[Federal Register Volume 59, Number 162 (Tuesday, August 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20688]
[[Page Unknown]]
[Federal Register: August 23, 1994]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[OPPTS-50571A; FRL-4896-6]
Certain Aromatic Ether Diamines; Significant New Use Rule
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)(2) of the Toxic Substances Control Act (TSCA) which will
require certain persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of the following
chemical substances for the uses identified in this preamble:
Benzenamine, 4,4'-[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis- (CAS Number
94148-67-1, premanufacture notice (PMN) P-85-335); 1,2,4,5-
benzenetetracarboxylic acid, diethyl ester, compound with 4,4'-[[1,1'-
biphenyl]-2,5-diylbis(oxy)]bis[benzenamine] (1:1) (PMN P-85-336); and
1,2,4,5-benzenetetracarboxylic acid, 1,4-diethyl ester, compound with
4,4'-[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis[benzenamine] (1:1), polymer
with 4,4'-[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis[benzenamine]-1,5-
diethyl-1,2,4,5-benzenetetracarboxylate (1:1), reaction products with
phthalic anhydride (CAS number 130097-33-5, PMN P-86-1153). These
substances are identified generically as certain aromatic ether
diamines. Hereinafter, these substances will be referred to by their
respective PMN numbers. For P-85-336, the significant new use is any
use; for P-85-335 and P-86-1153, the significant new uses are the
manufacture, import, or processing in quantities of 100,000 pounds per
year, or greater, and 225,000 pounds per year, or greater,
respectively, for any use. EPA believes that this action is necessary
because these chemical substances may be hazardous to human health and
the uses identified in this rule may result in significant human
exposures. The required notice will provide EPA with the opportunity to
evaluate the intended use and associated activities, and an opportunity
to protect against potentially adverse exposure before it can occur.
DATES: This rule becomes effective on October 6, 1994. In accordance
with 40 CFR 23.5, this rule shall be promulgated for purposes of
judicial review at 1 p.m. eastern time on September 6, 1994.
FOR FURTHER INFORMATION CONTACT: Susan B. Hazen, Director,
Environmental Assistance Division (7408), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW.,
Rm. E-545, Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202)
554-0551.
SUPPLEMENTARY INFORMATION: This SNUR for P-85-335, P-85-336, and
P-86-1153 requires persons to notify EPA at least 90 days before
commencing the manufacture, import, or processing of these substances
for the significant new uses described in this final rule. The required
notice will provide EPA with the information needed to evaluate an
intended use and associated activities, and an opportunity to protect
against unreasonable risks related to exposure to P-85-335, P-85-336,
and P-86-1153 before it can occur. This rule was proposed in the
Federal Register of May 30, 1990 (55 FR 21887). Since proposal, the
TSCA Inventory chemical name for P-85-336 has been amended; the new
name is used in this preamble. Additionally, the chemical substance
1,2,4,5-benzenetetracar-boxylic acid, 1,4-diethyl ester, compound with
4,4'-[[1,1'-biphenyl]-2,5-diylbis (oxy)]bis[benzenamine] (1:1), polymer
with 4,4'-[[1,1'-biphenyl]-2,5-diylbis (oxy)]bis[benzenamine]-1,5-
diethyl-1,2,4,5-benzenetetracarboxylate (1:1), the subject of PMN P-85-
337, which was also included in the proposed SNUR, is not included in
this final rule. EPA is not issuing a final SNUR on P-85-337 for
reasons described in Unit V. of this preamble. This final rule serves
to terminate the TSCA section 12(b) export notification requirements
for P-85-337 that were triggered by the proposed SNUR. Finally, since
proposal, the significant new use reporting triggers for P-85-335 and
P-86-1153 have been waived as claims of confidential business
information (CBI). These reporting triggers are now included in the
regulatory text 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.'' EPA 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's production or to 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 notice to EPA at least 90 days before they
manufacture, import, or process the chemical substance for that use.
