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Thursday

June 12, 1986

Part II

Environmental

Protection Agency

40 CFR Part 710

Partial Updating of TSCA Inventory DataBase; Production and Site Reports; Final

Rule

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21438 Federal Register / Vol. 51, No. 113 / Thursday, June 12, 1986 / Rules and Regulations

ENVIRONMENTAL PROTECTION

'AGENCY

40 CFR Part 710

I OPTS-82015A; FRL-2973-31

Partial Updating of TSCA Inventory

Data Base; Production and Site

Reports

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule, promulgated under

the authority of section 8(a) of the Toxic

Substances Control Act (TSCA),

requires 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 sitelimited status of the-substances. After

the initial reporting, recurring reporting

will be required every 4 years for as

long as this rule is in effect.

Promulgation of this rule does not affect

the status of a chemical substance listed

on the Inventory.

DATES: This rule shall be promulgated

for purposes of judicial review under

section 19 of TSCA at 1 p.m. eastern

daylight time on June 26,1986. This rule

is effective on August 25, 1986.

FOR FURTHER INFORMATION CONTACT:

Edward A. Klein, Director, TSCA

Assistance Office (TS-799), Office of

Toxic Substances, Environmental

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

SW., Washington, DC 20460, Toll free:

(800-424-9065), In Washington, DC:

(554-1404). Outside the U.S.A.:

(Operator-202-554-1404).

SUPPLEMENTARY INFORMATION:

I. Authority

This rule is promulgated under section

8(a) of TSCA, which provides the

Administrator of EPA the authority to

require, by rule, manufacturers,

importers, arid processors of chemical

substances to submit such information

as the Administrator may reasonably

require. Failure to comply fully with any

provision of this rule is a violation of

section 15 of TSCA and will subject the

violator to the penalties of TSCA

sections 16 and 17.

II. Summary of the Rule

This rule requires manufacturers and

importers to report current data ofn the

production volume, plant site, ahd sitelimited 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 the purposes of this rule and

preamble, the term "manufacturer"

includes importer, unless otherwise

specified. A person is 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 specified in

this rule.

This rule requires both initial and

recurring reporting. During the initial

reporting period, every manufacturer of

a chemical substance covered by this

rule who produces over 10,000 pounds

(4,540 kilograms) of a reportable

substance at a plant site will be required

to report separately on every such

substance. Low-volume substances, i.e.,

substances with an annual site-specific

production volume (or total amount

imported) of less than 10,000 pounds, are

excluded from this rule. After the initial

reporting period, the same type of

reporting will be required every 4 years

for as long as this rule is in effect.

The substances covered by this rule

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. Four categories of substances,

though on the Inventory, are generally

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. However, no substance,

except one which is naturally occurring, is excluded from this rule if that

substance is the subject of an order

issued pursuant to TSCA section 5(e) or.

5(f), or is the subject of a rule proposed

or promulgated under TSCA section 4,

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

relief granted under a civil action under

section 5 or 7 of TSCA.

In addition to the proposed exclusions

of substances, two categories of persons

are exempt from certain reporting and

recordkeeping requirements: Small

manufacturers and persons

manufacturing substances in limited

circumstances. The small manufacturer

exemption, however, does not apply if

the substance to be reported by the'

small manufacturer is the subject of an

order issued pursuant to TSCA section

5(e),'or is the subject of a rule ;*

promulgated under TSCA section 4,

5(b)(4). or 6, or is the subject of relief

granted under a civil action under

section 5 or 7 of TSCA.

The information reported under this

rule includes chemical identity, plant

site, annual production volume, and sitelimited status of a reportable substance.

For each submission, EPA also requires

the name, address, and telephone

number of a person who can answer

technical questions related to the

submission. Persons subject to this rule

are required to maintain records that

support the information in their

submissions. Such records are to be kept

for 4 years beginning with the effective

date of each reporting period.

III. Background

In the Federal Register of March 12,

1985 (50 FR 9944), EPA published a

proposed rule for reporting of current

data on the production volume, plant

site, and site-limited status of certain

chemical substances included on the

TSCA Chemical Substances Inventory.

EPA indicated in the proposal that it

needs this information to update a

critical portion of the TSCA Inventory

data base which is used to support a

number of TSCA activities. A 60-day

public comment period followed the

publication of the proposed rule:

This notice discusses the major

comments, modifies certain provisions

of the proposed rule, and promulgates

the final rule under the authority of

section 8(a) of TSCA. This rule is

promulgated as an amendment to 40

CFR Part 710 which currently contains

the Inventory Reporting Regulations of

1977. This amendment formally

designates existing § § 710.1 through

710.8 as Subpart A and adds new

Subpart B.

IV. Provisions of the Final Rule

A. Substances Covered by the Rule

Reportable substances under this rule

are 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 are

therefore not reportable under this rule.

As an aid to submitters under this

rule, EPA is publishing a 1985 edition of

the TSCA Chemical Substances

Inventory which supersedes the Initial

Inventory published In 1979 and the

supplements to the Initial Inventory.

This reissued Inventory covers over

3,000 substances, including 6,000

substances which have been added

since the last publication in 1982. Since

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the printed Inventory can never be as

complete as the Agency's Master

Inventory File (which also contains

specific identities for confidential

substances), the Master Inventory File

is, therefore, the only source which can

conclusively determine whether a

substance in question is on the

Inventory. Manufacturers who may be

subject to the requirements of this rule

are urged to first use the printed

Inventory for reporting purposes,

especially for substances with '

nonconfidential identities, before

requesting EPA to perform a search of

the Master Inventory File. Procedures

for requesting a search of the Master

Inventory File are discussed in the

instruction booklet entitled "Instructions

for Reporting for the Partial Updating of

the TSCA Chemical Inventory Data

Base." A copy of this instruction booklet

can be obtained by contacting the

Agency at the address listed in § 710.39

of this rule.

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 start of a reporting period become

reportable in the next reporting period,

unless otherwise excluded from this

rule.

B. Substances Excluded From the Rule

Four categories of substances, though

included on the Inventory, are generally

excluded from the reporting and.

recordkeeping requirements of this rule.

These categories are polymers,

inorganics, microorganisms, and

naturally occurring chemical substances.

However, if a polymer, an inorganic

substance, or a microorganism is the

subject of an order issued pursuant to

TSCA section 5(e) or 5(f), or is the

subject of a rule proposed or

promulgated under TSCA section 4,

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

relief granted under a civil action under

TSCA section 5 or 7, that substance is

not excluded from the rule.

To assist manufacturers subject to this

rule to quickly. identify an excluded

substance, EPA has labeled with a

special "XU".flag in the 1985 edition of

the printed Inventory most of the

substances that are excluded from this

rule. Where a flag is found,.:

manufacturers may rely on it as a signal

that labelled substance is not subject to

reporting. Where no flag is found and a

substance may appear to fall within an

excluded category, manufacturers

should consult EPA. This is a

consequence of technical difficulties

with the application of flags by

computer.

The four excluded categories are

discribed below:

1. Polymers. For the purposes of this

rule, a polymer is identified by the

presence of any one (or more) of the

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

Service (CAS) Index or Preferred

Nomenclature of a particular substance,

where the asterisk (*) indicates that any

set of characters may precede, or follow,

the character string defined. The CAS

Index or Preferred Nomenclature can be

easily obtained from the printed

Inventory's "Chemical Substances

Identities" section.

Polymers which are UVCB (i.e.,

chemical substances of unknown or

variable composition, complex reaction

products, and biological materials]}

substances, which do not contain one of

the aforementioned character strings,

can be identified in the hierarchy of

subset headings in the printed

Inventory's UVCB Index section. These

UVCB subset headings are as follows:

siloxanes and silicones, silsesquioxanes,

proteins (albumin, casein, gelatin,

gluten, hemoglobin), enzymes,

polysaccharides (starch, cellulose,

gums), rubber, or lignin. In general, all

individual substances listed under any

of the above UVCB subset headings are

considered polymers and are therefore

excluded from this rule. However,

polymers which have been hydrolyzed,

depolymerized, or chemically modified

to the extent that the final products are

no longer'polymeric (e.g., a protein

Which is completely hydrolyzed into

amino acids) are reportable.

