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Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9, 710, and 723

[OPPT-2002-0054; FRL-6767-4]

RIN 2070-AC61

TSCA Inventory Update Rule

Amendments

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating

amendments to the Toxic Substances

Control Act (TSCA) section 8(a)

Inventory Update Rule (IUR). The IUR

currently requires manufacturers

(including importers) of certain

chemical substances on the TSCA

Chemical Substances Inventory to report

data on each chemical's current

production volume, site-limited status,

and plant site information every 4 years.

Through these IUR amendments (IURA),

EPA is requiring the reporting of

additional data for certain chemicals to

assist EPA and others in screening

potential exposures and risks resulting

from industrial chemical operations and

commercial and consumer uses of TSCA

chemical substances. EPA is also

modifying the IUR reporting and

recordkeeping requirements, removing

one reporting exemption and creating

others, and modifying its procedures for

making Confidential Business

Information claims. EPA is also making

certain non-substantive technical

corrections.

DATES: This final rule is effective

February 6, 2003. For purposes of

judicial review, this rule shall be

promulgated at 1 p.m. eastern daylight/

standard time on January 21, 2003.

FOR FURTHER INFORMATION CONTACT: For

general information contact: Barbara

Cunningham, Acting Director,

Environmental Assistance Division,

Office of Pollution Prevention and

Toxics (7401M), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (202) 564-8170; email address: TSCA-Hotline@epa.gov.

For technical information contact:

Susan Sharkey, Project Manager,

Economics, Exposure and Technology

Division (7406M), Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460;

telephone number: (202) 564-8789; email address: sharkey.susan@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if

you manufacture (defined by statute to

include import) chemical substances

currently subject to reporting under the

Inventory Update Rule (IUR) at 40 CFR

part 710 or if you manufacture inorganic

chemical substances. Any use of the

term "manufacture" in this document

will encompass "import," unless

otherwise stated. In the past, persons

that only are processors of chemical

substances have not been required to

comply with the requirements of 40 CFR

part 710. These 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:

Chemical manufacturers and

importers currently subject to IUR

reporting, and chemical manufacturers

and importers of inorganic chemical

substances (NAICS codes 325, 32411).

This listing is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this action. Other types of

entities not listed in this unit could also

be affected. North American Industrial

Classification System (NAICS) codes

have been provided to assist you and

others in determining whether this

action applies to certain entities. To

determine whether you or your business

is affected by this action, you should

carefully examine the applicability

provisions in § 710.48 in the regulatory

text. If you have any questions regarding

the applicability of this action to a

particular entity, consult the technical

contact person listed under FOR FURTHER

INFORMATION CONTACT.

B. How Can I Get Copies of this

Document or Other Related

Information?

1. Docket. EPA has established an

official public docket for this action

under docket ID number OPPT-2002-

0054. The official public docket consists

of the documents specifically referenced

in this action, any public comments

received, and other information related

to this action. Although a part of the

official docket, the public docket does

not include Confidential Business

Information (CBI) or other information

whose disclosure is restricted by statute.

The official public docket is the

collection of materials that is available

for public viewing at the EPA Docket

Center, Rm. B102-Reading Room, EPA

West, 1301 Constitution Ave., NW.,

Washington, DC. The EPA Docket

Center is open from 8:30 a.m. to 4:30

p.m., Monday through Friday, excluding

legal holidays. The EPA Docket Center

Reading Room telephone number is

(202) 566-1744 and the telephone

number for the OPPT Docket, which is

located in EPA Docket Center, is (202)

566-0280.

2. Electronic access. You may access

this Federal Register document

electronically through the EPA Internet

under the "Federal Register" listings at

http://www.epa.gov/fedrgstr/. An

electronic version of the public docket

is available through EPA's electronic

public docket and comment system,

EPA Dockets. You may use EPA Dockets

at http://www.epa.gov/edocket/to view

public comments, access the index

listing of the contents of the official

public docket, and access those

documents in the public docket that are

available electronically. Although not

all docket materials may be available

electronically, you may still access any

of the publicly available docket

materials through the docket facility

identified in Unit I.B.1. Once in the

system, select "search," then key in the

appropriate docket identification

number.

II. Background

A. What Action is the Agency Taking?

1. Substantive changes to the CFR.

EPA is promulgating amendments to the

IUR (IURA) which were proposed on

August 26, 1999 (64 FR 46772) (FRL6097-4), taking into consideration

comments received on the proposal. The

amendments to the IUR that are

contained in this final rule, as well as

the inventory update provisions of 40

CFR part 710 that are unchanged by

these amendments, appear in a new

subpart C to 40 CFR part 710. The

inventory update provisions that apply

to the 2002 update remain unchanged

although the Agency has added subpart

headings in order to distinguish the

provisions that apply to the 2002 update

(i.e., the existing IUR) and the new and

revised provisions promulgated in this

rule. The following is a brief listing of

the primary changes to the IUR, which

do not affect the regulations in place for

IUR reporting in 2002. These changes

are described in more detail in this

document, along with a summary of the

comments received and the Agency's

summary response to those comments.

First, EPA is amending the existing

IUR regulations, 40 CFR 710.28 and

710.32, which appear in the new

subpart C as §§ 710.48 and 710.52, to

raise the production volume basic

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reporting threshold from the current

10,000 pounds (lbs.) per year to 25,000

lbs. per year, and to add a new largervolume reporting threshold of 300,000

lbs. per year for the reporting of

processing and use information.

Second, EPA is amending 40 CFR

710.32, which appears in the new

subpart C as § 710.52, to add exposurerelated information to the existing

reporting requirements for chemical

substances covered by the IUR.

Specifically, the Agency is requiring

that manufacturers subject to the

amended rule ("submitters") report, in

ranges: (1) The number of workers

reasonably likely to be exposed to the

chemical substance at the site of

manufacture; (2) the physical form(s) in

which the chemical substance is sent

off-site; (3) the percentage of total

reported production volume associated

with each physical form; and (4) the

maximum concentration of the chemical

substance at the time it leaves the

submitter's manufacturing site or, if the

chemical substance is site-limited, the

maximum concentration at the time it is

reacted on-site to produce a different

chemical substance.

Third, EPA is amending 40 CFR

710.32, which appears in the new

subpart C as § 710.52, to require

chemical manufacturers of chemical

substances with production volumes of

300,000 lbs. or greater to report certain

exposure-related information

concerning the processing and use of

each reportable chemical substance that

is conducted at sites that receive the

reportable chemical substance from the

submitter site directly or indirectly

(whether the recipient site(s) are

controlled by the submitter site or not)

(including through a broker/distributor,

from a customer of the submitter, etc.).

Specifically, manufacturers of these

larger-production volume chemical

substances will be required to report, to

the extent the information is readily

obtainable:

* The type of industrial processing

or use operation(s) at each site,

including downstream sites.

* The five-digit NAICS codes that

best describe the industrial activities

during the processing or use operation.

* The industrial function of each

chemical substance during the

processing or use operation, for each

NAICS code reported.

* The percentages of the submitter's

production volume used in each

industrial function category.

* The number of sites where the

various processing or use operations

occur.

* The number of workers reasonably

likely to be exposed to the chemical

substance in each processing or use

operation.

* The categories of commercial and

consumer uses of the reportable

chemical substance.

* An indication of the presence of

the reportable chemical substance in or

on consumer products intended for use

by children.

* The percentages of the submitter's

production volume associated with each

commercial and consumer product

category.

* The maximum concentration of

the reportable chemical substance in

each commercial and consumer product

category.

Fourth, EPA is revoking the current

full exemption from IUR reporting at 40

CFR 710.26(a) for inorganic chemical

substances, and is phasing in reporting

for these substances, which appears in

the new subpart C as § 710.46(b)(3). For

the first submission period following

promulgation of IURA (i.e., the 2006

submission period), EPA is requiring

partial reporting for these substances

(i.e., inorganic chemical substances will

not be subject to the reporting of

processing and use information). In

subsequent submission periods,

manufacturers of an inorganic substance

will be subject to full reporting (i.e.,

including the processing and use

information reporting requirements), to

the extent that they manufacture at least

300,000 lbs. of the substance at a site

during a given reporting year.

Fifth, EPA is amending 40 CFR

710.26, which appears in the new

subpart C as § 710.46(b)(1), to create a

partial reporting exemption for certain

chemical substances termed "petroleum

process streams" for purposes of

reporting under the IURA (i.e., these

chemical substances are not subject to

the reporting of processing and use

information).

Sixth, EPA is providing, in 40 CFR

710.46(b)(2), a partial exemption for

specific chemical substances (i.e., these

chemical substances are not subject to

the reporting of processing and use

information) where EPA has identified

that there is a low current interest in the

IURA processing and use information

related to the chemical. EPA has

identified a list of chemicals that are

covered by this partial exemption, and

provides a process for revising this list

over time because interest in the IURA

processing and use information for a

particular chemical can change.

Seventh, EPA is amending 40 CFR

710.26, which appears in the new

subpart C as § 710.46(a)(4), to provide a

full exemption from IUR reporting for

certain forms of natural gas.

Eighth, EPA is amending 40 CFR

710.32, which appears in the new

subpart C as § 710.52, to require the

reporting of more specific information

to assist in the accurate identification of

plant sites reporting under IUR.

Ninth, EPA is amending 40 CFR

710.28, 710.32, and 710.33, which

appear in the new subpart C as

§§ 710.48, 710.52, and 710.53, to change

the period for which reporting is

required from a corporate fiscal year to

a calendar year basis.

Tenth, EPA is amending 40 CFR

710.32, which appears in the new

subpart C as § 710.52, to allow

submitters to claim their production

volume range as CBI, in addition to the

existing requirement that submitters

report a specific production volume

number and the CBI status of that specific number. Under the IURA, some

submitters may choose to assert a

confidentiality claim for specific

production volume information while

releasing the more general production

volume range as public information.

Eleventh, EPA is amending 40 CFR

710.38, which appears in the new

subpart C as § 710.58, to require

substantiation of plant site

confidentiality claims at the time such

claims are made in IUR submissions to

EPA (i.e., "upfront substantiation"), in a

manner similar to the upfront

substantiation of chemical identity,

which will continue to be required

under 40 CFR 710.38, which appears in

the new subpart C as § 710.58.

Finally, EPA is amending 40 CFR

710.37, which appears in the new

subpart C as § 710.57, to extend the

records retention period from 4 years to

5 years.

2. Technical changes to the CFR. The

amendments that are contained in this

final rule, as well as the parts of 40 CFR

part 710 that are unchanged by these

amendments, are codified in a new

subpart C in 40 CFR part 710. Because

promulgation of IURA will overlap a

current IUR reporting cycle, EPA must

maintain the existing IUR provisions in

40 CFR part 710 in effect throughout the

2002 submission period for the existing

IUR. Submitters filing IUR reports in

2002 must follow the regulations

currently contained in 40 CFR part 710,

which will now appear under the new

heading as subpart B. On January 1,

2003, the regulations in this final rule

that are promulgated in subpart C of 40

CFR part 710 will become effective for

use by submitters filing IURA reports in

2006 and beyond. (See § 710.1(b) of the

regulatory text) Since the Agency has

duplicated in subpart C those provisions

from subpart B (i.e., the existing part

710) that are unchanged by these

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amendments, once the current reporting

cycle is complete, subpart B will no

longer be applicable and the Agency

will issue a technical amendment to

remove it from the CFR. The creation of

subparts in 40 CFR part 710 does not

make any substantive changes other

than those that have been presented in

this final rule.

Although there are no substantive

changes to the provisions from existing

40 CFR part 710 that have been

incorporated into the new subpart C, the

Agency has made minor technical

corrections to those provisions, as well

as technical changes to the existing

provisions that now appear in subpart

A. Specifically, the Agency is correcting

several typographical errors that appear

in the existing 40 CFR part 710, and is

making other minor non-substantive

edits to that text. These technical

corrections include the following. (Note

wherever a change is being made to a

new regulatory text provision, a

regulatory text citation to the

corresponding existing 40 CFR part 710

provision is provided in parentheses,

e.g., § 710.59 (§ 710.39). This

parenthesized citation is provided in

order to identify where the new

regulatory text originated.)

In accordance with plain language

principles, EPA has substituted "will"

or "must" for "shall." These three terms

are considered to be equivalent, and

delineate requirements to be followed or

met. Corrections were made in the

following sections: § 710.1(d)

(§ 710.1(c)); § 710.3(a) (§ 710.2(a));

§ 710.3(b) (§ 710.2(b)); § 710.3(c)

(§ 710.2(c)); § 710.3(d) in the definition

for "Administrator" (§ 710.2(e));

§ 710.3(d) in the definition for "site"

(§ 710.2(w)); § 710.3(d) in the note

following the definition for "small

quantities for research and

development" (§ 710.2(y)); and

§ 710.4(b)(2) (§ 710.4(b)(2)).

EPA has corrected some punctuation

and spelling errors: commas were added

in § 710.1(a) (§ 710.1(a)), in § 710.3(d) in

the definition for "distribute in

commerce" (§ 710.2(j)) and in the

definition for "small quantities for

research and development" and in the

note following the same definition

(§ 710.2(y)); commas were removed in

the definition for "distribute in

commerce" (§ 710.2(j)) and in the note

following the definition for "distribute

in commerce" (§ 710.2(y)); in § 710.3(d)

"Process 'for commercial purposes'

was substituted for "Process for

'commercial purposes"' in the

definition for "Process 'for commercial

purposes"' ( § 710.2(u)); in § 710.3(d)

"juridical" was substituted for

"juridicial" in the definition for

"person" (§ 710.2(s)) and "appropriate" was substituted for "appropriated" in

the definition for "technically qualified

person" (§ 710.2(aa)(2)); in § 710.4(d)(2) "premanufacture" was substituted for

"premanufacturing" (§ 710.4(d)(2)); and

in § 710.4(d)(5) "photographic films"

was substituted for "photographic,

films" (§ 710.4(d)(5)).

EPA has made certain additional nonsubstantive changes. In § 710.3(d), EPA

substituted "1,000 lbs. (454 kg)" for

"1,000 pounds" in the note following

the definition for "small quantities for

research and development" (§ 710.2(y)).

EPA has substituted "his/her" for "his"

in sections where the word "his" was

used: in two instances in § 710.3(d) in

the definition for "Administrator"

(§ 710.2(e)); in § 710.3(d) in the

definition for importer (§ 710.2(l)(2));

and in § 710.3(d) in the definition for

"technically qualified person"

(§ 710.2(aa)).

EPA has made certain additional nonsubstantive changes and updated

information submission information in

§ 710.59 by substituting "Availability of

reporting form and instructions" for

"How do I submit the required

information for the 1998 reporting

cycle?" (§ 710.39); in § 710.59(a) by

substituting "http://www.epa.gov/oppt/

iur" for "http://www.epa.gov/opptintr/

iur98" and by removing "or Fax-onDemand by using a faxphone to call

(202) 401-0527 and selecting item

5119" as Fax-on-Demand is no longer

available (§ 710.39(a)); in § 710.59(b) by

substituting "Guidance for completing

the reporting form and preparing an

electronic (magnetic media) report will

be made available prior to each

submission period." for the existing

paragraph after the heading

(§ 710.39(b)); in § 710.59(c) by

substituting "will send" for "is mailing"

and "reporting package (consisting of a

copy of Form U and a copy of the

reporting instructions) to those

submitters that reported in the IUR

submission period that occurred

immediately prior to the current

submission period." for "reporting

package to those companies that

reported in 1994. " (§ 710.39(c)); in

§ 710.59(c)(1), EPA substituted "By

telephone" for "By phone" and

removed "or TDD 202-554-0551" as the

TDD number is no longer available

(§ 710.39(c)(1)); in § 710.59(c)(2), EPA

substituted "TSCA-Hotline@epa.gov"

for "TSCA-Hotline@epamail.epa.gov"

(§ 710.39(c)(2)); and in § 710.59(c) and

(d) EPA substituted "7408M" for

"7408," "OPPT Document Control

Officer (DCO)" for "Document Control

Officer," and "Environmental Protection

Agency" for "U.S. Environmental

Protection Agency" (§ 710.39(c)(3)); and

by adding § 710.59(c)(4) to state that the

reporting form and instructions will

additionally be available via the

Internet.

EPA has also made minor technical

corrections to the existing provisions in

§ 710.39 that now appear in subpart B.

EPA removed "for the 1998 reporting

cycle" from the section heading to

clarify that the section applies to the

current reporting cycle. In § 710.39(a),

EPA replaced the website address with

the current address, www.epa.gov/oppt/

iur/iur02/index.htm, and removed the

Fax-on-Demand information, which is

no longer available. In § 710.39(c)(1),

EPA removed the TDD number, which

is no longer available. The Agency

corrected dates and addresses in

§ 710.39(c), (c)(3), and (d) by replacing

"1994" with "1998," "Mail Code 7408"

with "Mail Code 7408M," and inserting

"OPPT" before "Document Control

Officer."

EPA made minor revisions to clarify

the meaning of certain provisions. In

§ 710.1(a) "and recordkeeping" was

inserted after "governing reporting,"

"(TSCA)" was inserted after "(15 U.S.C.

2607(a))," and "and keeping current"

was inserted after "purpose of

compiling" (§ 710.1(a)); in § 710.1(d),

the note following the paragraph was

added to the end of the paragraph and

"Note: As a matter of traditional Agency

policy," was removed (§ 710.1(b)); in

§ 710.52(c)(1) "submitter" was

substituted for "respondent" and "as

described in § 710.59" for "from EPA at

the address set forth in § 710.39"

(§ 710.32(c)(1)); in § 710.52(c)3(ii)

"indicating, for each reportable

chemical substance at each site," was

substituted for "for each substance for

which information is being submitted

indicating" and added ", or both

manufactured in the United States and

imported in the United States"

(§ 710.32(c)(5)); in § 710.52(c)(3)(iii)

"designation indicating, for each

reportable chemical substance at each

site," was substituted for "statement for

each substance for which information is

being submitted indicating"

(§ 710.32(c)(6)); in §§ 710.45 and

710.55(a) "submission period" was

substituted for "reporting period"

(§§ 710.25 and 710.35(a)); in § 710.48

"section" was substituted for "§ 710.28"

(§ 710.28); in § 710.48(b) "paragraphs (a)

and (b)" were deleted (§ 710.28(c)); in

§ 710.52(c)(3)(iv) "reportable" was

substituted for "subject" (§ 710.32(c)(7));

in § 710.58(b) "Chemical identity." was

added as a section header to more

clearly identify the topic of the section,

and "The following steps must be taken

to assert" was substituted for "To

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assert," and "reportable" was

substituted for "specific" (§ 710.38(c)(b)

and (c)); in § 710.58(b)(1) "submitter"

was substituted for "person"

(§ 710.38(c)(1)); in § 710.58(b)(1)(i) "subpart" was substituted for "part"

(§ 710.58(c)(1)(i)); in § 710.58(b)(1)(vi)

substituted "have been taken" for "have

you taken" and "the" for "this"

(§ 710.38(c)(1)(vi)); in § 710.58(c)(2)

"listed in paragraph (c)(1) of this

section" was added for clarification

purposes, "submitter" was substituted

for "person" and "clearly identify the

information that is claimed confidential

by marking the specific information on

each page with a label such as 'confidential business information,'

'proprietary,' or 'trade secret."' was

substituted for "mark that information

as 'trade secret,' 'confidential,' or other

appropriate designation."

(§ 710.38(c)(2)); and in § 710.58(d) "is

indicated on the reporting form" was

substituted for "accompanies

information at the time it is" and

"confidentiality claim substantiation"

was substituted for "substantiation"

(§ 710.38(d)).

EPA replaced "manufactured or

imported" with "manufactured

(including imported)" to provide

consistency and clarification. EPA made

this change in: § 710.52(c)(3)(iv)

(§ 710.32(c)(7)); § 710.58(c)(1)(v)

(§ 710.38(c)(1)(v)); § 710.58(c)(1)(vi)

(§ 710.38(c)(1)(vi)); § 710.58(c)(1)(vii)

(§ 710.38(c)(1)(vii)); § 710.58(c)(1)(viii)

(§ 710.38(c)(1)(viii)); § 710.58(c)(1)(x)

(§ 710.38(c)(1)(x)); and § 710.48

(§ 710.28).

EPA moved three definitions that

currently appear in § 710.2 to § 710.23,

to clarify that they apply to the existing

IUR. In § 710.3(d), three changes were

made in recognition that the definitions

are no longer separated into sections,

but are contained within paragraph (d):

in the § 710.3(d) definition for

"Commerce," "paragraph (1) of this

definition" was substituted for

"paragraph (1) of this section"

(§ 710.2(i)), and in the § 710.3(d)

definition for "Technically qualified

individual," "this paragraph" was

substituted for "paragraph (aa)(3) of this

section" and "paragraph (1) of this

definition" was substituted for

"paragraph (aa)(1) of this section"

(§ 710.2(aa)(3)).

Section 553 of the Administrative

Procedure Act (APA), 5 U.S.C.

553(b)(B), provides that, when an

agency for good cause finds that notice

and public procedure are impracticable,

unnecessary or contrary to the public

interest, the agency may promulgate a

rule without providing notice and an

opportunity for public comment. EPA

has determined that there is good cause

for making these minor regulatory

changes in this final rule without prior

notice and opportunity for comment

because these minor corrections are

non-substantive and do not affect the

meaning or legal effect of the provisions

affected, which remains the same as it

was when the provision appeared in 40

CFR part 710. Thus, notice and public

procedure are unnecessary for these

minor changes to the existing or new

provisions in 40 CFR part 710. EPA

finds that this constitutes good cause

under 5 U.S.C. 553(b)(B).

B. What is the Agency's Authority for

Taking this Action?

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. This inventory

is known as the TSCA Chemical

Substances Inventory (the TSCA

Inventory). 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 commerce at

that time. In 1986, EPA promulgated the

initial IUR at 40 CFR part 710 (51 FR

21447, June 12, 1986), also under TSCA

section 8(a), to facilitate the periodic

updating of the TSCA Inventory and to

support activities associated with the

implementation of TSCA.

TSCA section 8(a)(1) authorizes the

EPA Administrator to promulgate rules

under which manufacturers and

processors of chemical substances and

mixtures (referred to hereinafter 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 associated with chemical

substances to the extent that it is known

to or reasonably ascertainable by the

submitter. TSCA section 8(a) gives EPA

broad discretion in determining the

information for which reporting can be

required. 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 in their places of employment;

and the duration of such exposure.

TSCA section 8(a) generally excludes

small manufacturers and processors of

chemical substances from the 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 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 section 5 or 7. The

standard for determining whether an

entity qualifies as a "small

manufacturer" for purposes of 40 CFR

710.29, and for 40 CFR part 710

generally, is defined in 40 CFR 704.3.

Processors are not currently subject to

the regulations at 40 CFR part 710.

This document promulgates the IURA

as subpart C in 40 CFR part 710, which

includes provisions copied from the

existing IUR regulations in 40 CFR part

710 that are not substantively changed

as a part of this rulemaking, and the

new IURA provisions in this final rule.

Failure to comply fully with any

provision of this final rule will be a

violation of TSCA section 15 and will

subject the violator to the penalties of

TSCA sections 16 and 17.

C. What is the Inventory Update Rule

(URY

The IUR requires U.S. manufacturers

of organic chemicals to report to EPA

every 4 years the identity of chemical

substances manufactured annually

during the reporting year in quantities

of 10,000 lbs. or more at each plant site

they own or control. The current IUR

generally excludes several categories of

substances from its reporting

requirements, i.e., 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 each reportable

chemical substance. Data were reported

to EPA under the IUR in 1986, 1990,

1994, and 1998, and a collection is

occurring in 2002.

The data reported under IUR are used

to update the information maintained

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 II.E. for

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further explanation of some of these

activities).

D. Why is EPA amending the IUR?

EPA is amending the IUR for three

primary reasons: (1) To tailor the

chemical substance reporting

requirements to more closely match the

Agency's information needs; (2) to

obtain new and updated information

relating to potential exposures to a

subset of chemical substances listed on

the TSCA Inventory; and (3) to improve

the utility of the information reported.

These amendments will enhance the

information collected through the IUR,

improve the scope of chemicals covered

by the rule, and improve CBI claims,

thereby accomplishing these three goals.

These goals are supported by the

policy in section 2(b)(1) of TSCA, 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." The data

currently available to EPA are generally

inadequate for risk screening purposes.

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

require manufacturers and processors of

chemical substances to report a wide

variety of data, including exposurerelated information which will be

reported for certain chemical substances

under IURA. These amendments remove

certain reporting requirements and add

others to focus reporting under the IUR

on that information which is most

needed by EPA and other Federal

agencies for screening, assessing, and

managing risk. Additionally, the

availability of these data will enhance

public awareness of basic information

about chemical substances.

Any evaluation of potential "risk" is

generally based on a combination of

hazard information and exposure

information. EPA relies on risk

screening to indicate which chemical

substances pose a potential risk to

human health or the environment, and

thus warrant a more detailed, resource

intensive analysis. The EPA Science

Advisory Board's report "Reducing

Risk: Setting Priorities and Strategies for

Environmental Protection" (Ref. 1) and

the National Academy of Public

Administration's report "Setting

Priorities, Getting Results, A New

Direction for EPA" (Ref. 2) recognize

that EPA's ability to use risk screening

to set priorities and allocate its limited

resources has been significantly

impeded by a lack of exposure data. The

manufacturing, processing, and use of

chemicals on the TSCA Inventory result

in a wide array of exposure scenarios.

The exposure-related data included in

IURA will greatly improve EPA's ability

to conduct risk screening to identify

chemical substances that could pose an

unreasonable risk to human health or to

the environment, or that otherwise

warrant further investigation.

E. What are EPA's TSCA-Related

Chemical Screening and Assessment

Activities?

TSCA authorizes EPA to gather

chemical hazard and exposure data, as

well as related information such as

production volume, to determine

whether a chemical may pose an

unreasonable risk of injury to human

health or the environment. The Agency

is able to institute risk management

actions when necessary to mitigate or

avoid unreasonable risk. Important

elements in a successful chemical risk

management program include

identifying the chemical substances,

manufacturing sites, and exposure

scenarios of greatest potential concern,

and using that information to set

priorities for more detailed risk

assessment, further research, advisory

notices, or other appropriate actions. To

help fulfill its TSCA responsibilities,

EPA has established the IUR and other

regulations to collect information on

commercial chemicals.

The TSCA Inventory currently

includes more than 76,000 chemical

substances. Approximately 8,900 of

these chemical substances are nonpolymer, organic chemical substances

manufactured at at least one site in

quantities of 10,000 lbs. or more per

year, as reported under the 1998 IUR

data collection. EPA estimates that

IURA will continue to collect

information on approximately 8,900

chemical substances. However, the set

of substances that will be reported

under IURA will be somewhat different

than the set of substances that was

reported under the previous IUR

collections primarily because of two

changes: Raising the basic reporting

threshold (see Unit II.F.2.) and adding

reporting on the manufacture of

inorganic chemical substances (see Unit

II.F.1.a.). Data collected under IURA

will enable EPA to more effectively

conduct initial risk screening on a

subset of the chemical substances

within its purview, as described in the

remaining part of this section and in

Unit III.A. 1.

EPA conducted tiered risk evaluations

of chemical substances even prior to the

enactment of TSCA in 1976. A tiered

approach allows EPA to sort through

many chemicals, focus on those

chemical substances of greatest concern,

and take appropriate actions. The

Agency is thus able to optimize

resources while limiting overall

regulatory burdens. The essential steps

of the tiered risk evaluation generally

include: An initial evaluation

(sometimes preceded by a prescreen of

candidate chemicals); basic risk

management decisions resulting from

the initial screening; more detailed risk

assessment when appropriate; and

resulting risk management actions, such

as regulatory or voluntary efforts to

reduce risk. Each of these steps is only

as effective as the available data inputs-

-if little data exist to inform the process,

each step suffers as a result.

Exposure-related information

collected through the IURA will inform

the initial risk screening step. Initial risk

screening is conducted using readily

accessible information from the

scientific literature, as well as other data

readily available to the Agency, such as

those provided by manufacturers and

processors. This information set often is

incomplete or of insufficient quality to

allow the Agency to reach definitive

conclusions about the set of chemicals

under review, but may be sufficient to

decide which chemicals appear to

warrant further evaluation, or

conversely, appear to be low priority

and therefore do not currently warrant

further review. These initial reviews are

often more qualitative than quantitative.

Also, continual updates to these data,

such as the recurring reporting of

exposure-related data under IURA, will

ensure that the most serious concerns

will be addressed even as chemical

quantities and exposure potentials

change between submission periods.

The effectiveness of risk screening,

risk assessment, and risk management is

dependent upon the quality as well as

the availability of both hazard and

exposure information. While past

approaches to priority setting have

emphasized relative chemical hazards

and used production volume as a simple

surrogate for exposure, EPA must

increase its emphasis on the exposure

component of risk screening and

assessment. EPA no longer believes that

reporting under the current IUR is

adequate for these purposes. The IURA

will provide EPA with data that will

more accurately and realistically gauge

potential exposures. The exposurerelated information reported under

IURA will be used in combination with

hazard information developed under

TSCA section 4 test rules and

enforceable consent agreements/orders,

through voluntary efforts such as the

High Production Volume (HPV)

Challenge Program (see www.epa.gov/

opptintr/chemrtk/volchall.htm), and

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other sources. These more current and

complete data from the IURA will allow

the Agency and others to screen and

prioritize chemicals based on potential

risk more effectively than it is currently

able to do.

Although the inherent hazard

associated with a chemical substance

will generally remain the same over

time, exposure of workers and affected

populations can change significantly. If

the amount of a chemical substance

produced increases significantly,

releases to the environment and human

exposures would also be expected to

increase. Conversely, if the amount

produced remains constant,

environmental releases and human

exposures may decline as engineering

controls are added and pollution

prevention practices are implemented.

Although the hazard associated with a

chemical generally remains constant,

the risk associated with the

manufacturing, processing, and use of a

chemical substance will change as

exposure increases or changes. The

Agency needs to be able to identify

changes in exposures as well as specific

exposure scenarios, making it important

to collect exposure data on a regular

basis. Chemicals that present low

hazard may still pose a risk if they are

produced in large amounts and have

high exposure potential, are released

into the environment at high volumes

and/or concentrations, or involve

exposures to particularly sensitive

subpopulations.

A voluntary effort called the Use and

Exposure Information Project (UEIP)

demonstrated that useful screening level

exposure information is available to and

can be reported by industry. The UEIP

was a cooperative effort begun in the fall

of 1992 between government and

industry in recognition of the

difficulties encountered in obtaining

accurate and up-to-date exposure

information on HPV TSCA chemicals.

Participants included EPA, the

Chemical Manufacturers Association

(CMA) (now the American Chemistry

Council, or ACC), the Chemical

Specialty Manufacturers Association

(CSMA), the Synthetic Organic

Chemical Manufacturers Association

(SOCMA), and the American Petroleum

Institute (API) (Ref. 3). Data collected by

EPA under the UEIP were similar to

those now being required under IURA,

and included the following: Production

volume, site location, percentage of

production volume for a given use,

environmental releases, number of

workers, worker activities, monitoring

data, and industrial and consumer uses.

EPA's experience with UEIP has shown

that the types of data requested by the

UEIP are available from industry and

can be used to prepare screening level

exposure assessments.

The UEIP, however, provided onetime reporting of information by a

subset of the manufacturers of a small

number of selected HPV chemicals.

Given these efforts, the limitations of

the data available from past and current

information collections that are

described in detail in the proposal for

these amendments (64 FR 46772,

August 26, 1999), and the amount of

time it would otherwise take to acquire

screening level exposure data for the

chemical substances on the TSCA

Inventory, it is appropriate to develop a

more systematic and broadly applied

approach to the prioritization process.

The Agency is doing this by requiring

that certain basic exposure-related

information be reported under this

amended rule instead of collecting the

information through a one-time

voluntary program.

F. What Are the Requirements of lURA?

The regulatory text of this document

describes the specific IURA reporting

requirements. EPA is also developing a

guidance document with specific

reporting instructions, and intends to

conduct workshops to help potential

IURA submitters become familiar with

the revised reporting form (Form U) and

amended reporting requirements. A

draft version of the revised Form U is

available in the docket, and EPA intends

to develop an electronic version of the

revised Form U. EPA will seek

additional feedback on the revised

form's structure, format, and layout

before finalizing it for use in 2006.

Submitters should note that the

information in § 710.52(c)(1) and (c)(2)

of the regulatory text (Part I of the

revised Form U) need only be reported

once per reporting cycle for each

submitter site manufacturing 25,000 lbs.

or more of a reportable chemical, while

the information in § 710.52(c)(3) and

(c)(4) of the regulatory text (Parts II and

III of the revised Form U, respectively)

will be reported for each reportable

chemical at a reporting site, depending

upon the chemical's production volume.

1. What are the changes to the

chemical substances covered by IUR?-

a. Inorganic chemical substances. EPA

is requiring partial reporting for

inorganic chemical substances for

reporting year 2005 information

submitted to EPA during the 2006

submission period, and full reporting

for inorganic chemical substances in

subsequent submission periods (see

§ 710.46(b)(3) of the regulatory text).

Partial reporting means that the

submitter must report the information

described in § 710.52(c)(1), (c)(2), and

(c)(3), as well as §710.58 of the

regulatory text, as applicable (i.e., Parts

I and II of revised Form U.). Full

reporting means that the submitter must

additionally report the processing and

use information as described in

§ 710.52(c)(4) of the regulatory text (i.e.,

all parts of revised Form U).

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

phasing-in of inorganic chemical

reporting provides manufacturers of

these chemicals with the opportunity to

familiarize themselves with IUR

reporting while providing EPA and

others with needed basic manufacturing

information on inorganic chemicals.

Future full reporting of exposure-related

information will provide EPA and

others with needed additional

information for those inorganic

chemicals with production volumes of

300,000 lbs. or more at a site. See Unit

III.A.1. for a discussion of the

importance of this exposure-related

information to EPA and others for both

organic and inorganic chemicals. Unit

III.C.l.a. contains a discussion specific

to inorganic chemicals. The basic

impetus for collecting information on

organic chemicals also holds for

inorganic chemicals.

b. Petroleum process streams. EPA is

exempting certain chemical substances,

termed "petroleum process streams" for

purposes of IURA, from reporting the

processing and use data contained in

the regulatory text at § 710.52(c)(4). For

purposes of this rule, the petroleum

process streams included in the

exemption are the multi-component

complex chemical substances listed by

Chemical Abstracts Service (CAS)

Registry Number in the regulatory text

at § 710.46(b)(1). This list of chemical

substances was 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. 4). Chemical

substances listed in the API document

consisting of a single component

chemical, except for water, will not be

considered petroleum process streams

for IURA reporting purposes. Water

(CAS number 7732-18-5) is partially

exempt from IURA reporting under the

petroleum process stream exemption.

The basis for this exemption is not

because these streams are of known low

toxicity. EPA believes that the

chemicals termed "petroleum process

streams" for purposes of IURA are often

toxicologically active. However, these

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chemicals are frequently processed at

the site where they are produced in

vessels which are designed to minimize

losses and, coincidentally, the potential

for releases and exposure. In many

cases, the flammable nature of these

products requires that they also be

transported, processed, and stored in

well controlled vessels. For these

reasons, EPA believes worker exposure

to the chemicals termed "petroleum

process streams" for purposes of IURA

is diminished and thus full IURA

exposure-related reporting is not

warranted at this time. Partial IURA

reporting includes site location and

production volume information which

have important uses by EPA and others

apart from gauging exposures and risk

screening. EPA may take action to

revoke this exemption if circumstances

warrant.

In the final rule, EPA is making

selected changes to the partial

exemption list of petroleum process

stream chemicals published in the

proposed rule. Certain chemicals are

being added to the list because they

were inadvertently left off the proposed

list covered by the exemption. These

multi-component chemicals, all of

which are listed in the 1983 API

publication (Ref. 4), include the

following chemical substances (CAS

numbers): 8052-41-3, 64742-21-8,

64742-26-3, 64742-94-5, 68476-32-4,

68515-29-7,68783-12-0,68918-98-9,

68919- 15-3, 68953-80-0, and 70693-

06-0.

In the final rule, EPA is also removing

a number of chemicals from the

petroleum process stream partial

exemption list published in the

proposed rule. These chemicals fall into

three groups:

(1) Certain chemicals that are already

part of the broader natural gas or

polymer exemptions. Those already

exempted under the natural gas

exemption are: 8006-14-2, 8006-61-9,

64741-48-6, 68410-63-9, 68425-31-0,

and 68919-39-1. Additionally, an

incorrect CAS number 68425-31-1 was

corrected to read 68425-31-0, which,

again, has been removed from the

partial exemption because it is already

fully exempt from IUR reporting under

the natural gas exemption. Chemicals

removed because they are already fully

exempt under the polymer exemption

are: 64741-71-5, 64741-72-6, 67891-

77-4, 67891-

79-3, 68131-

83-9, 68131-

01-5, 68410-

14-0, 68410-

27-4, 68425-

37-2, 68477-

46-3, 68477-

-5, 68131-77-

-6, 68131-81-

-7, 68132-00-

-6, 68410-13-

-2, 68410-59-

-5, 68476-87-

-0, 68477-45-

-9, 68477-51-

-1,68131-

-7,68131-

-3,68410-

-9,68410-

-3,68425-

-9,68477-

-2,68477-

-0,68477-

52-1, 68478-07-9, 68478-09-1, 68527-

24-2, 68527-25-3, 68783-10-8, 68783-

11-9, and 68955-30-6.

