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Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 710

[OPTS-82015; TSH-FRL 2710-4]

Partial Updating of TSCA Inventory

Data Base; Production and Site

Reports

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: Under the authority of

section 8(a) of the Toxic Substances

Control Act (TSCA),'15 U.S.C. 2607(a),

EPA proposes to require manufacturers

and importers of certain chemical

substances included on the TSCA

Chemical Substances Inventory to

report current data on the production

volume, plant site, and site-limited

status of the substances. EPA will use

the information collected under this rule

to update the Inventory data base and to

support activities associated with the

implementation of TSCA. This action

would not affect the status of chemical

substances listed on the Inventory. EPA

is requesting comments on this proposed

rule.

DATE: Comments must be received by

May 13, 1985.

ADDRESSES: Comments should be

forwarded to: TSCA Public Information

Office (TS-793), Office of Pesticides and

Toxic Substances, Environmental

Protection Agency, Rm. E-108, 401M

Street SW., Washington D.C. 20460.

Comments must be filed in triplicate

and must bear the identifying notation

(OPTS-82015). All written comments

filed pursuant to this notice, as well as

thq rulemaking record, will be available

for reviewing and copying in Rm. 107,

East Tower, at the address given above

from 8:00 a.m. to 4:00 p.m., Monday

through Friday except legal holidays.

FOR FURTHER INFORMATION CONTACT:

Edward A. Klein, Director, TSCA

Assistance Office (TS-7991, Office of

Toxic Substances, Environmental

Protection Agency, Rm. E-543, 401 M

Street SW., Washington, D.C. 20460, toll

free: 1800-424-9065], in Washington,

D.C.: [554-1404], outside the U.S.A.:

[Operator-202 554-1404].

SUPPLEMENTARY INFORMATION:

I. Authority

The Agency is proposing this rule

under section 8(a) of TSCA which

authorizes the Administrator of EPA to

promulgate rules under which

manufacturers, importers, and

processors of chemical substances must

submit such information as the

Administrator may reasonably require.

Failure to comply fully with any

provision of this rule would be a

violation of section 15 of TSCA and

would subject the violator to penalties

of TSCA sections 16 and 17.

It is proposed that this rule be

promulgated as an amendment to 40

CFR Part 710 which currently contains

the Inventory Reporting Regulations.

This amendment would designate

existing §§ 710.1 througth 710.8 as

Subpart A and add a new Subpart B.

II. Summary of the Rule

EPA is proposing to require

manufacturers and importers to report

current data on the production volume,

plant site, and site-limited status (i.e.,

whether a chemical substance is

manufactured and processed only

within a plant site and is not distributed

for commercial purposes as a substance

or as part of a mixture or article outside

the plant site) for certain chemical

substances included on the TSCA

Chemical Substances Inventory. For

purposes of this rule and preamble, the

term "manufacturer" includes importer,

unless otherwise specified. A person

would be considered to be a

manufacturer subject to this rule if that

person has manufactured or imported a

reportable substance in the United

States at any.time during that person's

most recent complete corporate fiscal

year preceding the effective date of a

relevant reporting period under this rule.

This rule requires both initial

reporting and subsequent reporting.

During the initial reporting period, every

manufacturer of a chemical substance

covered by this rule, unless otherwise

exempt, would be required to report on

every such substance for each plant site.

After the initial reporting, reporting

would only be required every other year

if a reportable event has occurred.

Reportable events reflect what EPA

considers as significant changes in

production volume or site-limited status

of areportable substance. Persons who

begin manufacture or import of a

reportable substance at a particular

plant site after the initial reporting

period would be required to submit an

initial report in the first subsequent

reporting period.

The substances covered by this rule

would include those that were initially

reported for the Inventory, as well as

substances added to the Inventory

following TSCA section 5(a)

premanufacture notification (PMN)

review and the Agency's receipt of a

notice of commencement of manufacture

or import: EPA proposes that four

categories of substances, though on the

Inventory, be specifically excluded from

this rule. These excluded substances are

those that are identified as polymers,

inorganic substances, microorganisms,

and naturally occurring chemical

substances, as described under

§ 710.4(b) of the Inventory Reporting

Regulations. Low-volume substances,

i.e., substances with an annual sitespecific production volume (or total

amount imported) of less than 10,000

pounds (4,540 kilograms), will generally

also be excluded from this rule.

In addition to the proposed exclusions

of substances, EPA proposes that two

categories of persons be exempt from all

reporting and recordkeeping

requirements: Small manufacturers and

persons manufacturing substances in -

limited circumstances.

The information reported under this

rule would include data on chemical

identity, plant site, annual production

volume, and site-limited status of a

reportable substance. For each

submission, EPA would also require the

name, address, and telephone number of

a person who can answer technical

questions related to the submission.

This information would be submitted on

EPA-designated reporting forms.

Persons subject to this rule .would be

required to maintain records that

support the information in their

submissions or that document a decision

not to report. Such records would be

kept for 5 years. The format for such

recordkeeping would be left up to the

individual manufacturer.

III. Background

A. Establishment of Inventory Data

Base

Section 8(b) of TSCA requires the

establishment and maintenance of an

Inventory of chemical substances in

United States commerce. To meet this

requirement, EPA promulgated the

Inventory Reporting Regulations in

December 1977. The regulations resulted

in the compilation of both the Inventory

of Chemical Substances in Commerce

and the Inventory data base.

The Inventory of Chemical Substances

in Commerce is now maintained by EPA

in the Agency's Master Inventory File

which includes approximately 60,000

substances originally reported for the

Inventory and over 1,500 substances

which have completed PMN review

under section 5(a) of TSCA and for

which a notice of commencement of

manufacture or import has been

received by EPA.

The Inventory data base compiled by

EPA currently contains only 1977

production information on the

approximately 60,000 chemical

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substances originally reported for the

Inventory, including:

1. Chemical identity data including

Chemical Abstracts Service (CAS]

Preferred or Index Names, CAS Registry

Numbers, synonyms, and, wherever

available, molecular formulas.

2.1977 manufacturing plant site name and address for each firm that-reported

in 1977 as manufacturers of one or more or the 60,000 substances originally

reported for the Inventory.

3.1977 production range for each

* chemical substance produced by each

reporting plant site.

4. 1977 manufacturing activity. i.e..

whether a submitter was a

manufacturer, an importer, or a

processor.

5. Whether the substance was sitelimited in 1977.

B. Uses of Inventory Data Base

The production volume, plant site, 5nd

site-limited status information contained

in the Inventory data base have been

used by EPA to support numerous TSCA

activities. To implement TSCA

effectively, EPA requires current

knowledge of where and in what

quantity chemical substances on the

Inventory are manufactured. This

information supports the Agency's

investigations of health and

environmental effects and'commercial

status of chemical substances and the

development of regulations under TSCA.

Production volume information is an important factor in selecting chemical

substances for attention because it gives

preliminary indications of the potential

for human and environmental exposure.

In general, EPA needs production data

to set priorities for further investigation,

to perform first-level screening of

chemical substances for testing under

TSCA section 4, to estimate, along with

other data, the potential for human and

environmental exposure to specific

substances, to support the

implementation of various TSCA

regulations, and to perform economic

impact analyses for potential TSCA

regulations.

EPA uses plant site data to identify

and communicate with manufacturers

and to estimate the extent and location

of potential exposure. Information on

whether a substance is site-limited is

also used by EPA in estimating

exposure. A site-limited substance is

presumed to have a lower exposure

potential than a substance distributed

outside the manufacturing plant site.

The nonconfidential data in the

Inventory data base have been used for'

purposes other than TSCA

implementation. For example, the

National Toxicology Program (NTP)

uses the production data as a tool in

screening chemical substances for

testing and the plant site data to identify

and communicate with manufacturers.

The EPA Office of Solid Waste and

Emergency Response has used the data

base to identify manufacturers of

various chemical substances under

study and to estimate amounts

produced. EPA Headquarters and

Regional Offices use the nonconfidential

data to respond to inquiries from State

governments, industry, and the public,

and to support TSCA compliance

monitoring activities.

A more detailed discussion of the

various uses of Inventory data can be

found in a supporting document

included in the rulemaking record for

this rule.

IV. Need for Updating Inventory Data

Base

Data proposed to be gathered under

this rule would be used by EPA to

update a portion of the Inventory data

base. EPA needs an accurate and

readily available source for basic

information for a significant number of

the substances listed on the Inventory.

EVA has not been able to identify an

alternate data source that can provide

the Agency with adequate information

in an accurate, complete, and costeffective manner.

