+(,121/,1(

Citation: 42 Fed. Reg. 64572 1977 

Content downloaded/printed from 

HeinOnline (http://heinonline.org)

Wed Jul 21 17:06:52 2010

-- Your use of this HeinOnline PDF indicates your acceptance

 of HeinOnline's Terms and Conditions of the license

 agreement available at http://heinonline.org/HOL/License

-- The search text of this PDF is generated from 

 uncorrected OCR text.
64572

[6560-01]

Title 40-Protection of Environment

CHAPTER I-ENVIRONMENTAL

PROTECTION AGENCY

SUBCHAPTER R-TOXIC SUBSTANCES CONTROL

[OTS-081002A; FRL 817-1l

PART 710-INVENTORY REPORTING

REGULATIONS

AGENCY: Environmental Protection

Agency.

ACTION: Final rules.

SUMMARY: This notice promulgates the

Inventory reporting regulations proposed on March 9 and August 2, 1977 in the

FEDERAL REGISTER and supplemented

thereafter. Specifically, these regulations

require some persons who manufacture

or import chemical substances:

(1) To report the identity of each

chemical substance manufactured at

each site of manufacture, or imported

Into the United States, for a commercial

purpose;

(2) To estimate the amount of each

chemical substance manufactured at

each site, or imported during calendar

year 1977; and

(3) To indicate whether each such

chemical substance is manufactured and

used only within one site.

Based upon the reports of manufactur- ers and importers, EPA will publish an initial inventory of chemical substances.

After publication of the initial inventory, these regulations authorize reporting by processors of additional chemical

substances. EPA will publish- a revised

inventory including these substances in

1979.

DATES: These regulations are effective

January 1, 1978. Reporting for the initial

inventory by manufacturers and Importers 6f chemical substances will begin

January 1, 1978 and end May 1, 1978.

During the 210 days after publication of

the Initial inventory in late 1978, processors of chemical substances, and importers of chemical substances as part of

mixtures or articles, may report additional chemical substances for a revised

inventory. (NOTE: Many of the terms

used in these regulations, such as "manufacturer" and "processor" have a special meaning for purposes of these regulations. Persons should read the regulations, especially the definition section

carefully, and be sure they understand

the special meanings of these terms.)

VoR FURTHER INFORMATION CONTACT:

Mr. John B. Ritch, Jr., Director, Office

of Industry Assistance, Office of Toxic

Substances (TS-788), Environmental

Protection Agency, 401 M Street, SW,

Wa-shington, D.C. 20460, 202-755-0535.

To obtain reporting forms and instructions, call this toll-free number 800-

424-9065.

SUPPLEMENTARY INFORMATION;

The regulations are promulgated under

the authority of subsection 8(a) of the

Toxic Substances Control Act (90 Stat.

2003; 15 U.S.C. 2601 et seq.) hereinafter

referred to as TSCA.

RULES AND REGULATIONS

On March 9, 1977, EPA first published

in the FEDERAL REGISTER (42 Fn 13130)

proposed inventory reporting regulations

to govern reporting of chemical substances required by subsection 8(a) of

TSCA. On April 12, 1977, EPA published

a supplemental notice of proposed rulemaking in the FEDERAL REGISTER (42 FR

19298) providing additional information

pertaining to the proposed inventory

regulations. This notice set forth instructions for use of a Candidate List of

Chemical Substances and specified minerals which EPA proposed to include in

the inventory of chemical substances.

On April 18, 1977, EPA held a public

meeting in Washington, D.C. to provide

interested persons an opportunity to

comment publicly on the proposed regulations. On April 28, 1977, EPA published a notice of availability of the Candidate

List of Chemical Substances for use in

reporting chemicals for inclusion on the

inventory (42 FR 21639). On July 8, 1977,

the Agency published a notice to amend

the procedures for securing a copy of the

Candidate List on computer-readable

tape (42 PR 35183). EPA is preparing to

supplement the Candidate List with at

'least one additional list of substances. As

soon as any supplementary list is available, EPA will publish a notice of availability in the FEDERAL REGISTER to enable

persons to request copies.

On August 2, 1977, EPA reproposed the

inventory reporting regulations. In order

to provide interested persons an opportunity to comment publicly on the proposed regulations, EPA held a public

meeting in Washington, D.C. on August

24, 1977. A transcript of the public meeting is available for public inspection in

the Office of Toxic Substances at the address provided above. Finally, on October

3, 1977, EPA published a supplementary

notice to the August 2 proposal. This

- notice clarified the applicability of the"

reporting regulations to importers and

invited comment on draft reporting

forms.

EPA has received over 400 comments in

response to the notices of proposed rulemaking published on March 9, August 2,

and October 3, 1977. These comments

were received from trade associations,

business firms, environmental organizations, labor unions, state and federal

agencies and others. Appendix A of this

notice summarizes and responds to the

* significant Issues raised in these comments. The major Issues that were resolved in promulgation of these final regulations are discussed below.

Appendix B of these regulations includes copies of the reporting forms for

these regulations. These forms are published here as samples of the official

forms which will be available from-EPA.

These forms may not be used for reportIng. The official forms; which will be distributed to persons included on EPA's

mailing list, each has a unique Identifying number for purposes of processing.

AuTHoRIY, PURPOSE AND SCOPE OF THE

* REGULATIONS

These regulations are promulgated

pursuant to the authority of section 8(a)

of TSCA. They accomplish two of the

purposes contained In that section of the

Act. In the first place, In accordance with

section 8(a) (1) of the Act, they require

reporting for compilation of the Inventory of chemical substances manufactured or processed for a commercial purpose in the United States. The Administrator Is required to compile and publish

an inventory of chemical substances

under section 8(b) of the Act. In the

second place, under the authority of

TSCA section 8(a) (1) (A), these regulations require reporting of production and

site Information on chemical substances,

which is reasonably necessary for establishing a profile of the chemical industry,

monitoring chemical substances In the

environment, and setting Agency priorities for implementing other provisions of

TSCA.

In the interest of accomplishing these

objectives, § 710.3(a) requires any person who manufactured or Imported

chemical substances during calendar year

1977 to report concerning all such substances If (a) thirty percent or more of

the weight of the products consists of

products of the types described under

Standard Industrial Classification (SIC)

groups 28 or 2911, or (b) If the total

pounds of reportable chemical substances

manufactured or Imported equals one

million pounds or more. In addition, any

person who manufactured at a site or imported a chemical substance in 100,000

pound quantities or greater during calendar ear 1977 must report concerning

that chenical substance.

By directing the reporting requirements to those persons who are significantly engaged In manufacturing chemical substances, EPA will create a profile

of the chemical industry useful In future

implementation of TSCA. As a minimum,

the Agency will know the site of manufacture of all chemicals manufactured

in quantities greater than 100,000 pounds.

Moreover, for every plant site substaitially engaged in producing chemical

substances or chemical products for com- mercial purposes, EPA will know the

Identities of the substances manufactured there and the relative quantities

in which they are produced.

As discussed further in the response to

comments (Appendix A); EPA desires to

minimize duplicative reporting to the

extent consistent with its needs in Implementing TSCA. Manufacturers and

Importers who do not meet the criteria

for required reporting do not need to report individually. Instead, they may re- port through a trade association or rely

upon another manufacturer or an Importer to report the substances for Inclusion on the inventory. Further, in tie

interest of minimizing duplicative reporting, persons who areprocessors of a chemical substance they neither manufacturo nor import are not subject to the initial

reporting requirements. Persons who

process or use chemical substances for

commercial purposes may report those

chemical substances not included in the

Initial inventory during a special reporting period. In addition, persons who ImFEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64572 1977
RULES AND REGULATIONS

port chemical substances as a part of a nx&=e or article may report during

the special reporting period. EPA expects

to publish a revised inventory based on these additional reports sometime in fall

1979.

SMALL LUNUFACTURER

As provided in TSCA section 8(a) and

discussed in the preamble to the August 2

proposal, EPA may require "small manu- facturers" to submit only information

necessary for compilation of the inventory or concerning'a chemical substance

which is subject to a proposed rule or order under TSCA section 4, 5 or 6 or court action under section 5 or 7. At this

time, any person who is required to re- port' and who is a small manufacturer is

only required to submit information re- quired for compilation of the inventory. Accordingly, any "small manufacturer"

need only identify chemical substances

and report certain limited information

required for purposes of the inventory.

Small manufacturers are exempt from

reporting production volumes and, if a small manufacturer has more than one plant site, he need not separately report

for each site. Since these regulations define "manufacture" to include "import,"

the provision applies equally to "small

importers."

The definition of "small manufacturer or importer" proposed in August has

been revised to exempt from these additional reporting requirements those man- ufacturers and importers with thtal sales

of less than $5 million. This exemption,

however, does not apply with respect to

any chemical substance produced by a manufacturer at one site or imported in

quantities equal to of greater than 100,-

000 pounds during calendar yebr 1977.

Accordingly, no manufacturer will be

considered a "small manufacturer or importer" with respect to any chemical substance manufactured at one site or imported in quantities over 100,000 pounds.

-In deciding how to define "small man- ufacturer or importer," EPA considered

both the relative burden to manufacturers and importers to submit additional

information and the value of that information to EPA and other federal agencies. Under this definition, the total cost

of reporting for the inventory for the

marginal small firm, in most cases, will

be about 1 percent of profits. While the

firms exempted under this definition represent nearly 80 percent of chemical

firms, they account for only 4 percent of

sales of chemical substances and only 6

percent of employment in SIC groups 28 and 2911.

In the interest of creating a data base

that is at least complete with respect to

the volumes of those chemical substances

produced in substantial-quantities, this

definition does not exempt any manufacturer or importer from reporting the vol- umes of individual substances produced in quantities of over 100,000 pounds during calendar year 1977. Reporting pro- duction volume will involve simply pro- viding the digit that is associated with a broad range (e.g., "4" is for production between 1 million and 10 million pounds),

as provided in the table at § 710.5(d) (4).

Since the manufacturer or importer will

already be reporting the names of substances, the additional burden of supplying production information in terms of

large ranges should be minimal, especially for substances produced in significant quantities.

REPORTING SCEDULE AM EuroncE. Max

These regulations provide for publication of an initial inventory based on re- porting by manufacturers and importers

of chemical substances, followed by publication of a revised inventory based on reporting by processors of chemical substances and Importers of chemical substances as part of mixtures and articles.

Reporting for the initial inventory will

begin on January 1, 1978, and end May 1,

1978. Manufacturers and Importers of

chemical substances must report, as provided In § 710.3(a), during this first re- porting period. Processors are only subject to the second reporting period which

will begin after publication of the initial

inventory and end 210 days later.

Thirty days after publication of the initial inventory, premanufacture notification will begin. After that date, any per- son who intends to manufacture or import (in bulk) a chemical substance not

included on the inventory must submit

premanufacture notice under section 5

(a) (1)(A). Processors and users of a chemical substance for a commercial

purpose, and importers of a chemical substance as a part of a mixture or article

will be able to supplement the initial inventory during the second reporting period, as provided in § 710.3(b).

TSCA section 15(1) makes it unlawful

for any person to fail or refuse to comply

with the premanufacture notification re- quirements of section 5. TSCA section

15(2) makes It unlawful for a person to use for a commercial purpose any substance which he had reason to know was manufactured in violation of section 5.

Sections 15(1) and 15(2) as they relate

to section 5(a)(1)(A) will not be ap- plied to persons who process or use for a commercial purpose chemical substances

not on the inventory or who import

chemical substances as a part of a mixture until after publication of the revised

inventory. By reporting any chemical

substance, not included on the initial

inventory during the second reporting period, these persons will be able to protect themelves from prosecution under

section 15(2) with respect to the requirements of section 5(a) (1) (A) of TSCA.

Imnporters- of a chemical substance as part of a mixture or article will not be

subject to premanufacture notification

requirements for "new" chemical substances until 30 days after publication of

the revised- inventory. Under these re- porting requirements, persons who import chemical substances as part of art!-

cles do not have to report concerning those chemical substances for the initial

inventory. EPA Is still considering

whether importers of certain chemical

substances as part of articles will be subject to premanufacture notification requirements under section 5(a) (1) (A).

64573

EPA will address this Issue prior to publication. of the Initial inventory. Refer

to comments 18 to 23 for further clarification of these Issues concerning importers of chemical substances.

Finally, EPA recognizes that it is inevitable, considering the large volume of

Information to be compiled and transmitted, that there may be some unintentional clerical errors In reporting. Accordingly, the note in § 710.1(b) of these

regulations provides that EPA does not

intend to focus its enforcement efforts

on reporting violations that are clerical

in nature. Instead, EPA will give priority

to bringing actions against persons wh6

(1) report false information, (2) report

for inclusion on the inventory chemical

substances which are excluded under

section 710.4() of these regulations,

(3) fail to report, or (4) fall to

maintain records documenting reported

information.

C0r urDErfxAL=

As discussed in the preamble to the

August proposal, there is an apparent

conflict between section 14 and sections

8(b) and 5(a) of TSCA with respect to

the inclusion of the Identities of certain

chemical substances on the inventory.

Section 8(b) requires EPA to publish a list of "each chemical substance --which

is manufactured or processed in the

United States. Such list shall include

each chemical substance which any per- son reports, under section 5 or subsection

(a) of this section, is manufactured or processed in the United States." (emphasis added) The list has two purposes,

to inform the public concerning which

chemical substances are manufactured

br processed for a commercial purpose

and to which the public may be exposed, and to define what constitutes a "'new

chemical substances" for purposes of

premanufacture notification requirements under section 5(a). However, sec- tion 14 states that any Information re- ported to EPA under TSCA that is ex- empt from disclosure under the Freedom

of Information Act fourth exemption (5 U.S.C. 552(b) (4)) may not be disclosed

except in specific circumstances set out

in section 14 (a) and (b).

In the absence of the requirements of

section 8(b) and 5(a). EPA would publish an inventory that would not include

the Identities of specific chemical substances for which the fact that the particular substance is manufactured or processed for commercial purposes is

confidential. In the absence of the re- quirements of section 14. EPA would pub- lkih a list of all chemical substances

manufactured or processed for com- mercial purposes. Since the term manu- facture includes "to import", this discussion and the regulations apply equally to imported chemical substances.

Having no explicit statutory guidance about how to resolve this conflict, EPA

has attempted to balance the concerns of

section 14 with those of sections 8(b) and

5(a). EPA balieves that Congress did not

intend manufacturers to be required to

furnish EPA premanufacture notification on existing chemical substances

whose Identities for purposes of the inFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64573 1977
64574

ventory have been claimed as trade,

secret. EPA believes that Congress did

intend EPA to preserve confidentiality to the maximum extent practicable without Impairing administration of TSCA.

Accordingly, EPA has developed the ap- proach set forth in § 710.7, and explained in greater detail in Appendix A, Response to Significant Comments. The approach balances confidentiality under section 14

with the regulatory scheme of sections

8(b) and 5(a). This approach will be

used for the submission of confidential

identities for the Inventory now under

section 8 (a) and subsequently under section 5(a) (1) (A). Should the approach fall to achieve its stated purposes, EPA

will re-examine the approach and consider alternatives.

EPA will allow manufacturers, importers and processors to claim as confidential the fact that a particular chemical substance is manufactured or proc- essed In the United States for commercial purposes. The manufacturer or

processor making such a claim must pro- vide certain information and agree to

certain provisions specified in § 710.7(e) of these regulations. EPA will make a

final determination concerning entitle-,

ment to confidentiality, in accordance

with EPA's procedures for handling confidentiality of business information in

40 CFR Part 2, Subpart B (41 FR 36906, September 1, 1976). If EPA determines

that the fact the particular chemical substance Is manufactured or processed in

the United States for commercial purposes is confidential, EPA will not place the specific chemical Identity on the

published inventory. Instead, EPA will

publish a generic chemical name in an

appendix to the inventory. The generic chemical name will inform

the public of at least the generic types of

confidential chemical substances manufactured or processed for a commercial

purpose in the United States. Further, the generic name will be helpful to manufacturers who consult the appendix to the

Inventory to determine whether they must submit premanufacture notification

under section 5(a) (1) (A) for a proposed "new" chemical substance. The generic

name will alert them to the possibility that the proposed "new" chemical substance may be included on the inventory under that name. The generic name

will not establish a category of chemical

substances for purposes of-the inventory and premanufacture notification requirements.

EPA wants to avoid the anti-competi- tive Impacts which may arise if new entrants into an existing market were required to give premanufacture notification while the existing manufacturer

who claimed the identity of the chemical

substance as confidential was able to

continue to manufacture it. If a manufacturer is required to give premanu- facture notification on a. chemical substance, he cannot manufacture the substance for at least the 90-day notice

period. This delay may be considerably longex if a testing rule under section 4

requires the manufacturer to develop and submit certain test data. EPA is also

RULES AND REGULATIONS

interested In distinguishing a "fishing.

expedition" by a competitor from a bona

fe inquiry concerning the Identities of

c6nfidential chemical substances on the

inventory.

Accordingly, § 710.7(g) permits an inquiring manufacturer to submit certain

information to establish his bona fide intent to manufacture the chemical substance. A manufacturer Is not required .to establish this intent; he can simply submit a premanuacture notification. If a manufacturer establishes bona fide intent to manufacture a chemical substance, EPA will tell the inquiring manu- facturer whether the chemical substance'

is included on the. inventory as a con- fidential identity, and therefore, whether

he must submit premanufacturenotifica- tion under TSCA section 5(a) (1) (A). The submitter who claimed that the

specific chemical identity should not appear on the inventory will be required by § 710.7(e) (2) to agree to have available

and furnish to EPA upon request certain

identifying information on the chemical

substance and agree that EPA may disclose to a person with a bona. lfde intent

to manufacture the substance whether

the particular chemical substance is ineluded on the inventory. Failure to furnish this information to EPA upon re- quest will be construed as a. waiver of

the claim of confidentiality, and the

specific identity will be placed on the inventory. The Agency believes that this

resolution of the conflict between sec- tions 5(a), 8(b), and 14-of the statute

balances the equities and interests of all

paxties.

There are several other issues concern- ing confidentiality that have been raised

by these regulations. These issues and

further elaboration of the above ap- proach are-discussed in Appendix A, Sig- nificant Comments and Responses.

DEFINITIONS

EPA wishes to emphasize that the

terms used in these regulations may not

be wholly consistent with the ordinary

usage of such terms. For egample, the

term "manufacturer" includes importers. As used in these regulations, the terms

"manufacturer" and "processor" may both apply to a person who normally would consider himself one or the other.

"Intermediate" refers only to those intermediates which are isolated or re- moved from the equipment in which they are manufactured. Persons should be sure they understand the special meanings of

the terms used for purposes of these reg- ulations.

OrrcAL RECORD OF RULEmAING

TSCA section 19(a) (3) defines the

term "rulemaking record" for the purposes of judicial review of a section 8(a) regulation as (1) the rule being reviewed,

(2) any written submission of interested

parties respecting the promulgation of

such rule and (3) any other information

which the Administrator considers to be

relevant to such rule and which the Adninistrator identified on or before the

date of the promulgation of such rule,

in a notice published in the FEDERAL

REsisTrr..

Accordingly, TSCA requires the

Agency to publish in the FEDERAL REosrR the list of documents that constitute

the record of this rulemaking. Public

comments are exempt from FEDERAL

REGISTER listing under section 19(a) (3) and have not been listed. A full listing of

the public comments is available on re- quest from the Record and Hearing Clerk. In .addition, those documents

listed below as part of this rulemaldng record are available at the Offilce of the

Record and Hearing Clerk In the Office

of Toxic Substance.

The factual and policy considerations

that are the basis of this rule were pub- lished in the preambles to the March 9

and August 2, 1977 proposed rules and

October 3, 1977 supplemental notice. In

response to public comment, EPA has

prepared a document analyzing the Impacts of these regulations which the Adminis-trator hereby Identifies under

TSCA section 19(a) (3) (E) as part of the

record of this rulemaking. This document surveys Information generally available to the public. It Is entitled, "Analysis of Options for Definition of

Small Business and 11stimated Cost of

the Initial Section 8(a) Reporting Requirements," prepared by Arthur D. Little, Inc., Cambridge, Mazsacbusett, con- tract number 68-01-4381 (November 1977).

During development of this rule, EPA

has conducted two public meetings and

several informal meetings attended by interested members of the public. Transcripts of the three public meetings and

minutes of several informal meetings are hereby included under section 19(a) (3) (e) as part of this rulemaking. 1. Transcript of public meeting on TSCA Inventory Reporting Regulations as proposed March 9, 1977-(Aprll 18, 1977).

2. Transcript of public meeting on TSCA Inventory Reporting Regulations, as proposed August 2, 1977-August 24, 1977).

Informal meetings were held with interested members of industry, labor, and

environmental groups on the following dates. Minutes of these meetings are included in the record.

December 13, 1976 ,ay 6, 1077

December 21,1976 ?Say 17, 1977

January 6, 1977 June 9, 1977

January 7.1977 August 4,1977 January 19, 1977 AUgust 18,1977 April 14,1977 September 30,1977 April 21,1977 October 0,1977 April 27,1977 October 31,1077

Transcripts of the informal meetings held May 6 (with the American Import- ers Association) and May 17 (concern- ing confidentiality) are also included In

the record.

In addition, during tile development of

these rules, Agency staff members had

phone conversations with interested

members of the public. Phone conversations relevant to this rulemaking are included in the record of this rulemaking,

A listing of these materials is available

upon request from the Record and Hearing CIer.'

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64574 1977
RULES AND REGULATIONS

EFFETc E DATE

These regulations shall take effect on January 1, 1978. In accordance with 5

U.S.C. 553(d) (3), the Administrator

finds for good cause that the effective

date of these regulations will not be postponed until 30 days after publication in

the FEDERAL REGIsTER. TSCA section 8 (b)

provides that'a chemical substance may

be included on the inventory only if it

was manufactured or processed within

three years before the effective date of

these regulations. If these regulations are effective on January 1, 1978, any

chemical substance manufactured or processed for a commercial purpose since

January 1, 1975 may be reported for the

inventory. The January 1, 1975 date has

been relied on by the industry in preparing for reporting under these regulations. Any greater delay in the effective- ness of-these regulations would interfere

with orderly and timely reporting for

the inventory.

