46772 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / 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.

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 sitelimited status. EPA is proposing to

require the reporting of additional data

that would assist EPA in evaluating

potential exposures and risks resulting

from industrial chemical operations and

commercial and consumer uses of

chemical substances. EPA is also

proposing to modify reporting and

recordkeeping requirements, to remove

one reporting exemption and to create

others, and to modify its Confidential

Business Information (CBI) reporting

procedures.

DATES: Comments on this proposed rule

must be received no later than October

25, 1999. A public meeting to allow the

opportunity for oral comment on this

proposed rule will be held on Monday,

October 4, 1999, from 9 a.m. to noon at

the EPA Auditorium, 401 M St., SW.,

Washington, DC 20460.

ADDRESSES: Comments may be

submitted by mail, electronically, or in

person. Please follow the detailed

instructions for each method as

provided in Unit I. of the

‘‘SUPPLEMENTARY INFORMATION’’

section of this document.

FOR FURTHER INFORMATION CONTACT: For

technical information contact: Susan

Krueger, Project Manager, Economics,

Exposure and Technology Division

(7406), Office of Pollution Prevention

and Toxics, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460; telephone: (202) 260-1713,

fax: (202) 260-1661; e-mail:

krueger.susan@epa.gov.

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; email: TSCA-Hotline@epa.gov.

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:

Category NAICS

Examples of

Potentially

Regulated

Persons

Chemical

manufacturers and

importers

325, 32411 Chemical

manufacturers (including importers)

currently

subject to

IUR reporting

Chemical

manufacturers (including importers) of

inorganic

chemical

substances

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. Other types of

entities not listed above could also be

regulated. To determine whether you or

your business is affected by this action,

carefully examine the applicability

provisions in title 40 of the Code of

Federal Regulations (CFR), part 710. If

you have questions regarding the

applicability of this action to a

particular entity, consult the technical

person listed in the preceding ‘‘FOR

FURTHER INFORMATION CONTACT’’

section.

B. How Can I Get Additional

Information or Copies of this Document

or Other Documents?

1. Electronically. You may obtain

electronic copies of this document and

various support documents from the

EPA Internet Home Page at http://

www.epa.gov/. On the Home Page select

‘‘Laws and Regulations’’ and then look

up the entry for this document under

the ‘‘Federal Register--Environmental

Documents.’’ You can also go directly to

the ‘‘Federal Register’’ listings at http:/

/www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPPTS–82053. The official record

consists of the documents specifically

referenced in this action, any public

comments received during an applicable

comment period, and other information

related to this action, including any

information claimed as confidential

business information (CBI). This official

record includes the documents that are

physically located in the docket, as well

as the documents that are referenced in

those documents. The public version of

the official record does not include any

information claimed as CBI. The public

version of the official record, which

includes printed, paper versions of any

electronic comments submitted during

an applicable comment period, is

available for inspection in the TSCA

Nonconfidential Information Center,

Rm. NE-B607, Waterside Mall, 401 M

St., SW., Washington, DC, from noon to

4 p.m., Monday through Friday,

excluding legal holidays. The TSCA

Nonconfidential Information Center

telephone number is (202) 260–7099.

C. How and to Whom Do I Submit

Comments?

You may submit comments through

the mail, in person, or electronically. Be

sure to identify the appropiate docket

number (i.e., OPPTS–82053) in your

correspondence.

1. By mail. Submit your comments to:

Document Control Office (DCO) (7407),

Office of Pollution Prevention and

Toxics (OPPT), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460.

2. In person or by courier. Deliver

your comments to: OPPT Document

Control Office (DCO) in the East Tower

Rm. G-099, Waterside Mall, 401 M St.,

SW., Washington, DC 20460. The DCO

is open from 8 a.m. to 4 p.m., Monday

through Friday, excluding legal

holidays. The telephone number for the

DCO is 202–260–7099.

3. Electronically. You may submit

your comments electronically by e-mail
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46773

to: ‘‘oppt.ncic@epa.gov,’’ or mail your

computer disk to the address identified

above. Do not submit any information

electronically that you consider to be

CBI. Avoid the use of special characters

and any form of encryption. Electronic

submissions will be accepted in

Wordperfect 5.1/6.1 or ASCII file

format. All comments in electronic form

must be identified by the docket control

number OPPTS–82053. Electronic

comments may also be filed online at

many Federal Depository Libraries.

D. How Should I Handle CBI

Information That I Want to Submit to

the Agency?

You may claim information that you

submit in response to this document as

CBI by marking any part or all of that

information as CBI. Information so

marked will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

that does not contain CBI must be

submitted for inclusion in the public

record. Information not marked

confidential will be included in the

public docket by EPA without prior

notice. If you have any questions about

CBI or the procedures for claiming CBI,

please consult with the technical person

identified in the ‘‘FOR FURTHER

INFORMATION CONTACT’’ section.

E. What Should I Consider As I Prepare

My Comments for EPA?

EPA invites you to provide your

views on the various options proposed,

new approaches EPA has not

considered, the potential impacts of the

various options (including possible

unintended consequences), and any

data or information that you would like

the Agency to consider during the

development of the final action. You

may find the following suggestions

helpful for preparing your comments:

• Explain your views as clearly as

possible.

• Describe any assumptions that you

used.

• Provide solid technical information

and/or data to support your views.

• If you estimate potential burden or

costs, explain how you arrived at the

estimate.

• Tell us what you support, as well

as what you disagree with.

• Provide specific examples to

illustrate your concerns.

• Offer alternative ways to improve

the rule or collection activity.

• Make sure to submit your

comments by the deadline in this

proposal.

• At the beginning of your comments

(e.g., as part of the ‘‘Subject’’ heading),

you must properly identify the

document you are commenting on by

providing the docket control number

assigned to the proposal. You may also

provide the name, date, and Federal

Register citation, and the appropriate

EPA or OMB ICR number.

II. Authority

EPA is required under TSCA section

8(b), 15 U.S.C. 2607(b), to compile and

keep current an inventory of chemical

substances in commerce. In 1977, EPA

promulgated a rule (42 FR 64572,

December 23, 1977) under TSCA section

8(a), 15 U.S.C. 2607(a), to compile an

inventory of chemical substances. In

1986, EPA promulgated the IUR (51 FR

21447, June 12, 1986), also under TSCA

section 8(a), to facilitate the periodic

updating of the inventory and to

support activities associated with the

implementation of TSCA.

This document proposes amendments

to 40 CFR part 710, which currently

contains the Inventory Update

Reporting Regulations. Failure to

comply fully with any provision of a

final rule would be a violation of TSCA

section 15 and would subject the

violator to the penalties of TSCA

sections 16 and 17.

TSCA section 8(a)(1) authorizes the

EPA Administrator to promulgate rules

under which manufacturers (including

importers) and processors of chemical

substances and mixtures (referred to

hereafter as ‘‘chemical substances’’)

must maintain such records and submit

such information as the Administrator

may reasonably require. Under TSCA

section 8(a), the Agency may collect

information, insofar as it is known to, or

reasonably ascertainable by the

submitter, on the manufacture

(including import) and processing of

chemical substances. EPA possesses

broad discretion in determining the

information to be reported under TSCA

section 8(a). Some of the types of

information which can be required

under TSCA section 8(a)(2) include:

categories of use for each chemical

substance, estimates of the amount

manufactured or processed for each

category of use, a description of the

byproducts resulting from the

manufacture, processing, use, or

disposal of each chemical substance, an

estimate of the number of individuals

exposed, and the duration of such

exposure. TSCA section 8(a) excludes,

with certain exceptions, small

manufacturers (including small

importers), and processors of chemical

substances from reporting requirements

established in TSCA section 8(a).

However, EPA is authorized by TSCA

section 8(a)(3) to require TSCA section

8(a) reporting from small manufacturers

(including importers) and processors

with respect to any chemical substance

that is the subject of a rule proposed or

promulgated under TSCA section 4,

5(b)(4), or 6, or that is the subject of an

order under TSCA section 5(e), or that

is the subject of relief that has been

granted pursuant to a civil action under

TSCA sections 5 or 7. For purposes of

the IUR, the standards for determining

whether a business qualifies as a ‘‘small

manufacturer or importer’’ are defined

at 40 CFR 704.3. For additional

information, see TSCA sections 2 and 8;

H. Rep. 1341, 94th Cong., 2d Sess. 6-7

(July 14, 1976); Sen. Rep. 698, 94th

Cong. 2d Sess. 3-5 (March 16, 1976).

III. Summary of the Amendments

In this document, EPA is proposing

several changes to the current IUR

reporting requirements. First, EPA is

proposing to amend 40 CFR 710.32 in

order to add exposure-related

information to the reporting

requirements for chemical substances

covered by the IUR. Specifically, the

Agency is proposing that manufacturers

(including importers) subject to the

proposed rule report, in ranges, the

number of workers reasonably likely to

be exposed to the chemical substance at

the site of manufacture or import, and

the physical form, average

concentration, and maximum

concentration of the chemical substance

as it leaves the submitter’s possession.

Second, EPA is proposing to amend

40 CFR 710.32 in order to require

chemical manufacturers (including

importers) (‘‘submitters’’) of largervolume chemical substances to report

information concerning the processing

and use of each reportable chemical

substance that is conducted at sites

controlled by the submitter and at

‘‘downstream’’ sites that receive the

reportable chemical substance from the

submitter directly or indirectly

(including through a broker/distributor,

from a customer of the submitter, etc.).

Specifically, manufacturers (including

importers) of these larger-volume

chemical substances would be required

to report:

1. The type of industrial processing or

use operation at each site, including

downstream sites.

2. The five-digit North American

Industrial Classification System

(‘‘NAICS’’) codes that best describe the

industrial activities conducted by the

facilities that use or process the

substance.

3. The ‘‘industrial functions’’ of the

chemical substances.

4. The approximate number of

processing and use sites.
46774 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

5. The estimated number of workers

reasonably likely to be exposed to each

chemical substance at each site at which

the chemical is used or processed.

6. The commercial and consumer uses

of reportable chemical substances.

7. The estimated percentages of the

submitter’s production volume in each

industrial function category and

commercial and consumer product

category.

8. The maximum concentration of the

reportable chemical substance in each

commercial and consumer product

category.

Third, EPA is proposing to revoke the

current full exemption from IUR

reporting at 40 CFR 710.26(a) for

inorganic chemical substances, and

instead require partial reporting for

these substances. EPA is also proposing

to amend 40 CFR 710.26 to create a

partial reporting exemption for

petroleum process streams.

Fourth, EPA is proposing to amend 40

CFR 710.26 to provide an exemption

from IUR reporting for certain forms of

natural gas.

Fifth, EPA is proposing to amend 40

CFR 710.32 to require the reporting of

additional information to assist in the

identification of plant sites reporting

under IUR.

Sixth, EPA is proposing to amend 40

CFR 710.28, 710.32, and 710.33 to

change the period for which reporting is

required from a corporate fiscal year to

a calendar year basis.

Seventh, EPA is proposing to amend

40 CFR 710.32 to include two separate

confidentiality boxes on the reporting

form (Form U) for production volume in

exact amounts and in ranges (see Unit

VI. of this preamble for a copy of the

proposed reporting form). These

confidentiality boxes would enable

submitters to assert a confidentiality

claim for specific production volume

information while releasing the more

general production volume range as

public information.

Eighth, EPA is proposing to amend 40

CFR 710.38 to require upfront

substantiation of plant site

confidentiality claims made in IUR

submissions to EPA.

Ninth, EPA is proposing to add a new

section, 40 CFR 710.39, to require

submitters to reassert CBI claims made

in past IUR reports during each

reporting cycle.

Finally, EPA is proposing to amend

40 CFR 710.28 and 710.32 to raise the

production volume reporting threshold

from the current 10,000 pounds (lbs.)

per year threshold to 25,000 lbs. per

year, and to add a new larger-volume

reporting threshold of 300,000 lbs. per

year for the reporting of processing and

use information.

Units VI. through VIII. of this

preamble provide a discussion regarding

changes to the current IUR that would

occur upon promulgation of these

proposed amendments. The discussion

includes the current reporting

requirements only to the extent that

they would be modified in this

proposal. EPA is not reopening the

existing requirements for comment

where they would not be modified in

this proposal. CBI issues are discussed

in Unit VIII. of this preamble, although

certain of these issues are mentioned

briefly in Unit VI. of this preamble.

IV. Background

A. Establishment of the Inventory

Update Rule

In the Federal Register of June 12,

1986 (51 FR 21447), EPA published the

Inventory Update Rule (IUR), which

requires chemical manufacturers

(including importers) to report to EPA

every 4 years the identity of chemical

substances manufactured (including

imported) annually in quantities over

10,000 lbs. per year at each plant site

they own or control. The current IUR

excludes several categories of

substances, including polymers,

inorganic substances, microorganisms,

and naturally occurring chemical

substances. Plant sites subject to the

rule are currently required to report

information such as company name,

plant site location, plant site Dun and

Bradstreet number(s), identity of the

reportable chemical substance, and

production volume of the reportable

chemical substance.

The data reported under IUR are used

to update the information collected on

the TSCA Inventory, which is a listing

of chemical substances in commerce.

EPA uses the TSCA Inventory and data

reported under the IUR to support many

TSCA-related activities and to provide

overall support for a number of EPA and

other Federal health, safety, and

environmental protection activities (See

Unit IV.B. of this preamble for further

explanation of some of these activities).

B. EPA’s TSCA-Related Chemical

Screening and Assessment Activities

Congress enacted TSCA to establish a

number of new requirements and

authorities for identifying and

controlling toxic chemical risks to

human health and the environment (See

TSCA section 2). To implement its

responsibilities under TSCA, EPA must

identify potential chemical risks, assess

the magnitude of the identified risks

and, where necessary, manage risks

determined to be unreasonable. TSCA

provides EPA with the authority to

gather data, such as chemical toxicity

data, chemical exposure data, and other

related data, to determine whether a

chemical substance may present an

unreasonable risk of injury to human

health or the environment, and to

institute control actions when risks are

determined to be unreasonable. As part

of the implementation of this authority,

EPA has established the IUR and other

regulations to collect information on

chemical substances.

Identification of chemical substances,

plant sites, and exposures of greatest

potential concern and setting priorities

for more detailed risk assessment and

potential risk management actions are

important elements in a successful

chemical risk management program.

The TSCA Inventory includes more than

75,000 chemical substances.

Approximately 8,300 of these chemical

substances are non-polymer organic

chemical substances manufactured or

imported in quantities of 10,000 lbs. per

year, as reported under the 1994 IUR

data collection. See ‘‘Economic Analysis

of Proposed Amendments to the TSCA

Section 8 Inventory Update Rule,’’

available in the public record for this

proposal and listed at Unit X.A.2.f. of

this preamble.

Once a chemical substance has been

identified for risk screening under

EPA’s Existing Chemicals Program, EPA

completes an initial review of the

chemical. This initial review is designed

to select the chemical substances that

raise particular concern regarding the

risks they present to human health and

the environment. At the close of the

initial review, three possible outcomes

may occur: a testing recommendation, a

recommendation for further evaluation,

or closure. ‘‘Closure’’ may include

referrals to other programs or agencies,

dissemination of initial review results,

or a decision to discontinue further

review based on the chemical’s low

hazard, low risk potential, or because it

will be considered for regulatory control

as part of a broader cluster of chemical

substances. This process is described in

more detail in the document entitled,

‘‘Economic Analysis of Proposed

Amendments to the TSCA Section 8

Inventory Update Rule,’’ which is

available in the public record for this

rulemaking and listed at Unit X.A.2.f. of

this preamble.

Between 1990 and 1994, 1,924

chemical substances were screened for

inclusion in the risk management (RM)

program. Of these candidate chemical

substances, 561 were selected for more

detailed review based on potential risks.

Of the 561 chemicals evaluated, 125
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46775

(22%) were recommended for testing;

156 (28%) were recommended for

further risk management; and 280 (50%)

were recommended for closure. The

Existing Chemicals Program represents a

significant outlay in EPA resources, and

is an important component in EPA’s

ability to manage unreasonable risks

presented by chemical substances in

commerce.

Effective risk screening and risk

management are dependent upon both

exposure information and hazard

information. The exposure-related

information reported under the IUR

amendments, in combination with

hazard information such as that

developed under TSCA section 4 test

rules, would allow the Agency to

effectively screen and prioritize

chemicals. In order to meet the

directives put forth by Vice President

Gore in his April 21, 1998

announcement (Ref. 1), EPA recently

undertook the drafting of a significant

proposed test rule for certain high

production volume chemicals. The test

rule would collect baseline hazard

information which, in conjunction with

the exposure-related information that

would be reported under these IUR

amendments, would be critical for

chemical screening purposes.

EPA’s Existing Chemicals Program is

currently evaluating risks from indoor

air pollutants, high release chemical

substances listed on the Toxics Release

Inventory (TRI) (established under

section 313 of the Emergency Planning

and Community Right-to-Know Act

(EPCRA), 42 U.S.C. sections 11001 to

11050), persistent bioaccumulators, and

high production volume chemicals.

While past approaches to priority

setting have been primarily based on

relative chemical hazards and

production volume as a simple

surrogate for exposure, EPA has

increased its emphasis on the exposure

component of risk screening and

assessment. An example of this

increased emphasis is reflected in the

voluntary effort within EPA called the

Use and Exposure Information Project

(UEIP), undertaken by EPA and the

Chemical Manufacturers Association

(CMA), the Chemical Specialty

Manufacturers Association (CSMA), the

Synthetic Organic Chemical

Manufacturers Association (SOCMA),

and the American Petroleum Institute

(API) (Ref. 2). The UEIP was undertaken

cooperatively by government and

industry in recognition of the

difficulties encountered in obtaining

current exposure information on TSCA

chemicals. The UEIP, however,

provided one-time reporting of

information on a small number of

selected high production volume

chemicals. Given these efforts, the

limitations of the data available from

past and current information collections

that are described in detail in Unit IV.B.

of this preamble, and the amount of

time it would take to acquire screeninglevel data for all of the chemical

substances on the Inventory otherwise,

EPA believes it is appropriate to

develop a more systematic and

comprehensive approach to the

prioritization process. The new

exposure-related information that would

be reported under this proposed rule is

necessary to allow more efficient and

effective chemical risk screening.

V. Development of this Proposed Rule

A. Need for Change in the Inventory

Update Rule

EPA is proposing to amend the

Inventory Update Rule (IUR) for three

primary reasons: (1) To tailor the

chemical substance reporting

requirements to more closely match the

Agency’s overall information needs; (2)

to obtain new and updated information

relating to potential exposures to a

subset of chemical substances listed on

the TSCA Chemical Substances

Inventory (‘‘the TSCA Inventory’’); and

(3) to improve the utility of the

information reported. Changes to the

information collected through the IUR,

the chemicals covered by the rule, and

CBI requirements accomplish these

three goals.

These goals are supported by a

primary policy underlying TSCA, which

is that ‘‘adequate data should be

developed with respect to the effect of

chemical substances and mixtures on

health and the environment and that the

development of such data should be the

responsibility of those who manufacture

and those who process such chemical

substances and mixtures’’ (TSCA

section 2(b)(1)). EPA believes that, for

basic risk screening purposes, the data

currently available are inadequate (See

Unit IV.B. of this preamble). TSCA

section 8(a)(2) authorizes EPA to require

manufacturers and processors of

chemical substances to report a wide

variety of data, including the exposurerelated 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 resourceintensive risk assessment. The EPA

Science Advisory Board’s ‘‘Reducing

Risk: Setting Priorities and Strategies for

Environmental Protection’’ report (Ref.

3) and the National Academy of Public

Administration’s ‘‘Setting Priorities,

Getting Results, A New Direction for

EPA’’ report (Ref. 4) recognize that

EPA’s ability to set priorities through

risk screening and EPA’s ability to

allocate its limited resources has been

significantly impeded by a lack of

exposure data. Screening the potential

risks posed by the chemical substances

included in the Inventory and setting

priorities for more detailed risk

assessment and possible risk

management is an enormous challenge.

The manufacturing, processing, and use

of Inventory chemicals result in a wide

array of exposure scenarios. By

collecting the exposure-related data

included in this proposed amendment

to the IUR, the Agency would acquire

information that would greatly improve

EPA’s ability to identify, through risk

screening, the chemical substances that

could pose a risk to human health and

to the environment.

1. Exposure-related data needed for

chemical risk screening. As discussed in

Unit IV. of this preamble, EPA must

screen thousands of chemical

substances for potential risk to

determine priorities for follow-up risk

assessment and management among the

chemical substances included on the

TSCA Inventory. Because so many

chemical substances and exposure

scenarios are involved, it is not practical

to devote the extensive resources that

would be required to develop more

precise exposure data, such as

occupational and environmental

monitoring data. Instead, EPA must

identify and rely on exposure-related

data that are more accessible and that

are reasonably accurate and useful for

identifying potential chemical risks.

EPA has had access to certain types of

exposure-related information which it

has found to be extremely useful. For

example, EPA’s New Chemicals

Program requires the submission of

exposure-related information in

Premanufacture Notice (PMN)

submissions. This information is used

in developing risk estimates to

determine the status of the chemical
46776 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

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. Exposurerelated 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 exposurerelated information submitted in a PMN

is not necessarily reflective of exposures

once a chemical substance is added to

the Inventory and is produced

commercially by the company that

originally submitted the PMN and/or

any number of additional companies.

Production volume information, for

example, is provided only once during

the PMN process, whereas production

volume information is tracked over time

under the IUR. EPA’s analysis of the

PMN data base is provided in a

document entitled, ‘‘Inventory Update

Rule (IUR) Amendment Technical

Support Document: Exposure-Related

Data Useful for Chemical Risk

Screening,’’ found in the record for this

proposal and listed at Unit X.A.2.a. of

this preamble.

Another example of EPA’s use of

available exposure-related information

is in the evaluation of chemical risks

and establishment of hazard testing

priorities in the Agency’s New

Chemicals and Chemical Testing

Programs. These programs rely upon

data that are similar to data that would

be collected under this proposal. EPA’s

New Chemicals Program, under the

authority of TSCA section

5(e)(1)(A)(ii)(II), has established an

exposure-based policy which utilizes

various exposure criteria to guide its

decisions regarding the issuance of

consent orders. These criteria include

estimates of production volume,

releases, potential dose rates, numbers

of potentially exposed workers and

consumers, and the size of the

potentially exposed general population

and are used to determine whether an

exposure concern exists (Ref. 5). These

decisions are based on the expected use

of the new chemical.

Similarly, the Chemical Testing

Program relies upon exposure-related

information to require testing under

TSCA section 4. In order to require

testing, EPA must initially make either

risk-based findings under TSCA section

4(a)(1)(A) or exposure-based findings

under TSCA section 4(a)(1)(B). Riskbased 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 exposurerelated information. Generally, EPA

relies upon production volume

information in addition to chemical

release information or human exposure

information (i.e., for general population

exposure, consumer exposure, or worker

exposure) to make exposure-based

findings. EPA’s interpretation of its legal

authority to make the findings necessary

to require testing under TSCA section

4(a)(1)(B) is articulated in a Statement of

Policy (‘‘B Policy’’) (58 FR 28736, May

14, 1993). Many of the exposure data

elements included in these proposed

amendments to IUR are specifically

relevant to the exposure-related findings

contained in the B Policy. As a result,

the exposure information submitted

under the IUR amendments would be

integral to the identification of

candidate chemicals for inclusion in test

rules. For example, the use information

reported under the IUR amendments

would assist in the selection of

chemicals for inclusion in a planned

test rule that would collect hazard

information on chemicals to which

children may be exposed, many of

which are present in consumer

products.

Other organizations recognize that

exposure-related data is useful for

screening chemical risks. The Chemical

Manufacturers Association (CMA), in a

letter to EPA (Ref. 6), noted that data on

chemical use volumes, numbers of

exposed workers, magnitudes of

chemical usage per worker, number of

use sites, and environmental releases

can supplement production volume data

in chemical risk screening. In addition,

the exposure-related information that

would be reported under these

amendments to IUR would support

chemical screening by the Consumer

Product Safety Commission (CPSC).

CPSC has stated that, ‘‘[a]t present, there

is no comprehensive source of

information on the ingredients of

household chemicals and CPSC does

not have the authority to obtain this

information. The [IUR amendments]

would be a first step in obtaining

information on product ingredients and

provide a more efficient means of

screening household chemicals for

emerging hazards under the Chemical

Hazard Program’’ (Ref. 7).

Certain international organizations

collect and utilize exposure-related

information. The European Union (EU),

in a regulation enacted in 1993

regarding the evaluation and control of

existing substances (Ref. 8), requires

chemical manufacturers and importers

to report a variety of hazard and

exposure information for the chemical

substances they manufacture or import

so that the EU can undertake

preliminary risk evaluations and

identify lists of priority substances

which require special attention.

Information on reasonably foreseeable

uses of chemical substances is included

in these reports. The types of use data

collected under the EU regulation are

similar to the types of use data that

would be reported under this proposed

rule.

