Benzidine-Based Chemical Substances; Proposed Significant New Uses of Certain Chemical Substances

ly marked confidential business information (CBI). If CBI

is claimed, three additional sanitized copies must also be submitted.

Nonconfidential versions of comments on this proposed rule will be

placed in the rulemaking record and will be available for public

inspection. Comments should include the docket control number. The

docket control number for this proposed SNUR is OPPTS-50617. Unit XI.

of this preamble contains additional information on submitting comments

containing CBI.

Comments and data may also be submitted electronically by sending

electronic mail (e-mail) to: [email protected]. Electronic comments

must be submitted as an ASCII file avoiding the use of special

characters and any form of encryption. Comments and data will also be

accepted on disks in WordPerfect in 5.1 file format or ASCII file

format. All comments and data in electronic form must be identified by

the docket number OPPTS-50617. No CBI should be submitted through e-

mail. Electronic comments on this proposed rule may be filed online at

many Federal Depository Libraries. Additional information on electronic

submissions can be found in Unit XII. of this preamble.

The discussion of EPA's risk management strategy in Unit V. of this

proposed rule is included only to provide context for this SNUR, and

comments are not solicited for this unit.

FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,

Environmental Assistance Division (7408), Office of Pollution

Prevention and Toxic Substances, Environmental Protection Agency, 401 M

St., SW., Rm. E-545, Washington, DC 20460, Telephone: (202) 554-1404,

TDD: (202) 554-0551, e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: The final version of this proposed SNUR

would require persons to notify EPA at least 90 days before commencing

the

onmental Assistance Division (7408), Office of Pollution

Prevention and Toxic Substances, Environmental Protection Agency, 401 M

St., SW., Rm. E-545, Washington, DC 20460, Telephone: (202) 554-1404,

TDD: (202) 554-0551, e-mail: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: The final version of this proposed SNUR

would require persons to notify EPA at least 90 days before commencing

the

manufacture, import, or processing of the benzidine-based chemical

substances listed in this proposed rule for any use other than those

listed in proposed Sec. 721.1660 of the regulatory text. These excepted

uses are: As a reagent to test for hydrogen peroxide in milk, as a

reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine,

as a stain in microscopy, and as a reagent for detecting blood. The

required notice would provide EPA with information needed to evaluate

this use and associated activities, and an opportunity to protect

against potentially adverse exposure to the chemical substances before

it can occur.

I. Authority

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to

determine that a use of a chemical substance is a ``significant new

use.'' The Agency must make this determination by rule after

considering all relevant factors, including those listed in section

5(a)(2). Section 5(a)(2) factors generally relate to the extent to

which a use changes the volume of a chemical substance's production or

the type, form, magnitude, or duration of exposure to it. Once EPA

determines that a use of a chemical substance is a significant new use,

section 5(a)(1)(B) of TSCA requires persons to submit a significant new

use notice (SNUN) to EPA at least 90 days before they manufacture,

import, or process the chemical substance for that use (15 U.S.C.

2604(a)(1)(B))

chemical substance's production or

the type, form, magnitude, or duration of exposure to it. Once EPA

determines that a use of a chemical substance is a significant new use,

section 5(a)(1)(B) of TSCA requires persons to submit a significant new

use notice (SNUN) to EPA at least 90 days before they manufacture,

import, or process the chemical substance for that use (15 U.S.C.

2604(a)(1)(B)).

Persons subject to the final version of this proposed SNUR would

comply with the same notice requirements and EPA regulatory procedures

as submitters of premanufacture notices (PMNs) under section 5(a)(1)(A)

of TSCA (15 U.S.C. 2604 (a)(1)(A)). In particular, these requirements

include the information submission requirements of TSCA section 5(b)

and (d)(1), the exemptions authorized by TSCA section 5(h)(1), (2),

(3), and (5), and the regulations at 40 CFR part 720. EPA may take

regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the

activities for which it has received a SNUN (15 U.S.C. 2604 (e), (f),

2605, and 2606). If EPA does not take action, section 5(g) of TSCA

requires EPA to explain in the Federal Register its reasons for not

taking action.

Persons who intend to export a chemical substance identified in a

proposed or final SNUR are subject to the export notification

provisions of TSCA section 12(b) (15 U.S.C. 2611(b)). The regulations

that interpret section 12(b) appear at 40 CFR part 707. Persons who

intend to import a chemical substance identified in a final SNUR are

subject to the TSCA section 13 import certification requirements, and

to the regulations codified at 19 CFR 12.118 through 12.127 and 12.128.

Such persons must certify that they are in compliance with the SNUR

requirements. The EPA policy in support of import certification appears

at 40 CFR part 707.

II. Applicability of General Provisions

a chemical substance identified in a final SNUR are

subject to the TSCA section 13 import certification requirements, and

to the regulations codified at 19 CFR 12.118 through 12.127 and 12.128.

Such persons must certify that they are in compliance with the SNUR

requirements. The EPA policy in support of import certification appears

at 40 CFR part 707.

II. Applicability of General Provisions

General regulatory provisions applicable to SNURs are codified at

40 CFR part 721, subpart A. In the Federal Register of August 17, 1988

(53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR part 700)

under the authority of TSCA section 26(b) (U.S.C. 2625(b)). Provisions

requiring persons submitting SNUNs to submit certain fees to EPA are

discussed in detail in that Federal Register document. Interested

persons should refer to the CFR and the cited Federal Register document

for further information.

III. Summary of This Proposed Rule

The chemical substances that are the subjects of this proposed SNUR

are benzidine-based chemical substances, which shall be defined as any

chemical substances that are listed in Table 1. of proposed

Sec. 721.1660(b) of the regulatory text.

