[Federal Register Volume 60, Number 168 (Wednesday, August 30, 1995)]
[Proposed Rules]
[Pages 45119-45125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-21518]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50617; FRL-4762-4]
RIN 2070-AC37
Benzidine-Based Chemical Substances; Proposed Significant New
Uses of Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing a significant new use rule (SNUR) under
section 5(a)(2) of the Toxic Substances Control Act (TSCA) which would
require persons to notify EPA at least 90 days before commencing the
manufacture, import, or processing of benzidine-based chemical
substances, defined herein, for any use other than those listed in the
regulatory text of this proposed rule. EPA believes that this action is
necessary because benzidine-based chemical substances may be hazardous
to human health and that the uses governed by this proposed rule may
result in significant human exposure. The required notice would provide
EPA with the opportunity to evaluate the intended new use and
associated activities, before the benzidine-based chemical substances
can be introduced into the marketplace, and an opportunity to protect
against potentially adverse exposure before it can occur.
DATES: Written comments, in triplicate, must be received by September
29, 1995.
ADDRESSES: All comments must be sent in triplicate to: TSCA Document
Receipt Office (7407), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, Rm. E-G99, 401 M St., SW, Washington,
DC 20460. Comments that contain information claimed as confidential
must be clearly marked confidential business information (CBI). If CBI
is claimed, three additional sanitized copies must also be submitted.
Nonconfidential versions of comments on this proposed rule will be
placed in the rulemaking record and will be available for public
inspection. Comments should include the docket control number. The
docket control number for this proposed SNUR is OPPTS-50617. Unit XI.
of this preamble contains additional information on submitting comments
containing CBI.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic comments
must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect in 5.1 file format or ASCII file
format. All comments and data in electronic form must be identified by
the docket number OPPTS-50617. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in Unit XII. of this preamble.
The discussion of EPA's risk management strategy in Unit V. of this
proposed rule is included only to provide context for this SNUR, and
comments are not solicited for this unit.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxic Substances, Environmental Protection Agency, 401 M
St., SW., Rm. E-545, Washington, DC 20460, Telephone: (202) 554-1404,
TDD: (202) 554-0551, e-mail: TSCA-H[email protected].
SUPPLEMENTARY INFORMATION: The final version of this proposed SNUR
would require persons to notify EPA at least 90 days before commencing
the
[[Page 45120]]
manufacture, import, or processing of the benzidine-based chemical
substances listed in this proposed rule for any use other than those
listed in proposed Sec. 721.1660 of the regulatory text. These excepted
uses are: As a reagent to test for hydrogen peroxide in milk, as a
reagent to test for hydrogen sulfate, hydrogen cyanide, and nicotine,
as a stain in microscopy, and as a reagent for detecting blood. The
required notice would provide EPA with information needed to evaluate
this use and associated activities, and an opportunity to protect
against potentially adverse exposure to the chemical substances before
it can occur.
I. Authority
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' The Agency must make this determination by rule after
considering all relevant factors, including those listed in section
5(a)(2). Section 5(a)(2) factors generally relate to the extent to
which a use changes the volume of a chemical substance's production or
the type, form, magnitude, or duration of exposure to it. Once EPA
determines that a use of a chemical substance is a significant new use,
section 5(a)(1)(B) of TSCA requires persons to submit a significant new
use notice (SNUN) to EPA at least 90 days before they manufacture,
import, or process the chemical substance for that use (15 U.S.C.
2604(a)(1)(B)).
Persons subject to the final version of this proposed SNUR would
comply with the same notice requirements and EPA regulatory procedures
as submitters of premanufacture notices (PMNs) under section 5(a)(1)(A)
of TSCA (15 U.S.C. 2604 (a)(1)(A)). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and (d)(1), the exemptions authorized by TSCA section 5(h)(1), (2),
(3), and (5), and the regulations at 40 CFR part 720. EPA may take
regulatory action under TSCA section 5(e), 5(f), 6, or 7 to control the
activities for which it has received a SNUN (15 U.S.C. 2604 (e), (f),
2605, and 2606). If EPA does not take action, section 5(g) of TSCA
requires EPA to explain in the Federal Register its reasons for not
taking action.
Persons who intend to export a chemical substance identified in a
proposed or final SNUR are subject to the export notification
provisions of TSCA section 12(b) (15 U.S.C. 2611(b)). The regulations
that interpret section 12(b) appear at 40 CFR part 707. Persons who
intend to import a chemical substance identified in a final SNUR are
subject to the TSCA section 13 import certification requirements, and
to the regulations codified at 19 CFR 12.118 through 12.127 and 12.128.
Such persons must certify that they are in compliance with the SNUR
requirements. The EPA policy in support of import certification appears
at 40 CFR part 707.