EPA has labeled with an "XU" flag in

the 1985 edition of the Inventory all of

those polymers which contain one of the

aforementioned character strings. UVCB

biopolymers, except for those that

contain a character string, or polymer

code, are generally not flagged.

Therefore, users of the printed Inventory

should be aware that substances other

than those labeled with the "XU" flag

may also be excluded from this rule.

EPA believes that the coverage for

polymers for the purposes of this rule is

sufficiently broad to include virtually all

those substances that are generally

considered as polymers.

2..Inorganics. For the purposes of this

rule, inorganic substances are those that

do not contain a carbon atom, or contain

carbon only in the form of carbonato [=

C03], cyano [-CNI; isocyano [-NC],

cyanato [-OCNI, or isocyanato [-NCO ]

groups, or the chalcogen analogues of

these groups.

In the 1985 edition of the Inventory,

"XU" flags are applied to all inorganic

substances that have molecular

formulas which do not contain the

element carbon. UVCB inorganics with

no molecular formulas or inorganics

containing carbon are not flagged on the

Inventory, although they are considered

inorganics and not reportable under this

rule.

3. Microorganisms. For the purposes

of this rule, this category includes

bacteria, eimeria, fungi, and yeasts

which are easily identifiable in the

hierarchy of UVCB subset headings 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. In

the 1985 edition of the Inventory, "XU"

label flags are applied to all substances

listed under one of these three UVCB

subset headings.

4. Naturally occurring chemical

substances. Chemical substances, as

described in.§ 710.4(b) of the Inventory

Reporting Regulations (40 CFR Part 710)

of 1977, are considered "naturally

occurring" and are not reportable under

this rule. However, persons who

produce a substance in a manner other

than as described in § 710.4(b) are

required to report unless otherwise

excluded.

This exclusion covers chemical

substances which are naturally.,

occurring and which are unprocessed or

processed only by manual, mechnical, 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

stkch substances include raw agricultural

commodities, water, air, natural gas,

crude oil, minerals, ores, and rocks.

Since whether a substance is

considered as "naturally occurring"

depends on the manner in which it is

produced, it is impossible to label such

substances with the "XU" flags because

"naturally occurring" substances are not

included on the Inventory.

C. Persons Subject to the Rule

Except for those persons desbribed in

unit IV.D below, a person is a

manufacturer subjectto this rule if that

person has manufactured or imported

for commercial purposes 10,000pounds

or more of a reportable substance at a

particular site at any time during that

person's most recent complete corporate

fiscal year immediately preceding the

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21440. Federal Register ' /'Vol. 51, No. 113 .'/ Thursday, June 12, 1986 / Rules and Regulations

effective date of the rule or the start of

any recurring reporting period.

D. Persons Exempt from the Rule

Two categories of persons are exempt frbi the' reporting and .recordkeeping

requirements of this rule, provided that

they qualify for one of the exemptions

during a reporting period. Since a person who qualifies for an exemption during

one reporting period may no longer qualify during the next reporting period, each person who may be. subject to this

rule must determine the person's exemption status during each

succeeding reporting period. 1. Small manufacturers. Persons

qualify as small manufacturers under

this rule if, at the time of reporting, they meet one of the two standards specified in the TSCA section 8(a) Small

Manufacturer Exemption Rule (40 CFR

704.5(d)) which was published in the

Federal Register of November 16, 1984

(49 FR 45425). However, no person is

considered a small manufacturer for the

purposes of reporting a chemical

substance that is the subject of an order

issued pursuant to TSCA section 5(e), or

is the subject of a rule proposed or

promulgated under TSCA section 4, or

5(b](4), or 6, or is the subject of relief

granted under a civil action under TSCA

section 5 or 7. Such persons must

comply with the reporting and

recordkeeping requirements under this

rule for that particular substance. . 2. Persons manufacturing substances

in limited circumstances. Persons who

manufacture reportable substances

either in limited ways or through coincidental manufacture are exempt from the requirements of this rule for

those substances. Therefore, persons who manufacture or import substances

solely in small quantities for research

and development or persons who import substances as part of articles, are

exempt from this rule for those

activities. Furthermore, persons who

manufacture substances as impurities, byproducts, or in a manner incidental to

another operation or upon end use of

another substance or mixture, as " described under § 720.30 (g) and (h) of

the Premanufacture Notification Rule of

1983, are also exempt from the

requirements of this rule for those

substances.

E. Low-Volume Threshold

For the purposes of this rule, a lowvolume reporting threshold is

established to exempt from reporting ,those substances that are produced at

low volumes. If a person's site-specific annual production volume for a

reportable substance is below 10,000

pounds during the person's most recent

complete corporate fiscal year before a

reporting period, no reporting will be

required for that substance for that

period. In the case of importers, the •

measurable volume is the total-amountof a substance imported during that year

by each site which contains an

operating unit responsible for the

import. Thus a company which allows

each plant to conduct its own import'

operations would make the

determination for each such plant; a

company which handles imports through •its corporate headquarters would make

the determination for all imports

handled through the headquarters on an

aggregate basis. Similarly, reports would

be made by the site which actually

conducts the import operation-either

the specific plant or the corporate

headquarters. If a substance's site-.

specific annual production volume or

total amount annually imported

increases to 10,000 pounds or more

during the fiscal year preceding a

subsequent reporting period, the person

would be required to comply with the

reporting requirements of this rule for

that substance at that site.

F When to Report

Current data, as described under unit

IV.G below, must be submitted for each

reportable substance at each plant site

once every 4 years. For each round of

reporting, submitters will have 120

calendar days to submit a report.

Therefore, the first reporting period will

commence on the effective date of this

rule and will end 120 days after the

effective date. Recurring reporting will

take place on the fourth anniversary of

the effective date and every 4 years

thereafter. EPA plans to publish in the

Federal Register a brief reminder

announcement 2 months prior to the

'beginning date of each recurring

reporting period.

G. What to Report

Persons who are subject to this rule

are required to report by completing

original numbered copies of the

reporting form designated in § 710.39 of

the rule, or by submitting the

information in a computer tape. No other

types of submissions will be acceptable.

Detailed instructions for filling out the

reporting form as well as specifications

for submitting computer tape are

discussed in the reporting instruction

booklet. Persons who report via

computer tape must follow the

specifications discussed in the

instruction booklet. Otherwise, the tape,

cannot be processed, will be rejected,.

and must be resubmitted.

To further simplify reporting

procedures, EPA has combined the two

previously proposed reporting forms into

one form. Submitters, however, must not

mix on one form information for

substances with confidential chemical

identities and information for those with

nonconfidential chemical identities.

Parts f, II, and III of the reporting form

include :the certification to be signed by

the submitter and other basic submitter

information. The extent to which Part IV

of the form is completed will depend on

the number of chemical substances

reported on that form. Copies of the

reporting forms can be obtained by

contacting EPA at the address listed in

§ 710.39 of this rule.

The information requirements for this

rule are discussed below.

1. Chemical identity. For each

chemical substance covered by this rule,

a submitter is required to provide

certain specific information which will

enable the Agency to identify quickly

and uniquely that substance. Where

known, such information must include

the CAS Registry Number and a

chemical name that is not a trade name.

For most of the nonconfidential

substances, the corresponding CAS

Registry Number can be easily obtained

from the 1985 edition of the Inventory. If

the identity of the substance is claimed

as confidential and no CAS Registry

Number has been assigned to that

substance, a submitter should provide a

chemical name and an EPA-designated

Accession Number for that substance.