The Organization for Economic

Cooperation and Development (OECD)

also recognizes the utility of exposurerelated 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
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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 exposurerelated information in the development

of risk estimates in EPA’s New

Chemicals Program (described in this

unit) illustrates that the data reported

under this proposed amendment to IUR

would support EPA’s risk screening of

existing chemicals in commerce. EPA is

proposing to collect readily obtainable

exposure-related data that can be used

to better establish priorities for its

Existing Chemicals Program. The new

IUR data elements included in this

proposed rule are related to or are

indicative of three components of

exposure: The number of ecosystems or

size of human populations potentially

exposed (for example, data elements

regarding number of sites, number of

workers, and use in consumer

products); the potential routes,

magnitudes, and concentrations of

exposures experienced by the

environment or by humans (for

example, data elements regarding

function of chemical substances in

industrial processes, physical form of

chemical substances, industrial sectors

where chemical substances are

manufactured and used, average

concentration, and maximum

concentration); and the frequency and

duration of potential exposures (for

example, data elements regarding

industrial function categories and

commercial and consumer use

categories). EPA intends to supplement

the current data collected under IUR

with additional data elements that

would improve the Agency’s ability to

evaluate each of these components of

exposure.

2. Need to screen risks of inorganic

chemical substances. In this action, EPA

is proposing to remove the IUR

reporting exemption for inorganic

chemical substances which currently

exists at 40 CFR 710.26(a). The

exemption exists because EPA believed

in the past that the hazard potential of

many inorganics was ‘‘relatively wellestablished’’ (50 FR 9944, 9947, March

12, 1985) and that information about

these hazards was a sufficient basis for

prioritization within inorganic chemical

substance risk assessment. EPA now

intends to increase the consideration

given to exposure, another component

of risk, in screening chemicals and in

setting priorities for risk assessment and

risk management activities due to its

belief that chemical hazard information

alone is an insufficient basis for

prioritization for these purposes. EPA

therefore believes that the basis for this

exemption is no longer applicable.

However, during interagency review it

was suggested that EPA first collect the

IUR information in Parts I., II., and IV.

of the revised Form U on these

substances before collecting processing

and use information in Part III. of the

revised Form U.

The need for additional basic

information regarding production

volume and other exposure-related data

on the ongoing uses of inorganic

chemical substances has been shown in

a variety of ways. For example, the use

of asbestos building materials led to the

exposure of workers and other building

occupants to asbestos. EPA has worked

toward controlling and mitigating this

exposure to asbestos. However, there is

evidence that builders have

unknowingly been incorporating new

materials containing asbestos into

buildings (Ref. 10). By including

inorganic chemicals under the IUR,

information needed to control exposure

to asbestos in buildings would be made

available to EPA. Such examples

highlight the importance not only of

production volume data, but of the use

and other exposure-related data EPA

may propose to collect through the IUR

in the future.

At this time, EPA is proposing that

inorganic chemicals would be subject to

only partial IUR reporting. Partial

reporting consists of the information in

Parts I, II, and IV of revised reporting

Form U, whereas full reporting consists

of all information on the reporting form

(see Unit VI. of this preamble). EPA is

choosing to only require partial

reporting on inorganic chemicals to

allow the Agency to become familiar

with information on inorganics; EPA

does not generally require reporting of

information on inorganics under the

existing IUR. Partial reporting would

identify inorganic chemicals that are

produced in quantities large enough to

report to IUR, and would allow EPA to

generally become familiar with the

production volumes of inorganic

chemicals. In addition, limiting IUR

reporting for inorganic chemicals to a

partial report would allow

manufacturers (including importers) of

these chemicals, who may never have

reported to IUR before, to familiarize

themselves with the most basic IUR

reporting requirements.

Because EPA and other IUR data users

have a need for processing and use

information on inorganic substances,

EPA will review the need for full IUR

reporting, i.e., all parts of revised

reporting Form U, from manufacturers

(including importers) of inorganic

chemicals in the future. Based on EPA’s

review of the information submitted on

inorganic chemicals in the first

reporting period under these IUR

amendments, EPA may propose to

require full IUR reporting on inorganic

chemicals by the second reporting

period.

3. Need for procedural reforms to

IUR—a. Linking IUR data to other

reporting. EPA is undertaking a

comprehensive facility identification

initiative to improve coordination and

comparability among different

information reporting mechanisms. To

facilitate this effort, EPA is establishing

the Facility Registry System (FRS) as a

central information resource of

definitive facility information, which

will link all facilities represented in

EPA program data bases through

common facility identification data

elements. As part of the program, the

FRS will include implementation of a

new facility numbering system

identifying each facility with a unique

Facility Registration Identifier (FRI)

which will be used for electronic and

integrated reporting and central

receiving. EPA and the States will

develop the business rules for assigning

the FRI to each facility and will

determine how the number will be used

in reporting. EPA anticipates releasing

the first version of the FRS and the new

numbering system in the fall of 1999.

In line with the FRS initiative, EPA is

proposing to amend IUR so that future

data collections include the reporting of

the submitting plant site’s FRI, as well

as the county in which the plant site is

located. Use of the new FRI number is
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important to EPA and others in linking

IUR information with information from

other data bases, such as the Toxics

Release Inventory (TRI).

In the alternative, should the FRS

initiative not be underway at the time

this proposed rule becomes final, EPA

will require submitters to report the

plant site’s EPA identification number

(ID), if it has one. The EPA ID is the 12-

character number assigned to sites

covered by the hazardous waste

regulations under RCRA (40 CFR

262.12). For sites that have not been

assigned an EPA ID, submitters would

report this item as ‘‘not applicable.’’

Section 262.12 states that plant sites

that generate hazardous waste can

obtain an EPA ID by applying to the

EPA Administrator using Form 8700-12

‘‘Notification of Regulated Activity.’’

Upon receipt of such a request, the

Administrator assigns an EPA ID

number. Plant sites are required to

report the EPA ID on RCRA manifests

and biennial reports.

EPA also is proposing to amend the

reporting basis from a corporate fiscal

year basis to a calendar year basis. This

amendment would make the

information submitted under these

amendments more consistent than the

information submitted under the

existing IUR because all submitters

would refer to the same period of time

when gathering reportable information.

In addition, this amendment would

make the IUR reporting schedule more

comparable with other EPA reporting

requirements, such as TRI, thereby

increasing EPA’s ability to link

information from various data bases.

b. Improving the process by which CBI

claims are made. IUR submitters

currently have the ability to claim much

of the information they report under the

IUR as CBI. The ability to make CBI

claims would continue under these

amendments; however, EPA is

proposing certain modifications to

existing CBI policies in order to ensure

that CBI claims are justified, and to

facilitate the submission and subsequent

release of non-confidential data.

TSCA section 14 provides that certain

information may be claimed as

confidential. The impact of a

confidentiality claim on information is

that the information may only be made

available to properly trained Federal

government employees and contractor

employees. Accordingly, under most

circumstances, non-Federal entities

cannot be authorized for access to CBI

data for independent assessment or

other purposes. In addition to

significantly increasing transaction

costs, CBI claims can impact EPA’s

ability to use IUR data, because it is

more difficult to justify risk screening,

assessment and management decisions

when data driving those decisions are

CBI and cannot be publicly shared.

While legitimate CBI claims protect

valuable proprietary information,

invalid claims thwart the Agency’s goal

of using TSCA data to support a wide

variety of chemical management

activities as intended by Congress.

Since the enactment of TSCA in 1976,

the Agency has grappled with its

related, but somewhat conflicting,

obligations to protect CBI but also to

make information available to the

public. In 1990, the Agency initiated a

program by which industry’s TSCA CBI

claims practices were examined and

assessed (Refs. 11 and 12). The program

revealed that the Agency’s transaction

costs are increased with CBI claims, the

Agency’s ability to use CBI data is

limited, and CBI claims make it difficult

to describe with specificity the facts

necessary to justify chemical risk

assessment and management decisions.

The program also demonstrated that CBI

claims prevent state governments

engaging in chemical management

activities from benefiting from access to

TSCA CBI information (Ref. 13).

EPA’s review of CBI claims practices

also revealed that some CBI claims

appeared to be unjustified. In some

cases, certain information was claimed

as confidential when the same

information was available in a variety of

publicly available sources such as

newspapers, advertisements, and

Internet websites. For example, site

identity was at times claimed as CBI in

IUR filings when that information was

available in a variety of public

documents. While it was widely

accepted that the need for CBI

protection for certain information

expired over time, there was no

mechanism which ensured that older

CBI claims would be reviewed by the

information submitter. The public

increasingly questioned the validity of

CBI claims over time as the overall

credibility of industry’s initial CBI

claims was diminished.

One of the purposes of the CBIspecific IUR amendments is to ensure

that CBI claims are valid at the time

they are filed. Another purpose is to

ensure that certain critical information,

such as production volume information,

is submitted in a way that generally

enables the Agency to characterize

industry-wide production volume, but

that protects the specific CBI

information involved. Finally, the new

CBI amendments are intended to act as

a mechanism that ensures that

submitters periodically review older CBI

claims and declassify information as

their need for confidentiality ends.

Specifically, in an effort to increase

the public availability of data and

reduce transaction costs, EPA is

proposing requirements in addition to

those currently in place to require that

submitters assert a separate CBI claim

for production volume data reported in

ranges; submitters substantiate CBI

claims for plant site identity at the time

the claims are made; and submitters

reassert CBI claims for information

claimed as CBI in past IUR filings. A

detailed discussion of confidentiality

issues is included in Unit VIII. of this

preamble.

4. Creating an exemption from IUR

reporting for certain forms of natural

gas. EPA is proposing to add an

exemption from IUR reporting to 40 CFR

710.26 for certain forms of natural gas.

The six chemical substances that would

be subject to this exemption are as

follows: CAS No. 64741-48-6, Natural

gas (petroleum), raw liquid mix; CAS

No. 68919-39-1, Natural gas

condensates; CAS No. 8006-61-9,

Gasoline natural; CAS No. 68425-31-0,

Gasoline (natural gas), natural; CAS No.

8006-14-2, Natural gas; and CAS No.

68410-63-9, Natural gas, dried.

EPA currently believes that additional

IUR information on these chemical

substances would be of limited value in

the execution of various assessment and

testing programs because EPA believes

that adequate IUR information on these

chemical substances is available to

fulfill EPA’s current needs, and the

current needs of other IUR information

users.

B. Consideration of Alternative Data

Sources

TSCA section 8(a)(2) states that, to the

extent feasible, the Administrator of

EPA shall not impose reporting

requirements under TSCA section

8(a)(1) which are unnecessary or

duplicative. In order to ensure that the

reporting requirements proposed in

these amendments are not unnecessary

or duplicative, EPA considered the

extent to which the data that would be

gathered as a result of this rulemaking

are available to EPA through existing

public data collections.

The data collections considered by

EPA include EPA sources such as the

current IUR, the TSCA Preliminary

Assessment Information Reporting

(PAIR) rule (40 CFR part 712), the TRI,

and the Use and Exposure Information

Project (UEIP), as well as other Federal

sources such as the National

Occupational Exposure Survey (NOES).

EPA has used these sources to support

its chemical review program. Although
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the sources can provide useful

information, EPA has been unable to

perform the large-scale screening

necessary to screen the chemicals on the

TSCA Inventory based on risk because

of limitations in the existing data. Some

sources are dated, others are narrow in

coverage of data elements or limited to

certain chemical substances, while

others entail procedural complications

which limit their effectiveness in

meeting EPA’s needs. Based on this

review, EPA has concluded that these

information sources, considered

individually or in the aggregate, do not

adequately substitute for the

information EPA is proposing to collect

in this rulemaking. A detailed

description of the basis for this

conclusion is provided in the several

documents provided in the public

record for this proposal. These

documents are: ‘‘Inventory Update Rule

(IUR) Amendment Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening,’’

‘‘Economic Analysis of Proposed

Amendments to the TSCA Section 8

Inventory Update Rule,’’ and ‘‘A Review

of Existing Exposure-Related Data

Sources and Approaches to Screening

Chemicals: A Response to CMA.’’ These

documents are listed at Unit X.A.2.a.,

Unit X.A.2.f., and Unit X.A.2.i. of this

preamble respectively.

The following is a brief description of

the extent to which each of these data

collections includes exposure-related

information (e.g., number of plant sites

and workers, industrial and consumer

uses, etc.), and whether they are

sufficient for the risk-based screening of

chemical substances listed on the TSCA

Inventory. The documents mentioned in

the preceding paragraph provide a more

comprehensive and detailed discussion

of existing exposure information data

sources.

1. The current IUR. Although certain

provisions in the current IUR would be

amended by this action, many of its

requirements would remain unchanged

under these amendments. The existing

IUR requires chemical manufacturers

(including importers) to provide to EPA

every four years the identity of chemical

substances manufactured (including

imported) in annual quantities of 10,000

lbs. or more at each plant site they own

or control. The information required

includes company name, plant site

location, plant site Dun and Bradstreet

number, the identity of the chemical

substance, and the production volume

of the chemical substance. The IUR has

been a reliable source of production

volume and site location data for

organic chemical substances. Inorganic

chemical substances are currently

excluded from reporting.

Past approaches to the risk screening

of chemical substances have been

primarily based on relative chemical

substance hazard, coupled with IUR

production volume data. EPA has

determined that production volume

information alone is not typically

adequate as a proxy for exposure

information for purposes of risk

assessment and risk screening (Ref. 14).

In the past, the absence in IUR of

exposure-related data beyond

production volume data has severely

limited the utility of IUR in a

comprehensive screening program for

chemicals in commerce.

2. PAIR rule. PAIR, which was

promulgated under TSCA section 8(a),

requires any person who manufactures

(including imports) a particular

chemical substance during the indicated

reporting year to complete and submit a

form that requests a variety of

information pertaining to the

manufacture and processing of TSCA

chemicals. In some ways this

information is similar to the information

that would be reported under these

amendments to IUR, while in other

ways the information reported under

PAIR is different.

Information reported under PAIR

includes, but is not limited to, the

following: chemical and company

identity, plant site location, annual

volume manufactured (including

imported), plant site and customer

activities (i.e., whether the substance is

manufactured or used as a reactant or

nonreactant, and whether operations are

enclosed, controlled release or open),

workers and worker hours, and types of

industrial products (i.e., whether the

substance is produced in pure form or

incorporated into a mixture or article),

and whether environmental releases

occur (see 40 CFR 712.28). This

information, on a per report basis, is

both broader and narrower than the

proposed IUR amendments information.

For instance, release information is

collected under PAIR, but would not be

collected under the proposed IUR

amendments. At the same time, PAIR

reporting does not include information

which can identify uses by specific

consumer groups or NAICS codes,

whereas the proposed IUR amendments

would require the reporting of such

information by certain entities.

Duplicative reporting under both PAIR

and IUR is avoided under the existing

IUR regulations at 40 CFR 710.35, and

would be avoided under the proposed

IUR amendments as well.

The TSCA Interagency Testing

Committee (ITC) determines which

chemical substances are included on the

TSCA section 4(e) Priority Testing List.

PAIR rules are primarily used to collect

information on those chemicals the ITC

is considering designating for testing

under TSCA section 4 (40 CFR 712.30).

PAIR reporting is done on a one-time

basis in response to the publication of

a chemical-specific rule amendment, as

opposed to the IUR which, in a single

rule, requires recurring reporting for a

large group of chemicals. About 458

chemicals have been subject to PAIR

reporting as of September 1996, and 360

companies have submitted 1,668 reports

(See ‘‘Preliminary Assessment

Information Rule (PAIR) Database,

Manufacturing Process Type/Release

Analysis and Number of Workers/

Production Quantity Analysis,’’

available in the public record for this

proposal, and listed at Unit X.A.2.b. of

this preamble). Other features of PAIR

include a reporting threshold of 500 kg/

yr/site and reporting based on a

corporate fiscal year.

Both PAIR and IUR could potentially

be utilized to require the reporting of

data regarding a greater number of

chemical substances than the IUR

currently covers. For example, the

current IUR exemption for polymers and

low volume chemicals could be

eliminated, or a PAIR rule could be used

to collect information for these

exempted chemicals.

There are two major differences

between reporting under IUR and PAIR

other than differences in specific data

elements. One of the differences is that

IUR requires the reporting of

information every 4 years, while PAIR

requires the reporting of information on

a one-time basis. However, the chemical

industry is dynamic, and 30% of the

chemicals for which IUR information

was reported in 1990 were not reported

in 1994. Because the industry is

dynamic, the information it would

report under the IUR amendments could

change from reporting year to reporting

year. Therefore, the information

collected under these amendments

would present a view of exposure to

chemical substances that recognizes

chemical industry dynamics which

PAIR rules are not able to reveal. The

other major difference between IUR and

PAIR is that IUR requires the reporting

of information on a large number of

chemical substances during each

reporting period, whereas each PAIR

rule typically covers only one or a much

more limited group of chemical

substances. As discussed above,

information on a large number of

chemicals is necessary for the effective

implementation of a chemical screening

program.
46780 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

3. Toxics Release Inventory (TRI).

EPCRA section 313 and section 6607 of

the Pollution Prevention Act (42 U.S.C.

13106(b)) require certain facilities that

manufacture, import, process, or

‘‘otherwise use’’ EPCRA section 313

listed toxic chemicals at or above

specified thresholds to annually report

their releases and other waste

management activities regarding such

substances. The reporting thresholds are

generally 25,000 lbs. per year for

chemicals that are manufactured

(including imported) and processed,

and 10,000 lbs. per year for chemicals

that are otherwise used. Included in the

report is the following information:

Chemical identity, facility identity,

parent company identity, certain general

activities and uses of the chemical at the

reporting facility, the maximum amount

on-site, releases on-site and quantities

sent off-site for disposal, quantities

combusted for energy recovery and

recycled both on-site and off-site, and

on-site waste treatment methods and

efficiencies.

Only about 650 chemicals and

chemical categories are currently

reportable, including chemicals

excluded from TSCA jurisdiction such

as pesticides, and chemicals currently

exempt from the IUR, such as

inorganics. This list consists of fewer

than 1% of the chemicals listed on the

TSCA Inventory. In addition, facilities

subject to the reporting requirements of

EPCRA section 313 are limited to

specific SIC codes and Federal facilities.

Only facilities with 10 or more full-time

employees are currently required to

report. About 22,000 facilities report to

TRI.

TRI data are useful for screening and

assessing releases from industrial

facilities for site-specific assessments of

potential general population or

environmental exposures to populations

near facilities that manufacture, process

or use EPCRA section 313 listed toxic

chemicals. However, the TRI universe of

chemicals is limited to a small portion

of the chemicals on the TSCA Inventory.

Also, TRI does not contain worker

exposure and use data. These data,

along with a larger universe of

chemicals than is included in the TRI,

are needed to accomplish the type of

broad based chemical screening process

that would be possible under the

proposed IUR amendments.

4. National Occupational Exposure

Survey (NOES). In 1983, NIOSH

completed a systematic effort to collect

data on potential occupational

chemical, physical, and biological

exposure agents in a representative

sample of businesses. The sample was

designed to be representative of

virtually all of the non-agricultural, nonmining, and non-governmental

businesses covered under the

Occupational Safety and Health Act

(OSH Act) of 1970. The survey consisted

of observational data collected at 4,490

establishments by NIOSH surveyors

through field visits, which included

walk-through surveys and interviews of

employees at the establishments. To

develop nationwide samples from the

data, the survey results were multiplied

by a weighting factor. A description of

the survey and the data base can be

found in the public record for this

proposal (Ref. 15).

The NOES data base includes

information on plant site location, plant

site SIC code, plant site occupational

safety and health programs,

occupational titles of workers

potentially exposed, number of

employees per occupational title,

process steps, and product trade names.

EPA has frequently used the NOES

survey to estimate the total number of

workers potentially exposed per

chemical per SIC code; to estimate the

number of chemical manufacturing,

processing, and use sites; to rank

potential exposures; and to develop

exposure assessments.

Now over 15 years old, the NOES data

have become progressively dated, and as

a consequence, less representative of

current exposure situations. In light of

this shortcoming, EPA believes that the

NOES data base cannot substitute for

the up-to-date data base that EPA would

develop with the proposed IUR

amendments.

5. Use and Exposure Information

Project (UEIP). The UEIP is a program

developed jointly by EPA and chemical

manufacturers. It provides a method for

chemical manufacturers to voluntarily

send readily obtainable use and

exposure information to EPA for

chemical substances entering the

Existing Chemicals Program’s screening

assessment process. A sample UEIP data

submittal package is included in the

public record for this rulemaking (Ref.

2). The program started in the fall of

1992 and was developed after CMA and

SOCMA asked EPA what the chemical

industry could do to help strengthen

EPA’s Existing Chemicals Program. EPA

explained that accurate use and

exposure information was not available

and that better information in this area

was a key need. A joint industry/EPA

workgroup was formed to address this

need, to define relevant exposure data,

and to develop a data transfer process

for industry to effectively transmit data

to EPA. More recently, the API and

CSMA have endorsed and participated

in further development of this project.

In the UEIP, manufacturers (including

importers) voluntarily report production

volume, site location, environmental

releases, number of potentially exposed

workers, monitoring data, industrial and

consumer uses, and percent of

production volume attributed to a given

use. For any given chemical substance,

the data transmitted to EPA via UEIP are

more detailed than the data EPA would

receive as a result of these IUR

amendments. Upon receipt of UEIP data

from manufacturers and importers, EPA

prepares an exposure profile. The UEIP

program is limited by agreement among

the parties to obtaining data on no more

than 40 chemical substances per year.

The screening information that would

be generated by this proposal would

assist with the selection of chemical

substances for inclusion in the UEIP

program.

The UEIP program has yielded

important advances for EPA’s risk

assessment and risk management efforts

for several chemical substances. For

example, exposure assessments based

on the UEIP data have in some instances

obviated the need for additional testing

or followup risk management action for

certain chemical substances under the

SIDS program. However, the proposed

amendments to IUR would include a

wider range of chemicals than the UEIP

and therefore would address the need

for exposure-related data from across a

wider segment of the chemical industry.

6. Use Cluster Scoring System (UCSS).

EPA has developed the UCSS to identify

potential risks of, and to establish

regulatory review priorities for,

chemical substances used in similar

applications, or ‘‘use clusters’’ (Ref. 16).

For example, instead of evaluating a

single chemical used as a paint stripper,

the UCSS evaluates the exposures and

risks posed by the entire set of chemical

substances that are used as paint

strippers.

The UCSS evaluates exposure based

on information from several sources.

Although the UCSS has proven to be a

valuable tool in conducting screening

level exposure assessments, some of the

sources of UCSS data are dated and

some of the methods used to further

develop the data are not yet validated

for accuracy. Some of these data are

discussed briefly below.

Use volume estimates are obtained

from past EPA studies and commercial

market reports. These sources are very

limited in the number of uses covered

and the detail of use information. Only

large volume uses (100,000 kilograms/

year or more) of chemical substances are

usually captured in commercial market

studies. These studies are further

discussed in the document entitled, ‘‘A
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Review of Existing Exposure-Related

Data Sources and Approaches to

Screening Chemicals: A Response to

CMA,’’ available in the public record for

this rulemaking and listed at Unit

X.A.2.i. of this preamble.

Consumer use data are obtained from

internal data bases (such as EPA’s

Indoor Air Chemical Database) and the

Hazardous Substances Data Bank

(HSDB), a database of Department of

Transportation (DOT) information

compiled by the National Library of

Medicine. Each of these data bases,

however, contains limited consumer use

information for a small number of

chemicals. These data bases are further

discussed in the document entitled,

‘‘Economic Analysis of Proposed

Amendments to the TSCA Section 8

Inventory Update Rule,’’ and in ‘‘A

Review of Existing Exposure-Related

Data Sources and Approaches to

Screening Chemicals: A Response to

CMA,’’ both of which can be found in

the public record for this proposal and

which are listed at Unit X.A.2.f. and

Unit X.A.2.i. of this preamble.

Environmental release estimates are

obtained from the TRI. The UCSS is not

limited to TRI chemicals; however, no

comprehensive sources of release data

are available for non-TRI chemical

substances. While the UCSS contains

data from the Biennial Reporting System

(BRS), these data are not used by UCSS

to rank potential exposures. BRS, a data

base maintained by EPA’s Office of

Solid Waste, is a collection of

information on the quantity,

management, and minimization of

hazardous solid or liquid wastes from

facilities that generate and/or manage

these wastes. Information is identified

by the RCRA waste codes. These waste

codes identify the type of waste and

frequently describe mixtures of

chemicals; they do not provide

information on the waste stream

composition. This lack of composition

information makes it difficult to

determine the quantity of an individual

chemical substance in the waste.

Therefore, there is little information to

use to determine potential exposures.

Estimates of the number of potentially

exposed workers and the number of

chemical processing and use sites are

obtained from the NOES and the Bureau

of Census’ Census of Manufacturers. As

in Unit V.B.4. of this preamble, the

NOES data (developed by NIOSH) are

over 15 years old and contain

uncertainties due to the age of the data

as well as sampling errors and

systematic biases. The Census of

Manufacturers data are not chemicalspecific; chemical-specific or usespecific conclusions are therefore based

upon data provided by four-and sixdigit SIC codes when Census of

Manufacturers data are used.

