced from a 
living microorganism is reportable under this part unless otherwise 
excluded.
    *    *    *    *    *
    (e) Certain forms of natural gas. Chemical substances with the 
following CAS Numbers: CAS No. 64741-48-6, Natural gas (petroleum), raw 
liquid mix; CAS No. 68919-39-1, Natural gas condensates; CAS No. 8006-
61-9, Gasoline natural; CAS No. 68425-31-0, Gasoline (natural gas), 
natural; CAS No. 8006-14-2, Natural gas; and CAS No. 68410-63-9, 
Natural gas, dried.
    4. By revising Sec. 710.28 to read as follows:


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 part. Persons must 
determine whether they must report under this section for each chemical 
substance that they manufacture (including import) at an individual 
site.
    (a) Persons subject to recurring reporting. Any person who 
manufactured (including imported) for commercial purposes 25,000 lbs. 
(11,350 kg) 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 
calendar year 1999 or during the calendar year at 4-year intervals 
thereafter is subject to reporting. A person who does not manufacture 
(including import) at least 25,000 lbs. of a chemical substance 
described in Sec. 710.25 at any single site owned or controlled by that 
person at any time during 1999 or during any year in 4-year intervals 
thereafter, but who chooses to reassert [a] confidentiality claim[s] 
made in [a] previous reporting period[s], as described in Sec. 710.39, 
must make the reassertion in each reporting period even if the person 
is not required to report the information described in Sec. 710.32(c).
    (b) Special provisions for importers. For purposes 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 United States (see also 
Sec. 710.35(b)).
    5. By revising Sec. 710.32 to read as follows:


Sec. 710.32   Reporting information to EPA.

    Any person who must report under this part, as described in 
Sec. 710.28, must submit the information described in this section for 
each chemical substance described in Sec. 710.25 that the person 
manufactured (including imported) for commercial purposes in an amount 
of 25,000 lbs. (11,350 kg) or more at any one site during calendar year 
2001 or during the calendar year at 4-year intervals thereafter. (The 
site for a person who imports a chemical substance is the site of the 
operating unit within the person's organization that 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 United States) Except as otherwise noted, a submitter of 
information under this part 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 
submitter under this part must report information that applies to the 
calendar year for which the person is required to report (i.e., 
calendar year 2001 and the calendar year at 4-year intervals 
thereafter).
    (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. 710.40(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. 710.40(b).
    (c) Information to be reported. Manufacturers (including importers) 
of a chemical substance described in Sec. 710.25 in an amount equal to 
or greater than 25,000 lbs. (11,350 kg) during a calendar year for 
which reporting is required must report the information described in 
paragraphs (c)(1), (c)(2), and (c)(3) of this section. Manufacturers 
(including importers) of an organic chemical substance described in 
Sec. 710.25 in an amount equal to or greater than 300,000 lbs. (136,200 
kg) during a calendar year for which reporting is required must report 
the information described in paragraphs (c)(4) and (c)(5) of this 
section in addition to the information described in paragraphs (c)(1), 
(c)(2), and (c)(3) of this section.
    (1) A certification statement signed and dated by an authorized 
official of the submitter 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. 710.40.
    (2) Company and plant site information. The following company and 
plant site information must be reported:
    (i) The name, company, address, city, State, zip code, and 
telephone number of a person who will serve as technical contact for 
the submitter company, and who 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. 710.40.
    (ii) The name, street address, city, State, and zip code of each 
site at which at least 25,000 lbs. (11,350 kg) or more of a chemical 
substance for which reporting is required under this part is 
manufactured (including 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 
submitter under this part must include the appropriate Dun and 
Bradstreet Number and any EPA Facility Registration Identifier (FRI) 
(once an FRI has been assigned to the facility) for each plant site 
reported. In addition, the county or parish (or other jurisdictional 
indicator) in which the plant site is located must be provided.
    (3) Chemical specific information. The following chemical-specific 
information must be reported:
    (i) The specific chemical name and Chemical Abstracts Service (CAS) 
Registry Number of each chemical