Each substance with a confidential

identity has been assigned an Accession

Number. Accession Numbers for

confidential substances are listed in the

generic names section of the printed

Inventory. If a person does not know

whether a substance is covered by one

of the generic names, the person should

contact EPA by following the

procedures described in the

aforementioned instruction booklet to

determine whether the substance in

question is reportable.

Other identifying numbers, i.e., PMN

Case Number, original Inventory

Reporting Form Number, Bona Fide

Document Control Number, or Test

Market Exemption Application Case

Number, should-be used only if a

submitter cannot identify a particular

substance by either its corresponding

CAS Registry Number or EPA Accession

Number,

2. Plant site. Manufacturers are

required to report by specific plant site

name and street address. Corporate

headquarters, business, or Post Office

Boxaddresses are not acceptable for

reporting. However, if a corporation has

a number of plant sites and wishes to

have the corporate headquarters

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coordinate the submission of reports, it

may do so as long as information for

different plant sites is reported on

separate reporting forms.

With regard to importers, the

definition under § 7-10.2(l) of the

Inventory Reporting-Regulations applies.

Therefore, an importer means ". * *

any person who imports a chemical

substance, including a chemical

substance as part of a mixture or article,

into the customs territory of the United

States," and includes .**. the person

primarily liable for the payment of any

duties on the merchandise * * i". For the

purposes of this rule, as discussed in

Unit IV.E. above, certain importers must

report by the United States

headquarters or similar central office.

However, if a plant Site imports a

substance directly from a foreign

supplier and is "primarily liable for the

payment of any duties". on that

substance, the plant is-then the importer

of that substance. In that case, the

imported substance must be reported

directly by that plant site. This approach

allows companies. to' report consistent

with the conduct of their importing.

Each submitter is also required to

provide a Dun & Bradstreet Number for

each site reported under this rule.

3. Manufacturer/importer. Every

submitter is required to indicate whether

that person is a manufacturer and/or an

importer for each of the substances

reported for each site,

4. Site-limited status. Manufacturers

are required to indicate whether a

chemical substance manufactured at a

plant site is distributed for commercial

purposes outside that Site, as a , substance or as part of a mixture or an

article. Imported substances cannot be

site-limited.

5. Production volume. Respondents to

this rule must report the plait site

production volume (or' total quantity

imported) of each substance for which

reporting is required. Quantities must be

reported in pounds. Reporting must be

accurate to the extent that the

information is known to or reasonably

ascertainable by the submitter, or to two

significant figures. Production volume

information reported within ±10

percent of the actual value will be

acceptable for purposes of this rule.

Manufacturers are required to report the

annual production volume of each

reportable substance at each plant site

at which it is produced. Importers may

report volume by plant site or as the

total quantity imported by the company.

6. Technical contact. For each report

submitted.undeir thig rule, a submitter is.

required to identify the name, address,

and telephone number.of an individual

who can answer questions concerning

the information on the reporting form..

H. Confidentiality

1. Asserting claims. While information

submitted under this rule can generally

be claimed as confidential, EPA strongly

encourages respondents to this rule to

carefully consider the necessity of

asserting such claims. As provided by

section 14 of TSCA, claims of

confidentiality cfin be asserted only if

release of the information would reveal

company trade secrets or other

confidential commercial or financial

information. Furthermore, claims of

confidentiality must be asserted at the

time information is submitted to EPA in

the manner specified in the rule and

reporting instructions. EPA's procedures

for processing and reviewing

confidentiality claims are set forth at 40

CFR Part 2, Subpart B.

To claim information as confidential,

a submitter is required to check the

appropriate: box and sign the

certification statement on the reporting

form. If a submitter fails.to do so, EPA

may release the information to the

public without further notice to the

submitter. By signing the certification

statement the submitter certifies that its

claims of confidentiality are made in

good faith and that the statements on

the back of the reporting form are true

for each claim. Procedures for claiming

as confidential information submitted by

computer tape are contained in the

instruction booklet.

2. Chemical identity. If a submitter

wishes to claim the specific identity of a

reportable substance as confidential

business information, the submitter must

report on the form (not by'computer

tape) and must check the "confidential"

box for chemical identity under Column

IV d of the reporting form and provide'

the required substantiation by:

answering the questions in § 710.38(c)(2)

of this rule. A submitter, however, may

not assert a claim of confidentiality for

the identity of a substance if such

identity is not already held confidential

on the Inventory as of the time of the

report. For each of the recurring

reporting periods under this rile, a

submitter is required to resubstantiate

each claim of confidentiality even if the

circumstances with regard to that claim

have not changed since the last report.

If a manufacturer reports'information

under this rule for a chemical substance

whose identity is held confidential on

the Inventory and the manufacturer does

not claim the chemical identity

confidential, EPAwill consider the

identity of that substance no longer

confidential for the purposes o.f the

Inventory and may therefore disclose

the identity of that substance. EPA

strongly encourages industry to

reconsider the necessity of retaining

those claims. If a submitter decides not

to assert again a claim of confidentiality

for the identity of a :substance which is

on the Inventory, that 'suibn'itterwill

simply submit the required data under

this rule for that substance, and Will

check the "nonconfidential" box for

chemical identity on the reporting form.

Submitters are required to segregate

information on substances with

confidential identities from the

information on those with

nonconfidential identities by using

separate forms for each.

I. Recordkeeping Requirements

Persons subject to this rule are

required to maintain records for a period

of 4 years beginning with the effective

date of a reporting period As long as the

records are maintained in a manner

consistent with normal business

practice, each submitter may determine

the exact format in.which the records

are to be kept. The records that are

required include those that show the

production volume, plant site, and sitelimited status of each of the -substances

reported. If a substance is not reported

because its site-specific annual

production is less than 10.000 pounds,

only the site-specific production records

for that substance need to be kept.

Persons who qualify as exempt small

manufacturers are not required to keep

records.

V. Discussion of Major Comments

EPA received comments from 37-

organizations. Although many of the

comments were received after the

closing date of the comment period, the

Agency fully considered all of'them in

promulgating the final rule. While

almost all of the commenters agreed that

EPA needs current data to update'the

Inventory data base, many presented

suggestions regarding specific

provisions of the proposed rule. Some

commenters requested that EPA grant

more chemical exclusions under this

rule. One commenter, however, argued

that the proposed chemical exclusions

are not justified and urged the Agency to

broaden the scope of the update'by

including all Inventory. substances under

the rule.

This unit discusses the major

comments that have the greatest impact

on the rule, and gives EPA's response

for each of'these cOmmients. EPA has

also classified into' generi6c aiegories !Il

comments rec eived and summarized the

Agency's response to these comments.

This summary, together-with copies of

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the public comments, is included in the

public record for this rulemaking Idocket

number OPTS- 82015Aj. Therefore,

EPA's response to comments that are

not specifically discussed in this unit

can be found in the rulemaking record.

A. Reporting Actual Production Volume

Comments. Eighteen commenters

objected to the proposed requirement

that production volume information be

reported in pounds, rather than in

ranges as used in reporting for the 1977

Inefitory. These commenters urged EPA

to reconsider its position toward precise

production data for the following

reasons:

First, the commenters noted that

reporting of precise production volume

would significantly increase the number

of confidentiality claims on production

information. They pointed out that such

a reporting requirement would directly

contradict EPA's expressed desire that

industry exercise restraint to reduce the

number of confidentiality claims for

data to be submitted under this rule.

Second, some commenters argued that

if the primary purpose of the Inventory

data base is to provide basic

information for priority setting or

.chemical screening, as EPA indicated in

the preamble to the proposed rule, the

need for precise production data for

these purposes is not fully justified

because these uses of the data would

not require such a level of accuracy. Third, certain commenters pointed out

that it would be technically difficult to

report precise production data for

certain types of substances. For

example, precise production data would

be difficult to calculate for ingredients in

formulated products or mixtures,

especially for imported mixtures. They,

maintained that a submitter would have

to review each product or mixture to

determine the percentage composition of

each of the ingredients. From the

percentage composition and total

production volume, the production

volume of each ingredient would be

calculated.

