[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-Hotline@epamail.epa.gov.
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:
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Examples of regulated
Category entities
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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.
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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
