[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]


-----------------------------------------------------------------------


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.

-----------------------------------------------------------------------

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