Because the listed benzidine-based chemical substances are

currently used only in small amounts in the following manners, any new

use would greatly increase exposure to these chemicals. Therefore, EPA

is proposing to designate any use of the listed benzidine-based

chemical substances as a significant new use, other than the following

uses: Use as a reagent to test for hydrogen peroxide in milk, a reagent

to test for hydrogen sulfate, hydrogen cyanide, and nicotine, a stain

in microscopy, and as a reagent for detecting blood. These are the only

uses of benzidine-based chemical substances identified by EPA as

ongoing

ny use of the listed benzidine-based

chemical substances as a significant new use, other than the following

uses: Use as a reagent to test for hydrogen peroxide in milk, a reagent

to test for hydrogen sulfate, hydrogen cyanide, and nicotine, a stain

in microscopy, and as a reagent for detecting blood. These are the only

uses of benzidine-based chemical substances identified by EPA as

ongoing.

This proposed rule would require persons who intend to manufacture,

import, or process benzidine or benzidine-based chemical substances

listed in this proposed rule to notify EPA, through the submission of a

SNUN, at least 90 days before commencing the manufacture, importation,

or processing of any of these chemicals for any use designated by this

SNUR as a significant new use. The required notice would provide EPA

with the opportunity to evaluate the intended use, and, if necessary,

to prohibit or limit that use before it occurs.

IV. Background Information on Benzidine-Based Chemical Substances

Based upon information on the carcinogenicity of benzidine and

benzidine-based dyes, the Agency is concerned for all the benzidine-

based chemical substances listed in this proposed rule. Because the

molecule benzidine can only be isolated for commerce or use in the form

of salts, the term ``benzidine'' shall refer to the molecule benzidine,

CAS No. 92-87-5, as well as all benzidine salts.

Benzidine is an aromatic amine that has been used as a feedstock

for production of man-made dyes since the late 1800's. Dyestuffs were

among the first products of the developing chemical industry, and

aromatic amines were the first synthetic chemicals found to cause

cancer in humans. This was first reported in the last century, when

some workers manufacturing dyes developed bladder cancer. Benzidine was

subsequently found to be a potent carcinogen in humans and animals

n of man-made dyes since the late 1800's. Dyestuffs were

among the first products of the developing chemical industry, and

aromatic amines were the first synthetic chemicals found to cause

cancer in humans. This was first reported in the last century, when

some workers manufacturing dyes developed bladder cancer. Benzidine was

subsequently found to be a potent carcinogen in humans and animals.

Several epidemiology studies of occupationally exposed workers have

demonstrated that benzidine exposure is associated with a high risk of

developing bladder cancer (Ref. 1). Benzidine is classified by the

International Agency for Research on Cancer (IARC) as a Group 1

carcinogen, chemicals which are known to cause cancer in humans and

animals (Ref. 2). Benzidine is also classified by the EPA as a Group A,

human carcinogen (IRIS, 1986).

Originally, only benzidine was considered to be carcinogenic.

However, studies found that dyes derived from benzidine release free

benzidine via metabolic routes (Ref. 3). The dyes were predicted to be

carcinogens based on these findings. Animal bioassays performed by the

National Cancer Institute (NCI) in 1978 confirmed that administration

of three different benzidine-based dyes each led to cancer (Ref. 4).

EPA's hazard analysis (Ref. 11) is based on studies of tested

representative benzidine-based dyes, as well as benzidine. The

overwhelming health concern for benzidine and benzidine-based dyes is

bladder cancer in humans, generally believed to be caused through any

route of exposure. As of June 1974, OSHA has required that manufacture

of benzidine be contained within a closed system (29 CFR 1910.1010:

Benzidine). In addition, the American Conference of Governmental

Industrial Hygienists (ACGIH) has classified benzidine as a

``recognized human carcinogen'' with no Threshold Limit Value (TLV)

assigned, and has recommended that

d to be caused through any

route of exposure. As of June 1974, OSHA has required that manufacture

of benzidine be contained within a closed system (29 CFR 1910.1010:

Benzidine). In addition, the American Conference of Governmental

Industrial Hygienists (ACGIH) has classified benzidine as a

``recognized human carcinogen'' with no Threshold Limit Value (TLV)

assigned, and has recommended that

``all exposure to benzidine should be kept to an absolute minimum''

(ACGIH 1986).

Twelve benzidine-based dyes have been demonstrated to metabolize to

benzidine in one or more of four species (Ref. 5). National Toxicology

Program (NTP) cancer bioassays by the oral route in rodents using

Direct Black 38 (CAS No. 1937-37-7), Direct Blue 6 (CAS No. 2602-46-2),

and Direct Brown 95 (CAS No. 16071-8-6), showed dose-related and

statistically significant tumor incidence of the liver, skin, and

Zymbal gland following oral administration. The time to tumor formation

was 5 to 13 weeks. No tumors were found in the controls (Ref. 4). In

response to these and other data, the National Institute for

Occupational Safety and Health (NIOSH) and NCI have jointly recommended

that these three dyes be handled in the workplace as if they were human

carcinogens, and have suggested guidelines for minimizing employee

exposure (Ref. 6).

Bioavailability studies in Rhesus monkeys, rats, and dogs revealed

levels of benzidine in the urine, after the administration of the

above-mentioned dyes, equivalent to the levels found after

administration of a comparable volume of straight benzidine (Refs. 3

and 5). For this reason, IARC has classified these benzidine-based dyes

as Group 2A chemicals, which are carcinogenic to animals and probably

carcinogenic to humans (Refs. 1, 6, and 7). Given the consistent

results from testing these dyes, as well as known mechanistic

similarities among benzidine-based dyes, the entire class of benzidine-

based dyes is expected to have a similar degree of toxicity

5). For this reason, IARC has classified these benzidine-based dyes

as Group 2A chemicals, which are carcinogenic to animals and probably

carcinogenic to humans (Refs. 1, 6, and 7). Given the consistent

results from testing these dyes, as well as known mechanistic

similarities among benzidine-based dyes, the entire class of benzidine-

based dyes is expected to have a similar degree of toxicity. In

addition, NIOSH has recommended that all benzidine-based dyes be

recognized as potential human carcinogens, based upon the evaluation of

information on the carcinogenicity and metabolism of these dyes (Ref.

8).

