[Federal Register Volume 61, Number 195 (Monday, October 7, 1996)]
[Rules and Regulations]
[Pages 52287-52297]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25650]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 9 and 721

[OPPTS-50617A; 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.

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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 benzidine-based 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: TSCA-H[email protected].

SUPPLEMENTARY INFORMATION: This SNUR requires persons to notify EPA at

[[Page 52288]]

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 Sec. 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 Sec. 721.1660(a)(2). Regulated categories and entities 
include:

                                                                        
------------------------------------------------------------------------
                                                Examples of regulated   
                 Category                             entities          
------------------------------------------------------------------------
Industry                                    Manufacturers, importers,   
                                             and processors of cyclic   
                                             organic crudes and         
                                             intermediates, and organic 
                                             dyes.                      
Industry                                    Entities which plan to use  
                                             the listed dyes in         
                                             conjunction 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 Sec. 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), (f), 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 
Sec. 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 Sec. 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 1 of Sec. 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.

[[Page 52289]]

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 1 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 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. 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 benzidine-based 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 manufacturing 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

[[Page 52290]]

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 Sec. 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 Sec. 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 
benzidine-based chemical substances listed in Sec. 721.1660, except for 
those uses listed in Sec. 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 
Sec. 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 Sec. 721.1660 of this final rule. Inaccurate CAS numbers 
were also identified and corrected in table 1 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 benzidine-based 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

[[Page 52291]]

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 benzidine-based 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 benzidine-based chemical substances were 
identified. Ongoing uses, as identified in Sec. 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 benzidine-based 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 benzidine-based 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 benzidine-based 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 Sec. 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 manufacturing 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 
benzidine-based 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

[[Page 52292]]

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 
import textiles dyed with such chemicals into the US.
    Response. While EPA does not presently have a sufficient basis to 
support a regulatory action related to the import of articles 
manufactured with benzidine-based chemical substances, we have taken 
steps to address concerns with benzidine-based chemical substances on 
an international level. EPA has helped the Organization for Economic 
Cooperation and Development (OECD) organize an information 
clearinghouse so the OECD member countries can share information 
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 chemicals in their current limited use''.
    Response. Because this SNUR is not intended to subject ongoing uses 
of benzidine-based chemical substances to SNUR reporting requirements, 
EPA did not specifically assess risk posed by ongoing uses of 
benzidine-based chemical substances. Such an assessment would fall 
outside the scope of this rule and therefore, is unnecessary to support 
this rule.
    Comment. The rule as proposed would not regulate significant new 
uses of an existing product, but rather would regulate ``old, 
established products and applications which are 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. 3149, Sept. 28, 1976, Legislative History of the Toxic 
Substances Control Act at 723.
    Comment. Thirty days is not a fair and reasonable comment period 
for such complex regulations, with extensive dockets.
    Response. EPA disagrees that 30 days is not a fair and reasonable 
comment period. EPA allows a reasonable amount of time for comments 
based upon the complexity of the proposed rule and the record. Due to 
the relatively routine nature of SNURs and the limited nature of the 
material in the docket for this particular rule, the Agency believes 
that a 30-day comment period is reasonable in this case. EPA received 
no requests from 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.

[[Page 52293]]

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 subchronic 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 56:248-258 (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

[[Page 52294]]

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 (OPPTS-50617A). 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

[[Page 52295]]

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:


Sec.  9.1   OMB 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 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) 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      
----------------------------------------------------------------------------------------------------------------
                                                                                                                
92-87-5                                  Benzidine                         N/A         [1,1'-Biphenyl]-4,4'-    
                                                                                                                
531-85-1                                 Benzidine  2HCL           N/A         [1,1'-Biphenyl]-4,4'-    
                                                                                        diamine, dihydrochloride
                                                                                                                
573-58-0                                 C.I. Direct Red 28               22120        1-Naphthalenesulfonic    
                                                                                        acid, 3,3'-[[1,1'-      
                                                                                        biphenyl]-4,4'-         
                                                                                        diylbis(azo)]bis[4-amino-
                                                                                        ,           disodium    
                                                                                        salt                    
                                                                                                                