A recent review of the UCSS by EPA’s

Science Advisory Board (Ref. 17) found

that ‘‘the cluster scoring system heavily

weights exposure data. . . Unfortunately,

there are no easily accessible data on

exposure.’’ The proposed amendments

to the IUR would create a data source

that would be used to augment the

information in the UCSS, giving EPA a

tool for use in prioritizing chemical

clusters in a way that is consistent with

the Science Advisory Board’s

suggestions (Ref. 16). Because the

exposure information sources used to

support many of EPA’s existing

chemical assessments are essentially the

same as those relied upon by the UCSS,

this comment is generally applicable to

most of EPA’s efforts to assess exposure

to existing chemical substances.

7. Other data sources. Other data

sources that have been considered are

listed in the ‘‘Inventory of ExposureRelated Data Systems Sponsored by

Federal Agencies’’ (Ref. 18). This

document is a compilation of

information on federally managed data

systems that contain exposure

information. These systems access

collections of analytical results that

assess environmental media such as air,

soil, or water as well as analytical

results from food, human samples, or

bulk chemicals.

Each of the data bases described in

the document is of limited utility due to

a small or specialized sample size, the

limited number of chemicals, or the age

of the data. None of the data bases,

either alone or combined, provide the

Agency with the full array of screening

level data on chemical substances that

would be collected by the proposed

amendments to IUR.

The information in available data

systems does not provide a sufficiently

clear picture of the potential for

chemical exposure. Some of the systems

are regional, rather than national in

scope. Several systems cover only a very

limited set of chemical substances, or a

limited number of chemical uses, or

only specific industry sectors. Several

systems collect information on

categories of pollutants or on waste

streams rather than on specific chemical

substances, making it difficult to use the

data in chemical risk screening. Many of

these systems collect monitoring data

which are frequently media-specific

(e.g., air or water), but do not collect

information on the potential sources of

chemical releases to the environment.

This proposed rule would provide the

exposure information needed for

screening the chemical substances

included on the TSCA Inventory for

potential risk.

VI. Amendments Affecting All

Manufacturers (Including Importers)

As discussed in detail in Unit VI.B. of

this preamble, plant sites that

manufacture (including import) a

chemical substance in annual quantities

of 25,000 lbs. or more would be required

to report the information in Parts I., II.,

and IV. of Revised Reporting Form U.

This information relates to basic site

identification, manufacturing

information, and CBI reassertion. Sites

that manufacture (including import) a

chemical substance in annual quantities

of 300,000 lbs. or more would be

required to report the information in

Part III. of Reporting Form U in addition

to the information in Parts I., II., and IV.

This additional information relates to

the processing and use of chemical

substances.

BILLING CODE 6560–50–F
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BILLING CODE 6560–50–C
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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 multicomponent complex chemical

substances listed by Chemical Abstracts

Service (CAS) Registry Number in the

proposed regulatory text at § 710.26(d).

The reporting excluded by this

exemption would be the exposurerelated data contained in Part III. of

Revised Reporting Form U. The

chemical substances listed as petroleum

process streams in the proposed

regulatory text were derived from the

1983 publication of the API entitled

‘‘Petroleum Process Stream Terms

Included in the Chemical Substances

Inventory Under the Toxic Substances

Control Act (TSCA)’’ (Ref. 19). Chemical

substances listed in the API document

consisting of a single component

chemical, except for water, would not

be considered petroleum process

streams for IUR reporting purposes.

This exemption is not being proposed

because these streams are of known low

toxicity. In fact, EPA believes that

several petroleum process streams are

toxicologically active; however, EPA

believes that it, as well as other IUR

information users, will not have a need

in the near future for full IUR reporting

on petroleum process streams. EPA will

take action to revoke this exemption if

its needs change. About 5,850 of the

about 24,000 IUR reports submitted to

EPA during the 1994 reporting period

were for chemical substances that fit the

definition of petroleum process streams.

Therefore, this proposed exemption is

expected to significantly reduce

submitters’ reporting burdens from the

burden that would exist without the

exemption.

3. Natural gas. EPA is proposing to

exempt certain forms of natural gas from

IUR reporting. The chemical substances

that would be covered by this

exemption are the following: CAS No.

64741-48-6, Natural gas (petroleum),

raw liquid mix; CAS No. 68919-39-1,

Natural gas condensates; CAS No. 8006-

61-9, Gasoline natural; CAS No. 68425-

31-0, Gasoline (natural gas), natural;

CAS No. 8006-14-2, Natural gas; and

CAS No. 68410-63-9, Natural gas, dried.

EPA believes that adequate IUR

information collected on these chemical

substances to date is available to fulfill

EPA’s current needs, and the current

needs of other IUR information users.

EPA specifically requests comment on

whether IUR reporting for these six

natural gas substances should be

required in upcoming reporting periods,

and whether the six CAS numbers

identified are the appropriate natural

gas substances for inclusion in this

exemption. EPA will take action to

revoke this exemption if its needs

change in the future. Approximately

1,225 of the 24,000 IUR reports

submitted to EPA during the 1994

reporting period were for the six

chemical substances included in this

proposed exemption. Therefore, this

proposed exemption would likely result

in a beneficial burden reduction for IUR

submitters.

B. Amendments to Reporting

Thresholds

EPA is proposing to raise the IUR

reporting threshold from a production

volume of 10,000 lbs. per year to 25,000

lbs. per year. Every person

manufacturing (including importing) a

non-excluded substance at or above the

threshold would be required to report

the information in Parts I., II., and IV.

of Revised Reporting Form U. The

increased IUR reporting threshold

would make the IUR and TRI reporting

thresholds equivalent at 25,000 lbs. per

year for manufacturers (including

importers). These thresholds are also

approximately equal to the recently

amended PMN low volume exemption

threshold of 10,000 kg (approximately

22,000 lbs.). EPA is proposing to raise

this reporting threshold in order to

reduce the number of reports filed, thus

reducing industry burden. The new

reporting threshold does not represent a

finding of low exposure or low risk.

EPA is also proposing a second,

higher-volume threshold of 300,000 lbs.

per year. Persons who manufacture

(including import) a non-excluded

substance at or above this level would

be required to report the information in

Part III. of Revised Reporting Form U in

addition to the information in Parts I.,

II., and IV. The information reported

under Part III. relates to the processing

and use of chemical substances. EPA

recognizes that the requirement that

processing and use information be

reported would impose a burden on

industry. EPA originally considered

proposing a higher-volume threshold of

100,000 lbs. per year; however, in the

interest of further reducing the

paperwork burden imposed on industry,

EPA is proposing a higher-volume

threshold of 300,000 lbs. per year. EPA

is proposing this separate threshold to

limit exposure data reporting to a subset

of a few thousand IUR reportable

chemicals.

The new, higher thresholds proposed

in this action are consistent with a

report from the General Accounting

Office (Ref. 20), which recommended

that, ‘‘. . .the inventory could be more

useful to EPA and other interested

parties if it initially focused on a smaller

number of the highest-priority

chemicals known to present risks to

health and the environment and was

expanded as necessary.’’ EPA

considered a number of different

thresholds between 10,000 lbs. and

50,000 lbs. for basic IUR information

and between 10,000 lbs. and 10,000,000

lbs. for processing and use information

(See ‘‘Economic Analysis of Proposed

Amendments to the TSCA Section 8

Inventory Update Rule,’’ available in the

public record for this rulemaking and

listed in this preamble at Unit X.A.2.f.).

EPA examined each of these options in

light of the benefits that would be

obtained from the information collected,

EPA’s ability to utilize that information,

and the burden imposed on the public

to provide the information. EPA

concluded that processing and use

information would be highly valuable

(see Ref. 14), but that EPA would likely

focus initially on larger volume

chemical substances.

In order to retain information on

potential substitutes for the larger

volume chemical substances, but at the

same time reduce the public reporting

burden, EPA initially considered

proposing a 100,000 lb. higher-volume

reporting threshold for processing and

use information to reduce the

paperwork burden on industry.

Although EPA believes a 100,000 lbs.
46786 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

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 indepth regulatory review (see Ref. 14).

The new, higher reporting thresholds

would result in a reduction in the

number of currently reportable

chemicals. However, this reduction

would be partially offset by the

elimination of the exemption for

inorganic chemical substances. Under

the current IUR, EPA receives reports on

about 8,900 chemical substances. The

Agency estimates that raising the

reporting threshold from 10,000 lbs. to

25,000 lbs. reduces the number of

reportable chemicals to about 7,800,

while deleting the exemption for

inorganic chemical substances would

increase the number of reportable

chemicals by about 1,200. Of the

approximately 8,900 reportable

chemical substances expected under the

IUR amendments, about 4,050 would

likely be produced in volumes of

300,000 lbs. or more and would require

the completion of the entire revised

reporting form.

C. Amendments to Reporting Period and

Frequency

Under the current IUR regulations at

40 CFR 710.33(b), submitters are

required to report on a recurring basis

between August 25 and December 23

every 4 years (‘‘the reporting period’’).

EPA is not proposing to change this

requirement. However, the current IUR

regulations indicate that the information

reported during each reporting period is

from the submitter’s latest complete

corporate fiscal year prior to the

reporting period. In order to standardize

reporting time frames across IUR

submitters and across various other

reporting programs, such as the TRI

program, the Agency is proposing to

change this IUR reporting scheme from

a fiscal year reporting basis to a calendar

year reporting basis. This would mean,

for example, that the information that

would be reported during the reporting

period from August 25 to December 23

in the year 2002 would be from calendar

year 2001.

D. Amendments to Recordkeeping

Requirements

Currently, the Inventory regulations at

40 CFR 710.37 require submitters to

retain records on IUR reports for 4 years.

In these amendments to IUR, EPA is

proposing that persons subject to the

rule be required to retain records that

document information reported for 5

years after the end of the relevant

reporting period. For example, if a

person submits an IUR report in the

reporting year 2002, that person would

be required to retain the records on

which the report is based until

December 31, 2007. This change, which

would assist EPA’s enforcement of the

IUR, would result in the requirement

that submitters maintain records that

span successive reporting periods,

which would continue to occur every 4

years as under the existing IUR.

Persons who are not required to report

under the existing IUR because they

manufacture less than the 10,000 lb.

reporting threshold are required to

retain volume records as evidence to

support a decision not to submit a

report. In this rulemaking, EPA is

proposing that this provision be

eliminated because EPA believes that

this information is of the type that

companies would routinely retain in the

normal course of business.

E. Amendments to Reportable Data

Elements

The new and revised data elements

that would be reported under the rule

are discussed in this section. Data

elements that are currently reported

under IUR but that would not be revised

by these amendments (such as company

information, Part I., Section II. of

Revised Reporting Form U; site-limited

activity, Part II., Section II.; and

manufacturer/importer activity, Part II.,

Section II.) are not generally discussed

because EPA is not reopening these data

elements for comment. Although certain

CBI issues are mentioned in this section

(see Unit VI.E.3. of this preamble, for

example), changes to CBI procedures are

discussed more completely in Unit VIII.

of this preamble.

1. Plant site identification (Part I.,

Section III. of Revised Reporting Form

U). EPA currently requires the following

information to be reported for each

plant site at which a reportable

chemical substance is manufactured

(including imported) in amounts greater

than the reporting threshold: the plant

site name, Dun and Bradstreet number,

street address, city, state, and zip code.

The site for a chemical substance

importer is the site of the operating unit

within the importer’s organization that

is directly responsible for importing the

substance and that controls the import

transaction, and may in some cases be

the organization’s headquarters office in

the U.S.

EPA believes additional plant site

identifiers would allow for full

integration of IUR data with other

‘‘place-based’’ environmental data

collected by EPA or states under other

regulatory authorities into multi-source

and function data bases. By facilitating

this integration, the Agency would be

better able to address its obligations

under TSCA section 10, and would

thereby achieve the intended TSCA goal

that information collected under the Act

be made easily accessible to a wide

variety of governmental and

nongovernmental entities. With data

integrations, TSCA data could be fully

utilized as a ‘‘feedstock’’ for a wide

variety of chemical management

activities.

Providing linkages and achieving

integration for environmental data

across various data bases are important

EPA goals under TSCA. While it was

always intended that TSCA data be

made available to chemical managers,

until relatively recently, the primary

user of TSCA data has been OPPT and

the TSCA data systems were designed

with this user in mind. Over the last

several years, however, TSCA data has

been sought by a wide variety of

Federal, State and private organizations.

For example, several States routinely

contact the Agency to gain access to

TSCA data that might be useful for their

implementation of both State laws and

Federally delegated laws. As demand

has increased, EPA has recognized that

the existing TSCA data systems do not

always efficiently address the needs of

the non-OPPT user.

Another benefit associated with fully

integrating TSCA data into multi-source

and function data bases is that

duplicative information collections

would be more easily identified and
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46787

eliminated. Finally, improved linkages

among data bases would provide the

public with access to additional

information at little or no burden to the

regulated community.

EPA is proposing to require the

reporting of two identifiers for each

plant site reporting under IUR:

a. The Facility Registration Identifier

(FRI) (if the plant site has one).

b. The county or parish (or other

jurisdictional indicator) in which the

plant site is located.

EPA is establishing the Facility

Registry System (FRS) as a central

resource of facility information, which

will link all facilities represented in

EPA program data bases through

common facility identification data

elements. The FRS will include a new

facility numbering system identifying

each facility with a unique Facility

Registration Identifier (FRI) which will

be used for electronic and integrated

reporting and central receiving. The

business rules for assigning an FRI to

each facility will be developed by EPA

and the States. EPA anticipates releasing

the first version of the FRS and the new

numbering system in the fall of 1999.

The first reporting year under the final

IUR amendments should occur after this

system is in effect. For sites that have

not been assigned an FRI, submitters

would report this item as ‘‘not

applicable.’’

In the alternative, should the FRS

initiative not be underway at the time

this rule becomes final, EPA will require

submitters to report the plant site’s EPA

identification number (ID), if it has one.

The EPA ID is described by the 12-

character number assigned to sites

covered by the hazardous waste

regulations under RCRA (40 CFR

262.12). This number is further

described in Unit V.A.3.a. of this

preamble. For sites that have not been

assigned an EPA ID, submitters would

report this item as ‘‘not applicable.’’

The TRI program has demonstrated

that many public and private sector

organizations find it useful to aggregate

release data by county or parish of

reporting plant sites when evaluating

chemical risks. EPA believes that there

is merit to including similar geographic

identifiers in future IUR reporting so

that similar aggregations of IUR data can

be generated. The two proposed plant

site identifiers will facilitate improved

linkages of the IUR information to other

data bases, enabling the Agency to

perform more comprehensive risk

screening, assessment, and management

activities.

2. Chemical identification (Part II.,

Section I. of Revised Reporting Form U).

The IUR currently requires

manufacturers (including importers) to

report both the specific chemical

substance name and the Chemical

Abstracts Service (CAS) Registry

Number of each reportable chemical

substance manufactured (including

imported) in amounts over 10,000 lbs.

per year. EPA is proposing to require

that chemicals be identified only by

EPA Accession Number, PMN case

number or Inventory reporting form

number when the CAS Registry Number

is unknown to the submitter. Other

previously used substitute identifying

numbers (such as EPA-assigned

numbers for Test Market Exemption

applications) would not be allowed

because they cannot be efficiently crossreferenced to CAS Registry Numbers.

3. Confidentiality of production

volume range. In addition to the

requirement that specific production

volume be reported, EPA is proposing to

amend the IUR to allow submitters to

claim a pre-determined production

volume range corresponding to the

reported production volume number as

CBI. This claim would be separate from

a CBI claim for the specific production

volume. Production volume range

reporting is included in these

amendments because EPA believes that

the availability of range information is

less likely to raise CBI concerns than the

availability of specific production

volume figures. Accordingly, EPA

expects that the confidentiality claim

rates will be roughly 50% lower for the

reporting of volume ranges than for the

reporting of specific volumes. EPA’s

expectation of reduced CBI claims for

production volume ranges is based on

the CBI claim statistics associated with

the development of the original TSCA

Inventory (See ‘‘Inventory Update Rule

(IUR) Technical Support Document:

Evaluation of Likelihood of Confidential

Business Information Claims for

Production Volume Information,’’

available in the public record for this

rulemaking and listed at Unit X.A.2.g. of

this preamble) as well as comments

received from industry (Ref. 21). If this

expectation is correct, the public would

have greater access to data on chemical

production volumes, and the Agency

would be better equipped to publicly

release more data relevant to its risk

screening decisions.

EPA is proposing to use the following

production volume ranges for future CBI

determinations:

• At least 25,000 but less than

100,000 lbs.

• At least 100,000 but less than

1,000,000 lbs.

• At least 1,000,000 but less than

10,000,000 lbs.

• At least 10,000,000 but less than

50,000,000 lbs.

• At least 50,000,000 but less than

100,000,000 lbs.

• At least 100,000,000 but less than

500,000,000 lbs.

• At least 500,000,000 but less than

1,000,000,000 lbs.

• At least 1,000,000,000 lbs.

These ranges were first used in the

development of the original TSCA

Inventory, except that the proposed

ranges start at the proposed IUR

reporting threshold of 25,000 lbs. rather

than the existing 10,000 lb. threshold.

4. Number of potentially exposed

workers (Part II., Section III. of Revised

Reporting Form U). Workers involved in

chemical manufacturing (including

importing), processing and use are a

subpopulation of concern to EPA, the

Occupational Safety and Health

Administration (OSHA) (Ref. 22), the

National Institute of Occupational

Safety and Health (NIOSH) (Ref. 23),

and other organizations. Workers may

often be exposed to chemical substances

in higher doses and with greater

frequency than the general population,

and so are potentially at greater risk of

adverse health effects. Accordingly, EPA

and other organizations believe that it is

important to be able to estimate the

number of workers potentially exposed

to specific chemical substances when

developing priorities for testing, more

detailed risk assessment, and risk

management.

EPA is proposing to use ranges for the

reporting of certain quantitative

estimates, including number of workers

and number of processing sites (see Unit

VII.A. of this preamble), instead of

requiring the reporting of specific

values. In general, EPA believes that

reporting these estimates in ranges has

two advantages over requiring the

reporting of specific values:

a. Range reporting would reduce the

potential burden to submitters of

developing a precise point estimate for

the data element.

b. Range reporting should reduce CBI

claims because ranges tend to reveal less

sensitive information than specific

estimates while still conveying

information useful to more effectively

screen chemical risks.

Submitters would be permitted to claim

the reported ranges as confidential if

even revealing this general information

would disclose CBI.

EPA is proposing to require reporting

of the range code that corresponds to the

submitter’s estimate of the total number

of workers reasonably likely to be

exposed to each reportable chemical

substance at each reporting plant site.

EPA is proposing to define ‘‘reasonably
46788 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

likely to be exposed’’ as an exposure to

a chemical substance which, under

foreseeable conditions of manufacture

(including import), processing,

distribution in commerce, or use of the

chemical substance, is more likely to

occur than to not occur. Such exposures

would normally include, but not be

limited to, exposure during activities

such as charging reactor vessels;

drumming; bulk loading; cleaning

equipment; maintenance operations;

materials handling and transfers; and

analytical operations. Covered

exposures include exposures through

any route of entry (inhalation, ingestion,

skin contact or absorption, contact with

personal protective equipment, etc.), but

excludes accidental or theoretical

exposures. The use of protective

equipment or engineering controls to

minimize worker exposures cannot be

used by submitters as a rationale for

lowering their estimates of the total

number of exposed workers.

EPA has considered using the OSHA

hazard communication standard’s (29

CFR 1910.1200) definition of exposed

worker for amended IUR reporting. The

Hazard Communication Standard

defines ‘‘employee’’ as a worker who

may be exposed to hazardous chemicals

under normal operating conditions or in

foreseeable emergencies. Workers such

as office workers or bank tellers who

encounter hazardous chemicals only in

non-routine, isolated instances are not

covered. The Standard also defines

‘‘exposure’’ or ‘‘exposed’’ as the

subjection of an employee to a

hazardous chemical in the course of

employment through any route of entry

(inhalation, ingestion, skin contact or

absorption, etc.) and includes potential

(e.g. accidental or possible) exposure. In

EPA’s view, this definition is overly

broad for IUR purposes and for use in

exposure assessments. The definition,

for OSHA’s purposes, was intended to

be protective in order to ensure that all

workers that could conceivably be

exposed to a chemical substance would

receive hazard communication. EPA

solicits comment on the definition of

‘‘reasonably likely to be exposed’’ that

the Agency has selected for this

proposed rule.

The proposed ranges for reporting the

estimated number of potentially

exposed workers are as follows:

• Less than 10.

• At least 10 but less than 25.

• At least 25 but less than 50.

• At least 50 but less than 100.

• At least 100 but less than 250.

• At least 250 but less than 500.

• At least 500 but less than 1,000.

• At least 1,000 but less than 10,000

• At least 10,000.

5. Physical Form (Part II., Section III.

of Revised Reporting Form U). EPA is

proposing to require submitters to report

the physical form of each reportable

chemical substance as it leaves their

sites. EPA believes that the physical

form of a chemical is an important

factor to consider when estimating

magnitudes and concentrations of

potential exposures. Two technical

documents that support this proposed

rule, entitled, ‘‘Inventory Update Rule

(IUR) Amendment Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening,’’

and ‘‘Preliminary Assessment

Information Rule (PAIR) Database,

Manufacturing Process Type/Release

Analysis and Number of Workers/

Production Quantity Analysis,’’ both

available in the public record for this

proposal (listed at Unit X.A.2.a. and

Unit X.A.2.b. of this preamble), state

that an EPA data analysis demonstrated

that information regarding the physical

form of chemical substances provides an

indication of potential chemical

exposures to the environment or to

humans. EPA is proposing that

submitters would select the category

that best describes the physical form of

the chemical as it leaves their site. In the

event the submitter ships a chemical in

more than one physical form, the

submitter must report the code

corresponding to the physical form of

the majority of the chemical

manufactured (including imported). The

proposed categories for reporting the

physical form are as follows:

• Dry powder.

• Pellets or large crystals.

• Water- or solvent-wet solid.

• Other solid.

• Gas or vapor.

• Liquid.

The Agency recognizes that, for some

chemical substances, the physical form

of the substance at the time it leaves the

submitter’s site may not be the same

physical form of the substance during

processing and use; the Agency believes

that such substances constitute a

minority of all reportable chemical

substances, and that it can, based on its

knowledge of work practices in many

industrial sectors, successfully identify

many of the substances that undergo

changes in physical form during

processing and use. Therefore, to limit

submitters’ reporting burdens, EPA is

proposing that physical form reporting

be limited to the physical form of the

substance at the time it leaves a

submitter’s site. Comments are invited

on this proposed approach.

6. Average and maximum

concentration in commercial products

(Part II., Section III. of Revised

Reporting Form U). EPA is proposing to

require submitters to report the average

and maximum concentration, measured

by weight, of the reportable chemical

substance as it leaves their sites in a

commercial product. EPA believes that

concentration is an important factor to

consider when estimating magnitudes of

potential exposures. Information related

to average concentration is valuable

when estimating the potential for

concerns due to chronic exposures,

while information related to maximum

concentration is useful when estimating

the potential for concerns due to acute

exposures. EPA frequently uses models

to estimate potential human inhalation

and dermal exposures (Ref. 24). In the

absence of concentration data, EPA

often assumes that human inhalation

and dermal exposures are the result of

exposures to undiluted chemicals.

Chemical substance concentration data

would allow EPA to generate less

conservative exposure estimates for

chemicals that are diluted prior to

processing or use.

Information about the average and

maximum concentration of a chemical

substance present at processing and use

sites is used in chemical risk screening

in EPA’s New Chemicals Program.

Estimates of maximum concentration

assist EPA in establishing the maximum

concentrations to which the

environment and workers might be

exposed by releases from industrial

settings. For example, EPA has

developed standard methods to estimate

dermal exposures that workers may

experience while performing common

industrial operations such as sampling

and loading chemicals into drums. If

EPA is aware that a chemical substance

is not processed or used at

concentrations above a certain level,

exposure estimates may be adjusted

accordingly.

The following is the list of proposed

concentration codes for use in IUR

reporting under the proposed rule:

• Less than 1% by weight.

• 1 - 30% by weight.

• 31 - 60% by weight.

• 61 - 90% by weight.

• Greater than 90% by weight.

The Agency is proposing that

reporting on concentrations be limited

to concentrations at the time the

chemical substance leaves the

submitter’s site, for the reasons

discussed in Unit V.E.6. of this

preamble.

VII. Amendments Affecting Larger

Volume Manufacturers (Including

Larger Volume Importers)

As discussed in Unit VI.B. of this

preamble, EPA is proposing to replace
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46789

the current IUR reporting threshold of

10,000 lbs. per year with two new

reporting thresholds of 25,000 lbs. per

year and 300,000 lbs. per year. Every

person manufacturing (including

importing) a reportable substance at or

above the 25,000 lbs. threshold would

be required to report the information in

Parts I., II., and IV. of Revised Reporting

Form U. Persons who manufacture

(including import) a reportable

substance at or above the 300,000 lbs.

threshold would be required to report

the information in Part III. of Revised

Reporting Form U in addition to the

information in Parts I., II., and IV. Part

III. relates to the processing and use of

chemical substances.