There are exposure issues for both the parent amines and the

finished dyes. Most available exposure data are for groups of dyes,

rather than for individuals. Inhalation, skin absorption, and ingestion

are possible routes of exposure in a variety of settings where

benzidine-based dyes are either manufactured or used. Benzidine and

monoacetyl benzidine, a metabolite, have been found in the urine of

workers making or using benzidine-based dyes in the paper, textile,

leather, and dye manufacturing industries (NIOSH, 1980). The amount of

benzidine found in the urine was more than could be accounted for by

only benzidine impurities in the dyes.

Based on models from EPA (Chemical Engineering Branch/Office of

Pollution Prevention and Toxics) and industry, reasonable exposure

estimates have been calculated for those workers who weigh powder dyes.

From these estimates, EPA predicts the highest exposure would occur for

workers who would manufacture benzidine-based dyes or who would weigh

such dyes, and is also concerned about potential exposures to workers

who would operate dyeing machinery (Ref. 9).

V. EPA's Risk Management Strategy for Benzidine-Based and Benzidine

Congener-Based Dyes and Pigments

those workers who weigh powder dyes.

From these estimates, EPA predicts the highest exposure would occur for

workers who would manufacture benzidine-based dyes or who would weigh

such dyes, and is also concerned about potential exposures to workers

who would operate dyeing machinery (Ref. 9).

V. EPA's Risk Management Strategy for Benzidine-Based and Benzidine

Congener-Based Dyes and Pigments

Comments are not solicited for this unit, as it is included only to

provide context for this proposed SNUR.

This proposed SNUR is the first step in EPA's risk management

strategy for benzidine-based and benzidine congener-based dyes and

pigments.

The main objective of EPA's strategy is to reduce the risks

associated with the manufacture and use of benzidine-based and

benzidine congener-based dyes and pigments. Benzidine and benzidine-

based dyes have been phased out of commerce. The SNUR being proposed in

this document is intended to prevent the reintroduction of these

chemicals into commerce without prior notice to EPA, thus achieving

EPA's objective for these substances.

In order to complete the main objective in regards to benzidine

congener-based dyes, EPA is conducting a series of dialogues with dye

manufacturers, users, and importers, as well as labor unions,

environmental groups, and other agencies. EPA is also working with the

Organization for Economic Cooperation and Development (OECD) to

coordinate efforts internationally in dealing with these chemicals.

EPA will attempt to develop a series of Memoranda of Understanding

(MOUs) with dye manufacturers and importers to address the risk from

manufacture and use of benzidine congener-based dyes, which include

tolidine-based and nonmetallized dianisidine-based dyes. The Agency has

developed alternative strategies, in case voluntary agreements cannot

be reached. After the conclusion of these efforts, the Agency may

address metallized dianisidine-based dyes and benzidine congener-based

pigments

and importers to address the risk from

manufacture and use of benzidine congener-based dyes, which include

tolidine-based and nonmetallized dianisidine-based dyes. The Agency has

developed alternative strategies, in case voluntary agreements cannot

be reached. After the conclusion of these efforts, the Agency may

address metallized dianisidine-based dyes and benzidine congener-based

pigments. The MOUs are projected for completion during the next year.

VI. Objectives and Rationale for the Proposed Rule

To determine what would constitute a significant new use of

benzidine-based chemical substances, EPA considered relevant

information regarding the toxicity of the substances, likely exposure

and releases associated with potential uses, and the four factors

listed in TSCA section 5(a)(2). Benzidine has an IARC classification as

a Group 1 carcinogen, which are chemicals known to cause cancer in

humans and animals. IARC has also classified several benzidine-based

dyes as Group 2A chemicals, which are carcinogenic to animals and

probably carcinogenic to humans. The benzidine-based dyes that have not

been tested are suspected carcinogens.

The EPA has determined that there is no ongoing manufacture,

import, or processing of the listed benzidine-based chemical

substances, except for use in small amounts as a reagent to test for

hydrogen peroxide in milk, as a reagent to test for hydrogen sulfate,

hydrogen cyanide, and nicotine, as a stain in microscopy, and as a

reagent for detecting blood. Therefore, any use of these benzidine-

based chemical substances, except for those uses listed above, would

increase the volume of the chemicals' production as well as the type,

form, magnitude, or duration of exposure, and therefore can be

identified as a significant new use (Ref. 10).

Based on these considerations, EPA wishes to achieve the following

objectives with regard to the significant new uses that are designated

in this proposed rule. EPA wants to ensure that:

se uses listed above, would

increase the volume of the chemicals' production as well as the type,

form, magnitude, or duration of exposure, and therefore can be

identified as a significant new use (Ref. 10).

Based on these considerations, EPA wishes to achieve the following

objectives with regard to the significant new uses that are designated

in this proposed rule. EPA wants to ensure that:

(1) The Agency would receive notice of any company's intent to

manufacture, import, or process benzidine-based chemical substances

listed in this proposed rule for the significant new uses identified in

this proposed rule, before that activity begins.

(2) The Agency would have an opportunity to review and evaluate

data submitted in a SNUN before the notice submitter begins

manufacturing, importing, or processing the listed benzidine-based

chemical substances for the significant new uses identified in this

proposed rule.

(3) The Agency would be able to regulate prospective manufacturers,

importers, or processors of the listed benzidine-based chemical

substances before any significant new use occurs, provided that the

degree of potential health risk is sufficient to warrant such

regulation.

The benzidine-based chemical substances listed in this proposed

rule are not currently subject to any Federal regulations that require

notification of the Federal Government of activities that might result

in adverse exposures to

these substances and provide a regulatory mechanism that could

adequately protect human health or the environment from potentially

adverse exposure before it occurs.

For the preceding reasons, EPA is proposing to designate any use of

benzidine-based chemical substances listed in proposed Sec. 721.1660,

except for those uses listed in proposed Sec. 721.1660(a)(2) of the

regulatory text, as significant new uses.