[[Page 46809]]

substance for which reporting is required under this part (``reportable 
chemical substance''). As provided in the instruction booklet 
identified in Sec. 710.40(b), a submitter under this part may use an 
EPA-Designated Accession Number, a premanufacture notice (PMN) case 
number (see Sec. 720.65 of this chapter), or a TSCA Chemical Inventory 
reporting form number (see Sec. 710.40) in lieu of a CAS Registry 
Number when a CAS Registry Number is not known to the submitter.
    (ii) A statement indicating, for each reportable chemical 
substance, whether the substance is manufactured in the United States, 
imported into the United States, or both manufactured in the United 
States and imported into the United States.
    (iii) A designation indicating, for each reportable chemical 
substance, whether the substance is site-limited.
    (iv) The total volume (in pounds) of each reportable chemical 
substance manufactured (including imported) at each site. This amount 
must be reported to two significant figures of accuracy provided that 
the reported figures are within plus or minus 10% of the actual volume.
    (v) Any person claiming the volume reported under paragraph 
(c)(3)(iv) of this section is confidential business information under 
Sec. 710.38 must provide a statement indicating, for each reportable 
chemical substance, whether the total volume range (in pounds) which 
corresponds to the volume reported in response to paragraph (c)(3)(iv) 
of this section of each reportable chemical substance manufactured 
(including imported) at each site is claimed confidential. Volume 
ranges are listed in the following table:

          Volume Ranges for Non-Confidential Reporting Purposes
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
From 25,000 to 100,000 lbs.
From 100,000 to 1,000,000 lbs.
From 1,000,000 to 10,000,000 lbs.
From 10,000,000 to 50,000,000 lbs.
From 50,000,000 to 100,000,000 lbs.
From 100,000,000 to 500,000,000 lbs.
From 500,000,000 to 1,000,000,000 lbs.
Greater than 1,000,000,000 lbs.
------------------------------------------------------------------------

    (vi) The total number of workers reasonably likely to be exposed to 
each reportable chemical substance at each site where the substance is 
manufactured (including imported). For each substance, the submitter 
shall report the code that corresponds to the appropriate number of 
workers according to the range codes in the following table:

              Codes for Reporting Number of Workers Exposed
------------------------------------------------------------------------
                 Codes                                Range
------------------------------------------------------------------------
W1                                       Less than 10
W2                                       At least 10 but less than 25
W3                                       At least 25 but less than 50
W4                                       At least 50 but less than 100
W5                                       At least 100 but less than 500
W6                                       At least 500 but less than
                                          1,000
W7                                       At least 1,000 but less than
                                          10,000
W8                                       At least 10,000
------------------------------------------------------------------------

    (vii) The physical form of the reportable chemical substance as it 
is sent off-site. If the reportable chemical substance is sent in more 
than one physical form, the submitter shall report whichever physical 
form constitutes the largest portion of its total volume, measured by 
weight. For each substance, the submitter shall report the code that 
corresponds with the appropriate physical form code according to the 
following table.

         Codes for Reporting Physical Form of Chemical Substance
------------------------------------------------------------------------
                 Codes                            Physical Form
------------------------------------------------------------------------
F1                                       Dry powder
F2                                       Pellets or large crystals
F3                                       Water- or solvent-wet solid
F4                                       Other solid
F5                                       Gas or vapor
F6                                       Liquid
------------------------------------------------------------------------

    (viii) The average concentration and maximum concentration, 
measured by percentage of weight, of the reportable chemical substance 
at the time it is sent off-site. For each chemical substance, report 
the code that corresponds to the appropriate average concentration and 
maximum concentration according to the following table:

 Codes for Reporting Average Concentration and Maximum Concentration of
                           Chemical Substance
------------------------------------------------------------------------
                 Codes                    Concentration Range (% weight)
------------------------------------------------------------------------
M1                                       Less than 1% by weight
M2                                       Between 1 and 30% by weight
M3                                       Between 31 and 60% by weight
M4                                       Between 61 and 90% by weight
M5                                       Greater than 90% by weight
------------------------------------------------------------------------