Process is defined in 40 CFR 710.2 as

‘‘the preparation of a chemical

substance or mixture, after its

manufacture, for distribution in

commerce (1) in the same form or

physical state as, or in a different form

or physical state from, that in which it

was received by the person so preparing

such substance or mixture, or (2) as part

of a mixture or article containing the

chemical substance or mixture.’’

Process for commercial purposes

means ‘‘to process (1) for distribution in

commerce, including for test marketing

purposes, or (2) for use as an

intermediate.’’

Based on these definitions, processing

includes incorporating a reportable

chemical substance into a formulation,

an article, or a product. EPA is

proposing to define ‘‘use’’ as ‘‘any

utilization of a chemical substance or

mixture that is not otherwise covered by

the terms manufacture or process.

Relabeling or redistributing a container

holding a chemical substance or mixture

where no repackaging of the chemical

substance or mixture occurs does not

constitute use or processing of the

chemical substance or mixture.’’

TSCA section 8(a) authorizes EPA to

require persons to report information

that is ‘‘known to or reasonably

ascertainable by’’ them (see proposed

regulatory text § 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 § 710.2). Extensive file

searches would not be required. The

‘‘readily obtainable’’ standard proposed

for processing and use information

requires less effort on the part of the

submitter than the ‘‘known to or

reasonably ascertainable by’’ standard

that applies to all other IUR reporting.

The Agency believes that the ‘‘readily

obtainable’’ reporting standard would

provide processing and use information

of a sufficient precision for use in

screening level reviews. Reducing the

precision to ‘‘readily obtainable’’ from

‘‘known to or reasonably ascertainable

by’’ for processing and use information

also lowers the reporting burdens for

many submitters. Moreover, the

proposed reporting standard for

processing and use information under

these IUR amendments is the same

standard currently in effect under PAIR

(See 40 CFR 712.7).

Much of the additional information

required under Part III. of Revised

Reporting Form U would be provided in

ranges, rather than discrete values, as

described in more detail in this unit.

EPA preliminarily determined that the

planned use of information such as

percent production volume, number of

sites, number of potentially exposed

workers, average concentration, and

maximum concentration does not

warrant the reporting of discrete values.

In addition, the use of ranges for certain

data elements would reduce reporting

burdens, yet provide sufficient

information for screening level analyses.

EPA also believes that the use of ranges

would greatly diminish CBI claims for

information reported.

EPA considered the option of

requiring processing and use reporting

by larger volume manufacturers (i.e.,

those manufacturers that reach the

300,000 lbs. threshold) based upon

submitter owned or controlled sites

alone versus customer owned or

controlled sites in addition to submitter

owned or controlled sites. EPA

preliminarily determined that

manufacture, processing, and end use of

the chemical substance were important

to examining the potential exposure

scenarios for a chemical substance, but

that it did not matter if the processing

or use site was submitter controlled or

not. In addition, restricting the reporting

of this information to submitter owned

or controlled sites alone would not

capture much of the information needed

regarding the processing and use of

reportable chemicals. Therefore, EPA

decided to require the reporting of

processing and use information readily

obtainable by the submitter, including

information based upon submitters’

sites as well as their customers’ sites.

The two general types of information

that would be reported under Part III. of

Revised Reporting Form U are industrial

processing and use information and

commercial and consumer use

information.

A. Processing and Use Information (Part

III. of Revised Reporting Form U)

EPA is proposing to require

submitters to report the information

described in Unit VII.A.1-5. of this

preamble concerning the processing and

use of each reportable chemical

substance that are conducted both at

sites the submitter controls and at sites

that receive a reportable chemical

substance from the submitter either

directly or indirectly (including through

a broker/distributor, from a customer of

the submitter, etc.).

1. Industrial process or use code (Part

III., Section I.a. of Revised Reporting

Form U). The first item of reportable

information under this proposed section

is the industrial process or use code.

The proposed categories for reporting

the industrial processing and use are:

• Processing - as a reactant.

• Processing - incorporation into a

formulation or mixture.

• Processing - incorporation into an

article.

• Processing - repackaging.

• Use - non-incorporative activities.

Repackaging would be defined for

purposes of IUR reporting under the

proposed rule as the physical transfer of

a chemical substance or mixture, as is,

from one container to another container

or containers in preparation for

distribution of the chemical substance

or mixture in commerce. This

definition, therefore, would not include

sites which only relabel or redistribute

the reportable chemical substance

without removing the chemical

substance from the container in which

it is received or purchased.

2. The North American Industrial

Classification System (NAICS) Code and

Industrial Function Category (Part III.,

Section I.b. and c. of Revised Reporting

Form U). EPA is proposing to require

submitters to report the five-digit NAICS

code(s) that best describe(s) the

industrial activities at the sites under

the control of the submitter, as well as

at the sites that receive a reportable

chemical substance from the submitter

either directly or indirectly (including

through a broker/distributor, from a

customer of the submitter, etc.), and that

process and use the reportable chemical

substance (Ref. 25). The NAICS codes,

published by the Office of Management

and Budget (OMB), have superseded

OMB’s prior system of Standard

Industrial Classification (SIC) Codes.

EPA is proposing that, to the extent the

information is readily obtainable,

submitters will report on industrial

processing and use of chemical

substances they manufacture after the

chemical substances have passed
46790 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

through distributors or other

distribution or shipping systems. EPA

does not intend for manufacturers

(including importers) to survey their

customers or distributors to precisely

identify the appropriate NAICS codes at

their ‘‘downstream’’ sites.

The NAICS code classification system

is being used in this application solely

to describe the industrial setting in

which there may be chemical exposures

associated with the industrial

processing or use of a chemical

substance. The submitter would be

required to report all known and readily

obtainable NAICS codes for the

reportable chemical substances it

manufactures (including imports). If the

submitter is aware of more than 10

NAICS codes that describe the

industrial activities at sites that process

and use the reportable chemical

substance, the submitter would be

required under this proposed rule to

report only the 10 NAICS codes that

cumulatively represent the largest

percentage of production volume,

measured by weight. This limitation on

reporting is intended to minimize

submitters’ reporting burdens.

EPA is also proposing to require

submitters to report the industrial

function categories associated with each

NAICS code for each reportable

chemical substance that is processed or

used for industrial purposes. EPA

believes that a NAICS code and

industrial function category

combination sufficiently define a

potential exposure scenario for risk

screening and priority-setting purposes.

Two technical documents that support

this proposed rule, entitled ‘‘Inventory

Update Rule (IUR) Amendment

Technical Support Document:

Exposure-Related Data Useful for

Chemical Risk Screening,’’ and

‘‘Preliminary Assessment Information

Rule (PAIR) Database, Manufacturing

Process Type/Release Analysis and

Number of Workers/Production

Quantity Analysis,’’ both found in the

public record for this rulemaking (listed

at Unit X.A.2.a and X.A.2.b. of this

preamble), describe studies that

demonstrate that information regarding

the industrial sectors where a chemical

substance is produced and used and

information regarding the function that

a chemical substance performs within

industrial processes provide indications

of the route, magnitude, and

concentration of potential chemical

exposures to the environment and to

humans.

Industrial function categories are

helpful in estimating the frequency and

duration of chemical substance

exposures. For example, EPA has found

that the relationship between industrial

function categories and the frequency

and duration of exposure to chemical

substances is particularly useful in

developing exposure assessments for the

New Chemicals Program. Similarly, data

elements such as the number of sites

and the number of workers enable the

Agency to better estimate the scope of

potential exposure. These data elements

are important pieces in developing the

most accurate exposure scenarios

possible. In the absence of this data,

EPA often assumes, for chemical risk

screening purposes, that workers are

exposed to chemical substances for full

8–hour work days for the duration of

their careers. The data that would be

obtained under these proposed

amendments to IUR would enable EPA

to make more realistic characterizations

of exposure, instead of ‘‘worst case’’

assumptions.

Industrial function categories would

be reported by selecting from the

following list of proposed industrial

function category codes for chemical

processing and use:

• Adhesives and binding agents.

• Adsorbents and absorbents.

• Aerosol propellants.

• Agricultural chemicals (nonpesticidal).

• Anti-adhesive agents.

• Bleaching agents.

• Coloring agents, dyes.

• Coloring agents, pigments.

• Corrosion inhibitors and antiscaling agents.

• Fillers.

• Fixing agents.

• Flame retardants.

• Flotation agents.

• Fuels.

• Functional fluids.

• Intermediates.

• Lubricants.

• Odor agents.

• Oxidizing agents.

• pH-regulating agents.

• Photosensitive chemicals.

• Plating agents and metal surface

treating agents.

• Process regulators, used in

vulcanization or polymerization

processes.

• Process regulators, other than

polymerization or vulcanization

processes.

• Processing aid, not otherwise

listed.

• Reducing agents.

• Solvents (for chemical manufacture

and processing and are not part of the

end product at greater than one percent

by weight).

• Solvents (for cleaning or

degreasing).

• Solvents (that become part of

product formulation or mixture).

• Stabilizers.

• Surface active agents.

• Viscosity adjustors.

• Other.

As described in the document

entitled, ‘‘Inventory Update Rule (IUR)

Amendment Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening’’

(listed at Unit X.A.2.a. of this preamble),

these industrial function categories have

been developed and defined based on a

review of different chemical function

classification systems (including the

systems used in the Premanufacture

Notification, UCSS, UEIP, and EU

programs), as well as development of

data pertinent to the potential media of

releases, potential quantities released,

potential worker exposures, and

potential incorporation into commercial

and consumer products for each

industrial function category. This list of

specific categories is not meant to be

exhaustive, therefore, an ‘‘other’’

category is provided for miscellaneous

uses not captured in the listed

categories. These categories address a

wide range of industrial chemical

processing and use functions, and are

likely to be revised as analysis of

reported IUR data is further refined over

time.

3. Percentage of production volume

attributable to each combination of

NAICS code and industrial function

category (Part III., Section I.d. of Revised

Reporting Form U). EPA is proposing to

require submitters to estimate the

percentage of production volume that is

attributable to each reported

combination of NAICS code estimate

and industrial function category, to the

extent that such information is readily

obtainable. Estimates must be rounded

off to the nearest 10% of production

volume. However, under the proposed

rule, a particular NAICS code/industrial

function category (NAICS/IFC)

combination which accounts for 5% or

less of the total production volume of a

reportable chemical substance would

not be permitted to be rounded off to

zero if the production volume

attributable to that NAICS/IFC

combination is greater than or equal to

300,000 lbs. In such cases, submitters

must report the percentage of

production volume attributable to that

NAICS/IFC combination to the nearest

1% of production volume. This

exception to the general rounding off

rule is being proposed to ensure that

adequate use information is reported for

the very large production volume

chemical substances. The 300,000 lbs.

level was selected for consistency with

the proposed threshold for reporting

exposure and use data.
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46791

4. Number of sites (Part III., Section

I.e. of Revised Reporting Form U). For

risk screening purposes, the number of

sites at which chemical substances are

manufactured (including imported),

processed and used is a useful indicator

of the number of ecosystems and the

size of the general population

potentially exposed to the chemical

substances. EPA is proposing to require

submitters to report an estimate of the

total number of industrial sites,

including those beyond the submitter’s

control, that process or use each

reported chemical substance

manufactured (including imported) by

the submitter, as described by each

combination of NAICS code estimate

and industrial function category.

The ranges that would be used for

reporting the number of sites are as

follows:

• Less than 10.

• At least 10 but less than 25.

• At least 25 but less than 100.

• At least 100 but less than 250.

• At least 250 but less than 1,000.

• At least 1,000 but less than 10,000.

• At least 10,000.

EPA recognizes that there is a

possibility of double-counting sites, for

example, where two or more submitters

manufacture (including import) the

same reportable chemical substance and

each sends the chemical substance to

the same industrial processing or use

site. However, because the Agency is

proposing that the number of sites be

reported in the specified ranges, it

believes the impact of double-counting

sites will not significantly affect the use

of these estimates for screening

purposes. In the event a submitter both

manufactures (including imports) and

processes or uses the same reportable

chemical substance at the reporting

plant site, the site should be counted as

both a manufacturing site in Part II. of

Revised Reporting Form U, and as a

processing or use site reported in Part

III. of Revised Reporting Form U.

5. Number of workers (Part III.,

Section I.f. of Revised Reporting Form

U). As discussed in Unit V.A. of this

preamble, information related to the

exposure of workers to chemical

substances is of particular interest to

EPA and other organizations. EPA is

proposing to require submitters to report

an estimate of the total number of

workers reasonably likely to be exposed

while processing or using the reportable

chemical substance as described by each

combination of NAICS code estimate

and industrial function category. These

combinations relate to sites under the

control of the submitter as well as sites

that receive a reportable chemical

substance from the submitter either

directly or indirectly (see Unit VII.A.2.

of this preamble). The approximate

number of workers reasonably likely to

be exposed during processing and use

would be reported using the same

definitions and codes described under

Unit VI.E.4. of this preamble. The only

difference in reporting worker exposure

information under this section is that

such information need be reported only

to the extent that it is readily obtainable.

EPA recognizes that there is also a

possibility of double-counting workers

at industrial processing and use sites,

for example, when two or more

submitters manufacture the same

reportable chemical substance and each

ships the chemical substance to the

same processing or use site. Because

EPA is proposing that the number of

workers be reported through the use of

broad ranges, EPA believes the impact

of double-counting workers will not

significantly affect the use of the

estimates for risk screening purposes. In

addition, it will be possible to estimate

the maximum potential magnitude of

double counted workers at processing

and use sites because the total number

of manufacturers (including importers)

will be known to EPA.

B. Commercial and Consumer Use

Information (Part III., Section II. of

Revised Reporting Form U)

EPA is proposing to require

submitters to report the information

described in Unit VII.B.1-3. of this

preamble concerning the commercial

and consumer uses of each reportable

chemical substance that is

manufactured (including imported) at

sites the submitter controls and at sites

controlled by persons to whom the

submitter has either directly or

indirectly (including through a broker/

distributor or from a customer of the

submitter, etc.) distributed the

reportable chemical substance. As with

the industrial processing and use

information described in Unit VII.A. of

this preamble, this requirement would

apply only to each chemical substance

manufactured (including imported) in

annual quantities of 300,000 lbs. or

more and submitters would only be

required to report information to the

extent that it is readily obtainable.

For purposes of IUR reporting, a

commercial use means the use of a

chemical substance or mixture in a

commercial enterprise providing

saleable goods or a service, such as

painting contractors using paint

products. A consumer use, on the other

hand, means the use of a chemical

substance that is directly, or as part of

a mixture, sold to or made available to

consumers for their use in or around a

permanent or temporary household or

residence, in or around a school, or in

or around recreational areas. Exposures

to commercial and consumer products

are similar for risk screening purposes

because existing assessment methods

are not sophisticated enough to

distinguish between these exposures.

Consumers comprise a subpopulation

of particular concern to EPA, the

Consumer Products Safety Commission

(CPSC), and other organizations.

Information from submitters on whether

the chemical substances they

manufacture (including import) are used

in consumer products is useful in

estimating the potential risks to

consumers that result from chemical

exposures. EPA often assumes, for risk

screening purposes, that large,

unprotected populations may

potentially be exposed to the chemical

substances in consumer products. EPA

plans to propose a test rule to develop

hazard data regarding chemicals in

consumer products to which children

are exposed. The consumer product

information that would be reported

under these IUR amendments would be

used by EPA in the identification of

chemicals that might be included in the

test rule.

1. Commercial and consumer product

categories (Part III., Section II.a. of

Revised Reporting Form U). Commercial

and consumer product categories are

helpful in estimating the frequency and

duration of chemical substance

exposures. In the absence of other

information, consumers are often

assumed to experience less controlled,

but less frequent exposures than

workers. The data that would be

obtained under these proposed

amendments to IUR would enable EPA

to make more realistic characterizations

of exposure, instead of ‘‘worst case,’’

overly conservative assumptions.

The proposed commercial and

consumer product categories were

developed based on a review of various

data sources including national usage

surveys of consumer products, product

emissions testing, and exposure

monitoring data (See ‘‘Technical

Support Document: Technical Approach

for the Selection of Consumer End-Use

Categories for the Inventory Update

Rule,’’ available in the public record for

this proposal and listed at Unit X.A.2.h.

of this preamble). This review identified

an extensive list of consumer products

and provided subsequent categorization

of these products by common

characteristics, such as use scenarios,

into major groupings of commercial and

consumer products. The list is not

meant to be comprehensive, therefore,

an ‘‘other’’ category is provided for
46792 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

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 (nonpesticidal).

• Leather products.

• Lubricants, greases and fuel

additives.

• Metal products.

• Paints and coatings.

• Paper products.

• Photographic chemicals.

• Polishes and sanitation goods.

• Rubber and plastic products.

• Soaps and detergents.

• Transportation products.

• Wood and wood furniture.

• Other.

2. Percentage of production volume

attributable to each commercial and

consumer product category (Part III.,

Section II.b. of Revised Reporting Form

U). EPA is proposing to require

submitters to estimate the percentage of

their production volume for each

reportable chemical substance that is

attributable to each specific commercial

and consumer end-use carried out at

sites under the control of the submitter,

as well as at sites that receive a

reportable chemical substance from the

submitter either directly or indirectly

(including through a broker/distributor,

from a customer of the submitter, etc.),

to the extent that such information is

readily obtainable. Estimates must be

rounded off to the nearest 10% of

production volume. However, under the

proposed rule, a commercial and

consumer product (CCP) category which

accounts for 5% or less of the total

production volume of a reportable

chemical substance would not be

permitted to be rounded off to zero if

the production volume attributable to

that CCP category is greater than or

equal to 300,000 lbs. In such cases,

submitters must report the percentage of

production volume attributable to that

CCP category to the nearest 1% of

production volume. This exception to

the general rounding off rule is being

proposed to ensure that adequate use

information is reported for the very

large production volume chemical

substances. The 300,000 lbs. level was

selected for consistency with the

proposed threshold for reporting

processing and use data (see Unit VI.B.

of this preamble).

3. Maximum concentration, measured

by weight in commercial and consumer

products (Part III., Section II.c. of

Revised Reporting Form U). EPA is

proposing to require each submitter to

report estimates, in ranges, of the

maximum concentration (measured by

weight) of each reportable chemical

substance likely to be present in

commercial and consumer products

manufactured (including imported) at

sites under the submitter’s control and

at sites where the submitter’s

commercial and consumer products are

distributed directly or indirectly

(including through a broker/distributor,

from a customer of the submitter, etc.).

As with the other information in this

section, such information would be

required only to the extent that it is

readily obtainable by the submitter. The

proposed reporting range codes are the

same as those listed in Unit VI.E.6. of

this preamble.

VIII. Confidentiality

A. Asserting Claims

Submitters are able to claim certain

information submitted to EPA under

this proposed rule as confidential if they

have reason to believe that release of the

information would reveal trade secrets

or confidential commercial or financial

information, as provided by section 14

of TSCA and 40 CFR part 2. Claims of

confidentiality must be asserted at the

time information is submitted to EPA.

EPA’s procedures for processing and

reviewing confidentiality claims are set

forth at 40 CFR part 2, subpart B. EPA

strongly encourages submitters to

review confidentiality claims carefully

to ensure that the information in

question falls within the protection of

TSCA section 14 and to limit

confidentiality claims as much as

possible.

To claim information as confidential,

a submitter must check the appropriate

box and sign the certification statement

on the reporting form. If a submitter

failed to do so, EPA could release the

information to the public without

further notice to the submitter. As in the

last three TSCA Inventory Update

collections and the initial TSCA

Inventory collection and as reflected in

the regulations, by signing the

certification statement the submitter

certifies that its claims of confidentiality

are made in good faith. Procedures for

claiming information submitted

electronically (such as a submission on

diskette) as confidential will be

specified in the reporting rule

instruction manual. CBI should not be

submitted by e-mail. A discussion on

proposed procedures and policies for

making CBI claims in the context of this

proposed rule is provided in this unit.

B. Chemical Identity

Under the existing IUR,

confidentiality claims for chemical

identity can only be made for those

chemicals listed on the confidential

portion of the Inventory. A submitter

must currently assert a separate claim of

confidentiality for specific chemical

identity when submitting an IUR report.

To assert a claim of confidentiality for

the identity of a chemical substance

which is confidential on the TSCA

Inventory, submitters are currently, and

would continue to be, required to

indicate the claim on the IUR reporting

form and provide a detailed

substantiation of the claim as specified

in 40 CFR 710.38. If a submitter fails to

substantiate the chemical identity CBI

claims in accordance with the

applicable regulations, EPA may make

the information available to the public

without further notice to the submitter.

EPA is not proposing to change these

requirements.

C. Manufacturing Plant and Plant Site

Information

Under IUR, a submitter may assert a

claim of confidentiality for the specific

manufacturing plant and plant site

information if it is believed that release

of that identity would reveal trade

secrets or confidential commercial or

financial information as provided by

TSCA section 14. In past IUR

information collections, in excess of

15% of IUR information submitters have

claimed plant site name as CBI. While

the Agency does not question the

occasional need for this claim, it

believes that these claims should be

limited to only those circumstances in

which it is absolutely necessary. The

Agency has identified instances in

which submitters have claimed plant

site name as confidential yet this same

information was found in such public

filings as material safety data sheets and

State and Federal permits. Overall,

approximately 20% of the 1994 IUR

reports contained CBI claims for plant

site information. The IUR does not

currently require upfront substantiation

of CBI claims for plant site information.

In these amendments to IUR, EPA is

proposing a new upfront substantiation

requirement for CBI claims for plant site

information.

EPA has observed that, on occasion,

plant site information has been claimed

as confidential even though it was

revealed in filings required under
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46793

sections 311, 312 and 313 of EPCRA.

EPA believes that many of these CBI

claims are inappropriate and that the

new substantiation requirement would

reduce the occurrence of inappropriate

claims. A decrease in the number of CBI

claims under the new substantiation

requirement would facilitate EPA’s

ability to make current plant site

information available to other Federal

agencies and the public because more

information submitted under IUR could

be released publicly.

Under this proposed rule, in order to

assert a claim of confidentiality for plant

site information, the submitter would be

required to both check the appropriate

box on the reporting form indicating a

confidentiality claim for plant site

information, and to substantiate the

claim in writing by answering certain

questions provided in § 710.38(d)(1) of

the proposed rule. If a submitter fails to

substantiate the plant site CBI claim in

accordance with the applicable

regulations, EPA may make the

information available to the public

without further notice to the submitter.

D. Chemical Production Volume

Information

Under IUR, a submitter may assert a

claim of confidentiality for production

volume information if the release of that

information would reveal trade secrets

or confidential commercial or financial

information as provided by section 14 of

TSCA. EPA is not proposing to change

this.

EPA observed that, in the last three

IUR reporting periods when EPA sought

actual production volume information,

over 65% of the information was

claimed as confidential. In contrast,

overall CBI claims for production

volume information in the original

TSCA Inventory collection were 35%;

this information, however, was

collected in ranges. This high

proportion of CBI claims in IUR reports

has limited EPA’s ability to convey to

the public plant site production volume

information. Because over 95% of the

chemicals reported under IUR are

manufactured at three plant sites or less,

these CBI claims also greatly hinder

EPA’s ability to create national aggregate

statistics on overall chemical

production for specific chemical

substances. For example, if EPA

publishes a national aggregate

production volume for a chemical

substance that is manufactured at three

plant sites and one site claims its

production volume CBI and the other

two do not, it might be possible to

calculate the CBI production volume by

difference. In such a case, EPA would

not release aggregate data because of its

responsibility to protect the CBI claim of

the one submitter. However, EPA needs

to be able to convey chemical substance

production volume information to the

public to explain its chemical risk

assessment and risk management

decisions. Effective communication of

this information is vital to EPA’s overall

mission. To address this problem and

yet acknowledge industry’s legitimate

concerns about this data element, EPA

is proposing to require submitters to

report both actual plant site chemical

production volume information and a

corresponding production volume

range. Separate CBI claims could be

made for each.

EPA is proposing to use the

production volume ranges that are

similar to those that were successfully

used in the implementation of the

original TSCA Inventory collection.

Proposed production volume ranges for

use in this action are listed in Unit

VI.E.3. of this preamble. EPA anticipates

that the CBI claim rates will be around

50% lower for the reporting of volume

ranges than for the reporting of specific

claims (See ‘‘Inventory Update Rule

(IUR) Technical Support Document:

Evaluation of Likelihood of Confidential

Business Information Claims for

Production Volume Information,’’

available in the public record for this

proposal and listed at Unit X.A.2.g. of

this preamble).

EPA is seeking to develop and use

ranged chemical production volume

information at the suggestion of

industry representatives following a

dialogue with the public about TSCA

CBI claims. In correspondence, an

industry representative noted that

manufacturers were less sensitive about

ranged production volume information

than specific numbers (Ref. 21). The

representative suggested that collecting

information on ranges similar to those

used under the original TSCA Inventory

might reduce the incidence of CBI

claims for production volume

information and facilitate EPA

information dissemination goals. In this

proposed rule, EPA would seek

chemical production volume

information and would use that

information to make a production

volume range assignment. EPA intends

to use the production volume

information in the creation of national

statistics, whereas the ranged

production volume data may be most

useful in the creation of information

products conveying site-specific

chemical information.