VII. Alternatives

Before proposing this SNUR, EPA considered the following

alternative regulatory actions for the listed benzidine-based chemical

substances.

ding reasons, EPA is proposing to designate any use of

benzidine-based chemical substances listed in proposed Sec. 721.1660,

except for those uses listed in proposed Sec. 721.1660(a)(2) of the

regulatory text, as significant new uses.

VII. Alternatives

Before proposing this SNUR, EPA considered the following

alternative regulatory actions for the listed benzidine-based chemical

substances.

(1) Promulgate a TSCA section 8(a) reporting rule for these

chemical substances. Under such a rule, EPA could require any person to

report information to the Agency when they intend to manufacture,

import, or process the listed benzidine-based chemical substances, for

a significant new use as listed in this proposed rule (15 U.S.C. 2607).

However, in the case of these particular chemical substances, the use

of section 8(a) rather than SNUR authority would have several

drawbacks. First, EPA would not be able to take immediate follow-up

regulatory action under TSCA section 5(e) or 5(f) to prohibit or limit

the activity. In addition, EPA may not receive important information

from small businesses, because such firms are exempt from section 8(a)

reporting requirements. In view of the level of health concern for the

listed benzidine-based chemical substances, the Agency believes that a

section 8(a) rule for those chemical substances would not meet EPA's

regulatory objectives.

(2) Regulate benzidine-based chemical substances under section 6 of

TSCA. EPA may regulate under section 6 if there is a reasonable basis

to conclude that the manufacture, importation, processing, distribution

in commerce, use, or disposal of a chemical substance or mixture

``presents or will present'' an unreasonable risk of injury to human

health or the environment. A finding of unreasonable risk indicates a

determination that the reduction of health or environmental risk

resulting from a potential regulation outweighs the regulatory burden

to society

cture, importation, processing, distribution

in commerce, use, or disposal of a chemical substance or mixture

``presents or will present'' an unreasonable risk of injury to human

health or the environment. A finding of unreasonable risk indicates a

determination that the reduction of health or environmental risk

resulting from a potential regulation outweighs the regulatory burden

to society.

In the case of this proposed rule, EPA decided that a SNUR was more

appropriate than a section 6 rule because there are currently no

ongoing uses of concern to justify a section 6 ban. EPA's concerns are

for potential future uses, and the notification which would be required

by this proposed SNUR, when final, would be sufficient to allow the

Agency make the decisions necessary to protect against such uses.

VIII. Applicability of Proposed Rule to Uses Occurring Before

Effective Date of the Final Rule

EPA believes that the intent of section 5(a)(1)(B) is best served

by designating a use as a significant new use as of the proposal date

of the SNUR rather than as of the effective date of the final rule. If

uses begun during the proposal period of a SNUR were considered

ongoing, rather than new, as of the effective date, it would be

difficult for EPA to establish SNUR notice requirements, because any

person could defeat the SNUR by initiating the proposed significant new

use before the rule became final, arguing that the use was no longer

new.

Persons who begin commercial manufacture, importation, or

processing of the listed benzidine-based chemical substances for any

significant new use listed in this proposed rule between proposal and

the effective date of the SNUR must cease that activity before the

effective date of the rule. To resume their activities, these persons

would have to comply with all applicable SNUR notice requirements and

wait until the notice review period, including all extensions, expires

ted benzidine-based chemical substances for any

significant new use listed in this proposed rule between proposal and

the effective date of the SNUR must cease that activity before the

effective date of the rule. To resume their activities, these persons

would have to comply with all applicable SNUR notice requirements and

wait until the notice review period, including all extensions, expires.

If, however, persons who begin commercial manufacture, importation, or

processing of the chemical substances between proposal and the

effective date of the SNUR meet the conditions of advance compliance as

codified at Sec. 721.45(h), those persons will be considered to have

met the requirements of the final SNUR for those activities.

IX. Test Data and Other Information

EPA recognizes that under TSCA section 5, persons are not required

to develop any particular test data before submitting a SNUN. Rather,

persons are required only to submit test data in their possession or

control and to describe any other data known to or reasonably

ascertainable by them.

However, in view of the potential health risks that may be posed by

a significant new use of the listed benzidine-based chemical

substances, EPA suggests potential SNUR notice submitters conduct tests

that would permit a reasoned evaluation of risks posed by these

chemical substances when utilized for an intended use. EPA currently

believes that the results of the following tests could adequately

characterize possible health and environmental effects of the chemical

substances: Cancer bioassays, metabolism testing, and tests for

environmental fate and ecotoxicity. However, these studies may not be

the only means of identifying potential risks. SNUR notices submitted

without accompanying test data may increase the likelihood that EPA

would take action under TSCA section 5(e).

EPA encourages persons to consult with the Agency before selecting

a protocol for testing the chemical substances

bolism testing, and tests for

environmental fate and ecotoxicity. However, these studies may not be

the only means of identifying potential risks. SNUR notices submitted

without accompanying test data may increase the likelihood that EPA

would take action under TSCA section 5(e).

EPA encourages persons to consult with the Agency before selecting

a protocol for testing the chemical substances. As part of this

optional prenotice consultation, EPA will discuss the test data it

believes necessary to evaluate a significant new use of the chemical

substances. Test data should be developed according to TSCA Good

Laboratory Practice Standards at 40 CFR part 792. Failure to do so may

lead EPA to find such data to be insufficient to reasonably evaluate

the health or environmental effects of the chemical substances.

EPA urges SNUN submitters to provide detailed information on human

exposure or environmental release that may result from the significant

new use of the listed benzidine-based chemical substances. In addition,

EPA encourages persons to submit information on potential benefits of

the chemical substances and information on risks posed by the chemical

substances compared to risks posed by potential substitutes.