    (4) Industrial processing and use information--(i) The following 
information must be be reported only for reportable chemical substances 
manufactured (including imported) for commercial purposes in an amount 
of 300,000 lbs. (136,200 kg) or more at any one site during calendar 
year 1999 or during the calendar year at 4-year intervals thereafter. 
Persons subject to this paragraph must report industrial processing and 
use information for each reportable chemical substance at sites under 
their control and at sites that receive a reportable chemical substance 
from the submitter directly or indirectly (including through a broker/
distributor, from a customer of the submitter, etc.). Information 
regarding processing or use activities occurring at sites not under the 
control of the submitter must be reported only to the extent that it is 
readily obtainable by the submitter. If the required information is not 
readily obtainable by the submitter, the submitter shall provide 
estimates, using the submitter's best professional judgment, based upon 
the submitter's past experience for similar chemical substances in the 
same or similar markets, and/or any reasonable projections of likely 
processing and use scenarios for the chemical substance. The following 
items must be reported under this paragraph:
    (A) A designation indicating the type of industrial processing or 
use operation at each site subject to the industrial processing and use 
information reporting under this paragraph. For each reportable 
chemical substance, report the letters which correspond to the 
appropriate processing or use operation[s]:

 
------------------------------------------------------------------------
              Designation                           Operation
------------------------------------------------------------------------
PC                                       Processing as a reactant
PF                                       Processing - incorporation into
                                          formulation, mixture or
                                          reaction product
PA                                       Processing - incorporation into
                                          article
PK                                       Processing - repackaging
U                                        Use - non-incorporative
                                          activities
------------------------------------------------------------------------

    (B) The five-digit North American Industrial Classification System 
(NAICS) codes which best describe the industrial activities associated 
with each industrial processing or use operation reported under 
paragraph (c)(4)(i)(A) in this section. If more than 10 NAICS codes 
apply to a reportable chemical substance, submitters need only report 
the NAICS codes for the reportable chemical substance that cumulatively 
represent the largest percentage of production volume, measured by 
weight.

[[Page 46810]]

    (C) For each NAICS code reported under paragraph (c)(4)(i)(B) in 
this section, a code from the following list must be selected to 
designate the industrial function category that best represents the 
specific manner in which the reportable chemical substance is used:

           Codes for Reporting Industrial Function Categories
------------------------------------------------------------------------
                 Codes                              Categories
------------------------------------------------------------------------
U01                                      Adsorbents and absorbents
U02                                      Adhesives and binding agents
U03                                      Aerosol propellants
U04                                      Agricultural chemicals (non-
                                          pesticidal)
U05                                      Anti-adhesive agents
U06                                      Bleaching agents
U07                                      Coloring agents, dyes
U08                                      Coloring agents, pigments
U09                                      Corrosion inhibitors and anti-
                                          scaling agents
U10                                      Fillers
U11                                      Fixing agents
U12                                      Flame retardants
U13                                      Flotation agents
U14                                      Fuels
U15                                      Functional fluids
U16                                      Intermediates
U17                                      Lubricants
U18                                      Odor agents
U19                                      Oxidizing agents
U20                                      pH-regulating agents
U21                                      Photosensitive chemicals
U22                                      Plating agents and metal
                                          surface treating agents
U23                                      Processing aid, not otherwise
                                          listed
U24                                      Process regulators, used in
                                          vulcanization or
                                          polymerization processes
U25                                      Process regulators, other than
                                          polymerization or
                                          vulcanization processes
U26                                      Reducing agents
U27                                      Solvents (for cleaning or
                                          degreasing)
U28                                      Solvents (which become part of
                                          product formulation or
                                          mixture)
U29                                      Solvents (for chemical
                                          manufacture and processing and
                                          are not part of product at
                                          greater than one percent by
                                          weight)
U30                                      Stabilizers
U31                                      Surface active agents
U32                                      Viscosity adjustors
U33                                      Other
------------------------------------------------------------------------

    (D) The percentage, rounded off to the closest 10%, of total 
production volume of the reportable chemical substance associated with 
each combination of NAICS code and industrial function category. Where 
a particular combination of NAICS code and industrial function category 
accounts for 5% or less of the total production volume of a reportable 
chemical substance, the percentage shall not be rounded off to zero % 
if the production volume attributable to that NAICS code and industrial 
function category combination is equal to or greater than 300,000 lbs. 
during the calendar year for which data must be reported. Instead, in 
such a case, submitters shall report the percentage, rounded off to the 
closest 1%, of total production volume of the reportable chemical 
substance associated with the particular combination of NAICS code and 
industrial function category.
    (E) The number of processing and use sites, by number range, of 
each subject chemical substance for each combination of NAICS code and 
industrial function category. For each substance, report the code 
(e.g., 0 through 9) that corresponds to the appropriate number range 
according to the following table:

