164 

§ 721.1 40 CFR Ch. I (7–1–07 Edition) 

721.10012 Manganate (MnO2

1-), calcium (2:1). 

721.10013 Manganese yttrium oxide 

(Mn2YO5). 

721.10014 Halogenated naphthalic anhydride 

(generic). 

721.10015 Halogenated benzimidazole (generic). 

721.10016 Dibenzimidazothianaphthalene 

(generic). 

721.10017 Amine terminated bisphenol A 

diglycidyl ether polymer (generic). 

721.10018 Calcium hydroxide oxide silicate 

(Ca6(OH)2O 

2(Si2O5)3). 

721.10019 Benzoic acid, 2-chloro-5-nitro-, 1,1- 

dimethyl-2-oxo-2-(2-propenyloxy) ethyl 

ester. 

721.10020 Benzoic acid, 5-amino-2-chloro-, 

1,1-dimethyl-2-oxo-2-(2-propenyloxy) 

ethyl ester. 

721.10021 Magnesium potassium titanium 

oxide. 

721.10022 Benzenamine, N-phenyl-, ar′-(C9- 

rich C8-10-branched alkyl) derivs. 

721.10023 Benzenamine, N-phenyl-, ar ar′-(C9- 

rich C8-10-branched alkyl) derivs. 

721.10024 10H-Phenothiazine, ar-(C9-rich 

C8-10-branched alkyl) derivs. 

721.10025 10H-Phenothiazine, ar, ar′-(C9-rich 

C8-10-branched alkyl) derivs. 

721.10026 Cashew, nutshell liq., ethoxylated. 

721.10027 Ethoxylated alkylsulfate, substituted alkylamine salt (generic). 

721.10028 Disubstituted benzene metal salts 

(generic). 

721.10029 Isocyanate compound, modified 

with methoxysilane (generic). 

721.10030 Pyrimido[5,4-g]pteridine-2,4,6,8- 

tetramine, 4-methylbenzenesulfonate, 

base-hydrolyzed. 

721.10031 Lithium potassium titanium 

oxide. 

721.10032 Acrylic acid, polymer with substituted acrylamides (generic). 

721.10033 Zinc, [ethanedioato(2-)-. kappa. O1, 

. kappa. O2]-. 

721.10034 Substituted pyridine coupled with 

diazotized substituted nitrobenzonitrile, 

diazotized substituted benzenamine and 

substituted pyridinecarbonitrile (generic). 

721.10035 Alkylbenzene sulfonate (generic). 

721.10036 Acetaldehyde based polymer (generic). 

721.10037 Complex halogenated salt of 

tris(ethylatedaminocarbocyclic)methane 

(generic). 

721.10038 Trimellitic anhydride, polymer 

with substituted glycol, alkyl phenols 

and ethoxylated nonylphenol (generic). 

721.10039 Diethoxybenzenamine derivative, 

diazotized, coupled with 

aminonaphthalenesulfonic acid derivative, ammonium salt (generic). 

721.10040 Substituted acridine naphtha substituted benzamide (generic). 

721.10041 1-Butanone, 2-(dimethylamino)-2- 

[(4-methylphenyl)methyl]-1-[4-(4- 

morpholinyl)phenyl]-. 

721.10042 2-Propanol, 1-[bis(2-hydroxyethyl)amino]-. 

721.10043 Dineopentyl-4-substituted phthalate (generic). 

721.10044 Metal oxide, modified with alkyl 

and vinyl terminated polysiloxanes (generic). 

721.10045 Diazotized substituted 

heteromonocycle coupled with naphthalene sulfonic acid derivative, nickel 

complex, alkaline salt (generic). 

721.10046 Polyaromatic amine phosphate 

(generic). 

721.10047 Polyphosphoric acids, compds. 

with piperazine. 

721.10048 Substituted anthraquinone (generic). 

721.10049 Phenol, 4,4′- cyclohexylidene bis[2- 

methyl-. 

721.10050 Disubstituted-N′- hydroxybenzenecarboximidamide (generic). 

721.10051 Spiro naphthoxazine (generic). 

721.10052 Aminoalkyl substituted 

alkylphenol (generic). 

721.10053 Alkyl silane methacrylate (generic). 

721.10054 Phenol, polymer with formaldehyde, 3-[(2-aminocyclohexyl)amino]-2- 

hydroxypropyl ethers. 

721.10055 1-Propanaminium, 3-amino-N- 

(carboxymethyl)-N,N-dimethyl-, N-soya 

acyl derivs., inner salts. 

721.10056 Benzenemethanaminium, N-(3- 

aminopropyl)-N,N-dimethyl-, N-soya acyl 

derivs., chlorides. 

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

Subpart A—General Provisions 

§ 721.1 Scope and applicability. 

(a) This part identifies uses of chemical substances, except for microorganisms regulated under part 725 of this 

chapter, which EPA has determined are 

significant new uses under the authority of section 5(a)(2) of the Toxic Substances Control Act. In addition, it 

specifies procedures for manufacturers, 

importers, and processors to report on 

those significant new uses. This subpart A contains general provisions applicable to this part. subpart B of this 

part identifies generic requirements for 

certain significant new uses cross referenced in specific provisions of subpart E of this part. subpart C of this 

part identifies generic reporting requirements for certain significant new 

uses cross referenced in specific provisions of subpart E of this part. subpart 


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40 CFR Part 721, Subparts A - D
165 

Environmental Protection Agency § 721.3 

E of this part identifies chemical substances and their significant new uses. 

(b) This subpart A contains provisions governing submission and review 

of notices for the chemical substances 

and significant new uses identified in 

subpart E of this part. The provisions 

of this subpart A apply to the chemical 

substances and significant new uses 

identified in subpart E of this part, except to the extent that they are specifically modified or supplanted by specific requirements in subpart E of this 

part. In the event of a conflict between 

the provisions of this subpart A and the 

provisions of subpart E of this part, the 

provisions of subpart E of this part 

shall govern. 

(c) The provisions of part 720 of this 

chapter apply to this part 721. For purposes of this part 721, wherever the 

phrase ‘‘new chemical substance’’ appears in part 720 of this chapter, it 

shall mean the chemical substance subject to this part 721. In the event of a 

conflict between the provisions of part 

720 of this chapter and the provisions of 

this part 721, the provisions of this part 

721 shall govern. 

[53 FR 28358, July 27, 1988, as amended at 62 

FR 17932, Apr. 11, 1997] 

§ 721.3 Definitions. 

The definitions in section 3 of the 

Act, 15 U.S.C. 2602, and §720.3 of this 

chapter apply to this part. In addition, 

the following definitions apply to this 

part: 

Acutely toxic effects A chemical substance produces acutely toxic effects if 

it kills within a short time period (usually 14 days): 

(1) At least 50 percent of the exposed 

mammalian test animals following oral 

administration of a single dose of the 

test substance at 25 milligrams or less 

per kilogram of body weight (LD50). 

(2) At least 50 percent of the exposed 

mammalian test animals following dermal administration of a single dose of 

the test substance at 50 milligrams or 

less per kilogram of body weight 

(LD50). 

(3) At least 50 percent of the exposed 

mammalian test animals following administration of the test substance for 8 

hours or less by continuous inhalation 

at a steady concentration in air at 0.5 

milligrams or less per liter of air 

(LC50). 

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

Inventory. 

Chemical name means the scientific 

designation of a chemical substance in 

accordance with the nomenclature system developed by the International 

Union of Pure and Applied Chemistry 

or the Chemical Abstracts Service’s 

rules of nomenclature, or a name which 

will clearly identify a chemical substance for the purpose of conducting a 

hazard evaluation. 

Chemical protective clothing means 

items of clothing that provide a protective barrier to prevent dermal contact 

with chemical substances of concern. 

Examples can include, but are not limited to: full body protective clothing, 

boots, coveralls, gloves, jackets, and 

pants. 

Commercial use means the use of a 

chemical substance or any mixture 

containing the chemical substance in a 

commercial enterprise providing saleable goods or a service to consumers 

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

Common name means any designation 

or identification such as code name, 

code number, trade name, brand name, 

or generic chemical name used to identify a chemical substance other than 

by its chemical name. 

Consumer means a private individual 

who uses a chemical substance or any 

product containing the chemical substance in or around a permanent or 

temporary household or residence, during recreation, or for any personal use 

or enjoyment. 

Consumer product means a chemical 

substance that is directly, or as part of 

a mixture, sold or made available to 

consumers for their use in or around a 

permanent or temporary household or 

residence, in or around a school, or in 

recreation. 

Customer means any person to whom 

a manufacturer, importer, or processor 

distributes any quantity of a chemical 

substance, or of a mixture containing 

the chemical substance, whether or not 

a sale is involved. 

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


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§ 721.3 40 CFR Ch. I (7–1–07 Edition) 

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

delegated by the Office Director to 

carry out the Office Director’s functions under this part. 

Employer means any manufacturer, 

importer, processor, or user of chemical substances or mixtures. 

Environmentally transformed A chemical substance is ‘‘environmentally 

transformed’’ when its chemical structure changes as a result of the action 

of environmental processes on it. 

