Document ID: EPA-HQ-OPPT-2007-0094-0016
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-12-18T05:00Z

Attachment D

40 CFR Part 721

40 CFR  Protection of Environment  

CHAPTER I

ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

                 

SUBCHAPTER R -- TOXIC SUBSTANCES CONTROL ACT 

PART 721 -- SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

Subpart A -- General Provisions

Sec.

721.1   Scope and applicability.

721.3   Definitions.

721.5   Persons who must report.

721.11   Applicability determination when the specific chemical identity
is confidential.

721.20   Exports and imports.

721.25   Notice requirements and procedures.

721.30   EPA approval of alternative control measures.

721.35   Compliance and enforcement.

721.40   Recordkeeping.

721.45   Exemptions.

721.47   Conditions for research and development exemption.

                              Subpart B -- Certain Significant New Uses 

721.50   Applicability. 

721.63   Protection in the workplace. 

721.72   Hazard communication program. 

721.80   Industrial, commercial, and consumer activities. 

721.85   Disposal. 

721.90   Release to water. 

721.91   Computation of estimated surface water concentrations:
Instructions. 

                              Subpart C -- Recordkeeping Requirements 

721.100   Applicability. 

721.125   Recordkeeping requirements. 

Subpart D -- Expedited Process for Issuing Significant New Use Rules for
Selected Chemical Substances and Limitation or  Revocation of Selected
Significant New Use Rules 

721.160   Notification requirements for new chemical substances subject
to section 5(e) orders. 

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

721.185   Limitation or revocation of certain notification requirements.

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

                                Subpart A -- General Provisions

 

(721.1    Scope and applicability. 

(a) This part identifies uses of chemical substances, except for
microorganisms regulated under part 725 of this chapter, which EPA has
determined are significant new uses under the authority of section
5(a)(2) of the Toxic Substances Control Act. In addition, it specifies
procedures for manufacturers, importers, and processors to report on
those significant new uses. This subpart A contains general provisions
applicable to this part. subpart B of this part identifies generic
requirements for certain significant new uses cross referenced in
specific provisions of subpart E of this part. subpart C of this part
identifies generic reporting requirements for certain significant new
uses cross referenced in specific provisions of subpart E of this part.
subpart E of this part identifies chemical substances and their
significant new uses. 

(b) This subpart A contains provisions governing submission and review
of notices for the chemical substances and significant new uses
identified in subpart E of this part. The provisions of this subpart A
apply to the chemical substances and significant new uses identified in
subpart E of this part, except to the extent that they are specifically
modified or supplanted by specific requirements in subpart E of this
part. In the event of a conflict between the provisions of this subpart
A and the provisions of subpart E of this part, the provisions of
subpart E of this part  shall govern. 

(c) The provisions of part 720 of this chapter apply to this part 721.
For purposes of this part 721, wherever the phrase "new chemical
substance" appears in part 720 of this chapter, it shall mean the
chemical substance subject to this part 721. In the event of a conflict
between the provisions of part 720 of this chapter and the provisions of
this part 721, the provisions of this part 721 shall govern. 

[53 FR 28358, July 27, 1988, as amended at 62 FR 17932, Apr. 11, 1997]

(721.3   Definitions. 

The definitions in section 3 of the Act, 15 U.S.C. 2602, and (720.3 of
this chapter apply to this part. In addition, the following definitions
apply to this part: 

Acutely toxic effects A chemical substance produces acutely toxic
effects if it kills within a short time period (usually 14 days): 

(1) At least 50 percent of the exposed mammalian test animals following
oral administration of a single dose of the test substance at 25
milligrams or less per kilogram of body weight (LD50). 

(2) At least 50 percent of the exposed mammalian test animals following
dermal administration of a single dose of the test substance at 50
milligrams or less per kilogram of body weight (LD50). 

(3) At least 50 percent of the exposed mammalian test animals following
administration of the test substance for 8 hours or less by continuous
inhalation at a steady concentration in air at 0.5 milligrams or less
per liter of air (LC50). 

CAS Number means Chemical Abstracts Service Registry Number assigned to
a chemical substance on the Inventory. 

Chemical name means the scientific designation of a chemical substance
in accordance with the nomenclature system developed by the
International Union of Pure and Applied Chemistry or the Chemical
Abstracts Service's rules of nomenclature, or a name which will clearly
identify a chemical substance for the purpose of conducting a hazard
evaluation. 

Chemical protective clothing means items of clothing that provide a
protective barrier to prevent dermal contact with chemical substances of
concern. Examples can include, but are not limited to: full body
protective clothing, boots, coveralls, gloves, jackets, and pants. 

Commercial use means the use of a chemical substance or any mixture
containing the chemical substance in a commercial enterprise providing
saleable goods or a service to consumers (e.g., a commercial dry
cleaning establishment or painting contractor). 

Common name means any designation or identification such as code name,
code number, trade name, brand name, or generic chemical name used to
identify a chemical substance other than by its chemical name.  

Consumer means a private individual who uses a chemical substance or any
product containing the chemical substance in or around a permanent or
temporary household or residence, during recreation, or for any personal
use or enjoyment. 

Consumer product means a chemical substance that is directly, or as part
of a mixture, sold or made available to consumers for their use in or
around a permanent or temporary household or residence, in or around a
school, or in recreation. 

Customer means any person to whom a manufacturer, importer, or processor
distributes any quantity of a chemical substance, or of a mixture
containing the chemical substance, whether or not a sale is involved.  

Director of the Office of Pollution Prevention and Toxics means the
Director of the EPA Office of Pollution Prevention and Toxics or any EPA
employee delegated by the Office Director to carry out the Office
Director's functions under this part. 

Employer means any manufacturer, importer, processor, or user of
chemical substances or mixtures. 

Environmentally transformed A chemical substance is "environmentally
transformed" when its chemical structure changes as a result of the
action of environmental processes on it. 

Facility means all buildings, equipment, structures, and other
stationary items which are located on a single site or on contiguous or
adjacent sites and which are owned or operated by the same person (or by
any person which controls, is controlled by, or under common control
with such person). 

Identity means any chemical or common name used to identify a chemical
substance or a mixture containing that substance. 

Immediate use A chemical substance is for the "immediate use" of a
person if it is under the control of, and used only by, the person who
transferred it from a labeled container and will only be used by that
person within the work shift in which it is transferred from the labeled
container. 

Impervious Chemical protective clothing is "impervious" to a chemical
substance if the substance causes no chemical or mechanical degradation,
permeation, or penetration of the chemical protective clothing under the
conditions of, and the duration of, exposure. 

Manufacturing stream means all reasonably anticipated transfer, flow, or
disposal of a chemical substance, regardless of physical state or
concentration, through all intended operations of manufacture, including
the cleaning of equipment. 

Metalworking fluid means a liquid of any viscosity or color containing
intentionally added water and used in metal machining operations for the
purpose of cooling, lubricating, or rust inhibition. 

MSDS means material safety data sheet, the written listing of data for
the chemical substance as required under (721.72(c). 

NIOSH means the National Institute for Occupational Safety and Health of
the U.S. Department of Health and Human Services. 

 

Non-enclosed process means any equipment system (such as an open-top
reactor, storage tank, or mixing vessel) in which a chemical substance
is manufactured, processed, or otherwise used where significant direct
contact of the bulk chemical substance and the workplace air may occur. 

Non-industrial use means use other than at a facility where chemical
substances or mixtures are manufactured, imported, or processed. 

Personal protective equipment means any chemical protective clothing or
device placed on the body to prevent contact with, and exposure to, an
identified chemical substance or substances in the work area. Examples
include, but are not limited to, chemical protective clothing, aprons,
hoods, chemical goggles, face splash shields, or equivalent eye
protection, and various types of respirators. Barrier creams are not
included in this definition. 

Powder or dry solid form means a state where all or part of the
substance would have the potential to become fine, loose, solid
particles. 

Principal importer means the first importer who, knowing that a chemical
substance will be imported for a significant new use rather than
manufactured in the United States, specifies the chemical substance and
the amount to be imported. Only persons who are incorporated, licensed,
or doing business in the United States may be principal importers. 

Process for commercial purposes means the preparation of a chemical
substance or mixture containing the chemical substance, after
manufacture of the substance, for distribution in commerce with the
purpose of obtaining an immediate or eventual commercial advantage for
the processor. Processing of any amount of a chemical substance or
mixture containing the chemical substance is included in this
definition. If a chemical substance or mixture containing impurities

is processed for commercial purposes, the impurities also are processed
for commercial purposes. 

Process solely for export means to process for commercial purposes
solely for export from the United States under the following
restrictions on activity in the United States: Processing must be
performed at sites under the control of the processor; distribution in
commerce is limited to purposes of export; and the processor may not use
the chemical substance except in small quantities solely for research
and development. 

Process stream means all reasonably anticipated transfer, flow, or
disposal of a chemical substance, regardless of physical state or
concentration, through all intended operations of processing, including
the cleaning of equipment. 

Recipient means any person who purchases or otherwise obtains a chemical
substance directly from a person who manufacturers, imports, or
processes the substance. 

Serious acute effects means human injury or human disease processes that
have a short latency period for development, result from short-term
exposure to a chemical substance, or are a combination of these factors
and which are likely to result in death or severe or prolonged
incapacitation. 