E. Reasserting Claims

Submitters would use Part IV. of

Revised Reporting Form U to reassert

CBI claims made in their previous IUR

reporting. CBI claims made in IUR

submissions prior to 2002 (the first IUR

reporting year under these amendments)

would be not be subject to this

reassertion requirement.

Since 1990, EPA has been engaged in

a dialogue with the public on issues

associated with TSCA CBI. During this

dialogue, industry has confirmed EPA

understanding that the need for certain

confidentiality claims is reduced or

eliminated over time. What was

considered CBI to a submitter during

one reporting cycle may not be

considered CBI in subsequent years.

Some information submitted to EPA

with CBI claims is subsequently

released by the submitter to the public

because the submitter no longer believes

that the claims are necessary. The result

is that some information submitted to

EPA is withheld by EPA from the public

for long periods, at additional cost to the

Agency and with no appreciable

advantage to the submitter. This

situation complicates EPA’s efforts to

make information available to potential

users, including other Federal agencies,

State and local chemical management

authorities and local communities,

secure the participation of the public in

EPA’s chemical management efforts,

and in other ways allow for the effective

EPA implementation of TSCA.

EPA is proposing new procedures to

ensure that there is an ongoing need by

the submitter for continued CBI

protection. Under the proposed

procedures, manufacturers (including

importers) would be required, in

subsequent reporting periods, to

affirmatively represent the need for the

continued CBI protection of the claims

made in previous IUR reporting periods.

To illustrate, for data submitted to EPA

in the year 2010, a manufacturer

(including importer) would be required

to affirmatively represent on the

reporting form that: (1) The specific CBI

claims made for the first time in

reporting year 2006 and (2) the specific

CBI claims reasserted in reporting year

2006 continue to be necessary in order

to protect trade secrets or confidential

commercial or financial information as

provided by TSCA section 14. The CBI

certification statements would be

contained in Part IV. of Revised

Reporting Form U for the convenience

of the submitter. If either certification is

not provided by the submitter, EPA

would assume that the submitter is

waiving those claims of confidentiality

to the underlying information contained

in the earlier filings and the information

would be subject to public disclosure

without further notice.
46794 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

This policy would be applied even if

the submitter is not required to report in

the present reporting period due to low

production volume or other applicable

exclusions. In other words, if a

submitter who asserts a CBI claim in a

prior reporting period is not required to

report under the current IUR reporting

period, that submitter must file a

certification regarding its prior CBI

claim during the current reporting

period if it wishes to retain the claim.

Again, CBI claims made in IUR

submissions prior to 2002 (the first IUR

reporting year under these amendments)

would not be subject to this reassertion

requirement.

EPA will undertake certain

precautions in order to ensure that

persons that make CBI claims in IUR

submissions in the 2002 reporting

period and subsequent reporting periods

are aware of the requirement that these

claims be reasserted, as appropriate, in

subsequent reporting periods in order to

retain CBI protections. Prior to each IUR

reporting period, EPA will send an IUR

reporting package to each person who

submitted an IUR report or CBI

reassertion in the previous reporting

period. This package will contain a

cover letter which will: (1) Remind the

submitters of the reassertion

requirements and (2) advise that failure

to affirmatively reassert prior CBI claims

will result in the removal of CBI

protections for this information. The

package will also contain a reporting

form and reporting instructions which

will reiterate these reminders. In

addition, EPA will publish a Federal

Register notice at least 2 weeks before

the end of each reporting period which

will remind members of the public who

have not reasserted their prior CBI

claims of the pending declassification of

these claims if they do not reassert by

the end of the reporting period.

In addition to the reminders related to

CBI reassertion that are specifically

proposed in this document, EPA also

intends to publicize the need to

reexamine and reassert past CBI claims

via the EPA/OPPT Homepage on the

Internet, and in communications with

trade association publications.

It has been suggested that EPA

additionally send a followup certified

letter to persons who were sent IUR

reporting packages, but who fail to

indicate their intention to reassert/not

reassert previous CBI claims by the end

of the reporting period. The intent of the

letter would be to further notify

submitters that they need to reevaluate

their past CBI claims and reassert them,

as appropriate. EPA believes that this

additional step would be costly and

would result in an inefficient use of

Agency resources. For example, if a

submitter does not receive the reporting

package mailed by EPA because the

submitter’s address was changed

between the last IUR reporting period

and the current reporting period (EPA

sends packages to the addresses

submitted during the previous reporting

period), the submitter likewise would

not receive a followup letter from EPA

sent to the same incorrect address. As

discussed above, before each reporting

period ends, EPA is proposing to

publish a Federal Register notice which

EPA believes would reach a far broader

audience than individual letters would.

EPA seeks comment on the issue of

whether means beyond those proposed

in this action are needed to better

inform submitters of the requirement

that they reexamine their past CBI

claims and reassert them, as

appropriate, in order to retain CBI

protections.

IX. Request for Comment and Notice of

Public Meeting

The comment period for this

proposed rule will extend until October

25, 1999. EPA will hold a public

meeting on Monday, October 4, 1999,

from 9 a.m. to noon at the EPA

Auditorium, 401 M St., SW.,

Washington, DC 20460 to provide an

opportunity for the public to present

oral comments.

The following is a list of issues on

which the Agency is specifically

requesting public comment. EPA

encourages all interested persons to

submit comments on these issues, and

to identify any other relevant issues as

well. This input will assist the Agency

in developing a rule that successfully

addresses information needs while

minimizing potential reporting burdens

associated with the rule. EPA requests

that commenters making specific

recommendations include supporting

documentation where appropriate.

1. What (if any) specific mechanisms

or sources of data could EPA use to

acquire the exposure-related

information sought in this proposed rule

with greater ease and less burden to

industry?

2. EPA initially considered proposing

a larger-volume threshold for the

reporting of processing and use

information of 100,000 lbs. per year per

site, rather than the 300,000 lbs. per

year per site threshold proposed in this

document. EPA analyzed a number of

alternative thresholds in the Economic

Analysis (listed in Unit X.A.2.f. of this

preamble). EPA is specifically seeking

comment on the question of whether

this threshold should be modified.

3. During the interagency review

process, it was suggested that EPA

consider proposing a partial reporting

exemption for ‘‘low priority’’ chemicals.

Manufacturers of these chemicals could

be exempt from reporting the exposurerelated data contained in Part III. of the

reporting form. At one point during the

development of this proposal, EPA

considered developing such an

exemption, but was unable to develop a

satisfactory rationale for the exemption.

Therefore, EPA seeks comment on the

criteria the Agency might use to

establish such an exemption. EPA also

solicits comment on the specific

chemicals that would qualify for such

an exemption.

During the interagency review

process, various lists of chemicals were

suggested as candidates for such a ‘‘low

priority’’ partial exemption. EPA would

be interested in comments on the

alternative lists described below, as well

as any other suggested set of chemicals.

One set consists of those chemical

substances that: (1) EPA has previously

determined to be of low concern under

the Existing Chemicals Program and (2)

for which EPA has a minimum set of

hazard and exposure data. This could

include chemicals for which the

following exist: (1) A complete set of

basic test data as specified in the

OECD’s Screening Information Data Set

(SIDS) Manual; (2) the UEIP data set

(submitted by at least two-thirds of the

manufacturers of the subject chemical

substance based on the most recent IUR

report); and (3) a determination by

EPA’s Existing Chemicals Program that

the chemical substance is a ‘‘low

priority.’’

An alternative set is the list of

chemical substances that the European

Union exempted from its reporting

requirements for existing substances

(Ref. 8, Annex II).

A third option for a ‘‘low priority

substances’’ partial exemption is the list

of high production volume chemical

substances that are not considered

candidates for testing under the HPV

Challenge Program (Ref. 26). This list

currently consists of the following 41

chemicals:
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46795

CAS Number Chemical Name

50–70–4 Glucitol, D50–99–7 D-Glucose

56–81–5 Glycerol

57–50–1 Sucrose

69–65–8 Mannitol, D124–38–9 Carbon dioxide

1592–23–0 Stearic acid, calcium salt

7440–44–0 Carbon

8001–21–6 Sunflower oil

8001–22–7 Soybean oil

8001–26–1 Linseed oil

8001–29–4 Cottonseed oil

8001–30–7 Corn oil

8001–31–8 Coconut oil

8001–78–3 Castor oil, hydrogenated

8001–79–4 Castor oil

8002–03–7 Peanut oil

8002–75–3 Palm oil

8006–54–0 Lanolin

8016–28–2 Lard oil

8016–70–4 Soybean oil, hydrogenated

8021–99–6 Charcoal, bone

8029–43–4 Syrups, hydrolyzed starch

9050–36–6 Maltodextrin

16291–96–6 Charcoal

61788–61–2 Fatty acids, tallow, Me esters

61789–97–7 Tallow

61789–99–9 Lard

64147–40–6 Castor oil, dehydrated

64755–01–7 Fatty acids, tallow, calcium salts

68188–81–8 Grease, poultry

68334–00–9 Cottonseed oil, hydrogenated

68409–76–7 Bone meal, steamed

68425–17–2 Syrups, hydrolyzed starch, hydrogenated

68439–86–1 Bone, ash

68476–78–8 Molasses

68514–27–2 Grease, catch basin

68514–74–9 Palm oil, hydrogenated

68525–87–1 Corn oil, hydrogenated

68952–94–3 Soaps, stocks, vegetable-oil

73138–67–7 Lard, hydrogenated

Alternatively, it was suggested that

EPA create a ‘‘low priority chemicals’’

list by identifying chemicals that are

present on both the European Union list

and the HPV Challenge Program list.

Currently, the following chemicals are

included on both of these lists:

CAS Number Chemical Name

50–70–4 Glucitol, D50–99–7 D-Glucose

57–50–1 Sucrose

69–65–8 Mannitol, D124–38–9 Carbon dioxide

1592–23–0 Stearic acid, calcium salt

7440–44–0 Carbon

8001–21–6 Sunflower oil

8001–22–7 Soybean oil

8001–26–1 Linseed oil

8001–30–7 Corn oil

8001–79–4 Castor oil
46796 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

CAS Number Chemical Name

9050–36–6 Maltodextrin

61788–61–2 Fatty acids, tallow, Me esters

4. During the interagency review

process, it was suggested that the

information the Agency would collect

under the IUR amendments might be

duplicative of existing reporting for

manufacturers and importers of

petroleum chemicals, who may also be

required to report to the Department of

Energy’s (DOE) Energy Information

Administration. Under the existing IUR

4 year reporting cycle, if a manufacturer

or importer of a petroleum chemical

meets the 10,000 lbs. reporting

threshold, they must complete EPA

Form U to report to EPA. Under the

proposed IUR amendments, if a

manufacturer or importer of a petroleum

chemical meets the proposed 25,000 lbs.

reporting threshold, they must complete

Parts I., II., and IV. of Revised Reporting

Form U. The proposed IUR amendments

exempt these entities from reporting the

proposed processing and use

information in Part III. of revised

reporting Form U (see Unit VI.A.2. of

this preamble). In addition, EPA is

proposing to fully exempt certain forms

of natural gas from IUR reporting (see

Unit VI.A.3. of this preamble).

It has been suggested that information

provided to DOE in forms EIA 810, EIA

816, and EIA 64A might duplicate the

information that would be provided to

EPA under the proposed IUR

amendments. Operators of domestic

natural gas processing plants must

complete form EIA 64A to provide an

annual report of the origin of natural gas

liquids production to DOE. Operators of

all operating and idle petroleum

refineries, blending plants or blending

terminals must complete form EIA 810

to provide a monthly refinery report on

their operations to DOE. Operators that

extract liquid hydrocarbons from a

natural gas stream and/or separate a

liquid hydrocarbon stream into its

component products must complete

form EIA 816 to provide a monthly

natural gas liquids report to DOE.

EPA is concerned about potential

reporting duplication and is specifically

requesting comments on whether such

duplication exists, what specific

information may be duplicated, and

whether the information collected by

DOE would satisfy the proposed IUR

reporting requirements. EPA will also

work with DOE to identify potential

duplication, and investigate the

potential utility of the information

reporting to DOE in fulfilling EPA’s

statutory obligations under TSCA. Your

comments will further inform EPA’s

evaluation of this issue.

5. EPA is proposing to require only

partial IUR reporting for inorganic

chemicals, i.e. only the information in

Parts I., II., and IV. of Form U would be

reported by manufacturers of inorganic

chemicals. Full IUR reporting for

inorganic chemicals, i.e. all parts of

Form U, including the processing and

use-related data elements in Part III.,

would be considered for a future

amendments to the IUR regulations.

Alternatively, EPA could adopt a

phased-in approach to full reporting for

inorganics, e.g., partial reporting for

inorganic chemicals could be required

in the first reporting year, followed by

full reporting in subsequent reporting

years. EPA solicits public comment on

the proposed and alternate approaches.

6. During the interagency review

process, it was suggested that the

Agency limit the reporting of processing

and use information on Part III. of

Revised Reporting Form U to

manufacturers and importers of high

production volume (HPV) chemicals in

the U.S. (i.e., are produced in amounts

equal to or greater than 1 million

pounds), chemicals that are currently

subject to testing under TSCA section 4

(i.e., test rules and enforceable consent

agreements (ECAs)), chemicals

identified for voluntary testing,

chemicals designated for testing by the

ITC, and chemicals listed in the

Agency’s Master Testing List (the

current edition is available at http://

www.epa.gov/opptintr/chemtest/

mtl.htm). This would mean that, for

example, in order to determine whether

or not a chemical is an HPV chemical,

a manufacturer or importer would not

only need to know their own production

volume, but also whether the chemical

is produced nationally in amounts equal

to or greater than 1 million pounds. In

order to determine whether a chemical

is subject to testing under TSCA section

4, identified for voluntary testing, or

designated for testing by the ITC during

a particular reporting period, a

manufacturer or importer would be

required to review the regulations and

the most recent Master Testing List.

Therefore, EPA is specifically requesting

comment on whether manufacturers and

importers will be able to make these

determinations for the universe of

chemicals potentially subject to IUR

reporting, including any suggestions for

ways in which to make these

determinations.

EPA believes that for an HPV

determination procedure to be effective,

it must be able to accommodate the

frequency with which individual

chemicals may rise above or fall below

the HPV threshold criteria of a U.S.

aggregate production volume of 1

million lbs. or more per year. For

example, 17% of the chemicals which

were HPVs according to data submitted

under the 1990 IUR were not HPVs

according to data submitted under the

1994 IUR. To address this issue, EPA is

proposing in these IUR amendments to

use a submitter-specific processing and

use production volume threshold of

300,000 lbs. or more per site per year to

ensure that reporting is captured for a

great majority of HPVs (as defined on

the basis of national aggregate

production volume). EPA seeks

comments on alternative approaches for

identifying HPVs for IUR reporting

purposes that similarly account for the

dynamic nature of the set of HPV

chemicals.

EPA is also specifically interested in

receiving comments on the additional

burden imposed on manufacturers and

importers associated with the reporting

of processing and use information under

the IUR amendments to manufacturers

and imports of HPV chemicals. Under

EPA’s current proposal, in order to

determine whether a chemical is subject

to IUR reporting during a particular

reporting period, a manufacturer or

importer would first determine the

production volume of the chemicals

they produced during the year for which

reporting is required (i.e., was the

chemical produced in an amount of

25,000 lbs. or more, or in an amount of

300,000 lbs. or more for processing and

use information). They would then

determine if the chemical is otherwise

exempt from IUR reporting. The Agency

is concerned that limiting reporting to

the HPV chemicals would require a

manufacturer or importer to make

additional determinations, as described

in the beginning of this request for
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46797

comment, in order to ascertain whether

they must report under IUR.

In addition, EPA is interested in

receiving comment on whether this

suggestion would limit the utility of the

information that would be collected,

because it would change the focus and

purpose of the proposed IUR

amendments related to the collection of

processing and use information. As

discussed previously, EPA believes that

the basic processing and use

information that EPA is proposing to

collect on less than 3,500 of the 76,000

chemicals on the TSCA Inventory, is

critical for EPA to more effectively and

efficiently fulfill its obligations under

TSCA, e.g., to assess the risks of

chemicals in commerce, and to promote

pollution prevention by encouraging the

development of safer substitutes and

alternatives. In developing its proposal,

the Agency has taken steps to minimize

burden and costs, and believes that the

information that the Agency is

proposing to collect is essential to the

Agency’s chemical screening process.

The basic processing and use

information that EPA is proposing to

collect will allow the Agency and other

users of IUR information to better

prioritize their efforts based on a

chemical’s potential risks. The Agency

therefore believes that the burden and

costs associated with providing the

information proposed in this document

will assist the Agency and others to

avoid the imposition of additional

burden and costs related to further

actions, such as more in-depth

assessments and regulations.

7. Are the industrial function

categories listed in this proposed rule

the most appropriate ones?

8. Are the commercial and consumer

product categories in this proposed rule

the most appropriate ones?

9. Are there better alternatives to the

definition of ‘‘potentially exposed

worker’’ contained in this proposed rule

(i.e., § 710.2), ‘‘reasonably likely to be

exposed’’)? Is the OSHA hazard

communication standard’s definition

(i.e., 29 CFR 1910.1200(c), ‘‘employee’’)

more appropriate for this proposed rule?

10. Should EPA require the reporting

of TRI facility identification numbers,

where available?

11. Is the reporting of production

volume ranges, as proposed, likely to

result in fewer confidentiality claims

than when specific production volumes

are reported? What else could be done

to the reporting process and data

elements included in the final rule to

reduce CBI claims of submitters to allow

better public access to data?

12. Should the Agency collect

information on the use of personal

protective equipment during the

manufacture or import of chemicals

reported on the IUR? During the

interagency review process, it was

suggested that the Agency consider

collecting information on the use of

personal protective equipment (PPE).

Generic PPE recommendations exist

from Material Safety Data Sheets

(MSDS), and may be available from

other sources. As described in this

preamble, EPA plans to use the

information collected through these

proposed amendments mainly for initial

screening level assessments. EPA is

interested in receiving comment on

whether the Agency should collect

information on PPE, what kind of

specific PPE information should be

collected, and whether such additional

data reporting requirements would

result in a significant burden increase to

industry.

13. Are the data sought in this

proposed rule related to industrial

processing and use and commercial and

consumer products ‘‘readily obtainable’’

by those who are required to report?

14. What alternatives are available to

the procedures proposed in this

document that will protect submitters’

right to reassert their CBI claims? Can

you identify means other than those

discussed in this proposed rule which

the Agency might use to better inform

submitters of the requirement to

reexamine past CBI claims and to

reassert CBI claims, as appropriate, in

order to retain CBI protections?

15. Should EPA require data to be

reported using the metric system?

X. Materials in the Public Docket

The official record for this rulemaking

has been established under docket

control number OPPTS–82053. The

following is a listing of the documents

that have already been placed in the

official record for this proposal.

A. Supporting Documentation

1. Federal Register notices/EPA

documents/court opinions pertaining to

this proposed rule consisting of:

a. ‘‘TSCA Section 4(a)(1)(B) Final

Statement of Policy; Criteria for

Evaluating Substantial Production,

Substantial Release, and Substantial or

Significant Human Exposure,’’ (58 FR

28736, May 14, 1993).

b. 29 CFR 1910.1200 (OSHA hazard

communication standards for toxic and

hazardous substances).

c. Chemical Manufacturers

Association v. EPA, 859 F.2d 977, 991

(D.C. Cir. 1988).

2. Technical support documents and

studies consisting of:

a. EPA/OPPT, ‘‘Inventory Update Rule

(IUR) Amendment Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening,’’

Volumes 1 and 2, July 19, 1996.

b. Eastern Research Group, Inc.,

‘‘Preliminary Assessment Information

Rule (PAIR) Database, Manufacturing

Process Type/Release Analysis and

Number of Workers/Production

Quantity Analysis,’’ prepared for EPA/

OPPT, September 26, 1996.

c. Environmental Business Strategies,

‘‘U.S. Chemical Production, Use, and

Exposure Data: A Study of Existing

Information Sources,’’ on behalf of

Chemical Manufacturers Association,

October 1997.

d. GE Plastics, ‘‘IUR Reporting

Frequency and EPA’s Existing

Chemicals Program,’’ 1996.

e. NIOSH, National Occupational

Exposure Survey (NOES), 1981.

f. EPA/OPPT/EETD/EPAB, ‘‘Economic

Analysis of Proposed Amendments to

the TSCA Section 8 Inventory Update

Rule,’’ March 1, 1999.

g. EPA/OPPT, ‘‘Inventory Update Rule

(IUR) Technical Support Document:

Evaluation of Likelihood of Confidential

Business Information Claims for

Production Volume Information,’’ Final

Draft, August 26, 1996.

h. EPA/OPPT, ‘‘Technical Support

Document: Technical Approach for the

Selection of Consumer End-Use

Categories for the Inventory Update

Rule,’’ 1996.

i. EPA/OPPT, ‘‘A Review of Existing

Exposure-Related Data Sources and

Approaches to Screening Chemicals: A

Response to CMA,’’ March 1999.

3. Minutes or summaries of public

meetings:

a. American Chemical Society

Roundtable Forum, ‘‘A Pollution

Prevention Strategy for Toxic

Chemicals,’’ July 28, 1993.

b. EPA, ‘‘Chemical Use Inventory

(CUI) Meeting With Environmental and

Right-to-Know Groups,’’ September 29,

1993.

c. EPA, ‘‘The EPA Office of Pollution

Prevention and Toxics (OPPT) Meeting

on the Chemical Use Inventory,’’’

October 6, 1993.

d. EPA, ‘‘Chemical Use Inventory

(CUI) Meeting With Industry,’’ October

12, 1993.

e. EPA, ‘‘OPPT’s Chemical Use

Inventory Project: Presentation to

FOSTTA Chemical Management and

Chemical Information Project

Members,’’ October 19, 1993.

f. EPA, ‘‘Meeting with Labor

Constituents,’’ November 10, 1993.

g. EPA, ‘‘CUI Multi-stakeholder

Meeting,’’ January 5, 1994.

h. EPA, ‘‘Statement of Lynn R.

Goldman, M.D. Before the
46798 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

Subcommittee on Toxic Substances,

Research and Development, Committee

on Environment and Public Works, U.S.

Senate,’’ May 17, 1994.

i. U.S. Senate Committee on

Environment and Public Works,

Subcommittee on Toxic Substances,

Research and Development, ‘‘Hearing to

discuss reauthorization of the Toxic

Substances and Control Act (TSCA),’’

July 13, 1994.

j. Clean Sites, ‘‘CUI/IUR Amendments

Workshop, Meeting Summary,’’ April

13, 1995.

k. EPA, ‘‘Discussion Paper [for April

13, 1995 meeting], Amendments to the

TSCA Inventory Update Rule Needed to

Create A Chemical Use Inventory,’’

April 1995.

l. Mary Ellen Weber, EPA, ‘‘TSCA

Chemical Use Inventory, Inventory

Update Rule Amendments,’’ presented

to Chemical Manufacturers Association,

TSCA Information Forum, May 15,

1996.

m. Mary Ellen Weber, EPA,

‘‘Chemical Use Inventory, TSCA

Inventory Update Rule Amendments,’’

presented to Organization Resources

Counselors, Inc., Environmental Group,

June 26, 1996.

4. Communications consisting of:

a. Memorandum from Mark V. Stanga

and Patricia A. Franco, Electronic

Industries Association to EPA, May 5,

1993.

b. Letter from Claudette M. Cofta,

CMA to Mark A. Greenwood, EPA,

September 8, 1993.

c. Letter from Albert K. Langley, Jr.,

Georgia Department of Natural

Resources to Wardner G. Penberthy,

EPA, October 25, 1993.

d. Letter from Michael A. Babich,

Consumer Product Safety Commission

to Wardner G. Penberthy, EPA, October

26, 1993.

e. Letter from Stephen S. Kellner,

Chemical Specialties Manufacturers

Association to Mark Greenwood, EPA,

October 29, 1993.

f. Letter from Stephen D. Hanna,

California EPA to Mary Ellen Weber,

EPA, November 8, 1993.

g. Letter from Public Interest Groups

to Mark Greenwood, EPA, November 17,

1993 (with attachments).

h. Letter from Hillel Gray, National

Environmental Law Center, to Wardner

G. Penberthy, EPA, November 22, 1993.

i. Letter from Roger A. Kanerva, State

of Illinois EPA to Wardner G. Penberthy,

EPA, November 22, 1993.

j. Letter from F. David Petke, Eastman

Chemical Co. to Mary Ellen Weber, EPA,

November 23, 1993.

k. Letter from Stephen S. Kellner,

Chemical Specialties Manufacturers

Association to Tim Hunt, OMB,

November 30, 1993.

l. Letter from Andy Opperman, New

Jersey Dept. of Environmental

Protection and Energy to Wardner G.