Facility means all buildings, equipment, structures, and other stationary 

items which are located on a single site 

or on contiguous or adjacent sites and 

which are owned or operated by the 

same person (or by any person which 

controls, is controlled by, or under 

common control with such person). 

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

substance or a mixture containing that 

substance. 

Immediate use A chemical substance 

is for the ‘‘immediate use’’ of a person 

if it is under the control of, and used 

only by, the person who transferred it 

from a labeled container and will only 

be used by that person within the work 

shift in which it is transferred from the 

labeled container. 

Impervious Chemical protective clothing is ‘‘impervious’’ to a chemical substance if the substance causes no chemical or mechanical degradation, permeation, or penetration of the chemical 

protective clothing under the conditions of, and the duration of, exposure. 

Manufacturing stream means all reasonably anticipated transfer, flow, or 

disposal of a chemical substance, regardless of physical state or concentration, through all intended operations of 

manufacture, including the cleaning of 

equipment. 

Metalworking fluid means a liquid of 

any viscosity or color containing intentionally added water and used in 

metal machining operations for the 

purpose of cooling, lubricating, or rust 

inhibition. 

MSDS means material safety data 

sheet, the written listing of data for 

the chemical substance as required 

under §721.72(c). 

NIOSH means the National Institute 

for Occupational Safety and Health of 

the U.S. Department of Health and 

Human Services. 

Non-enclosed process means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in 

which a chemical substance is manufactured, processed, or otherwise used 

where significant direct contact of the 

bulk chemical substance and the workplace air may occur. 

Non-industrial use means use other 

than at a facility where chemical substances or mixtures are manufactured, 

imported, or processed. 

Personal protective equipment means 

any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, an identified chemical substance or substances 

in the work area. Examples include, 

but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or 

equivalent eye protection, and various 

types of respirators. Barrier creams are 

not included in this definition. 

Powder or dry solid form means a state 

where all or part of the substance 

would have the potential to become 

fine, loose, solid particles. 

Principal importer means the first importer who, knowing that a chemical 

substance will be imported for a significant new use rather than manufactured in the United States, specifies 

the chemical substance and the 

amount to be imported. Only persons 

who are incorporated, licensed, or 

doing business in the United States 

may be principal importers. 

Process for commercial purposes means 

the preparation of a chemical substance or mixture containing the 

chemical substance, after manufacture 

of the substance, for distribution in 

commerce with the purpose of obtaining an immediate or eventual commercial advantage for the processor. Processing of any amount of a chemical 

substance or mixture containing the 

chemical substance is included in this 

definition. If a chemical substance or 

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

Process solely for export means to 

process for commercial purposes solely 

for export from the United States 


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Environmental Protection Agency § 721.3 

under the following restrictions on activity in the United States: Processing 

must be performed at sites under the 

control of the processor; distribution in 

commerce is limited to purposes of export; and the processor may not use the 

chemical substance except in small 

quantities solely for research and development. 

Process stream means all reasonably 

anticipated transfer, flow, or disposal 

of a chemical substance, regardless of 

physical state or concentration, 

through all intended operations of 

processing, including the cleaning of 

equipment. 

Recipient means any person who purchases or otherwise obtains a chemical 

substance directly from a person who 

manufacturers, imports, or processes 

the substance. 

Serious acute effects means human injury or human disease processes that 

have a short latency period for development, result from short-term exposure 

to a chemical substance, or are a combination of these factors and which are 

likely to result in death or severe or 

prolonged incapacitation. 

Serious chronic effects means human 

injury or human disease processes that 

have a long latency period for development, result from long-term exposure 

to a chemical substance, or are a combination of these factors and which are 

likely to result in death or severe or 

prolonged incapacitation. 

Short-term test indicative of carcinogenic potential means either any limited 

bioassay that measures tumor or 

preneoplastic induction, or any test indicative of interaction of a chemical 

substance with DNA (i.e., positive response in assays for gene mutation, 

chromosomal aberrations, DNA damage and repair, or cellular transformation). 

Short-term test indicative of the potential to cause a developmentally toxic effect 

means either any in vivo preliminary 

development toxicity screen conducted 

in a mammalian species, or any in vitro 

developmental toxicity screen, including any test system other than the intact pregnant mammal, that has been 

extensively evaluated and judged reliable for its ability to predict the potential to cause developmentally toxic effects in intact systems across a broad 

range of chemicals or within a class of 

chemicals that includes the substance 

of concern. 

Significant adverse environmental effects means injury to the environment 

by a chemical substance which reduces 

or adversely affects the productivity, 

utility, value, or function of biological, 

commercial, or agricultural resources, 

or which may adversely affect a threatened or endangered species. A substance will be considered to have the 

potential for significant adverse environmental effects if it has one of the 

following: 

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

less. 

(2) An acute aquatic EC50 of 20 mg/L 

or less where the ratio of aquatic 

vertebrate 24-hour to 48-hour EC50 is 

greater than or equal to 2.0. 

(3) A Maximum Acceptable Toxicant 

Concentration (MATC) of less than or 

equal to 100 parts per billion (100 ppb). 

(4) An acute aquatic EC50 of 20 mg/L 

or less coupled with either a measured 

bioconcentration factor (BCF) equal to 

or greater than 1,000x or in the absence 

of bioconcentration data a log P value 

equal to or greater than 4.3. 

Site means a contiguous property 

unit. Property divided only by a public 

right-of-way is one site. There may be 

more than one manufacturing plant on 

a single site. 

Site-limited intermediate means an intermediate manufactured, processed, 

and used only within a site and not distributed in commerce other than as an 

impurity or for disposal. Imported 

intermediates cannot be ‘‘site-limited.’’ 

Spray application means any method 

of projecting a jet of vapor of finely divided liquid onto a surface to be coated; whether by compressed air, hydraulic pressure, electrostatic forces, or 

other methods of generating a spray. 

Use stream means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all 

intended operations of industrial, commercial, or consumer use. 

Waters of the United States has the 

meaning set forth in 40 CFR 122.2. 

Work area means a room or defined 

space in a workplace where a chemical 

substance is manufactured, processed, 


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§ 721.5 40 CFR Ch. I (7–1–07 Edition) 

or used and where employees are 

present. 

Workplace means an establishment at 

one geographic location containing one 

or more work areas. 

[53 FR 28358, July 27, 1988, as amended at 54 

FR 31306, July 27, 1989; 58 FR 63516, Dec. 1, 

1993] 

§ 721.5 Persons who must report. 

(a) The following persons must submit a significant new use notice as 

specified under the provisions of section 5(a)(1)(B) of the Act, part 720 of 

this chapter, and §721.25: 

(1) A person who intends to manufacture, import, or process for commercial 

purposes a chemical substance identified in a specific section in subpart E of 

this part, and intends to engage in a 

significant new use of the substance 

identified in that section. 

(2) A person who intends to manufacture, import, or process for commercial 

purposes a chemical substance identified in a specific section in subpart E of 

this part, and intends to distribute the 

substance in commerce. A person described in this paragraph is not required to submit a significant new use 

notice if that person can document one 

or more of the following as to each recipient of the substance from that person: 

(i) That the person has notified the 

recipient, in writing, of the specific 

section in subpart E of this part which 

identifies the substance and its designated significant new uses. 

(ii) That the recipient has knowledge 

of the specific section in subpart E of 

this part which identifies the substance 

and its designated significant new uses. 

(iii) That the recipient cannot undertake any significant new use described 

in the specific section in subpart E of 

this part. 

(b) A person described in paragraph 

(a)(2) of this section must submit a significant new use notice if that person 

has knowledge at the time of commercial distribution of the substance identified in the specific section in subpart 

E of this part that a recipient intends 

to engage in a designated significant 

new use of that substance without submitting a notice under this part. 

(c) A person who processes a chemical substance identified in a specific 

section in subpart E of this part for a 

significant new use of that substance is 

not required to submit a significant 

new use notice if that person can document each of the following: 

(1) That the person does not know the 

specific chemical identity of the chemical substance being processed. 

(2) That the person is processing the 

chemical substance without knowledge 

that the substance is identified in subpart E of this part. 

(d)(1) If at any time after commencing distribution in commerce of a 

chemical substance identified in a specific section in subpart E of this part a 

person described in paragraph (a)(2) of 

this section has knowledge that a recipient of the substance is engaging in 

a significant new use of that substance 

designated in that section without submitting a notice under this part, the 

person is required to cease supplying 

the chemical substance to that recipient and to submit a significant new use 

notice for that chemical substance and 

significant new use, unless the person 

is able to document each of the following: 

(i) That the person has notified the 

recipient and EPA enforcement authorities (at the address in paragraph 

(d)(1)(iii) of this section), in writing 

within 15 working days of the time the 

person develops knowledge that the recipient is engaging in a significant new 

use, that the recipient is engaging in a 

significant new use without submitting 

a significant new use notice. 

(ii) That, within 15 working days of 

notifying the recipient as described in 

paragraph (d)(1)(i) of this section, the 

person received from the recipient, in 

writing, a statement of assurance that 

the recipient is aware of the terms of 

the applicable section in subpart E of 

this part and will not engage in the significant new use. 