Serious chronic effects means human injury or human disease processes
that have a long latency period for development, result from long-term
exposure to a chemical substance, or are a combination of these factors
and which are likely to result in death or severe or prolonged
incapacitation. 

Short-term test indicative of carcinogenic potential means either any
limited bioassay that measures tumor or preneoplastic induction, or any
test indicative of interaction of a chemical substance with DNA (i.e.,
positive response in assays for gene mutation, chromosomal aberrations,
DNA damage and repair, or cellular transformation). 

Short-term test indicative of the potential to cause a developmentally
toxic effect means either any in vivo preliminary development toxicity
screen conducted in a mammalian species, or any in vitro developmental
toxicity screen, including any test system other than the intact
pregnant mammal, that has been extensively evaluated and judged reliable
for its ability to predict the 

potential to cause developmentally toxic effects in intact systems
across a broad range of chemicals or within a class of chemicals that
includes the substance of concern. 

Significant adverse environmental effects means injury to the
environment by a chemical substance which reduces or adversely affects
the productivity, utility, value, or function of biological, commercial,
or agricultural resources, or which may adversely affect a threatened or
endangered species. A substance will be considered to have the potential
for significant adverse environmental effects if it has one of the
following: 

(1) An acute aquatic EC50 of 1 mg/L or less. 

(2) An acute aquatic EC50 of 20 mg/L or less where the ratio of aquatic
vertebrate 24-hour to 48-hour EC50 is greater than or equal to 2.0. 

(3) A Maximum Acceptable Toxicant Concentration (MATC) of less than or
equal to 100 parts per billion (100 ppb).

(4) An acute aquatic EC50 of 20 mg/L or less coupled with either a
measured bioconcentration factor (BCF) equal to or greater than 1,000x
or in the absence of bioconcentration data a log P value equal to or
greater than 4.3. 

Site means a contiguous property unit. Property divided only by a public
right-of-way is one site. There may be more than one manufacturing plant
on a single site. 

Site-limited intermediate means an intermediate manufactured, processed,
and used only within a site and not distributed in commerce other than
as an impurity or for disposal. Imported intermediates cannot be
"site-limited." 

Spray application means any method of projecting a jet of vapor of
finely divided liquid onto a surface to be coated; whether by compressed
air, hydraulic pressure, electrostatic forces, or other methods of
generating a spray. 

Use stream means all reasonably anticipated transfer, flow, or disposal
of a chemical substance, regardless of physical state or concentration,
through all intended operations of industrial, commercial, or consumer
use. 

Waters of the United States has the meaning set forth in 40 CFR 122.2. 

Work area means a room or defined space in a workplace where a chemical
substance is manufactured, processed, or used and where employees are
present. 

Workplace means an establishment at one geographic location containing
one or more work areas. 

[53 FR 28358, July 27, 1988, as amended at 54 FR 31306, July 27, 1989;
58 FR 63516, Dec. 1, 1993]

(721.5    Persons who must report.

(a) The following persons must submit a significant new use notice as
specified under the provisions of section 5(a)(1)(B) of the Act, part
720 of this chapter, and (721.25: 

(1) A person who intends to manufacture, import, or process for
commercial purposes a chemical substance identified in a specific
section in subpart E of this part, and intends to engage in a
significant new use of the substance identified in that section. 

(2) A person who intends to manufacture, import, or process for
commercial purposes a chemical substance identified in a specific
section in subpart E of this part, and intends to distribute the
substance in commerce. A person described in this paragraph is not
required to submit a significant new use notice if that person can
document one or more of the following as to each recipient of the
substance from that person: 

(i) That the person has notified the recipient, in writing, of the
specific section in subpart E of this part which identifies the
substance and its designated significant new uses. 

(ii) That the recipient has knowledge of the specific section in subpart
E of this part which identifies the substance and its designated
significant new uses. 

(iii) That the recipient cannot undertake any significant new use
described in the specific section in subpart E of this part. 

(b) A person described in paragraph (a)(2) of this section must submit a
significant new use notice if that person has knowledge at the time of
commercial distribution of the substance identified in the specific
section in subpart E of this part that a recipient intends to engage in
a designated significant new use of that substance without submitting a
notice under this part. 

(c) A person who processes a chemical substance identified in a specific
section in subpart E of this part for a significant new use of that
substance is not required to submit a significant new use notice if that
person can document each of the following: 

(1) That the person does not know the specific chemical identity of the
chemical substance being processed. 

(2) That the person is processing the chemical substance without
knowledge that the substance is identified in subpart E of this part. 

(d)(1) If at any time after commencing distribution in commerce of a
chemical substance identified in a specific section in subpart E of this
part a person described in paragraph (a)(2) of this section has
knowledge that a recipient of the substance is engaging in a significant
new use of that substance designated in that section without submitting
a notice under this part, the person is required to cease supplying the
chemical substance to that recipient and to submit a significant new use
notice for that chemical substance and significant new use, unless the
person is able to document each of the following: 

(i) That the person has notified the recipient and EPA enforcement
authorities (at the address in paragraph (d)(1)(iii) of this section),
in writing within 15 working days of the time the person develops
knowledge that the recipient is engaging in a significant new use, that
the recipient is engaging in a significant new use without submitting a
significant new use notice. 

(ii) That, within 15 working days of notifying the recipient as
described in paragraph (d)(1)(i) of this section, the person received
from the recipient, in writing, a statement of assurance that the
recipient is aware of the terms of the applicable section in subpart E
of this part and will not engage in the significant new use. 

(iii) That the person has promptly provided EPA enforcement authorities
with a copy of the recipient's statement of assurance described in
paragraph (d)(1)(ii) of this section. The copy must be sent to the
Office of Enforcement and Compliance Assurance, Office of Compliance
(2224A), U.S. Environmental Protection Agency, Ariel Rios, 1200
Pennsylvania Ave., N.W., Washington, DC, 20044. 

(2) If EPA notifies the manufacturer, importer, or processor that the
recipient is engaging in a significant new use after providing the
statement of assurance described in paragraph (d)(1)(ii) of this section
and without submitting a notice under this part, the manufacturer,
importer, or processor shall immediately cease distribution to that
recipient until the manufacturer, importer, or processor or the
recipient has submitted a significant new use notice under this part and
the

notice review period has ended. 

(3) If, after receiving a statement of assurance from a recipient under
paragraph (d)(1)(ii) of this section, a manufacturer, importer, or
processor has knowledge that the recipient is engaging in a significant
new use without submitting a notice under this part, the manufacturer,
importer, or processor must immediately cease distributing the substance
to that recipient and notify EPA enforcement authorities at the address
identified in paragraph (d)(1)(iii) of this section. The manufacturer,
importer, or processor may not resume distribution to that recipient
until any one of the following has occurred: 

(i) The manufacturer, importer, or processor has submitted a significant
new use notice under this part and the notice review period has ended. 

(ii) The recipient has submitted a significant new use notice under this
part and the notice review period has ended. 

(iii) The manufacturer, importer, or processor has received notice from
EPA enforcement authorities that it may resume distribution to that
recipient. 

(e) Any significant new use notice relating to import of a substance
must be submitted by the principal importer. 

[53 FR 28359, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]

(721.11   Applicability determination when the specific chemical
identity is confidential.

(a) A person who intends to manufacture, import, or process a chemical
substance which is described by a generic chemical name is subpart E of
this part may ask EPA whether the substance is subject to the
requirements of this part. EPA will answer such an inquiry only if EPA
determines that the person has a bona fide intent to manufacture,
import, or process the chemical substance for commercial purposes. 

(b) To establish a bona fide intent to manufacture, import, or process a
chemical substance, the  person who intends to manufacture, import, or
process the chemical substance must submit the following information in
writing to the Document Control Office (7407), Office of Pollution
Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099,
1200 Pennsylvania Ave., NW., Washington, DC 20460, ATTN: SNUR Bonafide
submissions. 

(1) The specific chemical identity of the chemical substance that the
person intends to manufacture, import, or process.

(2) A signed statement that the person intends to manufacture, import,
or process the chemical substance for commercial purposes. 

(3) A description of the research and development activities conducted
to date, and the purpose for which the person will manufacture, import,
or process the chemical substance. 

(4) An elemental analysis. 

(5) Either an X-ray diffraction pattern (for inorganic substances), a
mass spectrum (for most other substances), or an infrared spectrum of
the particular chemical substance, or, if such data do not resolve
uncertainties with respect to the identity of the chemical substance,
additional or alternative spectra or other data to identify the
substance. 

(c) If an importer or processor cannot provide all the information
required in paragraph (b) of this section because it is claimed as
confidential business information by the importer's or processor's
manufacturer or supplier, the manufacturer or supplier may supply the
information directly to EPA. 

(d) EPA will review the information submitted by the manufacturer,
importer, or processor under paragraph (b) of this section to determine
whether than person has shown a bona fide intent to manufacture, import,
or process the chemical substance. If necessary, EPA will compare this
information either to the information requested for the confidential
chemical substance under (710.7(e)(2)(v) of this chapter or the
information requested under (720.85(b)(3)(iii) of this chapter. 

(e) If the manufacturer, importer, or processor has shown a bona fide
intent to manufacture, import, or process the substance and has provided
sufficient unambiguous chemical identity information to enable EPA to
make a conclusive determination as to the identity of the substance, EPA
will inform the manufacturer, importer, or processor whether the
chemical substance is subject to this part and, if so, which section in
subpart E of this part applies. 