Fourth, some commenters noted that

'precise production data would, in some

cases, create even more uncertainty

than production ranges because a

particular annual production may be

atypical. Furthermore, initial precision

could degrade substantially over time.

Reporting in exact figures would create,

at best, a false precision. They also

maintained that it is inconsistent for

EPA to require such'a degree of

accuracy when the low-volume

threshold provision of this rule Would

allow production data up to 10,000

pounds to be excluded entirely.

Almost all of the 18 commenters

agreed that the production ranges used

for the 1977 Inventory reporting are too

broad, and recommended that EPA

consider using ranges that are narrower.

As a minimum, they suggested that EPA

allow reporting of precise production

data to one or two significant figures or

rounding the figures to the nearest

10,000 pounds. . EPA 'W response. EPA is aware that

requiring precise production data under

this rule could result in more frequent

claims of confidentiality for production

data than were asserted under the

original Inventory rule. However, the

same result is likely if production data

were required to be reported under this

rule in ranges that are narrower than

those required under the oriqinal

Inventory. If broad ranges were

required, the data would be of

diminished use to EPA. Therefore, EPA

believes that the advantages of requiring

production data to be reported in

specific numbers will far outweigh the

possible' disadvantage of increased

confidentiality claims. It should be

noted that EPA will closely monitor

claims of confidentiality asserted under

this rule.

EPA disagrees with the commenters'

contention that precise production data

are not justified under this rule. In the

preamble to the proposed rule, EPA

stated that the Agency "needs

production data to set priorities for

further investigation, to perform firstlevel 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." These uses will

require data that are reasonably

accurate. The ranges used for reporting

the 1977 production data for the original

Inventory were so broad that the

resulting uncertainty became

unacceptable in many applications

including priority setting.

Many commenters perceived that they

would be required to count every pound

of a chemical substance produced at a plant site. This is not the intent of the

Agency. In fact, the preamble to the

proposed rule clearly states that "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:* * *' Some commenters.

urged EPA to permit the reporting of

production data to two significant.

figures. EPA agrees with this comment

and has included such a requirement in

the final rule.

Regarding the-technical difficulty in

obtaining production figures for

ingredients in formulated products or

mixtures, EPA believes that this

difficulty is overstated. Regardless of

whether production volume is reported

in ranges or in actual figures, a

submitter will have to do almost the

same amount of work to calculate the

production volume for each of the

ingredients in a product or a mixture.

Furthermore, the provision of two

significant figures will sufficiently lessen

the burden associated with that

calculation.

EPA recognizes that actual production

data, like production ranges, will

inevitably degrade over time. Actual

figures, however, are initially more

accurate than ranges. Over a period of

time, the initial uncertainty associated

with production ranges will be

compounded by degradation. thus

making the rianges less desirable.

EPA disagrees with the contention

that there is an inconsistency between

requiring precise production data to be

reported and exempting from reporting

those substances with an annual sitespecific production volume of less than

10,000 pounds. EPA established 'the lowvolume threshold for this rule to better

focus its information collection effort on

substances representing a greater

potential exposure concern and to

provide certain reporting relief for those

who manufacture only a small amount

of a reportable substance. However, if a

company's production volume of a

reportable substance increases to 10,000

pounds annually at a particular site,

reporting will be required. This -,

provision bears no relationship to the

level of accuracy at which the data are

reported.

B. Recurring Reporting and Reportable

Events

In the March 12 Federal Register

notice, EPA proposed that recurring

reporting be required every 2 years if a

reportable event has occurred.

Repo'rtable events generally reflected

what EPA considered as significant

changes in production volume or sitelimited status of a reportable substance.

In addition to the proposed approach,

two possible alternatives were :

discussed in the preamble. One of these

two alternatives would require

automatic reporting periodically on all

reportable substances, regardless of

whether a reportable event has:

occurred.

Comments. Seventeen commenters

addressed the issue of recurring

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reporting in their comments on the

proposed rule. While all of these

commenters agreed that some kind-of

recurring reporting is necessary to

maintain a current data base, they all.

disagreed with EPA's proposed

approach. Major• points of their

comments are summarized below:

First, many commenters contended

that recurring reporting at 2-year

intervals is not justified because

production does not change that N

frequently for many chemicals. For

chemicals that are produced in batches,

such an approach would provide

misleading information. Many

maintained that EPA has

underestimated the burden that would

be imposed by this approach while it

has overestimated the degree of data

obsolescence for the 2-year period. They

suggested that the frequency for

recurring reporting be determined after

the Agency has obtained initial

submissions under this rule and

compared the new data against the 1977

data to determine the extent to which

the information has become out-of-date.

Second, a number of commenters

indicated that EPA has underestimated

the burden associated with the

determination of whether a reportable

event has occurred. They maintained

that, in many cases, it would be less

burdensome to simply submit a report.

Some commenters argued that reporting

triggers would penalize smaller

companies more because they are less

equipped to make a determination of

whether reporting is necessary and

would therefore tend to overreport.

Third, most of the commenters

suggested that, if EPA decides that it

must include a recurring reporting

provision in the final rule, the Agency

should consider requiring recurring

reporting on all reportable chemicals

every 5 years regardless of whether a

reportable event has occurred during

that period. The 5-year interval

corresponds to the period used by the

U.S. Census Bureau for its Census of

Manufacturers. The commenters argued

that this approach would provide EPA

with a more complete update each time,

though less frequently. EPA will be able

to maintain a relatively current data

base. The commenters contended that,

even using EPA's own estimate, the

Inventory would only be 62.5 percent

obsolete and would still be more current

than the present Inventory which EPA

has been using for the past 8 years. The

commenters also pointed out that this'

approach would be less burdensome to

both EPA and industry, because the

absence of reporting triggers would

further simplify the reporting and

recordkeeping requirements under this

rule and would make EPA's compliance

monitoring much easier.

EPA's response. EPA's original

proposal that recurring reporting be

triggered by the occurrence of a

reportable event was based on the belief

that this approach would allow the

Agency to maintain a current data base

without imposing an unreasonable

burden on both the Agency and the

submitters. After carefully reviewing the

comments on this issue, EPA concludes

that the proposed approach may not

offer as many advantages as the Agency

previously believed. Therefore, EPA

agrees with the commenters that

compliance with the requirements of this

rule will be simpler and more

straightforward if recurring reporting is

not event-triggered.

The question of whether the

determination of the occurrence of a

reportable event is more burdensome

than actual reporting will most likely

vary from submitter to submitter. The

Agency still believes that the reportable

events governing recurring reporting, as

proposed in the March 12 Federal

Register notice, are not overly

complicated. In most cases, it would

simply require the comparison of

production data every 2 years against

the data previously reported. For those

submitters who have the capability of

storing the information in a

computerized system, such a

comparison should not be difficult.

However, smaller companies which do

not have access to computerized

systems would have to perform such

comparisons manually. Furthermore,

recordkeeping requirements could, in

most cases, become open-ended

because current production data would

be compared against the data last

reported reqardless of its age.

If recurring reporting is triggered by

events, EPA's compliance monitoring

effort could become, in many cases,

difficult and resource-intensive. The

Agency would have to inspect

production records before it could

conclude that a manufacturer had a

'legitimate reason not to report during a

particular reporting period. On the other

hand, if recurring reporting is automatic,

there will be fewer records to inspect

because more manufacturers will have

to report each time.

EPA believes that the provision

governing recurring reporting should be

part of the final rule and therefore

disagrees with the recommendation that

the frequency of recurring reporting be

determined at a later date. By the time

the initial submissions under this rule

can be analyzed and compared against

the 1977 data, the existing data would

be almost 10 years old. There could

have been successive changes at a plant

site which could make such a

comparison both difficult and

inconclusive.