(iii) That the person has promptly 

provided EPA enforcement authorities 

with a copy of the recepient’s statement of assurance described in paragraph (d)(1)(ii) of this section. The copy 

must be sent to the Office of Enforcement and Compliance Assurance, Office 

of Compliance (2224A), U.S. Environmental Protection Agency, Ariel Rios, 

1200 Pennsylvania Ave., N.W., Washington, DC, 20044. 


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Environmental Protection Agency § 721.11 

(2) If EPA notifies the manufacturer, 

importer, or processor that the recipient is engaging in a significant new use 

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

this section and without submitting a 

notice under this part, the manufacturer, importer, or processor shall immediately cease distribution to that recipient until the manufacturer, importer, or processor or the recipient 

has submitted a significant new use notice under this part and the notice review period has ended. 

(3) If, after receiving a statement of 

assurance from a recipient under paragraph (d)(1)(ii) of this section, a manufacturer, importer, or processor has 

knowledge that the recipient is engaging in a significant new use without 

submitting a notice under this part, 

the manufacturer, importer, or processor must immediately cease distributing the substance to that recipient 

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

manufacturer, importer, or processor 

may not resume distribution to that 

recipient until any one of the following 

has occurred: 

(i) The manufacturer, importer, or 

processor has submitted a significant 

new use notice under this part and the 

notice review period has ended. 

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

and the notice review period has ended. 

(iii) The manufacturer, importer, or 

processor has received notice from EPA 

enforcement authorities that it may 

resume distribution to that recipient. 

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

submitted by the principal importer. 

[53 FR 28359, July 27, 1988, as amended at 60 

FR 34464, July 3, 1995] 

§ 721.11 Applicability determination 

when the specific chemical identity 

is confidential. 

(a) A person who intends to manufacture, import, or process a chemical 

substance which is described by a generic chemical name is subpart E of 

this part may ask EPA whether the 

substance is subject to the requirements of this part. EPA will answer 

such an inquiry only if EPA determines 

that the person has a bona fide intent 

to manufacture, import, or process the 

chemical substance for commercial 

purposes. 

(b) To establish a bona fide intent to 

manufacture, import, or process a 

chemical substance, the person who intends to manufacture, import, or process the chemical substance must submit the following information in writing to the Document Control Office 

(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

20460–0001, ATTN: SNUR Bonafide submissions. 

(1) The specific chemical identity of 

the chemical substance that the person 

intends to manufacture, import, or 

process. 

(2) A signed statement that the person intends to manufacture, import, or 

process the chemical substance for 

commercial purposes. 

(3) A description of the research and 

development activities conducted to 

date, and the purpose for which the 

person will manufacture, import, or 

process the chemical substance. 

(4) An elemental analysis. 

(5) Either an X-ray diffraction pattern (for inorganic substances), a mass 

spectrum (for most other substances), 

or an infrared spectrum of the particular chemical substance, or, if such 

data do not resolve uncertainties with 

respect to the identity of the chemical 

substance, additional or alternative 

spectra or other data to identify the 

substance. 

(c) If an importer or processor cannot 

provide all the information required in 

paragraph (b) of this section because it 

is claimed as confidential business information by the importer’s or processor’s manufacturer or supplier, the 

manufacturer or supplier may supply 

the information directly to EPA. 

(d) EPA will review the information 

submitted by the manufacturer, importer, or processor under paragraph 

(b) of this section to determine whether than person has shown a bona fide intent to manufacture, import, or process the chemical substance. If necessary, EPA will compare this information either to the information requested for the confidential chemical 


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§ 721.20 40 CFR Ch. I (7–1–07 Edition) 

substance under §710.7(e)(2)(v) of this 

chapter or the information requested 

under §720.85(b)(3)(iii) of this chapter. 

(e) If the manufacturer, importer, or 

processor has shown a bona fide intent 

to manufacture, import, or process the 

substance and has provided sufficient 

unambiguous chemical identity information to enable EPA to make a conclusive determination as to the identity of the substance, EPA will inform 

the manufacturer, importer, or processor whether the chemical substance 

is subject to this part and, if so, which 

section in subpart E of this part applies. 

(f) A disclosure to a person with a 

bona fide intent to manufacture, import, or process a particular chemical 

substance that the substance is subject 

to this part will not be considered public disclosure of confidential business 

information under section 14 of the 

Act. 

(g) EPA will answer an inquiry on 

whether a particular chemical substance is subject to this part within 30 

days after receipt of a complete submission under paragraph (b) of this section. 

[53 FR 28359, July 27, 1988, as amended at 60 

FR 34464, July 3, 1995; 71 FR 33641, June 12, 

2006] 

§ 721.20 Exports and imports. 

Persons who intend to export a chemical substance identified in subpart E 

of this part, or in any proposed rule 

which would amend subpart E of this 

part, are subject to the export notification provisions of section 12(b) of the 

Act. The regulations that interpret 

section 12(b) appear at 40 CFR part 707. 

Persons who import a substance identified in a specific section in subpart E of 

this part are subject to the import certification requirements under section 

13 of the Act, which are codified at 19 

CFR 12.118 through 12.127 and 127.28. 

The EPA policy in support of the import certification requirements appears 

at 40 CFR part 707. 

[53 FR 28360, July 27, 1988] 

§ 721.25 Notice requirements and procedures. 

(a) Each person who is required to 

submit a significant new use notice 

under this part must submit the notice 

at least 90 calendar days before commencing manufacture, import, or processing of a chemical substance identified in subpart E of this part for a significant new use. The submitter must 

comply with any applicable requirement of section 5(b) of the Act, and the 

notice must include the information 

and test data specified in section 5(d)(1) 

of the Act. The notice must be submitted on EPA Form 7710–25, and must 

comply with the requirements of part 

720 of this chapter, except to the extent 

that they are inconsistent with this 

part 721. 

(b) If two or more persons are required to submit a significant new use 

notice for the same chemical substance 

and significant new use identified in 

subpart E of this part, they may submit a joint notice to EPA. Persons submitting a joint notice must individually complete the certification section of part I of the required notification form. Persons who are required to 

submit individually, but elect to submit jointly, remain individually liable 

for the failure to submit required information which is known to or reasonably ascertainable by them and test 

data in their possession or control. 

(c) EPA will process the notice in accordance with the procedures of part 

720 of this chapter, expect to the extent 

they are inconsistent with this part 

721. 

(d) Any person submitting a significant new use notice in response to the 

requirements of this part 721 shall not 

manufacture, import, or process a 

chemical substance identified in subpart E of this part for a significant new 

use until the notice review period, including all extensions and suspensions, 

has expired. 

[53 FR 28360, July 27, 1988, as amended at 60 

FR 16311, Mar. 29, 1995] 

§ 721.30 EPA approval of alternative 

control measures. 

(a) In certain sections of subpart E of 

this part, significant new uses for the 

identified substances are described as 

the failure to establish and implement 

programs providing for the use of either: specific measures to control 

worker exposure to or release of substances which are identified in such 


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Environmental Protection Agency § 721.35 

sections, or alternative measures to 

control worker exposure or environmental release which EPA has determined provide substantially the same 

degree of protection as the specified 

control measures. Persons who manufacture, import, or process a chemical 

substance identified in such sections 

and who intend to employ alternative 

measures to control worker exposure 

or environmental release must submit 

a request to EPA for a determination 

of equivalency before commencing 

manufacture, import, or processing involving the alternative control measures. 

(b) A request for a determination of 

equivalency must be submitted in writing to the Document Control Office 

(DCO) (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 

20460–0001; ATTN: SNUR Equivalency 

Determination, and must contain: 

(1) The name of the submitter. 

(2) The specific chemical identity of 

the substance. 

(3) The citation for the specific section in subpart E of this part which 

pertains to the substance for which the 

request is being submitted. 

(4) A detailed description of the activities involved. 

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

measures. 

(6) An analysis justifying why such 

alternative control measures provide 

substantially the same degree of protection as the specific control measures identified in the specific section in 

subpart E of this part which pertains to 

the substance for which the request is 

being submitted. 

(7) The data and information described in §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] 

§ 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: 


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§ 721.40 40 CFR Ch. I (7–1–07 Edition) 

(1) Seek to enjoin the manufacture, 

import, or processing of a chemical 

substance in violation of this part. 

(2) Act to seize any chemical substance which is being manufactured, 

imported, or processed in violation of 

this part. 

(3) Take any other appropriate action. 

[53 FR 28361, July 27, 1988] 

§ 721.40 Recordkeeping. 

Any person subject to the requirements of this part must retain documentation of information contained in 

that person’s significant new use notice. This documentation must be 

maintained for a period of 5 years from 

the date of the submission of the significant new use notice. 

[53 FR 28361, July 27, 1988] 

§ 721.45 Exemptions. 

The persons identified in §721.5 are 

not subject to the notification requirements of §721.25 for a chemical substance identified in subpart E of this 

part, unless otherwise specified in a 

specific section in subpart E, if: 

(a) The person has applied for and has 

been granted an exemption for test 

marketing the substance for a significant new use identified in subpart E of 

this part in accordance with section 

5(h)(1) of the Act and §720.38 of this 

chapter. 