ECONOMIC IsePACT AHALYSIS STATEMENT

EPA has determined that the regulation does not require the compilation of an Economic Impact Analysis Statement as required by Executive Order 11821.

This determination is based on the cost

estimate prepared by Arthur D. Little,

Inc., as part of their report, "Analysis of

Options for Definition of Small Business

and Estimated Cost of the Initial Section 8(a) Reporting Requirements,"

(November 1977), which is part of the

rulemnaking record. The total cost to indu~try of complying with the requirements of this regulation does not exceed

$15 million. Accordingly, EPA has not

performed an Economic Impact Analysis because the cost does not exceed the.

criteria for a major Agency action.

The Environmental Protection Agency has determined that this document does

not contain a major proposal requiring

preparation of an Economic Impact

Analysis Statement Under Executive

Order 11821 and OMB Circular A-107.

Dated: December 12, 1977.

DOUGLAS COSTLE,

Administrator.

Part 710 is established toread as follows:

Sec.

710.1 Scope and compliance.

710.2 Definitions.

710.3 Applicability: Reporting for the Initial and revised inventory. 710A Scope of the inventory.

710.5 How to report for the inventory.

710.6 When to report.

710.7 Confidentiality.

710.8 Effective date.

Au rnsr=: -Subsection 8(a), Toxic Substances Control Act (TSCA) (90 Stat. 2003,

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

§ 710.1 Scope and compliance.

(a) This Part establishes regulations

governing reporting by certain persons

who manufacture, import, or process

chemical subsances for commercial purposes under section 8(a) of the Toxic

Substances Control Act (15 U.S.C. 2607

(a)). Section 8(a) authorizes thi AdminIstrator to require reporting of information necessary for administration of the

Act and requires EPA to Issue regulations

for the purpose of compiling an Inventory of chemical substances manufactured or processed for a commercial purpose, as required by section 8(b) of the

Act. Following an initial reporting period, EPA will publish an initial inventory of chemical substances manufactured or imported for commercial purposes. After a supplemental reporting

period, EPA will. publish a revised inventory including those additional chemical substances processed or used for

commercial purposes or imported for

commercial purposes as a part of a mixture or article. Further, In accordance

with section 8(b), EPA periodically will

amend the inventory to include new chemical substances which are manufactured or imported for a commercial purpose and reported under section 5(a) (1)

of the Act. EPA also will revise thegcategories of chemical substances and make

other amendments as appropriate.

(b) Section 15(3) of TSCA makes It

unlawful for any person to fail or refuse

to submit information required under

these reporting regulations. In addition,

section 15(3) makes It unlawful for any

person to fail to keep, and permit access to, records'required by these regulations.

Section 16 provides that any person who

violates a provision of section 15 is liable to the United States for a civil penalty and may be criminally prosecuted.

Pursuant to section 17, the Government

may seek judicial relief to compel submission of section 8(a) information and

to otherwise restrain any violation of

section 15.

Noz -As a matter of traditional Agency policy, EPA does not intend to concentrate

its enforcement efforts on Insignificant clerical errors In reporting.

(C) Each person who reports under

these regulations shall maintain records

that document information reported un- der these regulations and, in accordance

with the Act, permit access to, and the

copying of such records by EPA officials.

§ 710.2 Definitions.

For the purposes of this Part: (a) The

following terms shall have the meaning

contained in the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. 321 et seq,, and

the regulations .issued under such Act:

"cosmetic," "device," "drug," "food." and

"food additive." In addition, the term

"food" includes poultry and poultry products, as defined In the Poultry Products

Inspection Act, 21 U.S.C. 453 et seq.;

meats and meat food products, as defined

in the Federal leat Inspection Act, 21

U.S.C. 60 et seq.; and eggs and egg products, as defined in the Egg Products Inspection Act. 21 U.S.C. 1033 et seq. (b) The term "pesticide" shall have

the meaning contained in the Federal

Insecticide, Fungicide, and Rodenticide

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

(c) The following terms shall have the

meaning contained in the Atomic Energy

Act of 1954, 42 U.S.C. 2014 et seq., and

the regulations Issued thereunder: "byproduct material." "source material,"

and "special nuclear material."

(d) "Act" means the Toxic Substances

Control Act, 15 U.S.C. 2601 et seq. - (e) "Administrator" means the Administrator of the U.S. Environmental

Protection Agency, -any employee or au- thorized representative of the Agency to

whom the Administrator may either

herein or by order delegate his authority

to carry out his functions, or any other

person who shall by operation of law be

authorized to carry out such functions.

(f) An "article" is a manufactured

Item (1) which is formed to a specific

shape or design during manufacture, (2)

which has end use function(s) dependent

in whole or in part upon Its shape or design during end use, and (3) which has

either no change of chemical composition

during its end use or only those changes

of composition which have no commercial

purpose separate from that of the article

and that may occur as described In § 710.4

(d) (5); except that fluids and particles are not considered articles regardless of

shape or design. (g) "Byproduct" means a chemical

substance produced without separate

commercial intent during the manufacture or processing of another chemical

substance(s) or mixture(s).

(h) "Chemical substance" means any

organic or inorganic substance of a particular molecular identity, including

any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in na- ture, and any chemical element or uncombined radical; except that "chemical

substance" does not include:

(1) Any mixture,

(2) Any pesticide when manufactured,

processed, or distributed in commerce for use as a pesticide,

(3) Tobacco or any tobacco product,

but not including any derivative products,

(4) Any source material, special nu- clear material, or byproduct material,

(5) Any pistol, firearm, revolver,

shells, and cartridges, and

(6) Any food. food additive, drug, cos- metic, or device, when manufactured,

processed, or distributed in commerce for use as a food, food additive, drug,

cosmetic, or device.

(I) "Commerce" means trade, traffic,

transportation, or other commerce (1)

between a place in a State and any place outside of such State, or (2) which affects trade, traffic, transportation, or commerce described in clause (1).

(j) 'istribute in commerce" and

"distribution in commerce" when used

to describe an action taken with respect

to a chemical substance or mixture or article containing a substance or mixture, mean to sell or the sale of, the substance, mixture, or article in commerce;

to introduce or deliver for introduction

into commerce, or the introduction or delivery for introduction into commerce of, the substance, mixture, or article; or to hold, or the holding of, the substance,

mixture, or article after Its introduction

into commerce.

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64575

HeinOnline -- 42 Fed. Reg. 64575 1977
64576

(k) "EPA" means the U.S. Environmental Protection Agency.

(1) "Importer" means any person who

Imports any chemical substance or any

chemical substance as part of a mixture or article Into the customs territory of

the U.S. and includes: (1) The person

primarily liable for the payment of any duties on the merchandise, or (2) an au- thorized agent acting on his behalf (a&

defined in 19 CFR 1.11).

(in) "Impurity" means a chemical substance which is unintentionally present

with another chemical substance.

(n) "Intermediate" means any chemical' substance (1) which is intentionally removed from the equipment in which it

Is manufactured, and (2) which either is

consumed in whole or in part in chemical reaction(s) used for the intentional

manufacture of other chemical substance(s) or mixture(s), or is intentionally present for the purpose of altering

the rate of such chemical reaction(s).

Noi -- The "equipment in which it was manufactured" Includes the reaction vessel

In which the chemical substance was manu- factured and other equipment which is

strictly ancillary to the reaction vessel, and

any other equipment through which the

chemical substance may flow during a con- tinuous flow process, but does not include

tanks or other vessels in which the chemical

substance Is stored after its manufacture.

(o) "Manufacture" means to produce or manufacture in the United States or Import into the customs territory of the

United States.

(p) "Manufacture or import 'for com- mercial purposes' '" means to manufacture or import:

(1) For distribution in commerce, including for test marketing purposes, or (2) For use by the manufacturer, including for use as an intermediate.

(q) "Mixture" means any combination of two or more chemical substances

If the combination does not occur in

nature and is not, in whole or in part,

the result of a chemical reaction; ex- cept that "mixture" does include (1)

any combination which occurs, in whole or In part, as a result of a chemical reac- tion if the combination could have been

manufactured for commercial purposes

without a chemical reaction at the time

the chemical substances comprising the

combination were combined and if, after

the effective date of premanufacture no- tification requirements, none of the

chemical substances comprising the

combination is a new chemical substance, and (2) hydrates of a chemical

substance or hydrated ions formed by association of a chemical substance with

water.

(r) "New chemical substance" means any chemical substance which is not included in the inventory compiled and

published under subsection 8(b) of the

Act.

(s) "Person" means any natural or

juridicial person including any individual, corporation, partnership, or association, any State or political subdivision thereof, or any municipality-, any

interstate body and any department,

RULES AND REGULATIONS

agency, or Instrumentality of the Fed- processed for research and development puteral government, poses. No person may report for the inventory

(t) 'Process" means the preparation any chemical substance in such quantities unless that person can certify that the sub- of a chemical substance or mixture, at- stance was not manufactured, Imported, or ter its manufacture, for distribution in processed solely in small quantities for recommerce (1) in the same form or phys- search and development, as defined In this

ical state as, or in a different form or section.

physical state from, that in which it was (z) "State" means any State of the

received by the person so preparing such United States, the District of Columbia,

substance or mixture, or (2) as part of a the. Commonwealth of Puerto Rico, tho

mixture or article containing the chemi- Virgin Islands, Guam, the Canal Zone, ca substance or mixture. American Samoa, the Northern Mariana

(u) "Process for 'qommereial pur- Islands, or any other territory or pos- poses'" means to process (1) for dis- session of the United States.

tribution in commerce, including for (aa) "Technically qualfiled individual"

test marketing purposes, or (2) for use means a person (1) who because of his as an intermediate. education, training, or experience, or a (v) "Processor" means any person combination of these factors, Is capable

who processes a chemical substance or of appreciating the health and environmixture. mental risks associated vith the chemi-

(w) "Site" means a contiguous prop- cal substance which is used under his

erty unit. Property divided only by a supervision, (2) who is responsible for

public right-of-way- shall be considered enforcing appropriated methods of con- one site There may be more than one ducting scientific experimentation, analmanufacturing plant on a single site. ysis, or chemical research In order to

For the purposes of imported chemical minimize such risks, and (3) who is re- substances, the site shall be the business sponsible for the safety assessments and

address of the importer. clearances related to the procurement,

(x) "Small manufacturer or importer" storage, use, and disposal of the chemical means a manufacturer or importer substance as may be appropriate or re- whose total annual sales are less than quired within the scope of conducting $5,000,000, based upon the manufac- the research and development activity.

turer's or importer's latest complete fis- The responsibilities In clause (3) of this

cal year as of January 1, 1978, except paragraph may be delegated to another

that no manufacturer or importer Is a individual, or other individuals, as long

"small manufacturer or importer" with as each meets the criteria in clause (1)

respect to any chemical substance which of this paragraph.

such person manufactured at one site or (bb) "Test marketing" means the disimported in quantities greater than tribution in commerce of no more than a 100,000 pounds during calendar year predetermined amount of a chemical

1977. In the ease of a company which Is substance, mixture, or article containing

owned or controlled by another com-, that chemical substance or mixture, by a

pany, total annual sales shall be based manufacturer or processor to no more

on the total annual sales of the owned than a defined number of potential

or controlled company, the parent com- customers to explore market capability

pany, and all companies owned or con- In a competitive situation during a pretrolled by the parent company taken determined testing period prior to the

together, broader distribution of that chemical

Nos.-The purpose of the exception o substance, mixture or article in comthe defnition Is to ensure that manufac- merce. turers and importers report production Vol- (cc) "United States," when used In the

umes for all chemical substances which they geographic sense, means all of the States,

manufactured at one site or imported in territories, and possessions of the United

quantities equal to" or greater than 100,0e0 States.

pounds during calendar year 1977. § 710.3 Applicability Reporting for the

(y> "Small quantities for purposes of initial inventory and revised invenscientific experimentation or analysis or tory: Who mu, report; who -ihould

chemical research on, or analysis of, report.

such substance or another substance, in- Based on reports from manufacturers

cluding any such research or analysis and some importers of chemical subfor the development of a product" stances, EPA will compile an initialn-

(hereinafter -sometimes shortened to ventory of chemical substances manu- "small quantities for research and de- factured for commerci.l purposes. Paravelopment") means quantities of a graph (a) of this section Identifies who

chemical substance manufactured, i- must report for this initial Inventory and

ported, or processed or proposed to be who should report. After publication of

manufactured, imported, or processed the initial inventory. EPA will compile a that (1) are no greater than reasonably revised inventory of chemical substances

necessary for such purposes and (2) af- manufactured or procesed for a comter the publication of the revised in- mercial purpose based on reports from

ventory, are used by, or directly under processors of chemical substances, and

the supervision of, a technically quali- from importers of chemical substances

fied individual(s), as a part of mixtures or articles. ParaNoTz.-Any chemical substances manu- graph (b) of this section Identifies who

factured, imported or processed in quantities

of less than 1,000 pounds annually shall be may report for this revised inventory.

presumed to be manufactured, imported, or Paragraph (c) of this section Identifies

FEDERAL REGISTER, VOL. 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64576 1977
RULES AND REGULATIONS

the persons not subject to the initial

inventory.

(a) The initial inventory-(-) Domestic manufacturers who must report con- cerning chemical substances. Any per- son who manufactured a chemical substance(s) in the United States for a commercial purpose during calendar year 1977 must report concerning:'

(i) All chemical substances which that

person manufactured in the United

States during calendar year 1977 at each

site for which:

(A) Thirty percent or more of the

i'weight of the products distributed from

that site consists of products of the types * described under Standard Industrial

Classification (SIC) Group 28 or 2911, or (B) The total pounds of reportable chemical substances- manufactured at

that site equals one million pounds or more; and

(ii) Any chemical substance not re- ported under paragraph (a) (1) (1) of this

section that was manufactured at a site

during calendar year 1977 in quanti- ties equal to or greater than 100.000

pounds.

Nom-Any person who is a "small manu- facturer," as defined in § 710.2, and who has more than one site. Is exempt from separately

reporting the chemical substances manufactured at each site.

(2) Importers who must rjport con- cerning chemical substances. Any per- son who imported a chemical substance

into the United States for a commercial

purpose during calendar year 1977 must

report concerning: (i) All chemical substances which that

person imported into the United States

during calendar year 1977 if:

(A) Thirty percent or more of the

weight of the products imported consists

of products of the types described under

Standard Industrial Classification (SIC)

Group 28 or 2911. or (B) "The total pounds of reportable chemical substances imported equals one million pourds or more; and

(ii) Any chemical substance not re- ported under paragraph (a) (2) (1) of

this section that was imported during

calendar year 1977 in quantities equal

to or greater.than 1O0,000 pounds.

Norm-These reporting requirements include all chemical substances imported ill

bulk form, including in cans, bottles, drums.

barrels, packages, tanks, bags and other con- tatners, but do not include chemical substances imported as part of mixtures or articles.

(3) Other manufacturers and import- ers Who should report chemical substances. (I) In order to ensure that a chPmical substance Is included in the

initial inventory, any person who manu- factures or imports, or who has manu- factured or imported a chemical substance (including the importation of a chemical substance as part of a mixture or an article) for a commercial purpose

since January 1, 1975, may report concerning that chemical substance.

'ii) Any person permitted to report

under paragraph (a) (3) of this section

may either report individually or, in

accordance with § 710.5(f), authorize a trade association or other agent to report on his behalf.

(b) Revised inventory. (1) During the reporting period for the revised inventory (§ 710.6(c)), a person may re- port concerning a chemical substance

which was not included in the initial

inventory if:

(i) The person has procesed or used

the chemical substance (including use In

the manufacture of a mixture or article

containing that chemical substance) for a commercial purpose since January 1,

1975; or (ii) The person has Imported the

chemical substance as part of a mixture or article for a commercial purpose since

January 1, 1975.

(2) Any person permitted to report un- der paragraph (b) of this section either

may report inlividually or, In accordance

with § 710.5(f), may authorize a trade

association or other agent to report on his behalf.

Noarc-The premanufacturo notification

requirements of sectlon 5(a) (1) (A) of the

Act for manufacturers of new chemical substances and Importers of new chemical substances In bulk will begin 30 days after the

publlcatlon of the initial Inventory and will

apply to all chemical substances not included

in the Initial inventory. The premanufacture notification requirements of section 5(a) (1) (A) will not- be applied to Importer of

chemical substances as part of a mixture

until 30 days after publication of the re- vised inventory. In addition, section 15(2)

of the Act as It relates to rectlon 5(a) (I) (A)

will not be applied to persons who procesa or use for a commercial purpose chemical

substances not on the inventory until after

publication of the revised Inventory.

(c) Persons not subject to the initial

inventory. Persons who have only pro- cessed or used a chemical substance for a commercial purpose are not subject to

the Initial inventory requirements.

§ 710.4 Scope of the inventory.

(a) Chemical substances subjct to

these regulations. Only chemical substances which are manufactured, imported, or processed "for a commercial

purpose," as defined in § 710.2, are subject to these regulations. (b) Naturally occurring chemical substances automatically included. Any chemical substance which is naturally oc- curring and (1) which is (I) unprocessed or () processed only by manual, me- chanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water; or (2) which is extracted frbm air by any

means, shall automaticaily be included

in the inventory under the category "Naturally Occurring Chemical Substances." Examples of such substances are: raw agricultural commodities, wa- ter, air, natural gas, and crude oil; and

rocks, ores, and minerals.

(c) Substances excluded by definition or section 8 (b) of TSCA. The following substances are excluded from the inventory:

(1) Any substance which is not con- sidered a "chemical substance" as pro- vided in subsection 3(2) (B) of the Act

and in the definiticn of "chemical substance" in § 710.2(h) ;

(2) Any mixture as defined in § 710.2

(q);

Nors.-A chemical ubstance that Is manu- factured as part of a mixture is subject to

these reporting regulations. This exclusion

applies only to the mixture and not to the

chemical substances of which the mixture is

conprised. The term "mixture- Includes alloys, Inorganic glasses. cerami, frits, and

cemen%, Including Portland cement.

(3) Any chemipal substance which is

manufactured, Imported, or processed

solely in small quantities for research

and development as defined in § 710.2

(y); and

(4) Any chemical substance not manu- factured, processed or imported for a commercial purpose since January 1,

1975.

(d) Chemical substances excluded

from the inventory. The following chemIcal substances are excluded from the inventory. Although they are considered

to be manufactured or processed for a commercial purpose for the purpose of

section 8 of the Act, they are not manu- factured or processed for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or ar- ticle of which they may be a part.

Norm.-In addition, chemical substances

excluded here will not be subject to premanufacture notification under section 5 of

the Act.

,1) Any impurity.

(2) Any byproduct which has no com- mercial purpose.

Nor -A byproduct which has commercial

value only to municipal or private organiza- tions who (I) burn it as a fuel, (i) "dispose of

It as a waste. Including In a Landi or for

enriching coil. or (1in) extract component chemical substances which have commercial

value, may be reported for the inventory, but

will not be subject to premanufacturing no- tifIcation under section 5 of the Act if not

Included,

(3) Any chemical substance which re- sults from a chemical reaction that occurs incidental to exposure of another

chemical substance, mixture, or article to

environmental factors such as air, moisture, microbial organisms, or sunlight.

(4) Any chemical substance which

results from a chemical reaction that occurs incidental to storage of another

chemical substance, mixture, or article.

(5) Any chemical substance which results from a chemical reaction that oc- curs upon end use of other chemical

substances, nixtures, or articles such as adhesives, paints, miscellaneous cleansers or other housekeeping products,

fuels and fuel additives, water softening

and treatment agents, photographic, films, batteries, matches, and safety

flares, and which is not itself manu- factured for distribution in commerce or for use as an intermediate.

(6) Any chemical substance which re- sults from a chemical reaction that oc- curs upon use of curable plastic or rubber molding compounds, inks, drying

oils, metal finishing compounds, adhesives, or paint; or other chemical

FEDERAL REGISTER, VOL 42, NO. 247--RIDAY, DECEMBER 23, 1977

64577

HeinOnline -- 42 Fed. Reg. 64577 1977
RULES AND REGULATIONS

substances formed during manufacture

of an article destined for the marketplace without further chemical change

of the chemical substance except for

those chemical changes that may occur as described elsewhere in this § 710.4(d).

(7) Any chemical substance which re- sults from a chemical reaction that oc- curs when (i) a stabilizer, colorant,

odorant, antioxidant, filler, solvent, car- rier, surfactant, plasticizer, corrosion

inhibitor, antifoamer or de-foamer, dispersant, precipitation inhibitor, binder,

emulsifier, de-emulsifier, dewatering

agent, agglomerating agent, adhesion

promoter, flow modifier, pH neutralizer,

sequesterant, coagulant, flocculant, fire

retardant, lubricant, chelating agent, or quality control reagent functions as intended or (ii) a chemical substance, solely intended to impart a specific physicochemical characteristic, functions as intended.

(8) Chemical substances which are not

Intentionally removed from the equipment in which they were manufactured.

NOTE.-See note to definition of "intermediate" at § 710.2(n) for explanation of

"equipment in which it was manufactured."

§ 710.5 How to report.

(a) General instructions. (1) Except

for small manufacturers or small importers, any person who is required to re- port under § 710.3(a) (1) or (2) shall

follow the reporting procedures of para- graphs (b), (c), and (d) of this sec- tion.