(2) Single component chemicals,

except for water, should not have been

included in the petroleum process

streams partial exemption. As stated in

the proposed rule, the exemption was

intended to include only certain multicomponent chemicals derived from the

1983 API publication (Ref. 4). As a

result, the following single-component

chemicals have been removed from the

petroleum process streams partial

exemption list as proposed: 8007-45-2

and 10024-97-2.

(3) Certain chemicals that are not

included on the TSCA Inventory and

therefore are not currently reportable

under IUR have also been removed from

the exemption list: 64741-93-1, 64741-

94-2, 64742-00- 3, 64742-02-5, 64742-

17-2,64742-66-1,64742-74-1,64742-

84-3, and 64754-96-7.

In this final rule, EPA is also making

some additional corrections to the

petroleum process streams partial

exemption list published in the

proposed rule.

(1) Incorrect CAS numbers for certain

chemicals were provided in the

proposed rule. These CAS numbers

were incorrect because of typographical

errors in the proposed rule. The correct

CAS numbers (incorrect CAS numbers

are in parentheses) are as follows: 8006-

20-0 (8006-20-2), 64742-18-3 (64742-

18-2), 64742-20-7 (64742-20-3),

68187-60-0 (68187-60-9), 68459-78-9

(68459-79-8), 68513-14-4 (68514-14-

4), 68513-19-9 (68512-19-9), and

68514-38-5 (68514-38-4). Two

additional incorrect CAS numbers were

provided in the proposed rule, i.e.,

64742-36-2 and 68741-41-9. The

corrected CAS numbers for these

chemicals, i.e., 64742-36-5 and 64741-

41-9 respectively, were also provided in

the proposed rule.

(2) Several duplicate CAS numbers

that were included in the proposed rule

have been removed.

(3) CAS numbers for certain

chemicals have been superceded by new

CAS numbers. The new CAS numbers

are as follows (superceded CAS

numbers are in parenthesis): 68187-58-

6 (68334-31-6), 68410-13-9 (68477-

56-5), 68308-08-7 (68478-21-7),

68334-30-5 (68512-90-3), 68918-99-0

(68513-26-8), 64742-83-2 (6851-30-7),

68988-79-4 (68515-31-1), 64742-93-4

(68516-21-2), 68606-10-0 (68606-35-

9), and 64742-93-4 (68650-78-2).

c. Natural gas. EPA is exempting

certain forms of natural gas from IUR

reporting. These substances are listed in

the regulatory text at § 710.46(a)(4). EPA

believes that, to date, adequate IUR

information has been collected on these

chemical substances to fulfill EPA's and

other IUR information users' current

needs. EPA will take action to revoke

this exemption if circumstances warrant

in the future.

d. Specific chemical substances. EPA

is exempting certain specific chemical

substances for which EPA has

determined that there is a low current

interest in the IURA processing and use

information from reporting the

processing and use information

contained in the regulatory text at

§ 710.52(c)(4). These chemicals are still

subject to the other requirements of

IURA. The chemical substances

included in this partial exemption are

listed by CAS Number in the regulatory

text at § 710.46(b)(2)(iv). EPA is also

establishing a process for revising the

list of exempted chemical substances

over time.

EPA is establishing this partial

exemption in an effort to improve

IURA's efficiency and effectiveness.

This partial exemption also provides

additional benefits in reducing the

potential reporting burden of IURA for

certain manufacturers of these

chemicals, and provides an efficient

process for amending the partial

exemption list as the need for

processing and use information under

IURA changes over time. The inclusion

of a chemical substance under this

partial exemption is not based on the

potential risks of a chemical. This

partial exemption is solely intended to

provide a tool to assist the Agency in

better managing the collection of

processing and use information under

IURA.

In the proposed rule, EPA specifically

sought comment on a partial reporting

exemption for "low priority" chemicals,

and requested comment on the criteria

the Agency might use to establish such

an exemption, as well as the specific

chemicals that might qualify for such an

exemption. (See Unit IX.3. of the

preamble to the proposal, at 64 FR

46794). EPA also offered several

approaches for identifying the

chemicals that could be considered for

such an exemption. A number of

commenters supported the creation of a

partial exemption, and several provided

suggestions for additional chemical

substances or classes of substances that

they wanted EPA to consider including

in this or an expanded partial

exemption.

In response to the comments received,

EPA has established a partial exemption

that applies when EPA has determined

that there is a low current interest in the

chemical's IURA processing and use

information. Because IURA reporting is

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chemical-specific, this exemption

applies to the specific chemical

substances that are listed within the

exemption, which are discussed in more

detail below. The need for EPA's

collection of IURA processing and use

information related to a particular

chemical substance can change over

time; therefore, EPA has also established

a process that will allow EPA to revise

the list by adding or removing a

chemical to reflect the change in

interest. The process allows anyone to

submit a written request for EPA to

consider revising the list of chemical

substances covered under this partial

exemption. EPA may also revise the list

on its own initiative. When a list

revision is necessary, EPA's preferred

approach will be to issue a direct final

rule, which affords an opportunity for

public comment, while providing an

efficient mechanism for revising the list.

In determining whether there is low

current interest in IURA processing and

use information related to a specific

chemical substance, EPA will look to

the specific circumstances surrounding

the chemical in question, and may use

one or more of the considerations

identified below, and/or considerations

not identified below, to make an

informed decision. EPA will consider

the totality of information available for

the chemical substance, including but

not limited to the following:

(A) Whether the chemical qualifies or

has qualified in past IUR collections for

the reporting of the information

described in § 710.52(c)(4) (i.e., at least

one site manufactures 300,000 pounds

or more of the chemical).

(B) The chemical substance's

chemical and physical properties or

potential for persistence,

bioaccumulation, health effects, or

environmental effects (considered

independently or together).

(C) The information needs of EPA,

other federal agencies, tribes, states, and

local governments, as well as members

of the public.

(D) The availability of other

complementary risk screening

information.

(E) The availability of comparable

processing and use information.

(F) Whether the potential risks of the

chemical substance are adequately

managed by EPA or another agency or

authority.

It is important to note that the inclusion

of these chemical substances under this

partial exemption is not based on the

potential risks of the chemicals, but is

based on the Agency's current

assessment of the need for collecting

IURA processing and use information.

Additionally, some of these chemicals

have issues that may renew interest in

them in the future, at which time EPA

will reconsider the applicability of this

partial exemption for those chemicals.

To create an initial list of specific

chemical substances covered by this

partial exemption, EPA started with:

(1) The list of chemical substances

identified as part of the HPV Challenge

Program for which, based upon a

preliminary review of known hazard

information, it was determined that the

SIDS data set would not further our

understanding of the chemical's

properties.

(2) The list of the chemical substances

that the European Union (EU) exempted

from its reporting requirements for

existing chemical substances.

(3) Certain other chemicals identified

during the Executive Order 12866

interagency review, for which EPA was

able to quickly determine, based on a

review of their chemical structures,

properties, existing hazard information,

and available exposure information, that

IURA processing and use information is

of low current interest.

This list was then adjusted based

upon the totality of information

available to EPA during the Executive

Order 12866 interagency review period

to ensure that the chemicals included in

this partial exemption were those for

which EPA determined that IURA

processing and use information is of low

current interest. EPA chose these

chemicals because almost all previously

underwent a review to have gotten on

these lists and, considering the time

available during the Executive Order

12866 interagency review, the Agency

was able to utilize these lists, along with

the Agency's current knowledge and

understanding of the individual

chemical's structure, properties,

indications of hazards and potential

exposures, to inform its determination

that there is a low current interest in

IURA processing and use information

for these specific chemicals (Ref. 5). As

indicated previously, EPA has

established a process for revising the list

of chemicals covered by this partial

exemption, and intends to reconsider

the chemicals identified in comments

for applicability under this partial

exemption.

The list currently consists of the

following chemicals:

(1) Chemicals for which it had been

determined that the SIDS data set would

not further our understanding of the

chemical's properties, and not otherwise

sponsored under the HPV Challenge

Program: 50-70-4, 50-99-7, 56-87-1,

57-50-1,59-02-9,69-65-8,124-38-9,

142-47-2, 1592-23-0, 7440-44-0,

8001-21-6, 8001-22-7, 8001-26-1,

8001-29-4, 8001-30-7, 8001-31-8,

8001-78-3, 8001-79-4, 8002-03-7,

8002-75-3, 8006-54-0, 8016-28-2,

8016-70-4, 8021-99-6, 8029-43-4,

9050-36-6, 16291-96-6, 61789-97-7,

61789-99-9,64147-40-6, 64755-01-7,

65996-63-6, 65996-64-7, 68188-81-8,

68334- 00-9, 68334-28-1, 68409-76-7,

68425-17-2, 68439-86-1, 68476-78-8,

68514-27-2, 68514-74-9, 68525-87-1,

68918-42-3, 68952-94-3, 68989-98-0,

and 73138-67-7.

(2) Chemicals from the EU Existing

Chemicals Program exempted list that

are not currently otherwise a part of

another Agency program such as the

HPV Challenge Program: 50-81-7, 58-

95-7, 59-51-8, 87-79-6, 123-94-4,

137-08-6, 150-30-1, 1317-65-3, 7440-

37-1, 7727-37-9, 7782-42-5, 8001-23-

8, 8002-13-9, 8002-43-5, 9004-53-9,

9005-25-8, 11103-57-4, 26836-47-5,

61789-44-4, 67701-01-3, 68002-85-7,

68131-37-3, 68308-54-3, 68424-45-3,

and 68424-61-3.

(3) Chemicals otherwise identified by

EPA based on consideration of the

chemical's structure, properties, existing

hazard information, and available

information concerning the extent of

exposure, and which are not currently a

part of another Agency program such as

the HPV Challenge Program: 1333-74-0,

7782-44-7, 68442-69-3, 68648-86-2,

68648-87-3, 129813-58-7, 129813-59-

8 and 129813-60-1.

You may use the process established

in § 710.46(b)(2) to submit a request for

the Agency to consider other chemical

substances for inclusion under this

partial exemption. Please ensure that

you provide sufficient information in

your requests to enable EPA to make the

necessary determination after

considering the totality of available

information. If you have any questions

about this process, please contact the

technical person listed under FOR

FURTHER INFORMATION CONTACT for

additional assistance.

Under the list revision process, EPA

will provide a written response to

requests within 120 days of receipt, and

will maintain copies of these responses

in a public docket that will be

established for each reporting cycle. In

order to assist the Agency in completing

any necessary revision to the list before

the reporting period, any request for

revising the list of chemicals under this

partial exemption must be received by

the Agency no later than January 1 of

the year before the reporting period in

question (i.e.,12 months prior to the

reporting period). For example, any

request for inclusion under this partial

exemption must be submitted to EPA no

later than January 1, 2004, i.e., 12

months prior to the next reporting

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period, which begins on January 1,

2005, for the 2006 submission period. If

the request is submitted after this date,

during an actual reporting period, or

during the submission period, EPA is

less likely to have sufficient time to

complete its evaluation and make a

determination, or issue the necessary

rulemaking such that the decision can

be effective for that submission period.

Submitters should check the Federal

Register for list revisions or may check

the electronic CFR to identify what

chemicals are on the partial exemption

list prior to each reporting period.

EPA intends to develop a standard

operating procedure (SOP) for this

specific chemical partial exemption

process, which will outline the process

steps, as well as provide guidance to

EPA personnel on making such

determinations. EPA would like to seek

your input during the development of

this SOP, as well as feedback on the

implementation of this process, as part

of IURA implementation workshops that

are planned.

One of the purposes of the Paperwork

Reduction Act (PRA), 44 U.S.C. 3501 et

seq., can be achieved through federal

agencies working together with the

affected industries to design surveys

that will achieve multiple purposes

with a single survey instrument. EPA

plans to identify and initiate dialogue

that has the potential for generating

additional paperwork burden reductions

for the IURA. For example, the current

USGS annual survey covers

approximately 80 minerals, and

accounts for at least 75% of the

industrial production and 75% of the

facilities included in the USGS survey.

If you have identified other federal

agency information collections that

could satisfy the IURA purposes, or for

which IURA information might serve as

a viable substitute and have the

potential to generate federal paperwork

burden reductions, please contact the

person listed under FOR FURTHER

INFORMATION CONTACT.

Under the PRA, an agency may not

conduct or sponsor, and a person is not

required to respond to a collection of

information, unless the agency has

obtained approval for the activity from

the Office of Management and Budget

(OMB), an approval which must be

renewed every 3 years. As part of the

PRA approval renewal process, which

includes an opportunity for public

review and comment prior to OMB

review, EPA intends to continue to

evaluate this exemption process and

will provide information about the

chemicals evaluated, requests received,

decisions made and related process

elements and experiences as part of the

information collection request (ICR)

submitted to OMB. The Agency will

also analyze the information collected

from one reporting year to the next, in

order to ensure that IURA information

collection activities continue to meet

the requirements of the PRA, including

the demonstration of practical utility.

e. Polymers. As a result of recent

inquiries regarding the exemption of

polymers from IUR reporting, EPA is

clarifying this existing exemption. The

exemption does not apply to a

polymeric substance that has been

hydrolyzed, depolymerized, or

otherwise chemically modified, except

in cases where the intended product of

this reaction is totally polymeric in

structure. The Agency's intent under the

exemption at 40 CFR 710.26(b) has

always been (and continues to be under

40 CFR 710.46(a)(1)) that the products of

such reactions carried out on polymeric

materials are excluded from IUR

reporting only if they are intended to

have a totally polymeric composition.

There is no change in the IUR status of

polymeric materials that have not

undergone such reactions and are

flagged in the TSCA Inventory.

f. Microorganisms. EPA is clarifying

this existing definition to ensure that

the definition used for IURA purposes is

consistent with the microorganisms rule

at 40 CFR part 725 and to clarify the

status of chemicals produced from

living microorganisms.

2. How have the reporting thresholds

changed? EPA is raising the basic IUR

reporting threshold from a production

volume of 10,000 lbs. per year per site

to 25,000 lbs. per year per site. Every

person manufacturing a non-excluded

chemical substance at or above the

threshold will be required to report the

information in Parts I and II of the

revised Form U (see the regulatory text

at §§ 710.52(c)(1), (c)(2), and (c)(3) and

710.58). The increased IUR reporting

threshold makes the IUR and Toxics

Release Inventory (TRI) reporting

thresholds equivalent for manufacturers.

These thresholds also approximate the

current TSCA section 5 premanufacture

notification (PMN) low volume

exemption threshold of 10,000 kg

(approximately 22,000 lbs.). EPA is

raising the basic IUR reporting threshold

in order to reduce the number of reports

filed, thus reducing the overall industry

burden associated with this regulation.

The new reporting threshold does not

represent a finding of low exposure or

low risk.

EPA is also instituting a second,

higher production volume threshold of

300,000 lbs. per year per site. Persons

who manufacture a reportable chemical

substance at or above this level will be

required to report the information in

Part III of the revised Form U (see

§ 710.52(c)(4) of the regulatory text) in

addition to the information in Parts I

and II of the revised Form U. The

information reported on Part III of the

form relates to the processing and use of

chemical substances. EPA is instituting

this separate threshold to limit

processing and use data reporting to a

subset of a few thousand IUR reportable

chemicals out of the approximately

76,000 chemicals listed on the TSCA

Inventory.

Information concerning lower

production volume chemical substances

is valuable, especially for identifying

trends and additional substitute

chemicals. However, wherever possible,

the Agency has attempted to limit the

reporting burden. In the future, EPA

may find it necessary to collect

information on chemicals at reporting

thresholds below the thresholds

introduced in this action. Although both

the 25,000 lbs. and 300,000 lbs.

thresholds are significantly higher than

the current IUR 10,000 lbs. threshold,

the enhanced information that will be

gathered under the amended rule will

enable the Agency and others to more

efficiently identify those chemical

substances warranting further, more indepth review, as well as chemicals of

lesser concern (see Ref. 6).

3. Have the reporting year, the

submission period, or the reporting

frequency changed? In order to provide

clarification, two new definitions are

being added at 40 CFR 710.43:

"reporting year" means the calendar

year in which information to be

reported to EPA during a submission

period is generated and "submission

period" means the period in which the

information generated during the

reporting year is submitted to EPA.

"Submission period" replaces the term

"reporting period," as used under the

current IUR regulations at 40 CFR part

710.

As proposed, EPA is changing the IUR

reporting year to a calendar year basis

from a corporate fiscal year basis. This

change standardizes reporting time

frames across IUR submitters and across

various other reporting programs, such

as the TRI program.

Under the current IUR regulations at

40 CFR 710.33(b), submitters are

required to report on a recurring basis

during a 120-day period from August to

December (the "submission period"

under IURA) every 4 years. In a separate

action following this final rule, EPA

intends to change the submission period

to occur earlier in the year, for example

from January 1 through May 1. This

potential change is related in part to the

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reporting year change in this final rule

from fiscal year to calendar year. The

August to December submission period

was originally used because many

companies' fiscal years end in July, and

starting the IUR submission period in

late August allowed these companies to

report their most current information.

Companies will now report on a

calendar year basis, making an earlier

submission period more appropriate.

Changing the submission period to

occur earlier in the year would allow

sites to submit their information closer

to the period during which it was

generated, as well as allow the Agency

to obtain the information early in the

year, thereby increasing the timeliness

of the availability of the data.

In this final rule, EPA has not

changed the reporting frequency (every

4 years), although EPA did consider

alternative reporting frequencies (see

the "Revised Economic Analysis for the

Amended Inventory Update Rule," Ref.

7). This means that the first reporting

year for IURA information will be 4

years after the reporting year under the

existing IUR, i.e., existing IUR reporting

year is 2001, so the first reporting year

under IURA will be 2005. The

submission period will continue to

occur in the year following the reporting

year, i.e., existing IUR submission

period is in 2002, so the first submission

period for IURA will be in 2006.

The final rule indicates that

subsequent reporting years and

submission periods will occur every 4

years. In a separate action following this

final rule, however, EPA intends to

change the reporting frequency after the

first reporting year under IURA (i.e.,

2005, with submission to EPA in 2006)

from every 4 years to every 5 years. This

would mean that, instead of occurring

in 2009, the second reporting year under

IURA would be 2010 (i.e., 5 years after

2005), and would then occur every 5

years thereafter. The submission period

would continue to occur in the year

following the reporting year, so it too

would occur every 5 years (i.e., 2011,

2016, etc.). In making this change, EPA

also intends to change the

recordkeeping period from 5 years to 6

years. EPA agreed to make these

changes within the next 12 months as

part of the interagency review under

Executive Order 12866 in an effort to

further reduce the potential reporting

burden related to IURA. EPA estimates

that a 5-year frequency would save

regulated entities about $50 million over

20 years at a 3% discount rate (about a

16% reduction), and $37 million over

20 years at a 7% discount rate, and

would still meet EPA's most critical

data needs (Ref. 8).

For the first reporting year under

IURA, EPA intends to issue guidance

and conduct workshops to help the

regulated community become

familiarized with the revised

regulations. A draft copy of the

guidance for the 2006 submission

period can be found in the docket for

this rulemaking (Ref. 9).

4. How have the recordkeeping

requirements changed? EPA is requiring

that persons subject to reporting under

IURA retain records that document any

information reported to EPA under

IURA for a period of 5 years beginning

with the effective date of that

submission period (see § 710.57 of the

regulatory text). The effective date of the

submission period is the last day of the

submission period (currently December

23, although EPA intends to change this

date, see Unit II.F.3.) in a year in which

data must be submitted to EPA under

IURA. Previously, submitters were

required to retain records for 4 years

(see 40 CFR 710.37). Under IURA, if a

person submits a report in the year

2006, that person will retain the records

on which the report is based until

December 23, 2011. This change ensures

that the submitter will have the

previous submission available when

determining future reporting. The

change will also aid in EPA's

enforcement of IUR by requiring that

submitters maintain records that span

successive submission periods. As

described in Unit II.F.3., in a separate

action EPA intends to change the

reporting frequency from every 4 years

to every 5 years. In that action, EPA also

intends to change the recordkeeping

period from 5 years to 6 years in order

to continue to span successive

submission periods. A 6-year

recordkeeping period would require,

under IURA, that if a person submits a

report in the year 2006, that person will

retain the records on which the report

is based until December 23, 2012.

Persons who are not required to report

under the existing IUR because they

manufacture less than the 10,000 lb.

reporting threshold have been required

to retain volume records as evidence to

support decisions not to submit a report.

In this rulemaking, EPA is eliminating

this provision because EPA believes that

this type of information is routinely

retained by companies in the normal

course of business.

5. How have the data elements

reported by all submitters changed? The

new and revised data elements to be

reported under the amended rule are

discussed in this section. Data elements

that are currently reported under IUR

but that are not revised by these

amendments are not generally discussed

in this document.

a. Technical contact identification

(§ 710.52(c)(2)(i) of the regulatory text).

In addition to the name of a person who

will serve as technical contact for the

submitter company, the parent company

name, the contact person's full mailing

address, and the contact person's

telephone number, submitters must

report the contact person's e-mail

address and the parent company Dun

and Bradstreet Number. The technical

contact person must be able to answer

questions about the information on the

revised Form U that is submitted by the

company to EPA.

b. Plant site identification

(§ 710.52(c)(2)(ii) of the regulatory text).

Submitters must report the plant site

county or parish in addition to the

information currently required for each

plant site that is subject to reporting.

EPA had additionally proposed to

require submitters to report a plant site

identification number in order to clearly

identify the reporting site in a way that

would allow the cross-linking of IUR

information with information reported

about the same plant site contained in

other data bases. EPA specifically

proposed requiring the reporting of a

newly assigned Facility Registration

Identifier (FRI), or, if the Facility

Registry System were not yet in place in

time for the publication of this final

rule, the submitter would report the

site's RCRA number, if one has been

assigned to the site. In this final rule,

EPA has decided not to require the

submission of a site identification

number in addition to the Dun and

Bradstreet number that submitters must

continue to report. The Agency may

instead make number assignments

either directly on the reporting form

after it is submitted to EPA, or prior to

mailing out the form at the beginning of

a submission period. Submitters will

not be responsible for obtaining or

reporting this number.

c. Chemical identification

(§ 710.52(c)(3)(i) of the regulatory text).

Submitters must indicate which type of

chemical identifying number they are

reporting, in addition to the number

itself. EPA no longer allows the use of

certain of the previously used substitute

identifying numbers (such as EPAassigned numbers for Test Market

Exemption Applications, original TSCA

Inventory form numbers, and numbers

associated with Notices of Bona Fide

Intent to Manufacture) because they are

difficult to cross-reference to CAS

Registry numbers. Submitters must

report a CAS Registry number, or, if a

CAS Registry Number is not known to

the submitter, the submitter must report

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either an EPA-designated accession

number for confidential substances or a

PMN case number.

d. Confidentiality of production

volume range (§ 710.52(c)(3)(v) of the

regulatory text). Submitters must

continue to report the specific

production volume of the reportable

chemical and may claim CBI protection

for that production volume.

Additionally, submitters may claim as

CBI a pre-determined production

volume range corresponding to the

reported production volume number.

This claim, if needed, would be separate

from a CBI claim for the specific

production volume.

Submitters of specific CBI production

volume data may allow the release of

more general range information. EPA

expects that roughly 50% of submitters

of specific CBI production volume data

will allow the public release of volume

ranges. This expectation of reduced CBI

claims 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" (Ref.

10)) as well as comments received from

industry concerning potential TSCA CBI

reforms (Ref. 11). The range option will

allow the public greater access to data

on chemical production volumes, and

the Agency will be better equipped to

publicly release more aggregate

production volume data relevant to its

risk screening and other decisions.

The production volume ranges in the

final rule are 25,000 to 300,000 lbs.;

300,000 to 1,000,000 lbs.; 1,000,000 to

10,000,000 lbs.; 10,000,000 to

50,000,000 lbs.; 50,000,000 to

100,000,000 lbs.; 100,000,000 to

500,000,000 lbs.; 500,000,000 to

1,000,000,000 lbs.; and greater than

1,000,000,000 lbs. per year. These

ranges are similar to those first used in

the development of the original TSCA

Inventory, except for one change, i.e.,

the lowest range starts at the IURA

reporting threshold of 25,000 lbs. rather

than the 10,000 lb. threshold that was

used in the current IUR. EPA

additionally made one change to the

ranges included in the proposed rule,

i.e, the upper end of the first range and

the lower end of the second range were

raised to 300,000 lbs. from the 100,000

lbs. range limit included in the

proposal, resulting in ranges of 25,000 -

300,000 lbs. and 300,000 - 1,000,000

lbs. This change makes the ranges

consistent with the second reporting

threshold of 300,000 lbs. or more (see

§ 710.52(c)(4) of the regulatory text), and

provides additional protection for

submitters' production volume range

CBI claims.

Under the proposed rule's 100,000

lbs. range limit for the lowest

production volume range, submitters

who did not claim the production

volume range as CBI might have

inadvertently provided the public with

more information than they intended.

For instance, for a submitter whose

production volume was in the 100,000

to 1,000,000 lbs. range, who did not

claim their production volume range

CBI, and who did not report any

information in Part III of reporting Form

U (the industrial processing and use and

the commercial and consumer use

information), public users of the data

would be able to infer that the

submitter's production was somewhere

between 100,000 to 300,000 lbs. per year

- information which the submitter

might have considered CBI. To protect

against such inadvertent disclosures of

CBI, EPA changed the production

volume ranges to reflect the second

reporting threshold of 300,000 lbs. EPA

does not believe that the change

significantly affects the utility of the

data to the public.

e. Number of potentially exposed

workers (§ 710.52(c)(3)(vi) of the

regulatory text). Submitters must report

the range code that corresponds to their

estimate of the total number of workers

reasonably likely to be exposed to each

reportable chemical substance at each

plant site. EPA defines "reasonably

likely to be exposed" as an exposure to

a chemical substance which, under

foreseeable conditions of manufacture,

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,

etc.), but exclude accidental or

theoretical exposures.

Workers involved in chemical

manufacturing, processing, and use are

a subpopulation of concern to EPA, the

Occupational Safety and Health

Administration (OSHA) (Ref. 12), the

National Institute of Occupational

Safety and Health (NIOSH) (Ref. 13),

and other organizations (e.g., labor

unions). Workers may often be exposed

to chemical substances in higher doses

and with greater frequency than the

general population, and may therefore

be at potentially greater risk of adverse

health effects. The number of workers

reasonably likely to be exposed to

specific chemical substances is

important to EPA and other

organizations in developing screening

level exposure scenarios. These

scenarios are then used to develop

priorities for testing, more detailed risk

assessment, and risk management.

Under IURA, submitters are required

to use ranges rather than specific values

for reporting certain data, including the

number of workers reasonably likely to

be exposed and the number of

processing or use sites. The ranges for

reporting the estimated number of

potentially exposed workers are found

in § 710.52(c)(3)(vi) of the regulatory

text. In general, reporting these ranges

reduces the potential burden to

submitters of developing a precise point

estimate for the data element. The use

of ranges should additionally result in

fewer CBI claims than if precise point

estimates were provided because ranges

tend to reveal less sensitive information

than specific estimates while still

conveying sufficient information useful

to effectively screen chemical risks.

Submitters are permitted to claim the

reported ranges as confidential if

revealing even this general information

would disclose information of a

sensitive nature.

f. Maximum concentration

(§ 710.52(c)(3)(vii) of the regulatory

text). Submitters must report the

maximum concentration, measured by

weight, of the reportable chemical

substance at the time it leaves the

submitter's manufacturing site or, if it is

a site-limited chemical, at the time it is

reacted on-site to produce a different

chemical substance. This information is

to be reported regardless of the various

physical forms in which the chemical

may be sent off-site or reacted on-site.

Concentration ranges for use in

reporting are found in § 710.52(c)(3)(vii)

of the regulatory text.

Concentration is an important

variable to consider when estimating the

magnitude of potential exposures.

Information about the maximum

concentration of a chemical substance

present at processing and use sites is

frequently used in chemical risk

screening in the review of PMNs for

new chemical substances required by

section 5 of TSCA and is used to the

extent it is available in screening

chemicals on the TSCA Inventory. 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. These

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standard methods use maximum

concentration information to estimate

upper limits to exposure estimates. If

EPA is aware that a chemical substance

is processed or used only as a fraction

of a mixture with other chemical

substances, exposure estimates may be

adjusted downward accordingly. For

example, a chemical substance which is

a component of a liquid mixture exerts

a lower vapor pressure than it would as

a pure chemical substance. Because

higher vapor pressure is associated with

increasing inhalation exposure to a

chemical substance, the concentration

of a chemical substance in a liquid

mixture impacts the exposure

assessment.

A chemical may be produced in

multiple physical forms and in multiple

formulations and products. As

described in Unit II.F.5.g., EPA is

requiring reporting of each of the

physical forms in which a chemical is

sent off-site. For the purpose of

exposure screening, EPA is requiring

only the reporting of the maximum

concentration, regardless of the various

physical forms in which a chemical may

be sent off-site.

EPA had proposed that submitters

also report the average concentration of

the chemical when leaving the

manufacturing site (at 64 FR 46788).

EPA is not promulgating this

requirement because of the potential

difficulty of determining the average

concentration. For example, a submitter

could produce many formulations

containing a particular chemical

substance, making a determination of

average concentration difficult.

g. Physical form (§ 710.52(c)(3)(viii) of

the regulatory text). Submitters must

report the physical form(s) of the

chemical at the time it leaves the site of

manufacture or, if the chemical is sitelimited, at the time it is reacted on site

to produce a different chemical

substance. The list of physical forms

from which submitters must select is

found in § 710.52(c)(3)(viii) of the

regulatory text. Further discussion on

physical form reporting is found in Unit

III.B.1.a.

The physical form of a chemical is an

important factor to consider when

estimating magnitudes and

concentrations of potential exposures.

EPA's analyses of TRI and PMN data

demonstrated that the physical state of

a chemical is a determining factor in

predicting the potential for industrial

releases of chemicals, and hence,

exposures to humans and the

environment. The results of the analyses

are provided in a technical support

document that was developed by EPA in

support of this rule ("Inventory Update

Rule (IUR) Amendments Technical

Support Document: Exposure-Related

Data Useful for Chemical Risk

Screening," Ref. 14). The physical state,

which provides information on

volatility and how the chemical is likely

to be handled during manufacturing,

processing, and use, is an important

data element for the purpose of

exposure and risk screening.

h. Percent production volume

(§ 710.52(c)(3)(ix) of the regulatory text).

Submitters are required to report the

percentage of total production volume

(as reported under regulatory text

§ 710.52(c)(3)(iv)) of the reportable

chemical substance that is associated

with each physical form reported.

Percent production volume estimates

will allow the Agency to aggregate, on

a case-by-case basis, the production

volume of a particular physical form for

a given chemical across multiple sites.

These determinations will allow EPA to

better characterize the risk associated

with chemicals that are manufactured in

physical forms that typically result in

higher exposures, such as volatile

liquids or powders, but that are

produced in small quantities. These

percent production volume estimates

will help put the physical form

information into context. Estimates

must be rounded off to the nearest 10%

of production volume.

6. What new definitions have been

added to explain or reworded to clarify

the reporting requirements? EPA has

reorganized the definition section of the

regulatory text associated with the

original Inventory and IUR. There are

now three definition sections. The

existing § 710.2 contains definitions

relevant primarily to the compilation of

the original Inventory, although a few of

these definitions are also relevant to

both IUR and IURA. EPA has recodified

these general definitions in § 710.3.

Definitions relevant only to IUR, which

were originally in § 710.2, are now in

§ 710.23. Section 710.43 contains

definitions relevant only to IURA. This

reorganization clarifies the relationships

between the definitions and the various

rules, and has no substantive effect.

Two existing definitions are being

clarified (§ 710.3 of the regulatory text).

EPA defines "manufacture" to mean to

manufacture, produce, or import for

commercial purposes and "manufacture

or import 'for commercial purposes"' to

mean to manufacture, produce, or

import 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.

Certain new definitions are being

added to § 710.43 as a result of this final

rule.

a. Known to or reasonably

ascertainable by. TSCA section 8(a)(2)

authorizes EPA to require persons to

report information that is known to or

reasonably ascertainable by the

submitter. For the purposes of reporting

under IURA, a submitter will report

information described in the regulatory

text at § 710.52(c)(1), (c)(2), and (c)(3)

that is known to or reasonably

ascertainable by the submitter. This

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.

b. Readily obtainable information.

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

require persons to report information

that is known to or reasonably

ascertainable by the submitter. Under

IURA, a submitter will report processing

and use information (i.e., the

information reported for sites at which

the 300,000 lbs. threshold has been met

or exceeded) 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 of the

reportable chemical substance (see

regulatory text § 710.43). Extensive file

searches are not required. The "readily

obtainable" standard 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 (see regulatory text

§ 710.43), while providing sufficiently

precise processing and use information

for screening level reviews. In addition,

the "readily obtainable" standard limits

the reporting burden associated with

processing and use reporting and is

identical to the standard currently in

effect under EPA's TSCA Section 8(a)

Preliminary Assessment Information

Rule (PAIR) (See 40 CFR 712.7). The

"readily obtainable" definition is

further discussed in Unit III.D.2.

c. Reasonably likely to be exposed.

For the purposes of reporting under

IURA, 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

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normally include, but would 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, etc.), but

excludes accidental or theoretical

exposures.

d. Use. For the purpose of reporting

under IURA, EPA is defining "use" as

any utilization of a chemical substance

or mixture that is not otherwise covered

by the terms "manufacture" or "process" (see regulatory text § 710.43).

For example, the activity of processing

a solvent into a paint formulation is

considered "processing" rather than

"use" because the activity incorporates

the chemical substance (the solvent)

into a formulation. If the paint

formulation containing the solvent is

then applied to a metal or wood surface

(e.g., cars), this application would be

considered a use activity. Relabeling or

redistributing a container holding a

chemical substance or mixture where no

repackaging occurs does not constitute

use or processing of the chemical

substance or mixture.

e. Repackaging. For the purpose of

reporting under IURA, "repackaging" is

defined as the physical transfer of a

chemical substance or mixture (as is)

from one container to another container

or containers in preparation for

distributing the chemical substance or

mixture in commerce. This definition

does not apply to sites that only relabel

or redistribute the reportable chemical

substance without removing the

chemical substance from the container

in which it is received or purchased.

f. Industrial use. EPA defines

"industrial use" for purposes of

reporting under IURA as use at a site at

which one or more chemical substances

or mixtures are manufactured or

processed (see § 710.43 of the regulatory

text).

g. Commercial and consumer use. For

purposes of reporting under IURA, EPA

defines "commercial use" as 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, a school, or recreational areas

(see § 710.43 of the regulatory text).

Exposures to commercial and consumer

products are similar for risk screening

purposes because existing screening

level assessment methods are not

sophisticated enough to distinguish

between these exposures.

h. Intended for use by children. For

purposes of reporting under IURA, EPA

defines "intended for use by children"

as the use of a chemical substance or

mixture in or on a product that is

specifically intended for use by children

age 14 or younger. A chemical substance

or mixture is intended for use by

children when the submitter answers "yes" to at least one of the following

questions for the product into which the

submitter's chemical substance or

mixture is incorporated: (1) Is the

product commonly recognized (i.e., by a

reasonable person) as being intended for

children age 14 or younger; (2) Does the

manufacturer of the product state

through product labeling or other

written materials that the product is

intended for or will be used by children

age 14 or younger; or (3) Is the

advertising, promotion, or marketing of

the product aimed at children age 14 or

younger?

i. Reportable chemical substance. For

the purposes of reporting under IURA,

a reportable chemical substance is a

chemical substance described in

§ 710.45 of the regulatory text.

j. Reporting year. For the purposes of

reporting under IURA, the reporting

year is the calendar year in which

information to be reported to EPA

during a submission period is generated,

i.e., calendar year 2005 and the calendar

year at 4-year intervals thereafter. For

instance, for information submitted in

2006, the information will be generated

during the period from January 1 to

December 31, 2005.

k. Submission period. For the

purposes of reporting under IURA, the

submission period is the period in

which the information generated during

the reporting year is submitted to EPA.

For instance information generated

during the period from January 1 to

December 31, 2005 (i.e., when the

chemical substance is manufactured)

will be submitted during the 2006

submission period.

1. Site-limited. For purposes of

reporting under IURA, EPA defines

"site-limited" to mean that 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.

Although a site-limited chemical

substance is not distributed for

commercial purposes outside the site at

which it is manufactured and processed,

the substance is considered to have been

manufactured and processed for

commercial purposes.

7. What new data elements are

reportable by only larger production

volume manufacturers? As described in

Unit II.F.2., EPA is replacing the current

IUR reporting threshold of 10,000 lbs.

per year per site with two new

production volume reporting thresholds

of 25,000 lbs. and 300,000 lbs. per year

per site. Each person manufacturing a

reportable substance at or above the

25,000 lbs. per year per site threshold is

required to complete at least a partial

report containing the information in

Parts I and II of the revised Form U.

