[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR721.170]

[Page 171-174]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES--Table of Contents
 
 Subpart D--Expedited Process for Issuing Significant New Use Rules for 
 Selected Chemical Substances and Limitation or Revocation of Selected 
                        Significant New Use Rules
 
Sec. 721.170  Notification requirements for selected new chemical substances 
that have completed premanufacture review.

    (a) Selection of substances. In accordance with the expedited 
process specified in this section, EPA may issue significant new use 
notification and recordkeeping requirements for any new chemical 
substance for which a premanufacture notice has been submitted under 
part 720 of this chapter if EPA determines that activities other than 
those described in the premanufacture notice may result in significant 
changes in human exposure or environmental release levels and/or that 
concern exists about the substance's health or environmental effects.
    (b) Concern criteria. EPA may determine that concern exists about a 
substance's health or environmental effects if EPA makes any one of the 
following findings:
    (1)(i) The substance may cause carcinogenic effects because the 
substance:
    (A) Has been shown by valid test data to cause carcinogenic effects 
in humans or in at least one species of laboratory animal.
    (B) Has been shown to be a possible carcinogen based on the weight 
of the evidence in short-term tests indicative of the potential to cause 
carcinogenic effects.
    (C) Is closely analogous, based on toxicologically relevant 
similarities in molecular structure and physical properties, to another 
substance that has been shown by test data to cause carcinogenic effects 
in humans or in at least one species of laboratory animal, provided that 
if there is more than one such analogue, the greatest weight will be 
given to the relevant data for the most appropriate analogues.
    (D) Is known or can reasonably be anticipated, based on valid 
scientific data or established scientific principles, to be metabolized 
in humans or transformed in the environment to a substance which may 
have the potential to cause carcinogenic effects under the criteria in 
paragraphs (b)(1)(i) (A), (B), or (C) of this section.
    (ii) No substance may be regulated based on a finding under 
paragraph (b)(1) of this section unless EPA has also made the finding 
under Sec. 721.170(c)(2)(ii).
    (2) The substance has been shown by valid test data to cause acutely 
toxic effects in at least one species of laboratory animal or is closely 
analogous, based on toxicologically relevant similarities in molecular 
structure and physical properties, to another substance that has been 
shown by valid test data to cause acutely toxic effects in at least one 
species of laboratory animal, provided that if there is more than one 
such analogue, the greatest weight will be given to the relevant data 
for the most appropriate analogues.
    (3) The substance may cause serious chronic effects, serious acute 
effects, or developmentally toxic effects under reasonably anticipated 
conditions of exposure because the substance:
    (i) Has been shown by valid test data to cause serious chronic 
effects, serious acute effects, or developmentally toxic effects in 
humans or in at least one species of laboratory animal at dose levels 
that could be of concern under reasonably anticipated conditions of 
exposure.
    (ii) Is closely analogous, based on toxicologically relevant 
similarities in molecular structure and physical properties, to another 
chemical substance that has been shown by valid test data to cause 
serious chronic effects, serious acute effects, or developmentally toxic 
effects in humans or in at least one species of laboratory animal at 
dose levels that could be of concern under reasonably anticipated 
conditions of exposure, provided that if there is more than one such 
analogue, the greatest weight will be given to the relevant data for the 
most appropriate analogues.
    (iii) Is known or can reasonably be anticipated, based on valid 
scientific data or established scientific principles, to be metabolized 
in humans or transformed in the environment to a substance which may 
have the potential to cause serious chronic effects, serious acute 
effects, or developmentally

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toxic effects under the criteria in paragraph (b)(3) (i) and (ii) of 
this section.
    (iv) Has been shown to potentially cause developmentally toxic 
effects based on the weight of the evidence in short-term tests 
indicative of the potential to cause developmentally toxic effects.
    (4) The substance may cause significant adverse environmental 
effects under reasonably anticipated conditions of release because the 
substance:
    (i) Has been shown by valid test data to cause significant adverse 
environmental effects at dose levels that could be of concern under 
reasonably anticipated conditions of release.
    (ii) Is closely analogous, based on toxicologically relevant 
similarities in molecular structure and physical properties, to another 
substance that has been shown by valid test data to cause significant 
adverse environmental effects at dose levels that could be of concern 
under reasonably anticipated conditions of release, provided that if 
there is more than one such analogue, the greatest weight will be given 
to the relevant data for the most appropriate analogues.
    (iii) Has been determined, based on calculations using the 
substance's physical and chemical properties, to be potentially able to 
cause significant adverse environmental effects at dose levels that 
could be of concern under reasonably anticipated conditions of release.
    (iv) Is known or can reasonably be anticipated, based on valid 
scientific data or established scientific principles, to be 
environmentally transformed to a substance which may have the potential 
to cause significant adverse environmental effects under the criteria in 
paragraph (b)(4) (i), (ii), and (iii) of this section.
    (5) Concern exists about the health or environmental effects of one 
or more impurities or byproducts of the substance because the impurity 
or byproduct meets one or more of the criteria in paragraph (b) (1) 
through (4) of this section and either:
    (i) The impurity or byproduct is a new chemical substance and may be 
present in concentrations that could cause adverse health or 
environmental effects under reasonably anticipated conditions of 
exposure or release.
    (ii) Reasonably anticipated manufacture, processing, or use 
activities involving the substance for which a premanufacture notice has 
been submitted may result in significantly increased human exposure to 
or environmental release of the impurity or byproduct compared to 
exposure or release levels resulting from existing activities involving 
the impurity or byproduct.
    (c) Designation of requirements. (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.
    (2) EPA may designate as a significant new use only those activities 
that (i) are different from those described in the premanufacture notice 
for the substance, including any amendments, deletions, and additions of 
activities to the premanufacture notice, and (ii) may be accompanied by 
changes in exposure or release levels that are significant in relation 
to the health or environmental concerns identified under paragraph (b) 
of this section.
    (d) Procedures for issuing significant new use rules. (1) 
Significant new use requirements designated under this section will be 
listed in subpart E of this part. For each substance, subpart E of this 
part will identify:
    (i) The chemical name.
    (ii) The activities designated as significant new uses, which may 
include one or more of the activities described in paragraph (c) of this 
section.
    (iii) Other specific requirements applicable to the substance.
    (2) When EPA determines that a substance is a candidate for a 
significant new use rule under this section, it will notify the person 
that submitted the premanufacture notice for the substance no later than 
7 calendar days before the expiration of the notice review period under 
Sec. 720.75 of this chapter. In providing this notice, EPA will describe 
the health or environmental