(2) Any person who reports under

§710.3(a) (3) shall follow the reporting procedures of paragraphs (b), (c), (d)

(1) and (d) (3) of this section. In addition, the Agency encourages these per- sons to report in accordance with para- graphs (d) (2) and (d) (4) of this sec- tion. A trade association or other agent

may report aggregated production data

under paragraph (d) (4) of this section,

(3) Any person who is required to

report under § 710.3(a) (1) or (2) and

who is a small manufacturer or smallImporter as defined in -§ 710.2 shall follow the reporting procedures of paragraphs (b), (c), and (d) (1) and (3)

of this section except that -uch person is exempt from reporting production

volume (for quantities less than 100,000

pounds) and site information.

(4) Any person who reports under sec- tion 710.3(b) shall follow the reporting procedures of paragraphs (b), (c), and

(d) (1) of this section.

(b) Reporting the identity of a chemical susbtance. (1) Any person re- porting under these regulations should

first read and carefully follow the re- porting instructions, "Reporting for the

Chemical Substance Inventory," pub- lished by and available through EPA.

(2) To report a chemical substance, a person should first consult the TSCA

Candidate List of Chemical Substances

and any amendment to the Candidate

List. For assistance in using the Candidate List, consult the "Guide to the Use

of the TSCA Candidate List of Chemical

Substances."

(3) All persons required to report except "small manufacturers and importers" must use a separate Form A, B, or C to report chemical substances for

each site. Small manufacturers and importers may report several chemical substances manufactured at different sites on one form, as appropriate.

(4) To report a chemical substance

found in the Candidate List, or in an amendment to the list, a person must

complete, sign, and submit EPA inventory report Form A (EPA Form No. 7710-

3A). All forms, A through D, have OMB

No. 1585 77011.

(5) To report a chemical substance not

found in the Candidate List, or in an amendment to the list, but for which

there is a Chemical Abstracts Service

(CAS) Registry Number, a person must

complete, sign and submit EPA inventory

report Form B (EPA Form No. 7710-3B).

(6) To report a chemical substance

which is not found in the Candidate List, or in an amendment to the list, and for

which there is no known CAS Registry

Number, a person must complete, sign,

and submit EPA inventory report Form

C (EPA Form No. 7710-3C). Persons

must describe chemical substances on Form C as specifically as possible, in ac- cordance with the instructions published

by EPA, "Reporting for the Chemical

Substance Inventory." (7) -To report a chemical substance

whose chemical identity is"claimed to be

confidential, a person must complete, sign, and submit EPA inventory report Form C (EPA Form No. 7710-3C). In

addition, he must substantiate the claim

that the chemical identity is confidential

at the'time he submits the form to EPA,

in accordance with Instructions published in "Reporting for the TSCA Inventory" and section 710.7.

NoT.--The reporting instructions afso describe a reporting Form D (EPA Form No.

7710-3D). This is for additional voluntary

reports which may be submitted by any person who manufactures trademarked products

comprised of ch6mical substances and is not

a substitute for any of the reports required

by these regulations.

- (c) Reporting polymers. (1) To report a polymer a person must list in the description of the polymer composition at

least those monomers used at greater

than two percent (by weight) in the

manufacture of the polymer. (2) Those monomers used at two percent (by weight) or less in the manufacture of the polymer may be included as part of the description of the polymer composition.

Noz.-TEhe "percent (by weight)" of a monomer is the weight of the monomer ex- pressed as a percentage of the weight of the

porymeric chemical substance manufactured.

(d) Reporting other information con- cerning a chemical substance. (1) For

purposes of the initial inventory, designate whether the person manufactures

and/or imports the chemical substance.

For purposes of the revised inventory, designate whether the person processes

and/or imports the chemical substance.

(2) Report thie site(s) at which the

person manufactures and/or imports the

chemical substance. The site, as defined

in § 710.2(w), for Importers Is their busi- ness address.

(3) Designate whether the person

manufactures and processes the chemical

substances only within a site and does

not distribute the chemical substance, or any mixture or article containing that

substance, for commercial purposes outside that site.

NOTE.-This requirement does not apply to importers.

(4) Report the amount of the chemical

substance which the person manufactured at each site and/or Imported during calendar year 1977. For each substance, report the digit (e.g., 0 through 9) which corresponds to the appropriate

volume range, according to the following table. Enter "N" in the space provided for production amounts If the person did not manufacture or import the substance during calendar year 1977. Small

manufacturers or Importers, as defined

in § 710.2(x), should enter "1X" In the

space provided for production amounts

of less than 100,000 pounds (45,400 kilograms). If a small manufacturer or importer reports these production amounts,

that person shall enter both "X" and the

appropriate digits (e.g., XO, Xl, or X2).

For other production ranges, do not Include an "X" (e.g., 3 through 0), Trade

associations or other agents should en- ter "A" in the space provided for pro- duction amounts. If trade associations or agents report production volumes,

they should enter both "A" and the appropriate digits (e.g., A2 or AG).

(0) Less than 1,000 pounds; Less than 454

kilograms. (1) 1,000 to 10,000 pounds; 4.4 to 4,540 kilograms. (2) 10,000 to 100,000 pounds; 4,540 to

45,400 kilograms. (3) 100.000 to 1 million pounds; 45,400 to

454.000 kilograms. (4) 1 million to 10 million pounds; 454,000

to 4.54 million kilograms. (6) 10 million to 50 million pounds; 4.54

million to 22.7 million kilograms. (6) 50 million to 100 million pounds: 22.7

million to 45.4 million kilograms, (7) 100 million to 500 mllion pounds: 45.4

-million to 227 million kilograms. (8) 500 million to 1 billion pounds: 237

million to 454 million kilograms.

(9) over 1 billion pounds; over 454 million

kilograms. (A) Trade associations or other agents.

(e) Importers. (1) Any Importer who

reports a chemical substance for the inventory may authorize the foreign supplier of the Imported chemical substance(s) to report to EPA on his behalf,

if both the foreign supplier and the importer sign the declarations provided on the reporting forms. A foreign supplier

may authorize an agent to act In his

behalf.

(2) The importer has the ultimate re- sponsibility for reporting all Information

required by this Part and for the com- pleteness and truthfulness of such information. If certain Information is not or cannot be provided by the foreign sup- plier or his duly authorized agent, It

must be provided by the importer.

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64578

HeinOnline -- 42 Fed. Reg. 64578 1977
RULES AND REGULATIONS

(f) Trade associations or other agents.

(1) A trade association or other agent

may report on belalf of any person who

is not required -to report for the initial

inventory under § 710.3 (a) (1) and (a)

(2). Accordingly, a trade association or other agent may report on behalf of a manufacturer or importer of a chemical substance who chooses to report un- der § 710.3(a) (3), or any processor or user of a chemical substance, or any importer of a chemical substance as part

of a mixture or an article who chooses

to report under § 710.3(b).

(2) For every chemical substance re- ported by a trade association or other

agent under this section, at least one manufacturer, importer or processor

must have cei-tified to that agent, and be

able to document to EPA, in accordance

with § 710.1(c). that the chemical substance was manufactured, imported, or processed for a commercial purpose since

January 1, 1975.

§ 710.6 -When to report.

(a) All reports for the initial inventory shall be submitted by May 1, 1978.

(b) All reports concerning chemical

substances which are manufactured or imported for a commercial purpose for

the first time during the period from

May 1, 1978 to the effective date of premanufacture notification requirements

shall be submitted when such manufacturing or importation begins.

(c) All reports for the revised inventory shall be submitted within 210 days after publication of the initial inventory .

§ 710.7 Confidentiality.

(a) A manufacturer, importer, or processor may claim that for a particular chemical substance any or all of the

following items of information.submitted under this Part are entitled to eonifdential treatment:

(1) Company name,

(2) Site. -

(3) The'specific chemical identity. (4) Whether the chemical substance is

manufactured, imported, or processed.

(5) Whether the chemical substance

is manufactured and processed only within one site and not distributed for

commercial purposes outside that site.

(6) The quantity manufactured, imported, or processed.

(b) Any claims of confidentiality must

accompany the information at the time

it is submitted to EPA. The claims must

appear on the form on which the information is submitted to EPA and in the manner prescribed on the form. In addition, any claims of confidentiality

must be substantiated at the time the

information is submitted to EPA in the manner specified in the form instructions.

(c) Any information that is Covered by a claim made as specified will be disclosed by EPA only to the extent permitted by, and by means Of, the proce- dures set forth in this section and in

Part 2 of this Title (41 FR 36902).

(d) If no claim accompanies information at the time it is submitted to EPA,

the information may be made public by

EPA without further notice to the submitter. Failure to provide substantiation

of any claim asserted on the forms will

be considered a waiver of the claim and

will result in a determination that the

information Is not entitled to confidential treatment.

(e) (1) A claim of confidentiality may

be asserted concerning the specific chemical Identity of a particular chemical substance. This claim may be asserted by

any submitter who believes that inclusion of the specific chemical Identity on the inventory would reveal the trade

secret fact that the particular chemical

substance is manufactured or processed

for commercial purposes. (2) If a submitter asserts such a claim

the submitter must

(I) Report the specific chemical Identity.

(I) Propose a generic chemical name which is only as generic as necessary to

protect the confidential Identity of the

particular chemical substance,

(Wii) Provide a detailed, written substantiation of the claim as specified in

the reporting instructions,

(1v) Agree that EPA may disclose to a person with a bona fide intent to manu- facture the substance (as defined in

paragraph (g) of this section) the fact

that the particular chencal substance

is included in the inventory for purposes

of TSCA section 5(a) (1) (A) premanufacture notification, and

(v) Have available, and agree to furnish to EPA upon request, for the particular chemical substance, either an X-ray diffraction pattern (in the case of

inorganic substances) or a mass spectrum for the particular chemical substance (in the case of most other substances), a sample of the substance in

its purest form, an elemental analysis,

any additional or alternative spectra, or other data that may be required to re- solve uncertainties with respect to the

Identity of the substance. Failure to

meet any of these five requirements will

be considered a waiver of the claim and

will result in inclusion of the particular

chemical Identity on the inventory.

() (1) If a submitter asserts that the

identity of a particular chemical substance should not be included on the

inventory, the submitter has met the

five requirements specified In paragraph

(e) of this section, and the EPA General

Counsel has made a determination, in

"accordance with Part 2 of this Title that

the particular chemical identity should

not appear on the inventory because inclusion wour disclose a trade secret,

EPA will publish a generic chemical name in an appendix to the inventory rather than place the specific chemical

identity on the inventory. Publication

of a generic name in the appendix does

not create a category for purposes of the

inventory. Any person proposing to manufacture a substance included in the appendix under a generic name must submit notice under section 5(a) (1) (A) of

the Act unless specifically exempted by

EPA (see paragraph (g) of this section).

(2) EPA will examine the generic

chemical name proposed by the submitter claiming confidentiality.

(i) If EPA determines that the generic name proposed by the submitter assertIng the claim is only as generic as neces- sary to protect the confidential identity

of the particular chemical substance,

EPA will place that generic name on the

inventory.

(iI) If EPA determines that the

generic name proposed by the submitter

asserting the claim Is more generic than

necessary to protect the confidential

Identity, EPA will ask the submitter to

submit further proposed generic names.

(iii) If EPA does not agree with the

further proposed generic names, EPA

will choose a generic name that EPA

determines is only as generic as neces- sary to protect the confidential identity.

EPA will give 30 days notice of this

choice to the submitter asserting the

claim. After the end of the 30-day

period EPA will place the chosen generic narne on the inventory.

fg) (1) If the particular chemical substance a person is proposing to manu- facture is not included on the inventory

by specific name but does fall within one of the generic chemical names in

the appendix entitled "Confldentiaidentities," the person may ask EPA wheth- er the specific substance Is included on the inventory. EPA will answer such an inquiry only if EPA determines that the

person has a bona Me intent to manu- facture the substance.

(2) In order to establish a bona Jlde

intent to manufacture the specific chemical substance the person proposing to

manufacture the chemical substance

must submit to EPA:

(I) A signed statement that that per- son intends to manufacture the substance for commercial purposes

(ID A description of the research and

development activities he has conducted

to date and the purposes for which the

substance will be manufactured,

(ill) An elemental apalysis,

(iv) Either an X-ray diffraction pattern (in the case of inorganic substances) or a mass spectrum (in the case of most other substances) of the particular chemical substance,

(v) A sample of the substance in its

purest form, if requested, and

(vi) Any additional or alternative

spectra, or other data that may be required to resolve uneertainities with re- spect to the Identity of the chemical substance.

(3) (1) Upon receipt of the information specifiedin paragraph (g) (2) of this

section, EPA may require the submitter

who asserted the confidentiality claim

for a specific chemical substance within

the generic name to submit to EPA:

(A) Either an X-ray diffraction pattern or a mass or alternative spectrum

for the substance,

(B) An elemental analysis of the substance,

(C) A sample of the substance in its

purest form, if requested, and

(D) Any additional spectral or other

data that may be required to resolve unFEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977

64579

HeinOnline -- 42 Fed. Reg. 64579 1977
6458O

certainties with respect to the identity

of the substance.

(ii) Failure to submit any of the information required by EPA under this

pargraph (g) (3) will be construed as a waiver of the submitter's confidentiality

claim, and EPA will place the specific

chemical identity on the inventory without further notice to the submitter.

(4) EPA will compare the information

submitted by the proposed manufacturer

under paragraph (g) (2) of this section

with the information submitted under

paragraph'(g) (3) of this section.

(5) If (1) the comparison of the elemental analyses and either the X-ray

diffraction patterns or mass or alternative spectra is sufficiently similar to be

consistent with a presumption that the

chemical substances are the same, and

(i) comparison of any of the other submitted information affirms this pre- sumption, EPA will tell the person pro- posing to -manufacture the particular

chemical substance that the particular

chemical substance -is included on the

inventory and, therefore, that premanu- facture notification is not required. (6) If (I) the comparison of either the

X-ray diffraction patterns or the mass or alternative spectra is not sufficiently similar to be consistent with a presumption that the chemical substances are the

same, and (ii) comparison of the other

information affirms this conclusion, EPA

will tell the person proposing to manu- facture the particular substance that the

information submitted does not support a conclusion that the substance is in--

cluded on the inventory, and, therefore,

that premanufacture notification is re- quired.

(7) A disclosure to a person with a bona fide intent to manufacture a par- ticular chemical substance will not be

considered a public disclosure.

§ 710.8 Effective date.

These regulations shall take effect on January 1, 1978,

APPENDIX A-SIGN'ICANT COMIMENTS AND

RESPONSES

Over 400 comments were received in re- sponse to the notices of proposed rulemaking

published in the FEDERAL REGISTER on March

0, August 2, and October 3, 1977. The follo,0-

ing summarizes and responds to the sig- nificant issues raised in these comments.

Comments which concern problems specific

to one particular company were not generally included in these comments. These com- ments were referred to EPA's Industry Assistance Office for direct reply.

CONTENTS

Overall Approach to these Reporting Rules.

Comments 1-12.

WhiC h Persons are Subject to these Regula- tions. Manufacturers, comments 13-17; Importers, comments 18-23; Definition of Small

Manufacturer or Importer, comments 24-27;

Processors, comment 28.

Chemical Substances Manufactured or Processed For a Commercial Purpose. Comments 29-30.

Exclusions to the Definition of Chemical

Substances. Mixtures, comments 31-36; Pesticides and Foods, Food Additives, Drugs.

Cosmetics and Devices, comments 37-42.

Chemical Substances Excluded from the

inventory. Small Quantities for Research and

RULES AND REGULATIONS

Development, comments 43-51; Byproducts,

comments 52-55; Articles, comments 56-60;

Impurities, comment 61.

Chemical Substances Included in the Inventory. Comments 62-63; Test Marketing, comments 64-66; Intermediates, comments

67-71; Naturally Occurring Substances, comments 72-74.

Inventory Reporting Procedures. General.

comment 76: Reporting of Polymers, comments 77-82; Inventory Reporting Forms,

comments 83-87.

When To Report. Comments 88-92.

Confidentiality. Comments 93-103.

OVERALL APPROACH TO THESE REPO4TING RULES

Comment 1: Reporting under these first

reporting rules should not only be for the

purpose of compiling the inventory required

by section 8(b), but also to establish a base

line of information for further regulatory

action under TSCA. Failure to gather site,

production, use, impurity, byproduct, disposal, and worker exposure information in a

comprehensive manner precludes a systematic approach to the regulation of chemicals.

Response: The Administrator agrees, in

part, with this comment. The August 2, 1977,

reproposal expanded the purpose of these

regulations as proposed on March 9, 1977.

These final regulations are similar to those

proposed on August 2nd.

In deciding the scope of these first section 8(a) reporting requirements, EPA considerdd not only the interest of compiling

an inventory of chemical substances as required by TSCA section 8(b), but also the

need for obtaining sufficient information

for monitoring chemical substances in the

environment and setting Agency priorities

for implementing other provisions of TSCA.

The .kgency decided that initial reporting

requirements should at least establish a profile of the chemical industry, Including

sites where chemicals are being manufactured and the relative quantities in which

they are produced or imported into the

United States. With this information, EPA

will be able to estimate the potential exposure to chemical substances for control, and

preventive actions. For example, plant site

information will be useful in identifying

possible sources of hazardous chemicals, especially in an emergency. Data on the quantities of chemical substances manufactured

for a commercial purpose will enable EPA

and other agencies to select substances for

priority attention fron among the tens of

thousands of chemicals In commerce.

The Agency will not be requiring use, impurity, byproduct, disposal, or worker exposure information in these regulations. The

Administrator has determined that this information is not now necessary for all chemical substances manufactured for a commercial purpose, and that the additional burden to industry and consequent delay in publication of the inventory would not be Justified. EPA intends, under the authority of

section 8(a), to require this additional information on a smaller number of chemicals

in order to assess their potential risks in

depth. These requirements will be directed at manufacturers and processors of the

chemical substances to enable the Agency to build a more complete profile on these

chemicals which are of concern.

Comment 2: EPA's proposed approach

would require unnecessarily burdensome

and needlessly duplicative reporting. EPA

should compile and publish a list of chemical substances from government, industry,

and other sources, and allow manufacturers

and trade associations to report any chemiCal substances not included.

Response: The Administrator disagrees

with this comment. The Agency reviewed

existing lists of chemical substances and

found them inadequate In several respects.

First, many existing lists contain chemical

substances which are not eligible for Inclusion on the TSCA inventory, Second, in

existing lists, many of the entries are in

broad categories or use groups (such as "optical brighteners") which would be Inappropriate for the purposes of compiling a list

of discrete chemical substances manufactured or processed for a commercial purpose

In the United States. Third, existing lists

would not permit EPA to identify the basia

manufacturers of a chemical substance, The

purposes of TSCA, accordingly, would not be met if EPA were simply to publish currently

available lists as the inventory of chemical

substances and permit manufacturers to re- port any substance not included.

EPA is Interested in minimizing the burden

of reporting for the inventory. Accordingly,

the Agency has published a Candidate List

of Chemical Substances which Includes those

substances we have reason to believe have

been manufactured or processed In the

United States. For any chemical substance

included on the Candidate List. reporting for

the inventory Is greatly simplified. By FEDERAL REGIsTER notice dated April 28, 1977

(42 FR 21639) and July 8, 1977 (43 PR

35183), the Agency announced the availability of the Candidate List in hard copy

and computer readable tape. EPA plans to supplement the Candidate List with at least

one additional list of substances. EPA will

announce the availability of any additional

list In the FEDERAL REGISTER. By FEDERAL

REGIsTER notice dated April 12, 1977 (42 PR

19298) the Agency published a proposed

Guide to the Use of the Candidate List. This

Guide will be republished with some changes to assist persons reporting for the Inventory. This document and any supplement to the Candidate List will be available from

EPA at the address listed above.

In a further effort to minimizo duplicative reporting to the extent consistent with

the needs of the Agency, § 710,5(f) of these

final regulations permits all manufacturers

or importers not required to report by § 7103

(a) (1) and (2) to report chemical substances through a trade assoclatlon or other

agent, Further, any person Who processes a

chemical substance is only Subjeet to the

revised inventory. These policies should eliminate a great amount of duplicative report-

.Ing.

Comment 3: Manufacturers should be re- quired to report chemical substances manu- factured for a commerical purpose by plant

site rather than by company headquarters.

Response: The Administrator agrees with

this comment. The March 9, 1977 proposal

would only have required manufacturers to report chemical substances by company

headquarters. As part of the decision to require reporting of Information which will

give the Administrator a profile of whore

chemicals are being manufactured, the

August 2, 1977 reproposal would require reporting by plant site. These final regulations continue this requirement, The Agency

intends to use this Information to monitor

for potential exposure and identify possible

sources of hazardous chemicals In an energency.

Comment 4: EPA has failed to demon- strate that production volume data are necessary to compile the Inventory, and It Is

unclear how EPA Intends to use this additional Information. In emergencies, EPA

needs to know where a chemical Is produced,

not the exact quantity. The delay In publishing the inventory Is not Justified, by the

Information to be gained by requiring more

detailed data.

Response: Production volume Information

is not being required to publish the Inventory under section 8(b). This Information Is

FEDERAL REGISTER, VOL. 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64580 1977
RULES AND REGULATIONS

being required under the general authority

of section 8(a) of the Act, to require submission of information necessary for administration of 7 CA.

EPA intends to use the production volume

data to help set priorities for Implementing

TSCA. In particular, EPA will initiate subsequent phases for reporting on chemical

,substances selected in part on the basis of

their production volume. Section 710.5 (d) (4)

requires reporting of production In fairly

broad ranges. (See comment 6.) Because

manufacturers should know generally how

much of a chemical substance they manu- facture on an annual basis. EPA does not anticipate that this requirement will significantly delay reporting. Combining reportIng of production with reporting of chemical

substance Identities is far more efficient, in terms of time and resources both for EPA

and the industry, than requiring separate

reporting. Saving many months of addltional

effort clearly justifies the few months of

delay in the publication of the initial Inventory.

Comment 5: Production volume data are available elsewhere, notably from trade as- ,sociations and other governmental agencies. EPA also has authorityunder Air and Water

Acts to gather the data.