Penberthy, December 6, 1993.

m. Letter from Claudette M. Cofta,

CMA to Mark A. Greenwood, EPA,

December 7, 1993.

n. Letter from Cheryl O. Morton,

SOCMA to Mark A. Greenwood, EPA,

December 10, 1993.

o. Letter from Jeanne Herb, State of

New Jersey Department of

Environmental Protection and Energy,

to Wardner G. Penberthy, EPA,

December 8, 1993.

p. Letter from Robert D. Bullard,

University of California, Los Angeles, to

Wardner G. Penberthy, EPA, December

14, 1993.

q. Letter from Stephen R. Sides and H.

Allen Irish, National Paint Coatings

Association to Wardner G. Penberthy,

EPA, January 11, 1994.

r. Letter from Mark V. Stanga, Litton

Corporate, to Wardner G. Penberthy,

EPA, January 17, 1994.

s. Letter from Stephen S. Kellner,

Chemical Specialties Manufacturers

Association to Lynn R. Goldman, EPA,

January 19, 1994.

t. Letter from Claudette M. Cofta,

CMA to Mark A. Greenwood, EPA,

January 25, 1994.

u. Letter from Hillel Gray, National

Environmental Law Center to Lynn R.

Goldman, EPA, February 11, 1994.

v. Letter from Richard I. Sedlak, The

Soap and Detergent Association to

Wardner G. Penberthy, EPA, February

24, 1994.

w. Letter from Lawrence E. Slimak,

American Automobile Manufacturers

Association to Mark Greenwood, EPA,

March 8, 1994.

x. Letter from Mark A. Greenwood,

EPA to Lawrence E. Slimak, American

Automobile Manufacturers Association,

March 28, 1994.

y. Letter from Sarah Doelp, CMA to

Mark Greenwood, EPA, June 20, 1994.

z. Report from Ken Geiser, Toxics Use

Reduction Institute, University of

Massachussetts, October 1994.

aa. Letter from Sarah Doelp, CMA to

Wardner G. Penberthy, EPA, February 2,

1995.

bb. Letter from Stephen S. Kellner,

Chemical Specialties Manufacturers

Association to Tim Hunt, OMB, March

23, 1995.

cc. Letter from Walter L. McLeod, API

to Allan Abramson, EPA, April 21,

1995.

dd. Letter from Lynn R. Goldman,

EPA to Steve Tiber, Office of

Administration and Resources

Management, August 18, 1995.

ee. Letter from Donald D. Helin,

Chemical Manufacturers Association to

William H. Sanders III, EPA, March 26,

1997.

ff. Letter from Larry Rampy, Chemical

Manufacturers Association to Arthur G.

Fraas, Office of Management and

Budget, May 26, 1999.

gg. Letter from Pamela Gilbert,

Consumer Product Safety Commission,

to Donald R. Arbuckle, Office of

Management and Budget, June 14, 1999.

hh. Letter from John D. Walter, TSCA

Interagency Testing Committee, to Mary

Ellen Weber, EPA, June 15, 1999.

B. References

1. Vice President Albert Gore, ‘‘EPA

Right-to-Know Announcement,’’ April

21, 1998.

2. Chemical Manufacturers

Association, Synthetic Organic

Chemical Manufacturers Association,

U.S. EPA, Chemical Specialties

Manufacturing Association, American

Petroleum Institute, ‘‘Round 3 of the

UEIP (Use and Exposure Information

Project),’’ June 3, 1996.

3. U.S. EPA, ‘‘Reducing Risk: Setting

Priorities and Strategies for

Environmental Protection,’’ Science

Advisory Board, (SAB-EC-90-021), 1990.

4. National Academy of Public

Administration, ‘‘Setting Priorities,

Getting Results - A New Direction for

EPA,’’ 1995.

5. U.S. EPA, ‘‘Decision Guidelines

Manual,’’ OPPT/CCD/NCB, December

1992.

6. Letter from M.L. Mullins, Chemical

Manufacturers Association, to EPA,

‘‘Proposed Alternative to Anticipated

Rule to Amend TSCA for the Creation

of a Chemical Use Inventory,’’ May 20,

1996.

7. Letter from Michael A. Babich, U.S.

Consumer Product Safety Commission,

to Wardner G. Penberthy, EPA, June 24,

1996.

8. Official Journal of the European

Communities, ‘‘Council Regulation

(EEC) No 793/93 of 23 March 1993 on

the evaluation and control of the risks

of existing substances,’’ L84, Volume 36,

April 5, 1993.

9. Organization of Economic

Cooperation and Development, ‘‘SIDS

Manual (Second Revision) Screening

Information Data Set Manual of the

OECD Programme on the Co-operative

Investigation of High Production

Volume Chemicals,’’ May 1996.

10. Memorandum from Norman R.

Niedergang, EPA to Dr. Lynn R.

Goldman, EPA, ‘‘Continuing Sources of

Asbestos Exposure,’’ June 26, 1998.

11. U.S. EPA, ‘‘Influence of CBI

Requirements on TSCA

Implementation,’’ OPPT, March 1992.

12. U.S. EPA, ‘‘Final Action Plan:

TSCA Confidential Business
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46799

Information Reform,’’ OPPT, June 20,

1994.

13. U.S. EPA, ‘‘TSCA CBI Reform

Program: State Access to TSCA Data,

Including CBI, Project; Forum on State,

Tribal Toxics Action Meeting’’ OPPT/

IMD, June 24, 1996.

14. U.S. EPA, ‘‘EPA Needs ExposureRelated Data: A Discussion of the

Justification for Collecting ExposureRelated Data Through the IUR

Amendments,’’ OPPT/EETD/EPAB,

1998.

15. Griefe, A. et al., ‘‘National

Institute for Occupational Safety and

Health General Industry Occupational

Exposure Databases: Their Structure,

Capabilities and Limitations,’’ Applied

Occupational and Environmental

Hygiene 10(4), April 1995.

16. U.S. EPA, ‘‘Chemical Use Clusters

Scoring Methodology,’’ Draft Report,

OPPT/EETD/CEB, July 23, 1994.

17. U.S. EPA, ‘‘An SAB Report:

Improving the Use Cluster Scoring

System, Recommendations for the Use

Cluster Scoring System Prepared by the

Environmental Engineering

Committee,’’ Science Advisory Board,

SAB-EEC-95-017, September 1995.

18. U.S. EPA, ‘‘Inventory of ExposureRelated Data Systems Sponsored by

Federal Agencies,’’ EPA/600/R-92/078,

http://www.epa.gov/ncepihom/

nepishom/index.html, 1992.

19. American Petroleum Institute,

‘‘Petroleum Process Stream Terms

Included in the Chemical Substances

Inventory Under the Toxic Substances

Control Act (TSCA),’’ Health and Safety

Regulation Committee Task Force on

Toxic Substances Control, February

1985.

20. General Accounting Office, ‘‘EPA

Should Focus Its Chemical Use

Inventory on Suspected Harmful

Substances,’’ GAO/RCED-95-165, July 7,

1995.

21. Letter from Mark N. Duvall, Union

Carbide, to EPA, ‘‘Additional Comments

of Union Carbide Corporation on EPA’s

Preliminary Actions to Reform TSCA

Confidential Business Information,

Docket No. OPPTS-00125,’’ August 31,

1993.

22. Letter from Stephen A. Newell,

Occupational Safety and Health

Administration, to Wardner G.

Penberthy, EPA, October 15, 1996.

23. Letter from Paul A. Schulte,

National Institute for Occupational

Safety and Health, to Wardner G.

Penberthy, EPA, October 8, 1996.

24. U.S. EPA, ‘‘Preparation of

Engineering Assessments,’’ Vol. 1, Ch. 4,

pp. 1-33, OPPT/EETD/CEB, February 28,

1991.

25. U.S. Census Bureau, North

American Industrial Classification

System (NAICS), http://

www.census.gov/epcd/www/

naics.html, 1999.

26. U.S. EPA, ‘‘Chemical Right-toKnow Initiative,’’ http://www.epa.gov/

chemrtk/index.htm, June 8, 1999.

XI. Regulatory Assessment

Requirements

A. Executive Order 12866

Pursuant to Executive Order 12866

(58 FR 51735, October 4, 1993), entitled

‘‘Regulatory Planning and Review,’’ the

Office of Management and Budget

(OMB) has determined that this is a

‘‘significant regulatory action’’ because

this action may raise novel policy issues

related to the collection of information.

This action was submitted to OMB for

review, and any comments or changes

made during that review have been

documented in the public record.

In addition, the Agency has prepared

an economic assessment of the

estimated costs and benefits attributable

to this proposed rule. This document,

entitled ‘‘Economic Analysis of

Proposed Amendments to the TSCA

Section 8 Inventory Update Rule,’’ is

available in the public version of the

official record for this proposal, at the

address listed in Unit I.B.2. of this

preamble. EPA estimates the proposed

amendments would cost between $36 to

$51 million for the first year of reporting

and $27 to $41 million for future years

of reporting, resulting in an annualized

cost of $10 to $14 million over the next

20 years.

Under the proposed amendments,

approximately 8,900 chemicals would

be subject to reporting, and the Agency

expects that it would receive

approximately 25,500 submissions

during the first reporting cycle.

Approximately 10,000 of those

submissions (providing information on

about 4,000 chemicals) would be full

reports which include information

found in Part III. of Revised Reporting

Form U, with the remainder reporting

only company, site and chemical

identification and manufacturing

information (Parts I., II., and IV. of

Revised Reporting Form U). In order to

keep the reporting burden as low as

possible, EPA is proposing to require

that certain information be reported in

ranges, that only the top 10 NAICS

codes be accounted for when reporting

industrial processing and use

information, and that only readily

obtainable information in Part III be

reported.

EPA analyzed the effects of a number

of different alternatives for the proposed

rule, including variations in

exemptions, different thresholds for

both partial- (i.e. Parts I., II., and IV. of

Revised Reporting Form U) and fullform (i.e. all parts of Revised Reporting

Form U), and various frequencies of

collection. These options are explored

further in the Economic Analysis.

In addition to the proposed option,

EPA considered continuing the

exemption from IUR reporting for

inorganic chemicals and adding an

exemption for site-limited petroleum

streams. EPA examined the effects of

keeping the partial-form threshold at

10,000 pounds and considered full-form

thresholds of 10,000, 25,000, 100,000,

500,000, 1,000,000 and 10,000,000

pounds, as well as a phased-in 100,000/

500,000 full-form threshold. EPA also

considered changes in the reporting

cycle, such as a one-time collection, a 2-

year cycle, and an option that would

have collected partial forms every 2

years and full forms every 4 years.

During the interagency review

process, EPA also considered a 50,000

lb. threshold for the partial form (see

Addendum to the economic analysis

referenced in Unit X.A.2.f. of this

preamble). While this threshold would

indeed reduce industry burden by $2-3

million when compared to the proposed

25,000 lb. threshold, EPA feels that the

benefit of the information obtained on

chemicals produced between 25,000

and 50,000 lbs. yearly, far outweighs the

costs. By increasing the threshold from

25,000 to 50,000 lbs., EPA would lose

data on roughly 880 discrete chemicals

from roughly 1,750 reports. Forgoing

this information would exclude a large

portion of the chemical industry from

oversight under TSCA, which requires

EPA to regulate the entire industry. In

addition, EPA feels that the data

collected at a 50,000 lb. threshold

would be insufficient to meet the TSCA

statutory requirement to update and

keep current the TSCA Inventory of

Chemical Substances.

During the interagency review

process, EPA altered its proposal to

include a natural gas exemption, an

inorganics partial exemption, and an

upper threshold of 300,000 lbs. These

options are also analyzed in the

addendum to the economic analysis

referenced in Unit X.A.2.f. of this

preamble. While the natural gas

exemption affects only six chemicals, it

reduces the number of reports by over

1,200. The inorganics partial exemption

reduces the number of chemicals

requiring full reports by about 1,200.

The increase in the upper threshold

from 100,000 to 300,000 pounds reduces

the number of chemicals reporting

processing and use information (Part III.

of Form U) to about 3,400.
46800 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

The costs of the proposed

amendments would be borne by two

groups: the chemical industry and EPA.

Industry costs are associated with

complying with the regulation, while

EPA costs are associated with

administering the regulation and

maintaining the collected data. In this

rulemaking effort, EPA has made every

attempt to balance data needs with

collection costs and burden. Wherever

possible, EPA has used exemptions or

partial exemptions to reduce the

number of reports filed by industry.

EPA has provided an upper threshold

for reporting use information required

in Part III of Revised Reporting Form U,

reducing the per report burden for

submitters. Recognizing that this

information would be used for

screening-level purposes, EPA has

reduced the specificity of the

information that would be required in

three ways:

• By requiring the reporting of only

readily obtainable information for the

use and non-manufacturing exposurerelated data.

• By requiring that submitters report

much of the information in ranges,

reducing the need to generate precise

estimates.

• By requiring processing and userelated information on only the top 10

NAICS codes, as determined by percent

of the chemical’s volume.

These steps limit the amount of

information required, reducing the time

and effort spent by the chemical

industry in complying with the

amendments.

First-year costs of the proposed rule

are estimated to be between $36 million

and $51 million, with subsequent

annual costs in future reporting years of

$27 to $41 million. This results in an

annualized cost of between $10 million

and $14 million over the first 20 years.

EPA assumes that the burden associated

with reporting under the IUR

amendments would decrease over time

as the industry’s familiarity with the

reporting rule increases and to the

extent that the information being

reported remains somewhat constant

from one reporting period to the next.

Projected costs to EPA are relatively

small and are estimated to be $525,000

in the first reporting year, and $275,000

in subsequent reporting years.

During the interagency review

process, EPA added the collection of the

data element for average concentration

(not included in the Economic Analysis)

to Part II. of the revised Reporting Form

U. EPA expects the addition of this data

element to result in only a negligible

increase in burden because similar

information is needed in order to report

both the maximum concentration as

well as the average concentration. EPA

therefore did not find a reason to adjust

the Economic Analysis to reflect this

change.

B. Regulatory Flexibility Act

Pursuant to section 605(b) of the

Regulatory Flexibility Act (RFA), 5

U.S.C. 601 et seq., the Agency hereby

certifies that this proposed rule, if

promulgated as proposed, will not have

a significant impact on a substantial

number of small entities. This

certification is based on the Agency’s

analysis of potential impacts on small

entities, which is included in the

Economic Analysis summarized in

section A. of this Unit.

Small entities include small

businesses, small not-for-profit

organizations, and small governmental

jurisdictions (5 U.S.C. 601(6)). Because

not-for-profit organizations and

governmental jurisdictions will not be

affected by this proposed rule, ‘‘small

entity’’ for purposes of this proposed

rule is synonymous with ‘‘small

business.’’

Section 601(3) of the RFA establishes

as the default definition of small

business the definition used in section

3 of the Small Business Act (15 U.S.C.

632) under which the SBA establishes

small business size standards (13 CFR

121.201). The RFA recognizes, however,

that it may be appropriate at times for

Federal agencies to use an alternate

definition of small business. As a result,

RFA section 601(3) provides that an

agency may establish a different

definition of small business after

consultation with the SBA Office of

Advocacy and after notice and an

opportunity for public comment. EPA

established a different definition of

small business, found in the existing

IUR at 40 CFR 704.3, in accordance with

these requirements. Manufacturers and

importers who meet the 40 CFR 704.3

definition of small business are

generally exempted from IUR reporting

in 40 CFR 710.29. This exemption is

retained under these amendments and is

not being reopened for comment.

Despite the fact that small

manufacturers and importers that fully

meet the 40 CFR 704.3 definition of

small manufacturers and importers are

generally exempt from reporting under

IUR, and thus are not significantly

impacted by these amendments to IUR,

EPA conducted an analysis of the

potential impact for submitters that

meet only part of the 40 CFR 704.3

definition. Specifically, an analysis of

the potential impact was conducted

only for those submitters that meet the

first criterion in the 40 CFR 704.3

definition of ‘‘small manufacturer or

importer,’’ i.e. total annual sales of less

than $40 million, but that do not meet

the second criterion, i.e. production or

import volume of less than 100,000

pounds at all sites.

For small entities manufacturing

(including importing) organic chemicals

subject to reporting, the Agency

estimates the impact to be 0.13% to

0.16% of sales. For small entities

manufacturing (including importing)

inorganic chemicals subject to reporting,

the Agency estimates the impact to be

0.15% to 0.20% of sales. These

estimates are based upon the Agency’s

belief that most small businesses

reporting will complete the full Form U,

unless the business is eligible for one of

the partial exemptions. These small

entity impacts are based on EPA’s

original proposal for the IUR

amendments. The revised proposal,

which has reduced industry cost and

burden even further, is expected to have

even less impact on small entities.

Information relating to this

determination has been provided to the

Chief Counsel for Advocacy of the Small

Business Administration, and is

included in the docket for this

rulemaking. Any comments regarding

the economic impacts that this proposed

regulatory action may impose on small

entities should be submitted to the

Agency according to the procedures

identified in the ‘‘ADDRESSES’’ section

at the beginning of this preamble.

C. Paperwork Reduction Act

The information collection

requirements contained in this proposed

rule have been submitted to OMB under

the Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., and in accordance

with the procedures at 5 CFR 1320.11.

An Information Collection Request (ICR)

document has been prepared by EPA

(EPA ICR No. 1884.01), and included in

the public version of the official record

that is described in Unit I.B.3. of this

preamble. In addition to viewing the

ICR document as described in Unit

I.B.3. of this preamble, you may obtain

a copy of the ICR by mail from Sandy

Farmer, OP Regulatory Information

Division; Environmental Protection

Agency (2137), 401 M St., SW.,

Washington, DC 20460, by calling (202)

260-2740, or by e-mail to

‘‘farmer.sandy@epa.gov.’’ An electronic

copy has also been posted on EPA’s

World Wide Website (http://

www.epa.gov/) with other information

related to this action.

The information requirements

contained in this proposal are not

effective until OMB approves them. An

Agency may not conduct or sponsor,
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46801

and a person is not required to respond

to a collection of information subject to

OMB approval under the PRA unless it

displays a currently valid OMB control

number. The OMB control numbers for

EPA’s regulations, after initial

publication in the Federal Register, are

displayed in a list at 40 CFR part 9.

The information that would be

reported under these amendments to

IUR would better enable EPA to screen

thousands of chemical substances for

potential risk. Risk screening is

necessary in order to conserve limited

Agency resources by focusing risk

assessment work on chemical

substances for which some level of

potential risk has been indicated. The

new information that would be reported

under this rule is critical to the risk

screening process and is unavailable

through other sources. Responses to this

collection of information would be

mandatory, pursuant to TSCA section

8(a).

CBI claims may be made for all of the

new information that would be reported

under these amendments to IUR. This

action proposes new substantiation

procedures for CBI claims regarding

plant site identity. (See § 710.38(d) of

the regulatory text). In addition, a new

provision for the reassertion of CBI

claims would be added. This provision

states that all CBI claims made in one

reporting period would be valid only

until the beginning of the reporting

period immediately following the

reporting period in which the

information was claimed as

confidential. To maintain the

confidential status of information, the

submitter would need to certify during

every reporting period following the one

in which the original claim of

confidentiality was made, that the

information should continue to be

treated as confidential by EPA.

Reassertions must be made to maintain

confidentiality even if the submitter is

not required to report during a given

reporting period. If a submitter fails in

a reporting period to reassert the

confidentiality claims made in the

previous reporting period, the claims

are presumed to be waived and EPA

will make the information available to

the public without further notice to the

submitter. (See § 710.39 of the

regulatory text).

The following annual burden and cost

figures represent the cost of a 4–year

reporting cycle, spread over 4 years.

Most or all of the burden would fall in

the first year of the cycle. The public

reporting burden for this collection of

information is estimated to be 150,000

to 210,000 hours for each of the 4 years

in the first reporting cycle for

approximately 3,050 respondents. The

average annual reporting burden per

response is 6 to 8 hours, with the

average company reporting 8.4 times per

collection and each information

collection occurring every 4 years. The

annual public reporting cost burden for

operation and maintenance expenses is

estimated to be $11 to $15 million

annually for the first four year reporting

cycle, and decreasing after that. The

total capital and start-up costs, as well

as the purchase of services, are

estimated to be zero.

Under the PRA, ‘‘burden’’ means the

total time, effort, or financial resources

expended by persons to generate,

maintain, retain, or disclose or provide

information to or for a Federal agency.

This includes the time needed to review

instructions; develop, acquire, install,

and utilize technology and systems for

the purposes of collecting, validating,

and verifying information, processing

and maintaining information, and

disclosing and providing information;

adjust the existing ways to comply with

any previously applicable instructions

and requirements; train personnel to be

able to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

Comments are requested on the

Agency’s need for this information, the

accuracy of the provided burden

estimates, and any suggested methods

for minimizing burden, including

through the use of automated collection

techniques. Send comments on the ICR

to the EPA according to the instructions

provided in Unit I.C. of this preamble.

Please remember to include the docket

control number OPPTS–82053, or the

ICR number in any correspondence. The

final rule will respond to any comments

on the information collection

requirements contained in this proposal.

D. Unfunded Mandates Reform Act

Pursuant to Title II of the Unfunded

Mandates Reform Act of 1995 (Public

Law 104-4), EPA has determined that

this proposed regulatory action does not

contain a Federal mandate that may

result in expenditures of $100 million or

more for State, local, and tribal

governments, in the aggregate, or for the

private sector in any 1 year. The

analysis of the costs associated with this

proposed action are described in Unit

XI.A. of this preamble. In addition, EPA

has determined that this proposed rule

does not significantly or uniquely affect

small governments. Accordingly,

today’s proposed rule is not subject to

the requirements of sections 202, 203,

204, and 205 of UMRA.

E. Executive Order 12875

Under Executive Order 12875,

entitled Enhancing Intergovernmental

Partnerships (58 FR 58093, October 28,

1993), EPA may not issue a regulation

that is not required by statute and that

creates a mandate upon a State, local or

tribal government, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by those governments, or

EPA consults with those governments. If

EPA complies by consulting, Executive

Order 12857 requires EPA to provide to

the OMB a description of the extent of

EPA’s prior consultations with

representatives of affected State, local

and tribal governments, the nature of

their concerns, copies of any written

communications from the governments,

and a statement supporting the need to

issue the regulation. In addition,

Executive Order 12875 requires EPA to

develop an effective process permitting

elected officials and other

representatives of State, local and tribal

governments ‘‘to provide meaningful

and timely input in the development of

regulatory proposals containing

significant unfunded mandates.’’

Today’s notice does not create an

unfunded Federal mandate on State,

local, or tribal governments. The rule

does not impose any enforceable duties

on these entities. Accordingly, the

requirements of section 1(a) of

Executive Order 12875 do not apply to

this proposed rule. Nevertheless, EPA

has sought the active participation of

State, local and tribal governments who

might be interested in this proposal. The

Agency has had several informal

consultations regarding the proposed

rule with some States through the EPA

regional offices and at regularly

scheduled State meetings. No significant

issues or information were identified as

a result of EPA’s discussion with the

States, who are primarily interested in

CBI issues and whether they will have

access to the information EPA collects

under these proposed amendments.

F. Executive Order 13084

Under Executive Order 13084,

entitled Consultation and Coordination

with Indian Tribal Governments (63 FR

27655, May 19, 1998), EPA may not

issue a regulation that is not required by

statute, that significantly or uniquely

affects the communities of Indian tribal

governments, and that imposes

substantial direct compliance costs on

those communitiies, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments, or EPA consults with
46802 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

those governments. If EPA complies by

consulting, Executive Order 13084

requires EPA to provide to the OMB, in

a separately identified section of the

preamble to the rule, a description of

the extent of EPA’s prior consultation

with representatives of affected tribal

governments, a summary of the nature

of their concerns, and a statement

supporting the need to issue the

regulation. In addition, Executive Order

13084 requires EPA to develop an

effective process permitting elected

officials and other representatives of

Indian tribal governments ‘‘to provide

meaningful and timely input in the

development of regulatory policies on

matters that significantly or uniquely

affect their communities.’’

G. Executive Order 12898

Pursuant to Executive Order 12898

(59 FR 7629, February 16, 1994),

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations, the Agency has considered

environmental justice-related issues

with regard to the potential impacts of

this action on the environmental and

health conditions in low-income and

minority communities. The Agency

believes that the information collected

under this proposed rule would assist

the Agency in determining the risks and

exposures associated with these

chemicals. Although not directly

impacting environmental justice-related

concerns, this information would enable

the Agency to protect human health and

the environment by being better able to

prioritize chemical substances of

concern.

H. Executive Order 13045

This rulemaking does not require

special consideration pursuant to the

terms of Executive Order 13045, entitled

Protection of Children from

Environmental Health Risks and Safety

Risks (62 FR 19885, April 23, 1997),

because it is not likely to have an

annual effect on the economy of $100

million or more and it does not have a

potential effect or impact on children.

As discussed in this preamble, this

proposed rule would provide the

Agency with information needed to

screen and prioritize chemical

substances. This information will allow

the Agency and others to determine

which chemical substances have

potential risks, allowing the Agency and

others to take appropriate action to

investigate and mitigate those risks.

I. National Technology Transfer and

Advancement Act

This proposed regulatory action does

not involve any technical standards that

would require Agency consideration of

voluntary consensus standards pursuant

to section 12(d) of the National

Technology Transfer and Advancement

Act of 1995 (NTTAA), Public Law 104-

113, section 12(d) (15 U.S.C. 272 note).