This rule would also enable EPA to

obtain current production volume

information for certain substances

added to the Inventory following the

completion of section 5 PMN review and

the Agency's receipt of a notice of

commencement of manufacture or

import. At the present time, the

Inventory data base contains production

volume data for only the substances

originally reported for the Inventory. For

the substances submitted under section

5, production estimates, rather than

actual production volumes, are reported.

These estimates are not included in the

Inventory data base. The actual

production volume information that

would be reported under this rule will

be added to the Inventory data base and

will be used by the Agency to set

priorities for further investigation of

these substances.

A. Age of Inventory Data Base

Since the Inventory data base

contains only information from 1977, the

accuracy of the data has been

diminishing significantly with time. The

growing obsolescence of the Inventory

data base has become a matter of

increasing concern to EPA. For any of

the regulatory purposes previously

described, it is important for the Agency

to be able to determine quftkly,

accurately, and efficiently who produces

these chemical substances, where they

are produced, and in what quantities.

The Inventory data base should be the

logical data base from which to obtain

such basic information. Unfortunately, it

cannot now be relied upon for accurate

information because the data have

become increasingly outdated.

Over the past several years, evidence

of significant changes in the production

volume and plant site for many

Inventory substances has been

observed. For example, the Interagency

Testing Committee (ITC) uses the

production ranges in the Inventory data

base as its first-level screening for

candidate substances for testing under

TSCA section 4. The ITC has found

changes in both the manufacturing plant

sites and production ranges for many

chemical substances reviewed for

testing. These changes have complicated

the ITC's initial screening process and

have complicated the ITC's initial

screening process and have forced the

ITC and EPA to spend additional time

and resources verifying the data listed

in the Inventory data base and

attempting to obtain current

information. Such efforts are not costeffective and do not always produce

adequate information.

Similarly, EPA discovered that the

plant site information in the Inventory

data base was not reliable when the

Agency attempted to identify and

contact manufacturers who would be

subject to reporting under the section

8(a) Preliminary Assessment

Information Rule (40 CFR Part 712].

Major discrepancies were also evident

when production volume data collected

under the Preliminary Assessment

Information Rule were compared against

the corresponding production ranges

reported for the Inventory data base.

There have been numerous instances

in which the Inventory data base has

been identified as not providing

accurate information on a particular

chemical substance when such

information was needed by EPA for

TSCA purposes. In some cases, EPA

was compelled to promulgate chemicalspecific section 8(a) rules to monitor the

production level of these substances.

The lack of readily available current

production data on these substances

has, therefore, complicated the Agency's

investigations of chemical substances,

compelled the Agency to obtain current

information in a resource-intensive and

inefficient manner..

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B. Alternate Sources and Their

Limitations

1. Alternate sources. EPA has

attempted to obtain current production

volume and plant site information, on a

case-by-case basis, directly from

industry, through the use of contractors,

and from other existing sources such as:

a. "The SRI Directory of Chemical

Producers (DCP)."

b. "Synthetic Organic Chemicals:

United States Production and Sales

(SYNORG)."

c. "Chemical Economics Handbook

(CEH}."

d. "Chemical Marketing Reports."

e. "Chemical Industry Notes."

f. Existing internal sources maintained

by EPA and other Federal agencies.

2. Limitations. The use of sources

other than the Inventory data base has

three major limitations.

First, many existing sources of similar

information, whether compiled by

Government or commercial entities,

often do not provide adequate

information for EPA's needs under

TSCA. Sources other than the Inventory

usually contain information on only a

limited number of substances. To use

production data as a tool in chemical

screening, EPA needs a data base which

provides .readily available information

for the many thousands of substances

over which EPA has jurisdiction under

TSCA. A case-by-case search for

information would be impractical and

costly because of the large number of

substances involved.

Second, the information from other

sources is often not comprehensive or

reliable, does not always relate to

specific plant sites, often pertains to

product classes rather than specific

substances, and, in certain cases,

represents plant capacity rather than

actual production volume.

Third, certain data bases compiled by

other Government agencies often

contain company proprietary

information which cannot be readily

made available to EPA.

V. Substances Covered by the Rule

Reportable substances under this rule

would include only those that are listed

in the Agency's Master Inventory File as

of the time of reporting and that are not

specifically excluded from this rule.

Substances which were originally

excluded from the initial Inventory

under 40 CFR 710.2 would therefore not

be reportable under this rule. For

example, any pesticide when

manufactured, processed, or distributed

in commerce for use solely as a

pesticide would not be reportable.

Prior to the effective date of the final

rule, EPA may publish an updated

Inventory which will list most of the

specific or generic. chemical names of

both substances initially reported for the

Inventory and substances subsequently

added to the Inventory. Since EPA

continually adds to the Master " Inventory File substances that have

undergone PMN review and that are

subsequently reported as manufactured

or imported, the Agency may publish

supplements to the Inventory from time

to time covering additions to the Master

Inventory File since a previous

publication. Substances added to the

Master Inventory File after the

beginning of a reporting period would

become reportable in the next reporting

period, unless otherwise excluded from

this rule.

VI. Substances Excluded From the Rule

EPA proposes that four categories of

substances, although included on the

Inventory, be excluded from reporting

under this rule. The purpose of these

exclusions is to focus the information

collection effort under this rule on those

substances for which the Agency has

the greatest need for current

information. The four categories of

substances proposed for exclusion are

polymers, inorganics, microorganisms,

and naturally occurring chemical

substances. These categories are

described below:

A. Polymers

The Inventory covers approximately

15,500 synthetic polymers and

biopolymers. Most polymers can be

identified in the Inventory's "Chemical

Substance Identities" section or in the

Agency's Master Inventory File with the

words "polymer(s)" or "polymerized," or

the prefix "poly" appearing in the

corresponding Chemical Abstracts

Service (CAS) Index or Preferred

Nomenclature for that substance. EPA

believes that the overwhelming majority

of the synthetic polymers and

biopolymers on the Inventory can be so

identified. The few synthetic substances

that may be borderline polymeric are

named differently on the Inventory and

would not, therefore, be excluded from

this rule.

.However, certain biopolymers which

are not always identifiable by the terms

"polymer(s)," "polymerized," or "poly"

would also be excluded from reporting

under this rule. These substances are

identified in the hierarchy of subset

headings for the Inventory's UVCB

section (i.e., Chemical Substances of

Unknown or Variable Composition,

Complex Reaction Products, and

Biological Materials). These

biopolymers are proteins (albumin,

casein, gelatin, gluten, hemoglobin),

enzymes, polysaccharides (starch,

cellulose, gums), rubber, or lignin.

Furthermore, biopolymers which have

been chemically modified to the extent

that the polymeric structure still remains

substantially intact would not be

reportable.

EPA's approach to identifying

polymers for purposes of this exclusion

is intended to be relatively simple, so

that a quick determination of whether a

substance is a polymer can be made. An

Inventory listing of a polymer could

represent a group of polymers with the

same constituent monomers,

irrespective of the proportion of the

monomers or chain structure. A more

sophisticated definition that would

characterize individual polymers based

on such criteria as chain structure or

molecular weight variations would make

a polymer determination more difficult,

especially in view of how polymers are

listed on the Inventory. The Agency

believes that this increased

administrative burden would

substantially reduce the benefit of the

exclusion.

EPA proposes to exclude polymers

from the proposed rule for two reasons.

First, only a small percentage of the

polymers reported under the PMN rule

are selected for detailed review because

of concern about their toxicity,

exposure, or use. Second, it appears

unlikely that EPA will use production

volume as a means to perform

preliminary screening of polymers for

further investigation under the existing

chemicals review program. Some of the

polymers that may become a matter of

concern would most likely be identified

by other criteria such as toxicity or use.

Therefore, there is no need to use this

rule to collect production volume and

plant site data on all polymers listed on

the Inventory, when only a small

number of these substances may be

assessed further under TSCA. In cases

in which production volume and plant -

site data are needed for specific

polymers, EPA could use the authority

of a chemical-specific section 8(a) rule

to obtain the information after those

polymers have been identified.

B. Inorganic Substances

For purposes of this proposed rule,

inorganic chemical substances are

substances that do not contain a carbon

atom, or contain carbon only in the form

of carbonato, cyano, cyanato, isocyano,

or isocyanato groups, or the chalcogen

analogues of these groups. Inorganic

substances on the Inventory can be

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easily identified and include

approximately 3,000 substances.