Response: The production data available to EPA from other sources are inadequate

in-several respects. Other government agen- ces. such as the International Trade ConemIsson, believe they are not permitted, by

statute, to disclose confidential production

detw to EPA. Further, these data are often

collected for groups of chemical substances,

and not for discrete chemical substances.

While EPA has gathered certain data for

several hundred chemical substances under

its other authorities, these substances repre- sent only a fraction of those EPA anticipates will be reported for the inventory. Only

by collecting production information along

with the chemical Identities as they are reported for the inventory will EPA be as- sured of having a comprehensive indication

of production for these substances.

Comment 6: Several commenters suggested

that production volume data should be re- ported in broad ranges because statistical

analysis shows that aggregate totals will provide enough accuracy for EPA to set relative

priorities. Others recommended that production volume data should be reported to one or two significant figures or to within a

specified percentage.

Response: As provided In § 710.5(d) (4),the

Administrator has determined that reporting

of production Tolume in ranges is adequate

for the purposes of these regulations. The

ranges established by these regulations are in terms of powers of ten, except in the upper

volumes where the difference between the

lower and upper limits of the ranges would

be too great. In subsequent section 8(a) re- porting requirements, when the Agency has

identified a particular interest in a chemical,

the Administrator may request production

volume information with greater specificity.

Comment 7: Total production volume information for a company should be required,

rather than site specific Information.

Response: The Administrator disagrees

with this comment. In order to establish an adequate profile of the chemical industry and properly assign agency resources, particularly the agency's regional resources, pro- duction information is necessary on a site

specific basis.

Comment 8: Production volume Information on intermediates, raw materials, and

byproducts should not be required. Response: Section 710.5(d) (4) of these

regulations will require reporting of produc- tion volume Information on intermediates.

As discussed in response to comment 67 below, the term "intermediate" has been defined to include only those chemical sub- stances that are Intentionally removed from

the equipment in which they are manu- factured. The Agency expects that a manu- facturer will be able to estimate the range

of production volume of the intermediatcs

which he Isolates In this manner. Under these regulations, manufacturers are not required to report the Identity of purchased raw materials or byproducts which

have no commercial value. Accordingly, a manufacturer would not be required to re- port the production volume of these sub- stances.

Comment 9: EPA should not set Its prlorities on the basis of production volume alone.

Response: EPA recognizes that priorltis

under T CA cannot be set on the basis of

any single factor. The production data obtained under these regulations will be only one factor In selecting chemical cubstances

for attention. Production volume information is Important because It gives some indication of the potential for human and environmental exposure. Other Information such as the toxicity of the subatance, Its uses, and byproducts will. as appropriate, also be

considered In assigning relative priorities to substances for testing and other regulatory

actions.

Comment 10: EPA should not require a designation of those chemical substances

that are site-limited. This Information uiy

be confidential and any use of such a -ub- stance for commercial purposes outside the

manufacturing sito is not necessarily a "sig- nificant new use" for the purpose of TSCA

section 5(a) (1) (B).

RESPONSE: Section 710.5(d) (3) will re- quire designation of these chemical sub- stances which are minufactured and processed within a alte and are not distributed

for a commercial purpose outside the site.

The information will be used by EPA and

other agencies to Identify thee chemical

substances which may have little exposure to the general environment.

Section 710.7 of these regulations recog- nizes that the fact that a particular chemical

substance is "site limited" may be claimed as confidential. If a claim of confidentiality

Is asserted It will be handled In accordance

with the Agen~y's businezs confidentiality

regulations. 40 CPR Part 2.

EPA has not decided exactly how it will

propose to define "signiflcant new use" for

the purposes of notification under section

5(a) (1) (B). The comments which we have

received are quite extensive on this point and

correctly emphasize the various considerations set forth In section 5(a) (2). EPA Intends to take Into account all these con- Biderations prior to Ising a proposed rule

under section 5(a) (2).

Comment I: Compilation of production

volume and site data will be a time-consuming and expensive procedure since many

companies will have to consult production

batch sheets and Inventories. This burden is

greatly increased by requiring the reporting

of Isolatable intermediates.

Response: In preparing the final regulations, EPA has attempted to reduce the burden of reporting to industry while obtaining

important information. As discussed In re- sponse to comment 6, these regulations would

require reporting In fairly broad ranges of

the production of chemical aub3tances. Further, as discussed In response to comment 67, EPA has revised Its definition of "intermediate" to exclude "isolatable intermediates", or those which "could be Isolated,"

but are not. These amendments should

greatly reduce the potential reporting burden to industry. Moreover, the burdens of

compiling the production and site Information required by these regulations has been

considered In establishing the definition of

"small manufacturer" under these regulations. As discumsed in greater detail in respouse to comment 24, small manufacturers

are not required to submit this information.

Comment 12: Certain industries may find

it more convenient to report their chemicals

In units other than pounds. Cubic feet for

g and barrels for petroleum products are

two examples. Further, manufacturers should

be able to report in metric units.

Response: In order to simplify reporting

and to enable EPA to process the Information

in a timely fashion, It is very important that

manufacturers report production volumes

according to the ranges established by § 710.-

5(d)(4). EPA-expects manufacturers who

normally deal In other units of measurement

to be able to convert to the specified ranges.

The table of ranges is provided in both

pounds and kilograms to facilitate reporting

by persons using the metric system. In instances where manufacturers cannot determine the actual welght of a chemical substance, a best estimate should be made.

wrecH P=s S Aosa SUBJXCr TO

Manufacturers

Comment 13: EPA wil lose valuable information by not requiring all chemical manufacturers to report for the inventory. There

are many chemical manufacturers outside

of SIC groups 28 and 2911 and EPA will not

be able to locate these potential sources of

hazardous chemicals. The Agency does not

have the discretion to exempt some chemIcal manufacturers from the reporting obilgatlon.

Response: The Administrator interprets

section 8(a) of the statute as giving EPA

broad discretion to determine the manufacturers who shall be subject to any reporting

rule.

By directing these reporting requirements

to manufacturers substantially engaged in

producing chemical products of the types

described under SIC 23 or 2911 the Agency is

focusing on that segment of the industry

which is of primary concern under TSCA. By

narrowing the population of manufacturers

required to respond from a possible 225,0C0

establ'hments who may be engaged in processing chemical substances to approximately

8,400 establishments engaged in manufacturing chemicl substances, EPA will dramatically reduce potential duplication of reporting and still create a data base which is

comprehensive with respect to principal

chemical manufacturers. EPA expects the

Initial inventory to contain over 95% of the

chemical substances manufactured and proces-sed for a commercalpurpose in the United

States.

In response to this comment. however, in

order to increase the reliability of the data

base which the Agency wil generate. EPA

has expanded the category of manufacturers

who must report, in two respects. First,

§ 710.3(a) (1) (1) (B) requires manufacturers

who have produced one million or more

pounds of a reportable chemical substance (s)

at a plant site to report concerning all chemIcal substances manufactured at that site

during 1977. This criterion applies whether

or not the manufacturing establishment

would be included In SIC Code 23 or 2911.

Second § 710.3(a) (1) (il) requires all manufacturers to report -concerning any chemical

substance that they manufactured at one

plant site in quantities equal to or greater

than 100,000 pounds during calendar year

1977.

The Agency, accordingly, will receive reporting on all the chemical substances manuJactured at plants included in the chemical

and allied products sector of the industry and

at the plants of the largest manufacturers

in the other sectors. In addition, the data

ba-e will include at least all chemical subFEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977

64581

HeinOnline -- 42 Fed. Reg. 64581 1977
RULES AND REGULATIONS

stances produced in quantities equal to or

greater than 100,000 pounds annually at any

plant site.

Comment 14: Since any manufacturer

whose chemical substance is not included in

the initial inventory will be 'required to

comply with the premanufacture notification

requirements of section 5(a) (1) (A), manufacturers outside SIC groups 28 and 2911 will

still be forced to report their chemicals to

ensure that they are included on the inventory. Thus EPA's efforts to reduce duplicative reporting will not be successful.

Response: The Administrator believes that

these regulations will reduce duplicative reporting. Those manufacturers who are not required by §710.3(a) (1) or (2) to report

chemical substances have several options for

ensuring the chemical substances they man- ufacture are included on the inventory. First,

they can report individually. Second, these

manufacturers can rely on their knowledge

that another manufacturer is reporting the

chemical substance. Or, third, as provided in

§ 710.5(f), they can ensure that the chemical

substances are reported by a trade association

or other group. Thus, the inventory reporting

burden on these persons will be minimized

and the 'number of reports submitted to the

Agency will be greatly reduced.

Comment 15: EPA should clarify by notice

In the FEDERAL REGISTER or by direct mailing,

exactly who is Included in SIC groups 28 and

2911.

Response: The Agency intends by direct

mail to notify those persons included on the

Dun and Bradstreet list of SIC Code 28 or 2911 manufacturers, as well as others who are included on EPA's mailing list, concerning

these reporting regulations. Moreover, EPA

has decided for administrative and legal rea- sons not to rely on the designations of SIC

groups that the Bureau of Census assigns to all manufacturers. Instead, § 7103(a) (1) of

these regulations sets forth independent criteria for reporting for these regulations.

Manufacturers should be able to determine

for themselves whether the reporting require- ments are applicable to them. The proposed

criteria should encoinpass at least those man- ufacturers in SIC groups 28 and 2911, as designated by the Bureau of Census. Any manufacturer meeting the criteria of § 710.3(a) (1)

is subject to thege regulations regardless of

whether he has been assigned to SIC group 28 or 2911 by the Buerau of Census and whetho'

he receives a letter from this Agency

Comment 16: Trade associatiois should let

non-member firms add to any list of manufactured chemicals.

Response: In allowing trade associations to report, the reguations do not stipulate that

the persons for whom the trade associations

may report are actual members of that association. Section 710.5(f) of these regulations

only requires that for every chemical sub- stance reported by a trade association at least one manufacturer, importer, or processor must have certified to that trade asso iation,

and be able to document to EPA, that the

chemical substance was manufactured, imported, or processed In accordance with these

regulations.

Comment 17: A company which contracts

with another company to manufacture a chemical substance for a commercial purpose

should be allowed to report that chemical

substance for the inventory.

Response: The Administrator agrees with

this comment. EPA recognizes that there are companies who contract with other com- panies to ma~nufacture chemical substances

for commercial purposes. The company who

actually manufactures the substance Is, 'of

course, responsible for reporting any chemical substance manufactured during calendar

year 1977, in accordance with § 710.3(a) (1).

In addition, the manufacturer may report for

the inventory under § 710.3(a) (3) The company who has contracted for manufacture of

the chemical substance may also report for

the Initial Inventory, if he has reason to believe that the manufaoturer has no intention

of reporting the substance. For example, the

manufacturer may no longer be in business or

may not have manufactured the substance

since January 1, 1977, and does not intend

to continue manufacturing the chemical substance. If the contractor reports for the Inventory he must be able to certify that the

chemical substance was manufactured since

January 1, 1975, and provide the address of

the manufacturing site.

Importer

Comment 18: Importers and foreign suppliers should be permitted to appoint a mu- tually agreeable agent to report for the inventory. It is unfair to hold small importers

liable for reporting the chemicals manufactured by a large international corporation.

Response: Section 710.5(e) of these regulations provides that an importer required

to report chemical substances may authorize

a foreign manufacturer, or an agent of a foreign manufacturer, to report on the importer's behalf. Because the jurisdiction of

TSCA reaches the importer and not the

foreign manufacturer, EPA must hold the

importer liable. An importer Is free, however,

to take whatever legal measures are necessary In contracts with the foreign supplier

to protect himself from penalties. Whatever

conditions the Importer and reporting agent

agree to, however, are outside the purview of

these regulations.

In addition, the reporting instructions re- ferred to in § 710.5(b), "Reporting for the

TSCA Inventory," will provide that importers

may report certain information directly to

EPA and request a foreign manufacturer or his agent to supply other information. Thus,

an importer could arrange that he would

send directly to EPA the trade name of the

imported chemical substance and the amount

imported, and that a foreign manufacturer

or his agent would submit the specific chemical identity of the trade name substance.

Tne Agency expects such arrangements to

be useful in the event some information is a confidential trade secret.

Comment 19: Standard- Industrial Classification (SIC) codes should be used to determine which importers are required to re- port. EPA should insure that importers are not required to report under § 710.3(a) (1)

and should clarify the "site" for importers

for the purposes of these regulations.

Response: The Administrator agrees in

part with this comment. EPA has revised the

final regulations to require reporting by

importers concerning all chemical substances

imported if (1) thirty percent or more of

the weight of the products imported con- sists of products of the types described

under- SIC 28 or 2911, or (2) the total pounds

of reportable chemical substances imported

equals one million or more pounds. In addition, importers must report any chemical

substance imported during calendar year

1977 in quantities equal to or greater than

10D,000 pounds. These requirements parallel

those under § 710.3(a) (1) for domestic man- ufacturers. An importer, however, is not required to report under §710.3(a) (1); he Is

required to report under § 710.3 (a) (2).

As defined in § 710.2(w), the' business

address of an importer will be considered

his site for the purposes of these regulations. Importers need not specify the port of

entry for importation of a chemical substance.

Comment 20: If EPA allows mixtures which

contain substances not on the inventory to be imported, foreign competitors will have an unfair advantage. EPA should require

premanufacture notification of now chemical substances imported as parts of mixtures.

Response: The Administrator agrees with

this comment. On October 3, 1977. EPA published in the FEDERAL REGIsrta a supplemental notice (42 FR 53804) addressing the

applicability of these regulations and promanufacture notification requirements to Importers of chemical substances an part of

mixtures. Since an importer of a mixture Is

also importing the component chemical

substance in the mixture, such an Importet

would be subject to the premanufacturo no- tification requirements with respect to all new chemical substances. Accordingly, although Importers of chemical substances s part of mixtures are not required to report

for compilation of the inventory, they should ensure that the chemical substance3 they

import are included on the inventory. As

provided in §§710.3(a)(3) and 710.3(b),

they may report either during the reporting

period for the initial inventory or the reporting period for the revised Inventory.

And, as provided In 9 710.5(f), they may re- port through a trade association or other

agent. The premanufacture notification requirements of section 5(a) (1) (A) will not be applied to importers of chemical substances as part of mixtures until 30 days

after publication of the revised Inventory,

At that time, no person will be permitted to import any mixture containing a "now chemical substance" except in accordance

with TSCA section 5. Please refer to the October 3, 1977 notice for a discussion of the

legal and policy considerations supporting

this decision.

Comment 21: Importers of chemical substances as part of articles should not be re- quired to report for the inventory and

should not be subject to premanufacturo

notification.

Response: The Administrator agrees that

importers of chemical substances as part of

articles should not be required to report for

the inventory, and is reviewing whether any

importers of articles should be subject to

premanufacture notification requirements,

Sections 710.3(a) (3) and,710.3(b) provide,

however, that Importers of a chemical substance as part of an article may report for

the Initial and revised inventory.

The October 3, 1977 supplemental notice

(42 PR 53804) in the PlDE3AL MaEio=sT discussed- the applicability of these regulations,

and premanufacturo notification requirements to importers of chemical substances

as part of articles. Persons who Import articles also "import" the component chemical

substances. Thus, as discussed in response

to comment 20, the importer could be subject to the premanufacturo notification requirements with respect to all now chemical

substances comprising the article. However,

for reasons discussed in greater detail In the

October 3, 1977 notice, the Administrator

does not presently intend the premanufacture notification requirements of section

5(a) (1) (A) to be applied to the importation

of all articles that contain a new chemical

substance. As discussed in response to comment 22, EPA will carefully consider the

economic and international ramifications of

any premanufacture notification requirements that may be applied to chemical substances imported as part of articles, In the

interim, EPA will not consider persons who

import chemical substances as part of articles or who process or use such articles to be

In violation of section 5(a) (1) (A). If upon

re-evaluation, the Administrator determines

that these requirements should be applied

to importers of chemical substances imported as parts of some or all articles, or to Importers of selected chemical substances Imported as parts of. articles, a proposed notice

will be published for further public comment. Such change in policy would be finalFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64582

HeinOnline -- 42 Fed. Reg. 64582 1977
RULES AND REGULATIONS

Ised before publication of the initial Inventory so that any affected parties may report

during the reporting period for the revised

inventory.

Chemical substances or mixtures which are imported within articles, such as in drums.

barrels, or other containers used for purposes - of transportation or containment, are con- sidered to be chemical substances imported

in bulk and are subject to these reporting requirements. Chemical substances or mix- tures will be considered to be imported as a part of an article, if the substance or mixture is not intended to be removed from

that article and has no end use or commer- cial purposes separate from the article of

which it is" a part. Importers may report

these chemical substances but are not re- quired to do so. For example, transformer

fluids in transformers, lighter fluids In

cigarette lighters, and crankcase oil in auto- mobiles are not intended to be removed from

the articles of which they are a part and

.have no commercial purpose separate from

these articles. Accordingly, these chemical

substances need not be reported. These same chemical substances, however, if imported

in drums, cans, or other containers, must be

reported as required by these regulations. The Agency will exercise its authority to regulate the import of chemical substances

which are part of articles (as well as imported in bulk and in mixtures) under sec- tion 6 or other authorities of the Act, as necessary to protect against unreasonable

risks of injury to health and the environ- ment. This might, for example, Include prohibiting, limiting, or, in other ways, re- stricting the import of such chemical substances.

Comment 22: Importers of chemical sub- stances as part of an article have an unfair

competitive advantage over domestic manu- facturers because they can introdurce new chemical substances into domestic markets

without complying with premanufacture no- tification requirements. This policy should

be changed so that substances which are manufactured domestically at a site solely to be included in an article would not be

considered pommercial substances per se. Thus they would not be reported for the Inventory and would not be subject to premanufacture notification.

Response: The Administrator disagrees

with this comment. EPA recognizes that the

reporting requirements are not Identical for

importers and domestic manufacturers of

chemical substances as part of an article,

but EPA has tried to equalize the burdens

of complying with these regulations, as directed by the Act. With respect to the require- ments for premanufacture notification. EPA

will assess the Impact of those requirements over the next several months as they are

developed.

Under § 7104(d) of these regulations some chemical substances manufactured as part of an article which have no commercial purpose separate from the article of which they are a part, are excluded from the Inventory

and premanufacture notification require- ments. To exclude from the inventory other

chemical substances manufactured for a commercial purpose which are subsequently

incorporated in an article would create an unacceptable loophole and not fulfill the

purposes of the TSCA inventory. The domestic manufacturer of a chemical substance

who also manufactures an article Is only

required to report the chemical substance(s)

he actually manufactures. EPA does not believe that this is an unreasonable burden. If

under subsequent regulations the Agency imposes certain requirements on domestic manufacturers of chemical substances whichare

incorporated as parts of articles, in general the Agency will impose the same requirements on importers of those chemical substances.

Comment 23: In developing premanufacture requirements under section 5. EPA

should tako into account foreign manufacturers whose6 application for a patent for a new chemical substance with a foreign

government may be jeopardized by premanufacture notification under TSCA.

Response: If a foreign government will not award a patent for a chemical subs-tance

whose Identity has been disclosed, even to another government under a provision such as the premanufacture notification requirements of TSCA. persons should take this

into account and apply for the patent prior,

to the Importation of the chemical substance

into the United States.

Definition of Small Mfanulecturcr or

Importer

Comment 24: The definition of "small

manufacturer or Importer" proposed by EPA

is unduly restrictive and ought to be revised.

Response: The Administrator agrees with

this comment. The definition of the term

"small manufacturer or importer" at 1710.2

(x) has been revised to mean a "manufacturer or Importer whose total annual salcs

is less than $5 million, based upon the manufacturer's or Importer's latest complete fiscal

year as of January 1, 1978. except that no

manufacturer or importer is a 'small manufacturer or Importer' with respect to any

chemical substance which such person

manufactured or imported in quantitel

greater than 100.000 pounds during calendar year 19771

This definition Is different In several respects from the definition of "small manu- facturer or importer" which was proposed on August 2, 1977. In the first place, EPA has

deleted the criterion based on the number

of plant sites. It had been proposed that a manufacturer would be a small manufacturer

if he had only one plant site. The Admlnistrator has determined that for the purposes

of these regulations., such a criterion would

have little meaning. The one plant site

criterion had little relation to burden on the

small manufacturer. It also provided very little benefit to EPA because very few manu- facturers who meet the other criteria will

have more than one plant site.

In the second place, whereas the August proposal would have defined as a "small

manufacturer or importer" a person with

total sales of less than $100.000. these final

regulations consider a 'small manufacturer or importer" a person who, In part, has total

annual sales of less than 65 million, based on the manufacturers' or importers' latest fiscal

year as of January 1. 1978. The Agency re- ceived extensive comments that the $100,000

figure was unreasonably low, and has agreed

that It should be substantially Increased.

And, In the third place, these regulations

provide that no person Is a "small manufac- turer or Importer" with respect to any chemical substance produced In quantities greater than 100.000 pounds annually. The August

proposal had provided that a person would

be a small manufacturer if he had no more than 2,000 pounds annual production of a chemical substance. The Agency has established this criterion for the definition of the term "small manufacturer or Importer"

based on Its need for information on chemlcals produced in substantial quantitles.

It is important to emphasize that in ac- cordance "with section 8(a) (3) of 7SCA.

small manufacturers and importers are not exempt from reporting Information necessary

for compilation of the Inventory. Accordinely, under these regulations, small manu- facturers and importers who are required to

report (§ 710.3(a) (1) and (2)) must report

64583

at least (1) thL-identities of the chemical

substances, and (2) whether they manufacture. process, or Import the substance. Reporting of the chemical identities Is neces- sary to publish the list required under section 8(b). In order to enforce these inventory

reporting regulations, manufacturers, and

Importers must Indicate whether they do

manufacture or Import the substance.

