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Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations 52287

4. Section 355.50 is amended by

revising paragraphs (c)(1) and (c)(2), and

in the headings for paragraphs (d)(1)(i)

and (d)(1)(ii) by removing the word

"Paste" and adding in its place the

words "Gel or paste" to read as follows:

§ 355.50 Labeling of anticarles drug

products.

*t * * * *

(c) * * *

(1) For all fluoride dentifrice (gel,

paste, and powder) products. "Keep out

of the 'reach of children under 6 years

of age. If you accidentally swallow more

than used for brushing, seek

professional assistance or contact a

Poison Control Center immediately."

These warnings shall be used in place

of the general warning statements

required by § 330.1(g) of this chapter.

(2) For all fluoride rinse and

preventive treatment gel products.

"Keep this and all drugs out of the reach

of children. If you accidentally swallow

more than used for" (select appropriate

word: "brushing" or "rinsing"), "seek

professional assistance or contact a

Poison Control Center immediately."

These warnings shall be used in place

of the general warning statements

required by § 330.1(g) of this chapter.

Dated: September 30, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96-25599 Filed 10-4-96; 8:45 am]

BILUNG CODE 4160-01-P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1309, 1310, 1313

[DEA NUMBER 138P]

RIN 1117-AA32

Removal of Exemption for Certain

Pseudoephedrine Products Marketed

Under the Food, Drug, and Cosmetic

Act (FD&C Act)

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Final rule; withdrawal.

SUMMARY: DEA is withdrawing its

rulemaking regarding Removal of

Exemption for Certain Pseudoephedrine

Products Marketed Under the Food,

Drug, and Cosmetic Act (FD&C Act)

which was published in the Federal

Register on August 7, 1996 (61 FR

40981). The final rule has been

superseded by the Comprehensive

Methamphetamine Control Act of 1996,

which declares the final rule null and

void and of no effect.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Office of

Diversion Control, Drug Enforcement

Administration, Washington, DC. 20537,

Telephone (202) 307-7183.

SUPPLEMENTARY INFORMATION: DEA

published a notice of proposed

rulemaking (NPRM) regarding Removal

of Exemption for Certain

Pseudoephedrine Products Marketed

Under the Food, Drug, and Cosmetic Act

(FD&C Act) in the Federal Register on

October 31, 1995 (60 FR 55348). The

NPRM proposed certain amendments to

Title 21, Code of Federal Regulations

(CFR), Parts 1309, 1310, and 1313, and

was open for public comment until

January 2, 1996. Following the comment

period, DEA published a final

rulemaking on August 7, 1996 (61 FR

40981), which was to become effective

on October 7, 1996. However, on

September 29, 1996, Congress passed

the Comprehensive Methamphetamine

Control Act of 1996, which provides

that "The final rule concerning removal

of exemption for certain

pseudoephedrine products marketed

under the Federal Food, Drug, and

Cosmetic Act published in the Federal

Register of August 7, 1996 (61 FR

40981-40933) is null and void and of no

force or effect." As a result, the

amendments contained in the final rule

are canceled and the regulatory text of

21 CFR Parts 1309, 1310, and 1313

remains unchanged.

Accordingly, DEA's rulemaking

entitled Removal of Exemption for

Certain Pseudoephedrine Products

Marketed Under the Food, Drug, and

Cosmetic Act (FD&C Act), published in

the Federal Register as a proposed rule

on October 31, 1995 (60 FR 55348) and

as a final rule on August 7, 1996 (61 FR

40981), is withdrawn.

Dated: October 2, 1996.

Gene R. Haislip,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc. 96-25665 Filed 10-4-96; 8:45 am]

BILUNG CODE 4410-09-M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 9 and 721

[OPPTS-60617A; FRL 5396-6]

RIN 2070-AA58

Benzidine-Based Chemical

Substances; Significant New Uses of

Certain Chemical Substances

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: EPA is promulgating a

significant new use rule (SNUR) under

section 5(a) of the Toxic Substances

Control Act (TSCA) which requires

persons to notify EPA at least 90 days

before commencing the manufacture,

import, or processing of certain

benzidine-based chemical substances

for any significant new use as described

in this rule. EPA believes that this

action is necessary because benzidinebased chemical substances may be

hazardous to human health and that the

uses governed by this rule may result in

significant exposure to workers

handling those substances. The required

notice provides EPA with the

opportunity to evaluate any intended

new uses and associated activities

before the benzidine-based chemical

substances can be introduced into the

marketplace for a significant new use,

and an opportunity to protect against

potentially adverse exposure before it

occurs.

EFFECTIVE DATE: This rule becomes

effective on November 20, 1996. Persons

who begin commercial manufacture,

importation, or processing of listed

benzidine-based chemical substances

for any significant new use listed in this

rule between August 30, 1995, and

November 20, 1996 must comply with

the requirements of this final SNUR. See

Unit VII of this preamble for more

information. In accordance with 40 CFR

23.5, this rule shall be promulgated for

purposes of judicial review at 1 p.m.

eastern time on October 21, 1996.

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: TSCAHotline@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: This

SNUR requires persons to notify EPA at

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52288 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

least 90 days .before commencing the

manufacture, import, or processing of

the benzidine-based chemical

substances listed in this rule for any

significant new use as described in

§ 721.1660(a)(2). The SNUR does not

apply to uses of benzidine-based

substances in existence when this SNUR

was proposed which include uses 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; a reagent for

detecting blood; an analytical standard;

and also for Colour Index (C.I.) Direct

Red 28 (Congo Red, CAS No. 573-58-

0) as an indicator dye. The required

notification will provide EPA with

information needed to evaluate the new

use and associated activities, and an

opportunity to protect against

potentially adverse exposure to the

chemical substance before it can occur.

This rule was proposed on August 30,

1995 (60 FR 45119) (FRL-4762-4).

Regulated entities. Entities potentially

regulated by this action are those which

manufacture, import, or process the

benzidine-based chemical substances

listed in the rule for any use other than

those listed in § 721.1660(a)(2).