X. Economic Analysis

EPA has evaluated the potential costs of establishing SNUR

reporting requirements for benzidine-based chemical substances listed

in this proposed rule. While there is no precise way to calculate the

total annual cost of compliance with this proposed rule, EPA estimates

that the reporting cost for submitting a SNUN ranges from $7,198 to

$8,170, including a $2,500 user fee. EPA believes that there will be

few, if any, SNUNs submitted. Furthermore, while the expense of a

notice and the uncertainty of possible EPA regulation may discourage

certain innovations, that impact would be limited because such factors

are unlikely to discourage an innovation that has high potential value

cost for submitting a SNUN ranges from $7,198 to

$8,170, including a $2,500 user fee. EPA believes that there will be

few, if any, SNUNs submitted. Furthermore, while the expense of a

notice and the uncertainty of possible EPA regulation may discourage

certain innovations, that impact would be limited because such factors

are unlikely to discourage an innovation that has high potential value.

The Agency's economic analysis is available in the public record for

this proposed rule (OPPTS-50617).

XI. Comments Containing Confidential Business Information

All comments will be placed in the public record unless the

commenter claims that they contain CBI, and the comments are clearly

labeled as containing claimed CBI when they are submitted. Because of

the need to expedite this process, CBI claims should be accompanied by

comments substantiating the claim, as described in

40 CFR 2.204(e)(4). While a part of the record, CBI comments will be

treated in accordance with 40 CFR part 2. A sanitized version of all

CBI comments should be submitted to EPA, in triplicate, for the public

file.

It is the responsibility of the commenter to comply with 40 CFR

part 2 so that all materials claimed as confidential may be properly

protected. This includes, but is not limited to, clearly indicating on

the face of the comment (as well as on any associated correspondence)

that information claimed to be CBI is included, or marking

``Confidential,'' ``TSCA CBI,'' or similar designation on the face of

each document or attachment in the comment which contains the claimed

CBI. Comments not claimed as confidential at the time of submission or

not clearly labeled as containing CBI will be placed in the public

file. EPA will consider the failure to clearly identify the claimed

confidential status on the face of the comment as a waiver of any such

claim and will make such information available to the public without

further notice to the commenter or business.

XII. Rulemaking Record

laimed as confidential at the time of submission or

not clearly labeled as containing CBI will be placed in the public

file. EPA will consider the failure to clearly identify the claimed

confidential status on the face of the comment as a waiver of any such

claim and will make such information available to the public without

further notice to the commenter or business.

XII. Rulemaking Record

A record has been established for this rulemaking under docket

number OPPTS-50617 (including comments and data submitted

electronically as described below). The record includes basic

information considered by the Agency in developing the proposed rule.

A public version of this record, including printed, paper versions

of electronic comments, which does not include any information claimed

as CBI, is available for inspection from 12 noon to 4 p.m., Monday

through Friday, excluding legal holidays. The public record is located

in the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St.,

SW., Washington, DC 20460.

Electronic comments can be sent directly to EPA at:

[email protected]

Electronic comments must be submitted as an ASCII file avoiding the

use of special characters and any form of encryption.

The official record for this rulemaking, as well as the public

version, as described above will be kept in paper form. Accordingly,

EPA will transfer all comments received electronically into printed,

paper form as they are received and will place the paper copies in the

official rulemaking record which will also include all comments

submitted directly in writing. The official rulemaking record is the

paper record maintained at the address in ``ADDRESSES'' at the

beginning of this document.

EPA will accept additional materials for inclusion in the record at

any time between this proposal and designation of the complete record.

EPA will identify the complete rulemaking record by the date of

promulgation of the final rule

submitted directly in writing. The official rulemaking record is the

paper record maintained at the address in ``ADDRESSES'' at the

beginning of this document.

EPA will accept additional materials for inclusion in the record at

any time between this proposal and designation of the complete record.

EPA will identify the complete rulemaking record by the date of

promulgation of the final rule. A public version of this record

containing nonconfidential materials is available for reviewing and

copying from 12 noon to 4 p.m., Monday through Friday, except legal

holidays, in the TSCA Nonconfidential Information Center (NCIC),

located in Rm. E-G099, 401 M St., SW., Washington, DC.

XIII. References

(1) International Agency for Research on Cancer (IARC). IARC

Monographs 1982, 29,295-310, 311-330, 321-330).

(2) IARC Monographs, Supplement 7:123-125 (1987).

(3) Rinde, E. and Troll, W. ``Metabolic reduction of benzidine azo

dyes to benzidine in the rhesus monkey.'' Journal of the National

Cancer Institute 55: 181-182 (1975).

(4) National Cancer Institute (NCI). ``13-week subchronic toxicity

studies of Direct Black 38 and Direct Brown 95 dyes.'' NCI

Carcinogenesis. Technical Report Series Number 108. 127p (1978).

(5) Lynn, R.K. et al. ``Metabolism of bisazobiphenyl dyes derived

from benzidine, 3,3'-methylbenzidine and 3,3'-dimethoxybenzidine to

carcinogenic aromatic amines in the dog and rat.'' Toxicology and

Applied Pharmacology 56:248-258 (1980).

(6) NIOSH/NCI, Current Intelligence Bulletin, 24(1,5): 7-9 (1978).

(7) IARC Monographs, Supplement 7:125-126 (1987).

(8) NIOSH, Special Occupational Hazard Review for Benzidine-Based

Dyes (1980).

(9) USEPA. 1990a (April). U.S. Environmental Protection Agency.

Textile Dye Weighing Monitopring Study. EPA 560/5-90-009 and Supplement

560/5-90-010.

(10) USEPA. Regulatory Impact Branch, USEPA/OPPT,EETD, June 1,

1993. ``Production, Uses, and Imports of Benzidine and Benzidine Based

Chemicals.'' Prepared by Meridian Research, Inc.

Occupational Hazard Review for Benzidine-Based

Dyes (1980).

(9) USEPA. 1990a (April). U.S. Environmental Protection Agency.

Textile Dye Weighing Monitopring Study. EPA 560/5-90-009 and Supplement

560/5-90-010.

(10) USEPA. Regulatory Impact Branch, USEPA/OPPT,EETD, June 1,

1993. ``Production, Uses, and Imports of Benzidine and Benzidine Based

Chemicals.'' Prepared by Meridian Research, Inc.

(11) USEPA. Chemical Screening and Risk Assessment Division.