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. In
particular, these requirements include the information submission
requirements of section 5(b) and (d)(1), the exemptions authorized by
section 5(h)(1), (2), (3), and (5), and the regulations at 40 CFR part
720. EPA may take regulatory action under section 5(e), 5(f), 6, or 7
to control the activities for which it has received a significant new
use notice (SNUN). 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). The regulations that interpret
section 12(b) appear at 40 CFR part 707. Persons who intend to import a
chemical substance are subject to the TSCA section 13 import
certification requirements, which are codified at 19 CFR 12.118 through
12.127 and 127.28. Persons who import a chemical substance identified
in a final SNUR must certify that they are in compliance with the SNUR
requirements. The EPA policy in support of the importation
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). 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 Rule
The chemical substances which are the subjects of this final SNUR
are P-85-335, P-85-336, and P-86-1153. EPA is designating the
manufacture, import, or processing of P-85-336 for any use as a
significant new use. For P-85-335 and P-86-1153, EPA is designating the
manufacture, import, or processing in quantities of 100,000 pounds per
year, or greater, and 225,000 pounds per year, or greater,
respectively, for any use as significant new uses. This rule requires
persons intending to manufacture, import, or process the chemical
substances identified in this rule to submit a SNUN to EPA at least 90
days before they manufacture, import, or process these substances for
the significant new uses described above. With regard to P-85-337,
because EPA's concerns for the subject substances relate to the free
diamine and P-85-337 has no free diamine, EPA has decided not to issue
a final SNUR for P-85-337.
IV. Background Information on P-85-335, P-85-336, and P-86-1153
Background information on the regulatory history, production, use,
health effects, and exposure for P-85-335, P-85-336, and P-86-1153
appears in the preamble to the proposed rule. Interested persons should
refer to that document for further information.
V. Responses to Comments and Other Information Received Subsequent
to SNUR Proposal
One company submitted comments in response to the proposed rule. In
summary, the commenter believes that the proposed SNUR should be
withdrawn because of the industrial hygiene practices associated with
the substances' production, and the company's belief that the materials
are made and used safely. Additionally, the commenter believes the
proposed SNUR should be modified to reflect the absence of free diamine
in P-85-337, and that processors and customer/users should be exempt
from the SNUR requirements because of test data on P-85-335 and P-86-
1153 that indicate dermal exposure does not cause retinotoxic effects.
EPA disagrees with the comment submitter that the proposed SNUR
should be withdrawn in its entirety. Notwithstanding the status of the
industrial hygiene practices associated with the substances' past or
current production and use, EPA believes the designated significant new
uses for P-85-335, P-85-336, and P-86-1153 may increase the magnitude
and duration of exposure to the substances over that which currently
exists. EPA's concerns regarding potentially significant human
exposures that could be associated with the designated significant new
uses and EPA's belief that the chemical substances may be hazardous to
human health, provide more than an adequate basis for this rule.
As stated above with regard to P-85-337, because EPA's concerns for
the subject substances relate to the free diamine and P-85-337 has no
free diamine, EPA has decided not to issue a final SNUR for P-85-337.
Certain test data received from the commenter on P-85-335 and P-86-
1153 subsequent to the subject SNUR proposal suggest that the
substances are not likely to be absorbed through the skin in amounts
sufficient to produce retinopathy in rats. These data indicate that a
previous report of retinopathy following dermal administration of P-85-
335 was compromised because the test animals were also orally exposed
as a result of ingestion of the diamine from the application site.
Based on these data, the commenter argues that dermal exposure is not a
problem and asks that processors and users be exempted from the SNUR.
EPA believes such an action would be inappropriate. Exposures to the
subject substances during processing and use could potentially occur by
inhalation or orally, as well as by the dermal route. Consideration and
analysis of the potential routes of exposure associated with any
significant new use would be part of the SNUN review process. Any
regulatory follow-up action taken in response to a SNUN would take into
account exposures, or lack thereof, associated with the processing or
use of a substance. (It should be noted that only manufacturers,
importers, and processors are subject to SNURs; chemical substance
users who are not also manufacturers, importers, or processors are not
subject to the SNUR notification provisions.)