Section 12(d) of NTTAA directs EPA to

use voluntary consensus standards in its

regulatory activities unless to do so

would be inconsistent with applicable

law or otherwise impractical. Voluntary

consensus standards are technical

standards (e.g., materials specifications,

test methods, sampling procedures,

business practices, etc.) that are

developed or adopted by voluntary

consensus standards bodies. The

NTTAA requires EPA to provide

Congress, through OMB, explanations

when the Agency decides not to use

available and applicable voluntary

consensus standards. EPA invites public

comment on the Agency’s determination

that this regulatory action does not

require the consideration of voluntary

consensus standards.

List of Subjects in 40 CFR Part 710

Environmental protection, Chemicals,

Hazardous materials, Reporting and

recordkeeping requirements.

Dated: August 2, 1999.

Susan H. Wayland,

Acting Assistant Administrator, Office of

Prevention, Pesticides and Toxic Substances.

Therefore, it is proposed that 40 CFR

part 710 be amended as follows:

PART 710—[AMENDED]

1. The authority citation for part 710

would continue to read as follows:

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

2. By revising § 710.2 to read as

follows:

§ 710.2 Definitions.

In addition to the definitions in

§ 704.3 in this chapter, the following

definitions apply to this part:

(a) The following terms shall have the

meaning contained in the Federal Food,

Drug, and Cosmetic Act, 21 U.S.C. 321

et seq., and the regulations issued under

such Act: Cosmetic, device, drug, food,

and food additive. In addition, the term

food includes poultry and poultry

products, as defined in the Poultry

Products Inspection Act, 21 U.S.C. 453

et seq.; meats and meat food products,

as defined in the Federal Meat

Inspection Act, 21 U.S.C. 60 et seq.; and

eggs and egg products, as defined in the

Egg Products Inspection Act, 21 U.S.C.

1033 et seq.

(b) The term pesticide shall have the

meaning contained in the Federal

Insecticide, Fungicide, and Rodenticide

Act, 7 U.S.C. 136 et seq., and the

regulations issued thereunder.

(c) The following terms shall have the

meaning contained in the Atomic

Energy Act of 1954, 42 U.S.C. 2014 et

seq., and the regulations issued

thereunder: byproduct material, source

material, and special nuclear material.

(d) The following definitions also

apply to this part:

Act means the Toxic Substances

Control Act, 15 U.S.C. 2601 et seq.

Administrator means the

Administrator of the U.S.

Environmental Protection Agency, any

employee or authorized representative

of the Agency to whom the

Administrator may either herein or by

order delegate his authority to carry out

his functions, or any other person who

shall by operation of law be authorized

to carry out such functions.

An article is a manufactured item: (1)

Which is formed to a specific shape or

design during manufacture, (2) which

has end use function(s) dependent in

whole or in part upon its shape or

design during end use, and (3) which

has either no change of chemical

composition during its end use or only

those changes of composition which

have no commercial purpose separate

from that of the article and that may

occur as described in § 710.4(d)(5);

except that fluids and particles are not

considered articles regardless of shape

or design.

Byproduct means a chemical

substance produced without separate

commercial intent during the

manufacture or processing of another

chemical substance(s) or mixture(s).

Chemical substance means any

organic or inorganic substance of a

particular molecular identity, including

any combination of such substances

occurring in whole or in part as a result

of a chemical reaction or occurring in

nature, and any chemical element or

uncombined radical; except that

‘‘chemical substance’’ does not include:

(1) Any mixture,

(2) Any pesticide when manufactured,

processed, or distributed in commerce

for use as a pesticide,

(3) Tobacco or any tobacco product,

but not including any derivative

products,

(4) Any source material, special

nuclear material, or byproduct material,

(5) Any pistol, firearm, revolver,

shells, and cartridges, and

(6) Any food, food additive, drug,

cosmetic, or device, when
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46803

manufactured, processed, or distributed

in commerce for use as a food, food

additive, drug, cosmetic, or device.

Commerce means trade, traffic,

transportation, or other commerce:

(1) Between a place in a State and any

place outside of such State, or

(2) Which affects trade, traffic,

transportation, or commerce described

in paragraph (1) of this definition.

Commercial use means the use of a

chemical substance or mixture in a

commercial enterprise providing

saleable goods or services (e.g., dry

cleaning establishment, painting

contractor).

Consumer use means the use of a

chemical substance that is directly, or as

part of a mixture, sold to or made

available to consumers for their use in

or around a permanent or temporary

household or residence, in or around a

school, or in or around recreational

areas.

Distribute in commerce and

distribution in commerce when used to

describe an action taken with respect to

a chemical substance or mixture or

article containing a substance or

mixture, mean to sell or the sale of, the

substance, mixture, or article in

commerce; to introduce or deliver for

introduction into commerce, or the

introduction or delivery for introduction

into commerce of, the substance,

mixture, or article; or to hold, or the

holding of, the substance, mixture, or

article after its introduction into

commerce.

EPA means the U.S. Environmental

Protection Agency.

Importer means any person who

imports any chemical substance or any

chemical substance as part of a mixture

or article into the customs territory of

the U.S. and includes:

(1) The person primarily liable for the

payment of any duties on the

merchandise, or

(2) An authorized agent acting on his

behalf (as defined in 19 CFR 1.11).

Impurity means a chemical substance

which is unintentionally present with

another chemical substance.

Industrial use means use at a site at

which one or more chemical substances

or mixtures are manufactured (including

imported) or processed.

Intermediate means any chemical

substance:

(1) Which is intentionally removed

from the equipment in which it is

manufactured, and

(2) Which either is consumed in

whole or in part in chemical reaction(s)

used for the intentional manufacture of

other chemical substance(s) or

mixture(s), or is intentionally present

for the purpose of altering the rate of

such chemical reaction(s).

Note: The equipment in which it was

manufactured includes the reaction vessel in

which the chemical substance was

manufactured and other equipment which is

strictly ancillary to the reaction vessel, and

any other equipment through which the

chemical substance may flow during a

continuous flow process, but does not

include tanks or other vessels in which the

chemical substance is stored after its

manufacture.

Known to or reasonably ascertainable

by means all information in a person’s

possession or control, plus all

information that a reasonable person

similarly situated might be expected to

possess, control, or know.

Manufacture means to manufacture or

import for commercial purposes.

Manufacture or import ‘‘for

commercial purposes’’ means: To

import, produce, or manufacture with

the purpose of obtaining an immediate

or eventual commercial advantage, and

includes, for example, the manufacture

or import of any amount of a chemical

substance or mixture:

(1) For commercial distribution,

including for test marketing, or

(2) For use by the manufacturer,

including use for product research and

development, or as an intermediate.

Master Inventory File means EPA’s

comprehensive list of chemical

substances which constitute the

Chemical Substances Inventory

compiled under section 8(b) of the Act.

It includes substances reported under

subpart A of this part and substances

reported under part 720 of this chapter

for which a Notice of Commencement of

Manufacture or Import has been

received under § 720.120 of this chapter.

Mixture means any combination of

two or more chemical substances if the

combination does not occur in nature

and is not, in whole or in part, the result

of a chemical reaction; except that

‘‘mixture’’ does include:

(1) Any combination which occurs, in

whole or in part, as a result of a

chemical reaction if the combination

could have been manufactured for

commercial purposes without a

chemical reaction at the time the

chemical substances comprising the

combination were combined and if, after

the effective date or premanufacture

notification requirements, none of the

chemical substances comprising the

combination is a new chemical

substance, and

(2) Hydrates of a chemical substance

or hydrated ions formed by association

of a chemical substance with water.

New chemical substance means any

chemical substance which is not

included in the inventory compiled and

published under subsection 8(b) of the

Act.

Nonisolated intermediate means any

intermediate that is not intentionally

removed from the equipment in which

it is manufactured, including the

reaction vessel in which it is

manufactured, equipment which is

ancillary to the reaction vessel, and any

equipment through which the substance

passes during a continuous flow

process, but not including tanks or other

vessels in which the substance is stored

after its manufacture.

Person means any natural or juridicial

person including any individual,

corporation, partnership, or association,

any State or political subdivision

thereof, or any municipality, any

interstate body and any department,

agency, or instrumentality of the Federal

Government.

Process means the preparation of a

chemical substance or mixture, after its

manufacture, for distribution in

commerce (1) in the same form or

physical state as, or in a different form

or physical state from, that in which it

was received by the person so preparing

such substance or mixture, or (2) as part

of a mixture or article containing the

chemical substance or mixture.

Process for ‘‘commercial purposes’’

means to process (1) for distribution in

commerce, including for test marketing

purposes, or (2) for use as an

intermediate.

Processor means any person who

processes a chemical substance or

mixture.

Readily obtainable information means

information which is known by

management and supervisory employees

of the submitter company who are

associated with research, development,

distribution, technical services, or

marketing of the reportable chemical

substance. Extensive file searches are

not required.

Reasonably likely to be exposed

means an exposure to a chemical

substance which, under foreseeable

conditions of manufacture (including

import), processing, distribution in

commerce, or use of the chemical

substance, is more likely to occur than

not to occur. Such exposures would

normally include, but not be limited to,

activities such as charging reactor

vessels, drumming, bulk loading,

cleaning equipment, maintenance

operations, materials handling, and

transfers, and analytical operations.

Covered exposures include exposures

through any route of entry (inhalation,

ingestion, skin contact, absorption, etc.),

but excludes accidental or theoretical

exposures.
46804 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

Repackaging means the physical

transfer of a chemical substance or

mixture, as is, from one container to

another container or containers in

preparation for distribution of the

chemical substance or mixture in

commerce.

Reportable chemical substance means

a chemical substance described in

§ 710.25.

Site means a contiguous property

unit. Property divided only by a public

right-of-way shall be considered one

site. There may be more than one

manufacturing plant on a single site. For

the purposes of imported chemical

substances, the site shall be the business

address of the importer.

Site-limited means a chemical

substance is manufactured and

processed only within a site and is not

distributed for commercial purposes as

a substance or as part of a mixture or

article outside the site. Imported

substances are never site-limited.

Small maufacturer or importer means

a manufacturer or importer whose total

annual sales are less than $5,000,000,

based upon the manufacturer’s or

importer’s latest complete fiscal year as

of January 1, 1978, except that no

manufacturer or importer is a ‘‘small

manufacturer or importer’’ with respect

to any chemical substance which such

person manufactured at one site or

imported in quantities greater than

100,000 pounds during calendar year

1977. In the case of a company which

is owned or controlled by another

company, total annual sales shall be

based on the total annual sales of the

owned or controlled company, the

parent company, and all companies

owned or controlled by the parent

company taken together.

Note: The purpose of the exception to the

definition is to ensure that manufacturing

and importers report production volumes for

all chemical substances which they

manufactured at one site or imported in

quantities equal to or greater than 100,000

pounds during calendar year 1977.

Small quantities for purposes of

scientific experimentation or analysis or

chemical research on, or analysis of,

such substance or another substance,

including any such research or analysis

for the development of a product

(hereinafter sometimes shortened to

small quantities for research and

development) means quantities of a

chemical substance manufactured,

imported, or processed or proposed to

be manufactured, imported, or

processed that:

(1) Are no greater than reasonably

necessary for such purposes, and

(2) After the publication of the revised

inventory, are used by, or directly under

the supervision of, a technically

qualified individual(s).

Note: Any chemical substances

manufactured, imported, or processed in

quantities less than 1,000 pounds annually

shall be presumed to be manufactured,

imported, or processed for research and

development purposes. No person may report

for the inventory any chemical substance in

such quantities unless that person can

certify, that the substance was not

manufactured, imported, or processed solely

in small quantities for research and

development, as defined in this section.

State means any State of the United

States, the District of Columbia, the

Commonwealth of Puerto Rico, the

Virgin Islands, Guam, the Canal Zone,

American Samoa, the Northern Mariana

Islands, or any other territory or

possession of the United States.

Technically qualified individual

means a person:

(1) Who because of his/her education,

training, or experience, or a

combination of these factors, is capable

of appreciating the health and

environmental risks associated with the

chemical substance which is used under

his supervision,

(2) Who is responsible for enforcing

appropriated methods of conducting

scientific experimentation, analysis, or

chemical research in order to minimize

such risks, and

(3) Who is responsible for the safety

assessments and clearances related to

the procurement, storage, use, and

disposal of the chemical substance as

may be appropriate or required within

the scope of conducting the research

and development activity. The

responsibilities in this paragrah may be

delegated to another individual, or other

individuals, as long as each meets the

criteria in paragraph (1) of this

definition.

Test marketing means the distribution

in commerce of no more than a

predetermined amount of a chemical

substance, mixture, or article containing

that chemical substance or mixture, by

a manufacturer or processor to no more

than a defined number of potential

customers to explore market capability

in a competitive situation during a

predetermined testing period prior to

the broader distribution of that chemical

substance, mixture or article in

commerce.

United States, when used in the

geographic sense, means all of the

States, territories, and possessions of the

United States.

Use means any utilization of a

chemical substance or mixture that is

not otherwise covered by the terms

manufacture or process. Relabeling or

redistributing a container holding a

chemical substance or mixture where no

repackaging of the chemical substance

or mixture occurs does not constitute

use or processing of the chemical

substance or mixture.

3. In § 710.26, by revising the

introductory text and paragraphs (a) and

(c) and adding paragraph (e) to read as

follows:

§ 710.26 Chemical substances for which

information is not required.

The following categories of chemical

substances are excluded from the

reporting requirements of this part, with

two exceptions: a chemical substance

described in paragraph (a) only qualifies

for a partial reporting exemption, as

described in paragraph (a), and a

chemical substance described in

paragraph (a), (b), (c), or (e) of this

section is not excluded from the

reporting requirements of this part if

that substance is the subject of a rule

proposed or promulgated under section

4, 5(a)(2), 5(b)(4), or 6 of the Act, or is

the subject of an order issued under

section 5(e) or 5(f) of the Act, or is the

subject of relief that has been granted

under a civil action under section 5 or

7 of the Act.

(a) Petroleum process streams. All

chemical substances listed by Chemical

Abstract Service Registry Number (CAS

Number) in this paragraph are excluded

only from paragraphs (c)(4) and (5) of

§ 710.32. Such chemical substances are

not excluded from the other reporting

requirements under 40 CFR part 710.

The chemical substances included in

the list in this paragraph may be

modified and, if modified, a new list

will be published through direct final

rulemaking in the Federal Register by

EPA prior to the upcoming reporting

period. If a new list is not published

prior to a given reporting period, the list

in effect for the previous reporting

period is still in effect for the current

reporting period.

CAS Numbers of Partially Exempt

Chemical Substances Termed

‘‘Petroleum Process Streams’’

63231-60-7

64741-41-9

64741-42-0

64741-43-1

64741-44-2

64741-45-3

64741-46-4

64741-47-5

64741-48-6

64741-49-7

64741-50-0

64741-51-1

64741-52-2

64741-53-3

64741-54-4

64741-55-5
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46805

64741-56-6

64741-57-7

64741-58-8

64741-59-9

64741-60-2

64741-61-3

64741-62-4

64741-63-5

64741-64-6

64741-65-7

64741-66-8

64741-67-9

64741-68-0

64741-69-1

64741-70-4

64741-71-5

64741-72-6

64741-73-7

64741-74-8

64741-75-9

64741-76-0

64741-77-1

64741-78-2

64741-79-3

64741-80-6

64741-81-7

64741-82-8

64741-83-9

64741-84-0

64741-85-1

64741-86-2

64741-87-3

64741-88-4

64741-89-5

64741-90-8

64741-91-9

64741-92-0

64741-93-1

64741-94-2

64741-95-3

64741-96-4

64741-97-5

64741-98-6

64741-99-7

64742-00-3

64742-01-4

64742-02-5

64742-03-6

64742-04-7

64742-05-8

64742-06-9

64742-07-0

64742-08-1

64742-09-2

64742-10-5

64742-11-6

64742-12-7

64742-13-8

64742-14-9

64742-15-0

64742-16-1

64742-17-2

64742-18-2

64742-19-4

64742-20-3

64742-22-9

64742-23-0

64742-24-1

64742-25-2

64742-27-4

64742-28-5

64742-29-6

64742-30-9

64742-31-0

64742-32-1

64742-33-2

64742-34-3

64742-35-4

64742-36-2

64742-36-5

64742-37-6

64742-38-7

64742-39-8

64742-40-1

64742-41-2

64742-42-3

64742-43-4

64742-44-5

64742-45-6

64742-46-7

64742-47-8

64742-48-9

64742-49-0

64742-50-3

64742-51-4

64742-52-5

64742-53-6

64742-54-7

64742-55-8

64742-56-9

64742-57-0

64742-58-1

64742-59-2

64742-60-5

64742-61-6

64742-62-7

64742-63-8

64742-64-9

64742-65-0

64742-66-1

64742-67-2

64742-68-3

64742-69-4

64742-70-7

64742-71-8

64742-72-9

64742-73-0

64742-74-1

64742-75-2

64742-76-3

64742-78-5

64742-79-6

64742-80-9

64742-81-0

64742-82-1

64742-83-2

64742-84-3

64742-85-4

64742-86-5

64742-87-6

64742-88-7

64742-89-8

64742-90-1

64742-91-2

64742-92-3

64742-93-4

64742-95-6

64742-96-7

64742-97-8

64742-98-9

64742-99-0

64743-00-6

64743-02-8

64743-01-7

64743-03-9

64743-04-0

64743-05-1

64743-06-2

64743-07-3

64754-89-8

64754-96-7

64771-71-7

64771-71-7

64771-72-8

64771-72-8

67674-12-8

67674-13-9

67674-15-1

67674-16-2

67674-17-3

67674-18-4

67891-77-4

67891-79-6

67891-78-5

67891-80-9

67891-82-1

67891-83-2

67891-85-4

68131-05-5

68131-49-7

68131-75-9

68131-77-1

68131-79-3

68131-80-6

68131-81-7

68131-83-9

68131-99-7

68132-00-3

68153-22-0

68187-57-5

68187-58-6

68187-58-6

68187-60-9

68307-98-2

68307-99-3

68308-00-9

68308-01-0

68308-02-1

68308-03-2

68308-04-3

68308-05-4

68308-06-5

68308-07-6

68308-08-7

68308-09-8

68308-10-1

68308-11-2

68308-12-3

68308-27-0

68333-22-2

68333-23-3

68333-24-4

68333-25-5

68333-26-6

68333-27-7

68333-28-8

68333-29-9
46806 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

68333-30-2

68333-81-3

68333-88-0

68334-30-5

68334-31-6

68409-99-4

68410-00-4

68410-01-5

68410-05-9

68410-10-6

68410-12-8

68410-13-9

68410-14-0

68410-16-2

68410-59-3

68410-63-9

68410-71-9

68410-96-8

68410-97-9

68410-98-0

68411-00-7

68425-27-4

68425-28-5

68425-29-6

68425-31-0

68425-31-1

68425-33-2

68425-34-3

68425-35-4

68425-39-8

68441-09-8

68459-79-8

68475-57-0

68475-58-1

68475-59-2

68475-60-5

68475-61-6

68475-70-7

68475-79-6

68475-80-9

68476-26-6

68476-28-8

68476-29-9

68476-30-2

68476-31-3

68476-33-5

68476-34-6

68476-39-1

68476-40-4

68476-42-6

68476-43-7

68476-44-8

68476-45-9

68476-46-0

68476-47-1

68476-49-3

68476-50-6

68476-52-8

68476-53-9

68476-54-0

68476-55-1

68476-56-2

68476-77-7

68476-81-3

68476-84-6

68476-85-7

68476-86-8

68476-87-9

68477-25-8

68477-26-9

68477-29-2

68477-30-5

68477-31-6

68477-33-8

68477-34-9

68477-35-0

68477-36-1

68477-37-2

68477-38-3

68477-39-4

68477-40-7

68477-41-8

68477-42-9

68477-43-0

68477-44-1

68477-45-2

68477-46-3

68477-47-4

68477-48-5

68477-50-9

68477-51-0

68477-52-1

68477-53-2

68477-54-3

68477-55-4

68477-56-5

68477-58-7

68477-59-8

68477-60-1

68477-61-2

68477-62-3

68477-63-4

68477-64-5

68477-65-6

68477-66-7

68477-67-8

68477-68-9

68477-69-0

68477-70-3

68477-71-4

68477-72-5

68477-73-6

68477-74-7

68477-75-8

68477-76-9

68477-77-0

68477-79-2

68477-80-5

68477-81-6

68477-82-7

68477-83-8

68477-84-9

68477-85-0

68477-86-1

68477-87-2

68477-88-3

68477-89-4

68477-90-7

68477-91-8

68477-92-9

68477-93-0

68477-94-1

68477-95-2

68477-96-3

68477-97-4

68478-00-2

68478-01-3

68478-02-4

68478-03-5

68478-04-6

68478-05-7

68478-07-9

68478-08-0

68478-09-1

68478-10-4

68478-12-6

68478-13-7

68478-15-9

68478-16-0

68478-17-1

68478-18-2

68478-19-3

68478-20-6

68478-21-7

68478-22-8

68478-24-0

68478-25-1

68478-26-2

68478-27-3

68478-28-4

68478-29-5

68478-30-8

68478-32-0

68478-33-1

68478-34-2

68512-61-8

68512-62-9

68512-78-7

68512-90-3

68512-91-4

68513-02-0

68513-11-1

68513-12-2

68513-13-3

68514-14-4

68513-15-5

68513-16-6

68513-17-7

68513-18-8

68512-19-9

68513-26-8

68513-62-2

68513-63-3

68513-65-5

68513-66-6

68513-67-7

68513-68-8

68513-69-9

68513-74-6

68514-15-8

68514-29-4

68514-30-7

68514-31-8

68514-32-9

68514-33-0

68514-34-1

68514-35-2

68514-38-4

68514-36-3

68514-37-4

68514-79-4

68515-25-3

68515-26-4

68515-27-5

68515-28-6

68515-30-0

68515-31-1
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46807

68515-32-2

68515-33-3

68515-34-4

68515-35-5

68515-36-6

68516-20-1

68516-21-2

68526-52-3

68526-53-4

68526-54-5

68526-55-6

68526-56-7

68526-57-8

68526-58-9

68526-77-2

68526-99-8

68527-00-4

68527-11-7

68527-13-9

68527-14-0

68527-15-1

68527-16-2

68527-18-4

68527-19-5

68527-21-9

68527-22-0

68527-23-1

68527-24-2

68527-25-3

68527-26-4

68527-27-5

68553-00-4

68553-14-0

68602-79-9

68602-81-3

68602-82-4

68602-83-5

68602-84-6

68602-96-0

68602-97-1

68602-98-2

68602-99-3

68603-00-9

68603-01-0

68603-02-1

68603-03-2

68603-08-7

68603-09-8

68603-10-1

68603-11-2

68603-12-3

68603-13-4

68603-14-5

68603-31-6

68603-32-7

68606-09-7

68606-10-0

68606-11-1

68606-24-6

68606-25-7

68606-26-8

68606-27-9

68606-28-0

68606-31-5

68606-34-8

68606-35-9

68606-36-0

68607-11-4

68607-30-7

68608-56-0

68647-60-9

68647-61-0

68647-62-1

68650-36-2

68650-37-3

68650-78-2

68741-41-9

68782-97-8

68782-98-9

68782-99-0

68783-00-6

68783-01-7

68783-02-8

68783-04-0

68783-05-1

68783-06-2

68783-07-3

68783-08-4

68783-09-5

68783-10-8

68783-11-9

68783-13-1

68783-15-3

68783-61-9

68783-62-0

68783-61-9

68783-64-2

68783-65-3

68783-66-4

68814-47-1

68814-67-5

68814-89-1

68814-87-9

68814-90-4

68814-91-5

68855-57-2

68855-58-3

68855-59-4

68855-60-7

68911-58-0

68911-59-1

68915-96-8

68915-97-9

68918-69-4

68918-73-0

68918-93-4

68918-99-0

68919-00-6

68919-01-7

68919-02-8

68919-03-9

68919-04-0

68919-05-1

68919-06-2

68919-07-3

68919-08-4

68919-09-5

68919-10-8

68919-11-9

68919-12-0

68919-16-4

68919-17-5

68919-19-7

68919-20-0

68919-37-9

68919-39-1

68920-06-9

68920-07-0

68920-73-0

68920-64-9

68921-07-3

68921-09-5

68921-08-4

68921-67-5

68952-76-1

68952-77-2

68952-78-3

68952-79-4

68952-80-7

68952-81-8

68952-82-9

68955-27-1

68955-28-2

68955-30-6

68955-31-7

68955-32-8

68955-33-9

68955-34-0

68955-35-1

68955-36-2

68955-76-0

68955-96-4

68956-47-8

68956-48-9

68956-52-5

68956-54-7

68956-55-8

68956-70-7

68988-99-8

68989-88-8

68990-35-2

68991-49-1

68991-50-4

68991-51-5

68991-52-6

69013-21-4

69029-75-0

69430-33-7

70024-88-3

70528-71-1

70528-72-2

70528-73-3

70592-76-6

70592-77-7

70592-78-8

70592-79-9

70693-00-4

70913-85-8

70913-86-9

70955-08-7

70955-09-8

70955-10-1

70955-17-8

71243-66-8

71302-82-4

71329-37-8

71808-30-5

72230-71-8

72623-83-7

72623-84-8

72623-85-9

72623-86-0

72623-87-1

7732-18-5

8002-05-9

8002-74-2

8006-14-2
46808 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

8006-20-2

8006-61-9

8007-45-2

8008-20-6

8008-20-6

8009-03-8

8012-95-1

8030-30-6

8032-32-4

8042-47-5

8052-42-4

10024-97-2

* * * * *

(c) Microorganisms. Any combination

of chemical substances that is a living

organism, and that meets the definition

of ‘‘microorganism’’ at 40 CFR 725.3 of

this chapter. Any chemical substance

produced from a living microorganism

is reportable under this part unless

otherwise excluded.

