[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Proposed Rules]
[Pages 45119-45125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21518]



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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721

[OPPTS-50617; FRL-4762-4]
RIN 2070-AC37


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing a significant new use rule (SNUR) under 
section 5(a)(2) of the Toxic Substances Control Act (TSCA) which would 
require persons to notify EPA at least 90 days before commencing the 
manufacture, import, or processing of benzidine-based chemical 
substances, defined herein, for any use other than those listed in the 
regulatory text of this proposed rule. EPA believes that this action is 
necessary because benzidine-based chemical substances may be hazardous 
to human health and that the uses governed by this proposed rule may 
result in significant human exposure. The required notice would provide 
EPA with the opportunity to evaluate the intended new use and 
associated activities, before the benzidine-based chemical substances 
can be introduced into the marketplace, and an opportunity to protect 
against potentially adverse exposure before it can occur.

DATES: Written comments, in triplicate, must be received by September 
29, 1995.

ADDRESSES: All comments must be sent in triplicate to: TSCA Document 
Receipt Office (7407), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, Rm. E-G99, 401 M St., SW, Washington, 
DC 20460. Comments that contain information claimed as confidential 
must be clearly 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 

[[Page 45120]]
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)).
    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

    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.
    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.
    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 

[[Page 45121]]
``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. 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

    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. 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:
    (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 

[[Page 45122]]
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.
    (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.
    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. 
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. 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. 
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 

[[Page 45123]]
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

    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. 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.
    (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.
    (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 

[[Page 45124]]
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

    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.

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.
    (b) List of substances. The following Table 1. lists the benzidine-
based substances covered by this section.

                                                                        

[[Page 45125]]
                                  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. 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. 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.        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