Persons who manufacture a reportable

substance at or above the 300,000 lbs.

per year per site threshold are required

to complete a full report, providing the

information in Part III of the revised

Form U in addition to the information

in Parts I and II. Part III concerns the

processing and use of chemical

substances.

a. Processing and use information

(§ 710.52(c)(4) of the regulatory text).

Submitters with plant sites at which a

reportable chemical substance is

manufactured in annual quantities of

300,000 lbs. or more must report

processing and use information under

IURA. EPA requires submitters to report

the information described in

§ 710.52(c)(4) of the regulatory text

concerning the processing and use of

each reportable chemical substance at

sites that receive a reportable chemical

substance from the submitter site either

directly or indirectly (including through

a broker/distributor, from a customer of

the submitter, etc.), whether the

recipient site(s) are controlled by the

submitter site or not. Processing and use

information must be reported only to

the extent that the data, or an estimate,

is "readily obtainable" by the submitter

(see Unit II.F.6.b.).

i. Industrial processing or use

operations (§ 710.52(c)(4)(i)(A) of the

regulatory text). Submitters must report

the industrial processing or use

operation(s) at each site that receives the

reportable substance from the submitter

site (whether the recipient site(s) are

controlled by the submitter site or not).

The categories for reporting are listed in

§ 710.52(c)(4)(i)(A) of the regulatory

text.

ii. North American Industrial

Classification System (NAICS) Code

(§ 710.52(c)(4)(i)(B) of the regulatory

text). Submitters must report the fivedigit NAICS code(s) that best describe(s)

the industrial processing or use

activities at the sites that receive a

reportable chemical substance from the

submitter either directly or indirectly

(including through a broker/distributor,

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from a customer of the submitter, etc.),

whether the recipient site(s) are

controlled by the submitter site or not.

The NAICS codes, published by the

Office of Management and Budget

(OMB), have superseded the prior

system of Standard Industrial

Classification (SIC) codes (Ref. 15).

Submitters must report these codes to

the extent the information is readily

obtainable for processing or use

activities at sites that process or use a

reportable chemical substance received

from the submitter. EPA does not intend

for manufacturers to survey their

customers or distributors to precisely

identify the appropriate NAICS codes at

their downstream sites.

The NAICS classification system is

being used in IURA to describe the

industrial setting in which chemical

exposures associated with the industrial

processing or use of a chemical

substance may occur. Exposure to a

chemical substance typically varies

among industries. The NAICS code in

conjunction with the Industrial

Function Category (IFC) code and the

processing or use operation will define

the industrial, commercial, or consumer

setting so that the appropriate scenarios

can be applied to estimate worker,

community, and environmental

exposures to the chemical substance.

The NAICS codes which best describe

the industrial activities associated with

each reported industrial processing or

use operation must be provided. If more

than 10 NAICS codes apply to a

reportable chemical substance,

submitters need only report the 10

NAICS code, IFC and processing or use

operation combinations that

cumulatively represent the largest

percentage of the substance's

production volume, measured by

weight. Submitters may also report the

same NAICS code multiple times if the

chemical being reported has several

industrial functions or multiple

processing or use operations. This

limitation on reporting is intended to

minimize submitters' reporting burden.

iii. Industrial function category (IFC)

(§ 710.52(c)(4)(i)(C) of the regulatory

text). Submitters must report the IFCs

that best represent the specific manner

in which a chemical substance is used

within each NAICS code reported.

Submitters may report the same

function category under different NAICS

codes. The IFCs to be used are listed in

the regulatory text at § 710.52(c)(4)(i)(C).

A NAICS code and IFC combination

sufficiently defines a potential exposure

scenario for risk screening and prioritysetting purposes. EPA conducted

studies to determine whether

information regarding the industrial

sectors in which a chemical substance is

processed and used, and information

regarding the function a chemical

substance performs within industrial

processes, are useful for the purpose of

screening level exposure assessments.

These studies demonstrated that this

type of information provides indications

of the route, magnitude, and

concentration of potential chemical

exposures to humans and to the

environment. The results of the studies

are provided in two of the technical

support documents that EPA developed

in support of this rule (Refs. 14 and 16).

IFCs are also useful in estimating the

frequency and duration of chemical

substance exposures by indicating the

type of application in which a chemical

will be used (e.g., solvents (for cleaning

and degreasing) or intermediate). The

relationship between industrial function

categories and the frequency and

duration of exposure to chemical

substances is particularly useful in

developing exposure assessments in

EPA's New Chemicals Program. These

data elements are important elements in

developing useful exposure scenarios.

In the absence of these data, EPA often

uses conservative estimates that may

indicate a greater risk than is actually

the case. Data that will be obtained

under IURA will enable EPA to make

more realistic characterizations of

exposure, instead of "worst case"

assumptions.

iv. Percentage of production volume

attributable to each combination of

NAICS code and industrial function

category in each processing or use

operation (§ 710.52(c)(4)(i)(D) of the

regulatory text). Submitters must

estimate the percentage of total

production volume attributable to each

reported combination of NAICS code

and IFC in each processing or use

operation, to the extent that such

information is readily obtainable.

Estimates must be rounded off to the

nearest 10% of production volume.

Submitters are not permitted to round

off to zero percent if the production

volume attributable to a NAICS code/

IFC/processing or use operation

combination is 300,000 lbs. or more and

accounts for 5% or less of the total

production volume of a reportable

chemical substance. In such cases,

submitters must report the percentage of

production volume attributable to that

combination to the nearest 1% of

production volume. This exception to

the general rounding rule will ensure

that adequate use information is

reported for the larger production

volume chemical substances.

The total percent production volumes

associated with the NAICS code/IFC

combinations may add up to more than

100%, given that the submitter is

reporting on distribution of a chemical

to sites in its control as well as

downstream sites, some of which are

not immediate purchasers from the

original manufacturing site.

Additionally, the total percent

production volume may add up to less

than 100% if the submitter cannot

readily obtain information about how all

of its production volume is processed or

used by industry.

v. Number of processing or use sites

(§ 710.52(c)(4)(i)(E) of the regulatory

text). Submitters must report estimates

of the total number of industrial sites,

including those beyond the submitter's

control, that process or use each

reportable chemical substance

manufactured by the submitter, with

respect to each combination of NAICS

code and IFC in each processing or use

operation. The ranges that will be used

for reporting the number of sites can be

found at § 710.52(c)(4)(i)(E) of the

regulatory text. For risk screening

purposes, the number of sites at which

chemical substances are manufactured,

processed, or used is a useful indicator

of the number of ecosystems and the

size of the general population

potentially exposed to the chemical

substances.

vi. Number of workers

(§ 710.52(c)(4)(i)(F) of the regulatory

text). Submitters must report estimates

of the total number of workers,

including those at sites not under the

submitter's control, that are reasonably

likely to be exposed while processing or

using the reportable chemical substance,

with respect to each combination of

NAICS code and IFC in each processing

or use operation. The approximate

number of workers will be reported

using the same definitions and ranges

described under Unit II.F.5.e. The

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.

b. Commercial and consumer use

information (§ 710.52(c)(4)(ii) of the

regulatory text). Submitters must report

information concerning the commercial

and consumer uses of each reportable

chemical substance, whether the site(s)

at which the chemical substance is used

are controlled by the submitter site or

not. As for the industrial processing and

use information described in Unit

II.F. 7.a., commercial and consumer use

information must be reported only by

sites at which a chemical substance is

manufactured in annual quantities of

300,000 lbs. or more, and submitters are

only required to report the information

to the extent that it is readily obtainable.

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Consumers comprise a subpopulation

of particular concern to EPA, the

Consumer Products Safety Commission

(CPSC), and other governmental and

non-governmental organizations.

Information from submitters about

whether the chemical substances they

manufacture are used in consumer

products is useful in estimating the

potential risks to consumers that result

from chemical exposures. In the absence

of more specific data, EPA often

assumes for risk screening purposes that

large, unprotected populations may

potentially be exposed to the chemical

substances in consumer products. EPA

is also working with industry and other

stakeholders to develop hazard,

exposure, and risk assessments

regarding chemicals to which children

are exposed. The commercial and

consumer product information that will

be reported under IURA will be used by

EPA in the identification of chemicals

that might be included in these

programs, and may contribute to

exposure assessments for these

chemicals.

i. Commercial and consumer product

categories (§ 710.52(c)(4)(ii)(A) of the

regulatory text). Submitters must report

up to 10 categories that best describe the

commercial and consumer products in

which the reportable chemical

substance is used (whether the recipient

site(s) are controlled by the submitter

site or not). If more than 10 categories

apply, submitters need only report the

10 categories for the chemical substance

that cumulatively represent the largest

percentage of the submitter's production

volume, measured by weight. The

commercial and consumer product

(CCP) categories are listed at

§ 710.52(c)(4)(ii)(A) of the regulatory

text. Information on the use of

chemicals in CCPs is useful 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 will be

obtained under IURA will enable EPA to

make more realistic characterizations of

exposure, instead of "worst case,"

overly conservative assumptions.

ii. Products intended for use by

children (§ 710.52(c)(4)(ii)(B) of the

regulatory text). Submitters must

indicate, within each reported CCP

category, whether, based on readily

obtainable information, any amount of

each reportable chemical substance

manufactured by the submitter is or is

not present in (for example, a plasticizer

chemical used to make pacifiers) or on

(for example, as a component in the

paint on a toy) any products intended

for use by children, regardless of the

concentration of the substance, or

indicate that such information is not

readily obtainable.

EPA defines "intended for use by

children" in § 710.43 of the regulatory

text and in Unit II.F.6.h. Using this

definition, if a submitter determines,

based on readily obtainable information,

that its chemical substance or mixture is

used in or on a product that is intended

to be used by children age 14 or

younger, the submitter would indicate

this on Form U. For example, EPA

believes that certain products, like

crayons, coloring books, diapers, and

toy cars - to name a few - are typically

intended to be used by children age 14

or younger. As such, if a submitter

determines, based on readily obtainable

information, that its chemical substance

or mixture is used in crayons and toy

cars, that submitter would report a "Y"

in the Children's Use column on Form

U for categories Col and C10.

On the other hand, EPA believes that

certain products, like household

cleaning products, automotive products,

and lubricants--to name a few--are

typically not intended to be used by

children age 14 or younger. As such, if

a submitter determines, based on readily

obtainable information, that its chemical

substance or mixture is used in

automotive care products and

lubricants, that submitter could report a

"N" in the Children's Use column on

Form U for categories C03 and C09.

For further illustration, some

examples of products that are typically

intended for use by children 14 or

younger are provided for each

commercial and consumer use category

(this listing is not intended to be

exhaustive and should therefore not be

considered limiting):

Code Category Examples of Children's Products

C01 Artists' supplies Crayons, children's markers

C02 Adhesives and sealants Craft glue, model glue

C03 Automotive care products Typically products in this category are not likely to be

intended for use by children 14 or younger

C04 Electrical and electronic products Electronic games, remote control cars, toys

C05 Glass and ceramic products Porcelain dolls

C06 Fabrics, textiles and apparel Pajamas

C07 Lawn and garden products (non-pes- Lawn and gardening tools designed specifically for

ticidal) children, e.g., children's rake

C08 Leather products Shoes, jackets, baseball gloves

C09 Lubricants, greases and fuel additives Typically products in this category are not likely to be

intended for use by children 14 or younger

C10 Metal products Toy trucks, toy cars, wagon

C11 Paper products Diapers, baby wipes, coloring books

C12 Paints and coatings Finger paints, water color kits intended for children's

use

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EPA chose the phrase "intended for

use by children" because it appears in

the Federal Hazardous Substances Act

(FHSA) (15 U.S.C. 1261 et seq.) and has

been applied by the Consumer Product

Safety Commission (CPSC) for over 20

years. While not specifically defined in

FHSA or its implementing regulations,

the CPSC regulations list several factors

that CPSC considers in determining

whether a product is a "children's

product" intended for use by children

(16 CFR 1501.2(b)). After consultation

with CPSC, EPA adapted these factors

for the purpose of defining "intended

for use by children" for IURA purposes.

EPA based the ages for the definition,

i.e., 14 or younger, on the Standard

Consumer Safety Specification on Toy

Safety issued by the American Society

for Testing and Materials (ASTM),

Standard: ASTM F963-96a. This

standard covers age groups through 14

years and defines "toy" as: "any object

designed, manufactured, or marketed as

a plaything for children through the age

of 14 years" (Ref. 17, section 3.1.33).

Obtaining information indicating that

a chemical substance or mixture is used

in a product that is intended for use by

children will enable the Agency and

others to identify chemicals affecting

this particularly sensitive population.

EPA has long had an interest in

protecting children from unreasonable

adverse affects associated with exposure

to chemicals. In 1995, EPA established

a policy to ensure that environmental

health risks of children are explicitly

and consistently evaluated in our risk

assessments, risk characterizations, and

environmental and public health

standards (see http://yosemite.epa.gov/

ochp/ochpweb.nsf/homepage).

Environmental health threats to

children are often difficult to recognize

and assess because of limited

information to identify where children's

exposures occur and limited

understanding of when and why

children's exposures and responses are

different from those of adults.

In 1997, Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

specifically directed each Federal

agency to make it a high priority to

identify, assess, and address children's

environmental health and safety risks. It

also created a Task Force on

Environmental Health Risks and Safety

Risks to Children. On October 9, 2001,

President Bush signed Executive Order

13229, entitled Amendment to

Executive Order 13045, Extending the

Task Force on Environmental Health

Risks and Safety Risks to Children (66

FR 52013, October 11, 2001), extending

the work of the Task Force by another

18 months. These Executive Orders

illustrate the interest in and the

importance placed on addressing

children's environmental health and

safety risks.

The inclusion of the children's use

category in IURA will provide the

Agency and others with valuable

information about the relationship

between the IUR chemicals and

products intended for use by children

14 or younger. This information will

allow the Agency to respond to

concerns about chemicals used in the

manufacture of products intended for

use by children, enabling the Agency to

identify those chemicals that are

reported as not being used in children's

products, those chemicals that are used

in children's products, and those

chemicals where it is not known if they

are used in children's products. This

initial screen will then allow EPA and

others to identify those chemicals used

in children's products that might

warrant further investigation or

assessment, and thereby allow EPA, as

well as other interested parties and

affected entities, to better prioritize such

assessments and maximize available

resources.

iii. Percentage of production volume

attributable to each commercial and

consumer product category

(§ 710.52(c)(4)(ii)(C) of the regulatory

text). Submitters must estimate the

percentage of their site production

volume for each reportable chemical

substance that is attributable to each

specific commercial and consumer enduse. This information must be submitted

to the extent that it is readily obtainable.

Estimates must be rounded off to the

nearest 10% of production volume.

However, a CCP category which

accounts for 5% or less of the total

production volume of a reportable

chemical substance cannot be rounded

off to zero percent 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 rule

will ensure that adequate use

information is reported for the larger

production volume chemical

substances.

The total percent production volumes

reported may add up to more than

100%, given that the submitter is

reporting on distribution of a chemical

to sites in its control as well as

downstream sites, some of which are

not immediate purchasers from the

original manufacturing site.

Additionally, the total percent

production volume may add up to less

than 100% if the submitter cannot

readily obtain information about how all

of its production volume is used in

commercial and consumer products.

Code Category Examples of Children's Products

C13 Photographic chemicals Typically products in this category are not likely to be

intended for use by children 14 or younger

C14 Polishes and sanitation goods Typically products in this category are not likely to be

intended for use by children 14 or younger

C15 Rubber and plastic products Pacifiers, action figures, balls

C16 Soaps and detergents Baby shampoo, children's bubble bath

C17 Transportation products Child's car seat

C18 Wood and wood furniture Baby cribs, changing tables, wooden toys

C19 Other Other items specifically intended for use by children

age 14 or younger

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iv. Maximum concentration in

commercial and consumer products

(§ 710.52(c)(4)(ii)(D) of the regulatory

text). Submitters must report the

maximum concentration (measured by

weight) of each reportable chemical

substance in each commercial and

consumer product category. In

complying with this requirement,

submitters will select from the list of

concentration ranges provided in

§ 710.52(c)(3)(vii) in the regulatory text.

Concentration is further discussed in

Unit III.B.i.b. As with the other

processing and use information that

submitters must report, such

information will be reported only to the

extent that it is readily obtainable by the

submitter.

8. What changes have been made to

requirements for making CBI claims?

Submitters are able to claim information

submitted to EPA under this amended

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 invalid

confidentiality claims as much as

possible.

Submitters will have an opportunity

to make CBI claims for most of the

information reported under IURA. To

claim information as confidential, a

submitter must check the appropriate

box and sign the certification statement

on the reporting form. If a submitter

fails to do so, EPA could release the

information to the public without

further notice to the submitter. As in the

past TSCA Inventory Update collections

and the initial TSCA Inventory

collection, by signing the certification

statement the submitter certifies that its

claims of confidentiality are true and

correct. Procedures for claiming

information submitted electronically

(such as a submission on diskette) as

CBI will be specified in the instruction

manual that will be available each

submission period as described in

§ 710.59 of the regulatory text. CBI

should not be submitted by e-mail. A

discussion about CBI claims under

IURA is provided in this unit.

a. Upfront substantiation for plant site

identity. Submitters are required to

provide upfront substantiation for CBI

claims for plant site identity, in a

manner similar to the upfront

substantiation of chemical identity

under the existing IUR (see 40 CFR

710.38). Under IURA (see § 710.58(d) of

the regulatory text), a submitter may

assert a claim of confidentiality for a

plant site identity if the submitter

believes that releasing that identity

would reveal trade secrets or

confidential commercial or financial

information, as provided by TSCA

section 14. Submitters in past IUR

information collections have claimed in

excess of 15% of plant site identities 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 necessary.

Further discussion on upfront

substantiation is found in Unit III.E.2.

In order to assert a claim of

confidentiality for a plant site identity

under this amended rule, the submitter

must check the appropriate box on the

reporting form indicating a

confidentiality claim for plant site

identity and substantiate the claim in

writing by answering certain questions

provided in § 710.58(d) of the regulatory

text. If a submitter fails to substantiate

the plant site CBI claim, EPA could

make the information available to the

public without further notice to the

submitter.

b. CBI claims for chemical production

volume information. EPA did not

change the ability of the submitter to

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. However,

submitters may now make separate CBI

claims for both actual plant site

production volume information and a

corresponding production volume

range. Production volume ranges are

similar to those used in the

implementation of the original TSCA

Inventory collection and can be found at

§ 710.52(c)(3)(v) of the regulatory text.

In the last four IUR submission

periods when EPA sought actual

production volume information,

approximately 65% of the information

was claimed as confidential. In contrast,

only 35% of production volume data

collected in ranges in the original TSCA

inventory collection were claimed as

confidential. This difference indicates

that submitters may be significantly less

likely to make CBI claims for production

volume information reported in ranges

than for discrete production volume

figures. The high proportion of CBI

claims in IUR reports has severely

limited EPA's ability to convey

production volume information to the

public, even in the form of a national

aggregate production volume for the

chemical. EPA needs to be able to

convey 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. EPA has added the ability to

claim production volume range

information CBI in an effort to address

this problem. In some cases, submitters

may choose to claim their actual

production volume as CBI, while

allowing the more general production

volume range to be made public.

III. Public Comments

EPA carefully considered the

comments it received on the proposed

IURA. Major comments are discussed

below. Additional comment summaries

and more detailed responses are

contained in the "Summary of EPA's

Responses to Public Comments

Submitted in Response to Proposed

TSCA Inventory Update Rule

Amendments" (Ref. 18).

A. General Comments

1. How will EPA and others use the

new exposure-related data collected

under these amendments? Several

commenters expressed the view that

EPA has not provided adequate

justification supporting the Agency's

need for the new IUR data, nor enough

specific examples showing how EPA

would use the data for its intended

purpose.

EPA has an obligation under TSCA to

protect human health and the

environment from unreasonable risks

associated with chemicals under its

jurisdiction. In order to evaluate

potential chemical risks, EPA has

determined that a portion of the

chemicals (both inorganic and organic)

on the TSCA Inventory currently

warrant the collection of manufacturing

information, and that a subset of those

chemicals (i.e., those produced in

annual quantities of 300,000 lbs. or

more at a site) currently warrant the

collection of supplementary processing

and use information. EPA is amending

the IUR to provide an accurate and

readily available source of basic

exposure-related information for

approximately 4,000 of the 76,000

substances listed on the TSCA

Inventory. The amendments

significantly limit industry's reporting

burden while providing EPA with

information needed to screen for risks to

human health and the environment.

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EPA's primary use of these data will

be to identify priority TSCA chemicals

for more detailed information gathering,

risk assessment, and risk management

in order to develop targeted programs,

allowing the Agency to be proactive in

protecting human health and the

environment. Screening chemical risks

generally requires a combination of both

hazard and exposure information. The

lack of exposure-related data beyond

production volume data in the current

IUR has severely limited the usefulness

of the current IUR data for risk

screening. Moreover, the exposurerelated data that will be collected under

IURA are not otherwise readily available

from publicly available data sources (see

Unit III.A.3.). This lack of exposurerelated data has made it difficult for

EPA and others to identify chemicals

with potential exposures of concern,

and has resulted in the generation of

overly conservative screening level

exposure assessments.

The addition of manufacturing,

processing and use exposure-related

data to IURA, especially when compiled

by EPA into a searchable data base

format, will enable EPA and others to

more readily screen chemicals for

exposure and risk. These reviews will

allow for better prioritization of

chemicals to identify those warranting

more detailed assessments and to

eliminate chemicals of lesser concern

from further review.

Data generated by IURA will be used

in a wide variety of programs

fundamental to fulfilling the Agency's

TSCA statutory mandate. These

programs range from the more

traditional existing chemicals risk

screening efforts, to voluntary programs

such as EPA's Design for the

Environment program (see http://

www.epa.gov/opptintr/dfe), to

individual requests for analysis of

chemicals not associated with a

particular program. The IURA data base

will be searched to identify chemicals or

use scenarios meeting specific criteria.

For instance, the data base could be

searched to identify chemicals that,

based upon these data, have the greatest

potential for consumer exposure,

creating a list of chemicals arranged

according to the production volumes

associated with different consumer uses.

Additional examples of uses for IURA

data are provided in this section and in

EPA's "IURA Data Use Plan" (Ref. 19).

The Agency anticipates that, as was true

even for the basic production data

reported under the existing IUR, new

uses of IURA data by EPA and by others

will continually emerge and cannot be

predicted at this time.

Results from EPA tools such as the

Use Cluster Scoring System (UCSS) will

be greatly improved by IURA data. The

UCSS is a computerized tool that

combines hazard and exposure

information from a variety of data

sources, analyzes the data in relation to

groupings by commercial use, or "clusters," and identifies clusters of

potential concern to EPA. EPA's Science

Advisory Board (SAB) commented in its

evaluation of the UCSS that the lack of

exposure information in the system has

impaired its usefulness (Ref. 20). The

IURA data base will provide exposure

information that the UCSS will be able

to download directly and use. (For a

description of UCSS, see V.B.6. of the

proposed rule at 64 FR 46780 or

www.epa.gov/oppt/cahp/actlocal/

use.html)

EPA will also use IURA data to

perform preliminary exposure and risk

screening across a portion of the TSCA

Inventory chemicals. Some of the same

types of data that will be collected

under IURA have been collected under

the Agency's TSCA Existing and New

Chemicals Programs and have aided

EPA in performing exposure and risk

screening. These exposure-related data

were submitted as part of programs such

as: The voluntary UEIP (see http://

www.epa.gov/opptintr/exposure/docs/

ueip.htm for a description of this

project) and the PMN program under

TSCA section 5. Although the UEIP and

PMN programs involve the submission

of certain data that are the same as or

similar to data being submitted under

IURA, these programs cannot

sufficiently serve the needs that IURA

will serve (see Units V.A.l. and V.B.5.

of the proposed rule at 64 FR 46775 and

46780). However, these programs are

examples of the usefulness of certain

IURA data elements.

For example, several IURA data

elements were used in an Existing

Chemicals Program initial review of the

chemical methyl ethyl ketoxime

(MEKO). This review relied in part upon

data submitted by industry under the

UEIP. Some of the data are similar to

those that will be reported under IURA

and include the following: Production

volume, manufacturing process,

industry sector, industrial processing/

use activity, functional use, number of

sites, number of workers, physical/

chemical properties, and consumer

product information. Other UEIP

information submitted by industry on

MEKO are not of the sort that will be

collected under IURA, such as

environmental releases (releases to air,

water, etc.), worker exposure activities,

and monitoring data. The IURA is

designed to obtain information that is

the most critical for generating

screening level exposure profiles.

The UEIP submissions for MEKO

indicated that there were one

manufacturer and two importers of

MEKO in 1993 and five primary end

uses (submissions provided percentages

of MEKO production and import

volumes devoted to each use). The

submissions also reported the number of

workers at the manufacturing site, the

physical forms of products containing

MEKO, and the MEKO weight fraction

in each use.

The MEKO use information was

combined with information from

available workplace monitoring studies

and modeling approaches to compile a

screening level workplace exposure

assessment. The UEIP information on

use provided crucial information to

allow EPA to postulate process

operations, worker activities, and

possible exposures. For example,

MEKO's primary use (92% of

production and import volume) is as a

paint additive. This fact allows EPA to

refer to information on paint

manufacturing and use to estimate

exposures to workers who either

formulate paints or apply the paints

using spray guns or other techniques.

MEKO use in paint indicates a potential

for exposure to several large populations

(workers and consumers) because

exposure to even small amounts of paint

can result in significant exposure levels

to chemicals in paints. Such use

information can also be used by EPA to

generate estimated numbers of workers

in very small businesses (< 10 workers)

that may be poorly represented by

existing National Occupation Exposure

Survey (NOES) data. In the MEKO case,

such a population would be commercial

painters. Without the information about

MEKO use in paints and the large

percentage of MEKO volume devoted to

this use, exposed populations and

exposure level estimates may have been

severely underestimated or left as a data

gap (not estimated). Such

underestimations and data gaps can

artificially lower the appropriate level of

concern for potential risk(s) from a

chemical.

The usefulness of IURA data elements

is also demonstrated by EPA's use of

similar data in its New Chemicals

Program. PMNs for new chemical

substances submitted to EPA under

TSCA section 5 require many of the

same exposure-related data elements

that will be reported under IURA.

Exposure-related data in PMNs include

estimates of production volume,

categories of use, percent production

volume in the categories of use,

maximum number of workers exposed,

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and concentrations and physical forms

of the chemical. EPA uses these

exposure-related data to generate

screening level risk assessments for

regulatory decision-making under TSCA

section 5.

The manufacturer of a new chemical

provided the following information in a

recent PMN submission: An estimated

import volume; chemical uses and the

percentages of the import volume

devoted to each use (non-cosmetic

applications as a component of a

fragrance formulation used in

household products such as detergents,

cleaners, soaps, room fresheners, etc.);

number of sites and workers; and

consumer product information (weight

percent in products). EPA used this

information in combination with

technical references and other data to

estimate the number of manufacturers of

household products who may use the

new substance. Releases of the new

substance as a result of the fragrance

formulation process and from

manufacturers of the household

products were estimated, resulting in

estimated environmental concentrations

of the new substance due to its release

and estimated general population

exposures to the new substance. EPA

also used the information on processing

and use in combination with modeling

techniques to estimate the number of

workers and consumers who may be

exposed to the new substance and their

estimated exposures to the new

substance. These exposure-related

estimates, when combined with

information on the estimated hazards of

the new substance, indicated that the

estimated risks to potentially-exposed

workers, the general population,

consumers, and aquatic species were all

below levels of concern. Therefore, the

Agency could determine that no further

regulation under TSCA section 5 was

needed for this new substance. In

contrast, without this information, EPA

would have had to rely on generic

assumptions for approximating

potential exposures. These types of

assumptions are intended to be

conservative in nature and therefore

often result in higher than likely

exposure estimates.

Information from the IURA may also

be used in efforts to identify single

chemicals to support potential exposure

prevention activities. For example, EPA

recently learned that certain imports of

zinc sulfate were contaminated with

cadmium. Using the IURA processing

and use data on inorganic substances,

EPA could have quickly identified

importers of zinc sulfate and segments

of industry or the general population

that might use the chemical. EPA then

could have targeted warnings of the

potential for exposure to cadmium more

effectively, thereby preventing

exposures to the groups likely to be the

most highly exposed.

Other Federal agencies have also long

recognized the need for and importance

of exposure data. OSHA, NIOSH, and

CPSC have written letters supporting

EPA's and their own need for exposure

data (Refs. 12, 13, 21, 22, and 23). In

May 2000, the Government Accounting

Office (GAO) stated that "Various

federal agencies have collected such

human exposure data for a number of

purposes; historically, these collection

efforts have been limited to selected

chemicals, subpopulations, and time

periods" (Ref. 24).

Other government agencies, industry,

public interest groups, and the public in

general will be able to access and use

the non-CBI portion of IURA

information. The IURA exposure-related

data will be important to users beyond

those who accessed the existing IUR in

the past solely for production volume

information. The Natural Resources

Defense Council (NRDC), for example,

has expressed interest in using IURA

information (Ref. 25). In another case,

persons interested in reviewing the HPV

Challenge Program screening level

hazard data (see http://www.epa.gov/

opptintr/chemrtk/volchall.htm) will be

able to use the non-CBI exposure-related

IURA data to put the hazard data into

context. Risks identified via evaluation

of these screening level hazard and

exposure data then can be addressed.

Although EPA can envision a wide

variety of uses for the new IURA

exposure-related information as

described in this section, the Agency

anticipates that even more opportunities

exist for use of this information, as is

true for the basic production data

reported under the current IUR.

2. What is the practical utility of the

new exposure-related data?

Commenters have questioned whether

the data collected as a part of this

rulemaking will have "practical utility."

Practical utility is defined in the

Paperwork Reduction Act of 1995 (PRA)

(44 U.S.C. 3502(11)) to mean "the ability

of an Agency to use information,

particularly the capability to process

such information in a timely and useful

fashion." The OMB regulatory

definition of "practical utility" at 5 CFR

part 1320.3(1) addresses not only the

theoretical or potential usefulness of

information to an Agency, but also its

actual usefulness, taking into account its

accuracy, validity, adequacy, and

reliability, the Agency's ability to

process the information in a useful and

timely fashion, and whether the Agency

demonstrates actual timely use of the

data by the Agency's own functions.

The following discussion addresses

commenters' concerns in two parts:

First, the accuracy, validity, adequacy,

and reliability of the data; and second,

the timely use of the data by EPA.

a. How has the Agency ensured that

the data will be accurate, valid,

adequate, and reliable? Commenters

asserted that the data EPA proposed to

collect through IURA would not be

adequate for the purposes stated by

EPA, and would not be accurate, valid,

or reliable. Commenters stated that the

information collected through IURA

would be of limited accuracy and would

be inferior to data the Agency has

collected in other programs.

Commenters also stated that the

information would be so uncertain that

it would not be useful to predict

chemical risk, and that there are so

many other factors that affect exposure,

such as engineering controls, that the

data would provide a limited and

potentially inaccurate view of potential

exposure. Additionally, commenters

asserted that they do not know how

their chemicals are used downstream of

the manufacturing site, therefore if they

were required to report such

information, the resulting data would be

unreliable.

EPA considered the types of

information needed for screening level

exposure and risk assessments and

believes the information that will be

collected through IURA will have the

necessary level of accuracy, validity,

adequacy, and reliability for such

assessments. EPA agrees that there are

many ways to increase the accuracy,

validity, and reliability of the data.

However, in developing IURA and

considering various alternatives, EPA

relied on experience from programs

such as TSCA's PMN program and the

UEIP data collection, and maintained a

balance between data needs for

exposure screening and priority setting

and the burden associated with

providing the information. If the Agency

had required very precise, specific

reporting, submitter burden would have

increased beyond that which is

appropriate for a screening level data

collection. EPA also agrees that there are

many factors that can affect exposure

potential; however, the data provided by

the submitters will provide baseline

information sufficient for an initial

screen of exposure potential.

i. Adequacy of the data. Before

proposing the IURA, EPA analyzed

various exposure data collections and

assessments to determine the data

elements needed for a screening level

exposure assessment. This discussion

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and analysis are in the document

"Inventory Update Rule (IUR)

Amendment Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening"

(Ref. 14). Commenters' suggestions on

the proposed rule implied that more

extensive information about exposures

than was included in the proposed rule

would be necessary for even a screening

level analysis of potential exposure. One

commenter stated that there are many

other factors that can significantly affect

the potential for exposure. These factors

include engineering controls and

personal protective equipment

practices, the nature of the activities in

which workers are engaged, and the

physicochemical characteristics of the

chemical substances. This commenter

also stated that the data collected under

IURA will provide a limited and

potentially inaccurate view of potential

exposure. However, as summarized in

Unit III.A.1., risk analyses performed by

the Agency in general and OPPT in

particular are graduated and datadriven. As the initial levels of concern

and the quantity and quality of data

increase, the need for methodologies

used in risk review become more

detailed and exacting, and the reviews

become more accurate and reliable.

Based on its experience screening

chemical risks through such programs

as the TSCA New Chemicals Program,

the Agency believes IURA data will

provide information adequate to

perform initial screens of chemicals.

The Agency also will be better able to

prioritize and make basic risk

management decisions about those

chemicals of greatest concern as

indicated by the available data. These

better informed decisions will enhance

confidence that the most appropriate

chemicals are selected for more detailed

assessments.

ii. Accuracy and reliability of the

data. The Agency considered the data

accuracy and reliability needed for

screening level exposure analyses, and

took several steps to ensure IURA data

meet those needs. Screening level data

need not be absolutely precise, but

should be accurate and reliable enough

to make usable and defensible technical

assessments. The IURA will supply

exposure-related information the

Agency currently does not have,

recognizing that industry has a greater

knowledge than EPA about its own

operations and the uses of chemicals it

manufactures and sells. Without this

information, EPA either would not

screen these chemicals, would screen

them using outdated or anecdotal

exposure information, or would rely on

exposure estimates (typically

conservative) using modeling data.

Commenters stated that the accuracy

and reliability of much of the

information reported in Part III of the

proposed revised Form U (§ 710.32(c)(4)

of the proposed regulatory text, now

§ 710.52(c)(4)) would be highly

questionable because it relates to sites,

activities, and products that are not

under the direct or indirect control of

the reporting company. Industry

programs such as the ACC's Responsible

Care Program (see http://

www.americanchemistry.com for more

information) require that, as part of the

program, member companies work with

customers, carriers, suppliers,

distributors, and contractors to foster

the safe use, transport and disposal of

chemicals. The Responsible Care

Program, coupled with basic marketing

and sales force activities, suggests that

many companies are well informed

about downstream uses of their

chemicals. EPA recognizes that

submitters may not always have

detailed information about how the

chemical(s) they make are used. As a

result, submitters will only be required

to report this information to the extent

it is "readily obtainable" (see Unit

II.F.6.b.). In addition, the Agency

believes, based on its experience with

the New Chemicals Program, the UEIP,

stakeholder meetings, discussions with

industry about voluntary risk

management programs, and industry's

various self-regulation initiatives, that

most submitters have at least some basic

information about downstream uses,

such as the information that will be

reported under the IURA. These data are

believed to be of sufficient reliability for

use by the Agency and others for

purposes such as screening level risk

assessments and prioritization.

EPA also requires much of the IURA

information to be submitted in EPA

specified ranges. This requirement

benefits both the Agency and

submitters. First, range reporting is less

burdensome for the submitter than

calculating specific numeric estimates.

Demanding greater data accuracy

increases the burdens associated with

data collection. Second, information

reported in discrete numeric values can

indicate a level of accuracy that is not

necessarily present. EPA believes that a

higher level of confidence in data

accuracy can be achieved by specifying

ranges.

Commenters suggested that EPA use

other methods to obtain processing and

use information, such as voluntary data

collection programs. However,

voluntary industry efforts are not

uniformly reliable for collecting data,

and the Agency generally cannot ensure

that data submitted under voluntary

efforts will be complete and accurate.

For example, the UEIP was undertaken

by EPA in partnership with industry to

collect relatively detailed information

on 60 high production volume

chemicals. EPA received data for 48 of

the 60 UEIP chemicals. Many of the

forms received for those 48 chemicals

were not completely filled out, and only

a subset of manufacturers submitted

data. Thus, while the information that

EPA received was quite useful, it was

insufficiently complete for the purposes

to which IURA information will be put.

EPA's experience with UEIP is an

indicator that exposure data collected

under a voluntary effort are likely to be

uneven and fall short of meeting EPA's

needs.

iii. Validity of the data. Another

commenter had specific concerns about

the validity of the worker exposure data

and felt that an auditing program would

be necessary to generally ensure an

acceptable level of quality for data

collected under IURA.

EPA agrees that validated exposure

data are the most useful for the full

range of Agency risk assessment

activities. However, EPA's experience

with similar data collection efforts such

as TSCA's New Chemicals Program

demonstrates that the type of data EPA

is collecting under IURA are sufficient

for the purpose of screening to prioritize

follow-on efforts for risk assessment and

management. A rigorous validation

process for all IURA exposure-related

information would impose significant

additional burdens on industry and the

Agency that would likely outweigh the

benefits accruing to the screening

process. As discussed in Unit III.A.1.,

EPA exposure and risk evaluations are

often iterative, with screening level

assessments succeeded by more

intensive and data rich assessments, as

indicated by the screening level

assessments and as data become

available. The IURA data will be useful

to the Agency in evaluating potential

exposures and risks, serving as

indicators as to what levels and types of

exposures from which chemicals need

further review.

b. Will the Agency use the data in a

timely manner? Many commenters

questioned whether EPA would be able

to make effective and timely use of

IURA processing and use information,

stating that the large amount of data

submitted would overwhelm the

Agency. EPA acknowledges that IURA

will generate a significant quantity of

new data that EPA has not handled

under past IUR data collections.