1937-37-7                                C.I. Direct Black 38             30235        2,7-Naphthalenedisulfonic
                                                                                        acid, 4-amino-3-[[4'-   
                                                                                        [(2,     4-             
                                                                                        diaminophenyl)azo][1,1'-
                                                                                        biphenyl]-4-yl]azo]-5-  
                                                                                            hydroxy-6-          
                                                                                        (phenylazo)-, disodium  
                                                                                        salt                    
                                                                                                                
2302-97-8                                C.I. Direct Red 44               22500        1-Naphthalenesulfonic    
                                                                                        acid, 8,8'-[[1,1'-      
                                                                                        biphenyl]     -4,4'-    
                                                                                        diylbis(azo)]bis[7-     
                                                                                        hydroxy-, disodium salt 
                                                                                                                
2429-73-4                                C.I. Direct Blue 2               22590        2,7-Naphthalenedisulfonic
                                                                                        acid, 5-amino-3-[[4'-   
                                                                                        [(7-amino-1-hydroxy-3-  
                                                                                        sulfo-2-                
                                                                                        naphthalenyl)azo]  [1,1'-
                                                                                        biphenyl]-4-yl]azo]-4-  
                                                                                        hydroxy-,               
                                                                                        trisodium salt          
                                                                                                                

[[Page 52296]]

                                                                                                                
2429-79-0                                C.I. Direct Orange 8             22130        Benzoic acid, 5-[[4'-[(1-
                                                                                        amino-4-sulfo-2-        
                                                                                        naphthalenyl)azo][1,1'- 
                                                                                        biphenyl]-4-yl]azo]-2-  
                                                                                         hydroxy-, disodium salt
                                                                                                                
2429-81-4                                C.I. Direct Brown 31             35660        Benzoic acid, 5-[[4'-    
                                                                                        [[2,6-diamino-3-[[8-    
                                                                                        hydroxy-3,6-disulfo-7-  
                                                                                        [(4-sulfo-1-            
                                                                                        naphthalenyl)azo]-2-    
                                                                                        naphthalenyl]azo]-5-    
                                                                                        methylphenyl]azo][1,1'- 
                                                                                        biphenyl]-4-yl]azo]-2-  
                                                                                        hydroxy-,               
                                                                                        tetrasodium salt        
                                                                                                                
2429-82-5                                C.I. Direct Brown 2              22311        Benzoic acid, 5-[[4'-[(7-
                                                                                        amino-1-hydroxy-3-sulfo-
                                                                                        2-naphthalenyl)azo][1,1'-
                                                                                        biphenyl]-4-yl]azo]-2-  
                                                                                        hydroxy-, disodium salt 
                                                                                                                
2429-83-6                                C.I. Direct Black 4              30245        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      
                                                                                                                
2429-84-7                                C.I. Direct Red 1                22310        Benzoic acid, 5-[[4'-[(2-
                                                                                        amino-8-hydroxy-6-sulfo-
                                                                                        1-naphthalenyl)azo][1,1'-
                                                                                        biphenyl]-4-yl]azo]-2-  
                                                                                        hydroxy-, disodium salt 
                                                                                                                
2586-58-5                                C.I. Direct Brown 1:2            30110        Benzoic acid, 5-[[4'-    
                                                                                        [[2,6-diamino-3-methyl-5-
                                                                                        [(4-                    
                                                                                        sulfophenyl)azo]phenyl]a
                                                                                        zo][1,1'-biphenyl]-4-   
                                                                                        yl]azo]-2-hydroxy-,     
                                                                                        disodium salt           
                                                                                                                
2602-46-2                                C.I. Direct Blue 6               22610        2,7-Naphthalenedisulfonic
                                                                                        acid, 3,3'-[[1,1'-      
                                                                                        biphenyl]-4,4'-         
                                                                                        diylbis(azo)]bis[5-amino-
                                                                                        4-    hydroxy-,         
                                                                                        tetrasodium salt        
                                                                                                                