II. Applicability of General Provisions
General regulatory provisions applicable to SNURs are codified at
40 CFR part 721, subpart A. In the Federal Register of August 17, 1988
(53 FR 31252), EPA promulgated a ``User Fee Rule'' (40 CFR part 700)
under the authority of TSCA section 26(b) (U.S.C. 2625(b)). Provisions
requiring persons submitting SNUNs to submit certain fees to EPA are
discussed in detail in that Federal Register document. Interested
persons should refer to the CFR and the cited Federal Register document
for further information.
III. Summary of This Proposed Rule
The chemical substances that are the subjects of this proposed SNUR
are benzidine-based chemical substances, which shall be defined as any
chemical substances that are listed in Table 1. of proposed
Sec. 721.1660(b) of the regulatory text.
Because the listed benzidine-based chemical substances are
currently used only in small amounts in the following manners, any new
use would greatly increase exposure to these chemicals. Therefore, EPA
is proposing to designate any use of the listed benzidine-based
chemical substances as a significant new use, other than the following
uses: Use as a reagent to test for hydrogen peroxide in milk, a reagent
to test for hydrogen sulfate, hydrogen cyanide, and nicotine, a stain
in microscopy, and as a reagent for detecting blood. These are the only
uses of benzidine-based chemical substances identified by EPA as
ongoing.
This proposed rule would require persons who intend to manufacture,
import, or process benzidine or benzidine-based chemical substances
listed in this proposed rule to notify EPA, through the submission of a
SNUN, at least 90 days before commencing the manufacture, importation,
or processing of any of these chemicals for any use designated by this
SNUR as a significant new use. The required notice would provide EPA
with the opportunity to evaluate the intended use, and, if necessary,
to prohibit or limit that use before it occurs.
IV. Background Information on Benzidine-Based Chemical Substances
Based upon information on the carcinogenicity of benzidine and
benzidine-based dyes, the Agency is concerned for all the benzidine-
based chemical substances listed in this proposed rule. Because the
molecule benzidine can only be isolated for commerce or use in the form
of salts, the term ``benzidine'' shall refer to the molecule benzidine,
CAS No. 92-87-5, as well as all benzidine salts.
Benzidine is an aromatic amine that has been used as a feedstock
for production of man-made dyes since the late 1800's. Dyestuffs were
among the first products of the developing chemical industry, and
aromatic amines were the first synthetic chemicals found to cause
cancer in humans. This was first reported in the last century, when
some workers manufacturing dyes developed bladder cancer. Benzidine was
subsequently found to be a potent carcinogen in humans and animals.
Several epidemiology studies of occupationally exposed workers have
demonstrated that benzidine exposure is associated with a high risk of
developing bladder cancer (Ref. 1). Benzidine is classified by the
International Agency for Research on Cancer (IARC) as a Group 1
carcinogen, chemicals which are known to cause cancer in humans and
animals (Ref. 2). Benzidine is also classified by the EPA as a Group A,
human carcinogen (IRIS, 1986).
Originally, only benzidine was considered to be carcinogenic.
However, studies found that dyes derived from benzidine release free
benzidine via metabolic routes (Ref. 3). The dyes were predicted to be
carcinogens based on these findings. Animal bioassays performed by the
National Cancer Institute (NCI) in 1978 confirmed that administration
of three different benzidine-based dyes each led to cancer (Ref. 4).
EPA's hazard analysis (Ref. 11) is based on studies of tested
representative benzidine-based dyes, as well as benzidine. The
overwhelming health concern for benzidine and benzidine-based dyes is
bladder cancer in humans, generally believed to be caused through any
route of exposure. As of June 1974, OSHA has required that manufacture
of benzidine be contained within a closed system (29 CFR 1910.1010:
Benzidine). In addition, the American Conference of Governmental
Industrial Hygienists (ACGIH) has classified benzidine as a
``recognized human carcinogen'' with no Threshold Limit Value (TLV)
assigned, and has recommended that
[[Page 45121]]
``all exposure to benzidine should be kept to an absolute minimum''
(ACGIH 1986).
Twelve benzidine-based dyes have been demonstrated to metabolize to
benzidine in one or more of four species (Ref. 5). National Toxicology
Program (NTP) cancer bioassays by the oral route in rodents using
Direct Black 38 (CAS No. 1937-37-7), Direct Blue 6 (CAS No. 2602-46-2),
and Direct Brown 95 (CAS No. 16071-8-6), showed dose-related and
statistically significant tumor incidence of the liver, skin, and
Zymbal gland following oral administration. The time to tumor formation
was 5 to 13 weeks. No tumors were found in the controls (Ref. 4). In
response to these and other data, the National Institute for
Occupational Safety and Health (NIOSH) and NCI have jointly recommended
that these three dyes be handled in the workplace as if they were human
carcinogens, and have suggested guidelines for minimizing employee
exposure (Ref. 6).
