TSCA Inventory Update Rule Amendments
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Federal Register › Vol. 64 › 64 FR 46772
Text
Part III
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 710
TSCA Inventory Update Rule Amendments; Proposed Rule
Proposed Rules
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.
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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.
he 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:
le (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?
s 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?
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
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?
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
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
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
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
es 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.
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
n 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
lgation
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
ces 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
. 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
on 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
(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
emical 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
s
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
tures'' (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
ocate 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
seful 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
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
ure-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
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
monstration 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
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
f 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
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
ery
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)
es). 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)
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
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
lity 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
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
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
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
le 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
. 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
e 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
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
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
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
he 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
/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.
fference 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.
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
ently 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)
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
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
l
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
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
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
ntains 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)
``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
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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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
rements. 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
t 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.)
uired 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
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.
y 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.
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
sed 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
g 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
anufacture 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
nsible 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
ir 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
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
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
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)
m 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
e 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
d 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
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
ies. 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
is 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
ubstances 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
als 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
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
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
(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
, 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)
n 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)
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
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)
tes.
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
ed 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
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
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
tion 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.
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
bmitters 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
t 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
er 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
umer
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
lic 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
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
umer
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 contro
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