Under thee regulations "small manufacturers" are also required to report whether

the chemical substance Is manufactured and

prccezz:ed only within one site and not dst-lbuted outside that site. The Administrator

has determined that this Is very important

for utility of the inventory and that the

burden of reporting this additional Information by manufacturers i- neglIble. Spe- cifically. EPA may want to use this information. I.e. which chemical substances are now "site-limited". for purposes of requiring

notification under section 5(a) (1) (B) prior

to distribution of such substances outside

the manufacturing site.

Small manufacturers and Importers are exempt from reporting the production volume and site Information that win be required by thence regulations. As is discussed

In response to comments 1 through 12. this

Information is being required pursuant to

the general reporting authority of section

8(a) to obtain sufficient information to implement the prov1-ons of TSCA. In defining

"small manufacturer or importer" EPA has

attempted to balance the burdens to manufacturers and importers of submitting this

Information against the value of that information to the Agency.

The Administrator has determined that re- ouiring production and site information

from all manufacturers and Importers other

than "small nnufacturers and Importers"

as defined In these regulations, will not present an unreasonable burden. For those firms

with approximately $5 million in sales, the

.ots of reportlng will range from about 0.6

nercent of annual profits (for reporting for

the Inventory alone) to about 1.2 percent

(for also reporting product volume and Identity of substances manufactured by site).

These figures assume a 6 percent profit -rate.

For example, a firm with $5 mililon in sales

and $300,000 In profits (6 percent) would

have to spend about $3.500 (1.2 percent of

9300.000) to comply with these regulations.

The above costs would decrease as the size

of the flrdi increases.

The firms generally most impacted are

these with the largest number of chemicals

to report. Those firms with less than $5 million in sales must report production volume

by site for chemicals manufactured in quantitles in excess of 100.000 pounds. The costs

to these firms will fall between 0.6 and 1.

'percent of profits, or between the costs of

reporting for the inventory alone and the

costs of reporting all required information.

In analyzing the costs of reporting. EPA

examined the costs to those required to report under section 710.3. The bulk of reepondents would fall in SIC group 28. Chemicais and Allied Products, or SIC 2911, Petroleum Refining. The remaining resoondents

are those who are not classified as SIC 28 or

2911 firms but who have at least one site

from which thirty percent or more of products distributed are of the type described by

SrC 28 or 2911. or who either manufacture

a total of one million or more pounds of

renortable chemical substances or manufacture one or more chemical substance in

quantities of 100.000 pounds or greater. The

costs per chemical of reporting for these

additional firms would be simlar to the costs estimated for the SIC 28 and 2911 flims.

However, the costs as a percentage of sales

would be smaller because chemical sales are a

relatively smaller portion of their total sales.

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64583 1977
64584

In estimating the number of firms required to report by these rules, EPA started

with the firms classified as primarily producers of SIC 28 and 2911 products. 'This

number was then reduced to account for

those firms within SIC 28 and 2911 who are

not manufacturers (i.e., processors) and those

who e primary products are not covered by

TSCA (e.g., SIC 283. Drugs and SIC 2879,

Pesticides). Firms whose major products are

not in SIC 28 or 2911 but which had significant chemical manufacturing activities were

also examined and included in the analysis.

The total number of firms expected to be required to report is estimated to be approximately 6400.

This definition of small manufacturer will

exempt approximately 78 percent of the firms

required to report from complete reporting

of production and site information, Though

the number of firms defined as small s significant, they account for less than 5 percent

of the sales and 6 percent of employment.

EPA has consulted with the Small Business

Administration (SBA) in developing this

definition of "small manufacturer or importer." The SBA suggested that EPA define

as a "small manufacturer or importer" a

company with 100 employees or less. Such

a definition would exempt a slightly larger

percent of firms; it would be ecfuivalent to

exempting companies whose total annual

sales are approximately $6.8 million. These

final rules substantially reduce the burden

of reporting by requiring reporting only for

intermediates which are actually isolated

(see comment 67) and by requiring reporting

of production volumes in broad ranges (see

.comment 6). Based on these changes, EPA

believes that the definition of "small manufacturer or importer" In these reaulations is

adequate to prevent unreasonable burdens

on chemical mnanufacfurers. The SBA

concurs.

Further analysis of the costs associated

with this definition of "small manufacturer"

is contained in the report, "Analysis of Options for Definition of Small Business and

Estimated Cost of the Initial Section 8(a)

Reporting Requirements", prepared by

Arthur D. Little, Inc. and included in the

rulemaking record.

Comment 25: Several commenters suggested that EPA should define "'small manufacturer or importer" in terms of production

volume and total annual sales; other commenters suggested that the term should be

defined In terms of manufacturing sites.

number of employees, assets, or value of

sale3 per chemical.

Response: The Administrator considered

the utility of each of these parameters and,

as is discussed in response to comment 24,

has decided to rely on total annual sales

and production volume.

The total annual sales of a manufacturer or importer are generally known and, therefore, use of this criterion would require no

additional calculations. In addition, the

value of sales gives a good Indication of the

ability of the company to bear the reporting

'burden. Generally the larger the sales, the

larger the staff employed by the firm, and

the more resources the company will have

available to report to the Agency.

Production volume gives a good indication

of the potential for human and environmental exposure. Accordingly, these regulations

use this crterion in conjunction with the

sale3 criterion. However. a manufacturer or

importer with total annual sales of less

than 45 million dollars only must report production volumes for those chemical substances produced in quantities greater than

100,000 pounds. Informatlon on chemicals

produced in such quantities has greater value to the Agency.

AS discussed in response to comment 24,

the Administrator had determined that a criRULES AND REGULATIONS

terlon on number of manufacturing sites

would have little meaning for the purposes of

this regulation. It has no relation to cost or

burden on a company and the additional information gained by EPA by Including this

criterion would be minimal since very few

firms that satisfy the other criteria of the

definition would have more than one plant

site.

The number of employees of a manufacturer or importer may'be useful a parameter

for determining the burdens of a reporting

requirement. However, it is not as good a

measure as sales of the ability to bear the

burden of reporting. This is particularly true

since there are significant variations in dollar

sales per employee in various segments of the

chemical industry 'reflecting a substantial

difference in the abilities of various firms to

bear the burden of reporting. Over the entire industry, annual sales per employee is

about $68,000, varying from $45,000 in SIC

2816, Inorganic Pigments to over $225,000 in

SIC 2911, Petroleum Refining.

Criteria based on assets or value of sales

per chemical are also not included in these

regulations. The value of assets would provide an indication of the size of a firm. However, the components of total assets are complex and the information is not generally

available to the public. Further, assets may

not bear any relationship to a company's

ability to absorb these reporting costs. Value

of sales per chemical produced might provide

a good measure of a company's ability to

bear reporting costs; however, this criterion

would require a company to make a determination as to whether it was a "small manufacturer or importer" with respect to every

chemical manufactured. This would be an

unnecessary burden.

Comment 26: Including a volume of production limit as part of the definition of

"small manufacturer or importer" is consistent with the Act and will give EPA at

least a rough estimate of the quantities of

chemicals produced.

•Response: As discussed in comment 24,

in determining an appropriate definition of

"small manufacturer or importer," EPA considered the value of and need for this Information with respect to the costs to manufacturers and importers of submitting the

information. Production data are to be used

primarily in. decisions concerning prioritization of Agency actions and allocations of

Agency resources. Because of this, the

Agency's need for the information grows as

production volume increases, thus justifying

an increased burden to small businesses who

produce large quantities of chemical substances. EPA is requiring reporting of production volumes In excess of 100,000 pounds

from all companies. Under these final regulations, reporting production volumes should

not be burdensome, especially for those substances manufactured in substantial quantities.

Comment 27: EPA should defi~e the term

"small manufacturer" without respect to

whether a manufacturer is owned or controlled by another company. A manufacturer

who meets the basic criterion should be

considered a "small manufacturer," even if

the manufacturer's company is owned or

controlled by another company.

Response: The Administrator disagrees

with this comment. The legislative history

of TSCA makes it clear that in considering

what manufacturers and processors qualify

as "small manufacturers and processgrs," the

Administrator must consider whether the

company Is owned or controlled by another

company and apply the factors for determining "small manufacturers or processors" to

both companies. H. Rep. No, 94-1341, 94th

Cong., 2nd Sess. 5 (1976).

Proces3ors

Comment 28: EPA does not have the discretion to prevent processors of chemical

substances (including manufacturers of a

mixture or article containing the chemical

substance) from reporting for the Initial

Inventory.

Response: EPA interprets section 8(a) of

the statute as providing broad discretion to

determine which persons shall be subject to

any reporting rule. Section 710,3(o) provides that the processors are not subject

to the initial inventory. They may report

chemical substances not included on the

Initial inventory during the reporting period

for the revised inventory,

These regulations provide that persons who

will be subject to the premanufacture notiflcation requirements *of section 6(a) (1) (A)

of the Act are subject to the initial Inventory. The requirements of section 5 (a) (1) (A)

only apply to manufacturers and importers

of chemical substances, procemors of chemical substances are not required to give promanufacture notification on new chemical

substances. Therefore, proceszors are not subject to the initial inventory

If processors were subject to the initial

inventory, the Agency expects that the num- ber of respondents would increase ten-fold,

Moreover, the Agency expects the list of

chemical substances reported by manufacturers and importers to contain over 96 percent of the chemical substances which are manufactured or processed for a commercial

purvose in the United States. Accordingly, by

making processors and users of chemical substances subject to only the revised inventory, the Agency will avoid duplicative roporting and substantial delays in publica'

tion of the inventory. The Agency will not

Process any reports submitted for the initial

inventory by processors or users of chemical

substances. - it Is a prohibited act under section 16(1)

of TSCA for a person to use for a commer- cial purpose a chemical substance which he

had reason to know was manufactured in

violation of section 5. The Agency has an- nounced, however, that section 15(2) with

respect to section 5(a) (1) (A) will not be

aunlled to persons who process or use a chemical substance for a commercial pur- nose until Publication of the revised Inventory. Therefore. by reportina during the re- 'porting -Period for the revised Inventory€

Processors of chemical substanceo will be able

to protect themselves from prosecution under

the statute.

CHEMICAL SUBSTANCES MANrACrutlrD on rROCESSED FOP. A COMMERCIAL PUEPOSV

Comment 29: The definition of the term

"manufacture for a commercial purpose."

should be modified to exclude the manufacture of a chemical substance In small quantities for research and development.

Response: The Administrator disagrees with this comment, Chemical substances

which are manufactured for research and

development are "manufactured for com- mercial purposes" within the meaning of

TSCA and are appropriately included under

this definition. However, if these substances are produced solely In small quantities for

research and development they are speciflcally excluded from the inventory under sec- tion 8(b), and are exempt from the promanufacture notification requirementS of

section 5(a) by section 5(h) (3) of the Act.

Comn ent 30: Commercial biological preparations such as yeasts, bacteria, and fungi

should not be considgred "chemical substances" under TSCA.

Response: The Administrator disagrees

with this comment. The term chemical substance is defined to mean "any organic or Inorganic substance of a particular molecuFEDERAL REGISTER, VOL. 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64584 1977
lar Identity including any combination * *

occurring in nature." This definition does

not exclude life forms which may be manufactured for commercial purposes and nothIng In the legislative history would suggest

otherwise.

EXCLUSIONS TO THE DEFINTION Op CHErmIAL

SUasD&CES

Mixtures

Comment 31: EPA should clarify that

manufacturers, not processors, have the responsibility for reporting the component

chemical substances of a mixture.

Response: EPA believes that these regulations clarify that only manufacturers of

chemical substances must report for the

initial inventory. In fact, processors are not

-subject to the initial inventory. Processors,

including manufacturers of mixtures, may

report for the "revised" inventory.

Comment 32: Multi-nutrient "mixed fertilizers" that could have been prepared by

physically 'blending dry products such as

urea, superphosphate and potash, should be

considered mixtures, regardless of whether

they are produced by physically mixing or

by a method that involves a chemical reaction, such as by combining liquid ammonlum phosphate and granulating with

potash.

Response: Te Administrator agrees with

this comment and will consider multinutrient "mixed fertilizers" as mixtures of the

ingredients beIng mixed.

Comment 33: Manufacturers of alloys including steel, glasses, ceramics, enamels,

Portland cement, and similar combinations

of chemical substances should not be required to report for the inventory.

Response: The Administrator agrees with

this comment. Alloys. inorganic glasses, ceramics, frits, and cements, Including Portland cement, are mixtures under TSCA;

manufacturers of these products are not required to report them. However, as stated

in a note at § 710.4(c), the exclusion of these

products applies only to the mixture and

not to the chemical substances of which the

mixture Is comprised. Thus, the metals in

the case of alloys, or oxides in the case of

glasses and ceramics, and any additives or

components other than impurities, should

be included on the inventory. The manufacturers of the metals, oxides, and additives

would be responsible for reporting them.

Comment 34: "Hydrates" and "hydrated

ions" should be considered "mixtures."

Response: The Administrator agrees with

this comment and has defined the term

"mixture" to include 'hydrates." Hydrated

forms of chemical substances are accordingly

exempt from the inventory. The anhydrous

chemical substances, however, should be Included. Thus the manufacturer of hydrated

copper sulfate, CuSo, (H.O),. would report

that anhydrous form, CuSO4, for the nventory. As clarified in the preamble to the

March 9 regulations, this provision does not

apply to the product of discrete chemical reactions in which either water or a solvent Is

a reactant, e.g., water reacting with an ester

to form an acid and an alcohol. Similarly,

metal hydroxides formed by the reactions

of metal oxides with water are not considered to be hydrates.

Comment 35: If a person combines two or

more chemical substances to produce a "mixture." -the person should be considered a

"Mahufacturer of the miture," not a "processor of a chemical substance."

Response:- The Administrator disagrees

-with this comment. A person who combines

two chemical substances to produce a mixture," ttge person should be considered a

turer of the mixture" or a "processor of the

chemical substance." For the purposes of

these regulations, regardless of how such

RULES AND REGULATIONS

a person is characterized, he may only re- port during the reporting period for the re- vised Inventory. The Agency recognizes that the Congress in section 8(a) established a different standard for requiring reporting and retention of

Information on mixtures than on chemical

substances. EPA does not intend to require

reporting on mixtures from either their

manufacurers or processors when information concerning the chemical substances

which comprise the mixture Is adequate for

the Agency's purposes. Comment 36: The definition of the term

"mixture" should be expanded to include (1)

incidental reaction products, (2) some chemical substances, (3) chemical substances which are the result of a chemical

reaction that occurs upon use of certain

chemical substances, such as curable plastic or rubber molding compounds, or other substances which are formed during the manu- facture of an article, and (4) chemical substances which occur es the result of a chemical reaction when specified substances

including, for example, a stabilizer, colorant, or antioxdant, function as Intended, or when a chemical substance which is solely

intended to impart specific phyrlco-chemcal

characteristics, functions as intended.

Response: The Administrator disagrees

that the substances encompassed within this

comment are "mixtures" within the meaning

of TSCA. EPA believes that each of the reac- tion products Is a "chemical substance" for

thr purposes of TSCA and that the chemical

substance is manufactured or processed for a commercial purpose within the meaning

of section 8 of the Act. However. in keeping

with the legislative history of the Act,

§ 710.4(d) excludes all these substances

from the inventory because they are not

manufactured for distribution in commerce -as chemical substances per sc and have no commercal purposes separate from the mixture or article of which they may be a part.

In addition, they are not subject to the premanufacture notification requirements of

section 5. The Administrator may In the future Impose a section 8(a) reporting rule as to these substances. In addition, the provisions of sections 8(c), 8(d) and 8(e) are

applcable to these substances.

The term "mixture" under TSCA has. a meaning which Is diffcrent from its usual

meaning In some respects. Many compositions commonly considered to be mixtures are "chemical substances" rather than "mixtures" for purposes of these regulations.

A combination of two or more chemical

substances is Itself a "chemical substance"

for purposes of these regulations unless It

falls within the specific definition of the

term "mixture." In general, a combination

of two or more chemical substances Is a "mixture" If they have been combined by

actually mixing them together.

If, however, the combination occurs In

nature, it is a "chemical substance" and is

not a "mixture." If, further, the combination Is prepared by a chemical reaction. It

Is a "chemical substance" and not a 'ltixture," unless the combination could actually have been manufactured for commercial

purposes at this time without a chemical

reaction e.g., by mixing Its separate componehts with each other.

No r-Hydrates and hydrated Ions are treated separately, and are discussed In comment 34.

Pesticides and Foods, Food Additices, Drugs,

Cosmetics and Devices

Comment 37: Various commenters stated

that a substance should be excluded from

TSCA If It Ia Intended for use solely as a pesticide, food, food additive, drug, cosmetic, or device.

64585

Response: The Adminstrator agrees with

these comments. Pesticides are regulated

under the Federal Insecticide, Fungicide and

Rodenticde Act (FIFRA), as amended. 7

USC 136 et seq. Foods, food additives, drugs,

cosmetics, and devices are regulated under

the Federal Food, Drug and Cosmetic Act

(PDIA). 21 USC 321 et seq. If the manufacturing. processing, distribution, or use of

a substance Is regulated under either FIFRA

or FFDCA. the substance would not be subject to regulation under TSCA Insofar as It

is actually manufactured, processed or distributed in commerce for use as a pesticide.

fond. food additive, drug, cosnetic or device.

If a substance has multiple uses only some

of which are regulated under FIFRA or

FFDCA, the manufacture, processing, distribution, and use of the substance for the

remaining uses would come within the jurtadlction of TSCA. In cases where a substance Is manufactured, processed, or distributed for undifferentiated uses, the substance will be presumed to be subject to

TSCA for the purposes of these regulations.

EPA recognizes that the interrelationship of

TSCA, FIFRA, and FFDCA is complex and

that jurisdictional Issues need further exploration In light of the various types of

regulatory situations that may arise and

the Congressional Intent of avoiding both

dual jurisdiction and regulatory gaps. EPA

believes that an appropriate resolution has

been made In this particular Instance.

Comment 38: A substance should be considered a pesticide at the time that an appllcation for an experimental use permit or an

application for registration Is submitted.

Response: The Administrator agrees with

this comment. If a manufacturer, processor,

or distributor of a substance expects to receivo benefit In pest control from Its use, It

would be considered a pesticide within the

meaning of FIFRA. Submiion of an appllcaton for an experimental use permit (FIFRA)

section 5. 40 CFR Part 172) or an application for regIstration (FIFRA) section 3. 40

CFR Part 162) will be evidence that the substance is a "pesticide" within the meaning

of FIFRA. Prior to this stage, the substance

will be presumed to be a chemical substance

within the meaning of TSCA. Therefore, any

particular substance will first be subject to

the provisions of TSCA and then, the provisions of FIFRA.

Implementation of this approach will not

pose an unreasonable burden on registrants

of pesticide products. The substance will be

considered a "chemical substance" under

TSCA at the -esearch and development stage.

A.suming that the substance is only produced in small quantities for research and development (as defined in these rules), under

the exemption of section 5(h) (3), the TSCA

premanufacturo notification requirements

would not apply. The Administrator could require that all persons engaged in experimentation. research or analysis of the substance

ba notified of any risk to health w4uch may be

associated with the substance. This is entirely

in keeping with the purposes of TSCA.

In addition, the Administrator could take

regulatory action on the substance under

TSCA sections 4. 6 or 7, and could require

reporting under section 8(a) (1) (B). The

Agency recognizes the importance of research?

and development and does not intend to impede such innovation unneceszarly. Chemicas in the research and development stage

are generally handled by technically qualified

persons and only in small quantities. Accordingly. although the Agency may take regulatory action (including labelling and disposal

requirements) in order to regulate inadvertent mishandling of research chemicals

by an untrained person and inadvertent exposure to the environment of the research

chemical, submission of test data and extenasve regulation of the uses of the substance

FEDERAL REGISTER, VOL 42, NO. 247--FIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64585 1977
RULES AND REGULATIONS

would normally be limited to situations involving significant exposure. In the case of a

research chemical which becomes a pesticide,

these latter areas of concern would be addressed under FIFRA.

Comm .t 39: Various commenters maintained that raw materials, Intermediates, and

inert ingredients produced or used In the

manufacture of a pesticide should be considered "pesticides" and excluded from regulation under TSCA. Other commenters argued

that raw materials and intermediates produced or used in the manufacture of a pesticide are not "pesticides," are not covered

under FIFRA, and should be regulated under

TSCA.

Response: The A-dmlnistrator agrees that

raw materials, intermediates and inert ingredients produced or used in the manufac- ture of a pesticide are substances or mixtures

which can be regulated under TSCA.

In order to be considered a pesticide, a substance must be intended for use as a pesticide. Raw materials, intermediates, and inert

ingredients produced or used in the manufacture of a pesticide are not themselves regulated under F'IFRA (unless they happen to

be pesticides themselves) and, therefore, are

subject to TSCA. The pesticide regulations

at 40 CFR 162.4 are consistent with this view.

A manufacturing use product is considered a pesticide, (40 CPA 162.4(b) (3)); an Intermediate substance intended for the production of a pesticide product by chemical reaction with other substances Is not considered

r. pesticide, (40 CFR 162.4(c) (6)).

The legislative history of TSCA also supports this view. TSCA was enacted to provide' protection from harmful chemicals

where legal authority was previously Inadequate, cumbersome or Inefficient. Congress

intended to avoid the possibility that the

risks from a chemical would not be subject

to regulation. S. Rep. No. 94-698, 94th Cong.,

2d Eess. 5 (1976). H. Rep. No. 94-1341, 94th

Cong.. 2d Seas. 6 (1976). In addition, Senator Allen of the Senate Committee on Agriculture and Forestry in attempting to conform the language of TSCA to that of FIFRA

specifically addressed the interface between

FIFRA and TSCA stating: "* * * any chemical or toxic substance would first be subject

to the provisions of (TSCA) and yet when it

becomes a component of a pesticide, it would

be subject to FIFRA. In many instances the

manufacturer and registrant of the compo- nent Is also the manufacturer and registrant

of the pesticide." Committee on nterstate

and Foreign Commerce. 94th Cong., 2d Sess.,

Legislative History of the Toxic Substances

Control Act 232 (1976). A raw material, intermediate, or inert ingredient which is not

Itself a pesticide would, accordingly, be a

chemical substance within the jurisdiction of

TSCA; It would come within the jurisdiction

of FIFl.RA when it becomes a component of a pe3ticide product.