* * * * *

(e) Certain forms of natural gas.

Chemical substances with the following

CAS Numbers: CAS No. 64741-48-6,

Natural gas (petroleum), raw liquid mix;

CAS No. 68919-39-1, Natural gas

condensates; CAS No. 8006-61-9,

Gasoline natural; CAS No. 68425-31-0,

Gasoline (natural gas), natural; CAS No.

8006-14-2, Natural gas; and CAS No.

68410-63-9, Natural gas, dried.

4. By revising § 710.28 to read as

follows:

§ 710.28 Persons who must report.

Except as provided in §§ 710.29 and

710.30, the following persons are

subject to the requirements of this part.

Persons must determine whether they

must report under this section for each

chemical substance that they

manufacture (including import) at an

individual site.

(a) Persons subject to recurring

reporting. Any person who

manufactured (including imported) for

commercial purposes 25,000 lbs.

(11,350 kg) or more of a chemical

substance described in § 710.25 at any

single site owned or controlled by that

person at any time during calendar year

1999 or during the calendar year at 4–

year intervals thereafter is subject to

reporting. A person who does not

manufacture (including import) at least

25,000 lbs. of a chemical substance

described in § 710.25 at any single site

owned or controlled by that person at

any time during 1999 or during any year

in 4–year intervals thereafter, but who

chooses to reassert [a] confidentiality

claim[s] made in [a] previous reporting

period[s], as described in § 710.39, must

make the reassertion in each reporting

period even if the person is not required

to report the information described in

§ 710.32(c).

(b) Special provisions for importers.

For purposes of this section, the site for

a person who imports a chemical

substance described in § 710.25 is the

site of the operating unit within the

person’s organization which is directly

responsible for importing the substance

and which controls the import

transaction. The import site may in

some cases be the organization’s

headquarters in the United States (see

also § 710.35(b)).

5. By revising § 710.32 to read as

follows:

§ 710.32 Reporting information to EPA.

Any person who must report under

this part, as described in § 710.28, must

submit the information described in this

section for each chemical substance

described in § 710.25 that the person

manufactured (including imported) for

commercial purposes in an amount of

25,000 lbs. (11,350 kg) or more at any

one site during calendar year 2001 or

during the calendar year at 4–year

intervals thereafter. (The site for a

person who imports a chemical

substance is the site of the operating

unit within the person’s organization

that is directly responsible for importing

the substance and which controls the

import transaction, and may in some

cases be the organization’s headquarters

office in the United States) Except as

otherwise noted, a submitter of

information under this part must report

information in writing or by magnetic

media as prescribed in this section, to

the extent that such information is

known to or reasonably ascertainable by

that person. A submitter under this part

must report information that applies to

the calendar year for which the person

is required to report (i.e., calendar year

2001 and the calendar year at 4–year

intervals thereafter).

(a) Reporting in writing. Any person

who chooses to report information to

EPA in writing must do so by

completing the reporting form available

from EPA at the address set forth in

§ 710.40(b). The form must include all

information prescribed in paragraph (c)

of this section. Persons reporting in

writing must submit a separate form for

each site for which the person is

required to report.

(b) Reporting by magnetic media. Any

person who chooses to report

information to EPA by means of

magnetic media must submit the

information prescribed in paragraph (c)

of this section. Magnetic media

submitted in response to this subpart

must meet EPA specifications, as

described in the instruction booklet

available from EPA at the address set

forth in § 710.40(b).

(c) Information to be reported.

Manufacturers (including importers) of

a chemical substance described in

§ 710.25 in an amount equal to or

greater than 25,000 lbs. (11,350 kg)

during a calendar year for which

reporting is required must report the

information described in paragraphs

(c)(1), (c)(2), and (c)(3) of this section.

Manufacturers (including importers) of

an organic chemical substance

described in § 710.25 in an amount

equal to or greater than 300,000 lbs.

(136,200 kg) during a calendar year for

which reporting is required must report

the information described in paragraphs

(c)(4) and (c)(5) of this section in

addition to the information described in

paragraphs (c)(1), (c)(2), and (c)(3) of

this section.

(1) A certification statement signed

and dated by an authorized official of

the submitter company. Persons

reporting by means of magnetic media

must submit this information on the

reporting form available from EPA at the

address set forth in § 710.40.

(2) Company and plant site

information. The following company

and plant site information must be

reported:

(i) The name, company, address, city,

State, zip code, and telephone number

of a person who will serve as technical

contact for the submitter company, and

who will be able to answer questions

about the information submitted by the

company to EPA. Persons reporting by

means of magnetic media must submit

this information on the reporting form

available from EPA at the address set

forth in § 710.40.

(ii) The name, street address, city,

State, and zip code of each site at which

at least 25,000 lbs. (11,350 kg) or more

of a chemical substance for which

reporting is required under this part is

manufactured (including imported).

(The site for a person who imports a

chemical substance is the site of the

operating unit within the person’s

organization which is directly

responsible for importing the substance

and which controls the import

transaction, and may in some cases be

the organization’s headquarters office in

the U.S.) A submitter under this part

must include the appropriate Dun and

Bradstreet Number and any EPA Facility

Registration Identifier (FRI) (once an FRI

has been assigned to the facility) for

each plant site reported. In addition, the

county or parish (or other jurisdictional

indicator) in which the plant site is

located must be provided.

(3) Chemical specific information.

The following chemical-specific

information must be reported:

(i) The specific chemical name and

Chemical Abstracts Service (CAS)

Registry Number of each chemical
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46809

substance for which reporting is

required under this part (‘‘reportable

chemical substance’’). As provided in

the instruction booklet identified in

§ 710.40(b), a submitter under this part

may use an EPA-Designated Accession

Number, a premanufacture notice

(PMN) case number (see § 720.65 of this

chapter), or a TSCA Chemical Inventory

reporting form number (see § 710.40) in

lieu of a CAS Registry Number when a

CAS Registry Number is not known to

the submitter.

(ii) A statement indicating, for each

reportable chemical substance, whether

the substance is manufactured in the

United States, imported into the United

States, or both manufactured in the

United States and imported into the

United States.

(iii) A designation indicating, for each

reportable chemical substance, whether

the substance is site-limited.

(iv) The total volume (in pounds) of

each reportable chemical substance

manufactured (including imported) at

each site. This amount must be reported

to two significant figures of accuracy

provided that the reported figures are

within plus or minus 10% of the actual

volume.

(v) Any person claiming the volume

reported under paragraph (c)(3)(iv) of

this section is confidential business

information under § 710.38 must

provide a statement indicating, for each

reportable chemical substance, whether

the total volume range (in pounds)

which corresponds to the volume

reported in response to paragraph

(c)(3)(iv) of this section of each

reportable chemical substance

manufactured (including imported) at

each site is claimed confidential.

Volume ranges are listed in the

following table:

Volume Ranges for Non-Confidential

Reporting Purposes

From 25,000 to 100,000 lbs.

From 100,000 to 1,000,000 lbs.

From 1,000,000 to 10,000,000 lbs.

From 10,000,000 to 50,000,000 lbs.

From 50,000,000 to 100,000,000 lbs.

From 100,000,000 to 500,000,000 lbs.

From 500,000,000 to 1,000,000,000 lbs.

Greater than 1,000,000,000 lbs.

(vi) The total number of workers

reasonably likely to be exposed to each

reportable chemical substance at each

site where the substance is

manufactured (including imported). For

each substance, the submitter shall

report the code that corresponds to the

appropriate number of workers

according to the range codes in the

following table:

Codes for Reporting Number of

Workers Exposed

Codes Range

W1 Less than 10

W2 At least 10 but less than 25

W3 At least 25 but less than 50

W4 At least 50 but less than 100

W5 At least 100 but less than 500

W6 At least 500 but less than

1,000

W7 At least 1,000 but less than

10,000

W8 At least 10,000

(vii) The physical form of the

reportable chemical substance as it is

sent off-site. If the reportable chemical

substance is sent in more than one

physical form, the submitter shall report

whichever physical form constitutes the

largest portion of its total volume,

measured by weight. For each

substance, the submitter shall report the

code that corresponds with the

appropriate physical form code

according to the following table.

Codes for Reporting Physical Form

of Chemical Substance

Codes Physical Form

F1 Dry powder

F2 Pellets or large crystals

F3 Water- or solvent-wet solid

F4 Other solid

F5 Gas or vapor

F6 Liquid

(viii) The average concentration and

maximum concentration, measured by

percentage of weight, of the reportable

chemical substance at the time it is sent

off-site. For each chemical substance,

report the code that corresponds to the

appropriate average concentration and

maximum concentration according to

the following table:

Codes for Reporting Average Concentration and Maximum Concentration of Chemical Substance

Codes Concentration Range (%

weight)

M1 Less than 1% by weight

M2 Between 1 and 30% by weight

M3 Between 31 and 60% by

weight

M4 Between 61 and 90% by

weight

M5 Greater than 90% by weight

(4) Industrial processing and use

information—(i) The following

information must be be reported only

for reportable chemical substances

manufactured (including imported) for

commercial purposes in an amount of

300,000 lbs. (136,200 kg) or more at any

one site during calendar year 1999 or

during the calendar year at 4-year

intervals thereafter. Persons subject to

this paragraph must report industrial

processing and use information for each

reportable chemical substance at sites

under their control and at sites that

receive a reportable chemical substance

from the submitter directly or indirectly

(including through a broker/distributor,

from a customer of the submitter, etc.).

Information regarding processing or use

activities occurring at sites not under

the control of the submitter must be

reported only to the extent that it is

readily obtainable by the submitter. If

the required information is not readily

obtainable by the submitter, the

submitter shall provide estimates, using

the submitter’s best professional

judgment, based upon the submitter’s

past experience for similar chemical

substances in the same or similar

markets, and/or any reasonable

projections of likely processing and use

scenarios for the chemical substance.

The following items must be reported

under this paragraph:

(A) A designation indicating the type

of industrial processing or use operation

at each site subject to the industrial

processing and use information

reporting under this paragraph. For each

reportable chemical substance, report

the letters which correspond to the

appropriate processing or use

operation[s]:

Designation Operation

PC Processing as a reactant

PF Processing - incorporation into

formulation, mixture or reaction product

PA Processing - incorporation into

article

PK Processing - repackaging

U Use - non-incorporative activities

(B) The five-digit North American

Industrial Classification System

(NAICS) codes which best describe the

industrial activities associated with

each industrial processing or use

operation reported under paragraph

(c)(4)(i)(A) in this section. If more than

10 NAICS codes apply to a reportable

chemical substance, submitters need

only report the NAICS codes for the

reportable chemical substance that

cumulatively represent the largest

percentage of production volume,

measured by weight.
46810 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

(C) For each NAICS code reported

under paragraph (c)(4)(i)(B) in this

section, a code from the following list

must be selected to designate the

industrial function category that best

represents the specific manner in which

the reportable chemical substance is

used:

Codes for Reporting Industrial

Function Categories

Codes Categories

U01 Adsorbents and absorbents

U02 Adhesives and binding agents

U03 Aerosol propellants

U04 Agricultural chemicals (nonpesticidal)

U05 Anti-adhesive agents

U06 Bleaching agents

U07 Coloring agents, dyes

U08 Coloring agents, pigments

U09 Corrosion inhibitors and antiscaling agents

U10 Fillers

U11 Fixing agents

U12 Flame retardants

U13 Flotation agents

U14 Fuels

U15 Functional fluids

U16 Intermediates

U17 Lubricants

U18 Odor agents

U19 Oxidizing agents

U20 pH-regulating agents

U21 Photosensitive chemicals

U22 Plating agents and metal surface treating agents

U23 Processing aid, not otherwise

listed

U24 Process regulators, used in

vulcanization or polymerization processes

U25 Process regulators, other than

polymerization or vulcanization processes

U26 Reducing agents

U27 Solvents (for cleaning or

degreasing)

U28 Solvents (which become part

of product formulation or

mixture)

U29 Solvents (for chemical manufacture and processing and

are not part of product at

greater than one percent by

weight)

U30 Stabilizers

U31 Surface active agents

U32 Viscosity adjustors

U33 Other

(D) The percentage, rounded off to the

closest 10%, of total production volume

of the reportable chemical substance

associated with each combination of

NAICS code and industrial function

category. Where a particular

combination of NAICS code and

industrial function category accounts for

5% or less of the total production

volume of a reportable chemical

substance, the percentage shall not be

rounded off to zero % if the production

volume attributable to that NAICS code

and industrial function category

combination is equal to or greater than

300,000 lbs. during the calendar year for

which data must be reported. Instead, in

such a case, submitters shall report the

percentage, rounded off to the closest

1%, of total production volume of the

reportable chemical substance

associated with the particular

combination of NAICS code and

industrial function category.

(E) The number of processing and use

sites, by number range, of each subject

chemical substance for each

combination of NAICS code and

industrial function category. For each

substance, report the code (e.g., 0

through 9) that corresponds to the

appropriate number range according to

the following table:

Codes for Reporting Numbers of

Sites

Codes Range

S1 Less than 10

S2 From 10 to 25

S3 From 25 to 100

S4 From 100 to 250

S5 From 250 to 1,000

S6 From 1,000 to 10,000

S7 Greater than 10,000

(F) An estimate of the number range

of workers reasonably likely to be

exposed to each reportable chemical

substance at the site(s) where the

chemical substance is processed or

used. For each substance, report the

code (e.g., W1 through W8) which

corresponds to the appropriate worker

range according to the table in

paragraph (c)(3)(vi) of this section.

(ii) [Reserved]

(5) Commercial and consumer use

information.—(i) The following

information must be reported only for

reportable chemical substances

manufactured (including imported) for

commercial purposes in an amount of

300,000 lbs. (136,200 kg) or more at any

one site during calendar year 1999 or

during the calendar year at 4–year

intervals thereafter. Persons subject to

this paragraph must report information

for each reportable chemical substance

at sites under their control and at sites

that receive a reportable chemical

substance from the submitter directly or

indirectly (including through a broker/

distributor, from a customer of the

submitter, etc.). Information regarding

use activities occurring at sites beyond

the control of the submitter must be

reported only to the extent that it is

readily obtainable by the submitter. If

the required information is not readily

obtainable by the submitter, the

submitter shall provide estimates, using

the submitter’s best professional

judgment, based upon the submitter’s

past experience for similar chemical

substances in the same or similar

market, and/or any reasonable

projections on likely use scenarios for

the chemical substance. The following

information must be reported under this

paragraph:

(A) Using the codes listed, submitters

must designate each commercial and

consumer product category for which

the reportable chemical substance is

used:

Codes for Reporting Commercial and

Consumer Product Categories

Codes Category

C01 Artists’ supplies

C02 Adhesives and sealants

C03 Automotive care products

C04 Electrical and electronic products

C05 Glass and ceramic products

C06 Fabrics, textiles and apparel

C07 Lawn and garden products

(non-pesticidal)

C08 Leather products

C09 Lubricants, greases and fuel

additives

C10 Metal products

C11 Paper products

C12 Paints and coatings

C13 Photographic chemicals

C14 Polishes and sanitation goods

C15 Rubber and plastic products

C16 Soaps and detergents

C17 Transportation products

C18 Wood and wood furniture

C19 Other

(B) The percentage, rounded off to the

closest 10%, of total production volume

of the reportable chemical substance

associated with each commercial and

consumer product category. Where a

particular commercial and consumer

product category accounts for 5% or less

of the total production volume of a

reportable chemical substance, the

percentage shall not be rounded off to

zero % if the production volume

attributable to that commercial and

consumer product category is equal to

or greater than 300,000 lbs. during the

calendar year for which data must be

reported. Instead, in such a case,

submitters shall report the percentage,

rounded off to the closest 1%, of total

production volume of the reportable

chemical substance associated with the

particular commercial and consumer

product category.

(C) Where the reportable chemical

substance is used in commercial or

consumer products, the typical

maximum concentration, measured by
Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules 46811

weight, of the chemical substance in

each commercial and consumer product

category reported under paragraph

(c)(5)(i)(A) of this section.

(ii) [Reserved]

6. By revising § 710.33 to read as

follows:

§ 710.33 When to report.

All information reported to EPA in

response to the requirements of this part

must be submitted during an applicable

reporting period. The first reporting

period is from August 25, 2002, to

December 23, 2002. Subsequent

recurring reporting periods are from

August 25 to December 23 at 4-year

intervals after the first reporting period.

Any person described in § 710.28(a)

must report during each reporting

period for each chemical substance

described in § 710.25 that the person

manufactured (including imported)

during the preceding calendar year.

7. By revising § 710.37 to read as

follows:

§ 710.37 Recordkeeping requirements.

Each person who is subject to the

reporting requirements of this part must

maintain records that document any

information reported to EPA. Records

relevant to reporting during a reporting

period described in § 710.33 must be

retained for a period of 5 years

beginning with the effective date of that

reporting period.

8. By revising § 710.38 to read as

follows:

§ 710.38 Confidentiality.

(a) Any person submitting

information under this part may assert

a business confidentiality claim for the

information at the time it is submitted.

These claims will apply only to the

information submitted with the claim.

New confidentiality claims, if necessary,

must be asserted with regard to

information submitted during the next

reporting period. Guidance for asserting

confidentiality claims is provided in the

instruction booklet identified in

§ 710.40. Information claimed as

confidential in accordance with this

section will be treated and disclosed in

accordance with the procedures in part

2 of this chapter.

(b) A person may assert a claim of

confidentiality for the chemical identity

of a specific chemical substance only if

the identity of that substance is treated

as confidential in the Master Inventory

File as of the time the report is

submitted for that substance under this

part.

(c) Chemical identity. The following

steps must be taken to assert a claim of

confidentiality for the identity of a

reportable chemical substance:

(1) The person must submit with the

report detailed written answers to the

following questions signed and dated by

an authorized official.

(i) What harmful effects to your

competitive position, if any, do you

think would result from the identity of

the chemical substance being disclosed

in connection with reporting under this

part? How could a competitor use such

information? Would the effects of

disclosure be substantial? What is the

causal relationship between the

disclosure and the harmful effects?

(ii) How long should confidential

treatment be given? Until a specific

date, the occurrence of a specific event,

or permanently? Why?

(iii) Has the chemical substance been

patented? If so, have you granted

licenses to others with respect to the

patent as it applies to the chemical

substance? If the chemical substance has

been patented and therefore disclosed

through the patent, why should it be

treated as confidential?

(iv) Has the identity of the chemical

substance been kept confidential to the

extent that your competitors do not

know it is being manufactured or

imported for a commercial purpose by

anyone?

(v) Is the fact that the chemical

substance is being manufactured

(including imported) for a commercial

purpose available to the public, for

example in technical journals, libraries,

or State, local, or Federal agency public

files?

(vi) What measures have been taken to

prevent undesired disclosure of the fact

that the chemical substance is being

manufactured (including imported) for a

commercial purpose?

(vii) To what extent has the fact that

this chemical substance is manufactured

(including imported) for commercial

purposes been revealed to others? What

precautions have been taken regarding

these disclosures? Have there been

public disclosures or disclosures to

competitors?

(viii) Does this particular chemical

substance leave the site of manufacture

(including import) in any form, e.g. as

product, effluent, emission, etc.? If so,

what measures have been taken to guard

against the discovery of its identity?

(ix) If the chemical substance leaves

the site in a product that is available to

the public or your competitors, can the

substance be identified by analysis of

the product?

(x) For what purpose do you

manufacture (including import) the

substance?

(xi) Has EPA, another Federal agency,

or any Federal court made any pertinent

confidentiality determinations regarding

this chemical substance? If so, please

attach copies of such determinations.

(2) If any of the information contained

in the answers to the questions is

asserted to contain confidential business

information, the person must mark that

information as ‘‘trade secret,’’

‘‘confidential,’’ or other appropriate

designation.

(d) Site identity. A person may assert

a claim of confidentiality for a submitter

site only if the linkage of the site with

a chemical submitted in this rule is

confidential and not publicly available.

The following steps must be taken to

assert a claim of confidentiality for a site

identity:

(1) The person must submit with the

report detailed written answers to the

following questions signed and dated by

an authorized official:

(i) Has site information been linked

with a chemical identity in any other

Federal, state or local reporting scheme?

For example, is the chemical identity

linked to a facility in a filing under the

Emergency Planning and Community

Right-To-Know Act (EPCRA) section

311, namely through a Material Safety

Data Sheet (MSDS)? If so, identify all

such schemes. Was the linkage claimed

as confidential in any of these

instances?

(ii) What harmful effect, if any to your

competitive position do you think

would result from the identity of the site

and the chemical substance? How could

a competitor use such information?

Would the effects of disclosure be

substantial? What is the causal

relationship between the disclosure and

the harmful effects?

(2) If any of the information contained

in the answers to the questions is

asserted to contain confidential business

information, the person must mark that

information as ‘‘trade secret,’’

‘‘confidential,’’ or another appropriate

designation.

(e) If no claim of confidentiality is

indicated on the reporting form

submitted to EPA under this part, or if

confidentiality claim substantiation

required under paragraphs (c) and (d) of

this section is not submitted with the

reporting form, EPA may make the

information available to the public

without further notice to the submitter.

9. By revising § 710.39 to read as

follows:

§ 710.39 Reassertion of past

confidentiality claims.

(a) Any claim of confidentiality under

§ 710.38 is valid only until the end of

the reporting period immediately

following the reporting period in which

the information was claimed as

confidential. To maintain the
46812 Federal Register / Vol. 64, No. 165 / Thursday, August 26, 1999 / Proposed Rules

confidential status of information, the

submitter must certify during every

reporting period following the one in

which the original claim of

confidentiality was made, that the

information should continue to be

treated as confidential by EPA.

Reassertions must be made to maintain

confidentiality even if the submitter is

not required to report the information in

§ 710.32(c) during a given reporting

period.

(b) If the submitter fails in a reporting

period to reassert the confidentiality

claims made in the previous reporting

period, the claims are presumed to be

waived and EPA will make the

information available to the public

without further notice to the submitter.

EPA will publish a Federal Register

notice at least 2 weeks before the end of

each reporting period, which will

remind persons who made or reasserted

CBI claims in the previous reporting

period of the need to examine these

claims and reassert them, as

appropriate, in the current reporting

period. Claims not reasserted by the end

of a reporting period will be declassified

after the reporting period ends.

(c) CBI claims made in IUR

submissions prior to 2002 will not be

subject to this reassertion requirement.

CBI claims made in IUR submissions

beginning with the 2002 reporting year

will need to be reasserted in subsequent

reporting years in order to retain CBI

protections.

10. By adding § 710.40 to read as

follows:

§ 710.40 Availability of reporting form and

instructions.

(a) Use the proper EPA form. You

must use the EPA form identified as

‘‘Form U’’ to submit written information

in response to the requirements of this

subpart. Copies of Form U are available

from EPA at the address set forth in

paragraph (c) of this section, from the

EPA Internet Home Page at http://

www.epa.gov/opptintr, or via fax on

demand by using a faxphone to call

(202) 401-0527 and selecting item 5119.

You may also follow the automated

menus.

(b) Guidance for completing the

reporting form and preparing a magnetic

media report is available in the EPA

publication entitled ‘‘Instructions for

Reporting for Partial Updating of the

TSCA Chemical Inventory Data Base.’’

(c) EPA will mail a reporting package

(consisting of a copy of Form U and a

copy of the ‘‘Instructions for Reporting

for Partial Updating of the TSCA

Chemical Inventory Data Base’’) to those

companies that reported in the IUR

reporting period that occurred

immediately prior to the current

reporting period. If you did not receive

a reporting package, but are required to

report, you may obtain a copy of the

reporting package from EPA by

submitting a request for this information

as follows:

(1) By phone. Call the EPA TSCA

Hotline at 202-554-1404, or TDD 202-

554-0551.

(2) By e-mail. Send an e-mail request

for this information to the EPA TSCA

Hotline at TSCA-Hotline@epa.gov.

(3) By mail. Send a written request for

this information to the following

address: TSCA Hotline, Mail Code 7408,

ATTN: Inventory Update Rule, Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St. SW., Washington, DC 20460.

(d) Submit the completed reports. You

must submit your completed reporting

form(s) and/or magnetic media to EPA

at the following address: Document

Control Officer, Mail Code 7407, ATTN:

Inventory Update Rule, Office of

Pollution Prevention and Toxics,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

[FR Doc. 99–22243 Filed 8–25–99; 8:45 am]

BILLING CODE 6560–50–F