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 Amendment for Expedited Process To Issue Significant New Use


[Federal Register: March 29, 1995]








ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721


[OPPTS-50595B; FRL-4921-9]

RIN 2070-AC14

 

Amendment for Expedited Process To Issue Significant New Use 
Rules for Selected New Chemical Substances; Final Rule


AGENCY: Environmental Protection Agency (EPA).


ACTION: Final rule.





SUMMARY: EPA is promulgating an amendment to the regulations governing 
significant new uses of chemical substances. The amendment authorizes 
EPA to impose any of the ``significant new use'' designations in 40 CFR 
part 721 subpart B using expedited rulemaking procedures to promulgate 
``significant new use'' rules (SNURs) for [[Page 16312]] certain new 
chemical substances not subject to the Toxic Substances Control Act 
(TSCA) section 5(e) Orders (referred to as ``non-5(e) SNURs''). 
Currently, the significant new use regulations limit the type of 
activities which EPA can designate as a significant new use by 
expedited rulemaking without first issuing a section 5(e) Order. This 
amendment allows EPA to promulgate expedited SNURs for certain new 
chemical substances without issuing a section 5(e) Order for the 
substance, and thereby facilitates EPA's ability to efficiently and 
expeditiously regulate new chemical substances.
DATES: This rule will become effective on May 30, 1995. In accordance 
with 40 CFR 23.5, this rule shall be promulgated for purposes of 
judicial review at 1 p.m. eastern time on April 12, 1995.


FOR FURTHER INFORMATION CONTACT: James B. Willis, Acting Director, 
Environmental Assistance Division (7408), Office of Pollution 
Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460, Telephone: (202) 554-1404, TDD: (202) 554-0551.


SUPPLEMENTARY INFORMATION: Under section 5 of TSCA, when EPA regulates 
activities associated with a new chemical substance described in a 
premanufacture notice (PMN), EPA generally issues an Order under 
section 5(e) of TSCA regulating the PMN submitter and/or promulgates a 
SNUR under section 5(a)(2) regulating all manufacturers and processors 
of the PMN substance. EPA promulgated a procedural ``Generic SNUR'' (or 
``Expedited Follow-Up Rule'') in 40 CFR part 721 on July 27, 1989 (54 
FR 31298). On February 8, 1993, EPA proposed amending the SNUR 
regulations in 40 CFR 721.170(c)(1) to authorize EPA to impose any of 
the ``significant new use'' designations in 40 CFR part 721 subpart B 
using expedited rulemaking procedures to promulgate non-5(e) SNURs. 58 
FR 7676. (Public hearings were held in April 1993.) Previously, 
significant new use designations available for expedited non-5(e) SNURs 
were limited to environmental release activities and certain 
industrial, commercial, or consumer activities. This amendment 
authorizes EPA to include other important designations, such as 
protection in the workplace and hazard communication, in non-5(e) SNURs 
promulgated via expedited rulemaking procedures.
    As explained in the rule proposal: ``Whereas a section 5(e) Order 
applies only to the original PMN submitter who signs the Order, a SNUR 
applies to all manufacturers and processors of the chemical substance. 
The reporting requirements of a non-5(e) SNUR apply also to the 
original PMN submitter (because, without a section 5(e) Order, the PMN 
submitter is not exempted by 40 CFR 721.45(i)). Since only one Agency 
action is required instead of two, and fewer EPA resources are 
necessary to obtain similar regulatory results, a non-5(e) SNUR is more 
efficient than a combination of section 5(e) Order and `5(e)-SNUR' 
(under 40 CFR 721.160) to regulate new chemical substances.'' 58 FR 
7677. The rule proposal also stated that promulgation of a non-5(e) 
SNUR would allow the PMN submitter to commence commercial manufacture 
of the PMN substance sooner than would issuance of a section 5(e) Order 
followed by promulgation of a 5(e)-SNUR.