The inorganic chemical substances

are proposed for exclusion for reasons

somewhat similar to those for excluding

polymers. The hazard potentials of

many inorganic substances are

relatively well-established. Thus, it is

unlikely that the Agency would use

production volume as'a means to

perform preliminary screening of

inorganic substances. When production

data are needed on specific inorganic

substances or groups of inorganic

substances, EPA could use the authority

of a chemical-specific, section 8(a) rule

to collect the required information.

C. Microorganisms

EPA is pioposing to exclude from

reporting under this rule about 200

substances that are classified on the

Inventory as microorganisms. For

purposes of this rule, this category

includes bacteria, fungi, and yeasts

which are easily identifiable in the

hierarchy of subset headings for the

Inventory's UVCB section and are also

identified on the Inventory by their

corresponding CAS Preferred Names

which are usually standard names for

the species. Products of microorganisms

are, however, reportable unless

otherwise excluded.

Microorganisms are proposed for

exclusion under this rulebecause EPA is

formulating its policy in the area of

biotechnology, and TSCA information

requirements for microorganisms are

still being determined. Therefore, it

would not be necessary to collect sitespecific production data for

microorganisms at this time. Information

requirements relative to microorganisms

will be addressed under a separate rule.

D. Naturally Occurring Chemical

Substances

The Inventory includes a group of

substances which may be naturally

occurring, as described in § 710.4(b) of

the original Inventory Reporting

Regulations. These substances were not

reportable under the Inventory

Reporting Regulations, although they. are

included on the Inventory. For this

reason, EPA is proposing to exclude

from this rule all naturally occurring

chemical substances produced as

described in § 710.4(b). However,

persons who produce a substance in a

manner other than as described in

§ 710.4(b) would be required to report.

This proposed exclusion would cover

chemical substances which are naturally

occurring and which are unprocessed or

processed only by manual, mechanical,

or gravitational means, by dissolution in

water, by flotation, or by heating solely

to remove water or which are extracted

from air by any means. Examples of

such substances include raw agricultural

commodities, water, air, natural gas,

crude oil, minerals, ores, and rocks.

E. Other Possible Exclusions

In addition to the four categories of

substances proposed for exclusion, EPA

is alsoconsidering excluding other

categories of substances from this rule.

The possible candidates for exclusion

include those substances that are

petroleum refinery streams and wastes,

as well as other UVCB substances. EPA

invites public comments on these

additional categories.

VII. Persons Subject to the Rule

Except for those described in Unit VIII

below, a person would be considered to

be a manufacturer subject to this rule if

that person has manufactured or

imported for commercial purposes a

reportable substance at any time during

that person's most recent complete

corporate fiscal year immediately

preceding the effective date of the rule

or any subsequent reporting period. For

example,if the effective date of the

initial reporting period were January 1,

1986, and a company's fiscal year begins

on October 1, the most recent corporate

fiscal year for that company would be

October 1, 1984, through September 30,

1985.

A person who has reported

manufacture or import of a reportable

substance under the rule but has

subsequently discontinued such

manufacture or import is considered to

be a manufacturer subject to this rule for

the next reporting period.

This rule includes an initial reporting

period and subsequent reporting

periods, as discussed in Unit IX of the

preamble. In general, all persons subject

to the rule would be required to report

for the initial reporting. Subsequent

reporting will be required only when one

of the reportable events, as discussed in

Unit IX, occurs.

VIII. Persons Exempt From the Rule

EPA is proposing that two categories

of persons be exempt from the reporting

and recordkeeping requirements of this

rule if they qualify for one of the

proposed exemptions at the time of

reporting.

A. Small Manufacturers

EPA is proposing that small

manufacturers (including importers) of

reportable chemical substances be

exempted from all reporting and

recordkeeping requirements of this rule

except with respect to those who

manufacture or import chemical

substances regulated under TSCA

section 5(e). the purpose of this

exemption is to reduce the paperwork

burden on small chemical

manufacturers, while ensuring that

EPA's basic information requirements

will be satisfied.

Persons would qualify as small

manufacturers under this rule if, at the

time of reporting, they meet one of the

two standards specified in the recently

promulgated TSCA section 8(a) Small

Manufacturers Exemption Rule (40 CFR

Part 704). These two exemption

standards are as follows:

1. First standard. A chemical

manufacturer would qualify as "small"

under this standard if the total annual

sales of all plant sites that it owns or

controls (together with those that are

owned or controlled by its foreign or

domestic parent company, if any) are

less than $40 million. However, if a

manufacturer with total annual sales of

less than $40 million produces annually

over 100,000 pounds (45,400 kilograms)

of a particular chemical substance at a " particular plant site, that manufacturer

will not qualify as small with regard to

that chemical substance at that plant

site.

Under this first standard, a company

that meets the sales criterion for small

but does not meet the volume criterion

for all of its sites will be subject to

reporting or recordkeeping for a

particular chemical substance only for

sites producing 100,000 pounds or more

of the chemical substance per year.

2. Second standard. A chemical

manufacturer would qualify as small if

the total annual sales of all plant sites

that it owns or controls (together with

those that are owned or controlled by its

foreign or domestic parent company, if

any) are less than $4 million, regardless

of the quantity of chemical substances

produced by that manufacturer.

For purposes of these two standards,

total annual sales would mean the total

revenue generated by the sale of all

products, including non-chemical

products, that are produced at a plant

site. EPA will consider periodically

adjusting, as necessary, the sales values

of both standards to allow for inflation

after the promulgation of this rule. The

Agency will use an index from the

Bureau of Labor Statistics (BLS) for this

purpose: the Producer Price Index for

Chemicals and Allied Products.

Similarly, EPA recognizes the possibility

that the sales values may also be

subject to deflationary economic trends.

The Agency could adjust the sales

values downward if significant deflation

were to occur.

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Companies would use the corporate

fiscal year as the 12-month period for

which both annual sales and production

volume are to be calculated. In the first

standard, annual production volume

would mean the total amount of a

chemical substance produced or

imported during the designated 12

month period..

A parent mahufacturing company

would be one which owns or controls

another company. Ownership or control

would exist when one company owns 50

percent or more of another company's

voting stock or other equity rights, or

has the power to control the

management and policies of the other

company. This proposed definition is

drawn from the 1977 Economic Census

Report of Organization of the United

States Department of Commerce.

B. Persons Manufacturing Substances in

Limited Circumstances

EPA is proposing to exempt from this

rule persons who manufacture

reportable substances either in limited

ways or through coincidental

manufacture. Section 704.5(a) of the

general section 8(a) rules exempts

persons who manufacture or import

substances solely for research and

development; § 704.5(c) exempts persons

who import substances as part of

articles. EPA is proposing that these two

exemptions apply to this rule without

change.

For the original Inventory Reporting

Regulations and for the PMN rule, EPA

recognized that chemical substances are

often manufactured incidental to

another operation or upon end use of

another substance or mixture. For

example, a paper carton producer

applies adhesives and inks during the

carton-making operation and other

chemical substanecs are formed

coincidentally as these adhesives and

inks dry. EPA has exempted such types

of "manufacture" from the original

Inventory reporting and from PMN

requirements. Accordingly, EPA is

proposing to exempt these types of "manufacture" from'this rule as well,

because EPA believes that it does not

need information on such coincidental

manufacture to update the Inventory

Data Base.

Section 720.30(g) of the PMN rule

would apply to this rule exempting

manufacture of byproducts which are used only as a fuel, which are disposed

of as a waste, or from which component

chemical substances are extracted.

Section 720.30 (h) would also apply,

exempting manufacture of impurities

and substances from reactions upon end

use, as well as nonisolated

intermediates.

IX. Whether To Report

A. Initial Reporting

For the initial reporting period, all

manufacturers who are subject to this

rule would be required to report on

every reportable substance

manufactured at each particular plant

site. If a person later begins to

manufacture or import for commercial

purposes a reportable substance at a

plant site, that person would submit an

initial report for that substance and

plant site during the next reporting

period. The initial reporting would

enable EPA to establish a base line of

current information on those substances

that are in commercial production.

B. Recurring Reporting

After the initial reporting period,

reporting would be required every 2

years if one of the reportable events

occurred during the most recent

complete corporate fiscal year preceding

a relevant reporting period. For purposes

of this rule, reportable events reflect

what EPA considers as significant

changes in production volume, or sitelimited status of a reportable slibstance.

Based on its experience with the 1977

Inventory data, EPA estimates that

approximately 12.5 percent of the

production and site information in the

Inventory data base would become

obsolete each year. The Agency,

therefore, believes that the 2-year

reporting interval would be reasonable,

since this would enable the Agency to

maintain a relatively current data base

without imposing an unreasonable

reporting burden on industry.