Based on these comments, EPA has

adopted the concept of automatic

recurring reporting every 4 years on al!

reportable substances with a sitespecific production volume of 10,000

pounds or more. Although recurring

reporting will occur less frequently, as

compared to the originally proposed 2-

year interval, each round of reporting

will provide a much more complete

update of the information. Based on its

experience with the 1977 Inventory data,

EPA believes that the 4-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.

C. Definition of Polymer

Comments. Eleven commenters urged

EPA to broaden the "definition" of

polymer by including such terminologies

as "homopolymer," "copolymer," and

"terpolymer," and/or to add the

definition for polymer used under the

section 5(h)(4) premanufacture

notification polymer exemption rule (40

CFR 723.250(b)(11)).

EPA's response. EPA disagrees with

these comments for two reasons. First,

the terminologies used to describe

polymers, as discussed in the proposed

rule, already provide sufficiently broad

coverage of substances with a polymeric

structure. Some of the terminologies

suggested by the commenters, i.e.,

"homopolymer," "copolymer," and

"terpolymer," are already covered.

Second, the definition used for

identifying polymers for consideration

under the section 5(h)(4) polymer

exemption rule, (40 CFR 723.250(b)(11))

is not the only criterion which

determines whether a substance is

qualified for exemption under that rule.

Additional criteria must also be

satisfied before a substance can be

considered as eligible for exemption.

Some of the criteria require that an

eligible polymer not contain certain

reactive functional groups or elements,

not be a biopolymer or its synthetic

equivalent, not contain less than 32.0

weight percent of atomic carbon, and

must have a number-average molecular

weight of at least 1,000. A substance

that does not fully satisfy all of the

criteria listed in the polymer exemption

rule will not qualify for consideration

even'ifit is a polymer defined under 40

CFR 723.250(b)(11). Therefore, it would

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not be appropriate to include that

definition without the accompanying

criteria. If the criteria are also used.

many polymers that are currently

excluded from this rule would no longer

be eligible for exclusion.

Since issuing the March 12 Federal

Register notice, EPA has closely

examined the completeness of the

terminologies that were used in the

proposed rule to identify polymers. As a

result of this review, EPA has refined

the terminologies for the final rule. The

refined terminologies, which are

discussed in Unit IV. above, identify

virtually all those substances on the

Inventory that are generally considered

as polymers.

D. Chemical Exclusions

Comments. Almost all of the

commenters agreed with the four

chemical exclusion categories proposed

by EPA. One commenter, however,

strongly opposed excluding any

chemical categories from the

requirements of this rule. This

commenter contended that the Inventor3

data base is too important to update

only partially, and that section 8(b) of

TSCA requires thatthe entire Inventory

be kept current.

EPA's response. EPA believes that the

exclusions proposed in the March 12

Federal Register notice are justified.

Section 8(b) of TSCA requires the

Agency to " * * compile, keep current,

and publish a list of each chemical

substance which is manufactured or processed in the United States." EPA

has already been fulfilling this

mandated obligation of keeping the

Inventory current by continually adding

to the list those newly manufactured

substances that have completed section

5 PMN review, and by periodically

removing from the Inventory those

subftanes which were misreported

when the Inventory was compiled and

replacing them with the corrected

chemicil identities. The production

volume and plant site data associated

with the substances on the Inventory were not collected for the purposes of

the section 8[b) Inventory. Rather. these

'data were reported under the authority

of section 8(a). The "keep current"

provision under section 8(b) is restricted

to the addition of newly manufacturedsubstances and does not apply-to the

production volume and plant site data

associated with Inventory substances.

EPA must independently determine

the need for collecting current -data for

these substances under section 8(a) of

TSCA. The reasons for excluding-the

four categories were given-in the March

12 Federal Register notice. If EPA were ..to require manufacturers to report.data

on every substance listed on the

Inventory. this would result in an

unnecessary reporting burden for the

submitters, and the additional

information would be "of no practical

utility" to the Agency, thus violating the

Paperwork Reduction Act's standards

for information collection. However, the

Agency has included in the final rule a

provision which requires the reporting of

current data on an excluded substance if

such substance is the subject of a rule or

an order issued under TSCA section 4. 5,

6, or 7. This provision will ensure the

availability of current information if

EPA has expressed a concern in the

form of regulatory action on any of the

substances otherwise excluded from the

rule.

E. Petroleum Refinery Streams

Comments. Six commenters

responded to EPA's request for comment

on whether petroleum refinery streams

should be excluded from this rule. They pointed out that, for TSCA purposes,

EPA should be concerned about the

potential health and environmental

effects of products rather than

intermediate process streams. The

petroleum refinery streams are by their

nature site-limited and maintained

within closed systems. It is normally

only the final petroleum products that

leave the refinery and enter into

commerce. The commenters argued that

production volume data for refinery

streams are unnecessary to the ' evaluation of products, and can be used

inappropriately to give misleading results because they do not necessarily reflect the production volumes for

commercial petroleum products. Furthermore, they also pointed out that

the refining and manufacture of

petroleum products is a mature

technology, and no new refinery streams

or petroleum products have ever been

added to the Inventory through the PMN

process. Nor are major changes in

refinery technoloqy anticipated which

would significantly change the

composition of refinery streams.

Therefore, the commenters believed that

.a broad-based Inventory update of

petroleum production statistics would

serve little purpose in the absence of

technological developments or volume

changes with potential impacts on

human exposure or environmental

release. Even if EPA can establish a

need for such data, reporting under this

rule will not be necessary because the

data are already reported to the

Department of Energy (DOE). In addition to petroleum refinery

streams, fifteen commenters also

suggested additional substancesfor

exclusion. EPA's responses to these

suggestions are included in the public

record for this rule and are not

discussed in this unit.

EPA's response. EPA disagrees with

the contention that intermediate process

streams are inappropriate subjects of

risk identification activities under

TSCA. EPA has never limited its focus

to only final products sold in commerce.

Since intermediate products can raise

concerns with regard to occupational

exposure and release to the environment

during production and processing

operations, it is often necessary to know

the total production volume of a stream

which may appear as a fraction of

numerous products. If such a fraction is

hazardous, it is important to know the

total volume in commerce. EPA

routinely uses total production volume

as a decision factor in preliminary risk

identification activities.

Regarding the availability of

production data at DOE, as claimed by

these commenters, EPA has reviewed

reports published by the DOE Energy

Information Administration (EIA) and

concluded that site-specific production

volume information on refinery streams

is not available. EPA believes that the

rationale for site-specific information on

petroleum refinery streams and products

is basically the same as the rationale for

any other types of substances. For the

purposes of TSCA. EPA needs sitespecific production volume information

to support assessment of the number of

workers who may be exposed at a site,

the general population at risk in the area

surrounding a site, and the chemical

concentration in waterways

downstream from each site. Sitespecific information is also needed to

support the assessment of economic

impacts on affected companies in

rulemaking under TSCA, and to

determine the number of reports that

can be expected for each reporting rule.

Aggregated production data, which are

readily available from EIA, do not

provide useful information for any of the

aforementioned analyses.

F. Duplicative Reporting

Comments. Two commenters

requested that EPA clarify the potential

duplicative reporting requirements

between this rule and other TSCA

section 8(a) rules including the yet-to-be

proposed Comprehensive Assessment

Information Rule (CAIR).

EPA's response. EPA recognizes that

there could exist a potential for

duplicative reporting among the various

section 8(a) reporting rules, especially

regarding production volume data. The

Agency has decided that if similar

information has been submitted under a

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section 8(a), rule fora- substance within.

the year preceding; the start of a

reporting, period under. this. rule;. thesubmitter will not.be required to report.

the same information -again for that

reporting period..

G. Reporting by Importers

Comments. One.commenter asked

EPA to clarify in the final' rule which

person has the responsibility to report

as the "importer' of a, particular

substance as was done in the PMN rule.