(b) The person manufactures, imports, or processes the substance for a 

significant new use identified in subpart E of this part in small quantities 

solely for research and development in 

accordance with §721.47. 

(c) The person has applied for and 

been granted an exemption under section 5(h)(5) of the Act. 

(d) The person manufactures, imports, or processes the substance only 

as an impurity. 

(e) The person manufactures, imports, or processes the substance only 

as a byproduct which is used only by 

public or private organizations that (1) 

burn it as a fuel, (2) dispose of it as a 

waste, including in a landfill or for enriching soil, or (3) extract component 

chemical substances from it for commercial purposes. 

(f) The person imports or processes 

the substance as part of an article. 

(g) The person manufactures or processes the substance solely for export 

and, when distributing the substance in 

commerce, labels the substance in accordance with section 12(a)(1)(B) of the 

Act. 

(h) The person submits a significant 

new use notice for the substance prior 

to the promulgation date of the section 

in subpart E of this part which identifies the substance, and the person receives written notification of compliance from EPA prior to the effective 

date of such section. The notice submitter must comply with any applicable requirement of section 5(b) of the 

Act. The notice must include the information and test data specified in section 5(d)(1) of the Act and must be submitted on the notice form in Appendix 

A to part 720 of this chapter. For purposes of this exemption, the specific 

section in subpart E of this part which 

identifies the substance and §§721.1, 

721.3, 721.11, 721.35, and 721.40 apply; 

after the effective date of the section 

in subpart E of this part which identifies the substance, §721.5 applies and 

§721.20 continues to apply. EPA will 

provide the notice submitter with written notification of compliance only if 

one of the following occurs: 

(1) EPA is unable to make the finding 

that the activities described in the significant new use notice will or may 

present an unreasonable risk of injury 

to health or the environment under 

reasonably foreseeable circumstances. 

(2) EPA and the person negotiate a 

consent order under section 5(e) of the 

Act, such order to take effect on the effective date of the section in subpart E 

of this part which identifies the substance. 

(i) The person is operating under the 

terms of a consent order issued under 

section 5(e) of the Act applicable to 

that person. If a provision of such section 5(e) order is inconsistent with a 

specific significant new use identified 

in subpart E of this part, abiding by 

the provision of the section 5(e) order 

exempts the person from submitting a 

significant new use notice for that specific significant new use. 

[53 FR 28361, July 27, 1988] 


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Environmental Protection Agency § 721.47 

§ 721.47 Conditions for research and 

development exemption. 

(a) A person who manufactures, imports, or processes a chemical substance identifies in subpart E of this 

part for a significant new use identified 

in subpart E of this part is not subject 

to the notification requirements of 

§721.25 if the following conditions are 

met: 

(1) The person manufactures, imports, or processes the substance for 

the significant new use in small quantities solely for research and development. 

(2) The manufacturer, importer, or 

processor notifies all persons in its employ or to whom it directly distributes 

the chemical substance, who are engaged in experimentation, research, or 

analysis on the chemical substance, including the manufacture, processing, 

use, transport, storage, and disposal of 

the substance associated with research 

and development activities, of any risk 

to health, identified under paragraph 

(b) of this section, which may be associated with the substance. The notification must be made in accordance 

with paragraph (c) of this section. 

(3) The chemical substance is used 

by, or directly under the supervision 

of, a technically qualified individual. 

(b)(1) To determine whether notification under paragraph (a)(2) of this section is required, the manufacturer, importer, or processor must review and 

evaluate the following information to 

determine whether there is reason to 

believe there is any risk to health 

which may be associated with the 

chemicals substance: 

(i) Information in its possession or 

control concerning any significant adverse reaction by persons exposed to 

the chemical substance which may reasonably be associated with such exposure. 

(ii) Information provided to the manufacturer, importer, or processor by a 

supplier or any other person concerning a health risk believed to be associated with the substance. 

(iii) Health and environmental effects data in its possession or control 

concerning the substance. 

(iv) Information on health effects 

which accompanies any EPA rule or 

order issued under section 4, 5, or 6 of 

the Act that applies to the substance 

and of which the manufacturer, importer, or processor has knowledge. 

(2) When the research and development activity is conducted solely in a 

laboratory and exposure to the chemical substance is controlled through 

the implementation of prudent laboratory practices for handling chemical 

substances of unknown toxicity, and 

any distribution, except for purposes of 

disposal, is to other such laboratories 

for further research and development 

activity, the information specified in 

paragraph (b)(1) of this section need 

not be reviewed and evaluated. (For 

purposes of this paragraph (b)(2), a laboratory is defined as a contained research facility where relatively small 

quantities of chemical substances are 

used on a pro-production basis, and 

where activities involve the use of containers for reactions, transfers, and 

other handling of substances designed 

to be easily manipulated by a single individual). 

(c)(1) The manufacturer, importer, or 

processor must notify the persons identified in paragraph (a)(2) of this section 

by means of a container labeling system, conspicuous placement of notices 

in areas where exposure may occur, 

written notification to each person potentially exposed, or any other method 

of notification which adequately informs persons of health risks which the 

manufacturer, importer, or processor 

has reason to believe may be associated 

with the substance, as determined 

under paragraph (b)(1) of this section. 

(2) If the manufacturer, importer, or 

processor distributes a chemical substance manufactured, imported, or 

processed under this section to persons 

not in its employ, the manufacturer, 

importer, or processor must in written 

form: 

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

and development purposes. 

(ii) Provide the notice of health risks 

specified in paragraph (c)(1) of this section. 

(3) The adequacy of any notification 

under this section is the responsibility 

of the manufacturer, importer, or processor. 


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§ 721.50 40 CFR Ch. I (7–1–07 Edition) 

(d) Quantities of the chemical substance, or of mixtures or articles containing the chemical substance, remaining after completion of research 

and development activities may be: 

(1) Disposed of as a waste in accordance with applicable Federal, State, 

and local regulations, to the extent the 

disposal activity is not identified as a 

significant new use for the substance in 

subpart E of this part, or 

(2) Used for a commercial purpose, to 

the extent the use is not identified as a 

significant new use of the substance in 

subpart E of this part. 

(e)(1) Persons who manufacture, import, or process a chemical substance 

under this section must retain the following records: 

(i) Copies of or citations to information reviewed and evaluated under 

paragraph (b)(1) of this section to determine the need to make any notification of risk. 

(ii) Documentation of the nature and 

method of notification under paragraph 

(c)(1) of this section including copies of 

any labels or written notices used. 

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

(iv) The names and addresses of any 

persons other than the manufacturer, 

importer, or processor to whom the 

substance is distributed, the identity of 

the substance, the amount distributed, 

and copies of the notifications required 

under paragraph (c)(2) of this section. 

(2) [Reserved] 

[53 FR 28361, July 27, 1988, as amended at 58 

FR 34204, June 23, 1993] 

Subpart B—Certain Significant 

New Uses 

SOURCE: 54 FR 31308, July 27, 1989, unless 

otherwise noted. 

§ 721.50 Applicability. 

This subpart B identifies certain significant new uses of chemical substances identified in subpart E of this 

part. The provisions of this subpart B 

apply only when referenced as applying 

to a chemical substance identified in 

subpart E of this part. 

§ 721.63 Protection in the workplace. 

(a) Whenever a substance is identified in subpart E of this part as being 

subject to this section, a significant 

new use of the substance is any manner 

or method of manufacturing, importing, or processing associated with any 

use of the substance without establishing a program whereby: 

(1) Each person who is reasonably 

likely to be dermally exposed in the 

work area to the chemical substance 

through direct handling of the substance or through contact with equipment on which the substance may 

exist, or because the substance becomes airborne in the form listed in 

paragraph (a)(6) of this section, and 

cited in subpart E of this part for the 

chemical substance, is provided with, 

and is required to wear, personal protective equipment that provides a barrier to prevent dermal exposure to the 

substance in the specific work area 

where it is selected for use. Each such 

item of personal protective equipment 

must be selected and used in accordance with 29 CFR 1910.132 and 1910.133. 

(2) In addition to any other personal 

protective equipment selected in paragraph (a)(1) of this section, the following items are required: 

(i) Gloves. 

(ii) Full body chemical protective 

clothing. 

(iii) Chemical goggles or equivalent 

eye protection. 

(iv) Clothing which covers any other 

exposed areas of the arms, legs, and 

torso. Clothing provided under this 

paragraph need not be tested or evaluated under the requirements of paragraph (a)(3) of this section. 

(3) The employer is able to demonstrate that each item of chemical 

protective clothing, including gloves, 

selected provides an impervious barrier 

to prevent dermal exposure during normal and expected duration and conditions of exposure within the work area 

by any one or a combination of the following: 

(i) Testing the material used to make 

the chemical protective clothing and 

the construction of the clothing to establish that the protective clothing 

will be impervious for the expected duration and conditions of exposure. The 


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Environmental Protection Agency § 721.63 

testing must subject the chemical protective clothing to the expected conditions of exposure, including the likely 

combinations of chemical substances 

to which the clothing may be exposed 

in the work area. 