Bioavailability studies in Rhesus monkeys, rats, and dogs revealed
levels of benzidine in the urine, after the administration of the
above-mentioned dyes, equivalent to the levels found after
administration of a comparable volume of straight benzidine (Refs. 3
and 5). For this reason, IARC has classified these benzidine-based dyes
as Group 2A chemicals, which are carcinogenic to animals and probably
carcinogenic to humans (Refs. 1, 6, and 7). Given the consistent
results from testing these dyes, as well as known mechanistic
similarities among benzidine-based dyes, the entire class of benzidine-
based dyes is expected to have a similar degree of toxicity. In
addition, NIOSH has recommended that all benzidine-based dyes be
recognized as potential human carcinogens, based upon the evaluation of
information on the carcinogenicity and metabolism of these dyes (Ref.
8).
There are exposure issues for both the parent amines and the
finished dyes. Most available exposure data are for groups of dyes,
rather than for individuals. Inhalation, skin absorption, and ingestion
are possible routes of exposure in a variety of settings where
benzidine-based dyes are either manufactured or used. Benzidine and
monoacetyl benzidine, a metabolite, have been found in the urine of
workers making or using benzidine-based dyes in the paper, textile,
leather, and dye manufacturing industries (NIOSH, 1980). The amount of
benzidine found in the urine was more than could be accounted for by
only benzidine impurities in the dyes.
Based on models from EPA (Chemical Engineering Branch/Office of
Pollution Prevention and Toxics) and industry, reasonable exposure
estimates have been calculated for those workers who weigh powder dyes.
From these estimates, EPA predicts the highest exposure would occur for
workers who would manufacture benzidine-based dyes or who would weigh
such dyes, and is also concerned about potential exposures to workers
who would operate dyeing machinery (Ref. 9).
V. EPA's Risk Management Strategy for Benzidine-Based and Benzidine
Congener-Based Dyes and Pigments
Comments are not solicited for this unit, as it is included only to
provide context for this proposed SNUR.
This proposed SNUR is the first step in EPA's risk management
strategy for benzidine-based and benzidine congener-based dyes and
pigments.
The main objective of EPA's strategy is to reduce the risks
associated with the manufacture and use of benzidine-based and
benzidine congener-based dyes and pigments. Benzidine and benzidine-
based dyes have been phased out of commerce. The SNUR being proposed in
this document is intended to prevent the reintroduction of these
chemicals into commerce without prior notice to EPA, thus achieving
EPA's objective for these substances.
In order to complete the main objective in regards to benzidine
congener-based dyes, EPA is conducting a series of dialogues with dye
manufacturers, users, and importers, as well as labor unions,
environmental groups, and other agencies. EPA is also working with the
Organization for Economic Cooperation and Development (OECD) to
coordinate efforts internationally in dealing with these chemicals.
EPA will attempt to develop a series of Memoranda of Understanding
(MOUs) with dye manufacturers and importers to address the risk from
manufacture and use of benzidine congener-based dyes, which include
tolidine-based and nonmetallized dianisidine-based dyes. The Agency has
developed alternative strategies, in case voluntary agreements cannot
be reached. After the conclusion of these efforts, the Agency may
address metallized dianisidine-based dyes and benzidine congener-based
pigments. The MOUs are projected for completion during the next year.
VI. Objectives and Rationale for the Proposed Rule
To determine what would constitute a significant new use of
benzidine-based chemical substances, EPA considered relevant
information regarding the toxicity of the substances, likely exposure
and releases associated with potential uses, and the four factors
listed in TSCA section 5(a)(2). Benzidine has an IARC classification as
a Group 1 carcinogen, which are chemicals known to cause cancer in
humans and animals. IARC has also classified several benzidine-based
dyes as Group 2A chemicals, which are carcinogenic to animals and
probably carcinogenic to humans. The benzidine-based dyes that have not
been tested are suspected carcinogens.
The EPA has determined that there is no ongoing manufacture,
import, or processing of the listed benzidine-based chemical
substances, except for use in small amounts as a reagent to test for
hydrogen peroxide in milk, as a reagent to test for hydrogen sulfate,
hydrogen cyanide, and nicotine, as a stain in microscopy, and as a
reagent for detecting blood. Therefore, any use of these benzidine-
based chemical substances, except for those uses listed above, would
increase the volume of the chemicals' production as well as the type,
form, magnitude, or duration of exposure, and therefore can be
identified as a significant new use (Ref. 10).
Based on these considerations, EPA wishes to achieve the following
objectives with regard to the significant new uses that are designated
in this proposed rule. EPA wants to ensure that:
(1) The Agency would receive notice of any company's intent to
manufacture, import, or process benzidine-based chemical substances
listed in this proposed rule for the significant new uses identified in
this proposed rule, before that activity begins.