Regulated categories and entities

include:

Category Examples of regulated enti- ties

Industry Manufacturers, importers, and processors of cyclic organic crudes and intermediates, and organic dyes. Industry Entities which plan to use

the listed dyes in conjunc- tion with apparel and other

finished products made

from fabrics, leather, and

similar materials.

Industry Entities which plan to use

the listed dyes in conjunction with paper and allied

products. Industry Manufacturers, importers,

and processors of printing

ink.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. This table lists

the types of entities that EPA is now

aware could potentially be regulated by

this action. Other types of entities not

listed in the table could also be

regulated. To determine whether your

business is regulated by this action,

carefully examine the applicability

criteria set forth in § 721.1660 of this

rule. For questions regarding the

applicability of this action to a

particular entity, see "FOR FURTHER

INFORMATION CONTACT" at the

beginning of this document.

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 that 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

by rule 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 manufacturing, importing, or

processing the chemical substance for

that use (15 U.S.C. 2604(a)(1)(B)).

Persons subject to this SNUR must

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

sections 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. If during its review, EPA

identifies concerns, regulatory action

may be taken 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), (0, 2605, 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 (15 U.S.C. 2604(g)).

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 (15

U.S.C. 2612) 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

TSCA requirements. The EPA rule 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) (15

U.S.C. 2625(b)). Provisions requiring

persons submitting SNUNs to submit

certain fees to EPA are discussed in

detail in the Federal Register document.

Interested persons should refer to 40

CFR parts 700 and 721 and the August

17, 1988 Federal Register document for

further information.

III. Introduction

A. Summary

The chemical substances that are the

subjects of this SNUR are certain

benzidine-based chemical substance as

listed in table 1 of § 721.1660.

EPA has determined that there is no

ongoing manufacture, import, or

processing, of the listed benzidine-based

chemical substances, except for the

ongoing uses of such substances in

small amounts for a few, limited

purposes (identified in § 721.1660(a)(2)

of this rule). Because the listed

benzidine-based chemical substances

are currently only used for these limited

purposes, EPA is concerned that any

new use beyond the current ongoing

limited uses would increase production

volume resulting in increased potential

for exposure to workers which would be

significant because of their potential

carcinogenicity. Therefore, under TSCA

section 5(a)(2), EPA is designating any

use of the listed benzidine-based

chemical substances as a significant

new use, other than the following

ongoing uses of such chemical

substances: 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; a reagent for detecting

blood; an analytical standard; and also

for C. I. Direct Red 28 as an indicator

dye.

Except for the ongoing uses listed

above, this rule requires persons who

intend to manufacture, import, or

process the benzidine-based chemical

substances listed in table I of § 721.1660

of this 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 substances for the significant new

uses designated in this SNUR. The

required notice provides EPA with the

opportunity to evaluate the intended

use, and, if necessary, to prohibit or

limit that use before it occurs.

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B. Final Rule-Changes From the

Proposed Rule

The Agency reviewed all comments

received on the proposed rule. After

consideration of issues raised by the

commenters, the Agency has taken the

following actions:

1. Some inconsistencies in naming

and inaccuracies in CAS numbers in

table 1 of 40 CFR 721.1660 have been

corrected.

2. Chemical substances not listed on

the TSCA Inventory are no longer

covered by this rule.

3. The use of C.I. Direct Red 28 (CAS

No. 573-58-0) as an indicator dye and

the use of benzidine-based chemical

substances as an analytical standard were added to the list of uses not

designated as significant new uses

under this SNUR.

IV. Background Information on Benzidine-Based Chemical Substances

Based upon toxicity information on benzidine and benzidine-based dyes,

the Agency is concerned that all the

benzidine-based chemical substances

listed in this rule may be carcinogens.

The molecule benzidine can only be

isolated for commerce or use in the form

of a salt. In recognition of this fact,

whenever the term "benzidine" is used

in this section of the preamble, it refers

to the molecule benzidine, CAS No. 92-

87-5, as well as to 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.

Several epidemiologic 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 EPA as Group

A, a human carcinogen (IRIS, 1996).

Benzidine is also classified by the

International Agency for Research on Cancer (IARC) as a Group I carcinogen,

which are chemicals known to cause

cancer in humans and animals (Ref. 2).

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. 5) is based on studies of tested representative

benzidine-based dyes, as well as benzidine, from which they are synthesized, and to which they break

down or metabolize. The overwhelming

health concern for benzidine and

benzidine-based dyes is for bladder

cancer generally believed to be caused

through any route of exposure. As of

June 1974, the Occupational Safety and

Health Administration (OSHA) requires

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 "confirmed human carcinogen" with no Threshold Limit Value (TLV) assigned,

and has recommended that "all

exposure to benzidine should be kept to an absolute minimum" (Ref. 6).

Twelve benzidine-based dyes have

been demonstrated to metabolize to

benzidine in one or more of four species

(Ref. 7). 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. 16071-86-6), showed statistically

significantly elevated tumor incidence

of the liver fbllowing 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. 8).

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 7). 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, 8, and 9). 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 are expected to have a similar

degree of toxicity. In addition, NIOSH

has recommended that all benzidinebased dyes be recognized as potential

human carcinogens, based upon the

evaluation of information on the

carcinogenicity and metabolism of these

dyes (Ref. 10).

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

individual dyes. 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 (Ref. 10). The

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

by only benzidine impurities in the

dyes.

Exposure estimates for dyes were developed based on the result of a monitoring study conducted

collaboratively by EPA and industry

(Ref. 11). Using this information, and

based on models from EPA and

industry, exposure estimates have been

calculated for those workers who weigh

powder dyes in manufacturiig

establishments. 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. 11).

V. Rationale and Objectives for the 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). The

Agency has concerns for bladder cancer in workers which is generally believed

to be caused through any route of

exposure to benzidine-based chemical

substances (Ref. 5). EPA classified

benzidine as Group A, a human

carcinogen (IRIS, 1996). 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 also suspected

carcinogens (e.g., Ref. 10).