(f) A disclosure to a person with a bona fide intent to manufacture,
import, or process a particular chemical substance that the substance is
subject to this part will not be considered public disclosure of
confidential business information under section 14 of the Act. 

(g) EPA will answer an inquiry on whether a particular chemical
substance is subject to this part within 30 days after receipt of a
complete submission under paragraph (b) of this section. 

[53 FR 28359, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]

(721.20    Exports and imports.

Persons who intend to export a chemical substance identified in subpart
E of this part, or in any proposed rule which would amend subpart E of
this part, are subject to the export notification provisions of section
12(b) of the Act. The regulations that interpret section 12(b) appear at
40 CFR part 707. Persons who import a substance identified in a specific
section in subpart E of this part are subject to the import
certification requirements under section 13 of the Act, which are
codified at 19 CFR 12.118 through 12.127 and 127.28. The EPA policy in
support of the import

certification requirements appears at 40 CFR part 707. 

[53 FR 28360, July 27, 1988]

(721.25    Notice requirements and procedures.

(a) Each person who is required to submit a significant new use notice
under this part must submit the notice at least 90 calendar days before
commencing manufacture, import, or processing of a chemical substance
identified in subpart E of this part for a significant new use. The
submitter must comply with any applicable requirement of section 5(b) of

the Act, and the notice must include the information and test data
specified in section 5(d)(1) of the Act. The notice must be submitted on
EPA Form 7710-25, and must comply with the requirements of part 720 of
this chapter, except to the extent that they are inconsistent with this
part 721. 

(b) If two or more persons are required to submit a significant new use
notice for the same chemical substance and significant new use
identified in subpart E of this part, they may submit a joint notice to
EPA. Persons submitting a joint notice must individually complete the
certification section of part I of the required notification form.
Persons who are required to submit individually, but elect to submit
jointly, remain individually liable for the failure to submit required
information which is known to or reasonably ascertainable by them and
test data in their possession or control. 

(c) EPA will process the notice in accordance with the procedures of
part 720 of this chapter, expect to the extent they are inconsistent
with this part 721. 

(d) Any person submitting a significant new use notice in response to
the requirements of this part 721 shall not manufacture, import, or
process a chemical substance identified in subpart E of this part for a
significant new use until the notice review period, including all
extensions and suspensions, has expired. 

[53 FR 28360, July 27, 1988, as amended at 60 FR 16311, Mar. 29, 1995]

(721.30    EPA approval of alternative control measures. 

(a) In certain sections of subpart E of this part, significant new uses
for the identified substances are described as the failure to establish
and implement programs providing for the use of either: specific
measures to control worker exposure to or release of substances which
are identified in such sections, or alternative measures to control
worker exposure or environmental release which EPA has determined
provide substantially the same degree of protection as the specified
control measures. Persons who manufacture, import, or process a chemical
substance identified in such

sections and who intend to employ alternative measures to control worker
exposure or environmental release must submit a request to EPA for a
determination of equivalency before commencing manufacture, import, or
processing involving the alternative control measures. 

(b) A request for a determination of equivalency must be submitted in
writing to the Document Control Office (7407), Office of Pollution
Prevention and Toxics, U.S. Environmental Protection Agency, Room G-099,
1200 Pennsylvania Ave., NW., Washington, DC 20460; ATTN: SNUR
Equivalency Determination, and must contain: 

(1) The name of the submitter. 

(2) The specific chemical identity of the substance. 

(3) The citation for the specific section in subpart E of this part
which pertains to the substance for which the request is being
submitted. 

(4) A detailed description of the activities involved. 

(5) The specifications of the alternative worker exposure control
measures or environmental release control measures. 

(6) An analysis justifying why such alternative control measures provide
substantially the same degree of protection as the specific control
measures identified in the specific section in subpart E of this part
which pertains to the substance for which the request is being
submitted. 

(7) The data and information described in (720.50 (a) and (b) of this
chapter unless such data and information have already been submitted to
the Office of Pollution Prevention and Toxics, EPA. 

(c) Requests for determinations of equivalency will be reviewed by EPA
within 45 days. Determinations under this paragraph will be made by the
Director, Office of Pollution Prevention and Toxics, or designee. Notice
of the results of such determinations will be mailed to the submitter. 

(d) If EPA notifies the submitter under paragraph (c) of this section
that EPA has determined that the alternative control measures provide
substantially the same degree of protection as the specified control
measures identified in the specified section of subpart E of this part
which pertains to the substance for which the request is being
submitted, the submitter may commence manufacture, import, or processing
in accordance with the specifications for alternative

worker exposure control measures or environmental release control
measures identified in the submitter's request, and may alter any
corresponding notification to workers to reflect such alternative
controls. Deviations from the activities described in the EPA
notification constitute a significant new use and are subject to the
requirements of this part. 

[53 FR 28360, July 27, 1988, as amended at 60 FR 34464, July 3, 1995]

(721.35    Compliance and enforcement. 

(a) Failure to comply with any provision of this part is a violation of
section 15(1) of the Act (15 U.S.C. 2614). 

(b) Using for commercial purposes a chemical substance which a person
knew or had reason to know was manufactured, imported, or processed in
violation of this part is a violation of section 15(2) of the Act (15
U.S.C. 2614). 

(c) Failure or refusal to permit access to or copying of records, as
required by section 11 of the Act, is a violation of section 15(3) of
the Act (15 U.S.C. 2614). 

(d) Failure or refusal to permit entry or inspection, as required by
section 11 of the Act, is a violation of section 15(4) of the Act. 

(e) Violators of the Act or of this part may be subject to the civil and
criminal penalties in section 16 of the Act (15 U.S.C. 2615) for each
violation. The submission of false or misleading information in
connection with the requirement of any provision of this part may
subject persons to penalties calculated as if they never filed a notice.

(f) Under the authority of sections 7 and 17 of the Act, EPA may: 

(1) Seek to enjoin the manufacture, import, or processing of a chemical
substance in violation of this part. 

(2) Act to seize any chemical substance which is being manufactured,
imported, or processed in violation of this part. 

(3) Take any other appropriate action. 

[53 FR 28361, July 27, 1988]

 

(721.40    Recordkeeping. 

Any person subject to the requirements of this part must retain
documentation of information contained in that person's significant new
use notice. This documentation must be maintained for a period of 5
years from the date of the submission of the significant new use notice.

[53 FR 28361, July 27, 1988]

(721.45    Exemptions. 

The persons identified in (721.5 are not subject to the notification
requirements of (721.25 for a chemical substance identified in subpart E
of this part, unless otherwise specified in a specific section in
subpart E, if: 

(a) The person has applied for and has been granted an exemption for
test marketing the substance for a significant new use identified in
subpart E of this part in accordance with section 5(h)(1) of the Act and
(720.38 of this chapter. 

(b) The person manufactures, imports, or processes the substance for a
significant new use identified in subpart E of this part in small
quantities solely for research and development in accordance with
(721.47. 

(c) The person has applied for and been granted an exemption under
section 5(h)(5) of the Act. 

(d) The person manufactures, imports, or processes the substance only as
an impurity. 

(e) The person manufactures, imports, or processes the substance only as
a byproduct which is used only by public or private organizations that
(1) burn it as a fuel, (2) dispose of it as a waste, including in a
landfill or for enriching soil, or (3) extract component chemical
substances from it for commercial purposes. 

(f) The person imports or processes the substance as part of an article.

(g) The person manufactures or processes the substance solely for export
and, when distributing the substance in commerce, labels the substance
in accordance with section 12(a)(1)(B) of the Act. 

(h) The person submits a significant new use notice for the substance
prior to the promulgation date of the section in subpart E of this part
which identifies the substance, and the person receives written
notification of compliance from EPA prior to the effective date of such
section. The notice submitter must comply with any applicable
requirement of section 5(b) of the Act. The notice must include the
information and test data specified in section 5(d)(1) of the Act

and must be submitted on the notice form in Appendix A to part 720 of
this chapter. For purposes of this exemption, the specific section in
subpart E of this part which identifies the substance and ((721.1,
721.3, 721.11, 721.35, and 721.40 apply; after the effective date of the
section in subpart E of this part which identifies the substance, (721.5
applies and (721.20 continues to apply. EPA will provide the notice
submitter with written notification of compliance

only if one of the following occurs: 

(1) EPA is unable to make the finding that the activities described in
the significant new use notice will or may present an unreasonable risk
of injury to health or the environment under reasonably foreseeable
circumstances. 

(2) EPA and the person negotiate a consent order under section 5(e) of
the Act, such order to take effect on the effective date of the section
in subpart E of this part which identifies the substance. 

(i) The person is operating under the terms of a consent order issued
under section 5(e) of the Act applicable to that person. If a provision
of such section 5(e) order is inconsistent with a specific significant
new use identified in subpart E of this part, abiding by the provision
of the section 5(e) order exempts the person from submitting a
significant new use notice for that specific significant new use. 

[53 FR 28361, July 27, 1988]

(721.47    Conditions for research and development exemption. 

(a) A person who manufactures, imports, or processes a chemical
substance identifies in subpart E of this part for a significant new use
identified in subpart E of this part is not subject to the notification
requirements of (721.25 if the following conditions are met: 

(1) The person manufactures, imports, or processes the substance for the
significant new use in small quantities solely for research and
development. 