(2) The Agency would have an opportunity to review and evaluate
data submitted in a SNUN before the notice submitter begins
manufacturing, importing, or processing the listed benzidine-based
chemical substances for the significant new uses identified in this
proposed rule.
(3) The Agency would be able to regulate prospective manufacturers,
importers, or processors of the listed benzidine-based chemical
substances before any significant new use occurs, provided that the
degree of potential health risk is sufficient to warrant such
regulation.
The benzidine-based chemical substances listed in this proposed
rule are not currently subject to any Federal regulations that require
notification of the Federal Government of activities that might result
in adverse exposures to
[[Page 45122]]
these substances and provide a regulatory mechanism that could
adequately protect human health or the environment from potentially
adverse exposure before it occurs.
For the preceding reasons, EPA is proposing to designate any use of
benzidine-based chemical substances listed in proposed Sec. 721.1660,
except for those uses listed in proposed Sec. 721.1660(a)(2) of the
regulatory text, as significant new uses.
VII. Alternatives
Before proposing this SNUR, EPA considered the following
alternative regulatory actions for the listed benzidine-based chemical
substances.
(1) Promulgate a TSCA section 8(a) reporting rule for these
chemical substances. Under such a rule, EPA could require any person to
report information to the Agency when they intend to manufacture,
import, or process the listed benzidine-based chemical substances, for
a significant new use as listed in this proposed rule (15 U.S.C. 2607).
However, in the case of these particular chemical substances, the use
of section 8(a) rather than SNUR authority would have several
drawbacks. First, EPA would not be able to take immediate follow-up
regulatory action under TSCA section 5(e) or 5(f) to prohibit or limit
the activity. In addition, EPA may not receive important information
from small businesses, because such firms are exempt from section 8(a)
reporting requirements. In view of the level of health concern for the
listed benzidine-based chemical substances, the Agency believes that a
section 8(a) rule for those chemical substances would not meet EPA's
regulatory objectives.
(2) Regulate benzidine-based chemical substances under section 6 of
TSCA. EPA may regulate under section 6 if there is a reasonable basis
to conclude that the manufacture, importation, processing, distribution
in commerce, use, or disposal of a chemical substance or mixture
``presents or will present'' an unreasonable risk of injury to human
health or the environment. A finding of unreasonable risk indicates a
determination that the reduction of health or environmental risk
resulting from a potential regulation outweighs the regulatory burden
to society.
In the case of this proposed rule, EPA decided that a SNUR was more
appropriate than a section 6 rule because there are currently no
ongoing uses of concern to justify a section 6 ban. EPA's concerns are
for potential future uses, and the notification which would be required
by this proposed SNUR, when final, would be sufficient to allow the
Agency make the decisions necessary to protect against such uses.
VIII. Applicability of Proposed Rule to Uses Occurring Before
Effective Date of the Final Rule
EPA believes that the intent of section 5(a)(1)(B) is best served
by designating a use as a significant new use as of the proposal date
of the SNUR rather than as of the effective date of the final rule. If
uses begun during the proposal period of a SNUR were considered
ongoing, rather than new, as of the effective date, it would be
difficult for EPA to establish SNUR notice requirements, because any
person could defeat the SNUR by initiating the proposed significant new
use before the rule became final, arguing that the use was no longer
new.
Persons who begin commercial manufacture, importation, or
processing of the listed benzidine-based chemical substances for any
significant new use listed in this proposed rule between proposal and
the effective date of the SNUR must cease that activity before the
effective date of the rule. To resume their activities, these persons
would have to comply with all applicable SNUR notice requirements and
wait until the notice review period, including all extensions, expires.
If, however, persons who begin commercial manufacture, importation, or
processing of the chemical substances between proposal and the
effective date of the SNUR meet the conditions of advance compliance as
codified at Sec. 721.45(h), those persons will be considered to have
met the requirements of the final SNUR for those activities.
IX. Test Data and Other Information
EPA recognizes that under TSCA section 5, persons are not required
to develop any particular test data before submitting a SNUN. Rather,
persons are required only to submit test data in their possession or
control and to describe any other data known to or reasonably
ascertainable by them.
However, in view of the potential health risks that may be posed by
a significant new use of the listed benzidine-based chemical
substances, EPA suggests potential SNUR notice submitters conduct tests
that would permit a reasoned evaluation of risks posed by these
chemical substances when utilized for an intended use. EPA currently
believes that the results of the following tests could adequately
characterize possible health and environmental effects of the chemical
substances: Cancer bioassays, metabolism testing, and tests for
environmental fate and ecotoxicity. However, these studies may not be
the only means of identifying potential risks. SNUR notices submitted
without accompanying test data may increase the likelihood that EPA
would take action under TSCA section 5(e).