(ii) Evaluating the specifications 

from the manufacturer or supplier of 

the chemical protective clothing, or of 

the material used in construction of 

the clothing, to establish that the 

chemical protective clothing will be 

impervious to the chemical substance 

alone and in likely combination with 

other chemical substances in the work 

area. 

(4) Each person who is reasonably 

likely to be exposed to the chemical 

substance by inhalation in the work 

area in one or more of the forms listed 

in paragraph (a)(6) of this section and 

cited in subpart E of this part for the 

chemical substance, is provided with, 

and is required to wear, at a minimum, 

a NIOSH- approved respirator from one 

of the categories listed in paragraph 

(a)(5) of this section, and the respirator 

is used in accordance with 29 CFR 

1910.134 and 30 CFR part 11. 

(5) The following NIOSH approved 

respirators meet the minimum requirements for paragraph (a)(4) of this section: 

(i) Category 19C Type C supplied-air 

respirator operated in pressure demand 

or other positive pressure mode and 

equipped with a full facepiece. 

(ii) Category 19C Type C supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a tight-fitting facepiece. 

(iii) Category 19C Type C supplied-air 

respirator operated in pressure demand 

or continuous flow mode and equipped 

with a hood or helmet or tight-fitting 

facepiece. 

(iv) Category 21C air-purifying respirator equipped with a full facepiece 

and high efficiency particulate filters. 

(v) Category 21C powered air-purifying respirator equipped with a tightfitting facepiece and high efficiency 

particulate filters. 

(vi) Category 21C powered air-purifying respirator equipped with a loosefitting 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 tightfitting 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 loosefitting 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 tightfitting facepiece and organic gas/vapor 

cartridges. 

(xiv) Category 23C powered air-purifying respirator equipped with a loosefitting 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 


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§ 721.72 40 CFR Ch. I (7–1–07 Edition) 

this section if the concentration of the 

substance in the mixture does not exceed a concentration set in subpart E 

of this part. The exemption does not 

apply if the employer has reason to believe that during intended use or processing in the work area, the substance 

in the mixture may be concentrated 

above the level set in subpart E of this 

part. 

(c)(1) If at any time after commencing distribution in commerce of a 

chemical substance that is identified in 

subpart E of this part as subject to this 

section, the person has knowledge that 

a recipient of the substance is engaging 

in an activity that is not consistent 

with the implementation of a program 

specified in paragraph (a) of this section, the person is considered to have 

knowledge that the recipient is engaging in a significant new use and is required to follow the procedures in 

§721.5(d) unless the person is able to 

document the following: 

(i) That the person has notified the 

recipient in writing within 15 working 

days of the time the person first has 

knowledge that the recipient is engaging in an activity that is not consistent with the implementation of a 

program specified in paragraph (a) of 

this section, and that the person has 

knowledge of the failure of implementation. 

(ii) That within 15 working days of 

notifying the recipient that the recipient is engaging in an activity that is 

not consistent with the implementation of a program specified in paragraph (a) of this section the person has 

received from the recipient, in writing, 

a statement of assurance that the recipient has established the program required under paragraph (a) of this section, and will take appropriate measures to avoid activities that are inconsistent with implementation of the 

program required under paragraph (a) 

of this section. 

(2) If, after receiving a statement of 

assurance from a recipient under paragraph (c)(1)(ii) of this section, a manufacturer, importer, or processor has 

knowledge that the recipient is engaging in an activity that is not consistent with the implementation of the 

program specified in paragraph (a) of 

this section, that person is considered 

to have knowledge that the person is 

engaging in a significant new use and 

is required to follow the procedures in 

§721.5(d). 

§ 721.72 Hazard communication program. 

Whenever a substance is identified in 

subpart E of this part as being subject 

to this section, a significant new use of 

that substance is any manner or method of manufacture, import, or processing associated with any use of that 

substance without establishing a hazard communication program as described in this section. 

(a) Written hazard communication program. Each employer shall develop and 

implement a written hazard communication program for the substance in 

each workplace. The written program 

will, at a minimum, describe how the 

requirements of this section for labels, 

MSDSs, and other forms of warning 

material will be satisfied. The employer must make the written hazard 

communication program available, 

upon request, to all employees, contractor employees, and their designated representatives. The employer 

may rely on an existing hazard communication program, including an existing program established under the Occupational Health and Safety Administration (OSHA) Hazard Communication 

Standard (29 CFR 1900.1200), to comply 

with this paragraph provided that the 

existing hazard communication program satisfies the requirements of this 

paragraph. The written program shall 

include the following: 

(1) A list of each substance identified 

in subpart E of this part as subject to 

this section known to be present in the 

work area. The list must be maintained 

in the work area and must use the 

identity provided on the appropriate 

MSDS for each substance required 

under paragraph (c) of this section. The 

list may be compiled for the workplace 

or for individual work areas. 

(2) The methods the employer will 

use to inform employees of the hazards 

of non-routine tasks involving the substance, for example, the cleaning of reactor vessels, and the hazards associated with the substance contained in 

unlabeled pipes in their work area. 


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Environmental Protection Agency § 721.72 

(3) The methods the employer will 

use to inform contractors of the presence of the substance in the employer’s 

workplace and of the provisions of this 

part applicable to the substance if employees of the contractor work in the 

employer’s workplace and are reasonably likely to be exposed to the substance while in the employer’s workplace. 

(b) Labeling. (1) Each employer shall 

ensure that each container of the substance in the workplace is labeled in 

accordance with this paragraph (b)(1). 

(i) The label shall, at a minimum, 

contain the following information: 

(A) A statement of health hazard(s) 

and precautionary measure(s) for the 

substance, if any, identified in subpart 

E of this part or by the employer. 

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

(C) A statement of environmental 

hazard(s) and precautionary measure(s) 

for the substance, if any, identified in 

subpart E of this part or by the employer. 

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

employer. 

(ii) The employer may use signs, 

placards, process sheets, batch tickets, 

operating procedures, or other such 

written materials in lieu of affixing labels to individual stationary process 

containers, as long as the alternative 

method identifies the containers to 

which it is applicable and conveys information specified by paragraph 

(b)(1)(i) of this section. Any written 

materials must be readily accessible to 

the employees in their work areas 

throughout each work shift. 

(iii) The employer need not label 

portable containers into which the substance is transferred from labeled containers, and which are intended only 

for the immediate use of the employee 

who performs the transfer. 

(iv) The employer shall not remove 

or deface an existing label on incoming 

containers of the substance unless the 

container is immediately relabeled 

with the information specified in paragraph (b)(1)(i) of this section. 

(2) Each employer shall ensure that 

each container of the substance leaving 

its workplace for distribution in commerce is labeled in accordance with 

this paragraph. 

(i) The label shall, at a minimum, 

contain the following information: 

(A) The information required under 

paragraph (b)(1)(i) of this section. 

(B) The name and address of the manufacturer or a responsible party who 

can provide additional information on 

the substance for hazard evaluation 

and any appropriate emergency procedures. 

(ii) The label shall not conflict with 

the requirements of the Hazardous Materials Transportation Act (18 U.S.C. 

1801 et. seq.) and regulations issued 

under that Act by the Department of 

Transportation. 

(3) The label, or alternative forms of 

warning, shall be legible and prominently displayed. 

(4) The label, or alternative forms of 

warning, shall be in English; however, 

the information may be repeated in 

other languages. 

(5) If the label or alternative form of 

warning is to be applied to a mixture 

containing a substance identified in 

subpart E of this part as subject to this 

section in combination with another 

substance identified in subpart E of 

this part and/or a substance defined as 

a ‘‘hazardous chemical’’ under the Occupational Safety and Health Administration (OSHA) Hazard Communication 

Standard (29 CFR 1900.1200), the employer may prescribe on the label, 

MSDS, or alternative form of warning, 

the measures to control worker exposure or environmental release which 

the employer determines provide the 

greatest degree of protection. However, 

should these control measures differ 

from the applicable measures required 

under subpart E of this part, the employer must seek a determination of 

equivalency for such alternative control measures pursuant to §721.30 before prescribing them under this paragraph. 

(c) Material safety data sheets. (1) Each 

employer must obtain or develop a 

MSDS for the substance. 

(2) Each MSDS shall contain, at a 

minimum, the following information: 

(i) The identity used on the container 

label of the substance under this section, and, if not claimed confidential, 

the chemical and common name of the 


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§ 721.72 40 CFR Ch. I (7–1–07 Edition) 

substance. If the chemical and common 

name are claimed confidential, a generic chemical name must be used. 

(ii) Physical and chemical characteristics of the substance known to the 

employer (such as vapor pressure, flash 

point). 

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

and reactivity. 

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

(v) Signs and symptoms of exposure, 

and any medical conditions which are 

expected to be aggravated by exposure 

to the substance known to the employer. 

(vi) The primary routes of exposure 

to the substance. 

(vii) Precautionary measures to control worker exposure and/or environmental release identified in subpart E 

of this part for the substance, or alternative control measures which EPA 

has determined under §721.30 provide 

substantially the same degree of protection as the identified control measures. 