The commenter also questioned EPA's use, in the preamble of the
proposed rule, of a structure-activity analogy between P-85-335 and
nitrofen (CAS Number 1836-75-5) to support a concern for developmental
toxicity for the subject substances. In support of its position, the
commenter cited a study on unchlorinated and monochlorinated nitrofen
analogues where teratogenicity was either greatly reduced or absent as
compared to nitrofen (Francis, Toxicology 40:297-309 (1986)).
Additionally, the commenter cited a study that indicated both the
number and position of chlorine substitutes had an effect on potential
teratogenicity, although no simple structural relationship was found
between position of chlorine substitutes and the effect (Francis,
Teratology 41:443-51 (1990)).
EPA believes that the Francis studies, by themselves, are
inadequate to discount the potential developmental toxicity of the
subject substances. This 1986 study used too few animals per dose group
(8-13), whereas an adequate developmental toxicity study generally
requires 20 pregnant animals, and the highest dose tested for each
nitrofen analogue was insufficient to produce maternal toxicity.
Also, the study evaluated effects using only one mammalian species,
the mouse. According to EPA's Guidelines for Developmental Toxicity
Risk Assessment (56 FR 63798), the minimum evidence to determine that
an agent is unlikely to pose a hazard for developmental toxicity would
generally include data from appropriate, well-executed laboratory
animal studies in several species (at least two) which evaluated a
variety of the potential manifestations of developmental toxicity and
showed no adverse developmental effects at doses that were minimally
toxic to the adult animal.
Regarding EPA's rationale for issuing the SNUR, the comment
submitter disagreed with EPA's statement in the preamble to the
proposed rule that the subject substances are currently subject to no
regulation that would require notification to the Federal Government of
activities that might result in adverse exposures to the substances, or
provide a regulatory mechanism that could protect human health or the
environment from potentially adverse exposures before they occurred.
The commenter stated that EPA and OSHA have exercised their current
regulatory authority over these compounds through existing laws, site
audits, and information gathering. Notwithstanding this, the commenter
did not point to any regulatory mechanism that currently mandates prior
notification to the Federal Government of activities associated with
the subject substances that may result in new adverse exposures and
that provides the opportunity to prevent such exposures before they
occur.
Finally, the commenter believes that because EPA has not evaluated
all chemicals that may compete with the subject substances to the same
extent as the subject substances, EPA should not issue the final SNUR.
EPA disagrees. EPA is not required to evaluate all substances that may
compete with a chemical substance before taking a SNUR action on that
chemical substance. As discussed in the preamble to the proposed rule,
EPA received information under TSCA section 8(e) on P-85-335. This
information triggered EPA's review of P-85-335, as well as P-85-336, P-
85-337, and P-86-1153 because of their structural relationship to P-85-
335. EPA has not received information indicating a potential
substantial risk on materials known to compete with the subject
substances. The Agency believes it is not required to direct equal
resources to evaluating a substance solely on the basis that it
competes with another substance receiving regulatory attention. EPA is
taking action on this substance due to section 8(e) reports received by
the Agency indicating possible risk.
VI. Objectives and Rationale for This Rule
To determine what would constitute a significant new use of P-85-
335, P-85-336, and P-86-1153, EPA considered relevant information
on the toxicity of the chemical substances, likely exposures associated
with possible uses, and the four factors listed in section 5(a)(2) of
TSCA. Based on these considerations, EPA wishes to achieve the
following objectives with regard to the significant new uses that are
designated in this rule. EPA wants to ensure that:
(1) The Agency will receive notice of any company's intent to
manufacture, import, or process P-85-335, P-85-336, and P-86-1153 for a
significant new use before that activity begins.
(2) The Agency will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing,
importing, or processing P-85-335, P-85-336, and P-86-1153 for the
significant new use.
(3) The Agency will be able to regulate prospective manufacturers,
importers, or processors of P-85-335, P-85-336, and P-86-1153 before a
significant new use of those substances occurs, provided that the
degree of potential health and environmental risk is sufficient to
warrant such regulation. Currently, P-85-335, P-85-336, and P-86-1153
are subject to no regulation that requires prior notification to the
Federal Government of activities that might result in new adverse
exposures to these substances, or provides a regulatory mechanism that
could protect human health or the environment from potentially adverse
exposures, before they occur.