For purposes of this proposed rule,

reportable events that would trigger

reporting after the initial reporting are

defined as follows:

1. Production volume. For reportable

substances with a previously reported

annual production volume of 10,000

pounds or more, a reportable event

would occur when the previously

reported site-specific production volume

or the total quantity imported of a

substance increases or decreases by 5-

fold or more. EPA believes that such a

magnitude of change is significant in

terms of exposure potential. When there

is a 5-fold, i.e., 500 percent, increase in

production volume of a substance, the

Agency believes that such a substantial

increase in production volume would

result in a higher exposure potential for

the substance. In the case of a 5-fold,

i.e., 80 percent, decrease in production

volume of a substance, the Agency

believes that its concern would be

reduced, and priorities for regulatory

actions may change as a result.

If a reportable substance is produced

at 10,000 pounds or more at a given

plant site for the first time since the

previous reporting period, this fact

would constitute a reportable event for

the next reporting period. Similarly, if

production of a reportable substance

ceases at a given plant site during the 2

fiscal years since the previous reporting

period, that fact would be reportable for

the next reporting period. No further

reporting would be required unless and

until commercial production of that

substance has resumed at that plant site

at 10,000 pounds or more.

2. Site-limited status. A reportable

event would occur when a substance

previously reported as site-limited is

distributed outside that specific plant

site for commercial purposes for the first

time, or when a previously distributed

substance covered by this rule becomes

site-limited for the first time.

C. Low- Volume Threshold

EPA is proposing to establish a lowvolume threshold by exempting from

initial reporting substances produced at

low volumes. For purposes of this rule, if

the site-specific annual production

volume or the total amount annually

imported for a substance is below 10,000

pounds, no initial reporting would be

required. If a person's site-specific

annual production volume or total

amount annually imported increases to

10,000 pounds or more after the close of

the initial reporting period, the person

would be required to comply with the

reporting requirements of this rule for

that substance in the first subsequent

reporting period.

EPA's reason for exempting lowvolume substances from this rule is

based on its information need. Although

EPA may need production volume

information for certain low-volume

substances, it appears unlikely that the

Agency will need readily available

production volume information as a

general tool to screen these substances

for further investigation. When

production volume information is

needed for certain low volume

substances, EPA could use the authority

of a chemical-specific 8(a] rule to collect

the required information. EPA believes

that this exemption is reasonable and

consistent with the Agency's past efforts

in exempting low-volume substances

from the requirements of other rules

promulgated under TSCA.

X. What To Report

Persons who are subject to this rule

would be required to report by

completing an EPA-designated reporting

form. Proposed reporting forms are

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included in § 710.39 of the proposed rule.

Detailed instructions for filling out the

reporting forms will be made available

prior to the effective date of the final

rule.

There are two different versions of the

reporting form, each containing four

parts. The first version of the form, U-1,

would be used by persons i'eporting

information on substances whose

identity is not confidential at the time of

reporting or will not remain confidential

on the Inventory. The second version of

the form, U-2, would be used only by

persons reporting information on

chemical substances whose identity will

remain confidential on the Inventory.

Parts 1, 11, and III of the reporting form

include the certification to be signed by

the submitter and require the reporting

of other basic submitter information.

Part IV of the form would be used to

indicate whether the submission is an

initial reporting or a reporting of

changes. The extent to which Part V of

the form would be completed would

depend on the number of chemical

substances reported on that form.

EPA is also examining the feasibility

of allowing certain submitters to report

by computer tapes. If EPA determines

that reporting in this manner is a

feasible approach, it will provide, prior

to the effective date of the final rule,

complete instructions stipulating the

format specifications for preparing such

computer tapes.

The information requirements for this

rule are discussed below. In most cases,

a submitter would provide fiscal

information for the most recent complete

corporate fiscal year preceding the

relevant reporting period, unless

otherwise stated in this rule.

A. Chemical Identity

For each chemical substance covered

by this rule, a submitter would be

required to provide a specific chemical

name, a CAS Registry Number, and/or

other identifying numbers used on the

Inventory. Persons would check the

published Inventory to obtain the

correct name and Registry Number for

their substances. If the identity of a

substance is confidential, a submitter

would consult the generic names section

of the published Inventory to obtain an

EPA-designated Accession Number for

that substance. If a person is uncertain

whether a reportable substance is

covered by one of the generic names, the

person would have to contact EPA using

the bona fide procedures in § 710.7(g) of

the .Inventory Reporting Regulations or'

§ 720.25(b) of the PMN rule to determine

whether the substance in question is

reportable.

B. Plant Site

Importers would report by their

United States headquarters. Each

manufacturer would be required to

report by specific plant site name and

street address.

Certain manufacturers were permitted

to report for the original Inventory by

corporate headquarters, business or Post

Office Box addresses, or through trade

associations and other agents. EPA has

found that data on specific plant sites

are much more useful to the Agency.

Plant site data usually enable the Ageny

to develop a more accurate estimation

of potentially exposed populations and

to identify and communicate with

manufacturers of chemical substances

more easily.

C. Production Volume

Manufacturers would be required to

report the quantity of the substance

manufactured at each plant site in

separate reports, importers would be

required to report the total quantity

imported, regardless of destination, and

the information would be reported in

pounds. Although EPA does not plan to

prescribe specific accuracy ranges for

reporting quantities, a submitter should

provide the best available information,

i.e., production figures normally

maintained at a plant site for business

purposes and known to, or reasonably

ascertainable by, a submitter as

specified in section 8(a)(2) of TSCA.

Reporting of inaccurate data would

constitute a violation of the rule and

would subject the violator to EPA

enforcement actions.

EPA is proposing that precise

production data, rather than production

ranges, be reported under this rule

because in many applications the

Agency has found that the production

ranges reported for the 1977 Inventory

data base create a certain degree of

uncertainty in estimating exposure. This

uncertainty is compounded when

information from different plant sites is

aggregated. Precise production data

would minimize the uncertainties

prevalent in the Agency's use of the 1977

Inventory production data.

The use of narrower ranges was

considered by EPA as an alternative to

the wide ranges used for the 1977

Inventory. EPA has not adopted that

approach because the Agency believes

that production data are not maintained

by industry in ranges. Thefefore, the

reporting of precise production data

would not be more burdensome to the

submitters and would provide the

Agency with more useful information.

D. Site-Limited Status

Manufacturers would be required to

indicate whether a chemical sabstance

manufactured at a plant site is

distributed for commercial purposes

outside that site, including as part of

mixtures or articles.Imported

substances could not be site-limited.

E. Technical Contact

Persons reporting under this rule

would be required to identify the name,

address, and telephone number of an

individual who can answer questions

concerning the information on the

reporting form. This information would

be used by EPA to*resolve reporting

errors or technical problems related to

the submission.

XI. Reporting Period

As discussed above, after the initial

reporting, reporting of changes would

occur at two-year intervals. EPA is

proposing an initial reporting period of

120,days beginning on the effective date

of the rule. EPA believes that such a

period will be sufficient for initial

reporting. In subsequent reporting years

EPA is proposing a reporting period of

only 60 days because the volume and

burden of reporting would be

significantly reduced. Subsequent

reporting periods would begin on the

anniversary of the effective date of the -

rule every two years.

XII. Confidentiality

A. Asserting Claims

Submitters would be permitted to

claim information submitted to EPA

under this rule as confidential if release

of the information Would reveal trade

secrets or confidential commercial or

financial information, as provided by

section 14 of TSCA. Claims of

confidentiality could be asserted only at

the time information is submitted to EPA

and only in the manner specified in the

rule. EPA's procedures for processing

and reviewing confidentiality claims are

set forth at 40 CFR Part 2, Subpart B.

Any information submitted under this

rule could be claimed as confidential,

even if the same or similar information

(except chemical identity) was not so

claimed during reporting for the initial

Inventory. However, EPA would

strongly encourage submitters to review

their claims carefully to ensure that the

information in question falls within the

protection of section 14 of the Act and to

limit claims as much as possible.

To claim information as confidential,

a submitter would check the appropriate

box and sign the certification statement

on the reporting form. If a submitter

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failed to do so, EPA would release the

information to the public without further

notice to the submitter. As in reporting

under the fnitial Inventory Reporting

Regulations, by signing the certification

statement the submitter would certify

that its claims of confidentiality are

made in good faith afid that the four

statements on the back of the form are

true for each claim. Procedures for

claiming as confidential information

submitted by computer tapes will be

specified'at the time of the final rule, if

EPA determines that reporting in'this

manner is feasible.