(viii) Any generally applicable precautions for safe handling and use of 

the substance which are known to the 

employer, including appropriate hygienic practices, protective measures 

during repair and maintenance of contaminated equipment, and procedures 

for response to spills and leaks. 

(ix) Any generally applicable control 

measures which are known to the employer, such as appropriate engineering 

controls, work practices, or personal 

protective equipment. 

(x) Emergency first aid procedures 

known to the employer. 

(xi) The date of preparation of the 

MSDS or of its last revision. 

(xii) The name, address, and telephone number of the individual preparing or distributing the MSDS, or a 

responsible party who can provide additional information on the substance for 

hazard evaluation and any appropriate 

emergency procedures. 

(3) If no relevant information is 

found or known for any given category 

on the MSDS, the employer must mark 

the MSDS to indicate that no applicable information was found. 

(4) Where multiple mixtures containing the substance have similar 

compositions (i.e., the chemical ingredients are essentially the same, but the 

specific composition varies from mixture to mixture) and similar hazards, 

the employer may prepare one MSDS 

to apply to all of these multiple mixtures. 

(5) If the employer becomes aware of 

any significant new information regarding the hazards of the substance or 

ways to protect against the hazards, 

this new information must be added to 

the MSDS within 3 months from the 

time the employer becomes aware of 

the new information. If the substance 

is not currently being manufactured, 

imported, processed, or used in the employer’s workplace, the employer must 

add the new information to the MSDS 

before the substance is reintroduced 

into the workplace. 

(6) The employer must ensure that 

persons receiving the substance from 

the employer are provided an appropriate MSDS with their initial shipment and with the first shipment after 

an MSDS is revised. The employer may 

either provide the MSDS with the 

shipped containers or send it to the 

person prior to or at the time of shipment. 

(7) The employer must maintain a 

copy of the MSDS in its workplace, and 

must ensure that it is readily accessible during each work shift to employees when they are in their work areas. 

(8) The MSDS may be kept in any 

form, including as operating procedures, and may be designed to cover 

groups of substances in a work area 

where it may be more appropriate to 

address the potential hazards of a process rather than individual substances. 

However, in all cases, the required information must be provided for each 

substance and must be readily accessible during each work shift to employees when they are in their work areas. 

(9) The MSDS must be printed in 

English; however, the information may 

be repeated in other languages. 

(d) Employee information and training. 

Each employer must ensure that employees are provided with information 


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Environmental Protection Agency § 721.72 

and training on the substance identified in subpart E of this part. This information and training must be provided at the time of each employee’s 

initial assignment to a work area containing the substance and whenever 

the substance subject to this section is 

introduced into the employee’s work 

area for the first time. 

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

(i) The requirements of this section. 

(ii) Any operations in the work area 

where the substance is present. 

(iii) The location and availability of 

the written hazard communication program required under paragraph (a) of 

this section, including the list of substances identified in subpart E of this 

part as subject to this section, and 

MSDSs required by paragraph (c) of 

this section. 

(2) Training provided to employees 

shall include: 

(i) Methods and observations that 

may be used to detect the presence or 

release of the substance in or from an 

employee’s work area (such as monitoring conducted by the employer, continuous monitoring devices, visual appearance, or odor of the substance 

when being released). 

(ii) The potential human health and 

environmental hazards of the substance as specified in subpart E of this 

part. 

(iii) The measures employees can 

take to protect themselves and the environment from the substance, including specific procedures the employer 

has implemented to protect employees 

and the environment from exposure to 

the substance, including appropriate 

work practices, emergency procedures, 

personal protective equipment, engineering controls, and other measures 

to control worker exposure and/or environmental release required under subpart E of the part, or alternative control measures which EPA has determined under §721.30 provide substantially the same degree of protection as 

the specified control measures. 

(iv) The requirements of the hazard 

communication program developed by 

the employer under this section, including an explanation of the labeling 

system and the MSDS required by this 

section and guidance on obtaining and 

using appropriate hazard information. 

(e) Low concentrations in mixtures. If a 

substance identified in subpart E of 

this part is present in the work area 

only as a mixture, an employer is exempt from the provisions of this section if the concentration of the substance in the mixture does not exceed a 

concentration set in subpart E of this 

part. The exemption does not apply if 

the employer has reason to believe that 

during intended use or processing in 

the work area, the substance in the 

mixture may be concentrated above 

the level set in subpart E of this part. 

(f) Existing hazard communication program. The employer need not take additional actions if existing programs and 

procedures satisfy the requirements of 

this section. 

(g) Human health, environmental hazard, exposure, and precautionary statements. Whenever referenced in subpart 

E of this part for a substance, the following human health and environmental hazard, exposure, and precautionary statements shall appear on 

each label as specified in paragraph (b) 

of this section and the MSDS as specified in paragraph (c) of this section. 

Additional statements may be included 

as long as they are true and do not 

alter the meaning of the required 

statements. 

(1) Human health hazard statements: 

This substance may cause: 

(i) Skin irritation. 

(ii) Respiratory complications. 

(iii) Central nervous system effects. 

(iv) Internal organ effects. 

(v) Birth defects. 

(vi) Reproductive effects. 

(vii) Cancer. 

(viii) Immune system effects. 

(ix) Developmental effects. 

(2) Human health hazard precautionary statements: When using 

this substance: 

(i) Avoid skin contact. 

(ii) Avoid breathing substance. 

(iii) Avoid ingestion. 

(iv) Use respiratory protection. 

(v) Use skin protection. 

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

(i) Toxic to fish. 

(ii) Toxic to aquatic organisms. 


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§ 721.72 40 CFR Ch. I (7–1–07 Edition) 

(4) Environmental hazard precautionary statements: Notice to 

users: 

(i) Disposal restrictions apply. 

(ii) Spill clean-up restrictions apply. 

(iii) Do not release to water. 

(5) Each human health or environmental hazard precautionary statement identified in subpart E of this 

part for the label on the substance container must be followed by the statement, ‘‘See MSDS for details.’’ 

(h) Human health, environmental hazard exposure and precautionary statements. (1) Whenever referenced in subpart E of this part for a substance, the 

following human health, environmental hazard, exposure, and precautionary statements shall appear on 

each label as specified in paragraph (b) 

of this section. Additional statements 

may be included as long as they are 

true and do not alter the meaning of 

the required statements. 

(i) Precautionary statements. (A) The 

health effects of this chemical substance have not been determined. 

(B) When using this substance, use 

skin protection. 

(C) Use respiratory protection when 

there is a reasonable likelihood of exposure in the work area from dust, 

mist, or smoke from spray application. 

(D) Chemicals similar in structure to 

this substance have been found to 

cause cancer in laboratory animals. 

(ii) Human health hazard statements. 

This substance may cause: 

(A) Skin irritation 

(B) Respiratory complications 

(C) Central nervous system effects 

(D) Internal organ effects 

(E) Birth defects 

(F) Reproductive effects 

(G) Cancer 

(H) Immune system effects 

(I) Developmental effects 

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

substance: 

(A) Avoid skin contact 

(B) Avoid breathing substance 

(C) Avoid ingestion 

(D) Use respiratory protection 

(E) Use skin protection 

(iv) Environmental hazard statements. 

This substance may be: 

(A) Toxic to fish 

(B) Toxic to aquatic organisms 

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

(A) Disposal restrictions apply 

(B) Spill clean-up restrictions apply 

(C) Do not release to water. 

(vi) Additional statements. Each 

human health or environmental precautionary statement identified in subpart E of this part for the label on the 

substance container must be followed 

by the statement, ‘‘See MSDS for details.’’ 

(2) Whenever referenced in subpart E 

of this part for a substance, the following human health, environmental 

hazard, exposure, and precautionary 

statements shall appear on each MSDS 

as specified in paragraph (c) of this section. Additional statements may be included as long as they are true and do 

not alter the meaning of the required 

statements. 

(i) Precautionary statements. (A) The 

health effects of this chemical substance have not been determined. 

(B) When using this substance, use 

skin protection. 

(C) Use respiratory protection when 

there is a reasonable likelihood of exposure in the work area from dust, 

mist, or smoke from spray application. 

(D) Chemicals similar in structure to 

this substance have been found to 

cause cancer in laboratory animals. 

(ii) Human health hazard statements. 

This substance may cause: 

(A) Skin irritation 

(B) Respiratory complications 

(C) Central nervous system effects 

(D) Internal organ effects 

(E) Birth defects 

(F) Reproductive effects 

(G) Cancer 

(H) Immune system effects 

(I) Developmental effects 

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

substance: 

(A) Avoid skin contact 

(B) Avoid breathing substance 

(C) Avoid ingestion 

(D) Use respiratory protection 

(E) Use skin protection 

(iv) Environmental hazard statements. 

This substance may be: 

(A) Toxic to fish 

(B) Toxic to aquatic organisms 

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


rfrederick on PROD1PC67 with CFR
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Environmental Protection Agency § 721.80 

(A) Disposal restrictions apply 

(B) Spill clean-up restrictions apply 

(C) Do not release to water. 

