Document ID: EPA-HQ-OPPT-2008-0220-0004
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-06-18T04:00Z

ATTACHMENT 2

40 CFR Part 721 (Subpart A through Subpart D)

 This data is current as of the Federal Register dated January 1, 2007

 

                         40 CFR Part721

Subpart A_General Provisions

Sec.  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]

Sec.  721.3  Definitions.

    The definitions in section 3 of the Act, 15 U.S.C. 2602, and Sec.  

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 (LD<INF>50</INF>).

    (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 (LD<INF>50</INF>).

    (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 (LC<INF>50</INF>).

    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, boOPPTS, 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 Sec.  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 EC<INF>50</INF> of 1 mg/L or less.

    (2) An acute aquatic EC<INF>50</INF> of 20 mg/L or less where the 

ratio of aquatic vertebrate 24-hour to 48-hour EC<INF>50</INF> 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 EC<INF>50</INF> 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]

Sec.  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 Sec.  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 recepient'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]

Sec.  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 (DCO) (7407M), 

Office of Pollution Prevention and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-

0001, 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 Sec.  710.7(e)(2)(v) of this chapter or the
information 

requested under Sec.  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; 71

FR 33641, June 12, 2006]

Sec.  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]

Sec.  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]

Sec.  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 (DCO) (7407M), Office of 

Pollution Prevention and Toxics (OPPT), Environmental Protection Agency,

1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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 Sec.  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; 71

FR 33641, June 12, 2006]

Sec.  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]

Sec.  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]

Sec.  721.45  Exemptions.

    The persons identified in Sec.  721.5 are not subject to the 

notification requirements of Sec.  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

Sec.  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 Sec.  

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 Sec. Sec.  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, Sec.  

721.5 applies and Sec.  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]

Sec.  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 Sec.  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.

Sec.  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.

Sec.  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 Sec.  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 Sec.  721.5(d).

Sec.  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 Sec.  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 Sec.  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 Sec.  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]

Sec.  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.

Sec.  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.

Sec.  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

   ---------------------------------------      X 1000 = N parts per
billion

    Receiving stream flow (million liters/day)

exceeds the level specified in subpart E of this part when calculated 

using the methods described in Sec.  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

   ---------------------------------------       X 1000 = N parts per
billion

    Receiving stream flow (million liters/day)

exceeds the level specified in subpart E of this part when calculated 

using the methods described in Sec.  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

   ---------------------------------------       X 1000 = N parts per
billion

    Receiving stream flow (million liters/day)

exceeds the level specified in subpart E of this part, when calculated 

using the methods described in Sec.  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.

Sec.  721.91  Computation of estimated surface water concentrations: 

          Instructions.

    These instructions describe the use of the equation specified in 

Sec.  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

Sec.  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]

Sec.  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 Sec.  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 Sec.  721.63.

    (e) Records documenting the determinations required by Sec.  

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 Sec.  721.72.

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

[[Page 186]]

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

721.72(c).

    (i) Records documenting compliance with any applicable industrial, 

commercial, and consumer use limitations under Sec.  721.80.

    (j) Records documenting compliance with any applicable disposal 

requirements under Sec.  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 Sec.  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.

Sec.  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 

Sec.  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 Sec.  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 Sec. 

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.

Sec.  721.170  Notification requirements for selected new chemical 

          substances that have completed pre manu facture review.

    (a) Selection of substances. In accordance with the expedited 

process specified in this section, EPA may issue significant new use 

notification and recordkeeping requirements for any new chemical 

substance for which a premanufacture notice has been submitted under 

part 720 of this chapter if EPA determines that activities other than 

those described in the premanufacture notice may result in significant 

changes in human exposure or environmental release levels and/or that 

concern exists about the substance's health or environmental effects.

    (b) Concern criteria. EPA may determine that concern exists about a 

substance's health or environmental effects if EPA makes any one of the 

following findings:

    (1)(i) The substance may cause carcinogenic effects because the 

substance:

    (A) Has been shown by valid test data to cause carcinogenic effects 

in humans or in at least one species of laboratory animal.

    (B) Has been shown to be a possible carcinogen based on the weight 

of the evidence in short-term tests indicative of the potential to cause

carcinogenic effects.

    (C) Is closely analogous, based on toxicologically relevant 

similarities in molecular structure and physical properties, to another 

substance that has been shown by test data to cause carcinogenic effects

in humans or in at least one species of laboratory animal, provided that

if there is more than one such analogue, the greatest weight will be 

given to the relevant data for the most appropriate analogues.

    (D) Is known or can reasonably be anticipated, based on valid 

scientific data or established scientific principles, to be metabolized 

in humans or transformed in the environment to a substance which may 

have the potential to cause carcinogenic effects under the criteria in 

paragraphs (b)(1)(i) (A), (B), or (C) of this section.

    (ii) No substance may be regulated based on a finding under 

paragraph (b)(1) of this section unless EPA has also made the finding 

under Sec.  721.170(c)(2)(ii).

    (2) The substance has been shown by valid test data to cause acutely

toxic effects in at least one species of laboratory animal or is closely

analogous, based on toxicologically relevant similarities in molecular 

structure and physical properties, to another substance that has been 

shown by valid test data to cause acutely toxic effects in at least one 

species of laboratory animal, provided that if there is more than one 

such analogue, the greatest weight will be given to the relevant data 

for the most appropriate analogues.