Companies that assert claims of

confidentiality for chemical identity

would follow the procedures set forth in

the next section.

B. Chemical Identity

A submitter under this proposed rule

could not assert a claim of

confidentiality for specific chemical

identity of a substance unless the

chemical identity is held confidential on

the Inventory as of the time of the

report. All submitters reporting

information on a confidential substance

would be required to use the EPA

reporting form U-2 specially designed

for reports on confidential substances

and to check the appropriate box

indicating a confidentiality claim for

chemical identity. Chemical identity information reported on Form U-1

would be nonconfidential and would be

released by EPA without prior

notification to the submitter.

To assert a claim of confidentiality for

the identity of a chemical substance

which is confidential on the Inventory,

the person would also be required to

substantiate the claim by answering in

writing certain questions in §710.39 of

the proposed rule. These questions are

similar to those used for substantiating

claims of confidentiality for chemical

identity for the original Inventory

Reporting Regulations and for the PMN

rule. Persons who reported for the

original Inventory and persons whose

substances underwent PMN review and

were subsequently reported as

manufactured or imported asserted and

substantiated their claims of

confidentiality for chemical identity at

that time. Since considerable time has

passed since those claims were

substantiated, EPA is proposing that

those original submitters, as well as any

new manufacturers of a given substance

who report under this rule would be

required to substantiate claims of

confidentiality for specific chemical

identity at the time of reporting under

this rule. When a person submits a

report of changes in production volume

or site-limited status of a substance

under this rule, the person would be

required to substantiate the claim again.

However, if circumstances with regard

to the claim of confidentiality have not

changed, such a substantiation could be

submission of a copy of the previous

substantiation.

If a manufacturer reports under this

rule a chemical substance whose

identity is held confidential on the

inventory, and the manufacturer does

not claim the chemical identity

confidential, EPA will consider the

identity of that substance no longer

confidential for purposes of the

Inventory because the fact that someone

is manufacturing or importing it for

commercial purposes is not confidential..

In-such a situation, EPA would inform

all those persons who report the

substance under this rule and who

reported for the Inventory or under PMN

that the substance identity will no

longer be held confidential on the

Inventory or in the data base. This

policy is consistent with the policy

adopted for the original Inventory

reporting.

EPA strongly'encourages persons who

asserted claims of confidentiality for

chemical identity for substances they

reported for the Inventory to reconsider

the necessity of retaining those claims. If

a person decides not to assert again a

claim of confidentiality for the identity

of a substance which is on the

Inventory, that person would report

information on the substance on EPA

reporting form U-1.

C. Release of Data

EPA will continue to provide the

public with sufficient and informative

access to information collected for the

Inventory data base while protecting

submitters' valid proprietary interests.

This will be accomplished by disclosing

to the public all information reported

that is not claimed as confidential and

continuing to release aggregates of

confidential production information. By

releasing aggregate data, the Agency is

able to share with the public at least

general information about industry-wide

production totals for Inventory

substances. EPA is devising a data

aggregation methodology that is

sensitive to the specific production

levels and changes reported under this

rule.

XIII. Recordkeeping Requirements

EPA is proposing that persons subject

to this rule be required to maintain

records that document any information

reported or a decision not to report for

up to a 5-year period after the creation

of these records. For example, if a

person had determined that reporting

was not necessary for a reporting period

because the production volume of a

substance did not change sufficiently to

' be a reportable event, that person would

be required to retain records supporting

that determination for a 5-year period.

EPA believes that the types of

information being requested under this

rule are readily available to a submitter,

and that the records supporting

reporting under the proposed rule will

be records that the submitter would

normally retain in the course of

conducting business.

XIV. Economic Impact

Based on the proposed exclusions and

exemptions discussed in this preamble,

EPA believes that approximately 15,000

chemical substances would be covered

by this rule. EPA estimates that a total

of 4,600 plant sites would be required to

submit an initial report and that

approximately 25 percent of these sites

would be required to report in a

subsequent reporting period.

EPA estimates that chemical

manufacturers subject tQ this rule will

spefid a maximum of $5.184 million to

.report for the initial reporting period.

These estimates include both fixed and

variable costs.

The fixed costs per plant site to

comply with the initial reporting

requirements of this rule are estimated

at $911. This includes time to become

familiar with the reporting requirements,

time to determine which of the

substances produced at that site is

covered by the rule, and time to develop

an ongoing reporting mechanism.

Maximum variable costs of compliance

with the initial reporting are estimated

at an additional $242 per reporting form

that must be submitted. The variable

costs include time to gather necessary

data, and time to complete and review a

reporting form including a determination

of whether the information should be

claimed as confidential. '

The fixed and variable cost estimates

were based on the number of hours that

would be required to complete a

reporting form. EPA estimates an

average of 19 hours for a submitter to

become familiar with the rule, determine

which of the substances produced at a

plant site is reportable, and develop a

reporting mechanism. An additional 4.6

hours are estimated for a submitter to

gather the necessary information-and to

complete and review a reporting form.

At an average of one report per plant

site, these estimates allow 23.6 hours for

an average plant site's compliance. This

figure could be lower or higher

depending on the number of forms

involved at a plant site.

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For a subsequent reporting period, all

plant sites manufacturing a reportable

substance would have to make a

determination of whether a reportable

change has .occurred during the specified

period. EPA estimates that only 25

percent of these plant sites would be

required to report changes. The total

cost to manufacturers who must report

during a subsequent reporting period is

estimated to be $201,000. This estimate

includes both the cost for making the

determination and for gathering

information and completing a reporting

form. Additionally, the total cost to the

75 percent of non-reporting plant sites

that have to make a determination is

estimated to be $418,000.

A more detailed economic impact

analysis of the requirements of this rule

is included in the rulemaking record.

XV. Alternatives

In developing its approach for

updating the TSCA Inventory data base,

EPA reviewed a number of options

ranging from a complete update of the

entire Inventory data base to no update.

In its evaluation of the various options,

EPA considered the need for current

information and the cost to the Agency

for obtaining the required information as wdll as the reporting burden on industry.

EPA believes that the proposed

approach will provide the Agency with

adequate, but not unnecessary,

information that it needs to conduct its

activities under TSCA, while not

imposing any unreasonable burden on

industry or the Agency.

A possible alternative that EPA may

consider would require manufacturers

subject to this rule to submit information

if a reportable event has occurred within

a three year period. As compared with

the proposed approach, recurring

reporting under this option would occur less frequently and thus the burden

imposed on manufacturers would be

reduced; however, this option would

result in the Inventory data base being

less accurate (by the third year

approximately 37.5 percent of the

Inventory data base would be out of

date). Thus, EPA believes that the threeyear interval may not represent the most

appropriate balance between

maintaining a relatively current data

base and minimizing excessive reporting

burden.

Another alternative that EPA may

consider and would require

manufacturers subject to this rule to

automatically submit current

information all reportable substances

every three years. Since recurring

reporting under this option would not be

triggered by the occurrence of a

reportable event, there would be more

reports. However, manufacturers would

not have to determine whether recurring

reporting is necessary and this may

further simplify the recordkeeping

procedures. EPA invites public

comments on these reporting

alternatives.

A discussion of other alternatives

considered but not adopted by EPA is

included in a supporting document in the

rulemaking record.

XVI. Rulemaking Record

The record for ihis proposed

rulemaking includes basic information

considered by the Agency in developing

this proposed rule. The following

documents are included in the

rulemaking record:

(1) Analysis of reporting requirements

for the partial update of the TSCA

Inventory Data Base.

(2) Whether and how the TSCA

Inventory Data Base should be updated. (3) Analysis of TSCA section 8(a)

Small Manufacturer Exemption.

The Agency will supplement the

record with the following types of

additional information as they are

received or developed:

1. All comments on this proposed rule.

2. All relevant support documents and

studies.

3. Records of all communications

between EPA personnel and persons

outside the Agency pertaining to the

development of this rule. (This does not

include inter- or intra-agency

memoranda unless specifically noted in

the index of the rulemaking record.)

4. Minutes, summaries, or transcripts

of any public meetings held to develop

this rule.

5. Any factual information considered

by the Agency in developing the rule.

EPA will identify the complete

rulemaking record on or before the date

of promulgation of the rule, as

prescribed by section 19(a)(3) of TSCA,

and will accept additional material for

inclusion in the record at any time

between this notice and that date.