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). The 
enumerated factors pertain to the potential for increased manufacturing 
and processing volume, increased exposure, and changes in anticipated 
methods of manufacture, processing, distribution and disposal. Once EPA 
has, by rule, determined 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 commencing any 
manufacturing, importing, or processing activities designated by the 
SNUR as a ``significant new use.'' The mechanism for reporting under 
this requirement is set out in 40 CFR 721.10.
    The supporting rationale and background for SNURs are more fully 
set out in the preamble to EPA's first SNURs issued under the Expedited 
Follow-Up Rule and published on April 24, 1990 at 55 FR 17376. Consult 
that preamble for further information on the objectives, rationale, and 
procedures for the rules and on the basis for significant new use 
designations.


II. Applicability of General Provisions


    General provisions for SNURs appear in subpart A of 40 CFR part 
721. These provisions describe persons subject to SNURs, recordkeeping 
requirements, exemptions to reporting requirements, and applicability 
of SNURs to uses occurring before the effective date of a SNUR. Rules 
on user fees appear in 40 CFR part 700. Persons subject to a SNUR must 
comply with the same notice requirements and EPA regulatory procedures 
as submitters of PMNs under section 5(a)(1)(A) of TSCA. In particular, 
these requirements include the information submission requirements of 
section 5(d)(1) and 5(b), the exemptions authorized by section 5(h)(1), 
(2), (3), and (5), and the regulations at 40 CFR part 720. Once EPA 
receives a SNUR notice, EPA may take regulatory action, if appropriate, 
under sections 5(e), 5(f), 6, or 7 to control the activities on which 
it has received the SNUR notice. If EPA does not take action, EPA is 
required under section 5(g) to explain in the Federal Register its 
reasons for not taking action.

    Persons who intend to export a 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.


III. Discussion of Comments and Final Rule


    The public comments submitted to EPA on the proposed rule indicated 
a need for clarification regarding EPA's goals underlying this rule 
amendment. The goals that EPA believes are promoted by this amendment 
are: (1) to regulate new chemical substance risks using fewer EPA 
resources, and (2) to allow PMN submitters proposing to produce such 
substances to commence commercial manufacture sooner (subject to 
appropriate limitations that reduce risk). The amendment will achieve 
these goals by eliminating language in 40 CFR Sec. 721.170(c)(1) that 
previously prevented EPA from promulgating expedited non-5(e) SNURs 
containing worker protection or hazard communication requirements. In 
cases where those types of requirements are appropriate, this amendment 
will enable EPA and the PMN submitter to bypass development of a 
section 5(e) Order and proceed directly to promulgation of a SNUR. The 
PMN submitter and other interested parties will generally have a 
similar opportunity for dialogue with EPA and input into development of 
the specific regulatory terms as they do in the development of a 
section 5(e) Order/5(e)-SNUR combination.

    

  1.  Comment. Many comments indicated concern that EPA would use the 
amendment to promulgate more SNURs with less input from the PMN 
submitter.
    