However, EPA has carefully designed

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the data collection to facilitate efficient

data management and use. Data

collected through IURA will be put into

a relational data base format, which can

be easily searched, compared, and used.

The collection of data organized by

codes, rather than narrative information

presented in an unstructured manner,

lends itself to such a data base format.

In addition, providing for electronic

IURA submissions allows data to be

entered into the data base more

accurately and expeditiously, resulting

in a quick turnaround between the

submission of the data to the Agency

and the availability of the data for use.

The Agency anticipates that

approximately 95% of all reports will be

submitted electronically or on disks, as

opposed to hard copies. This compares

with 70% that were submitted on disks

in 1998. The IURA will facilitate EPA's

information management and the data

will be available quickly for the

Agency's and others' use.

3. Why doesn't EPA use other

available sources of data or mechanisms

to collect the data sought under IURA?

EPA requested comments on specific

mechanisms or data sources it could use

to obtain needed exposure-related

information with greater ease and less

burden to industry. Commenters

responded with a variety of sources,

ranging from current data collection

mechanisms within EPA (such as TSCA

8(a) PAIR, UEIP, and cooperative

approaches) to public data sources such

as the Hazardous Substances Data Bank

(HSDB) (HSDB is a toxicology data file

on the National Library of Medicine's

(NLM) Toxicology Data Network

(TOXNET)). In addition, many

commenters stated that EPA has not

made effective use of the exposurerelated data it has collected already

under current or prior programs. For

example, they stated that data collected

under two other TSCA rules - the PAIR

and the Comprehensive Assessment

Information Rule (CAIR) rules - have not

been used effectively to support Agency

risk assessment or risk management

decisions. Commenters went on further

to say that under the voluntary UEIP,

EPA was furnished exposure-related

data on 60 HPV chemicals (actually only

48), but only two reached the initial risk

assessment stage.

The alternate data sources

commenters described were generally

sources that EPA had already evaluated

in its analysis for the proposed rule or

with which EPA was otherwise familiar.

EPA explored a wide variety of public

data sources, as demonstrated in the

following: "Inventory Update Rule (IUR)

Amendments Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening"

(Ref. 14), "Economic Analysis of

Proposed Amendments to the TSCA

Section 8 Inventory Update Rule" (Ref.

26), and "A Review of Existing

Exposure-Related Data Sources and

Approaches to Screening Chemicals: A

Response to CMA" (Ref. 27) (see also

Unit V.B.5. of the proposed rule at 64

FR 46780)). For the most part,

commenters did not identify new

sources or provide additional

information to support the assertion that

these alternate data sources provide the

information that EPA proposed to

collect under IURA. After considering

the information provided, EPA believes

the decision not to use an alternate data

source as a replacement for IURA is still

sound. The Agency may, however,

evaluate an alternate source for

individual chemicals as part of its

consideration of a particular chemical

under the new exemption process

established in the final rule.

EPA has spent considerable effort and

resources evaluating other data sources

that could potentially provide the

accurate and up-to-date information that

the Agency needs. A primary

consideration, as mandated by TSCA,

was not to subject industry to

unnecessary or duplicative reporting.

The exposure information sought under

IURA is not currently accessible to EPA.

Although some useful exposure-related

data exist in some sources, the data are

insufficient for the purposes to which

IURA data will be put, typically because

they are neither timely or detailed

enough. Without IURA, EPA has

difficulty efficiently screening potential

risks posed by approximately 4,000

higher production chemicals on the

TSCA Inventory.

Commenters stated that, if EPA were

to have specific concerns about

information collection for substances or

categories of substances, the selective

use of TSCA section 8(a) PAIR (40 CFR

part 712) reporting would be more cost

effective than requiring all

manufacturers exceeding a production

trigger to report manufacturing,

processing, and use information. EPA

disagrees with the suggestion that PAIR

rules would be an efficient or cost

effective way to compile a data base to

allow the relatively large-scale risk

screening of chemicals on the TSCA

Inventory. PAIR is a very useful data

collection tool when one or a small

group of chemicals is targeted for risk

assessment; however, PAIR is limited

when collecting information on a large

number of chemicals. Additionally, the

PAIR rule has fewer, less definitive data

elements than IURA, is a one-time

collection versus the recurring

collection of IURA, and will not provide

data sufficient to meet the goals of

IURA. Use of PAIR rather than IURA

would force EPA to set risk screening

priorities based on hazard and

production volume alone, or in response

to requests from others. As discussed in

the document entitled "A Review of

Existing Exposure-Related Data Sources

and Approaches to Screening

Chemicals: A Response To CMA" (Ref.

27), this approach greatly hinders EPA's

ability to make effective and efficient

risk management decisions.

EPA plans to continue using existing

data sources and information sets. For

example, EPA has used data previously

collected under PAIR, CAIR, and the

UEIP in a variety of ways, such as to

support TSCA section 4 test rule

analyses, to provide analyses for the

Agency's efforts under the OECD SIDS

program, and in support of international

efforts (Refs. 18 and 27). However, the

existing sources are generally best used

when conducting a more detailed risk

assessment of a specific chemical of

concern, rather than preliminary risk

screening of a relatively large set of

chemicals. The IURA submissions will

provide a consistent set of screening

level exposure data that will allow EPA

to better identify on a relative basis the

chemicals of highest priority for further

risk evaluation. EPA will use IURA data

to identify those specific chemicals

which are of potential concern and need

follow up assessment. For instance,

IURA exposure data integrated with

HPV Challenge Program hazard data

will provide the input needed to

effectively develop risk-based priorities

for more detailed assessment of

chemicals. Once EPA has determined

that a specific chemical (or group of

chemicals) has sufficient potential for

exposure or risk to warrant further

assessment, the Agency will use the

other information sources and data

gathering tools as appropriate.

4. Can TSCA information be used for

right-to-know purposes? Some of the

commenters stated that TSCA does not

authorize EPA to promulgate IURA

based in part on EPA's goal of providing "right-to-know" information to the

public, non-governmental entities and

private organizations. In addition, some

commenters noted that OSHA and other

agencies have their own authorities to

collect information on chemicals.

TSCA contains many of the principles

embodied in the right-to-know concept.

For instance, TSCA section 14(b)

specifically authorizes EPA to disclose

health and safety data collected under

the statute. TSCA section 14 reflects the

legislative determination that certain

TSCA data should be available to the

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public and interested parties. In

addition, sections 4, 5, 6, as well as

section 21, for example, provide

opportunities for public participation in

chemical management decisions.

Participation must be meaningful, and

to be meaningful the public must have

access to TSCA non-confidential

information.

TSCA was designed in part to address

the lack of health, safety, and exposure

information government agencies and

the public faced in dealing with

chemicals. See, H.R. Rep. 94-1341 at 6

(1976), reprinted in Legislative History

of the Toxic Substances Control Act, at

414 (1976) ("Present authorities for

protecting against and regulating

hazardous chemicals are fragmented

and inadequate ... Most significant

among the deficiencies are ... (3) No

authority exists for collection of data to

determine the totality of human and

environmental exposure to chemicals.").

TSCA was seen as a way of providing

federal agencies and the public with

access to health, safety, and exposure

data so that the risks of chemical

substances could be more fully

evaluated and understood. See,

Statement of Sen. Hartke, Cong. Rec.,

March 26, 1976 [S4397- 4432], reprinted

in Legislative History of the Toxic

Substances Control Act, at 218 (1976)

("[T]he essential element of this

legislation is that it has attempted to

provide for the individual- not only who

works, but for the rest of American

society- the right to know what is in

store as far as the toxicity of the

chemicals is concerned."). Congress

envisioned TSCA as a tool for providing

the public and others with health,

safety, and exposure information about

chemical substances.

Finally, TSCA does not limit the use

or disclosure of data (except if data are

considered confidential) collected under

the statute. Congress drafted TSCA in

part to provide basic health, safety, and

exposure information to other federal

agencies, as well as state, local and

international governments. TSCA

provides several mechanisms--TSCA

sections 9, 10, and 12 for example--for

sharing health and safety data among

various levels of government. These

sections again demonstrate TSCA's role

as a tool for gathering and disseminating

information about chemicals.

B. Comments on Specific Data Elements

1. Manufacturing information-a.

Physical form. EPA requested comment

on its proposed requirement that

submitters report the physical form of a

chemical as it leaves the site of

manufacture. Several commenters

suggested variations on the specifics of

physical form reporting, but generally

agreed with reporting the physical form

as the chemical leaves the site of

manufacture. For instance, one

commenter suggested expanding the

types of physical forms that can be

reported. EPA has determined that the

six categories as proposed (see

§ 710.52(c)(3)(viii) of the regulatory text)

will be adequate for risk screening

purposes, and is not adding additional

physical form categories at this time.

Experience with the same six physical

form categories as part of EPA's

exposure screening assessment of over

20,000 chemicals in its New Chemicals

Program indicates that the categories of

physical forms that EPA is using under

IURA will be adequate.

Other commenters recommended that

EPA allow submitters to report more

than one physical form for each

reportable substance, because a

substance may leave a site in more than

one physical form. EPA agrees with this

comment and is requiring in this final

rule that submitters report all physical

forms of a substance when the substance

is sent off-site. Reporting on all physical

forms in IURA will lead to a better

assessment of exposure to a chemical

substance. For example, processing a

fine, nonagglomerating powder could

result in occupational exposure by

inhalation of chemical dust. Processing

the same chemical as a liquid solution

would eliminate, or at least reduce, the

inhalation risk (the liquid could become

an aerosol and be inhaled, depending on

the processing activity). By combining

data elements on the physical form of a

chemical substance, its production

volume, and the fraction directed to

each industrial processing or use

activity, a screening estimate of the

potential exposure associated with

manufacturing or processing of a

chemical substance can be derived. The

resulting exposure assessment will be

more representative and less

conservative than if the physical form(s)

were unknown. For these reasons, EPA

is requiring the reporting of all physical

forms in which a chemical substance

leaves the manufacturing site.

b. Concentration. EPA originally

proposed to require the reporting of

both maximum and average

concentrations of each reportable

chemical substance at the time the

substance is sent off-site. A number of

commenters felt that this information

would be difficult to report for the

following reasons: Chemicals may be

used in many product formulations at a

given plant site and there may often be

no consistent average or maximum

concentration of an individual chemical

across these formulations; such

information does not reside in any

currently available data bases and

would need to be generated for IURA

reporting (which would be particularly

difficult with respect to average

concentration information); and average

and maximum concentrations may vary

in product formulations during different

IURA reporting cycles. Commenters

suggested that maximum concentration

information will be misleading if only a

small amount of the reportable chemical

substance is made available

commercially at that concentration,

while the bulk of the total quantity

leaving the site has a lower

concentration. They also indicated that

determining average concentration

requires a complicated calculation

which falls outside the scope of

"reasonably ascertainable" information.

Commenters suggested that average

concentration can be calculated by

product or by the weighted average of

each product, and each of the

calculations can result in tremendously

different answers. The Agency has determined that

average concentration information is not

critical for purposes of screening level

exposure assessment and has not

included this element in this final rule.

Screening level review is typically

meant, in part, to serve as a method of

identifying chemicals that even at their

maximum concentration are less likely

to present a risk to human health or the

environment. Average concentration

information cannot be used to make

such a determination.

EPA recognizes that the concentration

of an IUR reportable chemical may vary

from shipment to shipment leaving a

submitter's site, or when reacted on-site

to produce a different chemical

substance. However, maximum

concentration is to be reported in wide

ranges and not specific numbers,

thereby alleviating the need to

determine specific concentrations.

Additionally, EPA does not intend for

submitters to go to great lengths to

determine what maximum

concentration ranges to select for IUR

reporting. Instead, EPA is simply

requiring that submitters select a range

of concentrations from a list of given

ranges. The ranges from which

submitters must select are: Less than 1%

by weight; 1-30% by weight; 31-60%

by weight; 61-90% by weight, and

greater than 90% by weight.

One commenter was concerned that

EPA did not specify whether it would

require submitters to conduct specific

chemical testing or statistical analysis in

order to report concentration data, or

whether submitters should merely

estimate concentrations. In addition, the

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commenter was unsure whether a

submitter should report the maximum

concentration level for each product it

manufactures/imports, or simply

estimate the overall maximum

concentration of the chemical

substance. EPA recognizes that

concentration data may vary from

product to product and from shipment

to shipment, and may be difficult to

report in some instances, particularly in

product formulations. EPA is not

requiring the reporting of concentrations

in all products and formulations but

rather only one maximum

concentration, regardless of the

chemical substance's physical form(s) or

product formulation(s). Because

concentration information will be

reported in ranges and not as individual

values, this information or at least an

estimate should be known to or

reasonably ascertainable by most

submitters. Submitters are not expected

to conduct chemical testing or statistical

analysis beyond any testing or analyses

already done by the submitter as part of

normal operations in order to report

maximum concentration information.

EPA anticipates that chemical importers

will frequently receive maximum

concentration information from their

suppliers, and manufacturers will

obtain this information from samples

analyzed for quality control. This

information is often found in the

physical property or hazardous

constituents sections of the MSDS.

2. Industrial processing and use. The

Agency received three comments

regarding the IFCs to be reported by

submitters that have plant sites at which

300,000 lbs. or more of a reportable

chemical substance are manufactured.

The first comment questioned how the

IFCs would apply to chemicals with

multiple industrial uses. The second

comment suggested that the Agency

provide submitters with a "free

response" option if their industrial

function is not represented among the

IFCs. The third comment stated that the

IFCs proposed by EPA were adequate.

Submitters are required to report up

to 10 unique combinations of processing

or use categories, IFCs, and NAICS

codes (see § 710.52(c)(4)(i)(A),

(c)(4)(i)(B), and (c)(4)(i)(C) of the

regulatory text). In making their

selection from among the IFC codes,

submitters must determine which IFC

best represents the specific industrial

use of the reportable chemical within a

given NAICS code/processing and use

category. The Agency will provide

examples of how to select which code

"best represents" an industrial use in

the instruction manual that will be

available to all submitters (see § 710.59

of the regulatory text). Submitters may

report multiple IFCs for the same NAICS

code, and multiple NAICS codes may be

paired with the same IFC. Unit II.F.7.

provides further information on

reporting industrial processing and use

information.

The set of IFCs adopted by EPA at

§ 710.52(c)(4)(i)(C) encompasses the vast

majority of uses for chemicals subject to

IUR reporting. Rather than include all

possible industrial functions, EPA

selected categories based upon

information developed due to other

Agency programs such as the TSCA

New Chemicals Program and believes

that the categories included in this final

rule are sufficient for initial risk

screening purposes. One commenter

suggested that the submitter be allowed

to supply a "free response" for an

industrial function that is not on the

EPA list. However, a "free response

option" could result in a wide array of

answers, which EPA would then have to

group. The Agency believes the

chemical manufacturer is best equipped

to determine with which industrial

function scenario the industrial

processing and use data should be

matched. If none of the categories fit,

however, the submitter could report the

"other" category. By aggregating similar

uses under a single NAICS and a single

IFC code, EPA will be able to more

effectively characterize the risk

associated with the totality of the

production of each chemical substance.

By requiring the submitter to identify

the appropriate IFC code(s) from the

provided list, EPA seeks to minimize

the errors that could occur if the

Agency, rather than the submitter,

attempted to aggregate uses other than

those identified in the prescribed list of

IFCs.

3. Commercial and consumer use-a.

Commercial and consumer product

categories. In the proposed rule, the

Agency requested comment on the

appropriateness of the commercial and

consumer product categories.

Commenters had a range of opinions

about the proposed categories. One

commenter felt that EPA should adopt

the use categories used by the European

Commission (EC) (Ref. 28). Another

commenter stated that the categories

appeared to be adequate. A third

commenter suggested that the "C-19

Other" category be deleted and that the

Agency consider requiring the submitter

to identify the specific use.

EPA is not changing the commercial

and consumer product categories at this

time, although the Agency may revisit

these categories in the future should a

need arise for more specific commercial

and consumer use information. EPA has

evaluated the EC's set of use categories

and has determined that these categories

blend functional use information with

end use information. They therefore

constitute a more complex identification

system than the one that will be used

under IURA. For the screening level

purposes of IURA data, EPA currently

believes that focusing on end use

information alone for commercial and

consumer uses provides the necessary

level of detail for its screening level

reviews. EPA is concerned that the use

of EC's scheme for the commercial and

consumer reporting would be overly

burdensome for the current needs

identified by EPA, due to the greater

number of categories (55 EC categories

versus 19 IURA categories). Further

guidance on the relationship between

EC and IURA categories can be found in

the instruction manual for IURA (see

§ 710.59 of the regulatory text) (Ref. 9).

In addition, the EC system does not

appear to describe the commercial or

consumer end uses in a way that meets

the needs identified by EPA and

targeted by IURA. For example, a

chemical that is used as a propellant

would be listed under the category "aerosol propellants" using the EC

system. Such a listing would not

provide the Agency with the

information it needs about the type of

commercial/consumer product in which

the submitter uses the propellant (e.g.,

paint, a lubricant). For more information

on EPA's commercial and consumer

category analysis, see the document

"Inventory Update Rule (IUR) Technical

Support Document Selection of

Consumer and Commercial End-Use

Categories" (Ref. 29). EPA will provide

examples of the types of products that

fit into its commercial and consumer

product categories in the instruction

manual that will be made available to

all submitters (see § 710.59 of the

regulatory text).

EPA considered requiring submitters

to identify the specific use of the

product, rather than the use a

miscellaneous "Other" category.

However, the Agency prefers to require

submitters to choose from among the

commercial and consumer product

categories provided at

§ 710.52(c)(4)(ii)(A) of the regulatory

text in order to encourage manufacturers

to more carefully consider the listed

categories, as opposed to being allowed

to provide their own specific

description. In this manner, EPA can

more effectively assign chemicals to the

correct categories, and avoid guessing

the appropriate categories because the

Agency believes the chemical

manufacturer is best equipped to

determine with which commercial or

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consumer category their product use

best fits. By aggregating similar product

categories, EPA will more effectively

characterize the risk associated with the

totality of the use of each chemical

substance. Requiring the submitter to

identify the appropriate product

categories from the provided list will

minimize the errors that could occur if

the Agency, rather than the submitter,

attempted to aggregate uses other than

those identified in the prescribed list of

product categories.

b. Non-TSCA end uses. Three

commenters requested that EPA not

only continue to exempt chemicals that

are manufactured only for non-TSCA

purposes (such as pesticides, drugs,

cosmetics, etc.) from all IURA reporting,

but also exempt manufacturers of IURAreportable TSCA chemicals from the

requirement that non-TSCA

downstream uses be reported (such as

use of a TSCA chemical by a

downstream processor in making a

pesticide, etc.). These commenters

assert that EPA does not have authority

under TSCA to implement requirements

of this sort.

EPA agrees that substances that are

manufactured only for non-TSCA

purposes, as described in TSCA section

3(2)(B), are exempt from all TSCA

requirements and are not subject to

reporting under IURA. Therefore,

substances that are intended at the time

of manufacture to be used for non-TSCA

purposes (e.g., as a pesticide, as a drug)

do not have to be reported.

The Agency also agrees that

submitters under IURA will not be

required to report on the non-TSCA

downstream uses of the TSCA

chemicals that they manufacture. It is

important to note that EPA was able to

reach this conclusion without reaching

the issue of whether it has the authority

to require such reporting. Descriptions

of IFCs (see § 710.52(c)(4)(i)(C) of the

regulatory text) have been clarified to

reflect the fact that they only include

TSCA uses. For example, one of the

IFCs is called "Agricultural chemicals

(non-pesticidal)." The consumer and

commercial product categories (see

§ 710.52(c)(4)(ii)(A) of the regulatory

text) are also restricted to TSCA uses.

An example of one of these categories is

"Lawn and garden products (nonpesticidal)." This category includes

chemicals such as compressed gasses in

delivery systems for many pesticides

used indoors and outdoors, and other

intermediates, but does not include

pesticides. Additionally, many lawn

amendments such as fertilizers contain

chemicals that may be regulated under

TSCA, (e.g., surfactants).

c. Exempt reporting of use

information for chemicals in articles.

Two commenters believed that to the

extent a submitter's reportable chemical

is used in an article, the submitter

should be exempt from the reporting of

consumer and commercial end-use

information (i.e., § 710.32(c)(5) of the

proposed regulatory text). The

commenters stated that there is no

reason to believe that consumer

exposure will result from chemicals in

articles.

EPA does not agree that

manufacturers of chemicals that are

later incorporated into articles should

be exempt from the reporting of

consumer and commercial end-use

information. Certain exposures do result

from chemicals incorporated in articles.

For example, potential dermal and

inhalation exposures occur from

chemicals incorporated into products in

the category "fabrics, textiles and

apparel." Specific cases, such as

formaldehyde from pressed wood

products used in mobile homes or

chlorinated flame retardants used on

children's sleep wear, also demonstrate

that potentially harmful exposures can

occur from chemicals incorporated into

articles.

d. Usefulness of percent production

data and maximum concentration data.

A commenter felt that in the case of

consumer products in particular, it is

unclear whether the percent production

data and maximum concentration data

required under § 710.32(c)(5)(i)(B) and

(c)(5)(i)(C) of the proposed regulatory

text would add any material information

to the production volume information

already required under the existing IUR.

The commenter stated that the volumes

of chemicals they will report as having

been manufactured, and for which they

will report maximum concentration

information, are in the products the

commenter sells. Therefore, the Agency

will already have the needed production

volume and concentration information

and does not need to collect these

particular data elements for consumer

products.

Production volume and concentration

information reported at the

manufacturing site is typically different

information than percent production

volume and concentration in consumer

and commercial categories. Often

manufacturers will sell a chemical for

multiple uses, in a variety of products,

or the chemical will be used multiple

times before reaching the consumer/

commercial product. For instance, a

manufacturer may report that a

chemical is used in three different

commercial and consumer product

categories-20% of the manufactured

production volume is used in category

A, 35% in category B, and 45% in

category C. Additionally, while the

manufacturer sells the product at a

certain concentration (say 90%), a final

product may have a different

concentration. For instance, the final

product may contain only 5% of the

chemical. The resulting potential

exposure scenario associated with such

a product would be very different from

a scenario where the concentration in

the final product is 90%. The Agency,

therefore, is retaining the commercial

and consumer percent production

volume and maximum concentration

data elements.

4. General data elements commentsa. Workers who are "reasonably likely to

be exposed" to a reportable chemical.

EPA requested comment on alternative

definitions of "potentially exposed

worker" and "reasonably likely to be

exposed." Specifically, EPA requested

comment on whether OSHA definition

of "employee" in its hazard

communication standard (29 CFR

1910.1200(c)) is more appropriate for

use in IURA. 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. OSHA's hazard

communication standard also defines

"exposure" or "exposed" as the

exposure 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.

One commenter stated that OSHA's

definition of an employee is appropriate

to identify persons reasonably likely to

be exposed to chemical substances. This

commenter stated that the Agency

should broaden the definition of

exposure in IURA to include potential

(accidental or possible) exposures to

chemical substances which workers

may experience in the course of their

employment. This commenter also

stated that this is what worker exposure

entails in the real world and to exclude

some portion of those worker exposures,

as EPA proposed, is inappropriate. A

second commenter felt that persons who

could be exposed to a chemical

substance in foreseeable emergencies

should be included in EPA's new

definition for persons who are

reasonably likely to be exposed to a

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EPA has determined that the OSHA

definition of "employee" does not

provide a more appropriate standard

than the one proposed and finalized in

IURA. Whereas OSHA wanted to

provide all persons who could

foreseeably be exposed to a chemical

substance with knowledge of the

potential hazards of that chemical, EPA

is seeking to specifically identify those

persons routinely exposed to chemical

substances and for whom engineering

controls and personal protective

equipment are likely to provide the

greatest benefit. The definition adopted

by EPA for a person "reasonably likely

to be exposed" in this rule will target

those individuals who routinely have

the potential to be exposed to chemical

substances, and for whom chronic risks

are greatest. This definition provides

more useful and realistic information for

the risk screening purposes for which

EPA envisions IURA data will be used.

b. Personal protective equipment. EPA

requested comment on whether the

Agency should collect information on

the use of PPE during the manufacture

of chemicals reported under IURA.

Several commenters stated that EPA

should not collect PPE information for

the purposes of risk screening. After

reviewing these comments, EPA agrees

that collecting information on the

availability of PPE would not enhance

the initial risk screening process, and

has determined that this data element

should not be added to the IUR as part

of this rulemaking. Because EPA cannot

ensure that protective equipment will be

available to all employees and, if

available, will be used properly in a

well managed hygiene program, the

potential risk encountered in the

manufacture, processing, or use of a

chemical substance is initially assessed

by EPA in the absence of PPE

information. The IURA is designed

primarily to collect only screening level

information. Inclusion of PPE in risk

assessment would require collection

and integration of location-specific

information on physical conditions and

the PPE used, and would greatly

complicate the risk assessment. This

type of information is more likely to be

included in assessments more detailed

than the initial risk screening

assessment for which IURA information

will be used.

A commenter suggested that EPA use

PPE information as a way to submit

lower estimates for various IUR data

elements, such as the number of

workers. For the reasons provided in the

previous paragraph, EPA will not use

PPE information to lower the estimates

of workers reasonably likely to be

exposed. Because the reporting of PPE

information would not contribute to the

initial risk screening process and would

impose an additional burden on persons

reporting under IUR, EPA is not

including information on PPE in the

reporting requirements for this rule.

c. Metric system reporting. Under IUR,

data are currently reported using the

U.S. customary system of measurement

units (e.g., pounds and yards). EPA

requested comment on changing

reporting requirements to require metric

system reporting instead (e.g., kilograms

and meters). Two commenters suggested

that EPA convert to metric system units

or at least give submitters the option of

using either metric or U.S. customary

units. One commenter requested that

EPA continue to require the use of U.S.

customary units or give submitters the

option of reporting in either metric or

U.S. customary units. EPA has decided

to continue to require the use of the U.S.

customary system because at least in the

short term, this allows the IUR data base

to remain compatible with other Agency

data bases, especially TRI, which also

typically use the U.S. customary system.

EPA believes allowing for reporting

using either the U.S. customary or

metric systems of units would create

confusion and increase reporting and

administrative error. EPA may revisit

this issue in future IUR amendments.

C. Reporting Universe Comments

EPA received a variety of comments

concerning which chemicals and sites

should be subject to reporting and

recordkeeping requirements.

1. Chemical categories undergoing

changes in reporting status. In the IURA

proposal, EPA created exemptions from

reporting for several groups of

chemicals that would otherwise be IURreportable. The IUR currently contains

full reporting exemptions for inorganic

chemicals, polymers, microorganisms,

and naturally occurring chemicals. EPA

proposed to modify these exemptions

by: (1) Requiring partial reporting for

inorganic chemicals in lieu of the

existing full exemption; (2) creating a

partial reporting exemption for chemical

substances termed "petroleum process

streams" for purposes of reporting

under IURA; and, (3) creating a full

exemption for certain forms of natural

gas. EPA also requested comment on the

creation of additional exemptions, but

asked that commenters provide a clear

supporting rationale for creating such

exemptions.

a. Inorganic chemicals - Many

commenters submitted comments about

the removal of the full exemption for

inorganic chemicals.

EPA originally created the inorganic

chemical exemption because it believed

that the hazard potential of many

inorganics was "relatively wellestablished" (50 FR 9944, 9947, March

12, 1985) and that hazard information

alone was sufficient for prioritization

within inorganic chemical substance

risk assessments. 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. The Agency no

longer believes that chemical hazard

information alone provides a sufficient

basis for prioritization for these

purposes. As a result, the former basis

for this exemption is no longer

applicable.

i. Why does the Agency need basic

IUR information on inorganic chemical

substances? During interagency review

prior to proposal it was suggested that

EPA first collect the IUR information in

§§ 710.52(c)(1), (c)(2), (c)(3), and 710.58

of the regulatory text (Parts I and II of

the revised Form U) on inorganic

substances before collecting the

processing and use information in

§ 710.52(c)(4) of the regulatory text (Part

III of the revised Form U). It was

thought that partial reporting would

allow EPA to become generally familiar

with the production volumes of

inorganic chemicals, and would permit

manufacturers of these substances to

familiarize themselves with the most

basic IUR requirements before being

required to comply with the processing

and use data requirements. Many

commenters stated that EPA had not

demonstrated the practical utility of

collecting basic information on

inorganic substances. Other commenters

felt the Agency should collect these data

and that inorganic chemicals should not

have had an exemption under IUR.

EPA uses basic IUR information in a

wide variety of ways (as described in

Units II.C. and E.) and expects the basic

IUR information on inorganic chemicals

to be used in similar ways. For example,

EPA used IUR information in the HPV

Challenge Program (see http://

www.epa.gov/opptintr/chemrtk/

volchall.htm) to identify chemicals

produced in aggregate national volumes

of one million pounds or more. The

HPV Challenge Program has not been

able to include inorganic chemicals as

EPA did not have the necessary

production volume information on the

inorganic chemicals produced in or

imported into this country.

Additionally, the TSCA Interagency

Testing Committee (ITC) has

encountered difficulties in its attempts

to identify inorganic chemicals for

recommendations to EPA for testing or

other further evaluations due to the lack

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of even the most basic IUR data for these

chemicals (Ref. 30).

ii. Why is EPA phasing in reporting

for inorganic chemical substances? EPA

requested comment on completely

removing the inorganic chemicals

exemption, requiring reporting of all of

IURA information, including the

information described in § 710.52(c)(4)

of the regulatory text on inorganic

chemicals manufactured in volumes of

300,000 lbs. or more at a site. Some

commenters supported phased-in

reporting of this information, where

EPA would maintain a partial

exemption (i.e., requiring the reporting

of all of IURA information except the

information in § 710.52(c)(4)) for the

first submission period only and would

require full reporting in subsequent

submission periods. EPA agrees with

this approach because it provides new

submitters with an opportunity to

become familiar with basic IUR

reporting, allows EPA to become

familiar with the current inorganic

chemical industry, and provides basic

production information in the first

submission period. Requiring full

reporting for inorganic chemicals in

subsequent submission periods provides

EPA with the processing and use

exposure-related information needed to

continue efforts begun with the first

reporting year information.

EPA's primary use of both the basic

data collected during the first

submission period and the additional

exposure-related data collected during

subsequent submission periods will be

to identify priority TSCA chemicals for

more detailed information gathering,

risk assessment, and risk management

in order to develop targeted programs to

protect human health and the

environment. Screening chemical risks

generally requires a combination of both

hazard and exposure information. The

absence of exposure-related data for

inorganic chemicals, beyond even the

basic production data collected during

the first submission period under IURA,

would severely limit the usefulness of

IURA data for risk screening. See Unit

III.A.1. for further discussion of

additional uses of IURA exposurerelated data.

While some commenters supported

the phasing-in approach, other

commenters suggested that EPA review

the information collected on inorganic

chemicals under the partial exemption

and collect additional information on

these chemicals through a future

rulemaking. Commenters suggested a

variety of ways to collect this additional

information, including specifically

listing chemicals that would be subject

to future IUR collections or using PAIR.

However, EPA's experience with using

information from other sources or

collecting information using PAIR has

demonstrated that this approach is

insufficient, as discussed in Unit III.A.3.

iii. Why doesn't EPA use already

available information on inorganic

chemical substances? Commenters

stated that the inorganic chemicals data

that EPA needs to conduct screening

level risk assessments are already

available from a variety of sources,

including the USGS's annual reports on

mineral production, health assessment

documents prepared by the Agency for

Toxic Substances and Disease Registry,

studies by OSHA, the TRI compiled by

EPA, and literature published by trade

associations. EPA closely examined

these data sources, and concluded that,

while useful, these sources are

inadequate to meet the Agency's data

needs for inorganic chemicals.

Some of the suggested data sources

pertain to naturally occurring

substances which are exempted from

reporting by a provision in IUR that EPA

has not proposed to change, i.e., 40 CFR

710.26(a)(3), which is codified as

§ 710.46(a)(3) for IURA. Many of the

remaining data sources identified by

commenters pertain to metallic alloys or

studies of a single metal species and do

not include information on the

multiplicity of pigments, flocculating

agents, oxidants, photochromic salts,

flame retardants, catalysts, and other

inorganic compounds for which data are

sought through IURA. In some cases, the

data sources are one-time collections of

information and therefore would not

provide current information on the

inorganic chemical industries. Others,

although revised from time to time, do

not identify the chemicals with

sufficient specificity, do not identify the

manufacturing site or a technical

contact, and/or do not provide

information on the use of the inorganic

chemical. In sum, the data sources

identified by commenters and by EPA

are not sufficient to provide the

information sought through IURA. EPA

has consulted with USGS to investigate

whether the USGS annual survey of

approximately 80 minerals could be

amended to better serve as a source for

use and exposure data that could be

used in place of IURA for those minerals

(Ref. 31). EPA plans to identify and

initiate dialogues with other federal

agencies about collection activities that

have the potential for generating

additional federal paperwork burden

reductions, particularly related to the

IURA. The new exemption process

established in the final rule provides an

opportunity for EPA to consider

alternate sources of information for

individual chemicals. EPA is extremely

sensitive to the PRA's directive for

federal agencies to reduce unnecessary

burden, and will continue to

consistently strive to find areas in

which burden can be decreased to the

maximum extent practical, as well as

carefully evaluate new or revised

information collections to ensure that

the Agency's informational needs are

met with the minimal burden possible.

Although none of the identified

alternate sources appear to be sufficient

to replace IURA, EPA believes that an

alternate information source could

provide sufficient information for a

particular chemical. EPA is also willing

to work with other agencies to perhaps

resolve differences in the various

information collection activities in an

effort to reduce overall reporting burden

on industry.

Additional discussion of the

applicability of available data sources is

found in "Summary of EPA's Responses

to Public Comments Submitted in

Response to Proposed TSCA Inventory

Update Rule Amendments" (64 FR

46772) (Ref. 18) and in "Inorganic

Chemicals: Sources of Information

Suggested by Commenters to the

Proposed Inventory Update Rule

Amendments" (Ref. 32).

b. Partial exemption for petroleum

process streams. EPA proposed a partial

exemption from IURA reporting for

certain chemical substances that the

Agency is calling "petroleum process

streams" for purposes of IURA and

requested comment on duplication of

reporting under the information

collections conducted by DOE's Energy

Information Administration (EIA)

through EIA forms EIA 810, EIA 816,

and EIA 64A. 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.

Operators of domestic natural gas

processing plants must complete form

EIA 64A to provide an annual report of

the geographical location and geological

formation of natural gas liquids

production to DOE. In the IURA

proposal, EPA stated its intention to

work with DOE to identify potential

duplication and to further investigate

the potential usefulness of DOE's

information collections in fulfilling

EPA's statutory obligations under TSCA.

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One commenter stated that EPA could

use the DOE data along with other

supplemental information sources to

generate the type of petroleum process

stream information that IURA proposed

to collect. Several commenters also

stated that the proposed IURA reporting

would be duplicative of DOE reporting

for certain chemicals, particularly fuel

oil #2 and kerosene, and that EPA

should therefore fully exempt those

chemicals from reporting under IURA.

EPA has investigated the information

collection conducted by DOE through

EIA forms EIA 64A, EIA 810, and EIA

816, and has determined that chemical

substances are not sufficiently identified

for EPA's purposes in the DOE reports.

For example, many of the chemical

substances in the DOE reports are

identified by nomenclature other than

the CAS nomenclature used by EPA for

TSCA purposes, are identified in broad

categories, or are not identified by CAS

number. Many of the chemical names

used by DOE are either generic or

represent groups of chemicals. For

example, distillate fuel oil, reported on

EIA Form 810, may refer to several

chemicals on the TSCA Inventory, such

as fuel oil #2, fuel oil #4, or fuel oil #6.

This lack of specific identifier

information means that EPA and others

cannot distinguish which information

collected by DOE is attributable to

which chemical. More specific

identification is needed to attribute the

appropriate hazard and physical and

chemical properties to the petroleum

stream.

The DOE information also lacks

important exposure components and

identifiers that are necessary for

exposure and risk screening activities.

For example, the DOE information does

not contain the number of workers

reasonably likely to be exposed to a

chemical or the maximum concentration

of the chemical. In addition, it may be

difficult to discern from the DOE data if

a petroleum process stream is used as a

solvent in a consumer product or as a

combustible fuel. This is an important

distinction because the likelihood of

exposure to a petroleum process stream

depends on its use. These data are

needed elements that will fill a vital

data gap in chemical risk screening.

Several persons commented that there

is no need to collect exposure-related

data for petroleum process stream

manufacturing operations because

physical hazards existing at many sites

currently necessitate extensive safety

precautions that limit worker exposure.