EPA's response. EPA recognizes that

more than one person might meet the

definition of "importer" in § 710.2(1) of

the original. Inventory Reporting. Rule

and § 704.3 of the general section 8(a)

definitions for a particular import.

transaction involving a-particular

substance. For PMN purposes, to

address, the same problem, EPA decidedto define a "principal importer'" (40' CFR

720.3(z)), which in most cases will be the

person most knowledgeable about a

new chemical substance; and to require

that person to submit the PMN. For this

rule EPA has decided'not to designate

which "importer" should report fora

particular import transaction involving a,

specific chemical. substance. Rather,

EPA will leave it to the parties to- the

transaction to determine which will

report. Section 710.35(b), of the-rule

makesi clear that EPA wants only a

single report for such a transaction, and

that EPA will hold each 'importer"

liable if a required report is not

submitted or does not contain the

required information. Thus, if a

company imports a substance several

times in a single year at a particular site.

and uses different agents each time, the

company could choose to submit the

report combining all the. imports, or it

could designate one of the agents to

submit the report; provided the-agent

had all the necessary information- about

all shipmentsH. Definition of "Parent- Company"far

Small Manufacturer Exemption

Comments.. One commenterraised

several concerns about the Agency'sdefinition of the. terms. "parent

company" and "small manufacturer,"

specifically,, the commenter noted that

the total annual: sales: criterion of the.

small manufacturer definition, should not

include sales revenue of parent and/or

subsidiary companies. In addition, the

commenter noted, that majbrity stock

ownership should not be: a determining factor in either the definition of "parent

company" or the determination of

responsibility for compliance with.

reporting requirements..

EPA.'s response. In an, effort to

simplify this final: rule,. EPA haw deleted,

the text of several definitions- from.the

rule, including the-definitions of "parent

company" and.'small.manufacturer:"

However, these definitions still are

applicable to. the final rule because they

, are incorporated by reference from the

list of standard section 8(a) definitions

contained in.40 CFR 704.3. The

definitions in § 704.3 are not

substantively different from the

definitions which were contained in the

proposed rule. Since this rule.adopts the

definitions contained in-40 CFR 704.3,

the commenter's points remain relevant

and are addressed-by EPA below.

The Agency's. definitions for the terms "parent company" and, "small

manufacturer" are part of'the generic

reporting provisions for section 8(a)

- rules, and already have been the subject

of public.comment. EPA received,

relatively few adverse comments on- the

generic definitions. The definition of "parent company' is based on the.

concept of. ownership or control, whi'ch

often is-determined by-majority stock

ownership. This- interpretation of the.

relationship between parent firm and

subsidiary reflects prevailing judicial

views on- the issue.

The "small manufacturer" definition

includes the total annual sales- of parent

firms and subsidiaries, if any, because

EPA believes that-a broadly defined

sales criterion is the. best available

measure-of a diversified firm's full

financial: resources available for

regulatory compliance. For a moredetailed discussion of'this definition, see

the preamble- discussions of both the -

proposed, and: final Small Manufacturer

Exemption Rules (proposed rule, at 47 FR,

27206, June 23, 1982;, final rule at 49-FR

45425 November 16, 1984).

EPA does not intend that a parent firm

owning a majority of stock in a

subsidiary report on behalf of-the

subsidiary. Any company that is subject

to reporting requirements under the

terms of this rule (and that does not'

qualify for any of the- exemptions in. the

rule) must submit the requisite

information, even if that firm is a subsidiary of*a larger company; it is up

to the companies involved to determine

internally who compiles-the requisitedata for submission. In the event of

noncompliance. the-legal principles of

liability in parent-subsidiary

relationships, will govern.

I. Recordkeeping Requirements.

Comments Nine organizations

expressed concern that. the, proposed

recordkeeping requirements would-be

unnecessarily burdensome. In generalI,.,

there- are two- main. objections. First, the

commenters, believed, that the proposed

5-year record retention, time is not

justified. A 2-year period would be,

consistent with standard practice.

Second, they objected to the

requirement that the submitters must

document- decisions, not to report.. Some,

indicated. that this requirement would:

take away the-benefits:of the various

exclusions and.exemptions.

Furthermore, all of the commenters

urged EPA to provide detailed guidance

regarding how and what records should.

be kept.

EPA's response. EPA agrees that,, as

proposed, the actual recordkeeping time;

could be open-ended. This, is because a

submitter, in order to make a

determination of whether recurring,

reporting isnecessary, would have. to.

compare, for each reportable substance,

current data against the information that

was last reported. To make that

comparison, the. submitter would have

to maintain records of the last reporting.

almost indefinitely; or until a reportable

event occurs. This is- one of 'the major

disadvantages of the event-triggered

approach for recurring reporting. Sincethe-Agency has abandoned the

previously proposed event-triggered'

approach, recordkeeping time for the

purpose of this rule. will no longer bel

open-ended. However,. there must: be

adequate time: from the closing of a

reporting period for the Agency to

anaryze the submissions and to examine

the corresponding records if an:

inspection of a-particular plant site is

found to, be necessary. For this reason,

EPA believes that a 2-year

recordkeeping period.;,. as suggested- by

the commenters,. will. not be sufficient.

As a minimum.,relevant records for, a

reporting period must be retained until,

the start of the. next. round. of reporting,'

i.e., for the entire.4 years between.2

reporting periods.

The proposed. requirement that

submitters document decisions. that

reporting is not necessary was also.

closelyrelated to the proposed eventtriggered- approach for. recurring

reporting..This requirement, meant that

the submitters should be able to show

evidence, upon request; that recurring:

reporting-was- not necessary because a

reportable- even t had notoccurred

during a particular period of time. Since

most of the reportable events relate to

production; the-submitter's prodictionrecords would have been sufficient

evidence Contrary to what many,

commenters believed, the-Agency had,

never.intended to.extend the. scopeof'

thi'n requirement to cover persons'wh9:'•

are not subject to this rule or the ,

excluded chemical categories. For the

purposes of this. rule , only those records.

that show the'production:volume, plant.

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site, and site-limited status of each

reportable substance are to be

maintained. In the case of low-volume

substances, only production records

must be kept to establish evidence that

those substances are not reportable at

the current production levels.

. Data Aggregation and Confidentiality

Comments. Several commenters

suggested that EPA publish prior to the

effective date of the final rule

methodologies that the Agency will use

to aggregate production volume data for

public disclosure. One commenter

claimed that even aggregated data could

be sensitive information, and' thus EPA

has no right to publish aggregated data. . A number of commenters urged that

EPA allow confidentiality claims for the

signing official of the reporting firm and

the name and address of the technical

contact. They also urged EPA to exempt

submitters from resubstantiating claime

for confidential.chemical identities if

such has been submitted to the Agency

within 2 years before the final rule takes.

effect.

EPA's response. EPA has yet to

determine which of the several data

aggregation methodologies it is

investigating will be used for production

volume data collected under this rule.

Even after a methodology is selected, it

is unlikely that EPA will be able to

describe it in great detail and still

preserve the confidentiality of the

information to be aggregated. EPA's

rationale for not publishing a detailed

description of the aggregation is to

protect the confidentiality of the

information.

EPA agrees with the comments on

confidentiality claims for the signing

official and the technical contact. The

reporting form has been revised to

permit these claims to be asserted.

EPA disagrees, however, with the

comment that resubstantiation of

confidentiality claims for chemical

identity is unnecessary under this rule if

such substantiation has been submitted

within 2 years before the rule takes

effect. EPA is actively reviewing claims

of confidentiality asserted for

information on substances added to the

Inventory via the PMN process, and will

also actively review claims asserted

under this rule. This review requires upto-date substantiation for the claims

asserted. If the substantiation previously

submitted is no longer valid, EPA must

have new substantiation for the

purposes of this rule. If the

substantiation is still valid, the burden

for resubmitting it should be minimal.