EPA has received no TSCA section 5 Notice of Commencement of
Manufacture for P-85-336 and therefore concludes that there is no
ongoing commercial use of the substance. EPA believes that any use of
P-85-336 may increase the magnitude and duration of exposure to the
substance over that which currently exists. In light of the toxicity/
potential toxicity of P-85-336, and for EPA to have the opportunity to
evaluate any intended use and potential exposures associated with such
use before that activity begins, EPA is designating ``any use'' as a
significant new use for P-85-336. EPA believes that it is appropriate
to designate ``any use'' as a significant new use for P-85-336 because
a substantial period of time (more than 9 years) has elapsed since the
original PMN submission, the substance has not been manufactured or
imported commercially during that time, and the section 8(e) data were
received well after PMN review ended.
The significant new uses being designated for both P-85-335 and P-
86-1153 are manufacture, import, or processing in volumes of 100,000
pounds per year, or greater, and 225,000 pounds per year, or greater,
respectively, for any use. These significant new uses, determined on a
company-specific basis, represent a substantial increase in the ongoing
manufacture, import, or processing volumes. EPA has determined that the
manufacture, import, or processing of P-85-335 and P-86-1153 at levels
at or above the volumes designated as significant new uses could
significantly increase the magnitude and/or duration of human exposure
to these substances over that which currently exists. EPA believes
exposures to these chemical substances associated with manufacturing,
importing, processing, use and associated activities could increase
should manufacturing, importing, or processing volumes equal or exceed
the volumes designated as significant new uses. EPA considers it is
necessary to review chemical manufacture, import, or processing
associated with new uses to ensure EPA has an opportunity to protect
against potentially adverse exposure before it can occur. Further
discussion of the rationale on which EPA bases its significant new use
determinations for P-85-335 and P-86-1153 will not be included in this
rule as it is derived from information claimed as CBI. A sanitized copy
of the document describing the rationale for the significant new use
determinations is available in the public record for this rule.
Given the toxicity and/or potential toxicity of these substances,
the reasonably anticipated situations that could result in exposure,
and the lack of sufficient regulatory controls, individuals could be
exposed to P-85-335, P-85-336, and P-86-1153 at levels which may result
in unreasonable risks. For the foregoing reasons, EPA is designating
significant new uses for P-85-335, P-85-336, and P-86-1153 as set forth
in Sec. 721.825(a)(2), (a)(3), and (a)(4) of the regulatory text.
VII. Alternatives
In the proposed SNUR, EPA considered alternative regulatory actions
for P-85-335, P-85-336, and P-86-1153, including a section 8(a)
reporting rule and a section 6 rule. For the reasons discussed in the
preamble to the proposed rule and elsewhere herein, EPA has decided to
proceed with the promulgation of a SNUR for these chemical substances.
VIII. Applicability of 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
as of the effective date, it would be difficult for EPA to establish
SNUN requirements, because any person could defeat the SNUR by
initiating the proposed significant new use before the rule became
effective, arguing that the use is no longer new.
Persons who began commercial manufacture, importation, or
processing of P-85-335, P-85-336, and P-86-1153 for the significant new
uses described in this rule between May 30, 1990, the date of the
proposal, and the effective date of this SNUR were notified in the
proposal that they must cease that activity before the effective date
of this rule. An exception to this general requirement appears at
Sec. 721.45(h). If a person met the conditions of advance compliance as
codified at Sec. 721.45(h), the person will be considered to have met
the requirements of the final SNUR for those activities. If persons who
began commercial manufacture, importation, or processing of the
chemical substance subject to the SNUR between proposal and the
effective date of the SNUR have not met the conditions of advance
compliance, they are required to cease that activity before the
effective date of the rule. To resume their activities, these persons
must comply with all applicable SNUN requirements and wait until the
notice review period, including all extensions, expires.