EPA has determined that there is no ongoing manufacture, import, or

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processing, of the listed benzidine-based

chemical substances, except for use in

small amounts 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; a reagent for detecting

blood; an analytical standard; and also

for C.I. Direct Red 28 as an indicator

dye. EPA believes that the use of the

subject benzidine-based substances for

the uses designated at § 721.1660 would

result in increases in production as well

as the type, form, magnitude, or

duration of exposure to these known or

suspected carcinogens. Therefore, EPA

is designating the uses at § 721.1660 as

significant new uses (Ref. 12).

Based on these considerations, EPA

wishes to achieve the following

objectives with regard to the significant

new uses that are designated in this

rule. Specifically, EPA wants to ensure

that it:

1. Receives notice of any company's

intent to manufacture, import, or

process the benzidine-based chemical

substances for the significant new uses

designated in this rule before that

activity begins.

2. Has 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

designated in this rule.

3. Can 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.

For the preceding reasons, EPA is

designating any use of the benzidinebased chemical substances listed in

§ 721.1660, except for those uses listed

in § 721.1660(a)(2), as significant new

uses.

VI. Alternatives

Before promulgating this SNUR, EPA

considered alternative regulatory

actions for the listed benzidine-based

chemical substances. It determined that

- -the-benzidine-based chemical

substances listed in this rule are

currently not subject to Federal

notification requirements nor are they

currently subject to any other Federal

rules that regulate risks to human health

or the environment to a sufficient extent

to justify using those regulations as an

alternative to this SNUR. EPA also

considered the following alternative

actions.

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 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 not provide the

opportunity for EPA to review human

and environmental risks associated with

new uses of a chemical substance and,

if necessary, take immediate follow-up

regulatory action under TSCA section

5(e) or section 5{f to prohibit or limit

the activity before it begins. In view of

the level of health concerns 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 the listed 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.

In the case of this rule, EPA decided

that a SNUR was more appropriate than

a section 6 rule because the Agency has

not determined that the ongoing uses

raise sufficient concerns to justify a

section 6 regulation. At the same time,

EPA's concerns are for potential future

uses, and the notification which is

required by this SNUR will be sufficient

to allow the Agency to make the

decisions necessary to protect against

such uses.

VII. Applicability to Uses Occurring

Before Effective Date of this 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 this SNUR rather than

as of the effective date of this 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 is no longer new.

Persons who began commercial

manufacture, importation, or processing

of the listed benzidine-based chemical

substances for any significant new use

listed in this rule between issuance of

the proposed rule and the effective date

of this SNUR must cease that activity

before the effective date of this 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 began

commercial manufacture, importation,

or processing of the chemical substances

between the issuance of the proposed

rule and the effective date of this SNUR

meet the conditions of advance

compliance as codified at § 721.45(h),

those persons will be considered to have

met the requirements of this final SNUR

for those activities.

VIII. Response to Comments Received

on Proposed Rule

The Agency received comments on

the proposed rule from two businesses

and two trade associations. The Agency

reviewed and considered all significant

comments received. These comments

and EPA's responses follow:

Comment. Some of the dyes listed in

the proposed rule are assigned incorrect

CAS numbers and nomenclature.

Response. EPA reviewed the list of

dyes in the proposed rule.

Inconsistencies in naming substances

were identified and corrected in table 1

in § 721.1660 of this final rule.

Inaccurate CAS numbers were also

identified and corrected in table I of

this final rule for C.I. Direct Blue 2 (CAS

No. 2429-73-4), C.I. Direct Brown 6

(CAS No. 2893-80-3), and C.I. Direct

Brown 74 (CAS No. 8014-91-3).

Additionally, chemical names were

added to table 1 of this rule to futher

identify substances subject to SNUR

reporting. These corrections were minor

in nature and did not change the types

of benzidine-based dyes subject to this

final SNUR.

Comment. A majority of the chemical

substances listed in the proposed rule

are not found on the TSCA Inventory. A

SNUR for substances that are not on the

TSCA Inventory is unnecessary because

the "PMN would serve the same

purpose".

Response. EPA conducted a review of

the TSCA Inventory. This review

revealed that 24 out of 149 benzidinebased chemical substances in the

proposed SNUR were'on the TSCA

Inventory and the remaining substances

were not. EPA has removed the

substances that are not on the TSCA

Inventory from the final list of

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substances requiring notification of a

significant new use. Those substances

continue to be subject to the reporting

requirements under TSCA section

5(a)(1) (15 U.S.C. 2604(a)(1)). Section

5(a)(1) requires a person who

manufactures a chemical substance that

is not on the Inventory, and not

otherwise excluded or exempted from

the requirements of section 5, to file a

premanufacture notification (PMN) with

EPA. When EPA proposed the SNUR it

based the proposal on certain objectives that it announced in the preamble to the

proposed rule (60 FR 45121, August 30,

1995). EPA has concluded that these

same objectives can be met through the

submission of a PMN for benzidinebased chemical substances that are not

on the Inventory and requiring a SNUN

in addition is not necessary. Comment. C.I. Direct Red 28, a

benzidine derivative, is used as a

mineral acid indicator but was not

identified in the proposed rule as an

ongoing use. Also, certain uses of

benzidine as an analytical laboratory

standard, as with EPA Reference

Method 8270, are also ongoing. These

uses are similar to other ongoing uses

identified in the proposed rule.

Response. EPA added the use of C.I.

Direct Red 28 (CAS No. 573-58-0) as an

indicator dye and the use of benzidine

and benzidine-based chemical

substances as an analytical standard to

the list of ongoing uses based on

information from commenters and

EPA's Office of Solid Waste and

Emergency Response (OSWER)

(Benzidine SNUR Memo, 50617A). No

additional ongoing uses of benzidinebased chemical substances were

identified. Ongoing uses, as identified

in § 721.1660(a)(2) of this final rule, are

not subject to SNUR reporting. EPA

decided to add these two uses because

they are similar to other ongoing uses

that were originally proposed. Like

some of the proposed ongoing uses, the

additional uses rely on benzidine-based

substances to test for the presence of

chemical substances. EPA received no

objections to the inclusion of the

original uses in this SNUR and has

concluded that additional notice is not

necessary to add these similar uses.