    EPA Response. To the contrary, EPA's intentions are to: (1) issue 
fewer section 5(e) Orders, not more SNURs; and (2) where appropriate, 
develop non-5(e) SNURs based on voluntary amendments of PMNs that 
accomplish the same end as section 5(e) Order/5(e)-SNUR combinations 
but without the extra step. [[Page 16313]] In particular, EPA intends a 
process involving the active participation of the original PMN 
submitter for the substance that may be subject to a SNUR; this process 
will be less formal than negotiating a section 5(e) Consent Order.
    As explained in the preamble to the proposed rule (58 FR 7678, 
February 8, 1993), the non-5(e) SNUR process provides interested 
persons several opportunities for comment. Section 721.170(d)(2) 
requires EPA to notify the PMN submitter at least 7 days before 
expiration of the 90-day PMN review period regarding the Agency's risk 
concerns and the activities under consideration for designation as a 
significant new use. In most cases, EPA actually expects to provide 
this notice many days before the ``Day-83'' deadline required by 
section 721.170(d)(2). Of course, once a PMN submitter receives this 
notice, the submitter may respond to EPA with comments regarding both 
the risk concerns and the potential regulatory terms or ``significant 
new use'' designations. Furthermore, the expedited ``direct final'' 
non-5(e) SNUR rulemaking procedure does provide a comment opportunity, 
which was described in the preamble to the proposed rule (58 FR 7678) 
as well as in the preamble to the Generic SNUR (54 FR 31305, July 27, 
1989). Thus, this expanded non-5(e) SNUR process will in fact provide 
individual notice to the PMN submitter before the non-5(e) SNUR is 
published, followed by notice and opportunity for comment to all 
persons when the non-5(e) SNUR is published in the Federal Register.
    Also as stated in the rule proposal: ``A non-5(e) SNUR is typically 
appropriate for PMNs on chemical substances expected to be toxic but 
where the PMN indicates the submitter's intention to limit activities, 
implement control measures, or otherwise adequately mitigate human 
exposures and environmental releases. Activities described in such PMNs 
may not present an unreasonable risk of injury to human health or the 
environment so as to warrant the issuance of an Order under section 
5(e) of TSCA [followed by promulgation of a 5(e)-SNUR], but deviations 
from the described activities may present an unreasonable risk 
warranting the imposition of regulatory controls via a section 5(e) 
Order. In those cases, a non-5(e) SNUR may be the least burdensome 
regulatory alternative for the Agency to pursue, as it will allow the 
PMN submitter to proceed with planned activities while requiring 
notification to, and review by, EPA for activities which have not been 
reviewed.'' 58 FR 7677.
    
    Additionally, using this non-5(e) SNUR process, where EPA perceives 
that use of a new chemical substance as described in the PMN may 
present unreasonable risk, then, instead of suggesting a section 5(e) 
Consent Order/5(e)-SNUR combination, EPA may informally request the 
submitter to amend its PMN to include appropriate exposure controls. If 
the submitter agrees to amend its PMN accordingly, EPA can then allow 
the submitter to commence manufacture immediately upon expiration of 
the 90-day PMN review period. Because the amended PMN would reflect the 
same controls that will be in the non-5(e) SNUR, EPA will not require 
the submitter to wait until the non-5(e) SNUR is published to commence 
commercial manufacture.
    
    If, instead, the PMN submitter cannot reach agreement with EPA 
regarding the need or appropriateness of the modified terms for the 
PMN, and/or prefers to negotiate a formal section 5(e) Consent Order, 
EPA may then issue a section 5(e) Order. However, experience shows that 
additional time and resources will very probably need to be expended 
before the section 5(e) Order can be finalized, which must occur before 
EPA will allow the PMN review period to expire, which in turn must 
precede commencement of commercial manufacture of the PMN substance. 
Section 5(e)(1)(B)(ii) of TSCA prohibits EPA from issuing a section 
5(e) Order after expiration of the 90-day statutory review period. 
Therefore, EPA will not allow the review period to expire until the 
section 5(e) Order is finalized, and ``extension'' (pursuant to TSCA 
section 5(c)) or ``suspension'' (pursuant to 40 CFR 720.75(b)) of the 
review period is usually necessary to allow sufficient time for 
development of the section 5(e) Order. TSCA section 5(a) prohibits 
commencement of commercial manufacture of the PMN substance before the 
90-day statutory PMN review period expires. Furthermore, if EPA and the 
submitter cannot agree on the terms for a section 5(e) Consent Order, 
EPA can issue a section 5(e) Order unilaterally.
    Thus, this rule amendment is intended to eliminate unnecessary 
section 5(e) Orders and should not itself increase the number of new 
chemical substances regulated by EPA via SNURs under section 5 of TSCA. 
Rather, substances that would formerly have been regulated by 5(e)-
SNURs may now be regulated by non-5(e) SNURs. The amendment still 
requires EPA to provide notice allowing the PMN submitter (or others) 
to respond to EPA with comments regarding the perceived risks and the 
proposed regulatory requirements for a given new chemical substance.

  2.  Comment. Some comments indicated a desire for criteria to 
restrict EPA's discretion as to when it would use the non-5(e) SNUR 
procedure. The Chemical Manufacturers' Association (CMA) suggested that 
EPA should commit to promulgating expedited non-5(e) SNURs only when 
EPA finds that the chemical substance ``may present an unreasonable 
risk,'' i.e., the standard articulated in TSCA section 5(e) for the 
issuance of administrative orders.
    