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 P-85-335, P-85-336, and P-86-1153, EPA
suggests potential SNUN submitters consider conducting tests that would
permit a reasoned evaluation of risks posed by P-85-335, P-85-336, and
P-86-1153 when utilized for an intended use. SNUNs submitted without
accompanying test data may increase the likelihood that EPA would take
action under section 5(e).
EPA encourages persons to consult with EPA before selecting a
protocol for testing P-85-335, P-85-336, and P-86-1153. As part of this
optional pre-notice consultation, EPA will discuss the test data it
believes necessary to evaluate a significant new use of the chemical
substance. 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 evaluate reasonably
the health or environmental effects of the chemical substance.
EPA urges SNUN submitters to provide detailed information on human
exposure or environmental release that may result from the significant
new use of P-85-335, P-85-336, and P-86-1153. In addition, EPA
encourages persons to submit information on potential benefits of the
chemical substance and information on risks posed by the chemical
substance compared to risks posed by potential substitutes.
X. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for P-85-335, P-85-336, and, P-86-1153. EPA believes that
costs imposed by the promulgation of this SNUR are not significant.
There are no known producers other than the PMN submitters. Agency
costs can be divided into three components: Issuing the SNUR, which has
a cost of $12,233 to $23,790; reviewing the SNUN, which has a cost of
$9,650; and modifying the SNUR, which has a cost of $10,323. Direct and
indirect costs to industry are uncertain, in some instances too
uncertain to estimate. The Agency estimates that the costs incurred by
industry would be those involved in submitting a SNUN, which are
estimated to be $2,133 to $10,323 per notice, as well as the related
costs due to delays in initiating the production and use of a chemical.
EPA's complete economic analysis is available in the public record for
this rule (OPPTS-50571A).
XI. Rulemaking Record
EPA has established a record for this rulemaking (docket control
number OPPTS-50571A). A public version of the record, without any CBI,
is available in the TSCA Nonconfidential Information Center (NCIC),
also known as, TSCA Public Docket Office, from 12 noon to 4 p.m.,
Monday through Friday, except legal holidays. NCIC is located in Rm.
NE-B607, 401 M St., SW., Washington, DC 20460. The record includes the
following basic information considered by the Agency in developing this
rule:
(1) USEPA, ``Certain Aromatic Ether Diamines; Proposed Significant
New Uses of Chemical Substances.'' (May 30, 1990, 55 FR 21887).
(2) USEPA, ``Certain Aromatic Ether Diamines; Proposed Significant
New Uses of Chemical Substances.'' Extension of Comment Period. (July
9, 1990, 55 FR 28063).
(3) USEPA, OPPT, EETD. Economic Analysis of Proposed Significant
New Use Rule for Certain Aromatic Ether Diamines. (October 1989).
(4) Comments received in response to rule proposal. The following
(5-19) are submissions received under TSCA 8(e). (8EHQ-1085-0571 S et
seq. submissions for Aromatic Ether Diamines.)
(5) Letter with attached notice of October 21, 1985, relating to
subchronic inhalation study of an aromatic diamine. (November 18,
1985).
(6) Additional information to be used by EPA in evaluating aromatic
diamines (January 10, 1986).
(7) Response to letter of December 10, 1985, requesting
confidentiality substantiation for a submission (January 10, 1986).
(8) Final report on the 2-week inhalation study of aromatic diamine
(February 14, 1986).
(9) Industrial hygiene monitoring study on aromatic diamine dated
September 4, 1986 (September 12, 1986).
(10) Ocular pathology and skin irritation studies with aromatic
diamine (January 26, 1987).
(11) Summary of Acute Toxicity Studies with Aromatic Diamine (March
5, 1987).
(12) Ocular toxicity produced by the aromatic diamine following
acute dermal and inhalation exposure in rats and acute oral exposure in
rabbits (May 22, 1987).
(13) Letter regarding studies with aromatic diamines (November 15,
1988).
(14) Copies of labels for aromatic ether diamine and mixtures
containing the chemical (January 17, 1989).