Discussed in more detail in Unit II.F.i.b.

c. Exemption for certain forms of

natural gas. EPA proposed that six

natural gas substances be fully exempt

from reporting under IURA. In addition,

EPA requested comment on whether

reporting for the six substances should

be required in upcoming submission

periods and whether they were the

appropriate natural gas substances for

inclusion in the proposed exemption.

Commenters expressed support for

the full exemption of the six natural gas

streams listed in the proposed IURA.

These commenters also recommended

adding fuel oil #2, kerosene, methane,

ethane, propane, butane, pentane, and

hexane, and liquefied natural gas to the

full exemption list. The commenters

stated that an exemption is warranted

for these chemicals because: (1) DOE

already requires annual and monthly

reports for the chemicals which contain

the same information requested by EPA;

(2) the chemicals are similar in chemical

composition to the six chemicals EPA

proposed to exempt; (3) their chemical

structure and identity remain the same

throughout processing; (4) a similar

amount of data is available for these

chemicals as for the six chemicals EPA

proposed to exempt; and, (5) a similar

number of TSCA reports are filed for

these chemicals as for the six chemicals

EPA proposed to exempt.

EPA has retained the exemption for

certain forms of natural gas as proposed.

Adequate IUR information has been

collected on the six chemical substances

to fulfill EPA's and other IUR

information users' current needs. EPA

will take action to revoke this

exemption if circumstances warrant in

the future.

Liquefied natural gas, which is a form

of natural gas (CAS No. 8006-61-9), is

covered under the natural gas

exemption. EPA did not include ethane,

methane, propane, butane, other

paraffinic hydrocarbons, fuel oil #2, or

kerosene in the list of substances

included in the natural gas exemption

because they are not just isolated

components of natural gas but are also

chemical substances which can be

produced from other source materials,

chemical process streams, feedstocks, or

reactants. These alkanes have significant

uses in chemical manufacturing,

including the production of ammonia

and methanol from synthesis gas

derived from methane, thermal cracking

of ethane/propane mixtures to produce

ethylene, and vapor-phase oxidation of

n-butane to produce maleic anhydride.

At present, there is not a sufficient basis

to conclude that data on all significant

uses of these alkanes are adequate.

EPA did not rely on the data

contained in the DOE reports discussed

in Unit III.C.l.b. in its creation of the

new exemption for certain forms of

natural gas. While some useful

information for these chemicals is

included in the DOE reports, it is

insufficient for exposure or risk

screening (see Unit III.C.l.b.).

Downstream processing and use

exposure information collected through

IURA for these chemicals will not

duplicate information collected by DOE.

2. Exemption of additional groups of

chemicals from IURA reporting or from

the reporting of specific data elements.

EPA requested comment in the

proposed rule on the selection of

chemicals that might be exempted from

reporting under IURA and on specific

criteria to distinguish these chemicals

from those that remain subject to

reporting. EPA received many industry

comments in favor of creating a new

exemption for chemicals that may be

considered to be "low priority," but

commenters did not indicate standard

criteria for establishing such

exemptions. However, in response to

these comments and comments received

during interagency review, EPA created

a partial exemption (i.e., an exemption

from the reporting of information

required under regulatory text

§ 710.52(c)(4)) for certain chemicals for

which the collection of processing and

use information is currently of "low

interest." This new partial exemption is

intended to improve IURA's efficiency

and effectiveness. EPA has established a

process by which future changes to the

chemicals included in the partial

exemption can be made after careful

examination of the totality of

information available for the chemical

substance, including but not limited to

the considerations provided in

§ 710.46(b)(2) and discussed in Unit

II.Fl.d. This partial exemption also

provides additional benefits in reducing

the potential reporting burden of IURA

for certain manufacturers of these

chemicals. The inclusion of a chemical

substance under this partial exemption

does not address the potential risks of

a chemical. This partial exemption is

solely intended to provide a tool to

assist the Agency in better managing the

collection of processing and use

information under IURA. See Unit

II.F.i.d for a discussion of the

exemption and the process to add or

remove chemical substances from the

exemption.

In addition, commenters suggested

classes of chemicals for exemption. EPA

has determined that none of these

suggested exemptions can be

implemented at this time, as described

in the remainder of this section.

a. HPV chemicals. A number of

commenters stated that industry is

already providing EPA with sufficient

hazard data via the HPV Challenge

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Program (see http://www.epa.gov/

opptintr/chemrtk/volchall.htm), as well

as exposure data through other

voluntary programs (e.g., International

Council of Chemical Associations

(ICCA) data collections and UEIP).

Therefore, providing exposure-related

information on HPV chemicals via IURA

would be duplicative and unnecessary.

The Agency recognizes that a variety

of voluntary and regulatory efforts to

collect hazard data are underway, such

as the voluntary HPV Challenge

Program. However, the scope and

expected output from the HPV

Challenge Program differ markedly from

those anticipated under IURA. The HPV

Challenge Program centers on providing

basic hazard data for HPV chemicals,

most of which will also be IURAreportable chemicals. The IURA focus is

on gathering exposure-related

information for moderate and high

volume chemicals in a wide range of

industrial operations, involving

multiple sites and covering

manufacturing, processing, and use of

the chemical substances.

The Agency is unable to limit its

IURA information collection efforts to

HPV chemicals alone, for several

reasons. The Agency could not know

definitively which chemicals are HPV

substances in any particular IURA

reporting cycle as of that reporting year.

A chemical substance meets the criteria

for an HPV chemical by meeting a one

million pound national production

volume threshold, based upon the

aggregate production volume in the

nation (as reported to IUR). Production

volumes can vary significantly over a 4-

year reporting cycle, and it is not

uncommon for chemicals to rise above

or fall below the HPV threshold each

reporting cycle. For instance, EPA used

1990 IUR reporting to identify

approximately 2,800 HPV substances.

An additional 500 substances which

were not HPV chemicals in 1990 were

identified as being HPV via the 1994

IUR production volume data. The IURA

collection could be limited to the HPV

Challenge Program chemicals (i.e., the

baseline set of chemicals for the

program, consisting of chemicals that

were HPV according to 1990 IUR

information). However, that restricts

IURA's ability to supply screening level

exposure information to only those HPV

chemicals. This would severely limit

the usefulness of IURA over time, as the

universe of chemicals that were HPV in

1990 will not be the same universe of

chemicals that are HPV in future years,

and would compromise the Agency's

broader responsibility for risk screening.

b. Existing Chemicals Program "low

concern" chemicals. Commenters

recommended that the chemicals

previously determined by EPA to be of

low concern via the Existing Chemicals

Program be exempt from reporting

under IURA. However, commenters did

not provide sufficient criteria that

would clearly distinguish exempted

chemicals from others subject to IUR

reporting. EPA cannot create

exemptions without a clear basis or

justification. During the development of

these amendments, EPA considered

exempting chemicals previously

reviewed by the Existing Chemicals

Program, but was unable to develop

standard criteria for such an exemption

(See Ref. 33 and Unit IX.3. of the

proposal preamble, at 64 FR 46794).

Under the Existing Chemicals Program,

no standard criteria were used for

determining which chemicals were

lower priority, because in the course of

the program many different chemicals

involve unique risk assessment or risk

management issues. For example, many

chemicals were analyzed within a

specific use, and other uses were not

examined. As an alternative to this

approach, EPA developed a partial

exemption for chemicals which are

determined to be of low current interest

for purposes of IURA processing and

use information reporting, based on

considerations described in Unit

II.F.i.d., and identified an initial list of

chemicals currently covered by the

partial exemption (Ref. 5).

c. Organization for Economic

Cooperation and Development (OECD)

chemicals. Commenters recommended

that the chemicals for which EPA has a

minimum set of hazard and exposure

data, such as OECD's SIDS chemicals

that have completed the SIDS process,

be exempt from reporting under IURA.

Commenters also suggested that

chemicals in the International Council

of Chemical Association (ICCA)

screening level data collection programs

be included in this exemption.

EPA disagrees that data collection

efforts through the OECD and ICCA

programs provide sufficient exposure

information to replace IURA

information. Data collection efforts

under the auspices of OECD and ICCA

concentrate on the development of

hazard assessments and generally

provide only a small fraction of the

exposure-related data called for under

IURA. A goal of the ICCA Program is to

process chemical cases through OECD's

HPV SIDS Program, which develops

hazard information for the program

chemicals. As hazard data do not

change from year to year, the data

collection supports a one-time report.

The IURA will provide current

exposure-related information for risk

screenings and preliminary assessments.

Exposure information, as collected

under IURA, will vary from reporting

year to reporting year and therefore

needs to be collected on a continuing

basis. While the OECD HPV SIDS

Program does not specifically disallow

the collection of exposure information,

the program does leave such collection

to the discretion of the sponsor country

(Ref. 34). Exposure information

available via SIDS is therefore generally

not specific to U.S. uses and concerns.

d. Metals. Various commenters stated

that either metals as a group, or specific

metals such as zinc and copper, should

be granted special consideration for

IURA reporting. Several commenters

asserted that providing information on

maximum concentrations is

unnecessary for the metals, because they

will generally have close to 100%

concentrations when they leave the

manufacturing site or whenever they are

present in consumer or commercial

products. Further, commenters indicate

that the only exposure potential for

these substances in commercial or

consumer products will be dermal (not

via other routes such as inhalation or

ingestion). Additionally, a commenter

stated that workers "in proximity" to or

handling solid metal articles should not

be considered to be exposed for

reporting purposes, because the metal is

in a form in which neither inhalation

nor dermal exposure will occur. Other

commenters believed that any IUR

reporting on metals is unnecessary

because ample information on metals

production and exposure potentials is

already available from other sources,

such as the USGS, or because specific

metals, such as copper and zinc, are

beneficial to human health and

therefore should be of no exposure

concern. Metals present some unique issues

regarding exposure potential, and the

information that will be collected under

IURA on metals will do much to

improve EPA's and others' knowledge

about the uses and exposures associated

with these chemicals. Not all metalcontaining products are pure metal. For

example, metal powders used in fine

arts, metal pastes used in repairs, and

commercial metallic paints contain

varying percentages of metals. In

addition, although some metals in trace

quantities, such as chromium, are

essential nutrients to plants and/or

animals, in greater exposure

concentrations these same metals can be

harmful.

Because metals are ubiquitous and

can be present in a variety of physical

forms, different routes of exposure are

possible. Chronic exposure to solutions

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containing metals such as nickel may

result in contact dermatitis. Milling

metal parts containing antimony and

beryllium creates dusts which, if

inhaled, can result in acute chemical

pneumonitis. Inhalation of fumes

containing chromium resulted in an

elevated incidence of bronchial

carcinoma among workers in the U.S.

chromate industry before the source of

the exposure was recognized and

corrected. Exposure by ingestion is of

concern for metals that may enter water

sources following improper disposal of

used materials, for example. The use of

cadmium in batteries for portable

electronic devices, including computers,

is increasing; long-term exposure to

cadmium has a potential to cause

kidney, liver, bone, and blood damage.

EPA has exempted submitters that

would otherwise be subject to IUR

reporting from reporting with respect to

chemicals that are imported in the form

of an article (see 40 CFR 710.30(b) and

§ 710.50(b) of the regulatory text).

However, submitters that manufacture a

reportable chemical and incorporate it

into an article will continue to be

subject to reporting under the IURA.

The Agency reviewed a number of

sources that provide information about

metals production and characteristics,

including USGS data specifically noted

by commenters (Ref. 32). The

information, although useful for

depicting global mining and production

of the major commercial metals, is not

comparable to the national scale and

domestic exposures data that will be

provided under IURA. Further, because

metals are subject chemicals in many

EPA programs, including the Great

Lakes Binational Toxics Strategy; the

revised drinking water standards; the

revised emission standards for

secondary metal refinishers; and the

Waste Minimization National Plan,

current information about domestic

metals production and use will benefit

many EPA offices and programs.

As indicated previously, EPA will be

reconsidering individual chemicals for

applicability under the new partial

exemption, and plans to identify and

initiate dialogues with other federal

agencies about collection activities that

have the potential for generating

additional federal paperwork burden

reductions, particularly related to the

IURA.

e. Other chemical groups.

Commenters suggested EPA exempt a

variety of additional groups of

chemicals from either full or partial

IURA reporting. These groups included

fossil fuel combustion byproducts such

as coal combustion products; fertilizers;

substances encapsulated in a polymer

matrix; pesticides; and certain

chemicals outside the scope of TSCA

jurisdiction (such as drugs).

Commenters stated that exposures

associated with fossil fuel combustion

byproducts are already well known,

and, with information currently being

submitted to EPA and other federal

organizations such as DOE, well beyond

the amount needed for "basic

screening." Commenters argued that

reporting on these byproducts under

IURA would be duplicative (therefore

unnecessary) and overly burdensome,

especially because these chemicals are

considered "beneficially used in an

environmentally sound manner" by

EPA's Office of Solid Waste (OSW). A

parallel argument was made for

fertilizers, in that certain commenters

consider them to be well-characterized

and generally "safe." Similarly, a

commenter believed encapsulated

substances are of little concern, due to

low exposure potentials for the

encapsulated chemicals, as implied by

the Agency's treatment of such

substances under Significant New Use

Rules (SNURs); the commenter believed

that, when chemicals are secured within

a polymer matrix, the SNUR

requirements no longer apply.

Commenters also stated that pesticides

and other chemicals not subject to

TSCA should be fully exempt from

reporting.

Comments specific to these different

groups of chemicals are addressed

below.

i. Fossil fuel combustion byproducts.

Commenters stated that fossil fuel

combustion byproducts have been

sufficiently studied for beneficial reuse

to justify their full exemption from

IURA reporting. They asserted that

EPA's OSW had adequately reviewed

data on these substances to allow their

use as solid waste in situations where

exposures were possible, such as in the

case of soil amendments. The

commenters believe that EPA offices

such as OPPT and OSW must

coordinate their efforts related to fossil

fuel combustion byproducts prior to

undertaking any actions under TSCA,

and suggested that continued reporting

on these chemicals would be

particularly burdensome.

EPA disagrees with these comments.

Review of the recent OSW Report to

Congress on the subject of fossil fuel

combustion byproducts (Ref. 35)

indicates that these products can be

hazardous to human health and the

environment when mismanaged. These

products not only typically contain

heavy metals such as cadmium,

chromium, lead, and mercury, but

leachates from fuel combustion

byproducts can contain significant

concentrations of arsenic. Despite these

concerns, OSW has decided to exempt

these substances from regulation as

hazardous waste when they are

beneficially reused. While OSW was not

able to identify damage cases or

significant risks to human health or the

environment associated with these types

of beneficial uses based on available

data, OSW plans to assess new

information on risks as that information

becomes available. The IURA will be

instrumental in providing

manufacturing, processing, and use data

for fossil fuel combustion byproducts to

enable OSW to monitor the potential

risk associated with these chemical

substances. Additionally, as with any

chemical byproduct with a use, EPA in

general needs information to be able to

screen these chemicals for potential

concerns outside of the OSW purview.

Review of such contemporary data, as

shared between OPPT and OSW, will

allow EPA to make well-informed risk

management decisions by constructing

realistic screening level exposure

profiles for these substances. These

profiles could be adjusted as the

production dynamics change between

IURA reporting cycles. EPA believes the

importance of accurate exposure-related

data in formulating sound risk

management decisions for fossil fuel

combustion byproducts justifies the

associated reporting burden.

ii. Fertilizers. Fertilizers that qualify

for the inorganic exemption have not

been subject to IUR reporting in the

past. A number of commenters

emphasized that, in general, fertilizers

are chemicals whose risks have already

have been well-characterized.

According to the commenters, ample

recent hazard and exposure data from

studies conducted by EPA's OSW

indicate that fertilizers generally are of

low toxicity, and some constituents of

major fertilizer types are "safe" because

the exposure potentials are low. Further,

as the commenter pointed out, recent

SIDS program studies on urea, a

common fertilizer, described the

chemical to be "of low priority" for

further investigation, thereby implying

that the chemical poses little hazard to

human health and the environment, and

that adequate risk information is

available. Commenters stated that

because they believe the constituents

are not harmful to human health or the

environment, fertilizers should be

exempt from downstream use and

exposure reporting under IURA (i.e., a

partial exemption from IURA reporting).

Other commenters stated that fertilizers

should be granted a full exemption from

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IURA reporting, or that EPA should

exempt certain fertilizers by CAS

number. One commenter suggested that

20 substances be included in the

fertilizer list (see list provided in

Comment C4b-6 of the comment

summary document, Ref. 18).

EPA does not believe the suggested

IURA exemptions for fertilizers and

fertilizer constituents are warranted at

this time. The Agency does not agree

with industry comments citing a 1999

EPA OSW risk evaluation on "nonnutritive" components in fertilizers as

adequate justification for classifying

fertilizers as "safe," and therefore

eligible for exemption. The OSW report

addresses trace quantities of metal

contaminants in those fertilizers (i.e.,

the non-nutritive elements), not the

fertilizers themselves. A review of basic

hazard identification guides, such as the

Merck Index, the Condensed Chemical

Dictionary, and Dangerous Properties of

Industrial Materials, shows that

exposure to many fertilizers and

fertilizer materials, including those

cited in industry comments such as

anhydrous ammonia, potassium sulfate,

and urea, can cause both reversible and

irreversible adverse health effects

ranging from acute to chronic. The

availability of IURA exposure-related

data will allow for the risk screening of

chemicals used as fertilizers and

fertilizer constituents to extend beyond

environmental effects and aid the

screening of risks to workers,

consumers, and the general population.

The Agency therefore believes it is

appropriate to require reporting for

fertilizers under IURA.

iii. Encapsulated substances. A

commenter stated that the import

volumes of IUR reportable components

contained within compounded

imported polymers should be exempt

from IURA reporting. The commenter

indicated that volumes of these

encapsulated components are difficult

to determine. Such components include

antioxidants, colorants, lubricants, and

stabilizers that are commonly used

additives in polymer products. The

polymers are sometimes manufactured

by a foreign company and imported into

the United States. The commenter stated

that these additives, which are

encapsulated in a polymer matrix, are

typically present in the matrix at a few

weight percent. The commenter's

understanding was that when chemicals

are secured within a polymer matrix,

the SNUR requirements no longer apply,

thus their suggestion was for EPA to

treat such substances similarly under

IURA.

The SNUR requirements in 40 CFR

part 721 do not exempt substances

encapsulated in a polymer matrix.

Although chemicals incorporated into a

polymer matrix are not subject to

SNURs in certain limited circumstances,

for example, when an individual SNUR

specifically states that the SNUR

requirements do not apply to such

substances (see, e.g., 40 CFR

721.8160(a)), such chemicals are not

otherwise generally exempt from SNUR

requirements.

Although EPA appreciates the

difficulty in ascertaining quantitative

production information from

manufacturers outside direct U.S.

jurisdiction, exempting IUR reportable

components encapsulated in a polymer

matrix from IURA is not warranted. Not

all polymers are inviolable. Additives

such as colorants and lubricants, which

can be hazardous to human health or

the environment, can leach from the

polymer matrix, resulting in subsequent

exposures. Also, additives which are

inherently insoluble in the polymer may

migrate to the surface of the polymeric

material and be released over time from

the polymer. Under IURA, each nonexempted mixture component is

reportable if imported above the stated

thresholds. Reasonably ascertainable

information can be used to estimate

these import quantities.

iv. Pesticides. Some commenters

stated that the Agency should exempt

pesticide chemicals from reporting

under the IURA, and also should

exempt those substances outside the

scope of TSCA, including drugs and

cosmetics.

The original IUR did not require

reporting for chemicals manufactured

for non-TSCA purposes. Similarly, in

IURA, amounts of an otherwise IURreportable substance that are intended at

the time of manufacture to be used for

non-TSCA purposes (e.g., as a pesticide,

as a drug) do not have to be reported.

For example, if a company were to

manufacture 300,000 lbs. of an IURreportable substance, 170,000 lbs. of

which were intended at the time of

manufacture to be sold as a drug

precursor, and 130,000 lbs. of which

were intended at the time of

manufacture to be used for a TSCA

purpose, only 130,000 lbs. of the

substance would have to be reported

under IUR. The company would not

have to report the processing and use

information described in § 710.52(c)(4)

of the regulatory text for that chemical

at that plant site, since the company did

not manufacture a total of at least

300,000 lbs. of the chemical at the site

for TSCA purposes. Many substances,

such as the pesticide active ingredient

pentachlorophenol, are also used in

industrial and commercial applications

regulated under TSCA. In those cases,

the chemicals will continue to be

reportable under IURA.

v. Food additives. Commenters stated

that low hazard chemicals, such as food

additives, should be categorically

excluded from the new reporting

requirements. The commenter stated

that food use substances, for example,

are regulated by the Food and Drug

Administration (FDA) and must either

be generally recognized as safe (GRAS),

the subject of a prior sanction, or the

subject of a food additive regulation

promulgated by FDA.

According to FDA's Office of

Premarket Approval (OPA), food use

substances for FDA's purposes are those

that are added directly to food, and

could inadvertently contact and be

incorporated into food because of use in

packaging material or in food

processing. FDA does not evaluate

chemicals for environmental effects--

only for human health effects. The

chemicals subject to FDA rules are not

inherently low hazard in many cases.

For example, substances such as

plasticizers, lubricants, release agents,

acids (e.g., hydrochloric acid), boiler

water additives, and solvents (e.g.,

acetone and hexane) are included as

food use substances. Furthermore, even

direct (i.e., listed) GRAS chemicals can

be of concern when used at industrial

concentrations, such as sulfuric acid.

Thus, as is true with other chemical

substances, food additives can present a

risk to human health or the environment

depending on use and the resulting

exposure pathways. EPA does not

believe a categorical exemption for

chemicals that may be used as food

additives is warranted at this time.

Again, such chemicals are only

reportable under IURA to the extent that

they are intended at the time of

manufacture to be used for TSCA

purposes.

3. Thresholds. EPA requested

comment on the 300,000 lbs. threshold

for reporting industrial processing and

use, and consumer and commercial use

information (required under

§ 710.52(c)(4) of the regulatory text).

Commenters generally were supportive

of having a second, higher reporting

threshold for this exposure-related

information. However, one commenter

stated that the 300,000 lbs. threshold is

too low, and that it should be set at one

million pounds to coincide with the

HPV Challenge Program threshold.

EPA considered chemicals with

aggregate, nationwide U.S. production

and importation volumes of one million

pounds or more (based on 1990 IUR

data) for the HPV Challenge Program.

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certain chemical were reported for the

1990 IUR as being produced or imported

collectively, by manufacturers

throughout the United States, then that

chemical was identified as an HPV

chemical for purposes of the HPV

Challenge Program. The 300,000 lbs.

IURA threshold captures at least one

report for more than 95% of the HPV

chemicals reported to the 1990 IUR.

The production volume that defines

chemicals as HPV should not be

confused with the 300,000 lbs. per year

reporting threshold for processing and

use data reporting in IURA. The 300,000

lbs. threshold applies to the amount

manufactured at a single site and is not

an aggregate, industry-wide production

number. EPA is implementing the

300,000 lbs. per year reporting threshold

for individual IUR submitters because it

limits the increase in burden associated

with the new IURA processing and use

reporting requirements and it limits the

number of chemicals for which

exposure-related data will be reported to

approximately 4,000. This number is

consistent with the "several thousand

chemicals" suggested by GAO in its

1995 report "EPA Should Focus Its

Chemical Use Inventory on Suspected

Harmful Substances" (Ref. 36), and

ensures that exposure-related data will

be reported for almost all HPV

chemicals (defined by national aggregate

production). Increasing the 300,000 lbs.

threshold to one million lbs. would

drastically undermine the Agency's

collection of processing and use

exposure-related data. The higher

threshold would reduce the number of

chemicals for which this information is

submitted and eliminate processing and

use data reporting on many of the HPV

chemicals. The Agency would be left

with very little information with which

to conduct the needed screening- level

assessments and the resulting

prioritization would be less meaningful.

In the proposed IURA, EPA also

solicited comments on the possibility of

replacing the chemicals identified using

the 300,000 lbs. annual production

volume threshold (by site) with any of

five other groups of chemicals. Those

groups include: (1) A set of HPV

chemicals that submitters identify as

being produced nationwide in amounts

of one million lbs. or more; (2)

chemicals that are currently subject to

testing under TSCA section 4 (i.e., test

rules and enforceable consent

agreements (ECAs)); (3) chemicals

identified for voluntary testing; (4)

chemicals designated for testing by the

ITC; and (5) chemicals listed in the

Agency's Master Testing List (the

current edition is available at http://

www.epa.gov/opptintr/chemtest/

mtl.htm).

With respect to the possibility of

limiting the collection of processing and

use information to HPV chemicals

identified by submitters, the Agency

asked for comment on: (1) Whether

submitters would be able to determine

which chemicals have exceeded the

nationally aggregated HPV threshold in

a given submission period, especially

given how frequently chemical

production rises above and falls below

this threshold from IUR submission

period to submission period; (2) what

additional burdens such a

determination would place on

submitters; and (3) whether IURA data

would be less useful if processing and

use data reporting were limited to HPV

chemicals.

Many commenters favored use of the

set of HPV chemicals in lieu of the

proposed IURA reporting with the

300,000 lbs. threshold, yet none directly

responded to the specific Agency

questions. Commenters failed to take

into account the added burden of

aggregating chemical production to

determine which substances are HPV

chemicals. They also offered no

justification for substituting the 300,000

lbs. plant site-specific threshold with a

one million lbs. national aggregate

threshold, beyond stating that relevant

information is being provided already

through other programs. Nor did they

offer possible solutions to the problem

of reliably aggregating production

volumes.

EPA does not believe that submitters

will be able to effectively aggregate

nationwide production volumes.

Aggregation is especially difficult in

light of continual, market-driven

changes in production and many

submitters' interest in protecting

individual plant site production volume

information as CBI. Additionally, for a

nationally aggregated one million lbs.

threshold 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 one 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.

D. Definitions and Clarification

Requests

1. Is mining considered

manufacturing? Commenters asked

whether mining is considered

"manufacturing" under TSCA. Under

TSCA, the term "manufacture" includes

production or importation of a chemical

substance as well as its manufacture

(TSCA section 3(7)). Mining, which

includes extracting metal ores or

minerals from their natural deposits by

any means, including secondary

recovery of metal ore from reuse or

other storage piles, wastes, or rock

dumps, or from mill tailings derived

from the mining, cleaning, or

concentration of metal ores, is

production and is considered to be a

manufacturing activity under TSCA.

However, chemical substances which

are naturally occurring and which,

among other things, are unprocessed or

processed only by manual, mechanical,

or gravitational means (see 40 CFR

710.4(b)(1)) are currently excluded from

IUR reporting and will continue to be

excluded under IURA (see 40 CFR

710.46(a)(3)). For example, rocks, ores,

and minerals are not IURA-reportable to

the extent they are manufactured only

via the means described in 40 CFR

710.4(b). The § 710.46(a)(3) exclusion is

a process-specific exclusion rather than

a chemical- or industry-specific one.

Therefore, persons who manufacture a

substance in a manner other than as

specified in § 710.4(b) are required to

report under IURA unless they or the

substance they manufacture are

otherwise excluded. As a result, many

mined materials are listed on the TSCA

Inventory because at least some of the

time they are produced by other than

manual, mechanical, or gravitational

means.

Section 710.46(a)(3) intentionally

exempts from IURA reporting any

chemical substance which is isolated or

removed from nature, for a commercial

purpose, by any means listed in

§ 710.4(b). It also exempts any other

chemical substance derived or separated

from the substance originally removed

from nature, provided such derivation

involved only the means specified in

§ 710.4(b). For example, when using

manual, mechanical, or gravitational

processes to separate one or more

substances from a naturally-occurring

mixture, these isolated component

substances are also considered

naturally-occurring and excluded from

reporting. However, any substance

manufactured from a naturally

occurring precursor substance via a

chemical reaction is not considered

naturally occurring and, therefore, not

excluded from reporting under

§ 710.46(a)(3).

2. What is the difference between

"reasonably ascertainable" information

and "readily obtainable" information?

A number of commenters raised

concerns about the meaning of "readily

obtainable" and "reasonably

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ascertainable," what level of effort is

required for each, and the difference in

the level of effort required. Commenters

also stated that the expectation that

submitters will provide data on users

outside their control seems to be an

unworkable and unrealistic mandate.

The reporting standard of TSCA section

8(a)(2) is "reasonably ascertainable,"

and commenters stated that this should

not be construed to include data that are

not in the possession of the person

reporting.

"Known to or reasonably

ascertainable by" is the current standard

for data collection under which IUR

operates and is the standard authorized

by TSCA section 8(a). "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. The "known to or reasonably

ascertainable by" standard is applicable

to the information required under

§ 710.52(c)(1), (c)(2), and (c)(3) of the

regulatory text.

"Readily obtainable" is a lesser

standard EPA is applying to the

reporting of information concerning the

processing and use of chemicals subject

to IURA (§ 710.52(c)(4) of the regulatory

text). The readily obtainable standard is

limited to information known by

management and supervisory employees

of the submitter, and does not require

additional effort to collect information

on processing or use of chemicals by

others not under the control of the

submitter. Although the Agency is

requiring submitters to provide only

information that it knows, EPA believes

that in many cases submitters will

possess some knowledge concerning use

of chemicals sold by the submitter to

their customers, even though the

submitter does not control its

customers' sites. For example, when a

company markets the substances for

certain end uses. EPA's experience with

over 30,000 TSCA section 5 PMNs

demonstrates that companies generally

do know the intended ultimate use, as

well as intervening processing steps, of

their products. In choosing the readily

obtainable standard, the Agency is

lessening the burden on submitters

compared to the "known to or

reasonably ascertainable by" standard,

while recognizing that the submitter is

supplying data on uses of chemicals that

are beyond his or her control. The

standard for reporting information on

processing and use of chemical

substances under IURA is the same as

the standard adopted in the PAIR,

which was also promulgated under the

authority of TSCA section 8(a). (See 40

CFR 712.7)

E. Confidential Business Information

The Agency's intent under these

regulations is to achieve balance and

ensure that the submitter only claims as

confidential that information which is

legally entitled to confidential

treatment. EPA believes that these

amendments will discourage the

assertion of invalid CBI claims by

focusing submitter's attention more

closely on their decision to make certain

claims.

1. General CBI.-a. Reducing the

amount of CBI claims. EPA solicited

suggestions from commenters on what

could be done to the IUR reporting

process and data elements to reduce CBI

claims, thereby allowing better public

access to the data. Some commenters

suggested that EPA is trying to

discourage legitimate CBI claims by

making assertion of such claims overly

burdensome. Some commenters stated

that the new data elements that are

being added by these amendments raise

significant CBI concerns and that IURA

can be expected to result in a significant

increase in the number of legitimate CBI

claims.

EPA agrees that submitters will make

CBI claims for the new data elements

that are being added by these

amendments, most likely resulting in a

greater number of CBI claims overall.

However, EPA is requiring reporting for

most of the new data elements in ranges,

a reporting method EPA believes will

result in fewer CBI claims compared to

reporting discrete numbers.

Additionally, EPA is amending the IUR

to encourage the assertion of only

legally valid CBI claims, and to ensure

that CBI claims are well thought out by

the submitter. The IURA includes a new

requirement to provide upfront

substantiation of CBI claims for site

identity. This requirement will

minimize claims by prompting

submitters to perform an initial

evaluation of the need for and validity

of a CBI claim for plant site identity, an

essential data element. These efforts

will greatly assist in limiting CBI claims

to those that are legitimate.

EPA wishes to clarify that it is not

attempting to discourage legitimate

confidentiality claims; rather, the

Agency intends only to discourage

inappropriate claims. This allows the

Agency to protect legitimate CBI while

also increasing the amount of

information available for public use.

EPA has information indicating the

existence of inappropriate or no longer

valid CBI claims. For instance, when

EPA has selectively challenged CBI

claims in the past, many of these claims

have been amended by the companies to

make the information available to the

public. Additionally, OPPT's

administrative record 00125, which

contains state CBI data reviews,

published articles, industry letters, and

other papers discussing CBI issues,

provides further indication that

inappropriate or no longer valid CBI

claims exist. For instance, the Georgia

Department of Natural Resources

reported in a 1996 CBI Data Review that

IUR data identified as confidential was

available in other non-confidential data

bases (Ref. 37). The administrative

record is in the same location as the

Docket and is available by following the

procedures identified in Unit I.B.1.

Some commenters suggested reducing

the number of data elements that will be

collected under IURA, perhaps using

instead a format such as the one used by

OECD for SIDS chemicals, which

aggregates information for all

manufacturers and thus protects

company-specific information. EPA

considered alternate reporting formats

with different data elements, and has

determined that the reporting of sitespecific information by the individual

sites is the best way to collect the

information needed. EPA will continue

to perform the aggregating function

when providing the public with

information that is subject to a sitespecific CBI claim. Collecting only

national aggregate values would

drastically reduce the usefulness of the

information to the Agency, even though

it may reduce the number of CBI claims.

The IUR is used to address both national

needs and local issues. For example,

IUR production volume information was

used to identify the national list of High

Production Volume (HPV) chemicals for

the Agency's HPV Challenge Program

(see http://www.epa.gov/opptintr/

chemrtk/volchall.htm). Moreover, sitespecific IUR information is used to

secure a better overall understanding of

activities at individual sites. This

information is used for site-specific risk

assessments for the use of federal, state

and local entities.

b. Protection of CBL. Some

commenters expressed concern about

the Agency's ability to protect against

the inappropriate release of CBI and

stated that, under section 14 of TSCA,

EPA has a statutory obligation to protect

information properly claimed as CBI.

These commenters are concerned about

past releases of information claimed as

confidential, and would like to see the

Agency take steps to guarantee greater

protection of CBI data.

EPA agrees that it has a statutory

obligation to protect information

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properly claimed CBI and is continually

involved in exploring ways to better

protect such information. In this light,

these amendments reflect the Agency's

efforts to assure that information it

protects qualifies for that protection

under the established legal standards.

The new IURA requirements will help

assure that EPA's system of information

protection is limited to valid claims.

c. Production volume ranges. EPA

requested comment on the use of

production volume ranges as a

mechanism to reduce the number of

confidentiality claims by allowing

characterizations of site-specific

chemical and specific production

volume information without releasing

CBI. In general, commenters felt that the

use of the ranges would not necessarily

result in reduced CBI claims.

Commenters cited a few examples

where production volume would still be

claimed CBI, including information

reported in ranges. Other commenters

suggested using broader ranges.

Despite these comments, the Agency

has determined that it is worthwhile to

require submitters to consider whether

their production volumes, within ranges

similar to those used for the original

TSCA Inventory, warrant protection as

CBI (EPA made adjustments to the

original TSCA Inventory ranges by

making the ranges consistent with the

second reporting threshold of 300,000

lbs., as described in Unit II.F.5.d.). EPA

recognizes that some submitters will

make CBI claims for both the specific

and the ranged production volume

information. However, EPA believes

that in many cases submitters will allow

the release of ranged production volume

information. This belief is supported by

some industry organizations. For

example, in a 1993 letter, a company

suggested the use of the original

Inventory production volume ranges for

non-confidential reporting. While the

company did state that "conceivably, a

submitter could be able to justify a CBI

claim for a range," the conclusion was

that many companies would be satisfied

with non-confidential reporting (Ref.

11). These conclusions are further

supported by EPA's experience with the

original TSCA Inventory, where only

35% of production volume values

reported were claimed CBI, compared to

the typical claim level of 65% for

production volumes under IUR.

d. Disclosing customer confidential

information. A commenter expressed

concern that, as a producer of chemical

feedstocks, they might inadvertently

report customer data and not claim the

data as CBI, while their customer

reports the same data and does claim

the data as CBI.

EPA does not believe that this will be

a significant issue. The downstream

processing and use information that

some submitters will be required to

provide under IURA is not tied to

customer identities. Submitters will not

report where or who their customers are

or how much their individual customers

produce. In addition, CBI claims can be

made as necessary for any information

provided on Form U.

2. Upfront substantiation.-a.

Authority for substantiation. A

commenter stated that the plant site

identity substantiation requirement is

not authorized under TSCA. Another

commenter felt that requiring upfront

substantiation is overly burdensome and

an arbitrary exercise of authority. The

commenter stated that substantiation

should only be required if and when a

request for public disclosure is made,

and substantial and reasonable need are

demonstrated.

Under TSCA section 14(c), "a

[confidential] designation under this

paragraph shall be made in writing and

in such manner as the Administrator

may prescribe." EPA is continuing to

require that those reporting under IURA

substantiate their chemical identity CBI

claims, and is requiring under these

amendments that submitters also

substantiate any plant site identity CBI

claims. Section 710.58 of the regulatory

text requires submitters to substantiate

these claims submitted under IUR by

providing answers to specified

questions. EPA has long required

upfront substantiation for specified CBI

claims under the authority specified in

TSCA (see, e.g., 40 CFR 710.38(c) of the

current regulatory text) and will

continue to require upfront

substantiation where appropriate.

The Agency is adding upfront

substantiation requirements for plant

site identity information because EPA

has observed that, on occasion, plant

site information has been claimed as

confidential even though, for example,

it was revealed in filings required under

sections 311, 312, and 313 of the

Emergency Planning and Community

Right-to-Know Act (EPCRA), 42 U.S.C.

sections 11021 to 11023. EPA believes

that many of these CBI claims are

inappropriate and that the new

substantiation requirement will 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.