Comment. There are other benzidinebased dyes on the TSCA Inventory which were not listed in the proposed

rule.

Response. EPA's intent is to require

notification prior to the manufacture,

import, or processing of all benzidinebased chemical substances on the TSCA

Inventory for all non-ongoing uses. EPA

conducted a thorough search of the

TSCA Inventory which revealed that

there are additional benzidine-based

chemical substances on the TSCA

Inventory that were not included in the

proposed SNUR. EPA will propose a

SNUR for these additional benzidinebased chemical substances in the near

future.

Comment. EPA should exempt all

laboratory uses of very small amounts of

benzidine-based chemical substances

from the SNUR where prudent

laboratory practices are employed.

Another comment suggested that the

SNUR should not apply to laboratory

uses of benzidine-based chemical

substances.

Response. EPA agrees with the first

comment and under existing EPA

regulations, a person who

manufacturers, imports, or processes a listed substance for a significant new

use is not subject to SNUR notification

requirements if the person is utilizing

small quantities for research and

development and meets the other

safeguards as specified in 40 CFR

721.47. In addition, this SNUR will not cover identified laboratory uses which are ongoing (listed in § 721.1660(a)(2) of

this rule). However, EPA does not agree

with the second comment that all

laboratory uses in general should be

excluded. The purpose of the SNUR is

to insure that EPA has an opportunity

to review human and environmental

risks associated with significant new uses of a chemical substance and, if

necessary, take further action to protect

against those risks. If EPA exempts all

laboratory uses without any of the

safeguards specified in 40 CFR 721.47, as suggested by the commenter, then

persons may engage in those uses

without further EPA review of these

additional human and environmental

exposures. The comment did not

provide adequate information to allow

EPA to determine the extent or possible

consequences of these exposures. Given

the potentially hazardous nature of

benzidine-based chemical substances,

EPA believes it is not appropriate to

exempt all -laboratory uses from the

SNUR. Anyone who wishes to engage in

such a new use in the future, however,

may submit a significant new use notice

and initiate the process for determining

whether those uses pose an unreasonable risk.

Comment. The use of benzidine as a laboratory standard or an indicator dye

does not constitute manufacturing,

importing, or processing for a

commercial purpose, i.e., for

distribution in commerce. The

analytical procedures, of which the

benzidine is part, either consume the

benzidine or produce by-products

which are properly disposed. No

benzidine is manufactured or processed

in the course of these uses, nor is it for

the purpose of distribution in

commerce.

Response. EPA generally agrees with

the commenter thAt a SNUR only

regulates manufaaturing and processing

activities that are undertaken for

commercial purposes; however, a

laboratory could be engaging in

regulated activities when it uses a listed

benzidine-based chemical substance.

TSCA provides that SNURs apply only

to persons who "manufacture or

process" subject substances (15 U.S.C.

2604(a)(1)(B)). TSCA also defines the

term "manufacture" to include

importation of as well as production (15

U.S.C. 2602(7)). TSCA further provides

that SNURs only regulate

manufacturing, importation, and

processing activities if those activities

are for "commercial purposes" (15

U.S.C. 5(I)). EPA interprets these

provisions broadly to encompass a wide

range of activities. TSCA and the SNUR

regulations define manufacturing to

include any activities associated with

the production or importation of

substances with the purpose of

obtaining an immediate or eventual

commercial advantage for the

manufacturer or importer (40 CFR

720.3(r), defining "manufacture or

import for commercial purposes").

Processing for commercial purposes is

also defined to encompass a wide range

of activities (40 CFR 721.3, defining "process for commercial purposes").

Based upon these regulations, a

laboratory could be engaged in regulated

activity when it uses a listed benzidinebased substance. Determining whether a

laboratory is engaged in a regulated

activity is very fact specific and requires an assessment of a variety of the

circumstances surrounding the

laboratory's activities. The commenter

has not provided enough information

for EPA to determine whether the

activities it describes would be subject

to the SNUR. Rather than speculate on

hypothetical situations, EPA advises a

laboratory that intends to engage in

activities involving a significant new

use of a listed benzidine-based chemical

substance to contact EPA as specified in

40 CFR 721.11 to determine in advance

whether it is subject to the SNUR.

Additionally, as stated in the previous

response to comment, under existing

EPA regulations, a person who

manufactures, imports, or processes a

listed substance for a significant new

use is not subject to SNUR notification

requirements if the person is utilizing

small quantities of research and

development and meets the other

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safeguards as specified in 40 CFR

721.47.

Comment. The SNUR will give an

unfair advantage to foreign producers of

benzidine-based chemical substances,

and to those who imblt textiles dyed

with such chemicals into the US.

Aesponse. While EPA does not

presently have a sufficient basis to

support a regulatory action related to

the import of articles manufact red with

benzidme-based chemical siAsmwes,

we have taken steps to addess concerns

wi eine-based s chemical'

substances on an international -evel.

EPA has helped the O(gauzzation for

Economic 'Cooperation and

Development {OECD) organize an

information clearinghouse so the OECD

member oountries can share inknuation regarding the issues, concerns, and risk

management activities surrounding

benzidine-based chemical substances.

EPA has also provided information to

India through the U.S. Department of

State. EPA plans to inform the OECD,

United Nations (UN) International

Program on Chemical Safety (IPCS) and

the International Register of Potentially

Toxic Chemicals (IRPTC) of the issuance

of this SNUR so that this action might

encourage other countries to examine

the risks associated with the

manufacture and use of benzidine-based

chemical substances in their countries.

Comment. The SNUR is a "complete

product ban", put into effect without

"sufficient analysis of the alternatives

and input from the interested public".

-Response. EPA disagrees. A SNUR

requires only that manufacturers,

importers, and processors of the listed

substances notify EPA at least 90 days

before beginning any activity that EPA

has designated as a "significant new

use." The advance notification required

by the SNUR allows EPA to evaluate the

proposed new use in more detail. If that

evaluation reveals a concern, EPA can

take action to prevent or limit

unreasonable risk from the new use of

the substance. Conversely if EPA

decides not to take any further action,

the activity may proceed.