    EPA Response. EPA has stated many times that TSCA authorizes EPA to 
promulgate a SNUR without finding that a chemical substance ``may 
present unreasonable risk.'' Rather, section 5(a)(2) of TSCA and 40 CFR 
721.170(b), which is not being amended in this rulemaking, set forth 
the criteria EPA has used and will continue to use for non-5(e) SNURs.
    As discussed above, where EPA perceives that the scenario described 
in a PMN may present an unreasonable risk, EPA may request the 
submitter to amend the PMN to include appropriate exposure controls. If 
the submitter refuses, EPA would not promulgate a non-5(e) SNUR, but 
would likely attempt to negotiate a section 5(e) Consent Order. Unlike 
promulgation of a non-5(e) SNUR, to issue a section 5(e) Consent Order, 
EPA must determine that activities associated with the PMN substance 
``may present an unreasonable risk'' of injury to human health or the 
environment. Again, however, extension or suspension of the review 
period would be necessary to allow sufficient time for development of 
the section 5(e) Order, and, if EPA and the submitter cannot agree on 
the need or terms for a section 5(e) Consent Order, EPA can issue a 
section 5(e) Order unilaterally.
    
    Nevertheless, as elaborated elsewhere, EPA believes that non-5(e) 
SNURs will save time and resources for both EPA and industry without 
unduly sacrificing the ability to negotiate the regulatory terms. EPA 
expects that PMN submitters will recognize this and will generally 
prefer a non-5(e) SNUR over a section 5(e) Order/5(e)-SNUR combination.

  3.  Comment. Many commenters disapproved of EPA's ability to use the 
expedited non-5(e) SNUR procedure to impose regulatory requirements not 
listed in subpart B of 40 CFR part 721.
    EPA Response. The final rule limits ``significant new use'' 
designations for non-5(e) SNURs to subpart B provisions only. EPA 
expects that limiting expedited non-5(e) SNURs to the standard 
``significant new use'' designations published in subpart B of 
[[Page 16314]] 40 CFR part 721 will help provide PMN submitters with a 
clear understanding when notified by EPA of the regulatory terms that 
EPA intends to apply to their PMN substance via a non-5(e) SNUR.
    If, in the future, EPA decides that additional ``significant new 
use'' designations are needed for non-5(e) SNURs, EPA can add those 
designations to subpart B via notice and comment rulemaking or 
promulgate individual SNURs containing those designations through 
notice and comment rulemaking.
    

  4.  Comment. Several commenters disagreed with EPA's assertion that, 
since suspensions to issue section 5(e) Orders would be eliminated, the 
proposed amendment would allow commercial manufacture to commence 
sooner. They stated the amendment would actually cause greater delay 
because EPA could declare any use inconsistent with the PMN to be a 
significant new use. They claim that the PMN submitter will need more 
time to identify all potential uses and associated information before 
submitting a PMN, so that EPA will not promulgate a SNUR requiring 
further notices for those uses of the substance.
    EPA Response. The comment indicates a need to clarify how EPA 
regulates new chemical substances and particularly how the word ``use'' 
is employed in the context of new chemical substance SNURs and section 
5(e) Consent Orders. The SNURs promulgated by EPA to date for new 
chemical substances show that EPA rarely, if ever, designates as a 
``significant new use'' every activity not expressly contemplated in 
the PMN. Rather, EPA generally defines a ``significant new use'' for 
new chemical substances as activities lacking specific exposure 
controls (such as gloves, goggles, respirators and waste disposal) 
which therefore may present an unreasonable health or environmental 
risk. EPA will define as ``significant'' any use not identified in the 
PMN only where the substance is expected to be toxic and EPA cannot be 
certain that specific exposure controls will adequately mitigate all 
concerns. In sum, the amendment is not intended to change the 
substantive content or terms that EPA has used to regulate new chemical 
substances or to write SNURs in the past; rather, it is a procedural 
change enabling EPA to establish those same terms in an expedited SNUR 
without first issuing a section 5(e) Consent Order. This amendment 
should not change the amount of time and effort a PMN submitter must 
invest to identify potential uses of the new chemical substance. PMN 
submitters will continue to be required to provide information that is 
known to or reasonably ascertainable by the submitter when the PMN is 
submitted and throughout the PMN review period. (15 U.S.C. 
2604(d)(1)(A), 40 CFR 720.45).
    