                  Codes for Reporting Numbers of Sites
------------------------------------------------------------------------
                 Codes                                Range
------------------------------------------------------------------------
S1                                       Less than 10
S2                                       From 10 to 25
S3                                       From 25 to 100
S4                                       From 100 to 250
S5                                       From 250 to 1,000
S6                                       From 1,000 to 10,000
S7                                       Greater than 10,000
------------------------------------------------------------------------

    (F) An estimate of the number range of workers reasonably likely to 
be exposed to each reportable chemical substance at the site(s) where 
the chemical substance is processed or used. For each substance, report 
the code (e.g., W1 through W8) which corresponds to the appropriate 
worker range according to the table in paragraph (c)(3)(vi) of this 
section.
    (ii) [Reserved]
    (5) Commercial and consumer use information.--(i) The following 
information must be reported only for reportable chemical substances 
manufactured (including imported) for commercial purposes in an amount 
of 300,000 lbs. (136,200 kg) or more at any one site during calendar 
year 1999 or during the calendar year at 4-year intervals thereafter. 
Persons subject to this paragraph must report information for each 
reportable chemical substance at sites under their control and at sites 
that receive a reportable chemical substance from the submitter 
directly or indirectly (including through a broker/distributor, from a 
customer of the submitter, etc.). Information regarding use activities 
occurring at sites beyond the control of the submitter must be reported 
only to the extent that it is readily obtainable by the submitter. If 
the required information is not readily obtainable by the submitter, 
the submitter shall provide estimates, using the submitter's best 
professional judgment, based upon the submitter's past experience for 
similar chemical substances in the same or similar market, and/or any 
reasonable projections on likely use scenarios for the chemical 
substance. The following information must be reported under this 
paragraph:
    (A) Using the codes listed, submitters must designate each 
commercial and consumer product category for which the reportable 
chemical substance is used:

     Codes for Reporting Commercial and Consumer Product Categories
------------------------------------------------------------------------
                 Codes                               Category
------------------------------------------------------------------------
C01                                      Artists' supplies
C02                                      Adhesives and sealants
C03                                      Automotive care products
C04                                      Electrical and electronic
                                          products
C05                                      Glass and ceramic products
C06                                      Fabrics, textiles and apparel
C07                                      Lawn and garden products (non-
                                          pesticidal)
C08                                      Leather products
C09                                      Lubricants, greases and fuel
                                          additives
C10                                      Metal products
C11                                      Paper products
C12                                      Paints and coatings
C13                                      Photographic chemicals
C14                                      Polishes and sanitation goods
C15                                      Rubber and plastic products
C16                                      Soaps and detergents
C17                                      Transportation products
C18                                      Wood and wood furniture
C19                                      Other
------------------------------------------------------------------------

    (B) The percentage, rounded off to the closest 10%, of total 
production volume of the reportable chemical substance associated with 
each commercial and consumer product category. Where a particular 
commercial and consumer product category accounts for 5% or less of the 
total production volume of a reportable chemical substance, the 
percentage shall not be rounded off to zero % if the production volume 
attributable to that commercial and consumer product category is equal 
to or greater than 300,000 lbs. during the calendar year for which data 
must be reported. Instead, in such a case, submitters shall report the 
percentage, rounded off to the closest 1%, of total production volume 
of the reportable chemical substance associated with the particular 
commercial and consumer product category.
    (C) Where the reportable chemical substance is used in commercial 
or consumer products, the typical maximum concentration, measured by

[[Page 46811]]

weight, of the chemical substance in each commercial and consumer 
product category reported under paragraph (c)(5)(i)(A) of this section.
    (ii) [Reserved]
    6. By revising Sec. 710.33 to read as follows:


Sec. 710.33   When to report.

    All information reported to EPA in response to the requirements of 
this part must be submitted during an applicable reporting period. The 
first reporting period is from August 25, 2002, to December 23, 2002. 
Subsequent recurring reporting periods are from August 25 to December 
23 at 4-year intervals after the first reporting period. Any person 
described in Sec. 710.28(a) must report during each reporting period 
for each chemical substance described in Sec. 710.25 that the person 
manufactured (including imported) during the preceding calendar year.
    7. By revising Sec. 710.37 to read as follows:


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. Records relevant to reporting during a reporting period described 
in Sec. 710.33 must be retained for a period of 5 years beginning with 
the effective date of that reporting period.
    8. By revising Sec. 710.38 to read as follows:


Sec. 710.38   Confidentiality.