(2) The manufacturer, importer, or processor notifies all persons in its
employ or to whom it directly distributes the chemical substance, who
are engaged in experimentation, research, or analysis on the chemical
substance, including the manufacture, processing, use, transport,
storage, and disposal of the substance associated with research and
development activities, of any risk to health, identified under
paragraph (b) of this section, which may be associated with the
substance. The notification must be made in accordance with paragraph
(c) of this section. 

(3) The chemical substance is used by, or directly under the supervision
of, a technically qualified individual. 

(b)(1) To determine whether notification under paragraph (a)(2) of this
section is required, the manufacturer, importer, or processor must
review and evaluate the following information to determine whether there
is reason to believe there is any risk to health which may be associated
with the chemicals substance: 

(i) Information in its possession or control concerning any significant
adverse reaction by persons exposed to the chemical substance which may
reasonably be associated with such exposure. 

(ii) Information provided to the manufacturer, importer, or processor by
a supplier or any other person concerning a health risk believed to be
associated with the substance. 

(iii) Health and environmental effects data in its possession or control
concerning the substance. 

(iv) Information on health effects which accompanies any EPA rule or
order issued under section 4, 5, or 6 of the Act that applies to the
substance and of which the manufacturer, importer, or processor has
knowledge. 

(2) When the research and development activity is conducted solely in a
laboratory and exposure to the chemical substance is controlled through
the implementation of prudent laboratory practices for handling chemical
substances of unknown toxicity, and any distribution, except for 
purposes of disposal, is to other such laboratories for further research
and development activity, the information specified in paragraph (b)(1)
of this section need not be reviewed

and evaluated. (For purposes of this paragraph (b)(2), a laboratory is
defined as a contained research facility where relatively small
quantities of chemical substances are used on a pro-production basis,
and where activities involve the use of containers for reactions,
transfers, and other handling of substances designed to be easily
manipulated by a single individual). 

(c)(1) The manufacturer, importer, or processor must notify the persons
identified in paragraph (a)(2) of this section by means of a container
labeling system, conspicuous placement of notices in areas where
exposure may occur, written notification to each person potentially
exposed, or any other method of notification which adequately informs
persons of health risks which the manufacturer, importer, or processor
has reason to believe may be associated with the substance, as
determined under paragraph (b)(1) of this section.  

(2) If the manufacturer, importer, or processor distributes a chemical
substance manufactured, imported, or processed under this section to
persons not in its employ, the manufacturer, importer, or processor must
in written form: 

(i) Notify those persons that the substance is to be used only for
research and development  purposes. 

(ii) Provide the notice of health risks specified in paragraph (c)(1) of
this section. 

(3) The adequacy of any notification under this section is the
responsibility of the manufacturer, importer, or processor.

(d) Quantities of the chemical substance, or of mixtures or articles
containing the chemical substance, remaining after completion of
research and development activities may be: 

(1) Disposed of as a waste in accordance with applicable Federal, State,
and local regulations, to the extent the disposal activity is not
identified as a significant new use for the substance in subpart E of
this part, or 

(2) Used for a commercial purpose, to the extent the use is not
identified as a significant new use of the substance in subpart E of
this part. 

(e)(1) Persons who manufacture, import, or process a chemical substance
under this section must retain the following records: 

(i) Copies of or citations to information reviewed and evaluated under
paragraph (b)(1) of this section to determine the need to make any
notification of risk. 

(ii) Documentation of the nature and method of notification under
paragraph (c)(1) of this section including copies of any labels or
written notices used. 

(iii) Documentation of prudent laboratory practices used instead of
notification and evaluation under paragraph (b)(2) of this section. 

(iv) The names and addresses of any persons other than the manufacturer,
importer, or processor to whom the substance is distributed, the
identity of the substance, the amount distributed, and copies of the
notifications required under paragraph (c)(2) of this section. 

(2) [Reserved] 

[53 FR 28361, July 27, 1988, as amended at 58 FR 34204, June 23, 1993] 

                           Subpart B -- Certain Significant New Uses 

Source: 54 FR 31308, July 27, 1989, unless otherwise noted.

(721.50    Applicability. 

This subpart B identifies certain significant new uses of chemical
substances identified in subpart E of this part. The provisions of this
subpart B apply only when referenced as applying to a chemical substance
identified in subpart E of this part. 

(721.63    Protection in the workplace. 

(a) Whenever a substance is identified in subpart E of this part as
being subject to this section, a significant new use of the substance is
any manner or method of manufacturing, importing, or processing
associated with any use of the substance without establishing a program
whereby: 

(1) Each person who is reasonably likely to be dermally exposed in the
work area to the chemical substance through direct handling of the
substance or through contact with equipment on which the substance may
exist, or because the substance becomes airborne in the form listed in
paragraph (a)(6) of this section, and cited in subpart E of this part
for the chemical substance, is provided with, and is required to wear,
personal protective equipment that provides a barrier to prevent dermal
exposure to the substance in the specific work area where it is selected
for use.  Each such item of personal protective equipment must be
selected and used in accordance with 29 CFR 1910.132 and 1910.133. 

(2) In addition to any other personal protective equipment selected in
paragraph (a)(1) of this section, the following items are required: 

(i) Gloves. 

(ii) Full body chemical protective clothing. 

(iii) Chemical goggles or equivalent eye protection. 

(iv) Clothing which covers any other exposed areas of the arms, legs,
and torso. Clothing provided under this paragraph need not be tested or
evaluated under the requirements of paragraph (a)(3) of this section.  

(3) The employer is able to demonstrate that each item of chemical
protective clothing, including gloves, selected provides an impervious
barrier to prevent dermal exposure during normal and expected duration
and conditions of exposure within the work area by any one or a
combination of the following: 

(i) Testing the material used to make the chemical protective clothing
and the construction of the clothing to establish that the protective
clothing will be impervious for the expected duration and conditions of
exposure. The testing must subject the chemical protective clothing to
the expected conditions of exposure, including the likely combinations
of chemical substances to which the clothing may be exposed in the work
area. 

(ii) Evaluating the specifications from the manufacturer or supplier of
the chemical protective clothing, or of the material used in
construction of the clothing, to establish that the chemical protective
clothing will be impervious to the chemical substance alone and in
likely combination with other chemical substances in the work area. 

(4) Each person who is reasonably likely to be exposed to the chemical
substance by inhalation in the work area in one or more of the forms
listed in paragraph (a)(6) of this section and cited in subpart E of
this part for the chemical substance, is provided with, and is required
to wear, at a minimum, a NIOSH- approved respirator from one of the
categories listed in paragraph (a)(5) of this section, and the
respirator is used in accordance with 29 CFR 1910.134

and 30 CFR part 11. 

(5) The following NIOSH approved respirators meet the minimum
requirements for paragraph (a)(4) of this section:  (i) Category 19C
Type C supplied-air respirator operated in pressure demand or other
positive pressure mode and equipped with a full facepiece. 

(ii) Category 19C Type C supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a tight-fitting
facepiece. 

(iii) Category 19C Type C supplied-air respirator operated in pressure
demand or continuous flow mode and equipped with a hood or helmet or
tight-fitting facepiece. 

(iv) Category 21C air-purifying respirator equipped with a full
facepiece and high efficiency particulate filters. 

(v) Category 21C powered air-purifying respirator equipped with a
tight-fitting facepiece and high efficiency particulate filters. 

(vi) Category 21C powered air-purifying respirator equipped with a
loose-fitting hood or helmet and high efficiency particulate filters. 

(vii) Category 21C air-purifying respirator equipped with a high
efficiency particulate filter including disposable respirators. 

(viii) Category 23C air-purifying respirator equipped with a full
facepiece and combination cartridges approved for paints, lacquers, and
enamels. (Approval label may preclude use for some paints, lacquers, or
enamels.)  

(ix) Category 23C powered air-purifying respirator equipped with a
tight-fitting facepiece and combination cartridges approved for paints,
lacquers, and enamels. (Approval label may preclude use for some paints,
lacquers, or enamels.) 

(x) Category 23C powered air-purifying respirator equipped with a
loose-fitting hood or helmet and combination cartridges approved for
paints, lacquers, and enamels. (Approval label may preclude use for some
paints, lacquers, or enamels.) 

(xi) Category 23C air-purifying respirator equipped with combination
cartridges approved for paints, lacquers, and enamels, including
disposable respirators. (Approval label may preclude use for some
paints, lacquers, or enamels.)  

(xii) Category 23C air-purifying respirator equipped with a full
facepiece and organic gas/vapor cartridges. 

(xiii) Category 23C powered air-purifying respirator equipped with a
tight-fitting facepiece and organic gas/vapor cartridges. 

(xiv) Category 23C powered air-purifying respirator equipped with a
loose-fitting hood or helmet and organic gas/vapor cartridges. 

(xv) Category 23C air-purifying respirator equipped with organic
gas/vapor cartridges, including disposable respirators. 

(6) When cited in subpart E of this part for a substance, the following
airborne form(s) of the substance apply to paragraphs (a) (1) and (4) of
this section: 

(i) Dust. 

(ii) Mist. 

(iii) Fume. 

(iv) Smoke. 

(v) Vapor. 

(vi) Gas. 

(b) If a substance identified in subpart E of this part is present in
the work area only as a mixture, an employer is exempt from the
provisions of this section if the concentration of the substance in the
mixture does not exceed a concentration set in subpart E of this part.
The exemption does not apply if the employer has reason to believe that
during intended use or processing in the work area, the substance in the
mixture may be concentrated above the level set in subpart E of this
part. 