[54 FR 31308, July 27, 1989, as amended at 55 

FR 45996, Oct. 31, 1990; 58 FR 34204, June 23, 

1993] 

§ 721.80 Industrial, commercial, and 

consumer activities. 

Whenever a substance is identified in 

subpart E of this part as being subject 

to this section, a significant new use of 

the substance is: 

(a) Use in non-enclosed processes. 

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

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

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

(e) Processing beyond the site of 

manufacture or import. 

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

(g) Use other than as an intermediate. 

(h) Use other than as a site-limited 

intermediate. 

(i) Use as an intermediate where the 

concentration of the intermediate substance in the product intended for distribution in commerce exceeds the concentration specified in subpart E of 

this part for the substance. 

(j) Use other than as described in the 

premanufacture notice referenced in 

subpart E of this part for the substance. 

(k) Use other than allowed by the 

section 5(e) consent order referenced in 

subpart E of this part for the substance. 

(l) Non-industrial use. 

(m) Commercial use. 

(n) Non-commercial use. 

(o) Use in a consumer product. 

(p) Aggregate manufacture and importation volume for any use greater 

than that specified in subpart E of this 

part for the substance. 

(q) Aggregate manufacture and importation volume for any use greater 

than that allowed by the section 5(e) 

consent order referenced in subpart E 

of this part for the substance. 

(r) Aggregate manufacture and importation volume for any use greater 

than that specified in subpart E of this 

part for the substance unless the manufacturer or importer has submitted 

the results of the health or environmental effects studies identified in subpart E of this part for the substance 

and those studies comply with the procedures and criteria for developing and 

evaluating data identified in subpart E 

of this part for the substance. 

(s) Annual manufacture and importation volume for any use greater than 

that specified in subpart E of this part 

for the substance. 

(t) Annual manufacture and importation volume for any use greater than 

that allowed by the section 5(e) consent order referenced in subpart E of 

this part for the substance. 

(u) Annual manufacture and importation volume for any use greater than 

that specified in subpart E of this part 

for the substance unless the manufacturer or importer has submitted the results of the health or environmental effects studies identified in subpart E of 

this part for the substance and those 

studies comply with the procedures and 

criteria for developing and evaluating 

data identified in subpart E of this part 

for the substance. 

(v) Use in the form of: 

(1) A powder. 

(2) A solid. 

(3) A liquid. 

(4) A gas. 

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

(1) A powder. 

(2) A solid. 

(3) A liquid. 

(4) A gas. 

(x) Any manner or method of processing of the substance in the following 

form associated with any use: 

(1) A powder. 

(2) A solid. 

(3) A liquid. 

(4) A gas. 

(y) Use involving an application 

method that generates: 

(1) A vapor, mist, or aerosol. 

(2) A dust. 


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§ 721.85 40 CFR Ch. I (7–1–07 Edition) 

§ 721.85 Disposal. 

Whenever a substance is identified in 

subpart E of this part as being subject 

to this section, a significant new use of 

the substance is any method of: 

(a) Disposal of the process stream associated with any use of the substance 

or with any manner or method of manufacturing associated with any use of 

the substance other than by the following. This provision does not 

supercede any applicable Federal, 

State, or local laws and regulations. 

(1) Incineration. 

(2) Landfill. 

(3) Deep well injection. 

(b) Disposal of the process stream associated with any use or with any manner or method of processing associated 

with any use other than by the following. This provision does not 

supercede any applicable Federal, 

State, or local laws and regulations. 

(1) Incineration. 

(2) Landfill. 

(3) Deep well injection. 

(c) Disposal of the use stream associated with any use, other than by the 

following. This provision does not 

supercede any applicable Federal, 

State, or local laws and regulations. 

(1) Incineration. 

(2) Landfill. 

(3) Deep well injection. 

(d) Disposal of the substance associated with any use of the substance, or 

with any manner or method of manufacture or processing in association 

with any use. This provision does not 

supercede any applicable Federal, 

State, or local laws and regulations. 

§ 721.90 Release to water. 

Whenever a substance is identified in 

subpart E of this part as being subject 

to this section, a significant new use of 

the substance is: 

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

from any site: 

(1) Into the waters of the United 

States. 

(2) Into the waters of the United 

States without application of one or 

more of the following treatment technologies as specified in subpart E of 

this part either by the discharger or, in 

the case of a release through publiclyowned treatment works, by a combination of treatment by the discharger 

and the publicly-owned treatment 

works: 

(i) Chemical precipitation and settling. 

(ii) Biological treatment (activated 

sludge or equivalent) plus clarification. 

(iii) Steam stripping. 

(iv) Resin or activated carbon adsorption. 

(v) Chemical destruction or conversion. 

(vi) Primary wastewater treatment. 

(3) Into the waters of the United 

States without primary wastewater 

treatment, and secondary wastewater 

treatment as defined in 40 CFR part 

133. 

(4) Into the waters of the United 

States if the quotient from the following formula: 

number of kilograms/day/site released

receiving stream flow (million liters/day)

× = 1000 N parts per billion

exceeds the level specified in subpart E 

of this part when calculated using the 

methods described in §721.91. In lieu of 

calculating the above quotient, monitoring or alternative calculations may 

be used to predict the surface water 

concentration which will result from 

the intended release of the substance, 

if the monitoring procedures or calculations have been approved for such 

purpose by EPA. EPA will review and 

act on written requests to approve 

monitoring procedures or alternative 

calculations within 90 days after such 

requests are received. EPA will inform 

submitters of the disposition of such 

requests in writing, and will explain 

the reasons therefor when they are denied. 


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Environmental Protection Agency § 721.90 

(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 publiclyowned treatment works, by a combination of treatment by the discharger 

and the publicly-owned treatment 

works: 

(i) Chemical precipitation and settling. 

(ii) Biological treatment (activated 

sludge or equivalent) plus clarification. 

(iii) Steam stripping. 

(iv) Resin or activated carbon adsorption. 

(v) Chemical destruction or conversion. 

(vi) Primary wastewater treatment. 

(3) Into the waters of the United 

States without primary wastewater 

treatment, and secondary wastewater 

treatment as defined in 40 CFR part 

133. 

(4) Into the waters of the United 

States if the quotient from the following formula: 

number of kilograms/day/site released

receiving stream flow (million liters/day)

× = 1000 N parts per billion

exceeds the level specified in subpart E 

of this part when calculated using the 

methods described in §721.91. In lieu of 

calculating the above quotient, monitoring or alternative calculations may 

be used to predict the surface water 

concentration which will result from 

the intended release of the substance, 

if the monitoring procedures or calculations have been approved for such 

purpose by EPA. EPA will review and 

act on written requests to approve 

monitoring procedures or alternative 

calculations within 90 days after such 

requests are received. EPA will inform 

submitters of the disposition of such 

requests in writing, and will explain 

the reasons therefor when they are denied. 

(c) Any predictable or purposeful release of a use stream containing the 

substance associated with any use of 

the substance from any site: 

(1) Into the waters of the United 

States. 

(2) Into the waters of the United 

States without application of one or 

more of the following treatment technologies as specified in subpart E of 

this part either by the discharger or, in 

the case of a release through publiclyowned treatment works, by a combination of treatment by the discharger 

and the publicly-owned treatment 

works: 

(i) Chemical precipitation and settling. 

(ii) Biological treatment (activated 

sludge or equivalent) plus clarification. 

(iii) Steam stripping. 

(iv) Resin or activated carbon adsorption. 

(v) Chemical destruction or conversion. 

(vi) Primary wastewater treatment. 

(3) Into the waters of the United 

States without primary wastewater 

treatment, and secondary wastewater 

treatment as defined in 40 CFR part 

133. 

(4) Into the waters of the United 

States if the quotient from: 

number of kilograms/day/site released

receiving stream flow (million liters/day)

× = 1000 N parts per billion


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184 

§ 721.91 40 CFR Ch. I (7–1–07 Edition) 

exceeds the level specified in subpart E 

of this part, when calculated using the 

methods described in §721.91. In lieu of 

calculating the above quotient, however, monitoring or alternative calculations may be used to predict the 

surface water concentration expected 

to result from intended release of the 

substance, if the monitoring procedures or calculations have been approved for such purpose by EPA. EPA 

will review and act on written requests 

to approve monitoring procedures or 

alternative calculations within 90 days 

after such requests are received. EPA 

will inform submitters of the disposition of such requests in writing, and 

will explain the reasons therefor when 

they are denied. 

§ 721.91 Computation of estimated surface water concentrations: Instructions. 

These instructions describe the use of 

the equation specified in §721.90(a)(4) 

and (b)(4) to compute estimated surface 

water concentrations which will result 

from release of a substance identified 

in subpart E of this part. The equation 

shall be computed for each site using 

the stream flow rate appropriate for 

the site according to paragraph (b) of 

this section, and the highest number of 

kilograms calculated to be released for 

that site on a given day according to 

paragraph (a) of this section. Two variables shall be considered in computing 

the equation, the number of kilograms 

released, and receiving stream flow. 