    (a) Any person submitting information under this part may assert a 
business confidentiality claim for the information at the time it is 
submitted. These claims will apply only to the information submitted 
with the claim. New confidentiality claims, if necessary, must be 
asserted with regard to information submitted during the next reporting 
period. Guidance for asserting confidentiality claims is provided in 
the instruction booklet identified in Sec. 710.40. Information claimed 
as confidential in accordance with this section 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) Chemical identity. The following steps must be taken to assert 
a claim of confidentiality for the identity of a reportable chemical 
substance:
    (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 
(including 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 been taken to prevent undesired disclosure 
of the fact that the chemical substance is being manufactured 
(including imported) for a commercial purpose?
    (vii) To what extent has the fact that this chemical substance is 
manufactured (including 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 (including import) in any form, e.g. as product, effluent, 
emission, etc.? If so, what measures have been taken to guard against 
the 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 (including 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) Site identity. A person may assert a claim of confidentiality 
for a submitter site only if the linkage of the site with a chemical 
submitted in this rule is confidential and not publicly available. The 
following steps must be taken to assert a claim of confidentiality for 
a site identity:
    (1) The person must submit with the report detailed written answers 
to the following questions signed and dated by an authorized official:
    (i) Has site information been linked with a chemical identity in 
any other Federal, state or local reporting scheme? For example, is the 
chemical identity linked to a facility in a filing under the Emergency 
Planning and Community Right-To-Know Act (EPCRA) section 311, namely 
through a Material Safety Data Sheet (MSDS)? If so, identify all such 
schemes. Was the linkage claimed as confidential in any of these 
instances?
    (ii) What harmful effect, if any to your competitive position do 
you think would result from the identity of the site and the chemical 
substance? 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?
    (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 another appropriate designation.
    (e) If no claim of confidentiality is indicated on the reporting 
form submitted to EPA under this part, or if confidentiality claim 
substantiation required under paragraphs (c) and (d) 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.
    9. By revising Sec. 710.39 to read as follows:


Sec. 710.39   Reassertion of past confidentiality claims.

    (a) Any claim of confidentiality under Sec. 710.38 is valid only 
until the end of the reporting period immediately following the 
reporting period in which the information was claimed as confidential. 
To maintain the

[[Page 46812]]

confidential status of information, the submitter must certify during 
every reporting period following the one in which the original claim of 
confidentiality was made, that the information should continue to be 
treated as confidential by EPA. Reassertions must be made to maintain 
confidentiality even if the submitter is not required to report the 
information in Sec. 710.32(c) during a given reporting period.
    (b) If the submitter fails in a reporting period to reassert the 
confidentiality claims made in the previous reporting period, the 
claims are presumed to be waived and EPA will make the information 
available to the public without further notice to the submitter. EPA 
will publish a Federal Register notice at least 2 weeks before the end 
of each reporting period, which will remind persons who made or 
reasserted CBI claims in the previous reporting period of the need to 
examine these claims and reassert them, as appropriate, in the current 
reporting period. Claims not reasserted by the end of a reporting 
period will be declassified after the reporting period ends.
    (c) CBI claims made in IUR submissions prior to 2002 will not be 
subject to this reassertion requirement. CBI claims made in IUR 
submissions beginning with the 2002 reporting year will need to be 
reasserted in subsequent reporting years in order to retain CBI 
protections.
    10. By adding Sec. 710.40 to read as follows:


Sec. 710.40   Availability of reporting form and instructions.

    (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 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, or via fax on demand 
by using a faxphone to call (202) 401-0527 and selecting item 5119. You 
may also follow the automated menus.
    (b) Guidance for completing the reporting form and preparing a 
magnetic media report is available in the EPA publication entitled 
``Instructions for Reporting for Partial Updating of the TSCA Chemical 
Inventory Data Base.''
    (c) EPA will mail a reporting package (consisting of a copy of Form 
U and a copy of the ``Instructions for Reporting for Partial Updating 
of the TSCA Chemical Inventory Data Base'') to those companies that 
reported in the IUR reporting period that occurred immediately prior to 
the current reporting period. If you did not receive a reporting 
package, but are required to report, you may obtain a copy of the 
reporting package 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-H[email protected].
    (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, 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, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460.

[FR Doc. 99-22243 Filed 8-25-99; 8:45 am]
BILLING CODE 6560-50-F