XVII. Judicial Review

When this proposed rule is

promulgated, judicial review may be

available under section 19 of TSCA in

the United States Court of Appeals for

the District of Columbia Circuit or for the

circuit in which the person seeking

review resides or has his principal place

of business. To provide all interested

persons an equal opportunity to file a timely petition for judicial review and to

avoid so-called "races to the

courthouse," EPA intends to promulgate

this rule for purposes of judicial review

two weeks after publishing the final rule

in the Federal Register. The effective

date will be calculated from the

promulgation date.

XVIII. Regulatory Assessment

Requirements

A. Executive Order 12291

Under Executive Order 12291, EPA

must determine whether a regulation is "major" and therefore requires a

Regulatory Impact Analysis. EPA has

determined that this proposed regulation

is not "major" because it will not have

an annual effect of $100 million or more

on the economy. It is not anticipated to

have a significant effect on competition,

costs, or prices.

This regulation was submitted to the

Office of Management and Budget

(OMB) for review as required by

Executive Order 12291.

B. Regulatory Flexibility Act

This rule contains a small

manufacturer exemption which would

exempt small manufacturers from all

reporting requirements. Therefore, in

accordance with the Regulatory

Flexibility Act, 5 U.S.C. 601 et seq., EPA

has determined that this rule will not

have a significant economic impact on a

substantial number of small entities.

C. Paperwork Reduction Act

The information collection

requirements contained in this proposed

rule have been submitted for approval to

OMB under the provisions of the

Paperwork Reduction Act of 1980, 44

U.S.C. 3501 et seq. Comments on the

information collection request (not on

the substantive content of the rule itself)

should be submitted to the Office of

Information and Regulatory Affairs of

OMB, marked "Attention: Desk Officer

for EPA." The final rule will respond to

any OMB or public comments on the

information collection requirements.

(Sec. 8 (a), Pub. L. 94-469, 90 Stat. 2027 (15

U.S.C. 2607)) '

List of Subjects in 40 CFR Part 710

Environmental protection, Chemicals,

Inventory, Hazardous materials,

Recordkeeping and reporting

requirements.

Dated: March 3, 1985.

Lee M. Thomas,

A dministrator.

PART 710-[AMENDED]

Therefore, it is proposed that Part 710

be amended as follows:

§§ 710.1-710.8 (Designated as Subpart A)

1. By designating the existing § §.710.1

through 710.8 as Subpart A, entitled:

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Subpart A-Compilation of the

Inventory

2. By.adding a new Subpart B to read

as follows:

Subpart B-Partial Updating of the

Inventory Data Base

Sec.

710.23 Definitions.

710.25 Chemical substances to be reported.

710.27 Persons subject to this subpart.

7.10.28 Persons not subject to this subpart.

710.30 Reporting requirements.

710.33 Recordkeeping requirements.

710.38 Confidentiality.

710.39 Reporting forms.

(Sec. 8(a), Pub. L. 94-469, 90 Stat. 2027 (15

U.S.C. 2607))

Subpart B-Partial Updating of the

Inventory Data Base

§ 710.23 Definitions.

The definitions in § 704.3 of this

chapter and § 710.2 apply except as

provided in this section.

(a) "Manufacturer" means a person

who manufactures or imports a chemical

substance for commercial purposes. A

person who extracts a component

chemical substance from a complex

combination of chemical substances is a

manufacturer of that component

chemical substance.

(b) "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.

(c) "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.

(d) "Parent company" means a

company which owns or controls

another company. Owership or control

exists when one company owns 50

percent or more of another company's

voting stock or other equity rights, or

has the power to control the

management and policies of the other

company.

(e) "Plant site" means a contiguous'

property unit under the ownership or

control of a manufacturer or importer.

Property divided only by a public rightof-way is one plant site. There may be

more than one manufacturing facility on

a single plant site. For an importer, the

plant site is the importers's United

States headquarters.

(f) "Site-limited"means that the

chemical substance in question is

manufactured and processed only

within a plant site and is not distributed

for commercial purposes outside the

plant site as a chemical substance or as

part of a mixture of article. No imported

chemical substance is site-limited.

(g) "Small manufacturer" means a

manufacturer meeting either of the

following standards:

(1) First standard. A manufacturer is

"small" under this standard if the total

annual sales of all plant sites that it

owns or controls (together with those

that are owned or controlled by its

foreign or domestic parent company, if

any) are less than $40 million. However,

if a manufacturer with total annual sales

of less than $40 million produces

annually over 100,000 pounds (45,400

kilograms) of a particular chemical

substance at a particular plant side, that

manufacturer will not qualify as small

with regard to that chemical substance

at that plant site. (For imports, the

100,000 pound figure applies to the total

amount imported.)

(2) Second standard. A manufacturer

is small under this standard if the total

annual sales of all plant sites that it

owns or controls (together with those

that are owned or controlled by its

foreign or domestic parent company, if

any) are less than $4 million, regardless

of the quantity of chemical substances

produced by that manufacturer.

(h) "Total annual sales" means the

total annual revenue (in dollars)

generated by the sale of all products of a

plant site.

§ 710.25 Chemical substances to be

reported.

(a) Inclusions, Any chemical

substance which is in the Master

Inventory File at the time of a reporting

period specified in § 710.30(c) is subject

to the reporting requirements of this

subpart unless specifically excluded by

paragraph (b) of this section.

(b) Exclusions. The following

categories of chemical substances are

excluded from reporting under this

subpart:

(1) Inorganic chemical substances.

Any chemical substance which does not

contain carbon or contains carbon only

in the form of carbonato, cyano.

cyanato, isocyano, or isocyanato groups,

or the chalcogen analogues of such

groups.

(2) Polymers. (i) Any chemical

substances described with the words

"polymer" or "polymerized" or the

prefix "poly-" in the Chemical Abstracts

Service Index or Preferred

Nomenclature in the Chemical

Substances Identities section of the

published Inventory or in the Master

Inventory File; (ii) Biopolymers that are

proteins (albumin, casein, gelatin,

gluten, hemoglobin), enzymes,

polysaccharides (starch, cellulose,

gums), lignin, or rubber. This exclusion

also applies to biopolymers which are

chemically modified to the extent that

the polymeric structure still remains

substantially intact.

(3) Microorganisms. Combinations of

chemical substances that are living

organisms, such as bacteria, fungi, and

yeasts. Chemical substances produced

from such living organisms are

reportable unless otherwise excluded.

(4) Naturally Occurring Chemical

Substances. Any naturally occurring

chemical substances, as described in

§ 710.4(b). This exclusion applies to the

specific activities of the person who

must report. 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 persdn

subject to this subpart manufactures a

chemical substance by means other than -

those described in § 710.4(b), the person

must report regardless of whether the

substance could also have been

produced as described in § 710.4(b).

Chemical substances produced from

such naturally occurring chemical

substances would be reportable unless

otherwise excluded.

§ 710.27 Persons subject to this subpart.

Except as provided in § 710.28, the

following persons are subject to the

requirements of this subpart:

(a) Initial reporting. (1) Any person

who manufactured for commercial

purposes 10,000 pounds (4,540

kilograms) or more of a chemical

substance subject to this subpart at a

particular plant site during that person's

last complete corporate fiscal year

before (effective date of final rule).

(2) Any person who manufactured for

commercial purposes 10,000 pounds

(4,540 kilograms) or more of a chemical

substance subject to this subpart at a

particular plant site during that person's

last complete corporate fiscal year

before a reporting period specified in

§ 710.30(c)(2) for which a report was not

previously submitted under

§ 710.30(a)(1).

(b) Reporting of changes. (1) Any

person who manufactured for

commercial purposes a chemical

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substance subject to this subpart at any

time during that person's last complete

corporate fiscal year before a reporting

period specified in § 710.30(c)(2).

(2) Any person who ceased

manufacture for commercial purposes of

a chemical substance subject to this

subpart at a particular plant site during

that person's last 2 complete corporate

fiscal years before a reporting pertod

specified in § 710.30(c)(2).

§ 710.28 Persons not subject to this

sqbpart.

The following persons are not subject

to this subpart except as otherwise

noted:

(a) Persons described in § 704.5 (a)

and (c) of this chapter and persons who

manufacture a chemical substance

subject to this subpart as described in

§ 720.30 (g) and (h) of this chapter.

(b) Persons who are small

manufacturers, except that such persons

shall be subject to this subpart with

respect to those chemical substances

subject to an order issued pursuant to

section 5(e) of the Act, 15 U.S.C. 2604(e).

§ 710.30 Reporting requirements.

(a) Initial reporting. Any person

described in § 710.27(a) must submit an

initial report for each chemical

substance subject to this subpart for

each plant site at which the substance is

manufactured for commercial purposes

as follows:

(1) A person described in

§ 710.27(a)(1) must submit the report

during the reporting period described in,

paragraph (c)(1) of this section.