EPA encourages persons to consult with the Agency before selecting
a protocol for testing the chemical substances. As part of this
optional prenotice consultation, EPA will discuss the test data it
believes necessary to evaluate a significant new use of the chemical
substances. Test data should be developed according to TSCA Good
Laboratory Practice Standards at 40 CFR part 792. Failure to do so may
lead EPA to find such data to be insufficient to reasonably evaluate
the health or environmental effects of the chemical substances.
EPA urges SNUN submitters to provide detailed information on human
exposure or environmental release that may result from the significant
new use of the listed benzidine-based chemical substances. In addition,
EPA encourages persons to submit information on potential benefits of
the chemical substances and information on risks posed by the chemical
substances compared to risks posed by potential substitutes.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUR
reporting requirements for benzidine-based chemical substances listed
in this proposed rule. While there is no precise way to calculate the
total annual cost of compliance with this proposed rule, EPA estimates
that the reporting cost for submitting a SNUN ranges from $7,198 to
$8,170, including a $2,500 user fee. EPA believes that there will be
few, if any, SNUNs submitted. Furthermore, while the expense of a
notice and the uncertainty of possible EPA regulation may discourage
certain innovations, that impact would be limited because such factors
are unlikely to discourage an innovation that has high potential value.
The Agency's economic analysis is available in the public record for
this proposed rule (OPPTS-50617).
XI. Comments Containing Confidential Business Information
All comments will be placed in the public record unless the
commenter claims that they contain CBI, and the comments are clearly
labeled as containing claimed CBI when they are submitted. Because of
the need to expedite this process, CBI claims should be accompanied by
comments substantiating the claim, as described in
[[Page 45123]]
40 CFR 2.204(e)(4). While a part of the record, CBI comments will be
treated in accordance with 40 CFR part 2. A sanitized version of all
CBI comments should be submitted to EPA, in triplicate, for the public
file.
It is the responsibility of the commenter to comply with 40 CFR
part 2 so that all materials claimed as confidential may be properly
protected. This includes, but is not limited to, clearly indicating on
the face of the comment (as well as on any associated correspondence)
that information claimed to be CBI is included, or marking
``Confidential,'' ``TSCA CBI,'' or similar designation on the face of
each document or attachment in the comment which contains the claimed
CBI. Comments not claimed as confidential at the time of submission or
not clearly labeled as containing CBI will be placed in the public
file. EPA will consider the failure to clearly identify the claimed
confidential status on the face of the comment as a waiver of any such
claim and will make such information available to the public without
further notice to the commenter or business.
XII. Rulemaking Record
A record has been established for this rulemaking under docket
number OPPTS-50617 (including comments and data submitted
electronically as described below). The record includes basic
information considered by the Agency in developing the proposed rule.
A public version of this record, including printed, paper versions
of electronic comments, which does not include any information claimed
as CBI, is available for inspection from 12 noon to 4 p.m., Monday
through Friday, excluding legal holidays. The public record is located
in the TSCA Nonconfidential Information Center, Rm. NE-B607, 401 M St.,
SW., Washington, DC 20460.
Electronic comments can be sent directly to EPA at:
[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
EPA will accept additional materials for inclusion in the record at
any time between this proposal and designation of the complete record.
EPA will identify the complete rulemaking record by the date of
promulgation of the final rule. A public version of this record
containing nonconfidential materials is available for reviewing and
copying from 12 noon to 4 p.m., Monday through Friday, except legal
holidays, in the TSCA Nonconfidential Information Center (NCIC),
located in Rm. E-G099, 401 M St., SW., Washington, DC.
XIII. References
(1) International Agency for Research on Cancer (IARC). IARC
Monographs 1982, 29,295-310, 311-330, 321-330).
(2) IARC Monographs, Supplement 7:123-125 (1987).
(3) Rinde, E. and Troll, W. ``Metabolic reduction of benzidine azo
dyes to benzidine in the rhesus monkey.'' Journal of the National
Cancer Institute 55: 181-182 (1975).
(4) National Cancer Institute (NCI). ``13-week subchronic toxicity
studies of Direct Black 38 and Direct Brown 95 dyes.'' NCI
Carcinogenesis. Technical Report Series Number 108. 127p (1978).
(5) Lynn, R.K. et al. ``Metabolism of bisazobiphenyl dyes derived
from benzidine, 3,3'-methylbenzidine and 3,3'-dimethoxybenzidine to
carcinogenic aromatic amines in the dog and rat.'' Toxicology and
Applied Pharmacology 56:248-258 (1980).
(6) NIOSH/NCI, Current Intelligence Bulletin, 24(1,5): 7-9 (1978).
(7) IARC Monographs, Supplement 7:125-126 (1987).
(8) NIOSH, Special Occupational Hazard Review for Benzidine-Based
Dyes (1980).
(9) USEPA. 1990a (April). U.S. Environmental Protection Agency.