  5.  Comment. One commenter stated that certain designations in 
subpart B are ``by their nature'' not appropriate for non-5(e) SNURs 
(quoting the preambles to the proposed and final Generic SNUR, see 
e.g., 54 FR 31304). The commenter also stated ``EPA should not 
designate the failure to use personal protective equipment as a 
significant new use of a chemical substance that has completed 
premanufacture review and is not subject to an Order under Section 
5(e). If such protection is required, it should be imposed on the 
initial manufacturer who submitted the PMN pursuant to a Section 5(e) 
Consent Order .... EPA should not shortcut this process simply because 
`a non-5(e) SNUR is more efficient than a combination of Section 5(e) 
order and a 5(e) SNUR ... to regulate new chemical substances.''' 58 FR 
7677.
    
    EPA Response. Several provisions in subpart B (i.e., 40 CFR 
721.80(k), (q), and (t)) expressly refer to terms of the section 5(e) 
Consent Order and are thus inapplicable to non-5(e) SNURs. There is no 
need to specifically exclude these provisions from Sec. 721.170.
    Based on over 4 years of experience with 5(e)-SNURs and non-5(e) 
SNURs under Secs. 721.160 and 721.170, EPA now believes that provisions 
for worker protection and hazard communication should be available if 
EPA and the PMN submitter prefer to bypass the cumbersome section 5(e) 
Order/5(e)-SNUR process and go directly to a non-5(e) SNUR. Under the 
revised non-5(e) SNUR process, allowing designation of any of the 
``significant new use'' provisions in subpart B, risks to workers can 
be controlled via SNURs without the need to also issue Consent Orders.
    EPA believes the imposition of worker protection requirements in a 
non-5(e) SNUR is appropriate where the new chemical substance is 
expected to be toxic to humans and the PMN indicates that the submitter 
will implement worker protection measures. Again, this non-5(e) SNUR 
will not only save EPA resources, but will also allow the PMN submitter 
to commence manufacture sooner (i.e., immediately upon expiration of 
the 90-day review period, rather than suspending or extending the 
review period to negotiate a section 5(e) Order), provided that the 
submitter does in fact implement the stated protective measures so that 
the submitter is not required by the SNUR to submit another notice to 
EPA. The non-5(e) SNUR will bind the PMN submitter as effectively as a 
section 5(e) Order while saving the submitter the costs of delayed 
marketing of the new chemical substance.

  6.  Comment. EPA should not disrupt business by defining as a 
``significant new use'' an activity which the original PMN submitter or 
another company commences between the filing of the notice of 
commencement (NOC) of manufacture (per 40 CFR 720.102) and the 
publication of the SNUR.
    
    EPA Response. EPA generally does not consider those activities that 
commenced prior to publication of a proposed SNUR to be ``significant 
new uses.'' In SNUR preambles for individual chemicals, EPA routinely 
states that a ``new'' use is one that is not ongoing when the proposed 
SNUR is published in the Federal Register. If EPA is informed that a 
use which it proposes to define as ``new'' was already ongoing before 
the proposal was published, EPA will generally determine that use is 
not ``new.'' See, e.g., 57 FR 31326, July 15, 1992. (One exception 
would be if the original PMN submitter engaged in an activity 
prohibited by a section 5(e) Order.)
    

  7.  Comment. Employers have hazard communication and worker 
protection obligations under the Occupational Safety and Health Act 
without regard to the existence of TSCA section 5(e) Orders and SNURs. 
EPA should not over extend itself into the area of occupational safety 
and health.
    