``Benzidine/Benzidine Congener Dyes Support Document, October 24, 1994.

XIV. Regulatory Assessment Requirements

A. Executive Order 12866

Under Executive Order 12866 (58 FR 51735, October 4, 1993), the

Agency must determine whether the regulatory action is ``significant''

and therefore subject to review by the Office of Management and Budget

(OMB) and the requirements of the Executive Order. Under section 3(f),

the order defines a ``significant regulatory action'' as an action

likely to result in a rule:

(1) Having an annual effect on the economy of $100 million or more,

or adversely and materially affecting a sector of the economy,

productivity, competition, jobs, the environment, public health or

safety, or State, local or tribal governments or communities (also

referred to as ``economically significant'').

(2) Creating serious inconsistency or otherwise interfering with an

action taken or planned by another agency.

(3) Materially altering the budgetary impacts of entitlement,

grants, user fees, or loan programs or the rights and obligations of

the recipient thereof.

ublic health or

safety, or State, local or tribal governments or communities (also

referred to as ``economically significant'').

(2) Creating serious inconsistency or otherwise interfering with an

action taken or planned by another agency.

(3) Materially altering the budgetary impacts of entitlement,

grants, user fees, or loan programs or the rights and obligations of

the recipient thereof.

(4) Raising novel legal or policy issues arising out of legal

mandates, the President's priorities, or the principles set forth in

this order.

Pursuant to the terms of this Executive Order, it has been

determined that this proposed rule is not ``significant'' and is

therefore not subject to OMB review.

B. Regulatory Flexibility Act

Under the Regulatory Flexibility Act (RFA) 5 U.S.C. 601-612, EPA is

required to consider whether a regulatory action will have an impact on

small entities. If the Administrator certifies that the rule, if

promulgated, will not have a significant economic impact on a

substantial number of small entities, then the RFA does not require the

EPA to prepare an initial regulatory flexibility analysis (5 U.S.C.

605(b)). Under EPA policy, however, when a proposed rule would have any

adverse economic impact on any number of small entities, then EPA will

conduct an initial regulatory flexibility analysis that contains an

appropriate level of detail. (Habicht, memorandum: Revised Guidelines

for Implementing the Regulatory Flexibility Act, EPA, Office of the

Administrator, April 9, 1992). EPA has determined that this proposed

rule would not have a significant impact on small businesses, but it

may have some, minimal, impact in the future.

Consequently, EPA has analyzed the impact of the proposed rule on

small entities based upon the criteria in the

emorandum: Revised Guidelines

for Implementing the Regulatory Flexibility Act, EPA, Office of the

Administrator, April 9, 1992). EPA has determined that this proposed

rule would not have a significant impact on small businesses, but it

may have some, minimal, impact in the future.

Consequently, EPA has analyzed the impact of the proposed rule on

small entities based upon the criteria in the

Regulatory Flexibility Act. In the SUMMARY unit of this preamble, EPA

describes reasons why it is considering taking the proposed action and

the objectives of, and legal basis for, the proposed SNUR. This SNUR

would apply to any small or large business that may wish to engage in

the significant new use described in the proposed rule. It appears that

no small or large businesses are currently engaged in activity that is

the subject of this proposed rule. Although there may be some small

businesses that may decide to conduct such activities in the future, it

is not possible at this time to determine for certain how many, if any,

there may be. Based upon past experiences, EPA expects to receive few,

if any, SNUNs from either small or large businesses in response to this

proposed SNUR. As of September 1992, the Agency had received no SNUNs

in response to any SNURs promulgated by EPA in the past. Unit XIV.C.

and the Economic Analysis to support this SNUR (docket number OPPTS-

50617) describe the reporting and other requirements of this proposed

rule and the costs of compliance. There are no existing Federal rules

that may duplicate, overlap, or conflict with this proposal. Finally

there are no significant alternatives to this proposed rule that

minimize economic impacts on small businesses and accomplish the

statutory objective of insuring that EPA has an opportunity to review

and evaluate the risks associated with a new use to determine whether

further regulatory activity is necessary.

C. Unfunded Mandate Reform Act

e, overlap, or conflict with this proposal. Finally

there are no significant alternatives to this proposed rule that

minimize economic impacts on small businesses and accomplish the

statutory objective of insuring that EPA has an opportunity to review

and evaluate the risks associated with a new use to determine whether

further regulatory activity is necessary.

C. Unfunded Mandate Reform Act

EPA has determined that this proposed rule does not contain

regulatory requirements that might significantly or uniquely affect

small governments and does not contain a Federal mandate that may

result in expenditures of $100 million or more for State, local, and

tribal governments, in the aggregate, or the private sector in any one

year. Thus this proposed rule is not subject to the requirements of

sections 202, 203, and 205 of the Unfunded Mandates Reform Act of 1995

(UMRA) (Public Law 104-4).

D. Paperwork Reduction Act

OMB has approved the information collection requirements contained

in this proposed rule under the provisions of the Paperwork Reduction

Act (44 U.S.C. 3501 et seq.) and has assigned OMB control number 2070-

0038. Public reporting burden for this collection of information is

estimated to vary from 94 to 113 hours per response, with an average of

103 hours per response, including time for reviewing instructions,

searching existing data sources, gathering and maintaining the data

needed, and completing and reviewing the collection of information.

Send comments regarding the burden estimate or any other aspect of

this collection of information, including suggestions for reducing this

burden, to Chief, Information Policy Branch (2131), U.S. Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office

of Information and Regulatory Affairs, Office of Management and Budget,

Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' The

final rule will respond to any OMB or public comments on the

information requirements contained in this proposal.

rden, to Chief, Information Policy Branch (2131), U.S. Environmental

Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office

of Information and Regulatory Affairs, Office of Management and Budget,

Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' The

final rule will respond to any OMB or public comments on the

information requirements contained in this proposal.

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals, Hazardous materials, Reporting

and rcordkeeping requirements, Significant new uses.

Dated: August 23, 1995.

Charles M. Auer,

Director, Chemical Control Division, Office of Pollution Prevention and

Toxics.