Upfront substantiation of CBI claims

imposes some additional burden,

although this burden is not substantial.

EPA's economic analysis for this rule

estimates 0.2 to 0.3 hour per plant site

reporting under IURA for the

incremental costs of reporting all

elements of plant site identity

information. The burden of upfront

substantiation for plant site identity CBI

claims is included in this estimate.

b. Alternate substantiation questions.

One commenter suggested a simplified

set of substantiation questions,

consisting of two questions: (1) Are the

specified data confidential? and, (2) In

as much detail as possible, explain why

this information should be given CBI

protection.

EPA believes that requiring responses

to the list of substantiation questions in

§ 710.58 of the regulatory text is

necessary to ensure that information

submitted for confidential protection

qualifies for that protection. The

commenter's proposed questions, while

providing the opportunity for a

submitter to express its business reasons

and preferences regarding the

information, do not provide all of the

necessary information to definitively

evaluate the eligibility of the

information for confidential treatment.

3. Reassertion. EPA received a

number of comments regarding the

proposed new CBI reassertion

provisions. All of these comments were

opposed to the proposed new

requirement. Some comments expressed

the position that reassertion is overly

burdensome and even punitive,

requiring submitters to retrace old steps

by answering all the original

substantiation questions anew.

Commenters were concerned that

reassertion could possibly require the

retention of voluminous old records.

Others felt the proposed standards

would violate the Agency's obligation

under TSCA to protect confidential

information and that EPA would exceed

its authority if it required the reassertion

of CBI claims.

EPA has considered these industry

comments, and weighed the concerns

expressed against the public's need for

access to information on chemicals in

commerce in the United States. While

the Agency believes the requirement to

reassert old claims of CBI is justified as

a practical measure to ensure that

information withheld meets the legal

criteria and that the expressions of

concern relating to burden associated

with reassertion, appear to be the result

of a misunderstanding of the practical

aspects of the proposed reassertion

requirement, the Agency is not

finalizing the proposed reassertion

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requirement. EPA has made this

decision in an effort to reduce the

overall burden of these amendments.

F. Administrative Comments

1. Frequency of reporting. Several

commenters stated that one-time

reporting of IURA information would be

more appropriate in most cases for the

intended purposes expressed by EPA. In

general, commenters stated that EPA

could use tools such as PAIR to identify

changes in a particular chemical's

exposure or use profile at the time the

Agency decides to do a risk analysis for

that chemical (see Unit III.A.3.). A few

commenters stated that there is

insufficient change in the chemical

industry to warrant recurring reporting

of IURA information, especially for

higher volume chemicals.

EPA's experience with past IUR

reporting demonstrates that the

chemical industry is dynamic, with a

30% change in the number of chemicals

reported from one submission period to

the next. The specific chemicals that are

reported or not reported in any single

submission period change at a variety of

production volumes; this change is by

no means limited to lower production

volume chemicals.

Although a chemical's hazards may be

fully characterized, EPA needs up-todate exposure information to stay

current with developments and

adequately screen chemicals for

possible risks to human health and the

environment. While the toxicity of a

chemical does not change (although

new information can modify the

assessment or identify new concerns), a

chemical's exposure profile can vary

greatly over time. Human and/or

environmental exposures to the

substance can at one time be minor, but

as uses change from industrial

applications to consumer uses, or as

production volumes increase, exposures

also tend to increase. Because exposures

and uses can and do change over time

as technologies develop or innovations

arise, updated exposure information is

needed to maintain an adequate

understanding of current exposures.

EPA did consider one-time reporting for

IURA processing and use data, but the

information would quickly become out

of date.

A primary goal of IURA is to provide

a data base of exposure-related

information which can be used for

screening level purposes to identify

chemicals for further assessment, as

well as chemicals of lesser concern (see

Unit III.A.1.). EPA intends to use other

data sources and collection tools, as

appropriate, once a chemical has been

identified as a candidate for further

assessment.

2. Calendar year reporting. One

commenter stated that the requirement

to report data on a calendar year basis

instead of a company fiscal year basis

would increase systems development

needs for companies who report their

manufacturing volume on a fiscal year

versus a calendar year (by creating the

need for a second tracking system),

while adding no additional value or

accuracy in the reporting of

manufacturing data. This commenter

pointed out that because the most that

companies' fiscal years can differ from

a calendar year is 6 months and IUR

reporting occurs every 4 years (instead

of every year), there can be little

difference in the data with a maximum

6-month time frame shift. Other

commenters supported the change to a

calendar year basis, supporting the idea

of having a consistent time frame to

better enable linkages with other data

bases.

EPA has retained the calendar year

reporting cycle as proposed. By moving

the collection to a calendar year basis,

the IURA data collection becomes more

compatible with other data bases such

as the TRI. This compatibility increases

the usefulness of the IURA collection by

allowing IURA data to be combined

with data from other collections.

Generally, companies should be

sufficiently familiar with their

production that this provision should

not present special challenges that are

unaccounted for in the burden estimates

provided by survey respondents, as

described in the economic analysis.

G. Economic Impact Estimates

Commenters raised a number of

concerns about the economic analysis.

In response, EPA has made a number of

changes to make the analysis a more

readable document and to incorporate

changes made to the final IURA

requirements.

1. General burden comments.

Commenters raised a variety of concerns

about the size of the burden associated

with the amendments, and EPA's

estimates of that burden. In general,

commenters felt that the Agency's

burden estimates were too low.

However, few commenters provided

evidence as to why they felt EPA

underestimated the burden, and none

provided any specific analytical basis

for amending the estimates. Some

commenters claimed that the revised

form represents a 5-, 10-, or 30-fold

increase in burden, at least partly based

upon the fact that the original Form U

was only 1 page and the sample revised

Form U provided in the proposed rule

was 3 pages.

In response to these comments, EPA

reviewed the burden analysis and,

although the estimated burden was

adjusted, determined that the comments

do not warrant modifications to the

Agency's general approach to the

analysis. EPA based much of the burden

analysis on a survey of 78 industry

respondents (Ref. 7). In addition, EPA

considered the burden associated with

such programs as the UEIP (described in

Unit III.A.1.), a voluntary project in

which EPA collected information

similar in some ways to IURA

information. UEIP respondents provided

estimates of the amount of time they

used to complete the survey forms (Ref.

7). However, EPA did reassess the

results of the burden survey and did

make some changes to the analysis. The

burden from the analysis associated

with the proposed rule was $36 to $51

million in the first year, and $27 million

to $41 million in future reporting years.

Changes in the rule and methodology

raised estimated costs of the final rule

to between $72 and $87 million in the

first reporting cycle, and $64 to $77

million in future reporting cycles. These

changes are primarily due to revising

the analysis from the survey data,

revising the analysis to remove the

reassertion burden, updating costs to

year 2000 dollars, and updating the

number of report submissions to

incorporate the 1998 IUR data

collection. These changes are discussed

further in "Revised Economic Analysis

for the Amended Inventory Update

Rule" (Ref. 7).

a. Burden over time. Commenters

raised concerns about specific burden

issues. Several commenters felt that

burden associated with IURA will not

decrease over time because of the 4-year

time lapse between submission periods.

Those commenters believe that the 4-

year period between submission periods

will result in changes to product lines

and personnel such that a complete

reintroduction to IUR reporting will be

necessary in each reporting cycle. EPA

disagrees, and expects rule

familiarization to require the most effort

in the first year of reporting. EPA

believes that there will be some

similarity in the information reported

from one submission period to the next,

especially for Parts I and II of the

revised Form U. Subsequent reporting

will be facilitated by the site's

maintenance of its previous submission

period's records.

b. Characterization of burden

reduction. Commenters asserted that the

economic analysis for the proposed rule

was misleading in its characterization of

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the actions that constitute burden

reduction and cost savings. Specifically,

commenters referred to EPA's claim of

a burden reduction and cost savings

associated with the 300,000 lbs.

threshold for reporting of Form U, Part

III information on industrial processing

and use, and consumer and commercial

use. EPA simply meant that providing a

partial exemption for chemicals below

the 300,000 lbs. threshold is a

concession to the burden that the rule

imposes on reporting sites, and that the

Agency has no other basis for this

exemption other than to mitigate the

increase in burden. EPA presented a

similar discussion comparing options

considered under the rule for other

partial reporting exemptions such as the

petroleum streams exemption. These

discussions are put into the appropriate

context in the economic analysis. A

commenter also took issue with the fact

that EPA asserts that reporting

processing and use information on the

top 10 NAICS codes will reduce costs

(versus reporting on an unlimited

number of NAICS codes), given that

identifying these top 10 could take

considerable effort. EPA continues to

believe that reporting only the top 10

NAICS codes will be less burdensome

than reporting all NAICS codes

associated with industrial processing or

use operations.

2. Cost comments. Two commenters

asserted that compliance costs for

chemicals manufactured in amounts

below the 25,000 lbs. threshold are not

zero and that, as production volume for

a chemical approaches the threshold,

tracking costs will accrue to determine

if production will cross the threshold.

Compliance determination (the act of

determining the need to comply with a

regulation) occurs on a per-site basis.

This means that all sites that report

under IURA are assumed to incur the

same average cost for determining

compliance, regardless of the number of

chemicals reported. Some small number

of firms that are not required to report

may incur some negligible costs in this

regard, but EPA believes the costs to be

relatively small given that it is standard

business practice for a company to be

aware of the volumes it produces. The

existence of voluntary submitters does

not imply that below-threshold

compliance costs are non-zero; it simply

indicates that some firms choose to

respond to IUR when reporting is not

required.

Another commenter determined that

member companies in its organization

would experience no savings from

raising the threshold from 10,000 lbs. to

25,000 lbs. as no reports are eliminated.

In 1994, EPA received approximately

3,800 reports for chemicals produced in

quantities between 10,000 and 25,000

lbs. As a result, the Agency anticipates

that a significant number of reports will

be eliminated by raising the reporting

threshold.

3. Benefits comments. Commenters

stated that EPA has overestimated the

benefits of this rule and should quantify

the benefits. However, given that IURA

is an information rule and its benefits

are therefore indirect, it is currently not

possible to quantify the benefits of the

rule. Only by collecting the information

required under the IURA can EPA begin

to assess thoroughly the risks from a

portion of the more than 76,000

chemicals in commerce. The actions

that result from EPA review of the IURA

data will have direct health and

environmental benefits, benefits that

typically can be quantified. Commenters

offered no alternate assessment,

quantitative or otherwise, of the benefits

from IURA. In the absence of quantified

benefit figures, it is impossible to make

simple comparisons to estimates of

reporting costs. Thus, EPA must balance

the needs of the Agency for data with

which to address important

environmental and health risks, with

the burdens of obtaining such data. In

doing so, the uses of and need for the

data are carefully addressed both within

the Agency, and during interagency

review. EPA has made every attempt to

collect only the information necessary

to meet Agency goals for obtaining

screening level exposure-related

information.

4. Small business impact comments.

Several commenters argued that EPA's

analysis of the impacts of IURA on

small businesses is insufficient to meet

the requirements of the Regulatory

Flexibility Act (RFA), as amended by

the Small Business Regulatory

Enforcement Fairness Act (SBREFA) of

1996. EPA's analysis of small business

impacts fully complies with the RFA, as

amended. For rules subject to the RFA,

the Agency is required to undertake

specific actions (such as preparing an

initial regulatory flexibility analysis and

convening a small business advocacy

review panel) unless it certifies that the

rule will not have a significant impact

on a substantial number of small

entities. EPA prepared a thorough small

entity analysis that meets the

requirements of the RFA. The analysis

for the final rule can be found in the

"Revised Economic Analysis for the

Amended Inventory Update Rule" (Ref.

7). For both the proposed and final

rules, EPA certified that there will not

be a significant impact on a substantial

number of small entities. A summary of

the analysis and the certification can be

found in Unit V.B.

5. Non-regulatory alternatives.

Commenters also stated that EPA did

not identify any non-regulatory

alternatives and failed to assess the

relative costs and benefits of an

alternative approach. In the economic

analysis for the proposed rule, the

Agency did not specifically identify

non-regulatory alternatives to the

reporting requirements. However, the

Agency did consider non-regulatory

alternatives and has added a discussion

to the economic analysis.

The Agency primarily considered two

non-regulatory alternatives. First, the

Agency considered using publicly

available information, as discussed in

Unit III.A.3. The Agency found that the

information to be collected through

IURA was not publicly available and

therefore this was not a viable option.

Second, the Agency considered a

voluntary approach to collecting this

information, similar to the UEIP

collection discussed in Unit III.A.1.

However, information collected through

a voluntary program may lack

consistency, may not be sufficiently

comprehensive, or may not occur on a

recurring basis, and therefore would not

fully serve the purposes of IURA

information. Therefore, a voluntary

approach was not a viable option.

IV. Materials in the Rulemaking Record

The public version of the official

record for this rulemaking has been

established as described in Unit I.B.1.

under docket ID number OPPT-2002-

0054. This record includes the

documents located in the docket as well

as the documents that are referenced in

those documents. The following is a

listing of the documents that are

specifically referenced in this final rule.

These documents, and the documents

referenced therein, are also included in

the public version of the official record.

Please note that some referenced

documents are already publicly

available and this list includes the

relevant location information.

1. U.S. EPA, "Reducing Risk: Setting

Priorities and Strategies for

Environmental Protection," Science

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

2. National Academy of Public

Administration, "Setting Priorities,

Getting Results - A New Direction for

EPA," 1995.

3. Chemical Manufacturers

Association, Synthetic Organic

Chemical Manufacturers Association,

U.S. EPA, Chemical Specialties

Manufacturing Association, American

Petroleum Institute, "Round 3 of the

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UEIP (Use and Exposure Information

Project)," June 3, 1996.

4. 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.

5. USEPA, "Methodology Used for the

Initial Selection of Chemicals for the

Inventory Update Rule Amendments

(IURA) 'Low Current Interest' Partial

Reporting Exemption," OPPT, July 24,

2002.

6. USEPA, "EPA Needs ExposureRelated Data: A Discussion of the

Justification for Collecting ExposureRelated Data Through the IUR

Amendments," OPPT/EETD/EPAB,

1998.

7. USEPA, "Economic Analysis for

the Amended Inventory Update Final

Rule," OPPT, August 2002.

8. USEPA, "Incremental Cost

Estimates for IURA: Interagency Review

Comparison and Five Year Reporting

Cycle," OPPT/EETD/EPAB, July 17,

2002.

9. USEPA, "Draft Instructions Manual

for the 2006 Inventory Update Rule

Reporting," OPPT, August 2002.

10. USEPA, "Inventory Update Rule

(IUR) Technical Support Document:

Evaluation of Likelihood of Confidential

Business Information Claims for

Production Volume Information,"

OPPT, August 26, 1996.

11. 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.

12. Letter from Stephen A. Newell,

Occupational Safety and Health

Administration, to Wardner G.

Penberthy, EPA, October 15, 1996.

13. Letter from Paul A. Schulte, Ph.D.,

National Institute for Occupational

Safety and Health, to Wardner G.

Penberthy, EPA, October 8, 1996.

14. USEPA, "Inventory Update Rule

(IUR) Amendment Technical Support

Document: Exposure-Related Data

Useful for Chemical Risk Screening,"

Volumes 1 and 2, OPPT, July 19, 1996.

15. U.S. Census Bureau, North

American Industrial Classification

System (NAICS), http://

www. census.gov/epcd/www/

naics.html, 1999.

16. USEPA, "Preliminary Assessment

Information Rule (PAIR) Database,

Manufacturing Process Type/Release

Analysis and Number of Workers/

Production Quantity Analysis," OPPT,

September 26, 1996.

17. Standard Consumer Safety

Inspection ASTM F963-96A (sec. 3.1-

3.3).

18. USEPA, "Summary of EPA's

Responses to Public Comments

Submitted in Response to Proposed

TSCA Inventory Update Rule

Amendments (64 FR 46772)," OPPT/

EETD, September 6, 2002.

19. USEPA, "IURA Data Use Plan,"

OPPT/EETD, August 23, 2002.

20. USEPA, "A 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. Also

available at www.epa.gov/sab/pdf/

eec95017.pdf.

21. Letter from Michael A. Babich,

U.S. Consumer Product Safety

Commission, to Wardner G. Penberthy,

EPA, June 24, 1996.

22. Letter from Robert Franklin, U.S.

Consumer Product Safety Commission,

to EPA, December 23, 1999.

23. Letter from Paul A. Schulte, Ph.D.,

National Institute for Occupational

Safety & Health, to EPA, December 21,

1999.

24. General Accounting Office, "Toxic

Chemicals: Long-Term Coordinated

Strategy Needed to Measure Exposures

in Humans," GAO/HEHS-00-80, May 2,

2000.

25. Letter from Linda Greer, Ph.D.,

Natural Resources Defense Council, to

Carol Browner, EPA, February 12, 1999.

26. USEPA, "Economic Analysis of

Proposed Amendments to the TSCA

Section 8 Inventory Update Rule,"

OPPT/EETD/EPAB, March 1, 1999.

27. USEPA, "A Review of Existing

Exposure-Related Data Sources and

Approaches to Screening Chemicals: A

Response to CMA," OPPT, March 1999.

28. European Commission,

"Technical Guidance Document in

Support of Commission Directive 93/67/

EEC on Risk Assessment for New

Notified Substances and Commission

Regulation (EC) No 1488/94 on Risk

Assessment for Existing Substances;

Part III."

29. USEPA, "'Inventory Update Rule

(IUR) Technical Support Document:

Selection of Consumer and Commercial

End-Use Categories," OPPT, 1996.

30. Letter from the TSCA Interagency

Testing Committee providing a response

to an Interagency proposed rule review

question, undated.

31. Letter from John DeYoung, Chief

Scientist, U.S. Geological Survey, to

Mary Ellen Weber, EPA, July 25, 2002.

32. USEPA, "Inorganic Chemicals:

Sources of Information Suggested by

Commenters to the Proposed Inventory

Update Rule Amendments," OPPT, June

2000.

33. Memorandum from Sandy

Zavolta, U.S. EPA, to Heidi King, Office

of Management and Budget, May 21,

1999.

34. OECD, "Guidance for Collection

and Transmission of Exposure

Information for SIDS Initial

Assessment," OECD SIDS Manual

(Third Revision), Section 2.5, July 1997,

available at http://www.epa.gov/

opptintr/sids/sidsman.htm.

35. USEPA, "Report to Congress:

Wastes from the Combustion of Fossil

Fuels (EPA Docket #F-2000-FF2FFFFFF) Public Comment Summary and

Response Document," OSW, April 25,

2000, available at http://www.epa.gov/

epaoswer/other/fossil/ffc-resp.pdf.

36. General Accounting Office, "EPA

Should Focus Its Chemical Use

Inventory on Suspected Harmful

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

1995.

37. Confidential Business Information

Data Review, Georgia Department of

Natural Resources, Docket entry 00125

B2a-010 filed June 19, 1996, page 4.

V. Statute and Executive Order Reviews

A. Executive Order 12866

Under Executive Order 12866,

entitled Regulatory Planning and

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

the Office of Management and Budget

(OMB) has determined that this is a "significant regulatory action" under

section 3(f) of the Executive Order,

because it raises "novel legal or policy

issues arising out of legal mandates"

relating to information collection. This

action was therefore submitted to OMB

for review under this Executive Order,

and any comments or changes made

during that review have been

documented in the public record.

In addition, EPA has prepared an

economic analysis of the potential

impacts of this action, which is

contained in a document entitled

Economic Analysis for the Amended

Inventory Update Rule (Ref. 7). The

Agency, in promulgating this rule, is

required under TSCA to consider the

potential costs and benefits associated

with IURA. The analysis was therefore

used by the decision-makers to help in

the selection of the final rule

requirements presented in this

document. This document is available

as a part of the public version of the

official record for this action and is

briefly summarized here.

EPA estimates that these amendments

will cost between $72 and $87 million

in the first reporting cycle, and $64 to

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$77 million in future reporting cycles,

resulting in an annualized cost of $17 to

$21 million over the next 20 years at a

3% discount rate, and $19 to $22

million at a 7% discount rate.

Under these amendments,

approximately 8,900 chemicals will be

subject to reporting, and the Agency

expects that it will receive

approximately 26,800 submissions

during the first submission period. In

the first submission period,

approximately 9,800 of those

submissions (providing information on

about 4,000 chemicals) will be full

reports which include information

found in Part III of revised reporting

Form U. The remainder will report only

company, site and chemical

identification and manufacturing

information (Parts I and II of revised

Form U). In future submission periods

with the addition of full reporting for

inorganic chemicals, EPA expects to

receive over 12,300 full forms, covering

4,600 chemicals. In order to keep the

reporting burden as low as possible,

EPA is requiring 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 of revised Form U be reported.

EPA analyzed the effects of a number

of different alternatives for the rule,

including variations in exemptions,

different thresholds for both partial-

(i.e., Parts I and II of revised Form U)

and full-form (i.e., all parts of revised

Form U) reporting, and various

frequencies of collection. These options

are explored further in the Economic

Analysis (Ref. 6).

EPA considered continuing the

existing full exemption from IUR

reporting for inorganic chemicals and

adding a full exemption for site-limited

petroleum streams. EPA examined the

effects of keeping the partial-form

threshold at 10,000 lbs. and considered

full-form thresholds of 100,000,

300,000, 500,000, and one million lbs.,

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, and

a 2-year cycle.

EPA believes that this final rule

represents an appropriate balance

between the burden placed on industry

to provide information and the Agency's

need for that information to fill its

statutory obligations and fulfill its

mission under TSCA and, as part of that

mission, to provide information needed

by other agencies (OSHA, NIOSH,

CPSC, etc.).

The costs of these amendments will

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 that would

potentially be filed by industry. EPA has

provided a second threshold for

reporting use information required in

Part III of revised Form U, reducing the

per report burden for submitters.

Recognizing that this information will

be used for screening level purposes,

EPA has reduced the specificity of the

information that will be required in

three ways: (1) By requiring the

reporting of only readily obtainable

information for the processing and use

exposure-related data; (2) by requiring

that submitters report much of the

information in ranges, reducing the

need to generate specific estimates; and,

(3) by requiring processing and use

exposure-related information on only

the top 10 uses/NAICS codes/IFCs, 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.

EPA assumes that the burden

associated with reporting under IURA

will decrease over time as industry's

familiarity with the reporting rule

increases and to the extent that the

information being reported remains

somewhat constant from one

submission period to the next. Projected

costs to EPA are relatively small and are

estimated to be $576,000 in the first

reporting year, and $270,000 in

subsequent reporting years.

Substantial changes in the economic

analysis have occurred since the

economic analysis produced for the

proposed rule, which is summarized in

Unit XI. of the proposed rule (at 64 FR

46799). The economic analysis was

revised primarily due to changes in the

final rule and changes to the cost

methodology that more fully reflect

potential industry burden. The revised

economic analysis in support of this

final rule can be found in the public

version of the official record for this

rulemaking (Ref. 6).

Changes made since the proposal due

to public comments or interagency

review include deleting the average

concentration data element, phasing-in

full reporting for inorganic chemicals,

adding a partial exemption for specific

chemical substances for which the

Agency has determined that the IURA

processing and use information is of low

current interest, and deleting the

proposed CBI reassertion requirement.

Changes made to the cost methodology

include increasing burden estimates for

reporting processing and use data. The

increase in burden estimate was

initiated in response to industry

comment, and stemmed from

differences in the survey instrument

used to estimate costs of IURA in 1996,

and the sample Form U in 1999.

Estimates for reporting processing and

use data were revised upward after

reviewing public comments and the

survey data. Differences between the

survey instrument and the proposed

Form U required EPA to aggregate

certain responses. After reading the

comments, EPA is using more

conservative assumptions in this

process. Therefore, it is more likely that

EPA cost estimates overestimate, rather

than underestimate, actual costs.

B. Paperwork Reduction Act

The OMB has approved the

information collection requirements

contained in this rule under the

provisions of the Paperwork Reduction

Act (PRA), 44 U.S.C. 3501 et seq., and

has assigned OMB control number

2070-0162. In accordance with the

procedures at 5 CFR 1320.11, EPA

submitted an Information Collection

Request (ICR) document to OMB in 1999

(identified as EPA ICR No. 1884.02),

which is also included in the public

docket that is described in Unit I.B.1.

The information that will be reported

under IURA will better enable EPA to

screen thousands of chemical

substances for potential risk. Risk

screening is necessary in order to

conserve limited Agency and industry

resources by focusing risk assessment

work on chemical substances for which

some level of potential risk has been

indicated. The new information that

will be reported under this rule is

critical to the risk screening process and

is unavailable through other sources.

Responses to this collection of

information will be mandatory,

pursuant to TSCA section 8(a), 15 U.S.C.

2607(a). The regulations codifying the

reporting requirements appear at 40 CFR

part 710. CBI claims may be made for

all or part of the information that will

be reported under IURA. This action

includes new substantiation procedures

for CBI claims regarding plant site

identity (See § 710.58(d) in the

regulatory text).

As a result of IURA, reporting sites

will submit either a full report for a

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chemical (which includes site

identification, manufacturing

information and processing and use

data) or a partial report (which does not

include processing and use data). For

the first reporting cycle, inorganic

chemical manufacturers will only

submit partial reports while organic

chemical manufacturers will submit a

mix of partial and full reports. The

IURA increases the average reporting

burden for both partial and full reports

compared to previous IUR reporting.

Companies will continue to report

under IURA once every 4 years, so the

average annual IURA reporting burden

and cost is calculated in the ICR as one

quarter of the burden and cost in a

reporting cycle. Thus, the results in the

ICR differ slightly from those in the

economic analysis prepared under

Executive Order 12866, which

calculates the annualized cost of

multiple reporting cycles over a 20-year

period. In addition, the economic

analysis calculates the incremental

increase in burden due to IURA, while

the ICR calculates the total reporting

and recordkeeping burden for IURA

(i.e., the sum of the incremental IURA

burden and the baseline IUR burden).

Companies may continue to report for

multiple chemicals on a single Form U

(as revised). Companies generally

submit one Form U per site, so the

burden per Form U is approximately

equivalent to the burden per site.

For the first reporting cycle, the

annual average burden for organic

chemical manufacturers is estimated to

be 121.5 to 152.4 hours per site at a cost

of $8,313 to $10,448 (reflecting an

average of 5.1 partial reports and 3.8 full

reports per site). For inorganic chemical

manufacturers, the annual average

burden is estimated at 43.3 to 66.1 hours

per site at a cost of $2,936 to $4,547

(reflecting an average of 8.3 reports per

site). These estimates include the time

needed to review instructions; search

data sources; gather and maintain the

data needed; complete and review the

collection of information; and transmit

or otherwise disclose the information.

The actual burden on any specific site

may be different from this estimate

depending on the complexity of the site,

the number of IURA reportable

chemicals at the site, and the profile of

the site's operations. There will be

approximately 2,500 submitters for

organic chemicals (including petroleum

process streams), and 500 submitters for

inorganic chemicals. For the first

reporting cycle, the total annual burden

is estimated to be approximately

325,000 to 414,000 hours at a total

estimated industry cost of $22.2 to $28.4

million per year.

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.

As part of the PRA approval renewal

process, which occurs every 3 years and

includes an opportunity for public

review and comment prior to OMB

review, EPA intends to evaluate this

collection activity, particularly the new

exemption process, in order to

demonstrate the practical utility of

IURA information collection activities.

The Agency will provide information in

the ICR renewal document that details

the chemicals evaluated under the

exemption process, the exemption

requests received, and the Agency's

decisions made, as well as provide

information about the process elements

and experiences.

An Agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

unless it displays a currently valid OMB

control number. The currently approved

ICR control numbers issued by OMB for

various EPA regulations are listed in 40

CFR part 9 and 48 CFR chapter 15. EPA

is amending the table in 40 CFR part 9

to list the OMB approval number for the

information collection requirements

contained in this final rule. This listing

of the OMB control numbers and their

subsequent codification in the CFR

satisfies the display requirements of the

PRA and OMB's implementing

regulations at 5 CFR part 1320. This ICR

was previously subject to public notice

and comment prior to OMB approval.

Due to the technical nature of the table,

EPA finds that further notice and

comment is unnecessary. As a result,

EPA finds that there is "good cause"

under section 553(b)(B) of the

Administrative Procedure Act, 5 U.S.C.

553(b)(B), to amend this table without

further notice and comment.

C. Regulatory Flexibility Act

Pursuant to section 605(b) of the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.), the Agency hereby certifies that

this final rule will not have a significant

economic impact on a substantial

number of small entities. The factual

basis for the Agency's determination is

presented in the small entity impact

analysis prepared as part of the

economic analysis for this rule (Ref. 6),

and is briefly summarized here.

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 rule, "small entity" for

purposes of this final 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 Small Business

Administration (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 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 in § 710.49 and was not

reopened for comment. In general, EPA

strives to minimize potential adverse

impacts on small entities when

developing regulations to achieve the

environmental and human health

protection goals of the statute and the

Agency.

Despite the fact that small

manufacturers that fully meet the 40

CFR 704.3 definition are generally

exempt from reporting under IUR, and

thus are not significantly impacted by

IURA, 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.

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For small manufacturers of organic

chemicals subject to reporting, the

Agency estimates the impact to be

0.15% to 0.18% of sales. For small

manufacturers of inorganic chemicals

subject to reporting, the Agency

estimates the impact to be 0.07% to

0.20% of sales.

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 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 action are described

in Unit V.A. In addition, EPA has

determined that this rule does not

significantly or uniquely affect small

governments. Accordingly, this rule is

not subject to the requirements of

sections 202, 203, 204, and 205 of

UMRA.

E. Executive Order 13132

Executive Order 13132, entitled

Federalism (64 FR 43255, August 10,

1999), requires EPA to develop an

accountable process to ensure "meaningful and timely input by State

and local officials in the development of

regulatory policies that have federalism

implications." "Policies that have

federalism implications" is defined in

the Executive Order to include

regulations that have "substantial direct

effects on the States, on the relationship

between the national government and

the States, or on the distribution of

power and responsibilities among the

various levels of government."

This final rule does not have

federalism implications, because it will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government, as specified in

Executive Order 13132. Thus, Executive

Order 13132 does not apply to this rule.

F. Executive Orders 13084 and 13175

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 communities, unless the Federal

government provides the funds

necessary to pay the direct compliance

costs incurred by the tribal

governments, or EPA consults with

those governments.

If EPA complies by consulting,

Executive Order 13084 requires EPA to

provide to 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."

This rule does not significantly or

uniquely affect the communities of

Indian tribal governments, nor does it

impose substantial direct compliance

costs on such communities.

Accordingly, the requirements of

section 3(b) of Executive Order 13084

do not apply to this rule.

On November 6, 2000, the President

issued Executive Order 13175, entitled

Consultation and Coordination with

Indian Tribal Governments (65 FR

67249). Executive Order 13175 took

effect on January 6, 2001, and revokes

Executive Order 13084 as of that date.

EPA developed this rule, however,

during the period when Executive Order

13084 was in effect; thus, EPA

addressed tribal considerations under

Executive Order 13084.

G. Executive Order 13211

This rule is not a "significant energy

action" as defined in Executive Order

13211, Actions Concerning Regulations

That Significantly Affect Energy Supply,

Distribution, or Use (66 FR 28355, May

22, 2001) because it is not likely to have

a significant adverse effect on the

supply, distribution, or use of energy.

This final rule modifies the existing IUR

reporting and recordkeeping

requirements that apply to chemical

manufacturers and importers. As such,

we have concluded that this rule is not

likely to have adverse energy effects.

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 rule

will provide the Agency with

information needed to screen and

prioritize chemical substances,

including information on potential

exposures to children. 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.

L National Technology Transfer and

Amendment Act

This 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, 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, and

business practices) 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.

J. Executive Order 12898

Pursuant to Executive Order 12898,

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), the Agency has considered

environmental justice-related issues

with regard to the potential impacts of

this action on the environmental and

health conditions in minority and lowincome populations. The Agency

believes that the information collected

under this rule will assist EPA and

others in determining the risks and

exposures associated with the chemicals

covered by the rule. Although not

directly impacting environmental

justice-related concerns, this

information will enable the Agency to

protect human health and the

environment by being better able to

prioritize chemical substances of

concern.

K. Executive Order 12630

EPA has complied with Executive

Order 12630, entitled Governmental

Actions and Interference with

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Constitutionally Protected Property

Rights (53 FR 8859, March 15, 1988), by

examining the takings implications of

this rule in accordance with the

"Attorney General's Supplemental

Guidelines for the Evaluation of Risk

and Avoidance of Unanticipated

Takings" issued under the Executive

Order.

L. Executive Order 12988

In issuing this rule, EPA has taken the

necessary steps to eliminate drafting

errors and ambiguity, minimize

potential litigation, and provide a clear

legal standard for affected conduct, as

required by section 3 of Executive Order

12988, titled Civil justice Reform (61 FR

4729, February 7, 1996).

VI. Submission to Congress and the

Comptroller General

The Congressional Review Act, 5

U.S.C. 801 et seq., as added by the Small

Business Regulatory Enforcement

Fairness Act of 1996, generally provides

that before a rule may take effect, the

Agency promulgating the rule must

submit a rule report, which includes a

copy of the rule, to each House of the

Congress and the Comptroller General of

the United States. EPA will submit a

report containing this rule and other

required information to the U.S. Senate,

the U.S. House of Representatives and

the Comptroller General of the United

States prior to publication of the rule in

the Federal Register. This rule is not a "major rule" as defined by 5 U.S.C.

804(2).

List of Subjects in 40 CFR Part 9

Environmental protection, Reporting

and recordkeeping requirements.

List of Subjects in 40 CFR Part 710

Environmental protection, Chemicals,

Hazardous materials, Reporting and

recordkeeping requirements.

List of Subjects in 40 CFR Part 723

Environmental protection, Chemicals,

Hazardous materials, Reporting and

recordkeeping requirements.

Dated: December 18, 2002.

Stephen L. Johnson,

Assistant A dministrator for Prevention,

Pesticides and Toxic Substances.

Therefore, 40 CFR chapter I is

amended as follows:

1. Part 9 is amended as follows:

PART 9-[AMENDED]

a. The authority citation for part 9

continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y;

15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671,

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,

1321, 1326, 1330, 1342, 1344, 1345 (d) and

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,

1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b,

243, 246, 300f, 300g, 300g-1, 300g-2, 300g-3,

300g-4, 300g-5, 300g-6, 300j-1, 300j-2, 300j-3,

300j-4, 300j-9, 1857 et seq., 6901-6992k,

7401-7671q, 7542, 9601-9657, 11023, 11048.

b. In § 9.1, the table is amended by

revising the heading "Inventory

Reporting Regulations" to read "TSCA

Chemical Inventory Regulations";

removing the existing entry under the

heading; and adding the following

entries to read as follows:

§9.1 OMB approvals under the Paperwork

Reduction Act.

* * * * * *

40 CFR citation OMB Control No.

TSCA Chemical Inventory Regulations

Part 710, Sub- 2070-0070

part B.

Part 710, Sub- 2070-0162

part C.

* * * * * *

2. Part 710 is amended as follows:

PART 710-[AMENDED]

a. The authority citation for part 710

continues to read as follows:

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

b. Revise the part heading and table

of contents for part 710 to read as

follows:

PART 710-TSCA CHEMICAL

INVENTORY REGULATIONS

Subpart A-General Provisions

Sec.

710.1 Scope and compliance.

710.3 Definitions.

710.4 Scope of the inventory.

Subpart B-2002 Inventory Update

Reporting

710.23 Definitions.

710.25 Chemical substances for which

information must be reported.

710.26 Chemical substances for which

information is not required.

710.28 Persons who must report.

710.29 Persons not subject to this

subpart.

710.30 Activities for which reporting

is not required.

710.32 Reporting information to EPA.

710.33 When to report.

710.35 Duplicative reporting.

710.37 Recordkeeping requirements.

710.38 Confidentiality.

710.39 How do I submit the required

information?

Subpart C-Inventory Update

Reporting for 2006 and Beyond

710.43 Definitions.

710.45 Chemical substances for which

information must be reported.

710.46 Chemical substances for which

information is not required.

710.48 Persons who must report.

710.49 Persons not subject to this

subpart.

710.50 Activities for which reporting

is not required.

710.52 Reporting information to EPA.

710.53 When to report.

710.55 Duplicative reporting.

710.57 Recordkeeping requirements.

710.58 Confidentiality.

710.59 Availability of reporting form

and instructions.

c. Sections 710.1 through 710.4 are

designated as subpart A and the subpart

heading is added to read as follows:

Subpart A-General Provisions

d. Revise § 710.1 to read as follows:

§710.1 Scope and compliance.

(a) This part establishes regulations

governing reporting and recordkeeping

by certain persons who manufacture,

import, or process chemical substances

for commercial purposes under section

8(a) of the Toxic Substances Control Act

(15 U.S.C. 2607(a)) (TSCA). Section 8(a)

authorizes the Administrator to require

reporting of information necessary for

administration of the Act and requires

EPA to issue regulations for the purpose

of compiling and keeping current an

inventory of chemical substances

manufactured or processed for a

commercial purpose, as required by

section 8(b) of the Act. Following an

initial reporting period, EPA published

an initial inventory of chemical

substances manufactured, processed, or

imported for commercial purposes. In

accordance with section 8(b), EPA

periodically amends the inventory to

include new chemical substances which

are manufactured or imported for a

commercial purpose and reported under

section 5(a)(1) of the Act. EPA also

revises the categories of chemical

substances and makes other

amendments as appropriate.