The manufacturer, processor, or distributor of the'chemlcal substance who does not also maufacture, process or distribute a pesticide product will not be subject to the dtal

jurisdiction of TSCA and FIFRA. That person will only be subject to TSCA. The manufactarer, processor, and distributor of the

oraw material, intermediate, or inert ingredi- ent who also manufactures the pesticide

product will be subject to the jurisdictioi of

both acts. TSCA and its legislative history

contemplates this, and EPA has no discretion

to reach a different result since a raw material, Intermediate, or inert ingredient (which

is not itself a pesticide) cannot be regulated

under FIFRA until It becomes a component

of a pesticide product. As a matter of policy,

however, EPA does not Intend to impose

duplicative requirements on these substances.

Comment 40. A substance should be considered a food, food additive, drug, cosmetic

or device at the time that the Food and

Drug Administration (FDA) regulates the,

substance.

Response: The Administrator agrees with

this comment. As soon as the FDA regulates

a product, its manufacture, processing, or

distribution in commerce solely for a FDA

regulated use will be excluded from the jurisdiction of TSCA. The FDA gives as examples

of such points in time: when an application

for exemption for an investigational use of

a new drug Is submitted (FFDCA 505(a);

21 CFR Part 312); when an application for

exemption for Investigational use of a new

animal drug Is submitted (FFDCA 512(a);

21 CFP Part 511); and when an application

for exemption for investigational use of a

device is submitted (FFDCA 520(g): 21

CFR Part 812, as proposed, 41 FR 35282,

August 20, 1976).-

Comment 41: Intermediates and catalysts

intended solely for use in the production of a

food, food additive, drug, cosmetic, or device are excluded from regulation under TSCA.

Response: The Administrator agrees with

this comment. The definitions of the FFDCA

provide that chemical substances which are

intended for use as a component of a food,

food additive, drug, cosmetic, or device are

encompassed within the meaning of such

terms, respectively. The FDA considers intermediates and catalysts to be such components. Therefore, they are subject to regulation under the FFDCA. Any such substance

is excluded from regulation under TSCA insofar as it is actually manufactured processed or distributed in commerce solely for

use in the production of a food, food additive,

drug, cosmetic or device.

Comment 42: Substances which are approved for use by the Food and Drug Administration as foods or food additives, should

be excluded from further regulation under

TSCA even when used for commercial (nonfood) uses. Response: As discussed in response to comment 37, if a substance has multiple utes only some of wltich are regulated under the

FPDCA, the manufacturing, processing, distribution, and use of the substance for the

remaining uses comes within the jurisdiction

of TSCA. Under these regulations, that sub-

.stance should be reported for the inventory.

EPA does not intend to impose duplicative

requirements on manufacturers and processors subject to regulation under another

Federal authority. Accordingly, EPA will consult with FDA or any other Federal agency,

as appropriate, prior to taking regulatory

action on substances which are also regulated

under other authorities.

CHESICAL SSBSTANCES EXCLUDED FROM THE

INVENTORY

Small Quantities for Research and

Development - ,

Comment 43: The exemption for "small

quantities for research and developmeht",

should include small quantities used for

quality control testing and for development

of a chemical substance or product.

Response: 'Mhe Administrator agrees, in

part, with this comment. Chemicals used for

quality control testing and for the development of a product are considered "small

quantities for researbh and development" if

they fall within the definition provided in

§ 710.2(y). Specifically, they must be manufactured or processed in quantities no greater

than reasonably necessary for such purposes

and, after publication of the revised inventory, they must be used by, or directly under

the supervision of "technically qualified individual(s)." a term defined In § 710.2(aa).

Substances can be "small quaftities for research and development" even if they are distributed In commerce. Comment 44: Numerical limits should be

Included in the definition of small quantities

for research and development.

Response: The Administrator considered

establishing upper limits for small quantities

for research and development and found that

different values might have to be assigned

for various groups of substances depending

upon their physical/cl~emical characteristics

and intended uses. For example, many plastics and fibers are commonly produced in

100,000 pound quantitiea during the develop- mental phase, while additives or minor uso substances may be manufactured in a few

thousand pounds or lets for research and development purposes. After compilation of the

inventory,.the Agency will consider developing a schedule of quantities to define small

quantities for different chemical substances

and different purposes.

For these reporting requirements, however,

EPA will in large part rely on the qualitative test contained in the definition at 1 710.-

2(y). In response to this comment, as provided In a note to the definition, If a substance is manufactured or imported in

quantities of less than one thousand pounds,

annually, It will be presumed to be for re- search and development purposes. If a man- ufacturer wishes to report for Inclusion on the inventory a chemical substance which Is

manufactured for commercial purposes In

quantities of less than one thousand pounds,

annually, he must be able to certify that the

substance Is used for purposes other than for

research and development. After the publi- cation of the revised inventory, in order to

qualify as a "small quantity for research or development." these quantities must be used

by, or directly under the supervision of, a technically qualified individual.

Comment 45: The exemption for "small

quantities" should not extend to research or analysis of chemical substances for the development of a product. The exemption

should apply only to research In a laboratory

and not to situations where production

workers are exposed.

Response: The Administrator disagrees

with this comment. The legislative history

of the Act makes clear that Congress Intended the exemption for "small quantities"

to extend to chemical substances in the developmental period and not only to research

chemicals In a laboratory. H.R. Rep, No. 04-

1341, 94th Cong., 2d Bess. 29-30 (1076). TI e Coneress contemplated that during the re- search and development phase, a chemical

substance would be within the control of

technically qualified individuals who would

Puoreciate the risks from exposure to the

substance and be able to minimize such risk . The regulations provide that a compound will

only qualify for the "small quantities" ex- emotion if it Is used by, or directly under the

suoervision of, technically qualified individual(s). The Agency expects this requirement to provide workers in the development

of a product the same protections as workers

in the laboratory. In addition, section 5(h)

(3) of the Act specifically provides that in

order for a substance to be exempted from

the requirements of premanufacture notification, all persons handling the chemical

substance for the manufacturer or proces- sor must be notified of any risk to health

which the manufacturer, processor or the

Administrator has reason to believe may be

associated with it.

Comment 46: The exemption for "small

quantities" should not extend to chemical

substances distributed in commerce. Response: The Administrator disagrees

with this comment. Congress recognized that

FEDERAL REGISTER, VOL. 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64586

HeinOnline -- 42 Fed. Reg. 64586 1977
RULES AND REGULATIONS

a manufacturer may not be able to evaluate

fully a potential-product in house. So long as the research and evaluation of the sub- stance is conducted by or under the direct

supervision of persons technically qualidee

to analyze and evaluate the physlcal.'chemical. and performance characteristics of the

substance, the Congress Intended the ex-

-emption to apply. H.R. Rep. No. 94-1341, 94th

Cong., 2d Sess. 30 (1976).

Comment 47: After the effective date of

the premanufacture notification requirements, EPA should require all research and

development chemicals to be labeled rather

than require a "certification of use" statement by a customer upon each sale.

Response: The Agency recognizes that it

may be unnecessarily burdensome to require

customers to certify upon each sale (or even annually) that the chemical substances

they purchase are for research and develop- ment only. EPA is considering imposing a labeling requirement on all research and development chemicals (such as 'Tor Research

And Development Use Only") and requiring

distributors of such chemicals to include

statements In their catalogs and sales literature detailing the restrictions on use. Comment 48: EPA should clarify the responsibilities under these r~gulations of persons who manufacture or import "chemical

substances solely in small quantities for re- search and development.

Response: Chemical substances manufactured, imported, or processed solely in

small quantities for research and development as defined at § 710.2(y) are excluded

from reportlng for the inventory under

§ 710.4(c) (3). As discussed above, if a person manufactures or imports a chemical

substance in quantities of less than one thousand pounds annually, the substance

is presumed to be for research and development. In such a case, in order to report the

substance a manufacturer or importer must

be able to certify that the substance is being

used for purposes other than research and

development.

With respect to quantities greater than

one thousand pounds, manufacturers and

importers 'are not required to obtain certification from their customers concerning

the intended use of such chemicals. However, unless a manufacturer or importer

knows that a customer is using a chemical

substance for other than research purposes,

he should not report that chemical substance. The special reporting period after

publication of the initial inventory is ex-.

uressly to provide an opportunity for people

to supplemeqt the initial Inventory with

chemical substances which are manufactured or processed for commercial purposes but

which were not reported by manufacturers

or importers. The customers of a company

selling primarily research chemical sub- stances could report any chemical substance

that belongs on the inventory at that time.

Comment 49: The provision that small

quantities for research and development

must be used by, or directly under the

supervision of a technically qualified individual, should be deleted.

Response: The Administrator disagrees

with this comment. As discussed in response

to comments 43. 44. 45, and 46 above. Congress clearly intended research and develop- ment chemicals, that are exempted from the

inventory and from premanufacture notification requirements, to be used only by, or under the supervision of technically quallfied individuals.

Comment 50: Professional certification

should be added as a factor which would

establish- that a person is "technically quail-.

fled."

Response: EPA believes that this factor is

already included in the definition of technically qualified individual. EPA presumes

that professional certification Would be

based on the education, training, or experi- ence of the Individual. Accordingly, it would

be redundant to Include professional certification as a separate factor. Persons could

cite their professional qualifications as evidence of being a "technically qualified Individual."

Comment 51: Can the responsibilities included within the definition of "technically

qualified individual" be delegated to more

than one person?

Response: The Agenqy recognizes that

some manufacturers may designate an individual other than the person actually conducting or directly supervising the research or development as the person responsible for

making safety assessments and clearances

with respect to the procurement, storage,

use, and disposal of the chemical substance.

Such responsibilities can be delegated, so

long as all phases of the research and development of a product are conducted, or directly supervised by a person who because of

his education, training, or experience, or a

combination of these factors, is capable of

appreciating the health and environmental

risks associated with the chemical substance.

For example, one person may be responsible for analyzing the properties of a chemical substance used as a glue to back a rug,

while a second person may have responsibility for determining how to dispose of

the rug samples that contain the experimental glue. Similarly, there may be a duly

authorized Individual responsl6le for pro- curement of research chemical substances

who is different from the technically qualilfied individuals who conduct the experiments with those chemical substances. So

long as each of these persons Is professionally

qualified, the "technically qualified individual" definition will be fulfilled.

Byproduct3

Comment 52: All byproducts should be required to be reported for the inventory.

Response: The Administrator disagrees

with this comment. As a matter of policy,

the Agency has decided that byproducts

'which have no commercial purpose should not be reported for the inventory. And. as Is

discussed in response to comment 54, byproducts which have some commercial value are not required to be reported for the inventory. Insofar as these wastes are hazardous, EPA intends to require reporting of them

under the Resource Conservation and Recovery Act (Pub. L. 94-580) next spring, or under 'SCA Eection 8(a) (2) during subsequent phases of reporting. Moreover the provisions of TSCA sections 8(e), 8(d), and 8(e)

are applicable to byproducts and the Agency

will use the authorities of TSCA sections 4. 6, and 7 to prevent and reduce any unreasonable risks posed by byproducts.

Comment 53: The definition of byproduct

in the March 9. 1977, proposal is confusing.

Chemical substances formed as a result of

secondary chemical reactions. Including thos

that occur uoon end-use or In storage, are

not "byproducts."

Response: EPA recognizes that the definition of byproduct In the March 9 proposal was confusing. The August 2 proposal and

these final regulations (§ 710.2(g)) have re- defined "byproduct" to include only those

chemical substances produced without Fepa- rate commercial intent during the mnnufacture or processing of other chemical substances or mixtures.

The legislative history of TSCA makes

clear that these secondary chemical substances are not to be subject to the Inventory

and premanufacture notification require- ments because they are not manufactured

for commercial purposes per se. S. Rep. No.

9t-98, 94th Cong. 2d Ses. 19 (1976). Accordingly, section 710A (d) (2) of these regulations excludes these substances from these

recuirements.

Comment 54: Should slags which have

some commercial value and that are byproducts in the manufacture of another substance be reported for the Inventory?

Response: Sactlon 710.4(d) (2) of these

regulations provides that byproducts that

have come specific kinds of commercial value

may be reported for the inventory, although

there Is no requirement that they be so reported. Byproducts that have no commercial value may not be reported for the Inventory.

Comment 55: Persons who extract component chemical substances from byproducts

should not be required to report those chemical substanccs.

Response: The Administrator agrees with

this comment. Persons who recover chemical

substances from byproducts of the manufacture or processing of other chemical substances, mixtures, or articles would be processors of the chemical substances and need

not report for the Inventory. There Is no

requirement that these persons report any

chemical substance which is extracted or

separated from a byproduct, Including by

means of heat or a chemical reaction, if the

chemical substance that Is recovered Is

actually present in the byproduct or was an

intermediate used in the manufacture of

the byproduct, and If also, to the best of

the knowledge of the person recovering the

substance, the manufacturer of the substance Is reporting the substance for inclusion on the inventory.

Articles

Comment 56: Can articles be reported for

the Inventory?

Response: Articles as defined at § 7102(f)

will not be included on the inventory. The

inventory is a list of chemical substances

manufactured or processed for a commercial

purpose in the United States. Chemical substances of which articles are comprised can.,

however, be reported for the inventory.

Comment 57: What are the reporting requirement3 with respect to manufactured

Items containing fluids or particles?

Response: The definitlon of "article" at

1710.2 excludes fluids and particles regardless of shape or design. Accordingly, all fluids

and particles will either be a "mixture" or

"chemical substance" for the purposes of

TSCA. Any fluid or particle which is a chemical substance should be reported for the inventory. See also response to comment 21.

Comment 58: The definition of "article"

should be modified to include products such

as films and batteries which undergo chemIcal changes during their end uses.

Response: The Administrator agrees with

this comment and has amended clause 3 of

the definition to include within the meaning of "article" a manufactured item "which

either has no change of chemical composttIQn during Its end-use or only those changes

In composition which have no commercial

purpose separate from the article of which

It is a part and that may occur as described in 1710.4(d)(5)." The provision In

1710A is an exclusion for chemical substances which are the result of reactions

that may occur upon end-use of other chemical substances, mixtures, or articles. Under

this revised approach, batteries, photographic

films, matches, flares, ablative nose cones,

brake linings, and other such products are

considered "articles.'

Comment 59: Fibers, filaments, and whiskers should be considered articles.

Response: As defined in 1 7102(f), fibrous

materials may be considered articles If (1)

their end-use functions depend in whole or

FEDERAL REGISTER, VOL 42, NO. 247--FRIDAY, DECEMBER 23, 1977

6M57

HeinOnline -- 42 Fed. Reg. 64587 1977
64588

in part upon their shape or design and (2)

they are functional in their end-use without a change of chemical composition except for changes that have no commercial

purpose separate from the articles of which

they are a part. If a person shapes a chemical

sub tance Into a filament or fiber, he would

be a processor of that substance. The chemical substance -would be reportable by the

manufacturer. The filament or fiber or whisker would be an article and could not be

reported. However, if that fibrous material

was Intended to be used as an intermediate

in the manufacture of another chemical

substance, it would not be considered an article. It would be considered a chemical

substance (or mixture). Particles are not articles whether they are round or asymmetric. If a whisker or other fibrous mate- rial may be used as a particle in its subsequent processing, It would not be considered

an article.

'Comment 60: Chemical substances used in

the finishing process of an article should not

be excluded from the inventory. Dyes and

fire retardants are two examples of substances which should be reported.

Response: The Administrator agrees with

this comment. There has been some confusion over the intent of the exclusion in

1710.6(d) (6) of these regulations. The ex- clusion is for chemical substances that are

not manufactured for distribution In commerce as chemical substances per so and

have no commercial purpose separate from

the mixture or article of which they may

bepart.

Dyes and fire retardants are chemical substances, manufactured for distribution in commerce as chemical substances, and there-.

fore do have a separate commercial purpose. These substances should be reporter,

by their manufacturers for inclusion on the

inventory. The exclusion in § 710.4(d) (6) is

for chemical substances formed when the

dye or fire retardant reacts with fibers of a garment or other article upon end-use of

those substandes by a processor. These reac- tion products must not be reported.

Impurities

Comment 61: Chemical substances should

be listed on the inventory with respect to their Impurities.

Response: The Administrator disagrees

with this comment. The Agency has detPrmined that as a matter of policy, this

first inventory should not distinguish among

chemical substances which are identical ex- cept with respect to their impurities. The

Agency recognizes the potential hazards of some Impurities and intends to use the alternative authorities of sections 4, 6, 7, and

8 to prevent and reduce any unreasonable

risks posed by impurities. In addition, in

the future EPA may revise the inventory to

take impurities of a chemical substance

into account.

CHEMICAL SUBSTANCES INCLUDED IN THE

INVENTORY

Comment 62: Since customer demand runs

In cycles, some provision should be made to allow companies to report chemical substances which they manufactured for a commercial purpose more than three years ago

and plan to produce again.

Response. The Administrator agrees in part

with this comment. Section 8(b) of TSCA

provides that a chemical substance may not

be included on the Inventory if it was not manufactured or processed within three years

before the effective date of these regulations.

Accordingly, § 710.3(a) (3) (i) of these regulations, provides that if a person manufactured a substance for a commercial purpose

before January 1, 1975, he may still report

RULES AND REGULATIONS

the substance for the inventory if he certifies that the substance was processed after

January 1, 1975. If a manufacturer neither

manufactured a chemical substance nor can

certify that the substance was processed

within the past three years, he may not report the substance for the inventory, even If

he plans to produce It again in the future.

If the substance is not reported for the inventory by the manufacturer or by another

manufacturer or processor, manufacturers

will have to submit premanufacture notification on the substance 90 days before manufacturing it again.

Comment 63: Manufactures should be

able to report chemical substances manufactured since July 1, 1974, as provided in

the March 9, 1977, proposal.

Response: The Administrator disagrees

with this comment. The July 1, 1974, date was included in the March 9, 1977, proposal on the assumption that final Inventory

reporting rules would be prondulgated by

July 1977. Section 8(b) of TSCA clearly provides that the inventory may not include any

chemical substance which was not manufactured or processed within 3 years of the effective date of these rules. As discussed in response to comment 62, a manufacturer may

report a substance for the Inventory if it was manufactured before January 1, 1975, so long

as it was processed after January 1, 1975.

Test Marketing

Comment 64: The Administrator has no

authority to exclude chemical substances

presently undergoing test marketing from the

Initial inventory.

Response: Any chemical substance which

is manufactured or imported for test mar- keting purposes Is eligible for inclusion on

the inventory. This is made clear by the definition of the term "manufacture or import

'for commercial purposes' 1 at § 710.2(p). Af- ter the effective date of the premanufacture

notification requirements of section 5(a) (1)

(A), a manufacturer may not test market a new chemical substance without first either

providing the premanufacture notification

required by that section or obtaining an exemption from the requirement under section 5(h) (1) of the Act.

Comment 85: The critical factor in distinguishing the "development phase" of a

product from its "test marketing" phase is

that the latter phase contemplates a sale. The

word "sale" must be ncluded in the definition of "test marketing" because accepted

and ordinary usage of the phrase Involves the

sale of a product under practical competitive

conditions.

Response: The Administrator does not agree with this comment. Sale of a product

does not always distinguish its development

phase from its test marketing phase. The

Congress itself recognized that "the fact that

the other industrial user may pay the costs

for the substance does not necessarily signal

the end of the development period." H.R.

Rep. No. 94-1341, 94th Cong, 2d Sess. 30

(1976).

For the purposes of these regulations, re- search and development activity will be

differentiated from test-marketing primarily

by the greater degree of control maintained

by the manufacturer and the greater technical qualifications of those handling and

supervising the use of the substance during

the research and development phase. Distribution of the product during the test marketing phase generally removes the product,

its use, and its disposal from the direct

supervision of the manufacturer. (See response to comments 43-51.)

Comment 66: EPA should place restrictions on both the population and geography which

may be'exposed to products In test marketing and should require labeling of products to Indicate potential hazards.

Response: The Administrator has authority under section 5(h) (1) to impose sueh

restrictions on test marketing of a chemical substance as are necessary prior to exempting the chemical from the premanufacture, notification requirements. In addition,

the Administrator will use the authorities of

sections 4. 6, and 7 of the Act to prevent

unreasonable risks to man and the environment.

Intermediates

Comment 67: The term "Intermediate"

should exclude intermediates that are merely

"isolatable", and are never encountered In

the environment. The Identification of these

intermediates will often require highly

trained chemists and will significantly Increase the costs of complying with the reporting requirements.

Response: The Adnlnistrator agrees with

this comment and the definition of "Intermediate" at § 710.2(n) has been amended

accordingly. Chemical substances which are

not removed from the equipment in which

they are manufactured are not considered

"Intermediates" for the purposes of there

regulations and are excluded from the Inventory by § 710.5(d) (8). EPA will require notification under section 5 for any chemical

substance which is not on the Inventory and

which, after the date of the premanufacturo

notification requirements, Is Isolated, or Intentionally removed from the equipment in

which It was manufactured. A manufacturer

may, however, apply for an exemption from

this requirement under section 5 (h) (5) If the

intermediate exists temporarily and there Lq

no, and will not be any, human or environ-

.mental exposure. Chemical substances eXcluded from the Inventory by § 710.4(d) (8)

are considered to be manufactured or processed for a commercial purpose for the purposes of section 8 of the Act.