Textile Dye Weighing Monitopring Study. EPA 560/5-90-009 and Supplement
560/5-90-010.
(10) USEPA. Regulatory Impact Branch, USEPA/OPPT,EETD, June 1,
1993. ``Production, Uses, and Imports of Benzidine and Benzidine Based
Chemicals.'' Prepared by Meridian Research, Inc.
(11) USEPA. Chemical Screening and Risk Assessment Division.
``Benzidine/Benzidine Congener Dyes Support Document, October 24, 1994.
XIV. Regulatory Assessment Requirements
A. Executive Order 12866
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether the regulatory action is ``significant''
and therefore subject to review by the Office of Management and Budget
(OMB) and the requirements of the Executive Order. Under section 3(f),
the order defines a ``significant regulatory action'' as an action
likely to result in a rule:
(1) Having an annual effect on the economy of $100 million or more,
or adversely and materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or State, local or tribal governments or communities (also
referred to as ``economically significant'').
(2) Creating serious inconsistency or otherwise interfering with an
action taken or planned by another agency.
(3) Materially altering the budgetary impacts of entitlement,
grants, user fees, or loan programs or the rights and obligations of
the recipient thereof.
(4) Raising novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this order.
Pursuant to the terms of this Executive Order, it has been
determined that this proposed rule is not ``significant'' and is
therefore not subject to OMB review.
B. Regulatory Flexibility Act
Under the Regulatory Flexibility Act (RFA) 5 U.S.C. 601-612, EPA is
required to consider whether a regulatory action will have an impact on
small entities. If the Administrator certifies that the rule, if
promulgated, will not have a significant economic impact on a
substantial number of small entities, then the RFA does not require the
EPA to prepare an initial regulatory flexibility analysis (5 U.S.C.
605(b)). Under EPA policy, however, when a proposed rule would have any
adverse economic impact on any number of small entities, then EPA will
conduct an initial regulatory flexibility analysis that contains an
appropriate level of detail. (Habicht, memorandum: Revised Guidelines
for Implementing the Regulatory Flexibility Act, EPA, Office of the
Administrator, April 9, 1992). EPA has determined that this proposed
rule would not have a significant impact on small businesses, but it
may have some, minimal, impact in the future.
Consequently, EPA has analyzed the impact of the proposed rule on
small entities based upon the criteria in the
[[Page 45124]]
Regulatory Flexibility Act. In the SUMMARY unit of this preamble, EPA
describes reasons why it is considering taking the proposed action and
the objectives of, and legal basis for, the proposed SNUR. This SNUR
would apply to any small or large business that may wish to engage in
the significant new use described in the proposed rule. It appears that
no small or large businesses are currently engaged in activity that is
the subject of this proposed rule. Although there may be some small
businesses that may decide to conduct such activities in the future, it
is not possible at this time to determine for certain how many, if any,
there may be. Based upon past experiences, EPA expects to receive few,
if any, SNUNs from either small or large businesses in response to this
proposed SNUR. As of September 1992, the Agency had received no SNUNs
in response to any SNURs promulgated by EPA in the past. Unit XIV.C.
and the Economic Analysis to support this SNUR (docket number OPPTS-
50617) describe the reporting and other requirements of this proposed
rule and the costs of compliance. There are no existing Federal rules
that may duplicate, overlap, or conflict with this proposal. Finally
there are no significant alternatives to this proposed rule that
minimize economic impacts on small businesses and accomplish the
statutory objective of insuring that EPA has an opportunity to review
and evaluate the risks associated with a new use to determine whether
further regulatory activity is necessary.
C. Unfunded Mandate Reform Act
EPA has determined that this proposed rule does not contain
regulatory requirements that might significantly or uniquely affect
small governments and does not contain a Federal mandate that may
result in expenditures of $100 million or more for State, local, and
tribal governments, in the aggregate, or the private sector in any one
year. Thus this proposed rule is not subject to the requirements of
sections 202, 203, and 205 of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4).
D. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in this proposed rule under the provisions of the Paperwork Reduction
Act (44 U.S.C. 3501 et seq.) and has assigned OMB control number 2070-
0038. Public reporting burden for this collection of information is
estimated to vary from 94 to 113 hours per response, with an average of
103 hours per response, including time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for reducing this
burden, to Chief, Information Policy Branch (2131), U.S. Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460; and to Office
of Information and Regulatory Affairs, Office of Management and Budget,
Washington, DC 20503, marked ``Attention: Desk Officer for EPA.'' The
final rule will respond to any OMB or public comments on the
information requirements contained in this proposal.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials, Reporting
and rcordkeeping requirements, Significant new uses.
Dated: August 23, 1995.