(b) The regulations in this part apply

to the activities associated with the

compilation of the TSCA Chemical

Inventory and the update of information

on a subset of the chemical substances

included on the Inventory. The

Inventory Update regulations were

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amended in 2002; however, these

amendments apply to updates after

2002, not to the 2002 update. In order

to prevent confusion as to which

regulations apply to which update, EPA

has preserved the provisions that apply

to the 2002 update in subpart B. The

new and revised requirements that

apply to updates after 2002 appear in

subpart C. Prior to January 1, 2003, the

regulations in subpart B of this part are

effective for purposes of Inventory

update activities. As of January 1, 2003,

subpart C is effective for purposes of

Inventory update activities. The Agency

intends to remove subpart B from the

CFR once the 2002 update is complete.

(c) Section 15(3) of TSCA makes it

unlawful for any person to fail or refuse

to submit information required under

these reporting regulations. In addition,

section 15(3) makes it unlawful for any

person to fail to keep, and permit access

to, records required by these

regulations. Section 16 provides that

any person who violates a provision of

section 15 is liable to the United States

for a civil penalty and may be

criminally prosecuted. Pursuant to

section 17, the Government may seek

judicial relief to compel submission of

section 8(a) information and to

otherwise restrain any violation of

section 15. (EPA does not intend to

concentrate its enforcement efforts on

insignificant clerical errors in

reporting.)

(d) Each person who reports under

these regulations must maintain records

that document information reported

under these regulations and, in

accordance with the Act, permit access

to, and the copying of, such records by

EPA officials.

§710.2 [Removed]

e. Remove § 710.2.

f. Add § 710.3 to subpart A to read as

follows:

§710.3 Definitions.

In addition to the definitions in

§ 704.3 of this chapter, the following

definitions apply to this part:

(a) The following terms will 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 will 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 will 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/her authority to carry

out his/her functions, or any other

person who will 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

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.

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/

her behalf (as defined in 19 CFR 1.11).

Impurity means a chemical substance

which is unintentionally present with

another chemical substance.

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.

Manufacture means to manufacture,

produce, or import for commercial

purposes.

Manufacture or import "for

commercial purposes" means to

manufacture, produce, or import with

the purpose of obtaining an immediate

or eventual commercial advantage, and

includes, for example, the manufacture

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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.

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 section 8(b) of the Act.

Person means any natural or juridical

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.

Site means a contiguous property

unit. Property divided only by a public

right-of-way will 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 will be the business

address of the importer.

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 lbs. (454 kg)

annually will 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/her supervision,

(2) Who is responsible for enforcing

appropriate 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 paragraph 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.

§ 710.4 [Amended]

g. Section 710.4 is amended as

follows:

i. In paragraphs (a), (c)(1), (c)(2),

(c)(3), and the Note at the end of

paragraph (d)(8), change the references

to "§ 710.2", "§ 710.2(h)", "§ 710.2(q)",

"§ 710.2(y)", and "§ 710.2(n)",

respectively to "§ 710.3(d)".

ii. In paragraph (b)(2), change "shall"

to "will".

iii. In the Note to paragraph (d)(2),

change "premanufacturing" to

"premanufacture".

iv. In paragraph (d)(5), change "photographic, films" to "photographic

films".

h. Sections 710.25 through 710.39 are

designated as subpart B and the subpart

heading is added to read as follows:

Subpart B-2002 Inventory Update

Reporting

i. Add § 710.23 to subpart B to read

as follows:

§710.23 Definitions.

In addition to the definitions in

§ 704.3 of this chapter and § 710.3, the

following definitions also apply to

subpart B of this part.

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.

Non-isolated 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.

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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.

§710.39 [Amended]

j. Section 710.39 is amended as

follows:

i. Revise the section heading to read

"How do I submit the required

information?"

ii. In paragraph (a), the second

sentence is revised to read: "Copies of

the Form U are available from EPA at

the address set forth in paragraph (c) of

this section and from the EPA Internet

Home Page at http://www.epa.gov/oppt/

iur/iur02/index.htm."

iii. In the introductory text of

paragraph (c), change "1994" to "1998".

iv. In paragraph (c)(1), insert a period

after "554-1404" and remove the

remainder of the sentence.

v. In paragraph (c)(3), change "7408,"

to "7408M,".

vi. In paragraph (d), change

"Document Control Officer" to "OPPT

Document Control Officer" and change

"7407," to "7407M,".

k. Add a new subpart C to read as

follows:

Subpart C-Inventory Update

Reporting for 2006 and Beyond

§710.43 Definitions.

In addition to the definitions in

§ 704.3 of this chapter and § 710.3, the

following definitions also apply to

subpart C of this part:

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.

Industrial use means use at a site at

which one or more chemical substances

or mixtures are manufactured (including

imported) or processed.

Intended for use by children means

the chemical substance or mixture is

used in or on a product that is

specifically intended for use by children

age 14 or younger. A chemical substance

or mixture is intended for use by

children when the submitter answers "yes" to at least one of the following

questions for the product into which the

submitter's chemical substance or

mixture is incorporated:

(1) Is the product commonly

recognized (i.e., by a reasonable person)

as being intended for children age 14 or

younger?

(2) Does the manufacturer of the

product state through product labeling

or other written materials that the

product is intended for or will be used

by children age 14 or younger?

(3) Is the advertising, promotion, or

marketing of the product aimed at

children age 14 or younger?

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.

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.

Non-isolated 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.

Readily obtainable information means

information which is known by

management and supervisory employees

of the submitter company who are

responsible for manufacturing,

processing, distributing, technical

services, and 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 would 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.

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

§ 710.45.

Reporting year means the calendar

year in which information to be

reported to EPA during an IUR

submission period is generated, i.e.,

calendar year 2005 and the calendar

year at 4-year intervals thereafter.

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.

Although a site-limited chemical

substance is not distributed for

commercial purposes outside the site at

which it is manufactured and processed,

the substance is considered to have been

manufactured and processed for

commercial purposes.

Submission period means the period

in which the information generated

during the reporting year is submitted to

EPA.

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.

§ 710.45 Chemical substances for which

information must be reported.

Any chemical substance which is in

the Master Inventory File at the

beginning of a submission period

described in § 710.53, unless the

chemical substance is specifically

excluded by § 710.46.

§ 710.46 Chemical substances for which

information is not required.

The following groups or categories of

chemical substances are exempted from

some or all of the reporting

requirements of this subpart, with the

following exception: A chemical

substance described in paragraph (a)(1),

(a)(2), or (a)(4), or (b) of this section is

not exempted from any of the reporting

requirements of this subpart if that

substance is the subject of a rule

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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) Full exemptions. The following

categories of chemical substances are

exempted from the reporting

requirements of this subpart.

(1) Polymers. (i) Any chemical

substance described with the word

fragments "*polym*", "*alkyd", or "*oxylated" in the Chemical Abstracts

Service Index or Preferred

Nomenclature in the Chemical

Substance Identities section of the 1985

edition of the Inventory or in the Master

Inventory File, where the asterisk (*)

indicates that any sets of characters may

precede, or follow, the character string

defined.

(ii) Any chemical substance which is

identified in the 1985 edition of the

Inventory or the Master Inventory File

as siloxane and silicone, silsesquioxane,

a protein (albumin, casein, gelatin,

gluten, hemoglobin), an enzyme, a

polysaccharide (starch, cellulose, gum),

rubber, or lignin.

(iii) This exclusion does not apply to

a polymeric substance that has been

hydrolyzed, depolymerized, or

otherwise chemically modified, except

in cases where the intended product of

this reaction is totally polymeric in

structure.

(2) Microorganisms. Any combination

of chemical substances that is a living

organism, and that meets the definition

of"microorganism" at § 725.3 of this

chapter. Any chemical substance

produced from a living microorganism

is reportable under this subpart unless

otherwise excluded.

(3) Naturally occurring chemical

substances. Any naturally occurring

chemical substance, as described in

§ 710.4(b). The applicability of this

exclusion is determined in each case by

the specific activities of the person who

manufactures the substance in question.

Some chemical substances can be

manufactured both as described in

§ 710.4(b) and by means other than

those described in § 710.4(b). If a person

described in § 710.48 manufactures a

chemical substance by means other than

those described in § 710.4(b), the person

must report regardless of whether the

substance also could have been

produced as described in § 710.4(b).

Any chemical substance that is

produced from such a naturally

occurring chemical substance described

in § 710.4(b) is reportable unless

otherwise excluded.

(4) Certain forms of natural gas.

Chemical substances with the following

Chemical Abstract Service (CAS)

Registry 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.

(b) Partial exemptions. The following

groups of chemical substances are

partially exempted from the reporting

requirements of this subpart (i.e., the

information described in § 710.52(c)(4)

need not be reported for these

substances). Such chemical substances

are not excluded from the other

reporting requirements under this

subpart. A chemical substance

described in paragraph (b)(3) of this

section qualifies for a partial reporting

exemption during the 2006 submission

period; in subsequent submission

periods, the chemical substances

described in paragraph (b)(3) of this

section will be subject to full reporting

under this subpart (i.e., all of the

information described in this subpart

must be reported), unless otherwise

exempted.

(1) Petroleum process streams. EPA

has designated the following chemical

substances, listed by CAS Number, as

partially exempt from reporting under

the IUR.

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING

CAS No.

7732-18-5 ...............

8002-05-9 ............... 8002-74-2 ............... 8006-20-0 ............... 8008-20-6 ............... 8009-03-8 ...............

8012-95-1 ............... 8030-30-6 ............... 8032-32-4 ...............

8042-47-5 ............... 8052-41-3 ...............

8052-42-4 ............... 63231-60-7 ............. 64741-41-9 .............

64741-42-0 ............. 64741-43-1 ............. 64741-44-2 .............

64741-45-3 ............. 64741-46-4 ............. 64741-47-5 ............. 64741-49-7 ............. 64741-50-0 .............

64741-51-1 ............. 64741-52-2 ............. 64741-53-3 .............

64741-54-4 ............. 64741-55-5 ............. 64741-56-6 .............

64741-57-7 ............. 64741-58-8 ............. 64741-59-9 .............

Product

Water

Petroleum

Paraffin waxes and hydrocarbon waxes

Fuel gases, low and medium B.T.U.

Kerosine (petroleum) Petrolatum

Paraffin oils

Naphtha

Ligroine

White mineral oil (petroleum) Stoddard solvent

Asphalt

Paraffin waxes and hydrocarbon waxes, microcryst. Naphtha (petroleum), heavy straight-run Naphtha (petroleum), full-range straight-run Gas oils (petroleum), straight-run Distillates (petroleum), straight-run middle

Residues (petroleum), atm. tower

Naphtha (petroleum), light straight-run Natural gas condensates (petroleum) Condensates (petroleum), vacuum tower

Distillates (petroleum), light paraffinic Distillates (petroleum), heavy paraffinic Distillates (petroleum), light naphthenic Distillates (petroleum), heavy naphthenic Naphtha (petroleum), heavy catalytic cracked

Naphtha (petroleum), light catalytic cracked

Residues (petroleum), vacuum

Gas oils (petroleum), heavy vacuum

Gas oils (petroleum), light vacuum

Distillates (petroleum), light catalytic cracked

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CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

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 ............. 64741-73-7 ............. 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 ............. 64741-95-3 .............

64741-96-4 ............. 64741-97-5 ............. 64741-98-6 .............

64741-99-7 ............. 64742-01-4 ............. 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 ............. 64742-18-3 ............. 64742-19-4 ............. 64742-20-7 .............

64742-21-8 .............

64742-22-9 ............. 64742-23-0 ............. 64742-24-1 .............

64742-25-2 ............. 64742-26-3 ............. 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 ............. 64742-36-5 ............. 64742-37-6 .............

Product

Distillates (petroleum), intermediate catalytic cracked

Distillates (petroleum), heavy catalytic cracked

Clarified oils (petroleum), catalytic cracked

Naphtha (petroleum), light catalytic reformed

Naphtha (petroleum), full-range alkylate

Naphtha (petroleum), heavy alkylate

Naphtha (petroleum), light alkylate

Residues (petroleum), catalytic reformer fractionator

Naphtha (petroleum), heavy catalytic reformed

Naphtha (petroleum), light hydrocracked

Naphtha (petroleum), isomerization

Distillates (petroleum), alkylate

Naphtha (petroleum), light thermal cracked

Residues (petroleum), hydrocracked

Distillates (petroleum), heavy hydrocracked

Distillates (petroleum), light hydrocracked

Naphtha (petroleum), heavy hydrocracked

Coke (petroleum)

Residues (petroleum), thermal cracked

Distillates (petroleum), heavy thermal cracked

Distillates (petroleum), light thermal cracked

Naphtha (petroleum), heavy thermal cracked

Naphtha (petroleum), solvent-refined light

Raffinates (petroleum), sorption process

Distillates (petroleum), sweetened middle

Naphtha (petroleum), sweetened

Distillates (petroleum), solvent-refined heavy paraffinic

Distillates (petroleum), solvent-refined light paraffinic

Gas oils (petroleum), solvent-refined

Distillates (petroleum), solvent-refined middle

Naphtha (petroleum), solvent-refined heavy

Residual oils (petroleum), solvent deasphalted

Distillates (petroleum), solvent-refined heavy naphthenic

Distillates (petroleum), solvent-refined light naphthenic

Extracts (petroleum), heavy naphtha solvent

Extracts (petroleum), light naphtha solvent

Residual oils (petroleum), solvent-refined

Extracts (petroleum), light naphthenic distillate solvent

Extracts (petroleum), heavy paraffinic distillate solvent

Extracts (petroleum), light paraffinic distillate solvent

Extracts (petroleum), middle distillate solvent

Raffinates (petroleum), residual oil decarbonization

Raffinates (petroleum), heavy naphthenic distillate decarbonization

Raffinates (petroleum), heavy paraffinic distillate decarbonization

Extracts (petroleum), residual oil solvent

Extracts (petroleum), heavy naphthenic distillate solvent

Gas oils (petroleum), acid-treated

Distillates (petroleum), acid-treated middle

Distillates (petroleum), acid-treated light

Naphtha (petroleum), acid-treated

Petroleum resins

Distillates (petroleum), acid-treated heavy naphthenic

Distillates (petroleum), acid-treated light naphthenic

Distillates (petroleum), acid-treated heavy paraffinic

Distillates (petroleum), acid-treated light paraffinic

Naphtha (petroleum), chemically neutralized heavy

Naphtha (petroleum), chemically neutralized light

Sludges (petroleum), acid

Lubricating oils (petroleum), acid-treated spent

Hydrocarbon waxes (petroleum), acid-treated

Distillates (petroleum), chemically neutralized heavy paraffinic

Distillates (petroleum), chemically neutralized light paraffinic

Gas oils (petroleum), chemically neutralized

Distillates (petroleum), chemically neutralized middle

Distillates (petroleum), chemically neutralized light

Lubricating oils (petroleum), chemically neutralized spent

Hydrocarbon waxes (petroleum), chemically neutralized

Distillates (petroleum), chemically neutralized heavy naphthenic

Distillates (petroleum), chemically neutralized light naphthenic

Distillates (petroleum), clay-treated heavy paraffinic

Distillates (petroleum), clay-treated light paraffinic

i

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CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

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 .............

64742-67-2 .............

64742-68-3 ............. 64742-69-4 ............. 64742-70-7 .............

64742-71-8 ............. 64742-72-9 ............. 64742-73-0 .............

64742-75-2 ............. 64742-76-3 ............. 64742-78-5 ............. 64742-79-6 .............

64742-80-9 ............. 64742-81-0 ............. 64742-82-1 .............

64742-83-2 ............. 64742-85-4 ............. 64742-86-5 .............

64742-87-6 .............

64742-88-7 ............. 64742-89-8 ............. 64742-90-1 .............

64742-91-2 ............. 64742-92-3 ............. 64742-93-4 ............. 64742-94-5 ............. 64742-95-6 .............

64742-96-7 .............

64742-97-8 ............. 64742-98-9 ............. 64742-99-0 .............

64743-00-6 ............. 64743-01-7 ............. 64743-02-8 .............

64743-03-9 ............. 64743-04-0 .............

64743-05-1 ............. 64743-06-2 .............

64743-07-3 ............. 64754-89-8 ............. 64771-71-7 .............

64771-72-8 ............. 67674-12-8 ............. 67674-13-9 .............

Product

Distillates (petroleum), clay-treated middle

Neutralizing agents (petroleum), spent sodium carbonate

Neutralizing agents (petroleum), spent sodium hydroxide

Residual oils (petroleum), clay-treated

Hydrocarbon waxes (petroleum), clay-treated microcryst.

Paraffin waxes (petroleum), clay-treated

Distillates (petroleum), clay-treated heavy naphthenic

Distillates (petroleum), clay-treated light naphthenic

Distillates (petroleum), hydrotreated middle

Distillates (petroleum), hydrotreated light

Naphtha (petroleum), hydrotreated heavy

Naphtha (petroleum), hydrotreated light

Lubricating oils (petroleum), clay-treated spent

Paraffin waxes (petroleum), hydrotreated

Distillates (petroleum), hydrotreated heavy naphthenic

Distillates (petroleum), hydrotreated light naphthenic

Distillates (petroleum), hydrotreated heavy paraffinic

Distillates (petroleum), hydrotreated light paraffinic

Distillates (petroleum), solvent-dewaxed light paraffinic

Residual oils (petroleum), hydrotreated

Lubricating oils (petroleum), hydrotreated spent

Gas oils (petroleum), hydrotreated vacuum

Hydrocarbon waxes (petroleum), hydrotreated microcryst.

Slack wax (petroleum)

Residual oils (petroleum), solvent-dewaxed

Distillates (petroleum), solvent-dewaxed heavy naphthenic

Distillates (petroleum), solvent-dewaxed light naphthenic

Distillates (petroleum), solvent-dewaxed heavy paraffinic

Foots oil (petroleum)

Naphthenic oils (petroleum), catalytic dewaxed heavy

Naphthenic oils (petroleum), catalytic dewaxed light

Paraffin oils (petroleum), catalytic dewaxed heavy

Paraffin oils (petroleum), catalytic dewaxed light

Distillates (petroleum), catalytic dewaxed middle

Naphtha (petroleum), hydrodesulfurized light

Naphthenic oils (petroleum), complex dewaxed heavy

Naphthenic oils (petroleum), complex dewaxed light

Residues (petroleum), hydrodesulfurized atmospheric tower

Gas oils (petroleum), hydrodesulfurized

Distillates (petroleum), hydrodesulfurized middle

Kerosine (petroleum), hydrodesulfurized

Naphtha (petroleum), hydrodesulfurized heavy

Naphtha (petroleum), light steam-cracked

Residues (petroleum), hydrodesulfurized vacuum

Gas oils (petroleum), hydrodesulfurized heavy vacuum

Gas oils (petroleum), hydrodesulfurized light vacuum

Solvent naphtha (petroleum), medium aliph.

Solvent naphtha (petroleum), light aliph.

Residues (petroleum), steam-cracked

Distillates (petroleum), steam-cracked

Petroleum resins, oxidized

Asphalt, oxidized

Solvent naphtha (petroleum), heavy arom.

Solvent naphtha (petroleum), light arom.

Solvent naphtha (petroleum), heavy aliph.

Distillates (petroleum), oxidized heavy

Distillates (petroleum), oxidized light

Residual oils (petroleum), oxidized

Hydrocarbon waxes (petroleum), oxidized

Petrolatum (petroleum), oxidized

Alkenes, C>10 alpha.-

Phenols (petroleum)

Coke (petroleum), recovery

Coke (petroleum), calcined

Extracts (petroleum), gas oil solvent

Sludges (petroleum), chemically neutralized

Naphthenic acids (petroleum), crude

Paraffins (petroleum), normal C>10

Paraffins (petroleum), normal C5-20

Residual oils (petroleum), oxidized, compounds with triethanolamine

Petrolatum (petroleum), oxidized, partially deacidified

i

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CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

67674-15-1 ............. 67674-16-2 ............. 67674-17-3 ............. 67674-18-4 .............

67891-79-6 ............. 67891-80-9 ............. 67891-82-1 ............. 67891-83-2 ............. 67891-85-4 ............. 68131-05-5 .............

68131-49-7 ............. 68131-75-9 ............. 68153-22-0 .............

68187-57-5 .............

68187-58-6 ............. 68187-60-0 .............

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 .............

68333-30-2 ............. 68333-81-3 .............

68333-88-0 ............. 68334-30-5 ............. 68409-99-4 .............

68410-00-4 ............. 68410-05-9 ............. 68410-12-8 .............

68410-71-9 ............. 68410-96-8 ............. 68410-97-9 ............. 68410-98-0 ............. 68411-00-7 .............

68425-29-6 .............

68425-33-2 ............. 68425-34-3 ............. 68425-35-4 .............

68425-39-8 ............. 68441-09-8 ............. 68459-78-9 .............

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 .............

Product

Petrolatum (petroleum), oxidized, Me ester

Hydrocarbon waxes (petroleum), oxidized, partially deacidified

Distillates (petroleum), oxidized light, compounds with triethanolamine

Distillates (petroleum), oxidized light, Bu esters

Distillates (petroleum), heavy arom.

Distillates (petroleum), light arom.

Hydrocarbon waxes (petroleum), oxidized, compounds with ethanolamine

Hydrocarbon waxes (petroleum), oxidized, compounds with isopropanolamine

Hydrocarbon waxes (petroleum), oxidized, compounds with triisopropanolamine

Hydrocarbon oils, process blends

Aromatic hydrocarbons, C6-10, acid-treated, neutralized

Gases (petroleum), C3-4

Paraffin waxes and Hydrocarbon waxes, oxidized

Pitch, coal tar-petroleum

Pitch, petroleum, arom.

Hydrocarbons, C4, ethane-propane-cracked

Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber

Tail gas (petroleum), catalytic polymn. naphtha fractionation stabilizer

Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer, hydrogen sulfide-free

Tail gas (petroleum), cracked distillate hydrotreater stripper

Tail gas (petroleum), distn., hydrogen sulfide-free

Tail gas (petroleum), gas oil catalytic cracking absorber

Tail gas (petroleum), gas recovery plant

Tail gas (petroleum), gas recovery plant deethanizer

Tail gas (petroleum), hydrodesulfurized distillate and hydrodesulfurized naphtha fractionator, acid-free

Tail gas (petroleum), hydrodesulfurized vacuum gas oil stripper, hydrogen sulfide-free

Tail gas (petroleum), isomerized naphtha fractionation stabilizer

Tail gas (petroleum), light straight-run naphtha stabilizer, hydrogen sulfide-free

Tail gas (petroleum), straight-run distillate hydrodesulfurizer, hydrogen sulfide-free

Tail gas (petroleum), propane-propylene alkylation feed prep deethanizer

Tail gas (petroleum), vacuum gas oil hydrodesulfurizer, hydrogen sulfide-free

Fuel gases, refinery

Residues (petroleum), atmospheric

Naphtha (petroleum), heavy coker

Hydrocarbon waxes (petroleum), oxidized, compds. with triethanolamine

Distillates (petroleum), hydrodesulfurized light catalytic cracked

Clarified oils (petroleum), hydrodesulfurized catalytic cracked

Distillates (petroleum), hydrodesulfurized intermediate catalytic cracked

Distillates (petroleum), hydrodesulfurized heavy catalytic cracked

Residues (petroleum), light naphtha solvent extracts

Distillates (petroleum), oxidized heavy thermal cracked

Alkanes, C4-12

Aromatic hydrocarbons, C9-17

Fuels, diesel

Gases (petroleum), catalytic cracked overheads

Distillates (petroleum), crude oil

Distillates (petroleum), straight-run light

Distillates (petroleum), steam-cracked, C5-10 fraction, high-temp. stripping products with light steamcracked petroleum naphtha C5 fraction polymers

Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.

Distillates (petroleum), hydrotreated middle, intermediate boiling

Distillates (petroleum), light distillate hydrotreating process, low-boiling

Distillates (petroleum), hydrotreated heavy naphtha, deisohexanizer overheads

Alkenes, C>8

Distillates (petroleum), naphtha-raffinate pyrolyzate-derived, gasoline-blending

Petrolatum (petroleum), oxidized, barium salt

Petrolatum (petroleum), oxidized, calcium salt

Raffinates (petroleum), reformer, Lurgi unit-sepd.

Alkenes, C>10 alpha.-, oxidized

Hydrocarbon waxes (petroleum), clay-treated microcryst., contg. polyethylene, oxidized

Alkenes, C18-24 alpha.-, dimers

Alkanes, C1-2

Alkanes, C2-3

Alkanes, C3-4

Alkanes, C4-5

Alkenes, C5, naphtha-raffinate pyrolyzate-derived

Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived

Distillates (petroleum), catalytic reformed depentanizer

Distillates (petroleum), light steam-cracked naphtha

Fuel gases

Fuel gases, C6-8 catalytic reformer

i

894

HeinOnline -- 68 Fed. Reg. 894 2003
Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003 / Rules and Regulations 895

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68476-29-9 ............. 68476-30-2 ............. 68476-31-3 ............. 68476-32-4 .............

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 .............

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 .............

68477-38-3 ............. 68477-39-4 ............. 68477-40-7 .............

68477-41-8 ............. 68477-42-9 .............

68477-44-1 ............. 68477-47-4 .............

68477-48-5 ............. 68477-53-2 ............. 68477-54-3 ............. 68477-55-4 .............

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 .............

Product

Fuel gases, crude oil distillates

Fuel oil, no. 2

Fuel oil, no. 4

Fuel oil, residues-straight-run gas oils, high-sulfur

Fuel oil, residual

Fuels, diesel, no. 2

Hydrocarbons, aliph.-arom.-C4-5-olefinic

Hydrocarbons, C3-4

Hydrocarbons, C4-5

Hydrocarbons, C4-6, C5-rich

Hydrocarbons, C>3

Hydrocarbons, C5-10 arom. conc., ethylene-manuf.-by-product

Hydrocarbons, C3-11, catalytic cracker distillates

Hydrocarbons, C2-6, C6-8 catalytic reformer

Hydrocarbons, C2-4, C3-rich

Hydrocarbons, C_>5, C5-6-rich

Hydrocarbons, C4, ethylene-manuf.-by-product

Hydrocarbons, C>20, petroleum wastes

Hydrocarbons, C3-5, polymn. unit feed

Hydrocarbons, C5-rich

Hydrocarbons, cyclic C5 and C6

Lubricating oils, refined used

Paraffin waxes and Hydrocarbon waxes, oxidized, calcium salts

Petroleum products, gases, inorg.

Petroleum gases, liquefied

Petroleum gases, liquefied, sweetened

Waste gases, vent gas, C1-6

Wastes, petroleum

Distillates (petroleum), catalytic reformer fractionator residue, high-boiling

Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling

Distillates (petroleum), catalytic reformer fractionator residue, low-boiling

Gases (petroleum), C3-4, isobutane-rich

Distillates (petroleum), C3-5, 2-methyl-2-butene-rich

Distillates (petroleum), C3-6, piperylene-rich

Distillates (petroleum), cracked steam-cracked, C5-18 fraction

Distillates (petroleum), cracked steam-cracked petroleum distillates

Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction

Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction

Gases (petroleum), extractive, C3-5, butadiene-butene-rich

Gases (petroleum), extractive, C3-5, butene-isobutylene-rich

Distillates (petroleum), heavy naphthenic, mixed with steam-cracked petroleum distillates C5-12 fraction

Distillates (petroleum), mixed heavy olefin vacuum, heart-cut

Distillates (petroleum), mixed heavy olefin vacuum, low-boiling

Distillates (petroleum), steam-cracked, C5-12 fraction

Distillates (petroleum), steam-cracked, C8-12 fraction

Distillates (petroleum), steam-cracked, C5-10 fraction, mixed with light steam-cracked petroleum naphtha

C5 fraction

Distillates (petroleum), steam-cracked petroleum distillates, C5-18 fraction

Distillates (petroleum), steam-cracked petroleum distillates cyclopentadiene conc.

Extracts (petroleum), cold-acid

Extracts (petroleum), cold-acid, C4-6

Extracts (petroleum), cold-acid, C3-5, butene-rich

Extracts (petroleum), reformer recycle

Gases (petroleum), acetylene manuf. off

Gases (petroleum), amine system feed

Gases (petroleum), benzene unit hydrodesulfurizer off

Gases (petroleum), benzene unit recycle, hydrogen-rich

Gases (petroleum), blend oil, hydrogen-nitrogen-rich

Gases (petroleum), butane splitter overheads

Gases (petroleum), C2-3

Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free

Gases (petroleum), catalytic-cracked naphtha debutanizer bottoms, C3-5-rich

Gases (petroleum), catalytic cracked naphtha depropanizer overhead, C3-rich acid-free

Gases (petroleum), catalytic cracker

Gases (petroleum), catalytic cracker, C1-5-rich

Gases (petroleum), catalytic polymd. naphtha stabilizer overhead, C2-4-rich

Gases (petroleum), catalytic reformed naphtha stripper overheads

Gases (petroleum), catalytic reformer, C1-4-rich

Gases (petroleum), C6-8 catalytic reformer recycle

Gases (petroleum), C6-8 catalytic reformer

Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich

i

HeinOnline -- 68 Fed. Reg. 895 2003
Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003 / Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

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 ............. 68478-08-0 .............

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 .............

68478-22-8 ............. 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 .............

68512-91-4 ............. 68513-02-0 ............. 68513-11-1 .............

68513-12-2 ............. 68513-13-3 ............. 68513-14-4 ............. 68513-15-5 ............. 68513-16-6 .............

68513-17-7 .............

68513-18-8 ............. 68513-19-9 ............. 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 ............. 68514-31-8 .............

68514-32-9 ............. 68514-33-0 ............. 68514-34-1 .............

Product

Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed

Gases (petroleum), C2-return stream

Gases (petroleum), C4-rich

Gases (petroleum), deethanizer overheads

Gases (petroleum), deisobutanizer tower overheads

Gases (petroleum), deethanizer overheads, C3-rich

Distillates (petroleum), depentanizer overheads

Gases (petroleum), depropanizer dry, propene-rich

Gases (petroleum), depropanizer overheads

Gases (petroleum), dry sour, gas-concn.-unit-off

Gases (petroleum), gas concn. reabsorber distn.

Gases (petroleum), gas recovery plant depropanizer overheads

Gases (petroleum), Girbatol unit feed

Gases (petroleum), hydrogen absorber off

Gases (petroleum), hydrogen-rich

Gases (petroleum), recycle, hydrogen-rich

Gases (petroleum), reformer make-up, hydrogen-rich

Gases (petroleum), reforming hydrotreater

Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich

Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich

Gases (petroleum), thermal cracking distn.

Naphtha (petroleum), light steam-cracked, C5-fraction, oligomer conc.

Naphtha (petroleum), light steam-cracked, debenzenized, C8-16-cycloalkadiene conc.

Residues (petroleum), butane splitter bottoms

Residues (petroleum), catalytic reformer fractionator residue distn.

Residues (petroleum), C6-8 catalytic reformer

Residual oils (petroleum), deisobutanizer tower

Residues (petroleum), heavy coker gas oil and vacuum gas oil

Residues (petroleum), heavy olefin vacuum

Residual oils (petroleum), propene purifn. splitter

Residues (petroleum), steam-cracked petroleum distillates cyclopentadiene conc., C4-cyclopentadienefree

Tail gas (petroleum), catalytic cracked naphtha stabilization absorber

Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurizer combined fractionater

Tail gas (petroleum), catalytic cracker refractionation absorber

Tail gas (petroleum), catalytic reformed naphtha fractionation stabilizer

Tail gas (petroleum), catalytic reformed naphtha separator

Tail gas (petroleum), catalytic reformed naphtha stabilizer

Tail gas (petroleum), cracked distillate hydrotreater separator

Tail gas (petroleum), hydrodesulfurized straight-run naphtha separator

Tail gas (petroleum), saturate gas plant mixed stream, C4-rich

Tail gas (petroleum), saturate gas recovery plant, C1-2-rich

Tail gas (petroleum), vacuum residues thermal cracker

Residues (petroleum), heavy coker and light vacuum

Residues (petroleum), light vacuum

Solvent naphtha (petroleum), light arom., hydrotreated

Hydrocarbons, C3-4-rich, petroleum distillates

Naphtha (petroleum), full-range coker

Fuel gases, hydrotreater fractionation, scrubbed

Fuel gases, saturate gas unit fractionater-absorber overheads

Fuel gases, thermal cracked catalytic cracking residue

Gases (petroleum), catalytic reformed straight-run naphtha stabilizer overheads

Gases (petroleum), full-range straight-run naphtha dehexanizer off

Gases (petroleum), hydrocracking depropanizer off, hydrocarbon-rich

Gases (petroleum), light straight-run naphtha stabilizer off

Gases (petroleum), reformer effluent high-pressure flash drum off

Gases (petroleum), reformer effluent low-pressure flash drum off

Disulfides, C5-12-alkyl

Distillates (petroleum), catalytic reformed straight-run naphtha overheads

Butane, branched and linear

Residues (petroleum), alkylation splitter, C4-rich

Residues (petroleum), cyclooctadiene bottoms

Residues (petroleum), deethanizer tower

Residues (petroleum), steam-cracked light

Waste gases, ethylene oxide absorber-reactor

Gasoline, vapor-recovery

Hydrocarbons, amylene feed debutanizer overheads nonextractable raffinates

Hydrocarbons, C1-4

Hydrocarbons, C10 and C12, olefin-rich

Hydrocarbons, C12 and C14, olefin-rich

Hydrocarbons, C9-14, ethylene-manuf.-by-product

i

896

HeinOnline -- 68 Fed. Reg. 896 2003
Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003 /Rules and Regulations 897

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68514-35-2 ............. 68514-38-5 ............. 68514-36-3 ............. 68514-37-4 .............

68514-79-4 ............. 68515-25-3 ............. 68515-26-4 ............. 68515-27-5 ............. 68515-28-6 ............. 68515-29-7 .............

68515-30-0 ............. 68515-32-2 ............. 68515-33-3 .............

68515-34-4 ............. 68515-35-5 ............. 68515-36-6 .............

68516-20-1 ............. 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 ............. 68527-26-4 ............. 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 .............

Product

Hydrocarbons, C14-30, olefin-rich

Hydrocarbons, C4-10-unsatd.

Hydrocarbons, C1-4, sweetened

Hydrocarbons, C4-5-unsatd.

Petroleum products, hydrofiner-powerformer reformates

Benzene, C1-9-alkyl derivs.

Benzene, di-C12-14-alkyl derivs.

Benzene, di-C10-14-alkyl derivs., fractionation overheads, heavy ends

Benzene, di-C1 0-1 4-alkyl derivs., fractionation overheads, light ends

Benzene, di-C10-14-alkyl derivs., fractionation overheads, middle cut

Benzene, mono-C20-48-alkyl derivs.

Benzene, mono-C12-14-alkyl derivs., fractionation bottoms

Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, heavy ends

Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, heavy ends

Benzene, mono-C10-12-alkyl derivs., fractionation bottoms, light ends

Benzene, mono-C12-14-alkyl derivs., fractionation bottoms, light ends

Naphtha (petroleum), steam-cracked middle arom.

Alkenes, C6

Alkenes, C6-8, C7-rich

Alkenes, C7-9, C8-rich

Alkenes, C8-10, C9-rich

Alkenes, C9-11, C10-rich

Alkenes, C10-12, C11-rich

Alkenes, C11-13, C12-rich

Aromatic hydrocarbons, ethane cracking scrubber effluent and flare drum

Alkenes, C6-9 alpha.-

Alkenes, C8-9 alpha.-

Alkenes, C5

Gases (petroleum), acid, ethanolamine scrubber

Gases (petroleum), methane-rich off

Gases (petroleum), oil refinery gas distn. off

Hydrocarbons, C1-3

Gas oils (petroleum), steam-cracked

Hydrocarbons, C1-4, debutanizer fraction

Naphtha (petroleum), clay-treated full-range straight-run

Naphtha (petroleum), clay-treated light straight-run

Naphtha (petroleum), light steam-cracked arom.

Naphtha (petroleum), light steam-cracked, debenzenized

Naphtha (petroleum), full-range alkylate, butane-contg.

Fuel oil, no. 6

Hydrocarbons, C8-11

Distillates (petroleum), benzene unit hydrotreater dipentanizer overheads

Distillates, hydrocarbon resin prodn. higher boiling

Gases (petroleum), benzene unit hydrotreater depentenizer overheads

Gases (petroleum), C1-5, wet

Gases (petroleum), secondary absorber off, fluidized catalytic cracker overheads fractionater

Distillates (petroleum), oxidized light, strong acid components, compds. with diethanolamine

Distillates (petroleum), oxidized light, strong acid components, sodium salts

Distillates (petroleum), oxidized light, strong acid components

Distillates (petroleum), oxidized light, strong acid-free

Distillates (petroleum), thermal cracked naphtha and gas oil

Distillates (petroleum), thermal cracked naphtha and gas oil, C5-dimer-contg.