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concerns identified under paragraph (b) of this section and the 
activities under consideration for designation as significant new uses. 
Such notice may be by telephone, but in this event will be confirmed in 
writing no later than 30 days after completion of the notice review 
period.
    (3) Federal Register documents issued to propose or establish 
significant new uses under this section will contain the following:
    (i) The chemical identity of the substance or, if its specific 
identity is claimed confidential, an appropriate generic chemical name 
and an accession number assigned by EPA.
    (ii) The premanufacture notice number.
    (iii) The CAS number, where available and not claimed confidential.
    (iv) A summary of the basis for action under this section.
    (v) Designation of the significant new uses subject to, or proposed 
to be subject to, notification and any other applicable requirements.
    (vi) Any modifications of subpart A of this part applicable to the 
specific substance and significant new uses.
    (vii) If the Federal Register document establishes a final rule, or 
notifies the public that a final rule will not be issued after public 
comment has been received, the document will describe comments received 
and EPA's response.
    (4) EPA will issue significant new use rules under this section by 
one of the following three processes: direct final rulemaking, interim 
final rulemaking, or notice and comment rulemaking. EPA will use the 
direct final rulemaking process to issue significant new use rules 
unless it determines that, in a particular case, one of the other 
processes is more appropriate.
    (i)(A) When EPA uses the direct final rulemaking procedure to issue 
a significant new use rule it will issue a direct final rule in the 
final rule section of the Federal Register following its decision to 
develop a significant new use rule under this section for a specific new 
chemical substance.
    (B) The Federal Register document will state that, unless written 
notice is received by EPA within 30 days after the date of publication 
that someone wishes to submit adverse or critical comments, the SNUR 
will be effective 60 days from date of publication. The written notice 
of intent to submit adverse or critical comments should state which 
SNUR(s) will be the subject of the adverse or critical comments, if 
several SNURs are established through the direct final rule. If notice 
is received within 30 days after the date of publication that someone 
wishes to submit adverse or critical comments, the section(s) of the 
direct final rule containing the SNUR(s) for which a notice of intent to 
comment was received will be withdrawn by EPA issuing a document in the 
final rule section of the Federal Register, and EPA will issue a 
proposed rule in the proposed rule section of the Federal Register. The 
proposed rule will establish a 30-day comment period.
    (C) If EPA, having considered any timely comments submitted in 
response to the proposal, decides to establish notification requirements 
under this section, EPA will issue a final rule adding the substance to 
subpart E of this part and designating the significant new uses subject 
to notification.
    (ii)(A) When EPA uses a notice and comment procedure to issue a 
significant new use rule, EPA will issue a proposed rule in the Federal 
Register following its decision to develop a significant new use rule 
under this section for a specific new chemical substance. Persons will 
be given 30 days to comment on whether EPA should establish notification 
requirements for the substance under this part.
    (B) If EPA, having considered any timely comments, decides to 
establish notification requirements under this section, EPA will issue a 
final rule adding the substance to subpart E of this part and 
designating the significant new uses subject to notification.
    (iii)(A) When EPA uses the interim final rulemaking procedure to 
issue a significant new use rule, EPA will issue an interim final rule 
in the final rule section of the Federal Register following its decision 
to develop a significant new use rule for a specific new chemical 
substance. The document will state EPA's reasons for using the interim 
final rulemaking procedure.

[[Page 174]]

    (1) The significant new use rule will take effect on the date of 
publication.
    (2) Persons will be given 30 days from the date of publication to 
submit comments.
    (B) An interim final rule issued under this section shall cease to 
be in effect 180 days after publication unless, within the 180-day 
period, EPA issues a final rule in the Federal Register responding to 
any written comments received during the 30-day comment period specified 
in paragraph (d)(4)(iii)(A)(2) of this section and promulgating final 
significant new use notification requirements and other requirements for 
the substance.
    (e) Schedule for issuing significant new use rules. (1) EPA will 
issue a proposed rule, an interim final rule, or a direct final rule 
within 270 days of receipt of the notice of commencement under 
Sec. 720.102 of this chapter for any substance for which the notice of 
commencement was received on or after October 10, 1989.
    (2) If EPA receives adverse or critical comments within the 
designated comment period following publication of a proposed rule or an 
interim final rule, EPA will either withdraw the rule or issue a final 
rule addressing the comments received.

[54 FR 31314, July 27, 1989, as amended at 60 FR 16316, Mar. 29, 1995]