VI. Rulemaking Record

EPA has established a public record

for this rulemaking (docket number '

OPTS 82015A), which is available for

inspection in Rm. E-107, 401 M St., SW.,

Washington, DC 20460, from 8 a.m. to 4

p.m., Monday through Friday, except

legal holidays. These records include all

basic information considered by the

Agency in developing this 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.

(4) All comments on proposed rule

and relevant documents and studies

submitted in support of these comments.

(5) A summary of EPA's responses to

the comments on the proposed rule.

(6) U.S. General Accounting Office

Fact Sheet for the Chairman,

Subcommittee on Commerce,

Transportation and Tourism, Committee

on Energy and Commerce, House of

Representatives: Chemical InventoryEnvirgnmental Protection Agency's

Proposed Inventory Update, December

1985, GAO/RCED-86-47FS.

(7) A Summary of EPA's Responses to

the GAO Report on the TSCA Inventory

Update.

(8) 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.)

VII. Economic Impact

Based on exclusions and exemptions

discussed in this preamble, EPA

estimates that a total of 4,800 plant sites

will be required to submit an initial

report on at least one chemical

substance.

EPA estimates that chemical

manufacturers subject to this rule will

spend approximately $5.5 million to

report forthe 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 $946. This includes time to become

familiar with the reporting requirements,

time to determine which of the

substances produced at the site are

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 $251 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. A maximum of 5

additional hours are esfimated for a

submitter to gather the necessary

information and to complete and review

a reportinq form. At an average of one

report per plant site, these estimates

allow 24 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.

For subsequent reporting years (every

fourth year following the initial

reporting year), all plant sites

manufacturing a reportable substance

will have to file a new reporting form.

The total cost of reporting in subsequent

reporting years is projected at $2.2

million. This estimate includes costs for

reviewing the rule, for making the

determination, and for completing a

reporting form.

A more detailed economic impact

analysis of the requirements of this rule

is included in the rulemaking record.

VIII. 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 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 bf Management and Budget

(OMB) for review as required by

Executive Order 12291.

B. Regulatory Flexibility Act

This rule contains a small

manufacturer exemption which

generally exempts small manufacturers

and importers from all reporting

requirements. Therefore, in accordance

with the Regulatory Flexibility Act, 5

U.S.C. 601 et seq., EPA has determined

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that this rule will not have a' significant

economic impact on asubstantial

number of small entities.

C. Paperwork Reduction Act

The information collection

requirements contained in: this rulew were

submitted.for approval ,to OMB under

the provisions of the-Paperwork

Reduction Act of 1980,,44 U.S.C. 3501 et,

seq. The information collection

requirements in this final, rule: were approved by OMB and assigned control

number 2070-0070.

List of Subjects ih 40 CFR Part 710'

Environmental protection, Chemicals;

Inventory, Hazardous materials,

Reporting and recordkeeping

requirements.

Dated: May 29, 1986.

Lee M. Thomas,

Administrator.

PARi 710-[AMENDED]

Therefore, 40 CFR Part 710 is

amended as follows:

1. The authority citation for Part 710

continues to read as follows:-

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

2. By designating the existing § § 710.1

through 710.8 as Subpart A, the heading

for which reads as follows:

Subpart A-Compilation of the

Inventory

3. 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 for which

information must be reported. 710.26 Chemical subs tances forwhich

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 Information to be reported.

710.33 When to report.

710.35 .Duplicative reporting. 710.37 Recordkeeping requirements.

710.38 Confidentiality.

710.39 Reporting form and instructions for . submitting information.

Subpart B-Partial Updating of the

Inventory Data Base

§ 710.23 Definitions.

The definitions in § 704.3 of this

chapter and § 710.2 of this Part apply

except as provided in this' section.

(a) "Master'Inventory'File" means

EPA's comprehensive list of'chemical

substances which constitute the

Chemical Substance's 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.

(b) "Nonisolated intermediate" means

any intermediate that is not

intentionally removed from the.

equipment in which it.is manufactured,

including the reaction vessel'in which it

is manufactured, equipment which is

ancillary to the reaction vessel,, and any

equipment through which- the substance

passes during a continuous flow

process, but not including tanks or other

vessels in which the substance is stored

after its manufacture.

(c) "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... >

§ 710.25 Chemical substances-for which

Information must be reported.

Any chemical substance which is in

the Master Inventory File at the

beginning of a reporting period

described in § 710.33, unless the

chemical substance is specifically

excluded by § 710.26.

§ 710.26 Chemical substances for which

Information Is not required.

The following categories of chemical

substances are excluded from the

reporting requirements of this subpart.

However, a chemical substance

described in paragraphs.(a), (b), or (c) of

this section is not excluded from the

reporting requirements of this subpart if

that substance is the subject ofa rule

proposed or promulgated under §ection

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) Inorganic chemical substances.

Any chemical substance which does nor

contain carbon or contains carbon only in the form of carbonato ['=CO3], cyano

[-CN], cyanato- [-OCN], isocyano [-NC], or isocyanato [-NCOJ groups,

or the chalcogen analogues of such.

groups.

(b) Polymers. (1) Any chemical

substance, described with- the word.

fragments."*polyin ',.", alkyd!', or; * oxylated" in the.Chemical;Abstracts:

Service Index or Preferred., - -' , "

Nomenclature in theChemical . Substance Identities section of the .1985

edition of'the Inventory or in the-Master

Inventory File, where the asterisk.(*)

indicates that any sets of chapacters

may precede, or follow,.the- character

string defined.

(2) 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. This exclusion,,

however, does not apply to a chemical

substance whichhas been h.ydrolyzed,.

depolymerized, or chemically modified.

to the extent that the final product is no.

longer polymeric in structure..

(c) Microorganisms. Any combination

of chemical substances that is a living

organism, such as bacteria, eimeria,

fungi, and-yeasts. Any chemical

substance produced firom such, a living

organism. is'reportable unless otherwise"

excluded.

(d) Naturally occurring btemical

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 inr

§ 710.4(b) and by means other than

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

described in § 710.28 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 unlessotherwise

excluded..

§ 710.28 Persons who must'report.

Except*asprovided'in § § 7 i0.29 and

710.30, the following persons are subject

to the requirements of this subpart.

Persons must determine whether they

must report under this §' 710.28 for each

chemical substance that they

manufacture at an individual site.

(a) Persons, subject to initial reportinq.

Any person who manufactured for

commercial purposes 10,000 pounds

(4,540 kilograms)'or more of a-chemical

substance. described in § 710.25 at any

single site ownedor controlled by that

person at any time during. the person's

latest c6mpletI corporate: fisca'yleari'"

before August 25, 1986.

(b) Persons subject to recurring

reporting., Any person who

manufactured for commercial purposes'

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10,000 pounds (4,540 kilograms) or more

of a chemical substance described in

§ 710.25 at any single site owned or

controlled by that person at any time.

during the person's latest complete

corpordte, fiscal year before August 25,,i

1990, or before August 25 at four-year

intervals thereafter.

(c). Special provisions for importers.

For purposes of paragraphs (a) and (b)

of this section, the site for a person who

imports a chemical substance described

in § 710.25 is 'the site of the operating

unit within the person's organization

which is directly responsible for

importing the substance and which

controls the import transaction..The

import site may in some cases be the

organization's headquarters in the U.S.

(See also § 710.35(b).)

§ 710.29 Persons not subject to this

subpart.

A person described in § 710.28 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(r) of this chapter.

Notwithstanding this exclusion, a

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.

§ 710.30 Activities for which reporting Is

not required.

.A person described in § 710.28 is not

subject to the requirements of this

subpart with respect to any chemical

substance described in § 710.25 that the

person manufactured or imported under

the following circumstances:

(a) The person manufactured or

imported the chemical substance

described in § 710.25 solely in small

quantities for research and

development,

(b) The person imported the chemical

substance described in § 710.25 as part

of an article,

(c) The person manufactured the

chemical substance described in

§ 710.25 in a manner described in

§ 720.30 (g) or (h) of this chapter.