Therefore, it is proposed that 40 CFR part 721 be amended as

follows:

PART 721--[AMENDED]

1. The authority citation for part 721 would continue to read as

follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(e).

2. By adding new Sec. 721.1660 to subpart E to read as follows:

Sec. 721.1660 Benzidine-based chemical substances.

(a) Chemical substances and significant new uses subject to

reporting. (1) Benzidine-based chemical substances, which shall be

defined as any chemical substances that are listed in Table 1. under

paragraph (b) of this section, are subject to reporting under this

section for the significant new uses described in paragraph (a)(2) of

this section.

(2) The significant new uses are: Any use other than: As a reagent

to test for hydrogen peroxide in milk, as a reagent to test for

hydrogen sulfate, hydrogen cyanide, and nicotine, as a stain in

microscopy, and as a reagent for detecting blood.

aragraph (b) of this section, are subject to reporting under this

section for the significant new uses described in paragraph (a)(2) of

this section.

(2) The significant new uses are: Any use other than: As a reagent

to test for hydrogen peroxide in milk, as a reagent to test for

hydrogen sulfate, hydrogen cyanide, and nicotine, as a stain in

microscopy, and as a reagent for detecting blood.

(b) List of substances. The following Table 1. lists the benzidine-

based substances covered by this section.

Table 1.--Benzidine-based Chemical Substances

----------------------------------------------------------------------------------------------------------------

Chemical name C.I. Number CAS Number Chemical name C.I. Number CAS Number

----------------------------------------------------------------------------------------------------------------

Acid Red 85.......... 22245 3567-65-5 C.I. Direct Brown 190 31750 Unknown

Benzidine............ n/a 92-87-5 C.I. Direct Brown 215 35720 83606-72-8

Benzidine.Ni2+....... n/a 67632-50-2 C.I. Direct Green 7.. 30330 6360-64-1

Benzidine.HCL........ n/a 75752-15-7 C.I. Direct Green 8.. 30315 5422-17-3

Benzidine.2HCL....... n/a 531-85-1 C.I. Direct Green 9.. 30310 6360-62-9

Benzidine.2HF........ n/a 41766-73-8 C.I. Direct Green 10. 30285 6360-61-8

Benzidine.2HI........ n/a 75534-79-1 C.I. Direct Green 12. 30290 6486-55-1

Benzidine.HDAC....... n/a 52754-64-0 C.I. Direct Green 19. 30305 6486-58-4

C.I. Acid Black 66... 30275 6360-59-4 C.I. Direct Green 21. 31790 8003-52-9

C.I. Acid Black 69... 30260 6486-53-9 C.I. Direct Green 22. 31775 6860-33-4

C.I. Acid Black 70... 30355 8005-88-7 C.I. Direct Green 39. 30220 6360-57-2

C.I. Acid Black 94... 30336 6358-80-1 C.I. Direct Green 58. 30225 110735-26-7

C.I. Acid Red 323.... 22238 6358-34-5 C.I. Direct Green 60. 22315 6426-56-8

C.I. Brown 165....... 22045 6486-32-4 C.I. Direct Orange 25 22135 6486-43-7

C.I. Direct Black 11. 30240 6486-52-8 C.I. Direct Orange 2. 22380 8005-97-8

C.I. Direct Black 14. 30345 4656-30-8 C.I

0355 8005-88-7 C.I. Direct Green 39. 30220 6360-57-2

C.I. Acid Black 94... 30336 6358-80-1 C.I. Direct Green 58. 30225 110735-26-7

C.I. Acid Red 323.... 22238 6358-34-5 C.I. Direct Green 60. 22315 6426-56-8

C.I. Brown 165....... 22045 6486-32-4 C.I. Direct Orange 25 22135 6486-43-7

C.I. Direct Black 11. 30240 6486-52-8 C.I. Direct Orange 2. 22380 8005-97-8

C.I. Direct Black 14. 30345 4656-30-8 C.I. Direct Orange 33 22385 13190-99-3

C.I. Direct Black 15. 22620 6426-75-1 C.I. Direct Orange 43 22193 Unknown

C.I. Direct Black 27. 31810 6360-39-0 C.I. Direct Orange 22190 6528-39-8

102.