(15) Waiver of confidentiality claim by DuPont (June 16, 1989).
(16) Results of additional studies with aromatic ether diamine
(September 16, 1989).
(17) Ocular Pathology in Rats After Dermal Application of 2-Phenyl-
APB-144 (July 29, 1991).
(18) Ocular Pathology in Rats After Dermal Application of Avimid K
Prepreg (July 29, 1991).
(19) Final Report. 2-Phenyl-APB-144: Species Comparisons of In
Vitro Skin Penetration Following a Single Application to the Excised
Skin of Humans, New Zealand White Rabbits and CD1B Rats. (April 14,
1994).
(20) Letter from DuPont waiving busines confidentiality claims for
the proposed SNUR production trigger volume limits (August 8, 1994).
XII. Regulatory 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 that
is 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 recipients
thereof; or, (4) raising novel legal or policy issues arising out of
legal mandates, the President's priorities, or the principles set forth
in the Executive Order.
Pursuant to the terms of this Executive Order, 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 (5 U.S.C. 605(b)), EPA has
determined that this rule would not have a significant impact on a
substantial number of small businesses. EPA has not determined whether
parties affected by this rule would likely be small businesses.
However, EPA expects to receive few SNUNs for the substances.
Therefore, the Agency believes that the number of small businesses
affected by the rule would not be substantial, even if all of the SNUN
submitters were small firms.
C. Paperwork Reduction Act
OMB has approved the information collection requirements contained
in the rule under the provisions of the Paperwork Reduction Act, 44
U.S.C. 3501 et. seq., and has assigned OMB control number 2070-0038 for
P-85-335 and P-86-1153 and OMB control number 2070-0012 for P-85-
336, which has not yet been produced commercially.
Public reporting burden for this collection of information is
estimated to vary from 30 to 170 hours per response, with an average of
100 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.
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous materials, Reporting
and recordkeeping requirements, Significant new uses.
Dated: August 15, 1994.
Joseph A. Carra,
Acting Director, Office of Pollution Prevention and Toxics.
Therefore, 40 CFR part 721 is amended as follows:
PART 721--[AMENDED]
1. The authority citation for part 721 continues to read as
follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
2. By adding new Sec. 721.825 to subpart E to read as follows:
Sec. 721.825 Certain aromatic ether diamines.
(a) Chemical substances and significant new uses subject to
reporting. (1) The following chemical substances are subject to
reporting under this section for the significant new uses described in
paragraphs (a)(2), (a)(3), and (a)(4) of this section: Benzenamine,
4,4'-[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis- (CAS Number 94148-67-1,
Premanufacture notice (PMN) P-85-335); 1,2,4,5-benzenetetracarboxylic
acid, diethyl ester, compound with 4,4'-[[1,1'-biphenyl]-2,5-
diylbis(oxy)]bis[benzenamine] (1:1) (PMN P-85-336); and 1,2,4,5-
benzenetetracarboxylic acid, 1,4-diethyl ester, compound with 4,4'-
[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis[benzenamine] (1:1), polymer with
4,4'-[[1,1'-biphenyl]-2,5-diylbis(oxy)]bis[benzenamine]-1,5-diethyl-
1,2,4,5-benzenetetra carboxylate (1:1), reaction products with phthalic
anhydride (PMN P-86-1153).
(2) The significant new use for P-85-335 is: Manufacture, import,
or processing in a quantity of 100,000 pounds per year, or greater, for
any use.
(3) The significant new use for P-85-336 is: Any use.
(4) The significant new use for P-86-1153 is: Manufacture, import,
or processing in a quantity of 225,000 pounds per year, or greater, for
any use.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Persons who must report. Section 721.5 applies to this section
except Sec. 721.5(a)(2). A person who intends to manufacture, import,
or process for commercial purposes a substance identified in paragraph
(a)(3) of this section and intends to distribute the substance in
commerce must submit a significant new use notice.
(2) [Reserved]
[FR Doc. 94-20688 Filed 8-22-94; 8:45 am]
BILLING CODE 6560-50-F