Charles M. Auer,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, it is proposed that 40 CFR part 721 be amended as
follows:
PART 721--[AMENDED]
1. The authority citation for part 721 would continue to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(e).
2. By adding new Sec. 721.1660 to subpart E to read as follows:
Sec. 721.1660 Benzidine-based chemical substances.
(a) Chemical substances and significant new uses subject to
reporting. (1) Benzidine-based chemical substances, which shall be
defined as any chemical substances that are listed in Table 1. under
paragraph (b) of this section, are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are: Any use other than: As a reagent
to test for hydrogen peroxide in milk, as a reagent to test for
hydrogen sulfate, hydrogen cyanide, and nicotine, as a stain in
microscopy, and as a reagent for detecting blood.
(b) List of substances. The following Table 1. lists the benzidine-
based substances covered by this section.
[[Page 45125]]
Table 1.--Benzidine-based Chemical Substances
----------------------------------------------------------------------------------------------------------------
Chemical name C.I. Number CAS Number Chemical name C.I. Number CAS Number
----------------------------------------------------------------------------------------------------------------
Acid Red 85.......... 22245 3567-65-5 C.I. Direct Brown 190 31750 Unknown
Benzidine............ n/a 92-87-5 C.I. Direct Brown 215 35720 83606-72-8
Benzidine.Ni2+....... n/a 67632-50-2 C.I. Direct Green 7.. 30330 6360-64-1
Benzidine.HCL........ n/a 75752-15-7 C.I. Direct Green 8.. 30315 5422-17-3
Benzidine.2HCL....... n/a 531-85-1 C.I. Direct Green 9.. 30310 6360-62-9
Benzidine.2HF........ n/a 41766-73-8 C.I. Direct Green 10. 30285 6360-61-8
Benzidine.2HI........ n/a 75534-79-1 C.I. Direct Green 12. 30290 6486-55-1
Benzidine.HDAC....... n/a 52754-64-0 C.I. Direct Green 19. 30305 6486-58-4
C.I. Acid Black 66... 30275 6360-59-4 C.I. Direct Green 21. 31790 8003-52-9
C.I. Acid Black 69... 30260 6486-53-9 C.I. Direct Green 22. 31775 6860-33-4
C.I. Acid Black 70... 30355 8005-88-7 C.I. Direct Green 39. 30220 6360-57-2
C.I. Acid Black 94... 30336 6358-80-1 C.I. Direct Green 58. 30225 110735-26-7
C.I. Acid Red 323.... 22238 6358-34-5 C.I. Direct Green 60. 22315 6426-56-8
C.I. Brown 165....... 22045 6486-32-4 C.I. Direct Orange 25 22135 6486-43-7
C.I. Direct Black 11. 30240 6486-52-8 C.I. Direct Orange 2. 22380 8005-97-8
C.I. Direct Black 14. 30345 4656-30-8 C.I. Direct Orange 33 22385 13190-99-3
C.I. Direct Black 15. 22620 6426-75-1 C.I. Direct Orange 43 22193 Unknown
C.I. Direct Black 27. 31810 6360-39-0 C.I. Direct Orange 22190 6528-39-8
102.
C.I. Direct Black 29. 22580 3626-23-1 C.I. Direct Red 10... 22145 2427-70-1
C.I. Direct Black 34. 35075 6473-08-1 C.I. Direct Red 13... 22155 1937-35-5
C.I. Direct Black 40. 31760 6449-81-6 C.I. Direct Red 17... 22150 2769-07-5
C.I. Direct Black 41. 30260 6486-53-9 C.I. Direct Red 18... 22280 6548-26-1
C.I. Direct Black 83. 31850 6837-80-5 C.I. Direct Red 29... 22305 6426-54-6
C.I. Direct Black 100 35415 6358-73-2 C.I. Direct Red 33... 22306 6253-15-2
C.I. Direct Black 131 30270 6486-54-0 C.I. Direct Red 42... 22180 6548-39-6
C.I. Direct Blue 11.. 30350 6451-04-3 C.I. Direct Red 43... 22205 6486-50-6
C.I. Direct Blue 16.. 22475 6426-66-0 C.I. Direct Red 44... 22500 2302-97-8
C.I. Direct Blue 19.. 22485 6426-68-2 C.I. Direct Red 52... 22290 6797-93-9
C.I. Direct Blue 38.. 30090 1324-83-0 C.I. Direct Red 53... 22405 6375-58-2