§ 710.32 Information to be reported.

Any person who must report under

this subpart must submit the information

prescribed in this section, for each

chemical substance dessrib!edin

§ 710.25 that the person manufactured

for commercial purposes in an amount

of 10,000 pounds (4;540 kilograms) or

more at a single site during a corporate

fiscal year described in § 710.28. (The

site for a person who imports a chemical

substance is the site of the operating

unit within the person's organization

which is directly responsible for

importing the substance and which

controls the import transaction, and may

in some cases be the organization's

headquarters office'in the U.S.). A

respondent to this subpart must report

information in writing or by computer

tape as prescribed in this section to the

extent that such information is known to

or reasonably ascertainable by that

person. A respondent to this subpart

must report information that applies to

the specific corporate fiscal year for

which the person is required to report.

Information on chemical substances for

which the chemical identities are •

claimed confidential under § 710.38 must

be submitted in writing. (a) Reporting in writing. Any person

who chooses to report information to

EPA in writing must do so by completing

the reporting form contained in § 710.39,

and inust submit a separate form for

each site for which the person is

required to report. Information on

substances for which the chemical

identity is claimed confidential under

§ 710.38 must be submitted in writing on

a separate reporting form: a respondent

to this subpart must not report

'confidential and non-confidential

chemical substance identities on the

same reporting form.

(b) Reporting by computer tape. Any

person who chooses to report

information.to EPA by means of

computer tape must submit the

information prescribed in this paragraph

(b), and must report separately for each

plant site for which the person is

required to report. Computer tape

submitted in response to this subpart

must meet EPA specifications, as

described in the instructibn booklet

identified in § 710.39(b). Persons

reporting by means of computer tape

also must submit a separate reporting

form, with certain basic data elements

completed, as specified below, for each

site for which the person is required to

report. The information to be.reported is

as follows:

(1) On the reporting form, the name,

address, city, State, Zip code, and

telephone number of a person who will

serve as technical contact for the

respondent company, and will be able to

answer questions about the information

submitted by the company to EPA.

(2) On-the reporting form, a ' " ' ':

certification statement signed and dated

by an authorized official of the

respondent company, and a written

statement on the form that information

is being submitted by means of

computer tape. The computer tape shall

be enclosed with the reporting form.

(3) On the computer tape, the specific

chemical name and Chemical Abstracts

Service (CAS) Registry Number of' each;

chemical substance for which reporting

is required under this subpart. A

respondent to this subpart may use

other chemical.identification numbers in

lieu of CAS Registry Numbers when a

CAS Registry Number is not known to

the respondent as provided in the

instruction booklet identified in

§ 710.39(b), including EPA-designated

Accession Numbers for confidential

substances, EPA-assigned numbers for

bona fide or Premanufacture

Notifidation submissions or Test Market

Exemption Applications, or original

Inventory form numbers.

(4) On the computer tape, the name,

street address, city, State, and Zip code

of each site at which 10,000 pounds

(4,540 kilograms) or.more of a chemical

substance for which reporting is

required under this subpart is

manufactured or imported. (The site for

a person who imports a chemical

substance is the site of the operating

unit within the person's brganization

which is directly responsible for

importing the substance and which

controls the import transaction, and may

in some cases be the organization's

headquarters office in the U.S.). A

respondent to this subpart must include

the appropriate Dun and Bradstreet

Number for each plant Site reported.

(5) On the computer tape, a statement

for each substance for which

information is being submitted

indicating whether the substance is

manufactured in the United States or

imported into the United States.

(6) On the computer tape, a statement

for each substance for which

information is being submitted

indicating whether the substance is sitelimited.

(7) On the computer tape, the total

volume (in pounds) of each subject

chemical substance manufactured or

imported at each site. This amount must

be reported to two significant figures of

accuracy provided that the reported

figures are within ±L10 percent of the

actual volume.

§ 710.33 When to report.

All information reported to EPA in

response to the requirements of this

subpart must be submitted during an

applicable reporting period. The,

followifig'reofing periods are

prescribed for this subpart.

(a) Initial reporting period. The first

reporting period is from August 25,.1986

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to October 10, 1986. Any person "

described in § 710.28(a) must report

during this period for each chemical

substance described in § 710.25 that the

person manufactured during the

corporate fiscal year described in

§ 710.28(a).

(b) Recurring reporting periods. The

first recurring reporting period is from

August 25, 1990 to October 10, 1990.

Subsequent recurring reporting periods

are from August 25 to October 10 at 4-

year intervals thereafter. Any person

described in § 710.28(b) must report

during the appropriate reporting period

for each chemical substance described

in § 710.25 that the person manufactured

during the, applicable corporate fiscal

year described in § 710.28(b).

§ 710.35 Duplicative reporting.

(a) With regard to section 8(a) rules..

Any person subject to the requirements

of this subpart who previously has

complied with reporting requirements of

a rule under section 8(a) of the Act by

submitting the information described in

§ 710.32 for a chemical substance

described in § 710.25 to EPA, and has

done so within one year of the start of a

reporting period described in § 710.33, is

not required to report again on the

manufacture of that substance at that

site during that reporting period.

(b) With regard to importers. This

subpart requires that only one report be

submitted on each import transaction

involving a chemical substance

described in § 710.25. 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 § 710.2(1) 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 subpart, EPA -will hold each such

person liable for failure to report..

§ 710.37 Recordkeeping requirements.

Each person who is subject to the

reporting requirements of this subpart

must maintain records that document

any information reported to EPA. For

substances that are manufactured or •

imported at less than 10,000 pounds

annually, volume records must be

maintained as evidence to support a

decision not to submit a report. Records

relevant to reporting during a reporting

period described in § 710.3.3 must be

retained for a period'of four years

beginning with the effective date of that

reporting period.

(Approved by the Office of Management and

Budget under control number 2070-0070)

§ 710.38 Confidentiality. '.

(a)Any person submitting information

under this subpart may assert abusiness confidentiality claim for the

information. The procedures for

asserting confidentiality claims are

described in the instruction booklet

identified in § 710.39. Information

claimed as confidential in accordance

with this section and those instructions

will be treated and disclosed ih

accordance with the procedures in Part

2 of this chapter.

(b) A person may assert a claim of

confidentiality for the chemical identity

of a specific chemical substance only if

the identity of that substance is treated

as confidential in the Master Inventory,

File as of the time 'the report is

submitted for that substance under this

subpart.

(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 the form

contained in § 710.39; 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 competitoruse .

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

available to the public, 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 manufacturpd

or imported for commercial purposes

been revealed to others? Whatprecautions 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

thepublic 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 ofconfidentiality

accompanies informationi a i.the' time it

is submitted to EPAjunder 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 form and Instructions

for submitting Information.

(a) All persons submitting written

information in response to the

requirements of this subpart must use

original copies of the form contained in

this §. 710.39.

(b) Complete instructions for . completing the reporting form and

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11-50 Federal Reister/ - ol. 5'I , sN . 1- ,4 ThuVrsday, June 12, 1986 I Rules and Regulations

prepafing a (computer tape reporttare given in ithe EPA -publication entitled

"InstructionsiforiRqpontingiforithe

Partial U.pdatingdf ithe TSCA Chemical

Inventory 'Data Base." !Rqpontirg ;forms

and instrucfion booklets maybe

(obtained from 'the followingaddress:

'OTS Document'Coiitrdl Officer:(Room

E-201), US. :Environmerital',Pritection

Agency, Officeof Toxic 'Stibtances

(TS-790), 401 M Street,,SW.,

-Washington, 'DC'20460, Attention:

'Inventory Update Rifle, Telephone:

'(202) 382-3698 or.(20Z),755-4880.

.(c) Completed 7rporting forms and

computertapes must besubmitted to i(he

address pecifiedin § 710,39(b) above.

(d) The reporting form isias-folows:

IiCLING CODE 6560W50-M

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