EPA also disagrees with the comment

that it failed to analyze alternatives or

public input. The commenter failed to

explain why it believed that there were

other viable alternatives to a SNUR.

Unit VI of this preamble includes EPA's

analysis of alternative regulatory actions

and other provisions of TSCA. EPA also

discussed plans to issue a SNUR at

several public meetings, and at a

meeting with industry representatives

held during in April, 1995 (Meeting

Minutes on Benzidine-Based and

Benzidine Congener-Based Dyes,

50617A). Additionally, the public

submitted comments when this SNUR

was proposed and EPA is responding to

them in this preamble.

Comment.'EPA has not addressed the

issue of the "actual risk posed by these

c1emicals in their curent limited use".

.Response. Because this SNUX'is not

inteded to subject ongoing usesof

benzidine-based chemcal substances to

SNJM4peiag qirements, EPA did

net pecicallyeassess risk posed %y

.e.g uses .of ezi&.e4bsed

c4IecaI sbsmtm. Such an

asessmment wouldal otitside the sCope

-ofikis rule d dAeidre, is unnecessary

to support this rule.

Comment. The rule as proposed

would not reulate signi~cant hew'uses

ofan existing product, but rther -would

regulate "old, establihed produets and

applications which me not currently

used" in the U.S.

Response. The statutory language of

TSCA section 5, the legislative history,

and underlying policy support EPA's

conclusion that it has the authority to

classify the resumption of

manufacturing or processing of

chemical substances as a "significant

new use." The term "new" generally

encompasses uses that are occurring for

the first time as well as uses that were

discontinued and then occur again. See,

e.g., Webster's II New Riverside

University Dictionary, 1988.

The factors that TSCA requires the

Administrator to consider before

determining that a use is "significant"

and "new" apply equally to first time

and resumed uses. Section 5(a)(2) states

that the Administrator's "significant

new use" determination shall be made

after considering all relevant factors

including "projected volume," increases

in "magnitude and duration of

exposure," and the reasonably

anticipated manner and methods of

manufacturing, processing, distribution,

and disposal. Both first time and

resumed use may result in an increase

in production volume and exposure to

a chemical substance. Both types of uses

also can lead to increased risks

associated with manufacture,

processing, distribution, and disposal.

Moreover, the legislative history of

section 5 suggests that Congress

intended that increased volume of

manufacturing or processing would be

subject to the requirements of that

section. This adds further support to the

conclusion that a resumption of

manufacture, which necessarily entails

an increase in production volume, may

be classified as manufacture for a

significant "new" use. See, e.g.,-H.R.

Rep. No. 94-1679, 94th Cong., 2nd Sess.

66 (1976), Legislative History of the

Toxic Substances Control Act 679;

Senate Consideration of Conference

Report on S. 3148, Sept. 28, 1976,

Legislative History of the Toxic

Substances Control Act at 723.

Comment.Thirty days is not a fair

and reasonable commentperiod for

such complex regulations, with

extensive okets'

'Response. EPA disares that3e ays

is not a lair aBd reasonAhe comment

period.:EPA allows't reasoable ammont

of'time for comments booe upon the

complexity of the proposed rule and the

reoord. Due to the relativwly routine

nature of SNU]Rs and the limited nature

of thbe.materol in Ae ,ecatfor this

paf6cular rule, the Agency believesthat

a 30-day commeat period is reasonabMe

in this case. EPA recived no requests

irom the public for an extension of the

comment period.

Comment. The Agency is not justified

in setting retroactive dates as the

effective dates for determining new

uses.

Response. EPA disagrees and believes

it is reasonable to make the effective

date of the Agency's "significant new

use" determination the proposal date of

the rule rather than the date of the final

rule. If EPA adopted the date of the final

rule as the effective date, then a person

could defeat the final rule simply by

engaging in the proposed significant

new use before the rule took effect.

Further, the notification requirements

for use of any listed benzidine-based

chemical substance only take effect

when the rule becomes final. This rule

operates prospectively, not retroactively

as the comment suggests.

Comment. EPA may be premature in

"extending its concern to the listed dye

products" due to SNUN requirements

for test data, protocol consultation, and

human exposure and environmental

release data.

Response. EPA disagrees that issuing

a SNUR is premature. Congress

designed SNURs to allow EPA to obtain

data about new uses of chemical

substances that may pose significant

concerns. This action is based on

Agency concerns for all benzidine-based

substances listed in the rule. Agency

concerns for all these benzidine-based

substances are based on existing

carcinogenicity and exposure data of

benzidine and benzidine-based

substances.

As stated in Unit IX of the proposed

rule (60 FR 45119, August 30, 1995),

TSCA section 5 does not require persons

to develop any particular test data

before submitting a SNUN. 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 (15 U.S.C.

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2604(d); 40 CFR 721.25). Further, while

EPA does require the submission of test

data in a submitter's possession, EPA

does not require the development of test

data when a SNUN is submitted. Rather,

EPA suggests to potential SNUR

submitters the kind of data that would

permit a reasoned evaluation of

potential risks posed by listed

benzidine-based chemical substances

for an intended use. The

characterization of potential health and

environmental effects will help the

Agency determine if regulation of the

listed SNUR substance for the intended

use is warranted.

Comment. According to the July 1995

American Association of Textile

Chemists and Colorists (AATCC)

Buyer's Guide, 15 companies were listed as distributing benzidine dyes.

Response. Of the 15 companies

identified in the 1995 AATCC Buyer's

Guide as selling benzidine-based

chemical substances identified in this

SNUR, EPA had previously contacted

nine that were listed in the 1994

AATCC Buyer's Guide prior to

publication of the proposed SNUR

(Phone Contacts with Benzidine Dye

Manufacturers and Distributors, 50617).