    EPA Response. TSCA section 5 authorizes EPA to review and regulate 
new chemical substances to prevent unreasonable risks to human health 
and the environment. A senate report discussion of TSCA section 5 
expressly notes that the Federal statutes existing when TSCA was 
enacted, including specifically the Occupational Safety and Health Act, 
``do not provide for this type of premarket scrutiny.'' S. Rept. No. 
698, 94th Cong. 2d Sess. 1 (1976). Requirements imposed by the 
Occupational Safety and Health Administration (OSHA) may not always 
apply to new chemical substances governed by TSCA section 5. For 
example, OSHA hazard communication requirements only apply to a 
substance for which there is at least one positive study (29 CFR 
1910.1200(d)(2)), whereas many new chemical substances have not been 
tested at all. Furthermore, OSHA permissible exposure limits (PELs) (29 
CFR Part 1910) generally apply only to specific chemical substances, 
and very few new chemical substances subject to section 5 of TSCA are 
subject to OSHA PELs. Lastly, the requirements of EPA's worker 
protection and hazard [[Page 16315]] communication provisions in 
section 5(e) Consent Orders and SNURs are consistent with OSHA's 
requirements.
    

  8.  Comment. One commenter stated that the increased incidence of 
non-5(e) SNURs would subject more chemicals to TSCA section 12(b) 
export notification requirements, increasing the burden on industry and 
EPA to report such activity. The commenter suggested a mechanism so 
that substances subject to a SNUR but contained in finished products or 
a small percentage of a mixture were not subject to TSCA 12(b) 
notification.
    
    EPA Response. As stated previously in response to other comments, 
the intent of this rule amendment is not to increase the number of new 
chemical substances regulated by EPA. Rather EPA expects to offer PMN 
submitters the option of a non-5(e) SNUR, instead of a section 5(e) 
Consent Order. In either instance, EPA has determined that exposure 
controls are needed and will regulate the substance through one of 
those procedural mechanisms. This rule will not increase the section 
12(b) reporting burden on industry or EPA.
    The same comment suggesting a de minimis exemption for section 
12(b) reporting was recently submitted on a proposed amendment to the 
section 12(b) rule at 40 CFR part 707, subpart D. EPA considered this 
comment in that rulemaking and stated in the preamble to the final rule 
amending the section 12(b) rule: ``While de minimis-type regulatory 
exemptions may be appropriate in many circumstances, at the present 
time, EPA believes it is preferable to provide foreign countries 12(b) 
notifications so they have the opportunity to make their own 
determinations regarding what level of a chemical in mixtures is deemed 
important. However, if further experience with the 12(b) or PIC [Prior 
Informed Consent joint program of the United Nations Environment 
Programme and the Food and Agriculture Organization] programs indicate 
that a de minimis regulatory exemption is warranted, EPA will reexamine 
this option at a later time.'' 58 FR 40240-41; July 27, 1993. 
Therefore, under the current rules implementing section 12(b) of TSCA 
(40 CFR part 707, subpart D), if a substance or mixture is subject to a 
section 5(e) Order or rule, then export notification is required, 
except for substances contained in ``articles'' (as defined in 40 CFR 
720.3(c)).
    

  9.  Comment. The original Generic SNUR, including the restriction on 
non-5(e) SNUR designations, was negotiated by a multi-interest dialogue 
group and should not be changed unilaterally by EPA.
    EPA Response. EPA has followed the notice and comment rulemaking 
procedures required by the Administrative Procedure Act, and believes 
it has improved the final rule amendment in direct response to the 
valuable comments that were submitted. Given the elimination of nonsubpart 
B provisions, the benefits to PMN submitters from this 
rulemaking, and the potential delays of procedural approaches other 
than promulgating this final rule at this time, EPA has decided that it 
is in the public interest to go forward with this final rule. EPA 
expects this final rule to satisfy all statutory requirements and most, 
if not all, interested parties.