C.I. Direct Black 29. 22580 3626-23-1 C.I. Direct Red 10... 22145 2427-70-1

C.I. Direct Black 34. 35075 6473-08-1 C.I. Direct Red 13... 22155 1937-35-5

C.I. Direct Black 40. 31760 6449-81-6 C.I. Direct Red 17... 22150 2769-07-5

C.I. Direct Black 41. 30260 6486-53-9 C.I. Direct Red 18... 22280 6548-26-1

C.I. Direct Black 83. 31850 6837-80-5 C.I. Direct Red 29... 22305 6426-54-6

C.I. Direct Black 100 35415 6358-73-2 C.I. Direct Red 33... 22306 6253-15-2

C.I. Direct Black 131 30270 6486-54-0 C.I. Direct Red 42... 22180 6548-39-6

C.I. Direct Blue 11.. 30350 6451-04-3 C.I. Direct Red 43... 22205 6486-50-6

C.I. Direct Blue 16.. 22475 6426-66-0 C.I. Direct Red 44... 22500 2302-97-8

C.I. Direct Blue 19.. 22485 6426-68-2 C.I. Direct Red 52... 22290 6797-93-9

C.I. Direct Blue 38.. 30090 1324-83-0 C.I. Direct Red 53... 22405 6375-58-2

C.I. Direct Blue 42.. 22505 6426-71-7 C.I. Direct Red 59... 22420 6655-94-3

C.I. Direct Blue 43.. 30205 7273-59-8 C.I. Direct Red 60... 22200 6486-49-3

C.I. Direct Blue 48.. 22565 6459-89-8 C.I. Direct Red 74... 22170 8003-75-6

C.I. Direct Blue 49.. 22540 6426-73-9 C.I. Direct Red 84... 22360 6459-86-5

C.I. Direct Blue 51.. 30340 6360-65-2 C.I. Direct Violet 3. 22445 6507-83-1

C.I. Direct Blue 58.. 22490 6426-69-3 C.I. Direct Violet 4. 22555 6472-95-3

C.I. Direct Blue 64.. 22595 6426-74-0 C.I. Direct Violet 12 22550 2429-75-6

C.I. Direct Blue 131. 35085 6661-39-8 C.I. Direct Violet 17 22465 6426-65-4

C.I

22170 8003-75-6

C.I. Direct Blue 49.. 22540 6426-73-9 C.I. Direct Red 84... 22360 6459-86-5

C.I. Direct Blue 51.. 30340 6360-65-2 C.I. Direct Violet 3. 22445 6507-83-1

C.I. Direct Blue 58.. 22490 6426-69-3 C.I. Direct Violet 4. 22555 6472-95-3

C.I. Direct Blue 64.. 22595 6426-74-0 C.I. Direct Violet 12 22550 2429-75-6

C.I. Direct Blue 131. 35085 6661-39-8 C.I. Direct Violet 17 22465 6426-65-4

C.I. Direct Blue 177. 22625 6426-76-2 C.I. Direct Violet 27 22460 6426-64-8

C.I. Direct Blue 230. 22455 6527-65-7 C.I. Direct Violet 36 22470 6472-94-2

C.I. Direct Brown 5.. 30135 6844-77-5 C.I. Direct Violet 38 22630 6426-77-3

C.I. Direct Brown 7.. 30035 6837-86-1 C.I. Direct Violet 42 22450 6459-88-7

C.I. Direct Brown 13. 35710 8003-82-5 C.I. Direct Violet 43 22440 6426-63-7

C.I. Direct Brown 14. 35715 8002-97-9 C.I. Direct Violet 45 22510 6426-72-8

C.I. Direct Brown 17. 30100 6661-48-9 C.I. Direct Violet 85 22520 6507-84-2

C.I. Direct Brown 20. 30060 1324-67-0 C.I. Direct Violet 88 22046 6358-33-4

C.I. Direct Brown 21. 30155 6442-05-3 C.I. Direct Yellow 1. 22250 6472-91-9

C.I. Direct Brown 24. 31700 8003-74-5 C.I. Direct Yellow 20 22410 6426-62-6

C.I. Direct Brown 25. 36030 33363-87-0 C.I. Direct Yellow 24 22010 6486-29-9

C.I. Direct Brown 26. 31730 8003-55-2 Direct Black 4....... 30245 2429-83-6

C.I. Direct Brown 27. 31725 6360-29-8 Direct Black 38...... 30235 1937-37-7

C.I. Direct Brown 33. 35520 1324-87-4 Direct Blue 2........ 22590 2425-73-4

C.I. Direct Brown 39. 35060 6473-06-9 Direct Blue 6........ 22610 2602-46-2

C.I. Direct Brown 43. 35700 6471-44-9 Direct Brown 1....... 30045 3811-71-0

C.I. Direct Brown 46. 31785 8003-51-8 Direct Brown 1.2..... 30110 2586-58-5

C.I. Direct Brown 51. 31710 4623-91-0 Direct Brown 2....... 22311 2429-82-5

C.I. Direct Brown 54. 31735 8003-50-7 Direct Brown 6....... 30140 2883-80-3

C.I. Direct Brown 56. 22040 6486-31-3 Direct Brown 31...... 35660 2429-81-4

C.I. Direct Brown 57. 31705 6360-28-7 Direct Brown 59...... 22345 3476-90-2

C.I. Direct Brown 58

C.I. Direct Brown 46. 31785 8003-51-8 Direct Brown 1.2..... 30110 2586-58-5

C.I. Direct Brown 51. 31710 4623-91-0 Direct Brown 2....... 22311 2429-82-5

C.I. Direct Brown 54. 31735 8003-50-7 Direct Brown 6....... 30140 2883-80-3

C.I. Direct Brown 56. 22040 6486-31-3 Direct Brown 31...... 35660 2429-81-4

C.I. Direct Brown 57. 31705 6360-28-7 Direct Brown 59...... 22345 3476-90-2

C.I. Direct Brown 58. 22340 6426-59-1 Direct Brown 74...... 36300 8014-71-3

C.I. Direct Brown 60. 22325 6426-57-9 Direct Brown 95...... 30145 16071-86-6

C.I. Direct Brown 61. 30055 6505-33-5 Direct Brown 154..... 30120 6360-54-9

C.I. Direct Brown 62. 31720 8003-56-3 Direct Green 1....... 30280 3626-28-6

C.I. Direct Brown 68. 30125 6449-85-0 Direct Green 6....... 30295 4335-09-5

C.I. Direct Brown 70. 35530 6428-42-8 Direct Green 8....... 30315 5422-17-3

C.I. Direct Brown 73. 35535 6428-43-9 Direct Orange 1...... Mixture 54579-28-1

C.I. Direct Brown 75. 30325 1324-84-1 22370 6459-87-6

C.I. Direct Brown 79. 30050 6483-77-8 22375 13164-93-7

C.I. Direct Brown 86. 22030 6486-30-0 22430 6472-93-1

C.I. Direct Brown 101 31740 8626-29-7 Direct Orange 8...... 22130 2429-79-0

C.I. Direct Brown 138 30070 6449-84-9 Direct Red 1......... 22310 2429-84-7

C.I. Direct Brown 151 31685 10130-38-8 Direct Red 28........ 22120 573-58-0

C.I. Direct Brown 159 31755 10214-11-6 Direct Red 37........ 22240 3530-19-6

C.I. Direct Brown 171 30040 Unknown Direct Violet 1...... 22570 2586-60-9

C.I. Direct Brown 173 30165 6826-64-8 Direct Violet 22..... 22480 6426-67-1

C.I. Direct Brown 175 30150 6528-58-1

----------------------------------------------------------------------------------------------------------------

[FR Doc. 95-21518 Filed 8-29-95; 8:45 am]

BILLING CODE 6560-50-F