Representatives of those nine companies

confirmed that they were not

manufacturing, importing, or distributing benzidine-based chemical

substances identified in this SNUR. EPA

representatives attempted to contact the

additional six companies newly listed

in the 1995 Buyer's Guide (Buyer's

Guide, 50617A). Five companies

indicated to EPA that they were not

manufacturing, importing, or distributing benzidine-based chemical

substances. EPA representatives were unable to contact the remaining

company although repeated attempts were made using the information

contained in the 1995 AATCC Buyer's

Guide. Thus, based on the information

currently available, EPA does not

believe that the benzidine-based

chemical substances identified in this

SNUR are in commerce at this time.

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 significant new use notice.

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 (15 U.S.C. 2604(d); 40 CFR

721.25).

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 include data 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 help 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 submitting a SNUN for benzidine-based 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 and advise in the

selection of a protocol for testing 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 the benzidine-based

chemical substances listed in this rule

(Ref. 12). While there is no precise way

to calculate the total annual cost of

compliance with this 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.

The Agency's economic analysis is

available in the public record for this

rule (OPPTS-50617A).

XI. Rulemaking Record

EPA has established a record for this

rulemaking (docket control number

OPPTS-50617A). The record includes

basic information considered by the

Agency in developing this rule and the

references listed in Unit XII of this

preamble.

A public version of this record,

without any Confidential Business

Information 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. NE-B607, 401 M St., SW., Washington, DC.

XII. 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 subcbronic toxicity studies of

Direct Blue 6, Direct Black 38 and Direct

Brown 95 dyes." NCI Carcinogenesis.

Technical Report Series Number 108.

127p (1978).

(5) USEPA. Chemical Screening and

Risk Assessment Division. Benzidine/

Benzidine Congener Dyes Support

Document, Ocotber 24, 1994.

(6) ACGIH. American Conference of

Government Industrial Hygienists, Inc.

"Documentation of the Threshold Limit

Values and Biological Exposure Indices.

6th ed." 121-122p (1991).

(7) Lynn, R.K. et al. "Metabolism of

bisazobiphenyl dyes derived from

benzidine, 3,3'-methylbenzidine and

3,3'-dimethoxybenzidine to

carconogenic aromatic amines in the

dog and rat." Toxicology and Applied

Pharmacology 56:248-2.58 (1980).

(8) NIOSH/NCI, Current Intelligence

Bulletin, 24(1,5):7-9 (1978).

(9) IARC Monographs, Supplement

7:125-126 (1987).

(10) NIOSH, Special Occupational

Hazard Review for Benzidine-Based

Dyes (1980).

(11) USEPA. 1990a (April). U.S.

Environmental Protection Agency. Textile Dye Weighing Monitoring Study.

EPA 560/5-90-009 and Supplement 560/5-90-010.

(12) USEPA. Regulatory impact

Branch, USEPA/OPPT/EETD, June 1,

1993. "Production, Uses, and Imports of

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Benzidine Based Chemicals." Prepared

by Meridian Research, Inc.

(13) USEPA. Regulatory Impacts

Branch, Economics, Exposure, and

Technology Division. "Economic

Analysis to Support the Proposed SNUR

for Benzidine and Benzidine-based

Dyes". May 12, 1995.

XIII. Regulatory Assessment

Requirements

A. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), it has been

determined that this 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 certifies

that this rule will not have a significant

impact on a substantial number of small

entities. This certification can be found

in the docket for this rule (OPPTS50617A). EPA has analyzed the impact

of the rule on small entities based upon

the criteria in the Regulatory Flexibility

Act. Unit XIII.C. of this preamble and

the Economic Analysis (Ref. 13) to

support this SNUR (docket number

OPPTS-50617A) describe the burden

and costs of compliance of this rule as

well as the potential impacts on small

entities.

This SNUR applies to any small or

large business that may wish to engage

in the significant new use described in

the rule. It appears that no small or large

businesses are currently engaged in

activity that is the subject of this 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 SNUR. To date, the

Agency has received less than 10

SNUNs in response to the many SNURs

promulgated by EPA in the past.

There are no existing Federal rules

that may duplicate, overlap, or conflict

with this rule. Finally there are no

significant alternatives to this 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.

Information relating to this

determination may be provided to the

Chief Counsel for Advocacy of the Small

Business Administration upon request,

and is included in the docket for this

rulemaking. Any comments regarding

the economic impacts that this

regulatory action may impose on small

entities should be submitted to the

Agency at the address listed above.

C. Unfunded Mandate Reform Act

This rule is not subject to the

requirements of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104-4) because this 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. Since no current ongoing manufacture, import, or processing of

the listed benzidine-based chemical

substance have been identified except

for uses of such substances 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; a reagent for detecting

blood; an analytical standard; or the use

of C.I. Direct Red 28 as an indicator dye,

this rule will not affect state, local, tribal

governments, or the private sector. EPA

expects to receive few, if any, SNUNs in

response to this SNUR.

D. Executive Order 12898

Pursuant to Executive Order 12898

(59 FR 7629, February 16, 1994),

entitled Federal Actions to Address

Environmental Justice in Minority

Populations and Low-Income

Populations, the Agency has considered

environmental justice related issues

with regard to the potential impacts of

this action on the environmental and

health conditions in low-income and

minority communities and does not

expect any negative impacts since no

current ongoing manufacture, import, or

processing of the listed benzidine-based

chemical substances were identified

except for uses of such substances 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; a reagent for

detecting blood; an analytical standard;

or the use of C.I. Direct Red 28 as an

indicator dye. Additionally, EPA

expects to receive few, if any, SNUNs in

response to this SNUR.

E. Submission to Congress and the

General Accounting Office

Under section 801 (a) (1) (A) of the

Administrative Procedure Act (APA) (5

U.S.C. 801) EPA submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in the Federal Register. This

rule is not a "major rule" as defined by

5 U.S.C. 804(2) of the APA as amended.

F. Paperwork Reduction Act

The information collection

requirements contained in this rule have

already been approved by the Office of

Management and Budget (OMB) under

the provisions of the Paperwork

Reduction Act (44 U.S.C. 3501 et seq.).