(2) A person described in

§ 710.27(a)(2) must submit the report

during the reporting period described in

paragraph (c)(2) of this section which

immediately follows the event described

in § 710.27(a)(2).

(b) Reporting of changes. Any person

described in § 710.27(b) must submit a report of changes for each chemical

substance subject to this subpart for

each plant site at which a reportable

change has taken place for that

substance since the person last reported on the production of the substance at

that site. The report must be submitted

during the reporting period described in

paragraph (c)(2) of this section which

immediately follows the reportable

change. The following are reportable

changes:

(1) For a chemical substance

previously reported under this subpart

with a production volume of 10,000

pounds (4,540 kilograms) or more at a

particular plant site, an increase in the

previously reported production volume

of 500 percent or more, or a decrease in

such volume of 80 percent or more, as

measured by the production volume at

that plant site for the most recent

complete corporate fiscal year preceding

the reporting period.

(2) For a chemical substance

previously reported under this subpart

with a production volume of greater

than zero but less than 10,000 pounds

(4,540 kilograms) at a particular plant

site, an increase in production volume to

10,000 pounds or more, as measured by

the production volume at that plant site

for the most recent complete corporate

fiscal year preceding the reporting

period.

(3) For a chemical substance

previously reported under this subpart with a production volume of 10,000

pounds (4,540 kilograms) or more at a

particular plant site, cessation of

manufacture at that site during the last

two complete corporate fiscal years

before the reporting period.

(4) for a chemical substance for which

a cessation of manufacture of that

substance was previously reported

under this subpart at a particular plant

site, manufacture of 10,000 (4,540

kilograms) pounds or more, as measured

by the production volume at that plant site for the most recent complete

corporate fiscal year preceding the

reporting period. (5) For a chemical substance with a

production volume of 10,000 pounds -

(4,540 kilograms) or more at a particular

plant site:

(i) A ehange in status from site-limited

for a plant site at which it was

previously reported as site-limited.

(ii) A change in status to site-limited

for a plant site at which it was

previously not reported as site-limited.

(c) Reporting periods. All reports

required under this subpart must be

submitted to EPA during the applicable

reporting period. The reporting periods

for this subpart are as follows:

(1) The first reporting period is from

(effective date) to (120 days after the

effective date). (2) The second reporting period is

from (effective date plus two years) to

(60 days after effective date plus two

years). Subsequent reporting periods are

from (effective date, without year) to (60

days after effective date, without year)

at .2-year intervals thereafter.

(d) Reporting procedures. Reports under this subpart must be submitted on

either the designated reporting forms or

on computer tape as follows:

(1) Reporting forms. Written reports

must be submitted in the form and

manner set forth in either EPA Form No.

U-1 or U-2 under § 710.39. Forms may

be obtained from the TSCA Assistance

Office (TS-799), Office of Toxic

Substances, Environmental Protection

Agency, Rm. E-543, 401 M St., SW.,

Washington, D.C. 20460. Initial reports

under paragraph (a) of this section must

be submitted on separate forms from

reports of changes under paragraph (b)

of this section. Each form submitted

must indicate whether it is an initial

report or a report of changes. Form No.

U-2 must be used when the specific

chemical identity is claimed confidential

as prescribed in § 710.38(c). Information

for different plant sites must be

submitted on separate forms.

(2) Reporting by computer tape.

Reports by computer tape must be

submitted in accordance with (name of

guidance document to be supplied at

time of final rule).

(e) Information to be reported. Each

person required to report under this

subpart must report on the production of

each chemical substance subject to this

subpart at each plant site, to the extent

known or reasonably ascertainable by

the person, as follows:

(1) A certification, signed and dated

by an authorized official, that all

information submitted is complete and

accurate, that certain confidentiality

statements are true, and that EPA will

be permitted access to and copying of

records to document information

reported.

(2) For manufactured substances, the

name, street address, city, State, and

ZIP code of the plant site. For imported

substances, the name, street address,

city, State, and ZIP code of the United

States headquarters.

(3) The name, street address, city,

State, ZIP code, and telephone number

of a technical contact able to answer

questions about the information.

(4) The Chemical Abstracts Service

Registry Number (and/or other

identifying numbers including EPAdesignated Accession Number for

confidential substances) and specific

chemical name of each chemical

substance.

(5) Whether each chemical substance

is manufactured or imported.

(6) The production volume in pounds,

for the person's last complete corporate

fiscal year, of each chemical substance

manufactured or imported, reported as

precisely as permitted by the person's

routine business records.

(7) Whether the.chemical substance

was site-limited.

§ 710.33 Recordkeeplng requirements.

Each person who is subject to this

subpart shall maintain. records that

document any information reported and

that support any decision not to submit

a report, and shall permit access to and

copying of such records by EPA officials

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upon request. Records shall be retained

for a period of 5 years after the creation

of such records.

§ 710.38 Confidentiality.

(a) Any person submitting information

under this subpart may assert a

business confidentiality claim for the

information, as described in the

instructions for the reporting forms in

§ 710.39 or in the instructions for

reporting by computer tape. Information

claimed as confidential will be treated

in accordance with the procedures in

Part 2 of this title.

(b) A person may assert a claim of

confidentiality for the chemical identity

of a specific chemical substance only if

the identity of that substance is treated

as confidential in the Master Inventory

File as of the time the report is

submitted.

(c) To assert a claim of confidentiality

for the chemical identity of a specific

chemical substance, the person must

take the following steps:

(1) The person must report on EPA

Form No. U-2, not by computer tape.

(2) The person must submit with the

report detailed written answers to the

following questions signed and dated by

an authorized official:

(i) What harmful effects to your

competitive position, if any, do you

think would result from the identity of

the chemical substance being disclosed

in connection with reporting under this

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 or

imported for a commercial purpose

publicly available, for example in

technical journals, libraries, or State,

local, or Federal agency public files?

(vi) What measures have you taken to

prevent undesired disclosure of the fact

that this chemical substance is being

manufactured or imported for a

commercial purpose?

(vii) To what extent has the fact that

this chemical substance is manufactured

or imported for a commercial purpose

been revealed to others? What

precautions have been taken regarding

these disclosures? Have there been

public disclosures or disclosures to

competitors?

(viii) Does this particular chemical

substance leave the site of manufacture

in any form, as product, effluent,

emission, etc.? If so, what measures

have you taken to guard against

discovery of its identity?

(ix) If the chemical substance leaves

the site in a product that is available to

the public or your competitors, can the

substance be identified by analysis of

the product?

(x) For what purpose do you

manufacture or import the substance?

(xi) Has EPA, another Federal agency,

or any Federal court made any pertinent

confidentiality determinations regarding

this chemical substance? If so, please

attach copies of such determinations.

(3) If any of the information contained

in the answers to the questions is

asserted to contain confidential

business information, the person must

mark that information as "trade secret," "confidential," or other appropriate

designation.

(d) If no claim of confidentiality

accompanies information at the time it

is submitted to EPA under this subpart

or if substantiation required under

paragraph (c) of this section is not

submitted with the reporting form, EPA

may make the information available to

the public without further notice to the

submitter.

§ 710.39 Reporting forms.

All persons subject to this subpart

must use the EPA-designated forms for

reporting, unless such reporting is

submitted in a computer tape in

accordance with § 710.30(d)(2). The

EPA-designated reporting forms for this

subpart follow.

BILLING CODE 6560-50-M

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I1) Before completing this form, carefully read the accompanying instructions. IMPORTANT (21 Use this form for reporting if chemical identiy iS NOT claimed confidential.

u -' f EPA

Form Approved. OMB No. 20xx-xxxx

Approval expires xx-xx-xx

US ENVIRONMENTAL PROTECTION AGENCY

PARTIAL UPDATING OF TSCA INVENTORY DATA BASE

PRODUCTION AND SITE REPORT

(Section 8(s) Toxic Substances Control Act 15 USC 2607)

I. CERTIFICATION STATEMENT: I hereby certify that (1) all information entered on this form is complete and accurate, and (2) the confidentiality statements on the back of this form are true as to that information for which I haveasserted a confidentiality claim. I agree to permit access to. and the copying of, records by a duly authorized representative of the

EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information reported here.

SIGNATURE DATE NAME/TITLE (Type or print)

11. TECHNICAL CONTACT ,om s~m, w ca. sm z, c.,.j III. PLANT SITE alve,.m sow air Cou. ite. zip ca*ri

IV. [ Initial L Report of changes

__ _ V. CHEMICAL SUBSTANCE IDENTITY/ACTIVITY/CONFIDENTIALITY

AciW.SITE coNiFiDedTiA.