IV. Economic Analysis


    The Agency's complete economic analysis is available in the public 
record for this rulemaking (OPPTS-50595B). The regulatory impact 
analysis estimates the costs and benefits attributable to the final 
regulation. In this case, the analysis also contains estimates for 
three amendments to other regulations, namely the Revisions of 
Premanufacture Notification Regulations, the Revision of Exemption for 
Chemical Substances Manufactured in Quantities of 1,000 Kilograms or 
Less Per Year, and the Revisions of Exemption for Polymers. As these 
regulations are amendments to current regulations, the costs and 
benefits are incremental and estimate the effect of the amendment with 
respect to the old regulation.
    
    This non-5(e) SNUR amendment will eliminate the need to develop a 
section 5(e) Consent Order before promulgating an expedited SNUR in 
those cases where EPA determines that activities described in the PMN 
submission will not present unreasonable risk. The major industry 
benefit is the avoidance of the delay and costs associated with 
negotiating a Consent Order; generally, the submitter will be able to 
commence commercial manufacture immediately after the 90-day PMN review 
period without suspending or extending it. The submitter, along with 
other manufacturers and processors, will be bound by the expedited 
SNUR.
    
    Industry savings from this amendment are based on avoidance of 
delay costs and are estimated to range from $65,000 to $330,000 per 
year. Annual government savings are estimated to range from $240,000 to 
$960,000. These estimates are based on the following assumptions: (1) 
1,000 to 3,000 PMNs will be submitted annually; (2) in the absence of 
this amendment, 512f these PMNs will be subject to section 5(e) 
Orders; and (3) with this amendment, 4012f these section 5(e) Orders 
will be avoided and replaced by non-5(e) SNURs.


V. Rulemaking Record


    EPA has established a record for this rulemaking (docket control 
number OPPTS-50595B). The record includes basic information and 
comments considered by the Agency in developing this rule. A public 
version of the record is available in the TSCA Nonconfidential 
Information Center, from 12 noon to 4 p.m., Monday through Friday, 
except legal holidays. The TSCA Nonconfidential Information Center is 
located in Rm. NE-B607, Northeast Mall, 401 M St., SW., Washington, DC.


VI. Regulatory Assessment Requirements


A. Executive Order 12866


    Under Executive Order 12866 (58 FR 51835, 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 (1) have an annual effect on the economy of $100 million 
or more, or adversely and materially affect 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) create serious 
inconsistency or otherwise interfere with an action taken or planned by 
another agency; (3) materially alter the budgetary impacts of 
entitlement, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raise novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in this Executive Order.
    Pursuant to Executive Order 12866 (58 FR 51735, October 4, `993) it 
has been determined that this rule is not a ``significant regulatory 
action'' under section 3(f) of the Order. This action is therefore not 
subject to OMB review.


B. Regulatory Flexibility Act


    Pursuant to the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), 
the Agency has determined that this regulatory action will not impose 
any adverse economic impacts on small entities. EPA believes that, even 
if all of the [[Page 16316]] SNUR notice submitters were small firms, 
the number of small businesses affected by this rule will not be 
substantial.


C. Paperwork Reduction Act


    There is no additional reporting burden associated with this 
amendment. The information collection requirements in this rule have 
been approved by the Office of Management and Budget (OMB) under the 
provisions of the Paperwork Reduction Act, 44 U.S.C. 3502 et seq., and 
have been assigned OMB control number 2070-0012.


List of Subjects in 40 CFR Part 721


    Chemicals, Environmental protection, Hazardous materials, 
Recordkeeping and reporting requirements, Significant new uses.


    Dated: March 21, 1995.


Carol M. Browner,
    
Administrator.


    Therefore, 40 CFR Chapter I, 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 revising Sec. 721.170(c)(1) to read as follows:



Sec. 721.170   Notification requirements for selected new chemical 
substances that have completed premanufacture review.


        

      •  *    *    *    *
        
    (c) *  *  *
        
    (1) When EPA decides to establish significant new use reporting 
requirements under this section, EPA may designate as a significant new 
use any one or more of the activities set forth in subpart B of this 
part. In addition, EPA may designate specific recordkeeping 
requirements described under subpart C of this part that are applicable 
to the substance.
        

      •  *    *    *    *
        
[FR Doc. 95-7710 Filed 3-24-95; 3:32 pm]
BILLING CODE 6560-50-F

 
 

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