2893-80-3                                C.I. Direct Brown 6              30140        Benzoic acid, 5-[[4'-    
                                                                                        [[2,4-dihydroxy-3-      
                                                                                             [(4-               
                                                                                        sulfophenyl)azo]phenyl]a
                                                                                        zo][1,1'-biphenyl]-4-   
                                                                                        yl]azo]-2-hydroxy-,     
                                                                                        disodium salt           
                                                                                                                
3530-19-6                                C.I. Direct Red 37               22240        1,3-Naphthalenedisulfonic
                                                                                        acid, 8-[[4'-[(4-ethoxy 
                                                                                        phenyl)azo][1,1'-       
                                                                                        biphenyl]-4-yl]azo]-7-  
                                                                                        hydroxy-, disodium salt 
                                                                                                                
3567-65-5                                C.I. Acid Red 85                 22245        1,3-Naphthalenedisulfonic
                                                                                        acid, 7-hydroxy-8-      
                                                                                        [[4'-[[4-[[(4-          
                                                                                        methylphenyl)sulfonyl]ox
                                                                                        y]phenyl]  azo][1,1'-   
                                                                                        biphenyl]-4-yl]azo]-,   
                                                                                        disodium salt           
                                                                                                                
3626-28-6                                C.I. Direct Green 1              30280        2,7-Naphthalenedisulfonic
                                                                                        acid, 4-amino-5-        
                                                                                             hydroxy-3-[[4'-[(4-
                                                                                        hydroxyphenyl)azo][1,1'-
                                                                                           biphenyl]-4-yl]azo]-6-
                                                                                        (phenylazo)-, disodium  
                                                                                        salt                    
                                                                                                                
3811-71-0                                C.I. Direct Brown 1              30045        Benzoic acid, 5-[[4'-    
                                                                                        [[2,4-diamino-5-[(4-    
                                                                                        sulfophenyl)azo]phenyl]a
                                                                                        zo][1,1'-biphenyl]-4-yl]
                                                                                        azo]-2-hydroxy-,        
                                                                                        disodium salt           
                                                                                                                
4335-09-5                                C.I. Direct Green 6              30295        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           
                                                                                                                
6358-80-1                                C.I. Acid Black 94               30336        2,7-Naphthalenedisulfonic
                                                                                        acid, 4-amino-5-        
                                                                                        hydroxy-3-[[4'-[[4-     
                                                                                        hydroxy-2-[(2-          
                                                                                        methylphenyl)  amino]phe
                                                                                        nyl]azo][1,1'-biphenyl]-
                                                                                        4-yl]azo]-6-[(4-        
                                                                                        sulfophenyl)azo]-,      
                                                                                        trisodium salt          
                                                                                                                
6360-29-8                                C.I. Direct Brown 27             31725        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          
                                                                                                                
6360-54-9                                C.I. Direct Brown 154            30120        Benzoic acid, 5-[[4'-    
                                                                                        [[2,6-diamino-3-methyl-5-
                                                                                        [(4-                    
                                                                                        sulfophenyl)azo]phenyl]a
                                                                                        zo][1,1'-biphenyl]-4-yl]
                                                                                        azo]-2-hydroxy-3-methyl-
                                                                                        , disodium salt         
                                                                                                                
8014-91-3                                C.I. Direct Brown 74             36300        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         
                                                                                                                
16071-86-6                               C.I. Direct Brown 95             30145        Cuprate(2-), [5-[[4'-    
                                                                                        [[2,6-dihydroxy-3-[(2-  
                                                                                        hydroxy-   5-           
                                                                                        sulfophenyl)azo]phenyl]a
                                                                                        zo][1,1'-biphenyl]      
                                                                                        -4-yl]azo]-2-           
                                                                                        hydroxybenzoato(4-)]-,  
                                                                                        disodium                
                                                                                                                
----------------------------------------------------------------------------------------------------------------



[[Page 52297]]

[FR Doc. 96-25650 Filed 10-4-96; 8:45 am]
BILLING CODE 6560-50-F