Comment 68: The definition of "intermediate" In the March 9, 1977 proposed regulations is more descriptive of an "impurity."

An "Intermediate" should refer to a chemical substance that is both created and

totally consumed during the chemical reaction process. This description would provide a meaningful distinction between an

"intermediate." a "byproduct," and tm

"impurity."

Response: The Administrator agrees In

part with this comment and has substantially revised the definition of "intermediate." The purpose of the definitions under

these regulations is tO clarify which chemical substances are Included and which arc

excluded from the Inventory. The Administrator does not agree that the term "Intermediate" should be restricted to chemical

substances that are totally consumed in

chemical reaction processes. A chemical substance may be an intermediate and also appear later as a byproduct or ao an impurity.

In such circumstances, the substance should

bL reported for the Inventory,

Under these definitions, the essential difference between a byproduct and an Intermediate Is that the Intermediate is consumed, in whole or In part, In a chemical

reaction used for the Intentional manufacture of other chemical substances, or Is intentionally present for the purpose of altering the rate of such reaction(s). A byproduct may be formed and then consumed in

whole or In part during the reaction squence but is not an "ntermediate" unless

it Is consumed in whole or In part in chemical reactions used for the intentional manufacture of other chemical substance3 or Is

Intended to alter the rate of such reactions.

Impurities are defined as chemical substances which are unintentionally present

with another chemical substance, While intermediates often appear as trace impurities

in a final product, they are In general disFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64588 1977
RULES AND REGULATIONS

tinguished from impurities in that they serve an intentional purpose In a reaction

sequence. Comment 69: Chain transfer agents or

cross linking agents used in the manufacture of polymers should be considered intermediates.

Response: The Administrator agrees with

this comment, Cross linking agents and

chain transfer agents which are used in the

manufacture of polymers are considered to be processed for commercial purposes and

should be included on the inventory. The

processor who buys such substances for use

In the manufacture of polymers need not

report such substances. However, he should

ensure that the substances are included on the initial inventory or report these substances during the special reporting period

for the revised inventory.

Section 710.5(c) requires listing In the

description of a polymer at least those mon- omers used at greater than two percent (by

weight) in the manufacture of the polymer.

In a similar fashion, a manufacturer would

list, as part of the polymer description, those

cross linking, chain transfer and other reactive agents which are present at greater

than two percent (by weight) in the manufacture of the polymer. Additives such as

plasticizers and emulsifiers which are only

entrained in the polymer are considered to

be components of a mixture and should not be considered to be components of the polymer. See response to comments 77-82 on

reporting of polymers.

Comment 70: In the manufacture of poly- mers, there are literally thousands of intermediates deliberately present in the reaction

sequence. The process may be interrupted,

occasionally, for examination and testing, at which point chemically reacted substances

are removed. Such substances should not be

considered "intermediates" for the purposes

-of these regulations and should not be re- ported for the inventory.

I Response: The Administrator agrees, In

part, with this comment. If a chemical substance satisfies the definition of "Intermediate" at § 710.2(n) of these regulations, for

the purposes of these regulations, it Is an

intermediate. However, an intermediate may

also fall within the exclusion from these

regulations at § 710.4(c) (3) for "small quantitles for research and development." If an "intermediate" is a "small quantity for research and development" it is excluded from

the inventory. Hence the removal of small

quantities of a chemical substance from the

equipment in-whlch it was manufactured

does not make that chemical substance a reportable "intermediate" if the amount removed is used solely for testing or research

purposes described In § 710.2(y).

Comment 71: The inclusion of "intentionally present catalysts" under the definition of

intermediates in the March 9 proposal is

confusing.

Response: The Administrator agrees With

this comment and has revised the term "intermediate" at § 710.2(n) to include "any

chemical substance which is intentially pres- ent for the purpose of altering the rate of

(such) chemical reaction(s) ." This definition

of the term "intermediate" is consistent with common usage. It considers "catalysts" as "intermediates".

Naturally Occurring Substances,

Comment 72: Which of the following sub- stances would be considered "naturally oc- curring substances." and therefore be excluded from the reporting requirements:

natural latex; "natural rubber"; enzymes;

and calcinateid clays?

Response: The natural latex obtained from

certain trees is considered a naturally oc- curring substance. However, the "natural

rubber" which is formed after chemical coagulants are added to the latex would not be considered in the category of "naturally

occurring substances". Thus. Importers of

"natural rubber" must report under these

regulations. Enzymes are not included In this

category unless they were extracted from nature only by the means described in 1 710.4

(b). And, calcinated clays which are formed

by heating naturally occurring clay are not

Included In this category because such beating is not done solely to remove water.

Comment 73: The category of "naturally

occurring substances" should be expanded to include those substances which are extracte from other naturally occurring substances using any solvent. not Just water.

Response: The Administrator disagrees

with this comment. EPA has decided that

the category should contain only those substances which are removed from nature es- sentially by natural means. Using water to

extract a chemical substance from a nat- urally occurring substance Is considered a

natural means of removal. Using other sol- vents is not considered a natural means of

removal.

Comment 74: The category for naturally

occurring substances should include substances that are processed by electrostatic means.

Response: The Administrator agrees with

this comment. In an electrostatic ceparation.

small particles are removed from a liquid or gas stream. The process I- e.sentially

analogous to a filtration or gravitational

separation. Substances which are procesed

by this means fall within the naturally occurring substances category.

Comment 75: How does EPA intend to regulate naturally occurring chemical substances which may be harmful?

Response: The Agency will use the authorities contained in sectlon 8(a) of the statute to require reporting on a celective

basis from manufacturers and processors of

naturally occurring chemical substances. In

addition, the Agency will use the authorities

of sections 4. 6. and 7 of TSCA to Identify and

regulate any unreasonable risks to health or the environment presented by naturally occurring' chemical substances.

INVNTORY RiEPOaro PnCEDWUIES

Comment 76: EPA should form a group

which can help Industry answer speciflc questions concerning illing out the reporting

forms. Responses should be available within

10 days and signed by an authorized Individual.

Response: The Office of Industry Assistance in the Office of Toxic Substances and

the staffs of the Agency's Regional offices will

be prepared to answer specific questions concerning the inventory reporting requirements. EPA will make every effort to respond

to inquiries as quickly as posible.

Reporting of Polymers

Comment 77: Polymers should be required to be identified with respect to their constituent monomers present at grediter than

two percent with the option of reporting

these monomers present at less than two percent. All monomers used In the manufacture

of the polymer should be reported for the

Inventory.

' Response: The Administrator agrees with

this comment. Section 710.5(d) of the regulations is written to accomplish this result.

Comment 78: Some commenters argued

that polymers should be required to be Identified with respect to the constituent mono- mers present at greater than five percent.

Other commenters argued that every constituent monomer of a polymer should be

reported.

Response: The Administrator disagrees

with these commehts. In the Interest of haying an inventory that accurately reflects the

identities of the polymers In commerce. EPA

felt that requiring reporting of only these

constituent monomers present at five percent or greater would be unsatisfactory. On

the other hand, since every monomer must

be identified on the inventory even though

not reported as part of a. specific polymer,

EPA did not believe it was essential to require reporting of each polymer with respect

to all of Its constituent monomers. Moreover. EPA recognizes important advantages

in requiring manufacturers of polymers to

identify only those monomers present at two

percent or more.

First, the principal Identities of many

polymers that might have been claimed to be

confidential If required to be fully disclosed

will be included on the Inventory. Further.

It Is sometimes difficult to distinguish what

chemical substances present at less than two

percent in a polymer would be appropriately

considered a reportable monomer or merely

an Impurity. Finally, small variations among

polymers due to minor process changes, for

example, will not be subject to premanufaclure notiication provided; the polymer dces

not contain a new chemical substance.

EPA recognizes that for the purpose of

evaluating potential toxicity, the proposed

description of polymers Is Insufhclent EPA

intends to obtain detailed information with

respect to specific claszes of polymers under

section 8(a). In addition, EPA will consider

po=sible refinement of description of polymers for purposes of the Inventory in the

future. However, because potential toxicity

may be dependent on properties such as

rolubillty molecular weight distribution, and

crystallinity, it is unlikely that even with

further revisions, the listing of monomers

would be sufficient to indicate the relative

potential toxicity of the polymers.

Finally these regulations do not exempt

from the inventory any chemical substance

which Is manufactured for commercial purposes as a monomer, regardless of its percentage use in the manufacture of polymers.

Additives which are not intended to be part

of polymeric chemical substances should not

be reported as part of the description of

polymers, but should be included separately

on the inventory as chemical substances.

Comment 79: Some numerical molecular

weight should be determined for purposes

of distinguishing reactive and relatively nonreactive polymers and copolymers. Above a

certain specified molecular weight, relatively

non-reactive polymers should not be listed

individually, but only the monomers that

comprise these polymers in various combinations should be listed. Below that weght.

each polymer or copolymer should be listed

separately with respect to its constituent

monomers. Response: The Administrator believes that

such an approach should be investigatedWhile it Is not feasible to adopt such an approach for the present Inventory, EPA may

revise the Inventory accordingly once an appropriate test method is adopted to ensure

consistency in measuring polymer weights.

Comment 80: Any, chemical substance

known as a polymer should be excluded from

the inventory, provided that each constituent

monomer and precursor chemical Is reported.

Response: The Administrator does not

agree with the proposal to exclude reporting

of all polymers. EPA does recognize, however,

that non-volatile or Inert polymers above

scme particular average molecular weight

could perhaps be handled differently. As

mentioned In response to comment 79 above,

EPA intends to investigate distinguishing

.polymers on. the basis of their average molecular weight and possibly modifying the

inventory in the future.

Comment 81: How should the weight of a

monomer be calculated and what is meant

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

6,4589

HeinOnline -- 42 Fed. Reg. 64589 1977
61590

by a monomer present at a certain "weight

percent" of a polymer?

Response For purpose of the inventory

reporting requirements, the percent (by

weight) of a monomer is the weight of the

monomer charged into the reactor and not

the weight incorporated into the polymer.

The weight of the monomer should be expressed as a percentage of the weight of the

polymeric chemical substance manufactured.

Comment 82 If a polymer listed on the

inventory contains five monomers, for example, a new polymer with four of those

five monomers should not be considered a

"new chemical substance" for the purposes

of section 5(a) (1) (A).

Response: The Administrator disagrees

with thit comment. If someone created a

polymer that contained fifty different monomers which were added in insignificant

quantities merely to include them, as part

of that reported polymer, a manufacturer

could then create thousands of polymeric

combinations based on those fifty monomers

without reporting them for the inventory or

submitting premanufacture notification.

Irmentory Reporting Forms

Comment 83: All forms should begin with

a certification to the effect that "to the best

of my knowledge and belief. I certify

that .

Response: The Administrator agrees with

this comment and has modified the forms

accordingly.

Comment 84: It should not be necessary

to report both chemical names and Chemical Abstracts Service (CAS) numbers on

Form B.

Response: The reason that EPA requires a

manufacturer to report both a chemical

name and the Chemical Abstract Service

Registry number on Form B is to ensure

that a manufacturer has reported correctly.

If EPA required only reporting of the sevendigit CA$ numbers, EPA would have no

means to check whether a manufacturer

correctly reported that number.

Commr t 85: It should be possible to fill

out all forms on computer print-out or tape.

Response: Manufacturers may report

chemical substances that have cAs registry

numbers by computer print-out or tape.

Instructions for reportine in this manner are

included in the instruction booklet accompanying the formn.

I Comment 86: The instructions for reporting should make clear that complex, undefined chemical substances may be reported

by describing the reaction process used to

manufacture the substances.

Response: EPA recognizes that if is often

difficult to describe complex reaction products whose composition is, variable or unknown. Many of these substances are commonly described by generic terms such as coal

tar, shellac, or vegetable extracts. For purposes of the inventory, manufacturers

should report as specifically as possible.

using generic terms and a description of the

method used ,in the final reaction sequence

to produce the reported: substunce. EPA will

publish detailed instructions in "Reporting

for the TSCA Inventory."

CommeOnt 67: Form D is an excellent Idea

which will be very useful for processors and

other; who buy trademarked chemicals

who , composition is unknown to them. It

should be updated frequently.

Response: EPA encourages manufacturers

who report for the initial inventory to inelude on Form D the trademarks, whether

registere'd or not, by which chemical substances reported for the inventory ar

known. A manufacturer may report a trademark. for a product which is a chemical

Pubstance, a mixture or an article containing a chemical substance. As provided In-the

RULES AND REGULATIONS

instructions to Fomn D. a manufacturer who

chooses to report,.must certify that all the

chemical substances which comprise the

trademarked product have been reported for

the inventory, either by him or by someone

else.

EPA recognizes that processors and users of

chemical substances do not always know the

identities of the substances they purchase

and thus, may have difficulty determining

whether or not the chemical substances they

purchase are included on the inventory

Processors could individually request suppliers to certify that the substances they sell

are included on the inventory. The Agencr

hopes to ease this burden somewhat by proriding manufacturers who sell their products

under a trademark an opportunity to certify

that the chemical substances contained in

the particular trademarked product have

been reported for the inventory. Any false

certification would subject a manufacturer to

criminal penalties under 18 U.S.C. 1001.

The usefulness of the trademark list is.

however. limited. EPA recognizes that the

composition of any particular trademark

product may vary over time. Further, the

Agency is not now requiring manufacturers

who choose to report their trademarks to link

the product name with specific chemical substances. Accordingly. the Agency will not be

able to verify the accuracy of the trademark

list.

Bemuse of the limited utility of the trademark list, the Agency does not now Intend to

update it. The list is designed, to assist processors and users in reporting for the revised

inventory. The Agency will be studying the

continuing problem presented by the fact

that persons in the chemical industry do not

always know the identity of the substances

they purchase.

WHEN TO REPORT

Comment 88: MLantufacturers and processors

need more than 90 days to report all the information required by thesa regulations.

Response: The Administrator agrees with

this comment. Section 710.6(a) provides manufasturers and Importers until May I, 1978 to

report for the initial inventory. Section 710.6

(c) provides processors and users of chemical

substances 210 days to report for the revised

inventory. The Agency encourages persons reporting for the inventory to sta'mor their

submissions throughout the reporting period

so that they can be processed in a timely

manner.

Comment 89: A manufacturer should be

able to add new chemicals to the inventory

any time prior to the start of premanufacture

notification.

Response: The Administrator agrees with

this comment. Section 710.6(b) provides this

authority. A manufacturer or importer of a

chemical substance in bulk may report a new

chemical substance until 30 days after publicalion of the initial inventory. An importer of

, chemical substance as part of a mixture or

article may report a new chemical substance

for the inventory until 30 days after publication of the revised inventory.

Comment 90: Anufacturers and importers

of chemical substances should be allowed to

report for the revised Inventory. Premanufacture notification should not begin until after

publication of the revised inventory.

Response:- The Administrator disagrees

with this comment. Postponement of promanufacture notification until after publication of the revised inventory would delay

the effectiveness of this provision of the Act

for an unacceptable period of time. The revised inventory may not be published until

November 1979 or later.

Comment 91' Thd Administrator should

provide by regulation that failure to report

for Inclusion in the inventory for "good

cause" will not subject the manufa cturer to

the premanufaoture notification requlroments of section 5 (a) (1) (A)

Response: The Administrator disagrec

with this comment. Such a provision is not

appropriate for these Inventory reporting

regulations, EPA doe3 recoonlzo, however,

that given the large volume of information

that is to be compiled and transmitted, It I

inevitable that there may be some clerical or

technical errors made in reporting chemical

substances for the inventory, Accordinrly.

the note at 9 710.1(b) of these regulations

provides that as a matter of traditional

Agency policy, EPA does not intend to concentrate its enforcement efforts on Insignificant clerical errors in reporting. instead.

EPA will give priority to bringing enforcement actions against persons who (1) report

false information, (2) report for Inclusion on

the inventory chemical substance3 Which are

excluded under § 710.4(c) of theze retulations, (3) fall to report, or (4) fail to maintain records documenting reported Information.

Comment 92: In asessing any penalty on

a manufacturer, the impa.cts on procezors

and users of the chemical substance(s)

should be considered.

Response: The Administrator agrems with

this comment. Section 16(R) (2) (B) of th

Act provides that in assejsing any penalty

the Administrator must tahe Into account

several factors. In assessing a civil penalty

against a manufacturer, the Administrator

as a matter of policy will consider the effoot

of the action on permous who prom-.:J and mae

that chemical substance.

CONVIDENTVLArrv

identity o/ Chemical Substanc

Comment 93: Some chemical Identittca are

entitled to confidential treatment f0 purposes of the TSOA inventory. Any ubmitter

should be allowed to claim that any chemnocal identity is confidential for the Inventory.

Response: The Administrator agriec With

this comment. The general approach EPA

will take to confidentiality of specific chemlcal Identities for purposes of the inventory

is set out in the preamble and 9 710.7 of

these regulations. In choosing this approch

EPA had to balance the competing concerns

of section 14 and seotons 8(a) and 5(b).

The reasons for taking thiG approach follow,

The inventory is a list of chemical hubstances manufactured (including lmported)

or proczssed for a commercial purpoe, Mtny

chemical substances have been doveloped

and synthesized for which no commorcial

purpose has been found. The fact that someone has found a commercial purpose for t

particular chemical substance may be a confidential trade secret. Placement of the

specific chemical Identity on the Inventory

would announce that fact to potential competitors who might be able to narrow their

research activities. Thi3 problem would ho

further compounded If the chemical substance were newly synthesized and known

only to the person reporting It to EPA or If

the substance were patentable, in which

case inclusion on the Inventory might constitute a publication and limit the pergon's

patent rights.

Were there no requirement in section 8(b)

of TSCA to publish a list of chemical substances manufactured and processed for

commercial purpose, there Is no doubt that

the fact that certain substances are manufactured or processed for commercial purposes would be confidential under traditional

trade secrets law and case law under the

Freedqm of Information Act fourth eiemption (5 U.S.C. 652(b) (4)). Section 14(a) of

TSOA states that any information reported

to EPA under TSCA that is exempt from

disclosure under 5 U.S.C. 552(b) (4) may not

FEORAL REGISTER, VOL 42; NO. 247--4RIDAY, DECEMBER 23, 1977

HeinOnline -- 42 Fed. Reg. 64590 1977
RULES AND REGULATIONS

be disclosed except In five situations specfied& in section 14 (a) and (b). Standing

alone section 14 would, accordingly, seem to

require that EPA not disclose the fact that a particular chemical substance is manufactured or processed for commercial purposes

if that fact would be exempt from disclosure

under 5 U.S.C. 552(b) (4). However, section

14 is part of a larger statutory scheme In

TSCA.

Section 8(b) requires EPA to publish a list

of 'each chemical substance which is manu- factured or processed in the United States.

Such list shall include each chemical sub- stance which any person reports, under section 5 or subsection (a) of this section. is

manufactured or processed in the United

States" (emphasis added). The Inventory Is

intended to inform the public which chemical substances are being manufactured or processed in the United States for commer- cial purposes. With this knowledge, the public would know the chemical substances to

which they may be exposed and would be

able to take an active participatory role in

EPA actions under TSCA. This s clearly

contemplated in sections 20 and 21 of TSCA

that provide for citizens' civil actions and

citizens' petitions. The inventory also has a regulatory purpose. It defines what is a "new

chemical substance" for purposes of section

5(a) (1)(A). A "new chemical substance" is

any substance that is not included In the

inventory. If a chemical substance s a new chemical substance no person may manufacture it without first submitting to EPA a

90-day premanufacture notice, during which

time the person may not manufacture the new chemical substance. If EPA has promulgated a testing rule under section 4 of TSCA,

the delay period before manufacture might

be significantly extended.

Were there no section 14 requirement in

TSCA, EPA would publish a list of all chemical substances manufactured or processed

in the United States for commercial purposes without provision for claiming confidentiality. The public would know all chemical substances to which It may be exposed

and would be able to participate fully under sections 20 and 21 of TSCA. Any person

proposing td manufacture a chemical substance'would be able to look at the inventory and determine whether the chemical

substance .was an existing chemical substance with a commercial purpose. If the

substance appeared on the list, there would

be no premanufacture-notiflcation requirements under section 5(a) (1) (A). If the sub- stance did not appear on the list, the person

would know.jt was a "new chemical substance." The Agency could conduct its investigation of all chemical substances in

open public forums. However, were EPA to

publish all chemical substances reported to EPA on the inventory, some persons submitting the inf~rmation would suffer com- petitive harm when the fact that certain

chemical substances have a commercial purpose was published.

Were EPA to give full effect to section 14

and publish a list of only those chemical

substances for which the fact of manufacture or processing for commercial purposes was not confidential, the public would have no information about those particular confidential chemical substances to which it

may be exposed. The Agency would have to conduct its investigation of some chemical

substances fn camera..A manufacturer proposing to manufacture a chemical substance

that did not appear on the list would not

know whether the substance was a new chemical substance. Therefore, the manu- facturer would be forced to give premanufacture notification under section 5(a) (1)

(A). If, in fact, the chemical substance had

been reported for the inventory list, and,

therefore, was not a new chemical substance,

this new manufacturer would be placed at

a competitive disadvantage by having to delay manufacture at least 90 days.

EPA has adopted the approach set out In

§ 710.7 of these regulations to balance the

concerns of section 14 with those of sections

8(b) and 5(a). In choosing this approach.

EPA looked to TSCA for guidance. It Is

clear that Congress intended section 5(a)

(1) (A) premanufacture notification to apply only to chemical substances which are

not currently manufactured for a commercial purpose. Congress created the section

8(b) Inventory for the express purpose of

determining this class of chemical substances. Congress did not seem to contemplate

that the fact that certain chemical substances are manufactured or processed for

commercial purposes would be claimed as confidential. Congress was clear In section

*14 that confidentiality should be preserved

to the maximum extent practicable without

Impairing the regulatbry scheme of TSCA.