(c)(1) If at any time after commencing distribution in commerce of a
chemical substance that is identified in subpart E of this part as
subject to this section, the person has knowledge that a recipient of
the substance is engaging in an activity that is not consistent with the
implementation of a program specified in paragraph (a) of this section,
the person is considered to have knowledge that the recipient is
engaging in a significant new use and is required to follow the 

procedures in (721.5(d) unless the person is able to document the
following: 

(i) That the person has notified the recipient in writing within 15
working days of the time the person first has knowledge that the
recipient is engaging in an activity that is not consistent with the
implementation of a program specified in paragraph (a) of this section,
and that the person has knowledge of the failure of implementation. 

(ii) That within 15 working days of notifying the recipient that the
recipient is engaging in an activity that is not consistent with the
implementation of a program specified in paragraph (a) of this section
the person has received from the recipient, in writing, a statement of
assurance that the recipient has established the program required under
paragraph (a) of this section, and will take appropriate measures to
avoid activities that are inconsistent with implementation of the
program required under paragraph (a) of this section. 

(2) If, after receiving a statement of assurance from a recipient under
paragraph (c)(1)(ii) of this section, a manufacturer, importer, or
processor has knowledge that the recipient is engaging in an activity
that is not consistent with the implementation of the program specified
in paragraph (a) of this section, that person is considered to have
knowledge that the person is engaging in a significant new use and is
required to follow the procedures in (721.5(d). 

 

(721.72    Hazard communication program. 

Whenever a substance is identified in subpart E of this part as being
subject to this section, a significant new use of that substance is any
manner or method of manufacture, import, or processing associated with
any use of that substance without establishing a hazard communication
program as described in this section. 

(a) Written hazard communication program. Each employer shall develop
and implement a written hazard communication program for the substance
in each workplace. The written program will, at a minimum, describe how
the requirements of this section for labels, MSDSs, and other forms of
warning material will be satisfied. The employer must make the written
hazard communication program available, upon request, to all employees,
contractor employees, and their designated representatives. The employer
may rely on an existing hazard communication program, including an
existing program established under the Occupational Health and Safety
Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200),
to comply with this paragraph provided that the existing hazard
communication program satisfies the requirements of this paragraph. The
written program shall include the 

following: 

(1) A list of each substance identified in subpart E of this part as
subject to this section known to be present in the work area. The list
must be maintained in the work area and must use the identity provided
on the appropriate MSDS for each substance required under paragraph (c)
of this section. The list may be compiled for the workplace or for
individual work areas. 

(2) The methods the employer will use to inform employees of the hazards
of non-routine tasks involving the substance, for example, the cleaning
of reactor vessels, and the hazards associated with the substance
contained in unlabeled pipes in their work area. 

(3) The methods the employer will use to inform contractors of the
presence of the substance in the employer's workplace and of the
provisions of this part applicable to the substance if employees of the
contractor work in the employer's workplace and are reasonably likely to
be exposed to the substance while in the employer's workplace. 

(b) Labeling. (1) Each employer shall ensure that each container of the
substance in the workplace is labeled in accordance with this paragraph
(b)(1). 

(i) The label shall, at a minimum, contain the following information: 

(A) A statement of health hazard(s) and precautionary measure(s) for the
substance, if any,  identified in subpart E of this part or by the
employer. 

(B) The identity by which the substance may be commonly recognized. 

(C) A statement of environmental hazard(s) and precautionary measure(s)
for the substance, if any, identified in subpart E of this part or by
the employer.  

(D) A statement of exposure and precautionary measure(s), if any,
identified in subpart E of this part or by the employer. 

(ii) The employer may use signs, placards, process sheets, batch
tickets, operating procedures, or other such written materials in lieu
of affixing labels to individual stationary process containers, as long
as the alternative method identifies the containers to which it is
applicable and conveys information specified by paragraph (b)(1)(i) of
this section. Any written materials must be readily accessible to the
employees in their work areas throughout each work shift. 

(iii) The employer need not label portable containers into which the
substance is transferred from labeled containers, and which are intended
only for the immediate use of the employee who performs the transfer. 

(iv) The employer shall not remove or deface an existing label on
incoming containers of the substance unless the container is immediately
relabeled with the information specified in paragraph (b)(1)(i) of this
section. 

(2) Each employer shall ensure that each container of the substance
leaving its workplace for distribution in commerce is labeled in
accordance with this paragraph. 

(i) The label shall, at a minimum, contain the following information: 

(A) The information required under paragraph (b)(1)(i) of this section. 

(B) The name and address of the manufacturer or a responsible party who
can provide additional information on the substance for hazard
evaluation and any appropriate emergency procedures. 

(ii) The label shall not conflict with the requirements of the Hazardous
Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations
issued under that Act by the Department of Transportation. 

(3) The label, or alternative forms of warning, shall be legible and
prominently displayed. 

(4) The label, or alternative forms of warning, shall be in English;
however, the information may be repeated in other languages. 

(5) If the label or alternative form of warning is to be applied to a
mixture containing a substance identified in subpart E of this part as
subject to this section in combination with another substance identified
in subpart E of this part and/or a substance defined as a "hazardous 
chemical" under the Occupational Safety and Health Administration (OSHA)
Hazard Communication Standard (29 CFR 1900.1200), the employer may
prescribe on the label, MSDS,  or alternative form of warning, the
measures to control worker exposure or environmental release which the
employer determines provide the greatest degree of protection. However,
should these control measures differ from the applicable measures
required under subpart E of this part, the employer must seek a 
determination of equivalency for such alternative control measures
pursuant to (721.30 before prescribing them under this paragraph. 

(c) Material safety data sheets. (1) Each employer must obtain or
develop a MSDS for the substance. 

(2) Each MSDS shall contain, at a minimum, the following information: 

(i) The identity used on the container label of the substance under this
section, and, if not claimed confidential, the chemical and common name
of the substance. If the chemical and common name are claimed
confidential, a generic chemical name must be used. 

(ii) Physical and chemical characteristics of the substance known to the
employer (such as vapor pressure, flash point).

(iii) The physical hazards of the substance known to the employer,
including the potential for fire, explosion, and reactivity.

(iv) The potential human and environmental hazards as specified in
subpart E of this part for the substance. 

(v) Signs and symptoms of exposure, and any medical conditions which are
expected to be aggravated by exposure to the substance known to the
employer. 

(vi) The primary routes of exposure to the substance. 

(vii) Precautionary measures to control worker exposure and/or
environmental release identified in subpart E of this part for the
substance, or alternative control measures which EPA has determined
under (721.30 provide substantially the same degree of protection as the
identified control measures. 

(viii) Any generally applicable precautions for safe handling and use of
the substance which are known to the employer, including appropriate
hygienic practices, protective measures during repair and maintenance of
contaminated equipment, and procedures for response to spills and leaks.

(ix) Any generally applicable control measures which are known to the
employer, such as appropriate engineering controls, work practices, or
personal protective equipment. 

(x) Emergency first aid procedures known to the employer. 

(xi) The date of preparation of the MSDS or of its last revision. 

(xii) The name, address, and telephone number of the individual
preparing or distributing the MSDS, or a responsible party who can
provide additional information on the substance for hazard evaluation
and any appropriate emergency procedures. 

(3) If no relevant information is found or known for any given category
on the MSDS, the employer must mark the MSDS to indicate that no
applicable information was found. 

(4) Where multiple mixtures containing the substance have similar
compositions (i.e., the chemical ingredients are essentially the same,
but the specific composition varies from mixture to mixture) and similar
hazards, the employer may prepare one MSDS to apply to all of these
multiple mixtures. 

(5) If the employer becomes aware of any significant new information
regarding the hazards of the substance or ways to protect against the
hazards, this new information must be added to the MSDS within 3 months
from the time the employer becomes aware of the new information. If the
substance is not currently being manufactured, imported, processed, or
used in the employer's workplace, the employer must add the new
information to the MSDS before the substance is reintroduced into the
workplace. 

(6) The employer must ensure that persons receiving the substance from
the employer are provided an appropriate MSDS with their initial
shipment and with the first shipment after an MSDS is revised. The
employer may either provide the MSDS with the shipped containers or send
it to the person prior to or at the time of shipment. 

(7) The employer must maintain a copy of the MSDS in its workplace, and
must ensure that it is readily accessible during each work shift to
employees when they are in their work areas. 

(8) The MSDS may be kept in any form, including as operating
procedures, and may be designed to cover groups of substances in a work
area where it may be more appropriate to address the potential hazards
of a process rather than individual substances. However, in all cases,
the required information must be provided for each substance and must be
readily accessible during each work shift to employees when they are in
their work areas. 

(9) The MSDS must be printed in English; however, the information may be
repeated in other languages. 

(d) Employee information and training. Each employer must ensure that
employees are provided with information and training on the substance
identified in subpart E of this part. This information and training must
be provided at the time of each employee's initial assignment to a work
area containing the substance and whenever the substance subject to this
section is introduced into the employee's work area for the first time. 

(1) Information provided to employees under this paragraph shall
include: 

(i) The requirements of this section. 

(ii) Any operations in the work area where the substance is present. 

(iii) The location and availability of the written hazard communication
program required under paragraph (a) of this section, including the list
of substances identified in subpart E of this part as subject to this
section, and MSDSs required by paragraph (c) of this section. 