    (3) The substance may cause serious chronic effects, serious acute 

effects, or developmentally toxic effects under reasonably anticipated 

conditions of exposure because the substance:

    (i) Has been shown by valid test data to cause serious chronic 

effects, serious acute effects, or developmentally toxic effects in 

humans or in at least one species of laboratory animal at dose levels 

that could be of concern under reasonably anticipated conditions of 

exposure.

    (ii) Is closely analogous, based on toxicologically relevant 

similarities in molecular structure and physical properties, to another 

chemical substance that has been shown by valid test data to cause 

serious chronic effects, serious acute effects, or developmentally toxic
effects in humans or in at least one species of laboratory animal at
dose levels that could be of concern under reasonably anticipated
conditions of exposure, provided that if there is more than one such
analogue, the greatest weight will be given to the relevant data for the
most appropriate analogues.

    (iii) Is known or can reasonably be anticipated, based on valid 

scientific data or established scientific principles, to be metabolized 

in humans or transformed in the environment to a substance which may 

have the potential to cause serious chronic effects, serious acute 

effects, or developmentally toxic effects under the criteria in 

paragraph (b)(3) (i) and (ii) of this section.

    (iv) Has been shown to potentially cause developmentally toxic 

effects based on the weight of the evidence in short-term tests 

indicative of the potential to cause developmentally toxic effects.

    (4) The substance may cause significant adverse environmental 

effects under reasonably anticipated conditions of release because the 

substance:

    (i) Has been shown by valid test data to cause significant adverse 

environmental effects at dose levels that could be of concern under 

reasonably anticipated conditions of release.

    (ii) Is closely analogous, based on toxicologically relevant 

similarities in molecular structure and physical properties, to another 

substance that has been shown by valid test data to cause significant 

adverse environmental effects at dose levels that could be of concern 

under reasonably anticipated conditions of release, provided that if 

there is more than one such analogue, the greatest weight will be given 

to the relevant data for the most appropriate analogues.

    (iii) Has been determined, based on calculations using the 

substance's physical and chemical properties, to be potentially able to 

cause significant adverse environmental effects at dose levels that 

could be of concern under reasonably anticipated conditions of release.

    (iv) Is known or can reasonably be anticipated, based on valid 

scientific data or established scientific principles, to be 

environmentally transformed to a substance which may have the potential 

to cause significant adverse environmental effects under the criteria in

paragraph (b)(4) (i), (ii), and (iii) of this section.

    (5) Concern exists about the health or environmental effects of one 

or more impurities or byproducts of the substance because the impurity 

or byproduct meets one or more of the criteria in paragraph (b) (1) 

through (4) of this section and either:

    (i) The impurity or byproduct is a new chemical substance and may be

present in concentrations that could cause adverse health or 

environmental effects under reasonably anticipated conditions of 

exposure or release.

    (ii) Reasonably anticipated manufacture, processing, or use 

activities involving the substance for which a premanufacture notice has

been submitted may result in significantly increased human exposure to 

or environmental release of the impurity or byproduct compared to 

exposure or release levels resulting from existing activities involving 

the impurity or byproduct.

    (c) Designation of requirements. (1) When EPA decides to establish 

significant new use reporting requirements under this section, EPA may 

designate as a significant new use any one or more of the activities set

forth in subpart B of this part. In addition, EPA may designate specific

recordkeeping requirements described under subpart C of this part that 

are applicable to the substance.

    (2) EPA may designate as a significant new use only those activities

that (i) are different from those described in the premanufacture notice

for the substance, including any amendments, deletions, and additions of

activities to the premanufacture notice, and (ii) may be accompanied by 

changes in exposure or release levels that are significant in relation 

to the health or environmental concerns identified under paragraph (b) 

of this section.

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

Significant new use requirements designated under this section will be 

listed in subpart E of this part. For each substance, subpart E of this 

part will identify:

    (i) The chemical name.

    (ii) The activities designated as significant new uses, which may 

include one or more of the activities described in paragraph (c) of this

section.

    (iii) Other specific requirements applicable to the substance.

    (2) When EPA determines that a substance is a candidate for a 

significant new use rule under this section, it will notify the person 

that submitted the premanufacture notice for the substance no later than

7 calendar days before the expiration of the notice review period under 

Sec.  720.75 of this chapter. In providing this notice, EPA will 

describe the health or environmental 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 Sec.  

720.102 of this chapter for any substance for which the notice of 

commencement was received on or after October 10, 1989.

    (2) If EPA receives adverse or critical comments within the 

designated comment period following publication of a proposed rule or an

interim final rule, EPA will either withdraw the rule or issue a final 

rule addressing the comments received.

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

Sec.  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 Sec.  721.160 or Sec.  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 Sec.  721.170 and has 

concluded that the substance does not meet the criteria under Sec.  

721.170(b).

    (5) For a substance added to subpart E of this part under Sec.  

721.160, EPA has examined new information, or has reexamined the test 

data or other in for ma tion 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 Sec.  

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 Sec.  721.160 or Sec.  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 

Sec.  721.160 or Sec.  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 

(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), 

Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460-0001. 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; 71 FR 33641, June 12, 2006]

Subpart E_Significant New Uses for Specific Chemical Substances

(40 CFR 721.225 through 40 CFR 721.9973 not included here for reasons of
length)