Distillates (petroleum), thermal cracked naphtha and gas oil, dimerized

Distillates (petroleum), thermal cracked naphtha and gas oil, extractive

Naphtha (petroleum), arom.-contg.

Hydrocarbon waxes (petroleum), oxidized, calcium salts

Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts

Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts

Hydrocarbon waxes (petroleum), oxidized, Me esters, sodium salts

Petrolatum (petroleum), oxidized, ester with sorbitol

Residual oils (petroleum), oxidized, calcium salts

Alkenes, C10, tert-amylene concentrator by-product

Alkenes, C15-20 alpha.-, isomerized

Fuel gases, expander off

Gasoline, pyrolysis, debutanizer bottoms

Gasoline, straight-run, topping-plant

Hydrocarbons, C4, butene concentrator by-product

Hydrocarbons, C2-4

Hydrocarbons, C3

Gases (petroleum), alkylation feed

Hydrocarbons, C5 and C10-aliph. and C6-8-arom.

i

HeinOnline -- 68 Fed. Reg. 897 2003
Federal Register/Vol. 68, No. 4/Tuesday, January 7, 2003 / Rules and Regulations

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

68606-31-5 ............. 68606-34-8 ............. 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 ............. 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 ............. 68783-12-0 ............. 68783-13-1 ............. 68783-15-3 .............

68783-61-9 ............. 68783-62-0 .............

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 ............. 68918-98-9 .............

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 .............

68919-15-3 ............. 68919-17-5 .............

68919-19-7 ............. 68919-20-0 ............. 68919-37-9 .............

68920-06-9 ............. 68920-07-0 ............. 68920-64-9 .............

Product

Hydrocarbons, C3-5, butadiene purifn. by-product

Gases (petroleum), depropanizer bottoms fractionation off

Hydrocarbons, C5-unsatd. rich, isoprene purifn. by-product

Petroleum products, refinery gases

Residues (petroleum), topping plant, low-sulfur

Waste gases, from carbon black manuf.

Hydrocarbons, C>4

Hydrocarbons, C4-5, tert-amylene concentrator by-product

Hydrocarbons, C4-5, butene concentrator by-product, sour

Aromatic hydrocarbons, C8, o-xylene-lean

Paraffin waxes (petroleum), oxidized, sodium salts

Distillates (petroleum), hydrofined lubricating-oil

Extracts (petroleum), clarified oil solvent, condensed-ring-arom.-contg.

Extracts (petroleum), heavy clarified oil solvent, condensed-ring-arom.-contg.

Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc.

Extracts (petroleum), heavy naphthenic distillate solvent, paraffinic conc.

Extracts (petroleum), intermediate clarified oil solvent, condensed-ring-arom.-contg.

Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent

Gases (petroleum), ammonia-hydrogen sulfide, water-satd.

Gases (petroleum), hydrocracking low-pressure separator

Gases (petroleum), refinery blend

Gas oils (petroleum), heavy atmospheric

Naphtha (petroleum), catalytic cracked light distd.

Naphtha (petroleum), unsweetened

Residues (petroleum), coker scrubber, condensed-ring-arom.-contg.

Alkenes, C6-7 alpha.-

Fuel gases, refinery, sweetened

Fuel gases, refinery, unsweetened

Gases (petroleum), catalytic cracking

Gases (petroleum), C2-4, sweetened

Naphtha (petroleum), light, sweetened

Waste gases, refinery vent

Gases (petroleum), refinery

Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted

Distillates (petroleum), full-range straight-run middle

Gases (petroleum), platformer products separator off

Alkenes, C5-9 alpha.-

Alkenes, C6-12 alpha.-

Alkenes, C10-16 alpha.-

Alkenes, C14-18 alpha.-

Alkenes, C14-20 alpha.-

Gases (petroleum), hydrotreated sour kerosine depentanizer stabilizer off

Gases (petroleum), hydrotreated sour kerosine flash drum

Distillates (petroleum), heavy straight-run

Gas oils (petroleum), straight-run, high-boiling

Petrolatum (petroleum), oxidized, zinc salt

Residues (petroleum), clay-treating filter wash

Paraffin waxes and Hydrocarbon waxes, oxidized, alkali metal salts

Fuel gases, refinery, hydrogen sulfide-free

Gases (petroleum), crude oil fractionation off

Gases (petroleum), dehexanizer off

Gases (petroleum), distillate unifiner desulfurization stripper off

Gases (petroleum), fluidized catalytic cracker fractionation off

Gases (petroleum), fluidized catalytic cracker scrubbing secondary absorber off

Gases (petroleum), heavy distillate hydrotreater desulfurization stripper off

Gases (petroleum), light straight run gasoline fractionation stabilizer off

Gases (petroleum), naphtha unifiner desulfurization stripper off

Gases (petroleum), platformer stabilizer off, light ends fractionation

Gases (petroleum), preflash tower off, crude distn.

Gases (petroleum), straight-run naphtha catalytic reforming off

Gases (petroleum), straight-run stabilizer off

Gases (petroleum), tar stripper off

Gases (petroleum), unifiner stripper off

Hydrocarbons, C6-12, benzene-recovery

Hydrocarbons, C12-20, catalytic alkylation by-products

Gases (petroleum), fluidized catalytic cracker splitter residues

Gases (petroleum), fluidized catalytic cracker splitter overheads

Naphtha (petroleum), full-range reformed

Hydrocarbons, C7-9

Hydrocarbons, C<10-linear

Disulfides, di-Cl-2-alkyl

i

898

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CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES TERMED "PETROLEUM PROCESS STREAMS" FOR

PURPOSES OF INVENTORY UPDATE REPORTING-Continued

CAS No.

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 .............

68953-80-0 .............

68955-27-1 .............

68955-28-2 .............

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 .............

68988-79-4 .............

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 .............

70693-06-0 .............

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 .............

93762-80-2 .............

Product

Distillates (petroleum), hydrotreated light catalytic cracked

Distillates (petroleum), naphtha unifiner stripper

Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads

Hydrocarbons, ethylene-manuf.-by-product distn. residues

Gases (petroleum), catalytic cracked naphtha debutanizer

Tail gas (petroleum), catalytic cracked distillate and naphtha stabilizer

Tail gas (petroleum), catalytic hydrodesulfurized distillate fractionation stabilizer, hydrogen sulfide-free

Tail gas (petroleum), catalytic hydrodesulfurized naphtha separator

Tail gas (petroleum), straight-run naphtha hydrodesulfurizer

Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber

Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabilizer, petroleum coking

Benzene, mixed with toluene, dealkylation product

Distillates (petroleum), petroleum residues vacuum

Gases (petroleum), light steam-cracked, butadiene conc.

Gases (petroleum), butadiene process, inorg.

Natural gas, substitute, steam-reformed desulfurized naphtha

Gases (petroleum), sponge absorber off, fluidized catalytic cracker and gas oil desulfurizer overhead

fractionation

Gases (petroleum), straight-run naphtha catalytic reformer stabilizer overhead

Naphtha (petroleum), catalytic reformed

Residues (petroleum), steam-cracked, resinous

Aromatic hydrocarbons, C9-16, biphenyl deriv.-rich

Disulfides, dialkyl and di-Ph, naphtha sweetening

Fuel oil, isoprene reject absorption

Fuel oil, residual, wastewater skimmings

Hydrocarbons, C4-8

Hydrocarbons, C4-unsatd.

Hydrocarbons, C5-unsatd.

Petroleum products, C5-12, reclaimed, wastewater treatment

Benzene, C10-12-alkyl derivs., distn. residues

Phenols, sodium salts, mixed with sulfur compounds, gasoline alk. scrubber residues

Gases (petroleum), crude distn. and catalytic cracking

Distillates (petroleum), arom., hydrotreated, dicyclopentadiene-rich

Alkanes, C10-13, arom.-free desulfurized

Alkanes, C14-17, arom.-free desulfurized

Alkanes, C10-13, desulfurized

Alkenes, C10-16

Fuel oil, pyrolysis

Oils, reclaimed

Hydrocarbons, C6-30

Ethene, thermal cracking products

Distillates (petroleum), heavy distillate solvent ext. heart-cut

Distillates (petroleum), heavy distillate solvent ext. vacuum overheads

Residues (petroleum), heavy distillate solvent ext. vacuum

Distillates (petroleum), intermediate vacuum

Distillates (petroleum), light vacuum

Distillates (petroleum), vacuum

Residues (petroleum), atm. tower, light

Hydrocarbon waxes (petroleum), oxidized, sodium salts

Aromatic hydrocarbons, C9-11

Residues (petroleum), solvent-extd. vacuum distilled atm. residuum

Alkanes, C18-70

Alkanes, C4-6

Alkenes, C13-14 alpha.-

Alkenes, C15-18 alpha.-

Aromatic hydrocarbons, C12-20

Hydrocarbon waxes (petroleum), clay-treated, microcryst., oxidized, potassium salts

Hydrocarbons, C5-8, Houdry butadiene manuf. by-product

Residues (petroleum), catalytic cracking depropanizer, C4-rich

Tail gas (petroleum), thermal cracking absorber

Distillates (petroleum), cracked steam-cracked, C5-17 fraction

Lubricating oils (petroleum), C>25, hydrotreated bright stock-based

Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, contg. solvent deasphalted residual

oil

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity

Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based

Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based

Alkenes, C15-18

899

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(2) Specific exempted chemical

substances-(i) Exemption. EPA has

determined that, at this time, the

information in § 710.52(c)(4) associated

with the chemicals listed in paragraph

(b)(2)(iv) of this section is of low current

interest.

(ii) Considerations. In making its

determination of whether this partial

exemption should apply to a particular

chemical substance, EPA will consider

the totality of information available for

the chemical substance in question,

including but not limited to, one or

more of the following considerations:

(A) Whether the chemical qualifies or

has qualified in past IUR collections for

the reporting of the information

described in § 710.52(c)(4) (i.e., at least

one site manufactures 300,000 pounds

or more of the chemical).

(B) The chemical substance's

chemical and physical properties or

potential for persistence,

bioaccumulation, health effects, or

environmental effects (considered

independently or together).

(C) The information needs of EPA,

other federal agencies, tribes, states, and

local governments, as well as members

of the public.

(D) The availability of other

complementary risk screening

information.

(E) The availability of comparable

processing and use information.

(F) Whether the potential risks of the

chemical substance are adequately

managed by EPA or another agency or

authority.

(iii) Amendments. EPA may amend

the chemical list in paragraph (b)(2)(iv)

of this section on its own initiative or

in response to a request from the public

based on EPA's determination of

whether the information in

§ 710.52(c)(4) is of low interest.

(A) Any person may request that EPA

amend the chemical list in paragraph

(b)(2)(iv) of this section. Your request

must be in writing and must be

submitted to the address provided in

§ 710.59(d). Requests must identify the

chemical in question, as well as its CAS

Number or other chemical identification

number as identified in § 710.52(c)(3)(i).

Your request should provide sufficient

information for EPA to determine

whether collection of the information in

§ 710.52(c)(4) for the chemical in

question is of low interest. In preparing

your request, please refer to the

considerations outlined in paragraph

(b)(2)(ii) of this section. If a request

related to a particular chemical is

resubmitted, any subsequent request

must clearly identify new information

contained in the request. EPA may

request other information that it

believes necessary to evaluate the

request. EPA will issue a written

response to each request within 120

days of receipt of the request, and will

maintain copies of these responses in a

public docket that will be established

for each reporting cycle.

(B) As needed, the Agency will

initiate rulemaking to make revisions to

the list in paragraph (b)(2)(iv) of this

section.

(C) To assist EPA in reaching a

decision regarding a particular request

prior to a given reporting year, requests

must be submitted to EPA no later than

12 months prior to the start of the

reporting year, i.e., by January 1, 2004,

or by each January 1 at 4-year intervals

thereafter.

(iv) List of chemical substances. EPA

has designated the following chemical

substances, listed by CAS Number, as

partially exempt from reporting under

the IUR.

CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES UNDER § 710.46(B)(2)

CAS No.

50-70-4 ................... 50-81-7 ...................

50-99-7 ...................

56-87-1 ...................

57-50-1 ................... 58-95-7 ...................

59-02-9 ...................

59-51-8 ...................

69-65-8 ...................

87-79-6 ................... 123-94-4 .................

124-38-9 .................

137-08-6 .................

142-47-2 ................. 150-30-1 .................

1317-65-3 ...............

1333-74-0 ...............

1592-23-0 ............... 7440-37-1 ...............

7440-44-0 ...............

7727-37-9 ...............

7782-42-5 ............... 7782-44-7 ...............

8001-21-6 ...............

8001-22-7 ...............

8001-23-8 ...............

8001-26-1 ............... 8001-29-4 ...............

8001-30-7 ............... 8001-31-8 ...............

8001-78-3 ............... 8001-79-4 ...............

8002-03-7 ............... 8002-13-9 ............... 8002-43-5 ............... 8002-75-3 ...............

Chemical

D-Glucitol

L-Ascorbic acid

D-Glucose

L-Lysine

.alpha.- D-Glucopyranoside, .beta.-D-fructofu ranosyl

2H-1 -Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, acetate, (2R)-

2H-1 -Benzopyran-6-ol, 3,4-dihydro-2,5,7,8-tetramethyl-2-[(4R,8R)-4,8,12- trimethyltridecyl]-, (2R)-

Methionine

D-Mannitol

L-Sorbose

Octadecanoic acid, 2,3-dihydroxypropyl ester

Carbon dioxide

.beta.-Alanine, N-[(2R)-2,4-dihydroxy-3,3-dimethyl-1 -oxobutyl]-, calcium alt (2:1)

L-Glutamic acid, monosodium salt

Phenylalanine

Limestone

Hydrogen

Octadecanoic acid, calcium salt

Argon

Carbon

Nitrogen

Graphite

Oxygen

Sunflower oil

Soybean oil

Safflower oil

Linseed oil

Cottonseed oil

Corn oil

Coconut oil

Castor oil, hydrogenated

Castor oil

Peanut oil

Rape oil

Lecithins

Palm oil

900

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CAS NUMBERS OF PARTIALLY EXEMPT CHEMICAL SUBSTANCES UNDER §710.46(B)(2)-Continued

CAS No.

8006-54-0 ...............

8016-28-2 ...............

8016-70-4 ...............

8021-99-6 ............... 8029-43-4 ...............

9004-53-9 ...............

9005-25-8 ...............

9050-36-6 ...............

11103-57-4 ............. 16291-96-6 .............

26836-47-5 .............

61789-44-4 .............

61789-97-7 ............. 61789-99-9 .............

64147-40-6 .............

64755-01-7 .............

65996-63-6 ............. 65996-64-7 ............. 67701-01-3 .............

68002-85-7 .............

68131-37-3 ............. 68188-81-8 ............. 68308-54-3 .............

68334-00-9 .............

68334-28-1 .............

68409-76-7 ............. 68424-45-3 .............

68424-61-3 ............. 68425-17-2 .............

68439-86-1 ............. 68442-69-3 .............

68476-78-8 ............. 68514-27-2 .............

68514-74-9 ............. 68525-87-1 .............

68648-86-2 ............. 68648-87-3 .............

68918-42-3 ............. 68952-94-3 .............

68989-98-0 ............. 73138-67-7 .............

129813-58-7 ...........

129813-59-8 ...........

129813-60-1 ...........

Chemical

Lanolin

Lard, oil

Soybean oil, hydrogenated

Charcoal, bone

Syrups, hydrolyzed starch

Dextrin

Starch

Maltodextrin

Vitamin A

Charcoal

D-Glucitol, monooctadecanoate

Fatty acids, castor-oil

Tallow

Lard

Castor oil, dehydrated

Fatty acids, tallow, calcium salts

Starch, acid-hydrolyzed Starch, enzyme-hydrolyzed Fatty acids, C12-18

Fatty acids, C14-22 and C16-22-unsatd.

Syrups, hydrolyzed starch, dehydrated Grease, poultry Glycerides, tallow mono-, di- and tri-, hydrogenated Cottonseed oil, hydrogenated Fats and glyceridic oils, vegetable, hydrogenated Bone meal, steamed

Fatty acids, linseed-oil

Glycerides, C16-18 and C18-unsatd. mono- and diSyrups, hydrolyzed starch, hydrogenated

Bone, ash

Benzene, mono-C10-14-alkyl derivs.

Molasses

Grease, catch basin

Palm oil, hydrogenated Corn oil, hydrogenated

Benzene, C14-16-alkyl derivs.

Benzene, C10-16-alkyl derivs.

Soaps, stocks, soya Soaps, stocks, vegetable-oil Fats and glyceridic oils, vegetable, residues

Lard, hydrogenated Benzene, mono-C10-13-alkyl derivs.

Benzene, mono-C12-14-alkyl derivs.

Benzene, mono-C14-16-alkyl derivs.

(3) Inorganic chemical substances.

For purposes of this subpart, an

inorganic chemical substance is any

chemical substance which does not

contain carbon or contains carbon only

in the form of carbonato [=CO3], cyano

[--CN], cyanato [--OCN], isocyano [--NC],

or isocyanato [--NCO] groups or the

chalcogen analogues of such groups.

During the 2006 submission period,

manufacturers are excluded only from

the reporting requirements under

§ 710.52(c)(4) for inorganic chemical

substances. During the 2006 submission

period, manufacturers of inorganic

chemical substances are not excluded

from the other reporting requirements

under this part. During submission

periods following the 2006 submission

period, manufacturers of inorganic

chemical substances are subject to all of

the reporting requirements in this

subpart.

§710.48 Persons who must report.

Except as provided in § § 710.49 and

710.50, the following persons are

subject to the requirements of this

subpart. 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.

(11,340 kg) or more of a chemical

substance described in § 710.45 at any

single site owned or controlled by that

person at any time during calendar year

2005 or during the calendar year at 4-

year intervals thereafter is subject to

reporting.

(b) Special provisions for importers.

For purposes of this section, the site for

a person who imports a chemical

substance described in § 710.45 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 § 710.55(b)).

§ 710.49 Persons not subject to this

subpart.

A person described in § 710.48 is not

subject to the requirements of this

subpart if that person qualifies as a

small manufacturer as that term is

defined in § 704.3 of this chapter.

Notwithstanding this exclusion, a

HeinOnline -- 68 Fed. Reg. 901 2003
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person who qualifies as a small

manufacturer is subject to this subpart

with respect to any chemical substance

that is the subject of a rule proposed or

promulgated under section 4, 5(b)(4), or

6 of the Act, or is the subject of an order

in effect under section 5(e) of the Act,

or is the subject of relief that has been

granted under a civil action under

section 5 or 7 of the Act.

§ 710.50 Activities for which reporting is

not required.

A person described in § 710.48 is not

subject to the requirements of this

subpart with respect to any chemical

substance described in § 710.45 that the

person solely manufactured or imported

under the following circumstances:

(a) The person manufactured or

imported the chemical substance

described in § 710.45 solely in small

quantities for research and

development.

(b) The person imported the chemical

substance described in § 710.45 as part

of an article.

(c) The person manufactured the

chemical substance described in

§ 710.45 in a manner described in

§ 720.30(g) or (h) of this chapter.

§710.52 Reporting information to EPA.

Any person who must report under

this subpart, as described in § 710.48,

must submit the information described

in this section for each chemical

substance described in § 710.45 that the

person manufactured (including

imported) for commercial purposes in

an amount of 25,000 lbs. (11,340 kg) or

more at any one site during calendar

year 2005 or during the calendar year at

4-year intervals thereafter. (See

§ 710.48(b) for the "site" for importers).

A separate form must be submitted for

each chemical substance at each site for

which the submitter is required to

report. A submitter of information under

this subpart must report information as

described in paragraphs (c)(1), (c)(2),

and (c)(3) of this section to the extent

that such information is known to or

reasonably ascertainable by that person

whereas a submitter must report

information as described in paragraph

(c)(4) of this section only to the extent

that such information is readily

obtainable by that person. A submitter

under this subpart must report

information that applies to the calendar

year for which the person is required to

report (i.e., calendar year 2005 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

§ 710.59. The form must include all

information described 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 described 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 § 710.59.

(c) Information to be reported.

Manufacturers (including importers) of

a reportable chemical substance in an

amount of 25,000 lbs. (11,340 kg) or

more at a site during a reporting year

must report the information described

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

this section. Manufacturers (including

importers) of a reportable chemical

substance in an amount of 300,000 lbs.

(136,077 kg) or more at a site during a

reporting year must report the

information described in paragraph

(c)(4) of this section in addition to the

information described in paragraphs

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

As described in § 710.46(b)(3),

manufacturers of certain inorganic

chemical substances are not required to

report the information described in

paragraph (c)(4) of this section during

the 2006 submission period, but are

required to report this information

during subsequent submission periods.

As described in § 710.46(b)(1) and (b)(2),

manufacturers of certain chemicals are

not required to report the information

described in paragraph (c)(4) 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 as described in

§ 710.59.

(2) Company and plant site

information. The following company

and plant site information must be

reported for each site at which at least

25,000 lbs. (11,340 kg) of a reportable

chemical substance is manufactured

(including imported) during calendar

year 2005 or during the calendar year at

4-year intervals thereafter (see

§ 710.48(b) for the "site" for importers):

(i) The name 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, the parent company name and

Dun and Bradstreet Number, the contact

person's full mailing address, the

contact person's telephone number and

the contact person's e-mail address.

(ii) The name and full street address

of each site. A submitter under this

subpart must include the appropriate

Dun and Bradstreet Number for each

plant site reported, and the county or

parish (or other jurisdictional indicator)

in which the plant site is located.

(3) Specific information for chemicals

manufactured in amounts of 25,000 lbs.

or more. The following chemicalspecific information must be reported

for each reportable chemical substance

manufactured at (including imported

into) each site in amounts of 25,000 lbs.

(11,340 kg) or more during calendar year

2005 or during the calendar year at 4-

year intervals thereafter:

(i) The specific chemical name and

CAS Number of each reportable

chemical substance at each site. A

submitter under this subpart may use an

EPA-designated Accession Number for

confidential substances, or a

premanufacture notice (PMN) case

number (see § 720.65 of this chapter) in

lieu of a CAS Number when a CAS

Number is not known to or reasonably

ascertainable by the submitter. In

addition to reporting the number itself,

submitters must specify the type of

number they are reporting by selecting

from among the following codes:

CODES TO SPECIFY TYPE OF

CHEMICAL IDENTIFYING NUMBER

Codes Number Type

A ................. Accession Number

C ................. CAS Registry Number

P ................. PM N Number

(ii) A statement indicating, for each

reportable chemical substance at each

site, 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 at each

site, whether the substance is sitelimited.

(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 that the

volume reported under paragraph

(c)(3)(iv) of this section is confidential

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business information under § 710.58

must indicate, for each reportable

chemical substance at each site, whether

the total volume range (in pounds)

which corresponds with the specific

volume figure reported in response to

paragraph (c)(3)(iv) of this section is

also confidential. Volume ranges are

listed in the following table:

VOLUME RANGES

From To

25,000 lbs ................. 300,000 lbs.

300,000 lbs ............... 1,000,000 lbs.

1,000,000 lbs ............ 10,000,000 lbs.

10,000,000 lbs .......... 50,000,000 lbs.

50,000,000 lbs .......... 100,000,000 lbs.

100,000,000 lbs ........ 500,000,000 lbs.

500,000,000 lbs ........ 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. For each reportable substance at

each site, the submitter must select from

among the ranges of workers listed in

the following table and report the

corresponding code (i.e., W1 through

W8):

CODES FOR REPORTING NUMBER OF

WORKERS REASONABLY LIKELY TO

BE EXPOSED

Codes Range

W1 .............. Less than 10 workers

W2 .............. At least 10 but less than 25

workers

W3 .............. At least 25 but less than 50

workers

W4 .............. At least 50 but less than 100

workers

W5 .............. At least 100 but less than 500

workers

W6 .............. At least 500 but less than

1,000 workers

W7 .............. At least 1,000 but less than

10,000 workers

W8 .............. At least 10,000 workers

(vii) The maximum concentration,

measured by percentage of weight, of

each reportable chemical substance at

the time it is sent off-site from each site.

If the chemical is site-limited, you must

report the maximum concentration,

measured by percentage of weight, of

the reportable chemical substance at the

time it is reacted on-site to produce a

different chemical substance. This

information must be reported regardless

of the physical form(s) in which the

substance is sent off-site/reacted on-site.

For each substance at each site, select

the maximum concentration of the

substance from among the ranges listed

in the following table and report the

corresponding code (i.e., M1 through

M5):

CODES FOR REPORTING MAXIMUM

CONCENTRATION OF CHEMICAL SUBSTANCE

Codes Concentration Range (% weight)

M1 .............. Less than 1% by weight

M2 .............. From 1 to 30% by weight

M3 .............. From 31 to 60% by weight

M4 .............. From 61 to 90% by weight

M5 .............. Greater than 90% by weight

(viii) The physical form(s) of the

reportable chemical substance as it is

sent off-site from each site. If the

chemical is site-limited, you must report

the physical form(s) of the reportable

chemical substance at the time it is

reacted on-site to produce a different

chemical substance. For each substance

at each site, the submitter must report

as many physical forms as apply from

among the physical forms listed below:

(A) Dry powder.

(B) Pellets or large crystals.

(C) Water- or solvent-wet solid.

(D) Other solid.

(E) Gas or vapor.

(F) Liquid.

(ix) Submitters must report the

percentage, rounded off to the closest

10%, of total production volume of the

reportable chemical substance, reported

in response to paragraph (c)(3)(iv) of

this section, that is associated with each

physical form reported under paragraph

(c)(3)(viii) of this section. The sum of

the percentages reported must not add

up to more than 100%.

(4) Specific information for chemical

substances manufactured in amounts of

300,000 lbs. or more. In addition to the

information required under paragraphs

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

the following information must be

reported for each reportable chemical

substance manufactured (including

imported) in an amount of 300,000 lbs.

(136,077 kg) or more at any one site

during calendar year 2005 or during the

calendar year at 4-year intervals

thereafter. Persons subject to paragraph

(c)(4) of this section must report the

information described in paragraphs

(c)(4)(i) and (c)(4)(ii) of this section 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 reported in response to this

paragraph must be reported only to the

extent that it is readily obtainable by the

submitter. If information responsive to a

given data requirement under this

paragraph, including information in the

form of an estimate, is not readily

obtainable, the submitter is not required

to respond to the requirement.

(i) Industrial processing and use

information.

(A) A designation indicating the type

of industrial processing or use

operation(s) at each site that receives a

reportable substance from the submitter

site directly or indirectly (whether the

recipient site(s) are controlled by the

submitter site or not). For each chemical

substance, report the letters which

correspond to the appropriate

processing or use operation(s). A

particular designation may need to be

reported more than once, to the extent

that a submitter reports more than one

NAICS code (under paragraph

(c)(4)(i)(B) of this section) that applies to

a given designation under this

paragraph.

Designa- Operation tion

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) of this section. Information

about how to find these codes is

provided in the instruction booklet

available from EPA at the address set

forth in § 710.59. A particular NAICS

code may need to be reported more than

once, to the extent that a submitter

reports more than one industrial

function code (under paragraph

(c)(4)(i)(C) of this section) that applies to

a given NAICS code under this

paragraph.

(C) For each NAICS code reported

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

section, code(s) from the following list

must be selected to designate the

industrial function category(ies) that

best represents the specific manner in

which the chemical substance is used.

A particular industrial function category

may need to be reported more than

once, to the extent that a submitter

reports more than one industrial

processing or use operation/NAICS code

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combination (under paragraphs

(c)(4)(i)(A) and (c)(4)(i)(B) of this

section) that applies to a given

industrial function category under this

paragraph. If more than 10 unique

combinations of industrial processing or

use operations/NAICS codes/industrial

function categories apply to a chemical

substance, submitters need only report

the 10 unique combinations for the

chemical substance that cumulatively

represent the largest percentage of the

submitter's production volume for that

chemical, measured by weight.

CODES FOR REPORTING INDUSTRIAL

FUNCTION CATEGORIES

Codes Category

U01 .............

U02 .............

U03 .............

U04 .............

U05 .............

U06 .............

U07 .............

U08 .............

U09 .............

Ul0 .............

Ull .............

U12 .............

U13 .............

U14 ............. U15 .............

U16 .............

U17 .............

U18 .............

U19 .............

U20 .............

U21 .............

U22 .............

U23 .............

U24 .............

U25 .............

U26 .............

U27 .............

U28 .............

U29 .............

U30 .............

U31 .............

U32 .............

U33 .............

Adsorbents and absorbents

Adhesives and binding agents

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

Processing aid, not otherwise

listed

Process regulators, used in

vulcanization or polymerization processes

Process regulators, other than

polymerization or vulcanization processes

Reducing agents

Solvents (for cleaning or

degreasing)

Solvents (which become part

of product formulation or

mixture)

Solvents (for chemical manufacture and processing and

are not part of product at

greater than one percent by

weight)

Stabilizers

Surface active agents

Viscosity adjustors

Other

(D) The estimated percentage,

rounded off to the closest 10%, of total

production volume of the reportable

chemical substance associated with

each combination of industrial

processing or use operation, NAICS

code and industrial function category.

Where a particular combination of

industrial processing or use operation,

NAICS code and industrial function

category accounts for 5% or less of the

submitter's site's total production

volume of a reportable chemical

substance, the percentage must not be

rounded off to zero % if the production

volume attributable to that industrial

processing or use operation, NAICS

code and industrial function category

combination is 300,000 lbs. (136,077 kg)

or more during the reporting year.

Instead, in such a case, submitters must

report the percentage, rounded off to the

closest 1%, of the submitter's site's total

production volume of the reportable

chemical substance associated with the

particular combination of industrial

processing or use operation, NAICS

code and industrial function category.

(E) For each combination of industrial

processing or use operation, NAICS

code and industrial function category,

the submitter must estimate the number

of sites at which each reportable

chemical substance is processed or

used. For each combination associated

with each substance, the submitter must

select from among the ranges of sites

listed in the following table and report

the corresponding code (i.e., S1 through

S7):

CODES FOR REPORTING NUMBERS OF

SITES

Codes Range

S1 ............... Less than 10 sites

S2 ............... From 10 to 25 sites

S3 ............... From 25 to 100 sites

S4 ............... From 100 to 250 sites

S5 ............... From 250 to 1,000 sites

S6 ............... From 1,000 to 10,000 sites

S7 ............... More than 10,000 sites

(F) For each combination of industrial

processing or use operation, NAICS

code and industrial function category,

the submitter must estimate the number

of workers reasonably likely to be

exposed to each reportable chemical

substance. For each combination

associated with each substance, the

submitter must select from among the

worker ranges listed in paragraph

(c)(3)(vi) of this section and report the

corresponding code (i.e., Wi though

W8).

(ii) Commercial and consumer use

information.

(A) Using the codes listed in this

paragraph, submitters must designate

the commercial and consumer product

category or categories that best describe

the commercial and consumer products

in which each reportable chemical

substance is used (whether the recipient

site(s) are controlled by the submitter

site or not). If more than 10 codes apply

to a chemical substance, submitters

need only report the 10 codes for the

chemical substance that cumulatively

represent the largest percentage of the

submitter's production volume for that

chemical, measured by weight:

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) Submitters must determine,

within each commercial and consumer

product category reported under

paragraph (c)(4)(ii)(A) of this section,

whether any amount of each reportable

chemical substance manufactured

(including imported) by the submitter is

present in (for example, a plasticizer

chemical used to make pacifiers) or on

(for example, as a component in the

paint on a toy) any consumer products

intended for use by children up to the

age of 14, regardless of the

concentration of the substance

remaining in or on the product.

Submitters must select from the

following options: the chemical

substance is used in or on any consumer

products intended for use by children,

the chemical substance is not used in or

on any consumer products intended for

use by children, or information as to

whether the chemical substance is used

in or on any consumer products

intended for use by children is not

readily obtainable.

(C) The estimated percentage,

rounded off to the closest 10%, of the

submitter's site's total production

volume of the reportable chemical

substance associated with each

commercial and consumer product

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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

must not be rounded off to zero % if the

production volume attributable to that

commercial and consumer product

category is 300,000 lbs. (136,077 kg) or

more during the reporting year. Instead,

in such a case, submitters must report

the percentage, rounded off to the

closest 1%, of the submitter's site's total

production volume of the reportable

chemical substance associated with the

particular commercial and consumer

product category.

(D) Where the reportable chemical

substance is used in commercial or

consumer products, the estimated

typical maximum concentration,

measured by weight, of the chemical

substance in each commercial and

consumer product category reported

under paragraph (c)(4)(ii)(A) of this

section. For each substance in each

commercial and consumer product

category reported under paragraph

(c)(4)(ii)(A) of this section, submitters

must select from among the ranges of

concentrations listed in the table in

paragraph (c)(3)(vii) of this section and

report the corresponding code (i.e., M1

through M5).

§710.53 When to report.

All information reported to EPA in

response to the requirements of this

subpart must be submitted during an

applicable submission period. The first

submission period is from August 25,

2006, to December 23, 2006. Subsequent

recurring submission periods are from

August 25 to December 23 at 4-year

intervals after the first submission

period. Any person described in

§ 710.48(a) must report during each

submission period for each chemical

substance described in § 710.45 that the

person manufactured (including

imported) during the preceding calendar

year (i.e., the "reporting year").

§710.55 Duplicative reporting.

(a) With regard to section 8(a) rules.

Any person subject to the requirements

of this part who previously has

complied with reporting requirements

of a rule under section 8(a) of the Act

by submitting the information described

in § 710.52 for a chemical substance

described in § 710.45 to EPA, and has

done so within 1 year of the start of a

submission period described in

§ 710.53, is not required to report again

on the manufacture of that substance at

that site during that submission period.

(b) With regard to importers. This part

requires that only one report be

submitted on each import transaction

involving a chemical substance

described in § 710.45. When two or

more persons are involved in a

particular import transaction and each

person meets the Agency's definition of

"importer" as set forth in § § 710.3 and

704.3 of this chapter, they may

determine among themselves who

should submit the required report; if no

report is submitted as required under

this part, EPA will hold each such

person liable for failure to report.

§710.57 Recordkeeping requirements.

Each person who is subject to the

reporting requirements of this subpart

must maintain records that document

any information reported to EPA.

Records relevant to reporting during a

submission period must be retained for

a period of 5 years beginning with the

effective date of that submission period.

§710.58 Confidentiality.

(a) Any person submitting

information under this subpart 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 submission period. Guidance for

asserting confidentiality claims is

provided in the instruction booklet

identified in § 710.59. 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) Chemical identity. 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 subpart. The

following steps must be taken to assert

a claim of confidentiality for the

identity of a reportable chemical

substance:

(1) The submitter 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

subpart? 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? 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 listed in

paragraph (b)(1) of this section is

asserted to contain confidential business

information, the submitter must clearly

identify the information that is claimed

confidential by marking the specific

information on each page with a label

such as "confidential business

information," "proprietary," or "trade

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(c) Site identity. A submitter may

assert a claim of confidentiality for a site

only if the linkage of the site with a

reportable chemical is confidential and

not publicly available. The following

steps must be taken to assert a claim of

confidentiality for a site identity:

(1) The submitter 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 being

disclosed in connection with reporting

under this subpart? 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 listed in

paragraph (c)(1) of this section is

asserted to contain confidential business

information, the submitter must clearly

identify the information that is claimed

confidential by marking the specific

information on each page with a label

such as "confidential business

information," "proprietary," or "trade

secret."

(d) If no claim of confidentiality is

indicated on the reporting form

submitted to EPA under this subpart, 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.

§ 710.59 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 and from

the EPA Internet Home Page at http://

www.epa.gov/oppt/iur.

(b) Follow the reporting instructions.

Guidance for completing the reporting

form and preparing an electronic

(magnetic media) report will be made

available prior to each submission

period.

(c) Obtain the reporting package and

copies of the form. EPA will send a

reporting package (consisting of a copy

of Form U and a copy of the reporting

instructions) to those submitters that

reported in the IUR submission period

that occurred immediately prior to the

current submission period. Failure to

receive a reporting package does not

obviate or otherwise affect the

requirement to submit a timely report. If

you did not receive a reporting package,

but are required to report, you may

obtain a copy of the reporting package

from EPA by submitting a request for

this information as follows:

(1) By telephone. Call the EPA TSCA

Hotline at 202-554-1404.

(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, Mailcode

7408M, ATTN: Inventory Update Rule,

Office of Pollution Prevention and

Toxics, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460.

(4) By Internet. To download a copy

of the form and/or instructions go to:

http://www.epa.gov/oppt/iur.

(d) Submit the completed reports. You

must submit your completed reporting

form(s) and/or magnetic media to EPA

at the following address: OPPT

Document Control Officer (DCO),

Mailcode 7407M, ATTN: Inventory

Update Rule, Office of Pollution

Prevention and Toxics, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. Part 723 is amended as follows:

PART 723-[AMENDED]

a. The authority citation for part 723

continues to read as follows:

Authority: 15 U.S.C. 2604.

b. In § 723.175, revise paragraph (b)(3)

to read as follows:

§723.175 Premanufacture Notification

Exemptions

* * * * *

(b) Definitions. * * *

(3) The terms byproduct, EPA,

impurities, person, and site have the

same meanings as in § 710.3 of this

chapter.

[FR Doc. 02-32909 Filed 12-31-02; 9:56 am]

BILLING CODE 6560-50-S

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