(2) Training provided to employees shall include: 

(i) Methods and observations that may be used to detect the presence or
release of the substance in or from an employee's work area (such as
monitoring conducted by the employer, continuous monitoring devices,
visual appearance, or odor of the substance when being released). 

(ii) The potential human health and environmental hazards of the
substance as specified in subpart E of this part. 

(iii) The measures employees can take to protect themselves and the
environment from the substance, including specific procedures the
employer has implemented to protect employees and the environment from
exposure to the substance, including appropriate work practices,
emergency procedures, personal protective equipment, engineering
controls, and other measures to control worker exposure and/or
environmental release required under subpart E of the

part, or alternative control measures which EPA has determined under
(721.30 provide substantially the same degree of protection as the
specified control measures. 

(iv) The requirements of the hazard communication program developed by
the employer under this section, including an explanation of the
labeling system and the MSDS required by this section and guidance on
obtaining and using appropriate hazard information. 

(e) Low concentrations in mixtures. If a substance identified in subpart
E of this part is present in the work area only as a mixture, an
employer is exempt from the provisions of this section if the
concentration of the substance in the mixture does not exceed a
concentration set in subpart E of this part. The exemption does not
apply if the employer has reason to believe that during intended use or
processing in the work area, the substance in the mixture may be
concentrated above the level set in subpart E of this part. 

(f) Existing hazard communication program. The employer need not take
additional actions if existing programs and procedures satisfy the
requirements of this section. 

(g) Human health, environmental hazard, exposure, and precautionary
statements. Whenever referenced in subpart E of this part for a
substance, the following human health and environmental hazard,
exposure, and precautionary statements shall appear on each label as
specified in paragraph (b) of this section and the MSDS as specified in
paragraph (c) of this 

section. Additional statements may be included as long as they are true
and do not alter the meaning of the required statements. 

(1) Human health hazard statements: This substance may cause: 

(i) Skin irritation. 

(ii) Respiratory complications. 

(iii) Central nervous system effects. 

(iv) Internal organ effects. 

(v) Birth defects. 

(vi) Reproductive effects. 

(vii) Cancer. 

(viii) Immune system effects. 

(ix) Developmental effects. 

(2) Human health hazard precautionary statements: When using this
substance: 

(i) Avoid skin contact. 

(ii) Avoid breathing substance. 

(iii) Avoid ingestion. 

(iv) Use respiratory protection. 

(v) Use skin protection. 

(3) Environmental hazard statements: This substance may be: 

(i) Toxic to fish. 

(ii) Toxic to aquatic organisms. 

(4) Environmental hazard precautionary statements: Notice to users: 

(i) Disposal restrictions apply. 

(ii) Spill clean-up restrictions apply. 

(iii) Do not release to water. 

(5) Each human health or environmental hazard precautionary statement
identified in subpart E of this part for the label on the substance
container must be followed by the statement, "See MSDS for details." 

(h) Human health, environmental hazard exposure and precautionary
statements. (1) Whenever referenced in subpart E of this part for a
substance, the following human health, environmental hazard, exposure,
and precautionary statements shall appear on each label as specified in
paragraph (b) of this section. Additional statements may be included as
long as they are true and do not alter the meaning of the required
statements. 

(i) Precautionary statements. 

(A) The health effects of this chemical substance have not been
determined. 

(B) When using this substance, use skin protection. 

(C) Use respiratory protection when there is a reasonable likelihood of
exposure in the work area from dust, mist, or smoke from spray
application. 

(D) Chemicals similar in structure to this substance have been found to
cause cancer in laboratory animals. 

(ii) Human health hazard statements. This substance may cause: 

(A) Skin irritation 

(B) Respiratory complications 

(C) Central nervous system effects 

(D) Internal organ effects 

(E) Birth defects 

(F) Reproductive effects 

(G) Cancer 

(H) Immune system effects 

(I) Developmental effects 

(iii) Human health hazard precautionary statements. When using this
substance: 

(A) Avoid skin contact 

(B) Avoid breathing substance 

(C) Avoid ingestion 

(D) Use respiratory protection 

(E) Use skin protection 

(iv) Environmental hazard statements. This substance may be: 

(A) Toxic to fish 

(B) Toxic to aquatic organisms 

(v) Environmental hazard precautionary statements. Notice to Users: 

(A) Disposal restrictions apply 

(B) Spill clean-up restrictions apply 

(C) Do not release to water. 

(vi) Additional statements. Each human health or environmental
precautionary statement identified in subpart E of this part for the
label on the substance container must be followed by the statement, "See
MSDS for details." 

(2) Whenever referenced in subpart E of this part for a substance, the
following human health, environmental hazard, exposure, and
precautionary statements shall appear on each MSDS as specified in
paragraph (c) of this section. Additional statements may be included as
long as they are true and do not alter the meaning of the required
statements. 

(i) Precautionary statements. 

(A) The health effects of this chemical substance have not been
determined. 

(B) When using this substance, use skin protection. 

(C) Use respiratory protection when there is a reasonable likelihood of
exposure in the work area from dust, mist, or smoke from spray
application. 

(D) Chemicals similar in structure to this substance have been found to
cause cancer in laboratory animals. 

(ii) Human health hazard statements. This substance may cause: 

(A) Skin irritation 

(B) Respiratory complications 

(C) Central nervous system effects 

(D) Internal organ effects 

(E) Birth defects 

(F) Reproductive effects 

(G) Cancer 

(H) Immune system effects 

(I) Developmental effects 

(iii) Human health hazard precautionary statements. When using this
substance: 

(A) Avoid skin contact 

(B) Avoid breathing substance 

(C) Avoid ingestion 

(D) Use respiratory protection 

(E) Use skin protection 

(iv) Environmental hazard statements. This substance may be: 

(A) Toxic to fish 

(B) Toxic to aquatic organisms 

(v) Environmental hazard precautionary statements. Notice to Users: 

(A) Disposal restrictions apply 

(B) Spill clean-up restrictions apply 

(C) Do not release to water. 

[54 FR 31308, July 27, 1989, as amended at 55 FR 45996, Oct. 31, 1990;
58 FR 34204, June 23, 1993]

(721.80    Industrial, commercial, and consumer activities. 

Whenever a substance is identified in subpart E of this part as being
subject to this section, a significant new use of the substance is: 

(a) Use in non-enclosed processes. 

(b) Any manner or method of manufacture in non-enclosed processes
associated with any use. 

(c) Any manner or method of processing in non-enclosed processes
associated with any use. 

(d) Use beyond the site of manufacture or import. 

(e) Processing beyond the site of manufacture or import. 

(f) Any manner or method of manufacture (excluding import) of the
substance associated with any use. 

(g) Use other than as an intermediate. 

(h) Use other than as a site-limited intermediate. 

(i) Use as an intermediate where the concentration of the intermediate
substance in the product intended for distribution in commerce exceeds
the concentration specified in subpart E of this part for the substance.

(j) Use other than as described in the premanufacture notice referenced
in subpart E of this part for the substance. 

(k) Use other than allowed by the section 5(e) consent order referenced
in subpart E of this part for the substance. 

(l) Non-industrial use. 

(m) Commercial use. 

(n) Non-commercial use. 

(o) Use in a consumer product. 

(p) Aggregate manufacture and importation volume for any use greater
than that specified in subpart E of this part for the substance. 

(q) Aggregate manufacture and importation volume for any use greater
than that allowed by the section 5(e) consent order referenced in
subpart E of this part for the substance. 

(r) Aggregate manufacture and importation volume for any use greater
than that specified in subpart E of this part for the substance unless
the manufacturer or importer has submitted the results of the health or
environmental effects studies identified in subpart E of this part for
the substance and those studies comply with the procedures and criteria
for developing and evaluating data identified in subpart E of this part
for the substance. 

(s) Annual manufacture and importation volume for any use greater than
that specified in subpart E of this part for the substance. 

(t) Annual manufacture and importation volume for any use greater than
that allowed by the section 5(e) consent order referenced in subpart E
of this part for the substance. 

(u) Annual manufacture and importation volume for any use greater than
that specified in subpart E of this part for the substance unless the
manufacturer or importer has submitted the results of the health or
environmental effects studies identified in subpart E of this part for
the substance and those studies comply with the procedures and criteria
for developing and evaluating data identified in subpart E of this part
for the substance. 

(v) Use in the form of: 

(1) A powder. 

(2) A solid. 

(3) A liquid. 

(4) A gas. 

(w) Any manner or method of manufacture of the substance in the
following form associated with any use: 

(1) A powder. 

(2) A solid. 

(3) A liquid. 

(4) A gas. 

(x) Any manner or method of processing of the substance in the following
form associated with any use: 

(1) A powder. 

(2) A solid. 

(3) A liquid. 

(4) A gas. 

(y) Use involving an application method that generates: 

(1) A vapor, mist, or aerosol. 

(2) A dust. 

(721.85    Disposal. 

Whenever a substance is identified in subpart E of this part as being
subject to this section, a significant new use of the

substance is any method of: 

(a) Disposal of the process stream associated with any use of the
substance or with any manner or method of manufacturing associated with
any use of the substance other than by the following. This provision
does not supercede any applicable Federal, State, or local laws and
regulations. 

(1) Incineration. 

(2) Landfill. 

(3) Deep well injection. 