This activity falls under OMB control

number 2070-0038 (EPA ICR No. 1188),

which covers the submission of SNUNs

related to existing chemicals.

Specifically, persons subject to this

SNUR must submit a SNUN to EPA at

least 90 days before manufacturing,

importing, or processing a chemical

substance for any significant new use

(15 U.S.C. 2604(a)(1)(B)). The SNUN

allows EPA to review and evaluate the

intended use and prohibit or limit that

use if the degree of potential health risk

is sufficient to warrant such regulation.

Persons subject to this SNUR would

comply with the same notice

requirements and EPA regulatory

procedures as submitters of PMNs under

section 5(a)(1)(A) of TSCA (15

U.S.C.2604(a)(1)(A)).

Additionally, persons who intend to

export a chemical substance identified

in the final SNUR are subject to TSCA

section 12(b) (U.S.C. 2611(b) and 40

CFR part 707). Persons who intend to

import a chemical substance identified

in the final SNUR are subject to the

TSCA section 13 (15 U.S.C. 2612)

import certification requirements and to

the regulations codified at 19 CFR

12.118 through 12.127 and 12.128. The

EPA policy in support of import

certification appears at 40 CFR part 707.

OMB has already approved these

activities under OMB Control No. 2070-

0030 (EPA#795). EPA must withhold

from disclosure trade secret or

confidential financial or commercial

information submitted under TSCA.

In submitting a SNUN, the 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.

These hours are included and accounted

for in the above-referenced existing ICR.

Burden means the total time, effort, or

financial resources expended by persons

to generate, maintain, retain, or disclose

or provide information to or for a

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Federal agency. This includes the time

needed to review instructions; develop,

acquire, install, and utilize technology

and systems for the purposes of

collecting, validating, and verifying

information, processing and

maintaining information, and disclosing

and providing information; adjust the

existing ways to comply with any

previously applicable instructions and

requirements; train personnel to be able

to respond to a collection of

information; search data sources;

complete and review the collection of

information; and transmit or otherwise

disclose the information.

An Agency may not conduct or

sponsor, and a person is not required to

respond to a collection of information

unless it displays a currently valid OMB

control number. EPA is also amending

the table of currently approved

information collection requests (ICR)

control numbers issued by OMB for

various regulations, which appears at 40

CFR part 9. This amendment updates

the table to accurately display OMB

approval of the information

requirements contained in this final

rule. The display of the OMB control

number in this notice and its

subsequent codification in the Code of

Federal Regulations satisfies the

requirements of the Paperwork

Reduction Act (44 U.S.C. 3501 et seq.)

and OMB's implementing regulations at

5 CFR part 1320. The ICR was

previously subject to public notice and

comment prior to OMB approval. As a

result, EPA finds that there is "good

cause" under section 553(b)(B) of the

Administrative Procedure Act (5 U.S.C.

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

additional notice and comment. Due to

the technical nature of the table, further

notice and comment would be

unnecessary.

Send comments on the burden

estimates and any suggested methods

for minimizing respondent burden,

including through the use of automated

collection techniques to Chief,

Information Policy Branch (2131), U.S.

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460; and

to the Office of Information and

Regulatory Affairs, Office of

Management and Budget, 725 17th St.,

NW., Washington, DC 20503, marked

"Attention: Desk Officer for EPA." The

ICR number must be included in any

correspondence.

List of Subjects

40 CFR Part 9

Reporting and recordkeeping

requirements.

40 CFR Part 721

Environmental Protection, Chemicals,

Hazardous materials, Recordkeeping

and reporting requirements, Significant

new uses.

Dated: September 26, 1996.

Charles M. Auer,

Director, Chemical Control Division, Office

of Pollution Prevention and Toxics.

Therefore, 40 CFR parts 9 and 721 are

amended to read as follows:

PART 9-OMB APPROVALS UNDER

THE PAPERWORK REDUCTION ACT

1. The authority citation for part 9

continues to read as follows:

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

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

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

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1321,

1326, 1330, 1344, 1345 (d) and (e), 1361; E.O.

11735, 38 FR 21243, 3 CFR, 1971-1975

Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246,

300f, 300g, 300g-1, 300g-2, 300g-3, 300g-4,

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

300j-9, 1857 et seq., 6901-6992k, 7401-

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

2. Section 9.1 is amended by adding

the following new entry to the table in

numerical sequence to read as follows:

§ 9.1 0MB approvals under the Paperwork

Reduction Act.

40 CFR citation OMB control no.

721.1660 ......................... 2070-0038

PART 721 -SIGNIFICANT NEW USES

OF CHEMICAL SUBSTANCES

3. The authority citation for part 721

continues to read as follows:

Authority: 15 U.S.C. 2604, 2607 and

2625(e).

4. By adding new § 721.1660 to

subpart E to read as follows:

§721.1660 Benzidine-based chemical

substances.

(a) Chemical substances and

significant new uses subject to reporting.

(1) The benzidine-based chemical

substances listed in table 1 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; a reagent to

test for hydrogen sulfate, hydrogen

cyanide, and nicotine; a stain in

microscopy; a reagent for detecting

blood; an analytical standard; and also

for Colour Index (C.I.) Direct Red 28

(Congo Red, CAS No. 573-58-0) as an

indicator dye.

(b) List of substances. The following

table 1 lists the benzidine-based

chemical substances covered by this

section.