The approach EPA has adopted preserves

confidentiality to the maximum extent practicable while allowing the section 8(b) inventory to perform Its regulatory function

for purposes of section 5(a) (1) (A), premanufacture notification.

EPA will allow any manufacturer or processor submitting information to EPA under

this rule to claim that a particular chemical

substance should not be included on the

inventory of chemical substances because

the fact that the chemical substance s man- ufactured or processed for commercial purposes in the United States is a confidential

trade secret. EPA will make a final confidentiality determination in accordance with the

procedures in 40 CFR Part 2, Subpart B, If

the fact that a particular chemical substance is manufactured or processed for a

commercial purpose in the United States iconfidential, a generic chemical name will be

included in an appendix to the Inventory; if

It Is not confidential, after 30 days notice to

the submitter, the chemical Identity w1il be

included on the inventory. If any pe Mon re- ports a particular Identity and does not

claim It as confidential EPA will place the

Identity on the Inventory.

Section 710.7(e) provides that a person

claiming confidentiality for the specific

chemical identity must provide a proposed

generic chemical name to EPA. The proposed

generic name must be only as generic as necessary to protect the identity of the particular

chemical substance. Pursuant to I 710.7(f),

EPA will review the proposed generic name. If the proposed generic name Is not acceptable to EPA, EPA will consult with the submitter concerning alternative names. EPA

may choose a name proposed by the submitter or a name proposed by EPA. In the

latter case, EPA will notify the submitter 30

days in advance of publishing the final

choice, during which time the submitter may

seek a judicial remedy.

Placement of the generic name In the appendix to the inventory will cerve two purposes. First, the public will know the generic

types of confidential chemical substances to

which It may be exposed. The public will

be able to use this knowledge to participate

In accordance with sections 20 and 21. Second, a manufacturer who is proposing to manufacture a substance not Included on

the inventory by name will be able to see

whether the substance Is described by one of the generic names. If It is not, It Is a "new

chemical substance," and the manufacturer

must submit notices under section 5(a) (1)

(A) at least 90 days prior to manufacture. If

the substance does fall within one of the

generic names, the manufacturer could come

to EPA. show a tona fide intent to manufac- ture the substance, and be Informed whether

the specific proposed substance was Included

on the Inventory. If It was, the manufacturer would be able to begin manufacture

without delay. If It was not, it would be a

"new chemical substance," and the manufacturer would have to submit notice under

section 5 at least 90 days prior to manufacture. No person may manufacture a substance within a generic name unless EPA has

notified the person that the particular substance is included in the Inventory.

To determine whether or not such a man- ufacturer has a bona fide intent to manufacture the proposed chemical substance, EPA

will require the manufacturer to submit a

statement of pretent Intent to manufacture

the particular chemical substance, including

a description of the research and development

activities to date and the purpose of manufacture. In addition. EPA will require an elemental analysis, either an X-ray diffraction

pattern of the substance (for inorganic substances) or a mass or alternative spectrum of

the substance (for other substances), and

any additional spectra or data. Including a

sample of the substance in its purest form,

that may be retlulred to resolve uncertainties

with respect to the identity of the substance.

At the time such an Inquiry is received, EPA

will contact the original submitter and ask

for an elemental analysis and either a mass or

alternative spectrum or an X-ray diffractio

pattern of the substance. Further, additional

spectra or data may be required to resolve uncertainties with respect to the identity of the

substance. EPA may require a. sample of the

substnce in Its purest form for compariso

with that submitted by the Inquiring manufacturer. Section 710.7(e) pro-Ades that any

peon aserting a claim of confidentiality

mut agree to make such information available to EPA upon request and mustagree that

EPA may disclose the fact that the specific

chemical substance is ncluded on the inventory to a manufacturer with a bona fide Intent to manufacture the substance. (Failure

to to aZree or to furnish requested data reEults in waiver of the claim of confIdentiality.)

If EPA determines that the manufacturer

has a bona fide Intent to manufacture the

substance, EPA will disclose whether the

substance In question is on the inventory.

EPA cientists will compare the technical

data submitted by the inquirer with that

prepared by the manufacturer of the confidential chemical substance to determine

whether the data from both Eources are sufficiently similar to be consistent with a presumption that the chemical substazces are

the came. If EPA determines that the mannfacturer'has not shown a tona fide intent to

manufacture the substance. EPA will not disclose whether the substance is on the Inventory. The manufacturer will then have the

choice of supplying further Information to

EPA to chow boa fide Intent to manufacturer

the substance or of submitting premanufacture notification under section 5(a) (1) (A).

This approach will place some burden on

manufacturers to come to EPA to show a

bona fide Intent to manufacture. However.

this burden s less than the burden of section 5(a) (1) (A) premanufacture notification.

Any manufacturer who does have a bona fide

Intent to manufacture a particular substance

should know the information required to

show that intent to EPA. This approach will

diccourage fishing expeditions by persons

without a bona fide intent to manufacture

and thereby protect trade secrets from disclosure to competitors. EPA dos not view

disclosure to a bona fide nianufacturer to

be a disclsure In violation of section 14.

The trade secret that I- being kept confidentl al is that the particular chemical substance is manufactured or precesed for

commercial purposes in the United States

by anyone. If the Inquiring manufacturer

shows a bona fide intent to manufacture the

particular substance, the manufacturer alFEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64591

HeinOnline -- 42 Fed. Reg. 64591 1977
RULES AND REGULATIONS

ready knows that it can be manufacture,

for a commercial purpose. Telling the man. ufacturer that the substance is on the in.

ventory does not reveal anything except tha' someone else already found a commerca purpose for the substance.

Maintaining specific chemical Identities a confidential for purposes of the Inventor,

has Impacts beyond those on sections 8(b]

and 5(a). It is conceivable that the Agence

will decide to direct a section 4 testing rub to a confidential chemical, that the Agencl

will decide to promulgate a section 5(a) (21

significant new use rule on a confidentisa

chemical, that the Agency will decide to pro. mulgate a section 8 reporting rule on a con. fidential chemical, and that proceedings un- der section 20 and 21 of the Act may pertair to confidential chemicals. The Agency intend, to honor the confidentiality of specific chemical identities to the extent practicable with- out Impairing the Agency's ability to perform

Its duties under TSCA. This means that EPA

may have to balance confidentiality with

other TSICA needs at future times under othez

rules. TSCA section 14 (a) and (b) directs

the Administrator to disclose information

otherwise entitled to confidential treatment in certain circumstances. The Agency intends to rely on these authorities to the fullest ex- tent provided by law.

A determination that an identity is confidential for purposes of the Inventory may be

reviewed if new facts suggest that confidential treatment is no longer appropriate.

Comment 94: Requiring substantiation at the time of submission of a claim that the

Identity of a chemical substance should not be placyd on the Inventory is overly burden- some. Such substantiation should only be re- quired when necessary to respond to a Freedom of Information Act request.

Response: The Administrator disagrees

with this comment. The requirement in

TSCA section 8(b) that the Agency publish an inventory of chemical substances re- quires the Agency to make individual final

determinations on the entitlement of the

identity of a particular chemical substance to confidential treatment under the test of

5 U.S.C. 552(b) (4) before publication of the

initial Inventory. Under the procedures of

40 CFR Part 2, Subpart B, this determination is made on- the basis of the substantiation of that claim provided by the person

asserting the claim. In order for EPA to re- view, prior to publication of the initial inventory. IIl claims that the identity of a chemical tubstance is entitled to trade se- cret protection, substantiation of the claim must b: submitted when the claim is as- serted. Failure to submit substantiation of

such a claim will be a waiver of the claim.

Comment 95: The statements for sub.

stantiating a claim for confidentiality on proposed Form C are too restrictive. A com- pany must be allowed to state for Itself the

basis of its claim of confidentiality.

Response: The Administrator agrees with

this comment. Any submiltter claiming that

the identity of a particular chemical sub- stance should not be included on the inventory must substantiate that claim. The

substantiation must be in the form of a let- ter attached to Form C stating the submitter's basis for Its claim of confidentiality, and

addressing a list of questions specified in the

Form C instructions. The burden for substantiating a 'claim that the particular

chemical identity should not appear in the

inventory is greater than that for substantiating other confidentiality claims under the

Inventory because of the increased burden

that will be placed on the public and future

manufacturers under section 5(a), Ir not knowing all of the specific chemical IdentiI ties reported for the inventory. Accordingly

- companies should be very careful in claimIng that specific identities- are entitled tc

confidential treatment.

I Comment 96: EPA should accept the gethe generic chemical name is too broad oi

s misleading request the submitter to modify

7 the generic name. EPA should not substitute

I its judgment. EPA should not substitute it,

y judgment for that of the submitter.

Response: The Administrator disagrees

with this comment. Submitters will have an

interest in submitting the broadest generic

L names possible. Since- EPA is balancing competing considerations of confidentiality, the

public's right to know, and the Interests of

manufacturers under section 5(a), EPA must

take an active role in choosing a generic name

that Is only generic enough to protect the

trade secret identity.

If EPA agrees with the generic chemical

name proposed by the submitter and the

chemical identity has been found to be confidential for purposes of the inventory. EPA

will place the proposed generic name in an

appendix to the inventory. If EPA believes

that the generic name Is too general so that

It will not serve the purpose of Informing

the public and future manufacturers under

section 5(a). EPA will consult with the submitter concerning more restrictive names. If

EPA and the submitter are unable to agree on

the generic name. EPA will choose a generic

name, notify the'submitter of the choice at

least 30 days before inclusion on the inventory. The submitter may seek a judicial

remedy under section 14. Unless a court Intervenes, after the end of the notice period,

EPA will place the generic name on the list.

Link of Company Name to Chemical Identity

Comment 97: The fact that a certain company manufactures a particular chemical

substance-may be a confidential trade secret.

EPA should not publish company names on

the inventory.

Response: The Administrator agrees with

this comment. Section 710.7(a) permits a manufacturer, importer, or processor to claim

that the link between the name of the manufacture. Importer, or processor with a particular chemical substance Is entitled to con- fidential treatment. The-8(b) Inventory will

consist only of a list of chemical substances

reported to EPA. It will not include any information concerning which companies re- ported the chemical substances. A claim that a particular chemical Identity should not appear on the inventory (see comment 92)

should not be made if the only confidential

trade secret is the link between the company name and chemical identity.

If a claim of confidentiality is asserted re- garding the link of company name with a particular chemical substance, it will be disclosed by EPA only to the extent permitted by, and by means of the procedures set forth

In 40 CFR Part 2, Subpart B.

Production data

Comment 98: Site specific production data

may be a confidential trade secret. Response: Section 710.7(a) recognizes that

production data may be entitled to con- fidential treatment and permits persons re- porting production volumes to the Agency to assert a claim of confidentiality. Section

710.5(d) (4). of these final regulations re- quires companies to report broad production

ranges, rather than the more specific production volumes which would have been required

by the August 2, 1977 propbsed rules. This

should eliminate the need for many claims

of confidentiality.

Comment 99: Does EPA plan to publish

asgregates of data from the inventory, espe- cially confidential data? If so. in what way

will EPA protect the confidential data?

* Response: EPA is considering alternative

W ays of publishing aggregates of production

and other data submitted for chemical substances. However, before EPA publishes any

- aggregation that includes data that have

r been claimed as confidential. EPA will develop

aggregation procedures designed to protect

P the confidentiality of the underlying data

and will publish these procedure for public

comment.

National Security Information

Comment 100: Some Information requirel

by these regulations may be entitled to confidential treatment because of national security reasons. How will EPA handle =turtions of confidentiality on these groundg?

Response: Section 22 of TSCA states that

EPA "shall waive compliance with any provision of this Act upon a request and dotermInation by the President that the requested

waiver is necessary In the interest of national defense." The President has, not requested that any walver be granted with regard to the Inventory regulations. Accordingly, any person subject to the reporting requirements of these regulations must report

any substance subject to these regulationm

even if that substance is being made for

national defense purposes. Production for

national defense purposes is a commercial

purpose as defined In these regulations, Any

person reporting under these regullItlons

must report all information required to be

reported concerning sites, production, etc.,

regardless of whether that informatlon relates to national defense.

If a person required to report under these

regulations would be reporting information

that iS or may be classified as national defense information under Executive Order

11652, that person should not report to CAB

Instead, the person must contact Kenneth

Olsen, Office of Toxic Substances. EPA. 401,

M Street, SW., Washington, D.C. 20460, by

letter stating that the person may be required to report classified information to

EPA under these regulations. Do not

report the classified Information to EPA

at that time. EPA will tend the person a letter with specific instructions how

to proceed. This will include forwarding the

information to the particular Systems program office that is managing the particular

work. involved. The systems program office

will examine the specific Information and

mark It with the appropriate classification,

The information will then be sent to EPA

where it Will be kept in a special system

senarate from the remainder of the inventory

Information. EPA will have art office with

personnel authorized to receive and use classified Information.

Please note, if the information in question

is also considered to be confidential business

information by the person submitting it, that

person must assert all claims of business confidentiality at the time the information is

submitted to EPA In accordance with these

regulations and the Instructions on the

forms.

Freedc;m of Information Requests

Comment 101: How will EPA handle Freedom of Information Act requests for the

confidential Information submitted under

these regulations?

Response: EPA will allow submitters to

claim any item of information submitted to

EPA under this rule as confidential. The re- porting forms are designed to allow all con- fidentiality claims to be made by checking

boxes on the forms. In addition, the certification statement has been, written to allow a submitter to substantiate all claims of

confidentiality, except chemical identity, on the reporting form. By using this approach,

EPA intends to minimize the need to go back

• FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64592

HeinOnline -- 42 Fed. Reg. 64592 1977
to specific submitters to require them to substatlate confidentiality claims. This will enable EPA to deal more effectively with the

anticipated large volume of Freedom of Information Act requests that will be received

under TSCA. .

All information submitted under these

rules will be computerized. All confidential

information (except confidential Identities)

wil be specially coded If a claim of confidentiality vs made and substantiated at

the time of submission.

When EPA receives FOIS requests, EPA wi

prepare a computer print out of the nonconfidential information requested; that Information will be disclosed to the requester.

The computer will then print out the requepted confidential information. The requester will receive an initial denial of the

request for any confidential Information in

accordancedwith the procedures In 40 CFR

Part 2, Subpart B. EPA wi then make a

final confidentiality determination, inform

the requester of the decision, give 30 days

notice to the submitter if the -determination

is that the Information is not entitled to

confidential treatment, and then disclose any

non-confidential information.

EPA will not have computer access capability until at least 6 to 8 months after the

end of the initial reporting period. During

that period the Agency will be processing

submitted information. The actual forms

submitted to EPA will not be filed in a retrievable form. If EPA receives FOIA requests

prior to the end of the processing period it

will be virtually impossible to search for the

requested Information. Consequently, EPA

requests that FOIA requesters refrain from

making FOTA requests for inventory information until the end of the processing period.

In some cases, whien responding to FOIA

requests. EPA will be forced to give uninformative denials.If a requester asks a question in such a way that t6 answer the request

would reveal confidential information. EPA

will answer the request in the following

fashion: "Your request Is denied either because the records you request are entftled to

confidential treatment under 5 U.S.C. 552(b)

(4) and EPA may not disclose them under

section 14 of TSCA, or because no such records exist.' The requester will have a final

EPA denial and will be able to go to a Federal district court to seek further review. Whe

-confidential information will be protected,

pending this review.

Confidentiality Procedures and Security

- Comment 102: How will EPA determine

the entitlement of information to confidential treatment; what procedures will it follow

to ensure that confidential information is

not disclosed?

- Response: The Agency's business confidentiality regulations are contained at 40

CPR Part 2, Subpart B. These regulations

will be amended to take into account specific

modifications required by TSCA section 14.

such as the extension of the notice period to

30 days. The basic approach for determining

confidentiality will not change.

EPA has estabillhed a Task Force to recommend procedures to the Administrator to

provide for the security of confidential Information submitted to EPA under TSCA.

The Task Force will work quickly so that EPA

will have procedures adopted by April 30,

1978. the end of the inventory reporting period. The Task Force will hold several public

-neetings and will publish proposals for publice, comment. The final security procedures

will be published. A more detailed discussion

of the work of the Task Force appeared in

RULES AND REGULATIONS

the FlEDEum E mxs-, 42 FR 57984, November 7.1977.

Access to Confldentt l Information by States

Comment 103: EPA should allow access to

confidential Information by the states.

Response: EPA does not have generar au-

.thority to disclose confident'l TECA Information to. the States. Section 14(a) lists

the parties to whom confidential information may be disclosed. In certain circumstances, EPA may discloce confidential In64593

formation to other Federal agencies, to CA

contractors, when relevant to a proceeding

under TSCA. or when necesary to protect

health or the environment against an unreasonable risk of injury. Accordnglb confidentlal information may only be disclosed

to a. State If the State is an EPA contractor,

if the State Is a party to a TSCA proceeding,

of when ne esary to protect health or the

environment from an unreasonable ris of

Injury.

IMPORTANTg &&o_ n" N b i i. . .M " IU.S. ENVIRONMENTAL PROTECTION AGENCY

CHEMICAL SUISTANCI INVENTORY REPORT (S$,.1 I id m (hi Ted S.e Cmh A€ I SC 2M72'

FORM lA j . w .. . sm.

M

uL 

lll .r.U l acra. m,, 

l _ .. + .. ... _______________________ 

................. W. lICPA&TNCt OTAcYtS)

| ................... _ ..... I

i , ~ ...-..................... ', , .I.........

alMA WMMIL I

V. TSCA cAN~DATE LST CHJEMICAL 3UISIANCtrLlr$ ADOOISONAL SU31AMCES ON C1431PARAT F*ASI

EPA ,CASREGSTRY CODE 0 -

NUMIS DESIGNATION .

Z Iwt 0flNMlte~ W?*I - ..

2 2

44

Ila

2 2

2 1

7 7

L99

Is Is:

21121

226

FEDEiAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

i

Ilwwdllll i m

HeinOnline -- 42 Fed. Reg. 64593 1977
64594 RULES AND REGULATIONS

IMOR T

NTa 10.f.,m. -,.

U. S. ENVIRONMENTAL PROTECTION AGENCY

CHEMICAL SUBSTANCE INVENTORY REPORT

(section a(.) nd (hi Texc SA4 0m n Cntr. Act 13 USC 2607)

'IN. .*o o. cOPMvo K, *

IlL PANTSITEND. */AnDRSSS IV. PlNCtPALIrM NIcMCACONACT(5I

A I ...............

| .. .. . . .. ... .. .. ..

C Y ................. ....... I StAt L x o " ...... . ........... I z,

N U M B E R * - q q J 4 a4 t i 2p

EPA lf

*CC.MP*Tb.

1. 00. - - -

z

z z

z

u

r NUMBERt - .C6N . a 0.

EPA I COPY

FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977

---Ap. "M

FORM

I B

I 1 roll III. m I.I! I I I -r/1

HeinOnline -- 42 Fed. Reg. 64594 1977
RULES AND REGULATIONS

IMPRTNT .Ie* & 4 wA3J,Sa l,. 

U. S. ENVIRONMENTAL PROTECTION AGENCY

CHEMICAL SUBSTANCE INVENTORY REPORT

(SecdI4h 9(4) sad (b) T.', Swbdom Cmft4 Ad 13 USC 2&Mr1

--- a

FORM

C L. aIPnr~ 5T!MNSI.v 'rr* . 5,h.4d. 4J.W ~ t .. , .U hr S 

ft-5.&S--

.In i- c .... 'I. . . . .

L'.e" .. . . . . . ...............

| " r . " -. . . . . . . . . . . . . . . .. . |

i.& ... n I ," ,L.. DIMSN~a POI• •

UA USA 4

CI')

"1.1

SITE UKTTED

Z;~g

u

u z

NUMBER

2 -.

.

ZU -6

.4

FEDERAL REGISTER, VOL 42, NO. 247-FRIDAY, DECEMBER 23, 1977

64595

I-- I

0 000 00

HeinOnline -- 42 Fed. Reg. 64595 1977
RULES AND REGULATIONS

IMPORTANT: I .. SdVmln Iq A" .lmb.."d h" w ... M ...AW. d A. w~ WA rd .&k-i.. Ow 2 t.p.. - A. k. A. " .d.C

e b

U.S. ENVIRONMENTAL. PROTECTON AGENCY

VOLUNTARY PRODUCT TRADEMARK REPORT (IM €OJUNCTION WITH T10 TOXIC SUSTAb4U CONROIK ACT INITORVi WlPeWt1l

FORM

D- LCE1ITwT ".ON 1TIHH.IS.i V A. .. - ~ WP4b. . . 9~. . U...D .-..

s .............. ............, M.2 PAt4C5.'AL TENACNAO

I ..... ...... I

rr I ............ .......... I STAT I ov' "IL.-.-.-.-.-.-.-.-.......... IV "j

C00OA 2T CUM . ... WAUSTaT O.

IV. L1t3 OF PRODUCT TRADEMARKS

PRODUCT TRArJEMAI-S (NAMES) PRODUCT TRADEMARKCS (NAMES)

I 21 _____________________9

2 2 201 3

3 3 3113

4 4 321 32

S 3S 2313

12i _________________0___ i|2 

16 6 113 1 , ,

14 104 32is

I1I I|. I , "I, - 9

16 ____1___________$4______

17 ______,_________________-_

i1 47

Lo 20 I 484

1 21 91 49

22 221501 so

22 231511s

4 224 2

25 25 $31fi

26 2 1 S4

27 ______________7____________ 55

21 - 2. 361 36

[FR Doc.77-36420 Filed 12-19-77;9:41 am]

FEDERAL REGISTER, VOL. 42, NO. 247--FRIDAY, DECEMBER 23, 1977

64596

.......... . .......... II II ,*_ evvmul ;4 (c'nt ql l

App.9-

PAIDI . .

t , HO, w; l.-a4l I

HeinOnline -- 42 Fed. Reg. 64596 1977