(b) Disposal of the process stream associated with any use or with any
manner or method of processing associated with any use other than by the
following. This provision does not supercede any applicable Federal,
State, or local laws and regulations. 

(1) Incineration. 

(2) Landfill. 

(3) Deep well injection. 

(c) Disposal of the use stream associated with any use, other than by
the following. This provision does not supercede any applicable Federal,
State, or local laws and regulations. 

(1) Incineration. 

(2) Landfill. 

(3) Deep well injection. 

(d) Disposal of the substance associated with any use of the substance,
or with any manner or method of manufacture or processing in association
with any use. This provision does not supercede any applicable Federal,
State, or local laws and regulations. 

(721.90    Release to water. 

Whenever a substance is identified in subpart E of this part as being
subject to this section, a significant new use of the substance is: 

(a) Any predictable or purposeful release of a manufacturing stream
associated with any use of the substance, from any site: 

(1) Into the waters of the United States. 

(2) Into the waters of the United States without application of one or
more of the following treatment technologies as specified in subpart E
of this part either by the discharger or, in the case of a release
through publicly-owned treatment works, by a combination of treatment by
the discharger and the publicly-owned treatment works: 

(i) Chemical precipitation and settling. 

(ii) Biological treatment (activated sludge or equivalent) plus
clarification. 

(iii) Steam stripping. 

(iv) Resin or activated carbon adsorption. 

(v) Chemical destruction or conversion. 

(vi) Primary wastewater treatment. 

(3) Into the waters of the United States without primary wastewater
treatment, and secondary wastewater treatment as defined in 40 CFR part
133. 

(4) Into the waters of the United States if the quotient from the
following formula: 

 number of kilograms/day/site released

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

 receiving stream flow (million liters/    X  1000 = N parts per billion

                  day)

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

exceeds the level specified in subpart E of this part when calculated
using the methods described in (721.91. In lieu of calculating the above
quotient, monitoring or alternative calculations may be used to predict
the surface water concentration which will result from the intended
release of the substance, if the monitoring procedures or calculations
have been approved for such purpose by EPA. EPA will review and act on
written requests to approve monitoring procedures or  alternative
calculations within 90 days after such requests are received. EPA will
inform submitters of the disposition of such requests in writing, and
will explain the reasons therefor when they are denied.  

(b) Any predictable or purposeful release of a process stream
containing the substance associated with any use of the substance from
any site: 

(1) Into the waters of the United States. 

(2) Into the waters of the United States without application of one or
more of the following treatment technologies as specified in subpart E
of this part either by the discharger or, in the case of a release
through publicly-owned treatment works, by a combination of treatment by
the discharger and the publicly-owned treatment works: 

(i) Chemical precipitation and settling. 

(ii) Biological treatment (activated sludge or equivalent) plus
clarification. 

(iii) Steam stripping. 

(iv) Resin or activated carbon adsorption. 

(v) Chemical destruction or conversion. 

(vi) Primary wastewater treatment. 

(3) Into the waters of the United States without primary wastewater
treatment, and secondary wastewater treatment as defined in 40 CFR part
133. 

(4) Into the waters of the United States if the quotient from the
following formula: 

 number of kilograms/day/site released

----------------------------------------           1000 = N parts per

 receiving stream flow (million liters/    X            billion

                  day)

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

exceeds the level specified in subpart E of this part when calculated
using the methods described in (721.91. In lieu of calculating the above
quotient, monitoring or alternative calculations may be used to predict
the surface water concentration which will result from the intended
release of the substance, if the monitoring procedures or calculations
have been approved for such purpose by EPA. EPA will review and act on
written requests to approve monitoring procedures or alternative
calculations within 90 days after such requests are received. EPA will
inform submitters of the disposition of such requests in writing, and
will explain the reasons therefor when they are denied. 

(c) Any predictable or purposeful release of a use stream containing the
substance associated with any use of the substance from any site: 

(1) Into the waters of the United States. 

(2) Into the waters of the United States without application of one or
more of the following treatment technologies as specified in subpart E
of this part either by the discharger or, in the case of a release
through publicly-owned treatment works, by a combination of treatment by
the  discharger and the publicly-owned treatment works: 

(i) Chemical precipitation and settling. 

(ii) Biological treatment (activated sludge or equivalent) plus
clarification. 

(iii) Steam stripping. 

(iv) Resin or activated carbon adsorption. 

(v) Chemical destruction or conversion. 

(vi) Primary wastewater treatment. 

(3) Into the waters of the United States without primary wastewater
treatment, and secondary wastewater treatment as defined in 40 CFR part
133. 

(4) Into the waters of the United States if the quotient from: 

 number of kilograms/day/site released

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

 receiving stream flow (million liters/    X  1000 = N parts per billion

                  day)

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

exceeds the level specified in subpart E of this part, when calculated
using the methods described in (721.91. In lieu of calculating the above
quotient, however, monitoring or alternative calculations may be used to
predict the surface water concentration expected to result from intended
release of the substance, if the monitoring procedures or calculations
have been approved for such purpose by EPA. EPA will review and act on
written requests to approve

monitoring procedures or alternative calculations within 90 days after
such requests are received. EPA will inform submitters of the
disposition of such requests in writing, and will explain the reasons
therefor when they are denied.  

(721.91    Computation of estimated surface water concentrations:
Instructions. 

These instructions describe the use of the equation specified in
(721.90(a)(4) and (b)(4) to compute estimated surface water
concentrations which will result from release of a substance identified
in subpart E of this part. The equation shall be computed for each site
using the stream flow rate appropriate for the site according to
paragraph (b) of this section, and the highest number of kilograms
calculated to be released for that site on a given day according to
paragraph (a) of this section. Two variables shall be considered in
computing the equation, the number of kilograms released, and receiving
stream flow. 

(a) Number of kilograms released. (1) To calculate the number of
kilograms of substance to be released from manufacturing, processing, or
use operations, as specified in the numerator of the equation, develop a
process description diagram which describes each manufacturing,
processing, or use operation involving the substance. The process
description must include the major unit operation steps and chemical
conversions. A unit operation is a functional step in a manufacturing,
processing, or use operation where substances undergo chemical changes
and/or

changes in location, temperature, pressure, physical state, or similar
characteristics. Include steps in which the substance is formulated into
mixtures, suspensions, solutions, etc. 

(2) Indicate on each diagram the entry point of all feedstocks (e.g.,
reactants, solvents, and catalysts) used in the operation. Identify each
feedstock and specify its approximate weight regardless of whether the
process is continuous or batch. 

(3) Identify all release points from which the substance or wastes
containing the substance will be released into air, land, or water.
Indicate these release points on the diagram. Do not include accidental
releases or fugitive emissions. 

(4) For releases identified in the diagram that are destined for water,
estimate the amount of substance that will be released before the
substance enters control technology. The kilograms of substance released
may be estimated based on: 

(i) The mass balance of the operation, i.e., totaling inputs and
outputs, including wastes for each part of the process such that outputs
equal inputs. The amount released to water may be the difference between
the amount of the substance in the starting material (or formed in a
reaction) minus the amount of waste material removed from each part of
the process and not released to water and the amount of the substance in
the final product. 

(ii) Physical properties such as water solubility where a known volume
of water being discharged is assumed to contain the substance at
concentrations equal to its solubility in water. This approach is
particularly useful where the waste stream results from separation of
organic/water phases or filtration of the substance from an aqueous
stream to be discharged. 

(iii) Measurements of flow rates of the process/use stream and known
concentrations of the substance in the stream.  

(5) After releases of a substance to water are estimated for each
operation on a site, total the releases of the substance to water from
all operations at that site. The value (number of kilograms) specified
in the numerator of the equation should reflect total kilograms of
substance released to water per day from all operations at a single
site. 

(6) Use the highest expected daily release of the substance for each
site. 

(b) Receiving stream flow. (1) The receiving stream flow shall be
expressed in million liters per day (MLD). The flow rate data to be used
must be for the point of release on the water body that first receives
release of the substance whether by direct discharge from a site, or by
indirect discharge through a Publicly-Owned Treatment Works (POTW) for
each site. The flow rate reported shall be the lowest 7-day average
stream flow with a recurrence interval of 10 years (7-Q-10). If the
7-Q-10 flow rate is not available for the actual point of release, the
stream flow rate should be used from the U.S. Geological Survey (USGS)
gauging station that is nearest the point of release that is expected to
have a flow rate less than or equal to the receiving stream flow at the
point of release. 

(2) Receiving stream flow data may be available from the National
Pollutant Discharge Elimination System (NPDES) permit for the site or
the POTW releasing the substance to surface  water, from the NPDES
permit-writing authority for the site or the POTW, or from USGS
publications, such as the water-data report series. 

(3) If receiving stream flow data are not available for a stream,
either the value of 10 MLD or the daily flow of wastewater from the site
or the POTW releasing the substance must be used as an assumed minimum
stream flow. Similarly, if stream flow data are not available because
the location of the point of release of the substance to surface water
is a lake, estuary, bay, or ocean, then the flow rate to be used must be
the daily flow of wastewater from the site or the POTW 

releasing the substance to surface water. Wastewater flow data may be
available from the NPDES permit or NPDES authority for the site or the
POTW releasing the substance to water. 

                           Subpart C -- Recordkeeping Requirements 

(721.100    Applicability. 