Table 1.-Benzidine-Based Chemical Substances

CAS number C.I. name C.I. number Chemical Name

Benzidine

Benzidine * 2HCL

C.I. Direct Red 28

C.I. Direct Black 38

C.I. Direct Red 44

C.I. Direct Blue 2

N/A

N/A

22120

30235

22500

22590

[1,1 '-Biphenyl]-4,4'-diamine

[1 ,1'-Biphenyl]-4,4'-diamine, dihydrochloride

1-Naphthalenesulfonic acid, 3,3'-[[1,1'-biphenyl]- 4,4'-diylbis(azo)]bis[4-amino-,

disodium salt

2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-[(2, 4-diaminophenyl)azo][1,1 '-biphenyl]-4-yflazo]-5-

hydroxy-6-(phenylazo)-, disodium salt

1-Naphthalenesulfonic acid, 8,8'-[[1,1'-biphenyl] -4,4'-diylbis(azo)]bis[7-hydroxy-, disodium salt

2,7-Naphthalenedisulfonic acid, 5-amino-3-[[4'- [(7-amino-l-hydroxy-3-sulfo-2-naphthalenyl)azo]

[1,1 '-biphenyl]-4-yl]azo]-4-hydroxy-,

trisodium salt

92-87-5

531-85-1

573-58-0

1937-37-7

2302-97-8

2429-73-4

HeinOnline -- 61 Fed. Reg. 52295 1996
52296 Federal Register / Vol. 61, No. 195 / Monday, October 7, 1996 / Rules and Regulations

Table 1.-Benzidine-Based Chemical Substances-Continued

CAS number C.1. name C.I. number Chemical Name

2429-79-0

2429-81-4

2429-82-5

2429-83-6

2429-84-7

2586-58-5

2602-46-2

2893-80-3

3530-19-6

3567-65-5

3626-28-6

3811-71-0

4335-09-5

6358-80-1

6360-29-8

6360-54-9

8014-91-3

16071-86-6

C.I. Direct Orange 8

C.I. Direct Brown 31

C.I. Direct Brown 2

C.I. Direct Black 4

C.l. Direct Red 1

C.I. Direct Brown 1:2

C.I. Direct Blue 6

C.l. Direct Brown 6

C.I. Direct Red 37

C.I. Acid Red 85

C.I. Direct Green 1

C.l. Direct Brown 1

C.I. Direct Green 6

C.I. Acid Black 94

C.l. Direct Brown 27

C.l. Direct Brown 154

C.1. Direct Brown 74

C.I. Direct Brown 95

22130

35660

22311

30245

22310

30110

22610

30140

22240

22245

30280

30045

30295

30336

31725

30120

36300

30145

Benzoic acid, 5-[[4'-[(1 -amino-4-sulfo-2-

naphthalenyl)azol[1,1 '-biphenyl]-4-yl]azo]-2-

hydroxy-, disodium salt

Benzoic acid, 5-[[4'-[[2,6-diamino-3-[[8-hydroxy3,6-disulfo-7-[(4-sulfo-l -naphthalenyl)azo]-2-

naphthalenyl]azo]-5-methylphenyl]azo][1,1'-

biphenyl]-4-yl]azo]-2-hydroxy-,

tetrasodium salt

Benzoic acid, 5-[[4'-[(7-amino-l-hydroxy-3-sulfo- 2-naphthalenyl)azo][1,1 '-biphenyl]-4-yl]azo]-2-

hydroxy-, disodium salt

2,7-Naphthalenedisulfonic acid, 4-amino-3-[[4'-

[(2,4-diamino-5-methylphenyl)azo][1 ,1'-

biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)-,

disodium salt

Benzoic acid, 5-[[4'-[(2-amino-8-hydroxy-6-sulfo1 -naphthalenyl)azo][1,1 '-biphenyl]-4-yl]azo]-2-

hydroxy-, disodium salt

Benzoic acid, 5-[[4'-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4-

yl]azo]-2-hydroxy-, disodium salt

2,7-Naphthalenedisulfonic acid, 3,3'-[[1, 1'-

biphenyl]-4,4'-diylbis(azo)]bis[5-amino-4-

hydroxy-, tetrasodium salt

Benzoic acid, 5-[[4'-[[2,4-dihydroxy-3-

[(4-sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4-

yl]azo]-2-hydroxy-, disodium salt

1,3-Naphthalenedisulfonic acid, 8-[[4'-[(4-ethoxy

phenyl)azo][1,1 '-biphenyl]-4-yl]azo]-7-hydroxy-,

disodium salt

1,3-Naphthalenedisulfonic. acid, 7-hydroxy-8-

[[4'-[[4-[[(4-methylphenyl)sulfonyl]oxy]phenyl]

azo][1 ,l'-biphenyl]-4-yl]azo]-, disodium salt

2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-3-[[4'-[(4-hydroxyphenyl)azo][1,1 '-

biphenyl]-4-yl]azo]-6-(phenylazo)-, disodium salt

Benzoic acid, 5-[[4'-[[2,4-diamino-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4-yl]

azo]-2-hydroxy-, disodium salt

2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-6-[[4'-[(4-hydroxyphenyl)azo][1,1'-

biphenyl]-4-yl]azo]-3-[(4-nitrophenyl)azo]-,

disodium salt

2,7-Naphthalenedisulfonic acid, 4-amino-5-

hydroxy-3-[[4'-[[4-hydroxy-2-[(2-methylphenyl)

amino]phenyl]azo][1,1 '-biphenyl]-4-yl]azo]-6-[(4-

sulfophenyl)azo]-, trisodium salt

Benzoic acid, 5-[[4'-[[4-[(4-amino-7-sulfo-1 -

naphthalenyl)azo]-6-sulfo-1 -naphthalenyl]azo]

[1,1 '-biphenyl]-4-yl]azo]-2-hydroxy-,

trisodium salt

Benzoic acid, 5-[[4'-[[2,6-diamino-3-methyl-5-[(4-

sulfophenyl)azo]phenyl]azo][1,1 '-biphenyl]-4-yl]

azo]-2-hydroxy-3-methyl-, disodium salt

Benzoic acid, 3,3'-[(3,7-disulfo-1,5-

naphthalenediyl)bis[azo(6-hydroxy-3,1-

phenylene)azo[6(or7)-sulfo-4, 1-

naphthalenediyl]azo[1,1 '-biphenyl]-4,4'-

diylazo]]bis[6-hydroxy-, hexasodium salt

Cuprate(2-), [5-[[4'-[[2,6-dihydroxy-3-[(2-hydroxy5-sulfophenyl)azo]phenyl]azo][1 ,1'-biphenyl]

-4-yl]azo]-2-hydroxybenzoato(4-)]-, disodium

HeinOnline -- 61 Fed. Reg. 52296 1996