ITY LIMITED CLAIMS

Ni CAS M 1. 91 1ib c) 4d, u1 REGISTRY AM MS P P ANDO/OR N F I A l OTHER U u 0 TO0

S EN71FYING

R UMBER T PRODUCTION S L SKeCtFiC CHEMICAL NAME VOLUME M I T

.i , IM I A 0 10 T

E A T N E 7 E

0

I

31

4

5

a

1

a

9

10

!P 'r 70U IZ5)EACP

9955

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1--rrlll; lj n:r v~r I C-1IiUAtllt. Wi.lU I At.L I

EPA Form 7740-SA 112-04) EPA COPY

HeinOnline -- 50 Fed. Reg. 9955 1985
Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

WHERE TO GET SUPPLIES Send Completed Forms To:

TSCA Section Sia) Forms U-i and U-2,and a copy of the instruction US Environmental Protection Agency

booklet may be obtained by contacting the TSCA Assistance Office, Office of Toxic Substances

Office of Toxic Substances, Environmental Protection Agency, 401

M Stroet. SW. Washington. DC 20480. TOLL FREE 800-424-9065. PO Box

in Washington, DC 202-554-1404.

CONCERNING EPA DISCLOSURE OF INFORMATION

Any person who submits information to EPA should be aware of EPA regulations (40 CFR Part 2) which govern disclosure

of such information. Those regulations provide that such person may, if he or she desires, assert a confidentiality claim

covering part or all of the information submitted. Information covered by such a claim will be publicly disclosed by EPA

onlyto the extent, and by means of the procedures, set forth in 40 CFR Part 2. However, if no such claim accompanies the

information when it is received, EPA may make that information public without notifying the submitter.

CONFIDENTIALITY STATEMENTS

Information except chemical substance identity reported to EPA on the front of this form may be claimed confidential by

checking the appropriate boxes under "Confidentiality Claims" of Block IV. In certifying this form, the person signing in

Block 1 attests to the truth of the following four statements concerning all information (except chemical substance

identity) which is claimed confidential.

1. My company has taken measures to protect the confidentiality of the information, and it intends to continue to take

such measures.

2. The information is not, and has not been, reasonably obtainable without our consent by other persons (other than

governmental bodies) by use of legitimate means (other than discovqry based on a showing of special need in a judicial or

quasi-judicial proceeding).

3. The information is not publicly available elsewhere.

4. Disclosure of the information would cause substantial harm to our competitive position.

The person signing in Block 1 also attests to the truth of the appropriate statement(s) below concerning other information

specifically claimed confidential for the particular chemical substance. By checking the box under:

(a) Manufacture/Import: I assert thay my activity as a manufacturer and/or an importer of the chemical substance is

confidential (Note; if only this box is checked, plant site information is not claimed as confidential and may be disclosed).

(b) Site Limited: I assert that the fact that the chemical substance is not distributed for a commercial purpose outside of

the plant site identified in Block II is confidential.

(c) Production: I assert that the production volume of the chemical substance for the plant site identified in Block II is

confidential.

(d) Plant Site: I assert that the link of this chemical substance to the plant site identified in Block II is confidential.

EPA Form 7740-SA (12-84) Reverse

9956

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Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

(1) Before completing this form, carefully read the accompanying instructions.

IMPORTANT (2) Use this form for revorting only if chemical identity is claimed confidential.

U- 2 ,,EPA

Form Approved OMB No 20xx-xxxx

Approval expires x-.xx-xx

US ENVIRONMENTAL PROTECTIUN AUNCY

PARTIAL UPDATING OF TSCA INVENTORY DATA BASE

PRODUCTION AND SITE REPORT

(Section 8(a) Toxic Substances Control Act 15 USC 2607)

I. CERTIFICATION STATEMENT: I hereby certify that (1) all information entered on this form is complete and accurate,

and (2) the confidentiality statements on the back of this form are true as to that information for which I have asserted a confidentiality claim. I agree to permit access to, and the copying of, records by a duly authorized representative of the

EPA Administrator, in accordance with the Toxic Substances Control Act, to document any information

reported here.

SIGNATURE DATE NAME/TITLE (Type or print)

II. TECHNICAL CONTACT wM,w sewe , *". Car. state. zop co*) Ill. PLANT SITE (N,. Stret.x C". Stw. ZIP Code)

TELEPHONE NUMBER OF TECHNICAL CONTACT IV. 0 Initial Report [] Report of changes

V. CHEMICAL SUBSTANCE IDENTITY/ACTIVITY/CONFIDENTIALITY

ACThJ- SITE CONFIOENTIAL

ITr L(TED CL.AIMS

N ACCESSION M I (no 415 40) 111 Is) U AND/OR AM MS PP C

OTHER N P F I . L H

WDENTIFYING U NOR AE S NUMBSR FA R y DN

A A T C PAOcIN ~ / U 7 PRODUC I iC I TION S L I

SPECIFIC CHEMICAL NAME T VOLUME MI T S

U p M I I

R (pounds) 0 a 0 T

E T N E

! I 2C

4

5-

9957

q -I

EPA Formi 7740-8B 112-84) EPA COPY

HeinOnline -- 50 Fed. Reg. 9957 1985
Federal Register / Vol. 50, No. 48 / Tuesday, March 12, 1985 / Proposed Rules

WHERE TO GET SUPPLIES Send Completed Forms To:

TSCA Inventory Updating Forms U-1 and U-2 and a copy o. the US Environmental Protection Agency instruction booklet may be obtained by contacting the TSCA Assist- Office of Toxic Substances ance Office. Office of Toxic Substances. Environmental Protection

Agency. 401 M Street, SW, Washington, DC 20460, TOLL FREE PO Box

800-424-9065, in Washington. DC 202-554.1404.

CONCERNING EPA DISCLOSURE OF INFORMATION

Any person who submits information to EPA should be aware of EPA regulations (40 CFR Part 2) which govern disclosure

of such information. Those regulations provide that such person may, if he or she desires, assert a confidentiality claim

covering part or all of the information submitted. Information covered by such a claim will be publicly disclosed by EPA

only to the extent, and by means of the procedures, set forth in 40 CFR Part 2. However, if no such claim accompanies the

information when it is received, EPA may make that information public without notifying the submitter.

CONFIDENTIALITY STATEMENTS

Chemical substance identity and other information reported to EPA on the front of this form may be claimed confidential

by checking the appropriate boxes under "Confidentiality Claims" of Block IV. In certifying this form, the person signing in

Block 1 attests to the truth of the following four statements concerning all information.

1. My company has taken measures to protect the confidentiality of the information, and it intends to continue to take

such measures.

2. The information is nct, and has not been, reasonably obtainable without our consent by other persons (other than

governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding).

3. The information is not publicly available elsewhere.

4. Disclosure of the information would cause substantial harm to our competitive position.

The person signing in Block 1 also attests to the truth of the appropriate statement(s) below concerning the information

specifically claimed confidential for the particular chemical substance. By checking the box under:

(a) Manufacturi/Import: I atsert thay my activity as a manufacturer and/or an importer of the chemical substar~ne is

confidential (Note: if onlythis box is checked, plant site information is not claimed as confidential and may be disclosed

(b) Site Limited: I assertthat the fact that the chemical substance is not distributed for a commercial purpose outside of

the plant site identified in Blook II is confidential.

(c) Production: I assert that the production volume of the chemical substance for the plant site identified in Block II is

confidential.

(d) Plant Site: I assert that the link of this chemical substance to the plant site identified in Block It is confidential.

(e) Chemical Identity: I assert that the identity of the chemical substance is confidential.

The submitter of this form, when claiming that the identity of a chemical substance to be confidential, must provide

written substantiation for such claim (see instructions) and also must agree to the following statement.

CONFIDE NTIAL CHEMICAL SUBSTANCE IDENTITY STATEMENT

I agree that EPA may disclose, for purposes of section 5(aX1 A) of the Act (premanufacture notification), to any person

with a bona fide intent to manufacture the substance(s) identified on this form (as determined by EPA under 40 710.7(g))

the fact that the chemical substance(s) is (are) included on the Inventory. Further, I have or will have available and agree

to furnish to EPA upon request, all Information required in 40 CFR 710.7(e) for the substance(s) identified on this form.

EPA Form 7740-88 (12-841

IFR Doc. 85-5810 Filed 3-11-85; 8:45 am]

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