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EPA ICR No. 1188.12; OMB Control No. 2070-0038

ATTACHMENT 2

40 CFR Part 721 (Subpart A through Subpart D)
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This data is current as of the Federal Register dated July 21, 2015

40 CFR Part 721

Significant New Uses of Chemical Substances

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>).
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 (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, boots, coveralls, gloves, jackets, and pants.

 Commercial use means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to 

consumers (e.g., a commercial dry cleaning establishment or painting contractor).

 Common name means any designation or identification such as code name, code number, 

trade name, brand name, or generic chemical name used to identify a chemical substance other 

than by its chemical name.

 Consumer means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or 

residence, during recreation, or for any personal use or enjoyment.

 Consumer product means a chemical substance that is directly, or as part of a mixture, sold or 

made available to consumers for their use in or around a permanent or temporary household or 

residence, in or around a school, or in recreation.

 Customer means any person to whom a manufacturer, importer, or processor distributes any

quantity of a chemical substance, or of a mixture containing the chemical substance, whether or 

not a sale is involved.

 Director of the Office of Pollution Prevention and Toxics means the Director of the EPA 

Office of Pollution Prevention and Toxics or any EPA employee delegated by the Office 

Director to carry out the Office Director's functions under this part.

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

mixtures.

 Environmentally transformed A chemical substance is ``environmentally transformed'' when 

its chemical structure changes as a result of the action of environmental processes on it.

 Facility means all buildings, equipment, structures, and other stationary items which are 

located on a single site or on contiguous or adjacent sites and which are owned or operated by

the same person (or by any person which controls, is controlled by, or under common control 

with such person).

 Identity means any chemical or common name used to identify a chemical substance or a 

mixture containing that substance.

 Immediate use A chemical substance is for the ``immediate use'' of a person if it is under the 

control of, and used only by, the person who transferred it from a labeled container and will only

be used by that person within the work shift in which it is transferred from the labeled container.
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 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.
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 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.
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 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 
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develops knowledge that the recipient is engaging in a significant new use, that the recipient is 

engaging in a significant new use without submitting a significant new use notice.

 (ii) That, within 15 working days of notifying the recipient as described in paragraph (d)(1)(i) 

of this section, the person received from the recipient, in writing, a statement of assurance that 

the recipient is aware of the terms of the applicable section in subpart E of this part and will not 

engage in the significant new use.

 (iii) That the person has promptly provided EPA enforcement authorities with a copy of the 

recipient's statement of assurance described in paragraph (d)(1)(ii) of this section. The copy must 

be sent to the Office of Enforcement and Compliance Assurance, Office of Compliance (2224A), 

U.S. Environmental Protection Agency, Ariel Rios, 1200 Pennsylvania Ave., N.W., Washington, 

DC, 20044.

 (2) If EPA notifies the manufacturer, importer, or processor that the recipient is engaging in a 

significant new use after providing the statement of assurance described in paragraph (d)(1)(ii) of 

this section and without submitting a notice under this part, the manufacturer, importer, or 

processor shall immediately cease distribution to that recipient until the manufacturer, importer, 

or processor or the recipient has submitted a significant new use notice under this part and the 

notice review period has ended.

 (3) If, after receiving a statement of assurance from a recipient under paragraph (d)(1)(ii) of 

this section, a manufacturer, importer, or processor has knowledge that the recipient is engaging 

in a significant new use without submitting a notice under this part, the manufacturer, importer, 

or processor must immediately cease distributing the substance to that recipient and notify EPA 

enforcement authorities at the address identified in paragraph (d)(1)(iii) of this section. The 

manufacturer, importer, or processor may not resume distribution to that recipient until any one 

of the following has occurred:

 (i) The manufacturer, importer, or processor has submitted a significant new use notice under 

this part and the notice review period has ended.

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

review period has ended. (iii) The manufacturer, importer, or processor has received notice 

from EPA enforcement authorities that it may resume distribution to that recipient.

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

principal importer.

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

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.
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 (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]
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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.
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 (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.
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 (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.
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 (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 
13

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.
14

 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:
15

 (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 
16

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.
17

 (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 
18

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 
19

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.

(i) 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 

(ii) 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.
20

 (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, 
21

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.
22

 (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.
23

 (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.
24

 (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 supersede 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 

supersede 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 supersede 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 

supersede 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:
25

 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 

therefore 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 

therefore when they are denied.
26

 (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 therefore 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 
27

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 
28

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.
29

 (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.
30

 (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.
31

 (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 manufacture 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 shortterm 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.
32

 (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.
33

 (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.
34

 (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 
35

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 information or analysis supporting its 

finding under section 5(e)(1)(A)(ii)(I) of the Act, and has concluded that a rational basis no 

longer exists for the findings that activities involving the substance may present an unreasonable 

risk of injury to human health or the environment required under section 5(e)(1)(A) of the Act.

 (6) For a substance added to subpart E of this part under 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.
36

 (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)