This subpart C identifies certain additional recordkeeping requirements
applicable to manufacturers, importers, and processors of substances
identified in subpart E of this part for each specific substance. The
provisions of this subpart C apply only when referenced in subpart E of
this part for a substance and significant new use identified in that
subpart E. If the provisions in this subpart C conflict with general
provisions of subpart A of this part, the provisions of this

subpart C shall apply. 

[54 FR 31313, July 27, 1989]

(721.125    Recordkeeping requirements. 

At the time EPA adds a substance to subpart E of this part, EPA will
specify appropriate recordkeeping requirements which correspond to the
significant new use designations for the substance selected from subpart
B of this part. Each manufacturer, importer, and processor of the
substance shall maintain the records for 5 years from the date of their
creation. In addition to the records specified in (721.40, the records
whose maintenance this section requires may include the following: 

(a) Records documenting the manufacture and importation volume of the
substance and the corresponding dates of manufacture and import.  

(b) Records documenting volumes of the substance purchased in the United
States by processors of the substance, names and addresses of suppliers,
and corresponding dates of purchase. 

(c) Records documenting the names and addresses (including shipment
destination address, if different) of all persons outside the site of
manufacture, importation, or processing to whom the manufacturer,
importer, or processor directly sells or transfers the substance, the
date of each sale or transfer, and the quantity of the substance sold or
transferred on such date. 

(d) Records documenting establishment and implementation of a program
for the use of any applicable personal protective equipment required
under (721.63. 

(e) Records documenting the determinations required by ( 721.63(a)(3)
that chemical protective clothing is impervious to the substance. 

(f) Records documenting establishment and implementation of the hazard
communication program required under (721.72. 

(g) Copies of labels required under (721.72(b). 

(h) Copies of material safety data sheets required under ( 721.72(c). 

(i) Records documenting compliance with any applicable industrial,
commercial, and consumer use limitations under ( 721.80. 

(j) Records documenting compliance with any applicable disposal
requirements under (721.85, including the method of disposal, location
of disposal sites, dates of disposal, and volume of the substance
disposed. Where the estimated disposal volume is not known to or
reasonably ascertainable by the manufacturer, importer, or processor,
that person must maintain other records which demonstrate establishment
and implementation of a program that ensures compliance with any
applicable disposal requirements. 

(k) Records documenting establishment and implementation of procedures
that ensure compliance with any applicable water discharge limitations
under (721.90. 

[54 FR 31313, July 27, 1989]

Subpart D -- Expedited Process for Issuing Significant New Use Rules for
Selected Chemical Substances and Limitation or Revocation of Selected
Significant New Use Rules 

Source: 54 FR 31314, July 27, 1989, unless otherwise noted.

 

(721.160    Notification requirements for new chemical substances
subject to section 5(e) orders. 

(a) Selection of substances. (1) In accordance with the expedited
process specified in this section, EPA will issue significant new use
notification requirements and other specific requirements for each new
chemical substance that is the subject of a final order issued under
section 5(e) of the Act, except for an order that prohibits manufacture
and import of the substance, unless EPA determines that significant new
use notification requirements are not needed for the substance. 

(2) If EPA determines that significant new use notification requirements
are not needed for a substance that is subject to a final order issued
under section 5(e) of the Act, except for an order that prohibits
manufacture or import of the substance, EPA will issue a notice in the
FEDERAL  REGISTER explaining why the significant new use requirements
are not needed. 

(b) Designation of requirements. (1) The significant new use
notification and other specific requirements will be based on and be
consistent with the provisions included in the final order issued for
the substance under section 5(e) of the Act. EPA may also designate
additional activities as significant new uses which will be subject to
notification. Designation of additional activities as significant new
uses will be done in accordance with the criteria and procedures

under (721.170, or through a separate rulemaking proceeding.  

(2) Significant new use requirements and other specific requirements
designated under this section will be listed in subpart E of this part.
For each substance, subpart E will identify: 

(i) The chemical name. 

(ii) The activities designated as significant new uses. 

(iii) Other specific requirements applicable to the substance, including
recordkeeping requirements or any other requirements included in the
final section 5(e) order. 

(c) Procedures for issuing significant new use rules. (1) 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. 

(2) 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 EPA's findings under section 5(e)(1)(A) of the Act for
the final order issued under section 5(e). 

(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. 

(3) Direct final rulemaking. (i) When EPA uses the direct final
rulemaking procedure to issue a significant new use rule, it will issue
a final rule in the FEDERAL REGISTER following its decision to develop a
significant new use rule under this section for a specific new chemical
substance. 

(ii) The FEDERAL REGISTER document will state that, unless written
notice is received by EPA within 30 days of publication that someone
wishes to submit adverse or critical comments, the rule will be
effective 60 days from the 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 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 a proposal will be published in the proposed rule
section of the FEDERAL REGISTER. The proposal will establish a 30-day
comment period. 

(iii) 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. 

(4) Notice and comment rulemaking. (i) When EPA uses a notice and
comment procedure to issue a significant new use rule, EPA will issue a
proposal 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. 

(ii) 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. 

(5) Interim final rulemaking. (i) 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. 

(A) The significant new use rule will take effect on the date of
publication. 

(B) Persons will be given 30 days from the date of publication to submit
comments. 

(ii) Interim final rules 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 (c)(5)(i)(B) of this section and promulgating final
significant new use notification requirements and other requirements for
the substance. 

(d) Schedule for issuing significant new use rules. (1) Unless EPA
determines that a significant new use rule should not be issued under
this section, EPA will issue a proposed rule, a direct final rule, or an
interim final rule within 180 days of receipt of a valid notice of
commencement under (720.102 of this chapter for any substance for which
the notice of commencement was received on or after October 10, 1989. 

(2) Unless EPA determines that a significant new use rule should not be
issued under this section, EPA will issue a proposed rule, a direct
final rule, or an interim final rule within 1 year of October 10, 1989,
for any substance for which the valid notice of commencement under
(720.102 of this chapter was received before October 10, 1989. 

(3) If EPA receives adverse or critical significant comments following
publication of a proposed or interim final rule, EPA will either
withdraw the rule or issue a final rule addressing the comments
received. 

(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
(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 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
(720.75 of this chapter. In providing this notice, EPA will describe the
health or environmental 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.  

(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 (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]

(721.185    Limitation or revocation of certain notification
requirements. 

(a) Criteria for modification or revocation. EPA may at any time modify
or revoke significant new use notification requirements for a chemical
substance which has been added to subpart E of this part using the
procedures under (721.160 or (721.170. Such action may be taken under
this section if EPA makes one of the following determinations, unless
other information shows that the requirements should be retained: 

(1) Test data or other information obtained by EPA provide a reasonable
basis for concluding that activities designated as significant new uses
of the substance will not present an unreasonable risk of injury to
human health or the environment. 

(2) EPA has promulgated a rule under section 4 or 6 of the Act, or EPA
or another agency has taken action under another law for the substance
that eliminates the need for significant new use notification under
section 5(a)(2) of the Act. 

(3) EPA has received significant new use notices for some or all of the
activities designated as significant new uses of the substance and,
after reviewing such notices, concluded that there is no need to require
additional notice from persons who propose to engage in identical or
similar activities. 

(4) EPA has examined new information, or has reexamined the test data or
other information or analysis supporting its decision to add the
substance to subpart E of this part under (721.170 and has concluded
that the substance does not meet the criteria under (721.170(b). 

(5) For a substance added to subpart E of this part under (721.160, EPA
has examined new information, or has reexamined the test data or other
information or analysis supporting its finding under section
5(e)(1)(A)(ii)(I) of the Act, and has concluded that a rational basis no
longer exists for the findings that activities involving the substance
may present an unreasonable risk of injury to human health or the
environment required under section 5(e)(1)(A) of the 

Act. 

(6) For a substance added to subpart E of this part under (721.160,
certain activities involving the substance have been designated as
significant new uses pending the completion of testing, and adequate
test data developed in accordance with applicable procedures and
criteria have been submitted to EPA. 

(b) Procedures for limitation or revocation. Modification or revocation
of significant new use notification requirements for a substance that
has been added to subpart E of this part using the procedures described
under (721.160 or (721.170 may occur either at EPA's initiative or in
response to a written request. 

(1) Any affected person may request modification or revocation of
significant new use notification requirements for a substance that has
been added to subpart E of this part using the procedures described in
(721.160 or (721.170 by writing to the Director of the Office of
Pollution Prevention and Toxics and stating the basis for such request.
All requests should be sent to the Document Control Office (7407),
Office of Pollution Prevention and Toxics, U.S.

Environmental Protection Agency, Room G-099, 1200 Pennsylvania Ave.,
NW., Washington, DC 20460. ATTN: Request to amend significant new use
rule. The request must be accompanied by information sufficient to
support the request. 

(2) The Director of the Office of Pollution Prevention and Toxics will
consider the request, make a determination whether to initiate
rulemaking to modify the requirements, and notify the requester of that
determination by certified letter. If the request is denied, the letter
will explain why EPA has concluded that the significant new use
notification requirements for that substance should remain in effect. 

(3) If EPA concludes that significant new use notification requirements
for a substance should be limited or revoked, EPA will propose the
changes in the FEDERAL REGISTER, briefly describe the grounds for the
action, and provide interested parties an opportunity to comment. 

[54 FR 31314, July 27, 1989, as amended at 58 FR 34204, June 23, 1993;
60 FR 34464, July 3, 1995]