C.I. Direct Blue 42.. 22505 6426-71-7 C.I. Direct Red 59... 22420 6655-94-3
C.I. Direct Blue 43.. 30205 7273-59-8 C.I. Direct Red 60... 22200 6486-49-3
C.I. Direct Blue 48.. 22565 6459-89-8 C.I. Direct Red 74... 22170 8003-75-6
C.I. Direct Blue 49.. 22540 6426-73-9 C.I. Direct Red 84... 22360 6459-86-5
C.I. Direct Blue 51.. 30340 6360-65-2 C.I. Direct Violet 3. 22445 6507-83-1
C.I. Direct Blue 58.. 22490 6426-69-3 C.I. Direct Violet 4. 22555 6472-95-3
C.I. Direct Blue 64.. 22595 6426-74-0 C.I. Direct Violet 12 22550 2429-75-6
C.I. Direct Blue 131. 35085 6661-39-8 C.I. Direct Violet 17 22465 6426-65-4
C.I. Direct Blue 177. 22625 6426-76-2 C.I. Direct Violet 27 22460 6426-64-8
C.I. Direct Blue 230. 22455 6527-65-7 C.I. Direct Violet 36 22470 6472-94-2
C.I. Direct Brown 5.. 30135 6844-77-5 C.I. Direct Violet 38 22630 6426-77-3
C.I. Direct Brown 7.. 30035 6837-86-1 C.I. Direct Violet 42 22450 6459-88-7
C.I. Direct Brown 13. 35710 8003-82-5 C.I. Direct Violet 43 22440 6426-63-7
C.I. Direct Brown 14. 35715 8002-97-9 C.I. Direct Violet 45 22510 6426-72-8
C.I. Direct Brown 17. 30100 6661-48-9 C.I. Direct Violet 85 22520 6507-84-2
C.I. Direct Brown 20. 30060 1324-67-0 C.I. Direct Violet 88 22046 6358-33-4
C.I. Direct Brown 21. 30155 6442-05-3 C.I. Direct Yellow 1. 22250 6472-91-9
C.I. Direct Brown 24. 31700 8003-74-5 C.I. Direct Yellow 20 22410 6426-62-6
C.I. Direct Brown 25. 36030 33363-87-0 C.I. Direct Yellow 24 22010 6486-29-9
C.I. Direct Brown 26. 31730 8003-55-2 Direct Black 4....... 30245 2429-83-6
C.I. Direct Brown 27. 31725 6360-29-8 Direct Black 38...... 30235 1937-37-7
C.I. Direct Brown 33. 35520 1324-87-4 Direct Blue 2........ 22590 2425-73-4
C.I. Direct Brown 39. 35060 6473-06-9 Direct Blue 6........ 22610 2602-46-2
C.I. Direct Brown 43. 35700 6471-44-9 Direct Brown 1....... 30045 3811-71-0
C.I. Direct Brown 46. 31785 8003-51-8 Direct Brown 1.2..... 30110 2586-58-5
C.I. Direct Brown 51. 31710 4623-91-0 Direct Brown 2....... 22311 2429-82-5
C.I. Direct Brown 54. 31735 8003-50-7 Direct Brown 6....... 30140 2883-80-3
C.I. Direct Brown 56. 22040 6486-31-3 Direct Brown 31...... 35660 2429-81-4
C.I. Direct Brown 57. 31705 6360-28-7 Direct Brown 59...... 22345 3476-90-2
C.I. Direct Brown 58. 22340 6426-59-1 Direct Brown 74...... 36300 8014-71-3
C.I. Direct Brown 60. 22325 6426-57-9 Direct Brown 95...... 30145 16071-86-6
C.I. Direct Brown 61. 30055 6505-33-5 Direct Brown 154..... 30120 6360-54-9
C.I. Direct Brown 62. 31720 8003-56-3 Direct Green 1....... 30280 3626-28-6
C.I. Direct Brown 68. 30125 6449-85-0 Direct Green 6....... 30295 4335-09-5
C.I. Direct Brown 70. 35530 6428-42-8 Direct Green 8....... 30315 5422-17-3
C.I. Direct Brown 73. 35535 6428-43-9 Direct Orange 1...... Mixture 54579-28-1
C.I. Direct Brown 75. 30325 1324-84-1 22370 6459-87-6
C.I. Direct Brown 79. 30050 6483-77-8 22375 13164-93-7
C.I. Direct Brown 86. 22030 6486-30-0 22430 6472-93-1
C.I. Direct Brown 101 31740 8626-29-7 Direct Orange 8...... 22130 2429-79-0
C.I. Direct Brown 138 30070 6449-84-9 Direct Red 1......... 22310 2429-84-7
C.I. Direct Brown 151 31685 10130-38-8 Direct Red 28........ 22120 573-58-0
C.I. Direct Brown 159 31755 10214-11-6 Direct Red 37........ 22240 3530-19-6
C.I. Direct Brown 171 30040 Unknown Direct Violet 1...... 22570 2586-60-9
C.I. Direct Brown 173 30165 6826-64-8 Direct Violet 22..... 22480 6426-67-1
C.I. Direct Brown 175 30150 6528-58-1
----------------------------------------------------------------------------------------------------------------
[FR Doc. 95-21518 Filed 8-29-95; 8:45 am]
BILLING CODE 6560-50-F