(a) Number of kilograms released. (1) To 

calculate the number of kilograms of 

substance to be released from manufacturing, processing, or use operations, 

as specified in the numerator of the 

equation, develop a process description 

diagram which describes each manufacturing, processing, or use operation involving the substance. The process description must include the major unit 

operation steps and chemical conversions. A unit operation is a functional 

step in a manufacturing, processing, or 

use operation where substances undergo chemical changes and/or changes in 

location, temperature, pressure, physical state, or similar characteristics. 

Include steps in which the substance is 

formulated into mixtures, suspensions, 

solutions, etc. 

(2) Indicate on each diagram the 

entry point of all feedstocks (e.g., 

reactants, solvents, and catalysts) used 

in the operation. Identify each feedstock and specify its approximate 

weight regardless of whether the process is continuous or batch. 

(3) Identify all release points from 

which the substance or wastes containing the substance will be released 

into air, land, or water. Indicate these 

release points on the diagram. Do not 

include accidental releases or fugitive 

emissions. 

(4) For releases identified in the diagram that are destined for water, estimate the amount of substance that will 

be released before the substance enters 

control technology. The kilograms of 

substance released may be estimated 

based on: 

(i) The mass balance of the operation, 

i.e., totaling inputs and outputs, including wastes for each part of the 

process such that outputs equal inputs. 

The amount released to water may be 

the difference between the amount of 

the substance in the starting material 

(or formed in a reaction) minus the 

amount of waste material removed 

from each part of the process and not 

released to water and the amount of 

the substance in the final product. 

(ii) Physical properties such as water 

solubility where a known volume of 

water being discharged is assumed to 

contain the substance at concentrations equal to its solubility in water. 

This approach is particularly useful 

where the waste stream results from 

separation of organic/water phases or 

filtration of the substance from an 

aqueous stream to be discharged. 

(iii) Measurements of flow rates of 

the process/use stream and known concentrations of the substance in the 

stream. 

(5) After releases of a substance to 

water are estimated for each operation 

on a site, total the releases of the substance to water from all operations at 

that site. The value (number of kilograms) specified in the numerator of 

the equation should reflect total kilograms of substance released to water 

per day from all operations at a single 

site. 

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


rfrederick on PROD1PC67 with CFR
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Environmental Protection Agency § 721.125 

(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-Q10 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 permitwriting authority for the site or the 

POTW, or from USGS publications, 

such as the water-data report series. 

(3) If receiving stream flow data are 

not available for a stream, either the 

value of 10 MLD or the daily flow of 

wastewater from the site or the POTW 

releasing the substance must be used 

as an assumed minimum stream flow. 

Similarly, if stream flow data are not 

available because the location of the 

point of release of the substance to surface water is a lake, estuary, bay, or 

ocean, then the flow rate to be used 

must be the daily flow of wastewater 

from the site or the POTW releasing 

the substance to surface water. Wastewater flow data may be available from 

the NPDES permit or NPDES authority for the site or the POTW releasing 

the substance to water. 

Subpart C—Recordkeeping 

Requirements 

§ 721.100 Applicability. 

This subpart C identifies certain additional recordkeeping requirements 

applicable to manufacturers, importers, and processors of substances identified in subpart E of this part for each 

specific substance. The provisions of 

this subpart C apply only when referenced in subpart E of this part for a 

substance and significant new use identified in that subpart E. If the provisions in this subpart C conflict with 

general provisions of subpart A of this 

part, the provisions of this subpart C 

shall apply. 

[54 FR 31313, July 27, 1989] 

§ 721.125 Recordkeeping requirements. 

At the time EPA adds a substance to 

subpart E of this part, EPA will specify 

appropriate recordkeeping requirements which correspond to the significant new use designations for the substance selected from subpart B of this 

part. Each manufacturer, importer, 

and processor of the substance shall 

maintain the records for 5 years from 

the date of their creation. In addition 

to the records specified in §721.40, the 

records whose maintenance this section requires may include the following: 

(a) Records documenting the manufacture and importation volume of the 

substance and the corresponding dates 

of manufacture and import. 

(b) Records documenting volumes of 

the substance purchased in the United 

States by processors of the substance, 

names and addresses of suppliers, and 

corresponding dates of purchase. 

(c) Records documenting the names 

and addresses (including shipment destination address, if different) of all persons outside the site of manufacture, 

importation, or processing to whom 

the manufacturer, importer, or processor directly sells or transfers the substance, the date of each sale or transfer, and the quantity of the substance 

sold or transferred on such date. 

(d) Records documenting establishment and implementation of a program 

for the use of any applicable personal 

protective equipment required under 

§721.63. 

(e) Records documenting the determinations required by §721.63(a)(3) that 

chemical protective clothing is impervious to the substance. 

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

under §721.72. 

(g) Copies of labels required under 

§721.72(b). 


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§ 721.160 40 CFR Ch. I (7–1–07 Edition) 

(h) Copies of material safety data 

sheets required under §721.72(c). 

(i) Records documenting compliance 

with any applicable industrial, commercial, and consumer use limitations 

under §721.80. 

(j) Records documenting compliance 

with any applicable disposal requirements under §721.85, including the 

method of disposal, location of disposal 

sites, dates of disposal, and volume of 

the substance disposed. Where the estimated disposal volume is not known to 

or reasonably ascertainable by the 

manufacturer, importer, or processor, 

that person must maintain other 

records which demonstrate establishment and implementation of a program 

that ensures compliance with any applicable disposal requirements. 

(k) Records documenting establishment and implementation of procedures that ensure compliance with any 

applicable water discharge limitations 

under §721.90. 

[54 FR 31313, July 27, 1989] 

Subpart D—Expedited Process for 

Issuing Significant New Use 

Rules for Selected Chemical 

Substances and Limitation or 

Revocation of Selected Significant New Use Rules 

SOURCE: 54 FR 31314, July 27, 1989, unless 

otherwise noted. 

§ 721.160 Notification requirements for 

new chemical substances subject to 

section 5(e) orders. 

(a) Selection of substances. (1) In accordance with the expedited process 

specified in this section, EPA will issue 

significant new use notification requirements and other specific requirements for each new chemical substance 

that is the subject of a final order 

issued under section 5(e) of the Act, except for an order that prohibits manufacture and import of the substance, 

unless EPA determines that significant 

new use notification requirements are 

not needed for the substance. 

(2) If EPA determines that significant new use notification requirements 

are not needed for a substance that is 

subject to a final order issued under 

section 5(e) of the Act, except for an 

order that prohibits manufacture or 

import of the substance, EPA will issue 

a notice in the FEDERAL REGISTER explaining why the significant new use 

requirements are not needed. 

(b) Designation of requirements. (1) The 

significant new use notification and 

other specific requirements will be 

based on and be consistent with the 

provisions included in the final order 

issued for the substance under section 

5(e) of the Act. EPA may also designate 

additional activities as significant new 

uses which will be subject to notification. Designation of additional activities as significant new uses will be 

done in accordance with the criteria 

and procedures under §721.170, or 

through a separate rulemaking proceeding. 

(2) Significant new use requirements 

and other specific requirements designated under this section will be listed 

in subpart E of this part. For each substance, subpart E will identify: 

(i) The chemical name. 

(ii) The activities designated as significant new uses. 

(iii) Other specific requirements applicable to the substance, including 

recordkeeping requirements or any 

other requirements included in the 

final section 5(e) order. 

(c) Procedures for issuing significant 

new use rules. (1) EPA will issue significant new use rules under this section 

by one of the following three processes: 

direct final rulemaking, interim final 

rulemaking, or notice and comment 

rulemaking. EPA will use the direct 

final rulemaking process to issue significant new use rules unless it determines that, in a particular case, one of 

the other processes is more appropriate. 

(2) FEDERAL REGISTER documents 

issued to propose or establish significant new uses under this section will 

contain the following: 

(i) The chemical identity of the substance or, if its specific identity is 

claimed confidential, an appropriate 

generic chemical name and an accession number assigned by EPA. 

(ii) The premanufacture notice number. 

(iii) The CAS number, where available and not claimed confidential. 


rfrederick on PROD1PC67 with CFR
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Environmental Protection Agency § 721.160 

(iv) A summary of EPA’s findings 

under section 5(e)(1)(A) of the Act for 

the final order issued under section 

5(e). 

(v) Designation of the significant new 

uses subject to, or proposed to be subject to, notification and any other applicable requirements. 

(vi) Any modifications of subpart A 

of this part applicable to the specific 

substance and significant new uses. 

(vii) If the FEDERAL REGISTER document establishes a final rule, or notifies the public that a final rule will not 

be issued after public comment has 

been received, the document will describe comments received and EPA’s 

response. 

(3) Direct final rulemaking. (i) When 

EPA uses the direct final rulemaking 

procedure to issue a significant new 

use rule, it will issue a final rule in the 

FEDERAL REGISTER following its decision to develop a significant new use 

rule under this section for a specific 

new chemical substance. 

(ii) The FEDERAL REGISTER document 

will state that, unless written notice is 

received by EPA within 30 days of publication that someone wishes to submit 

adverse or critical comments, the rule 

will be effective 60 days from the date 

of publication. The written notice of 

intent to submit adverse or critical 

comments should state which SNUR(s) 

will be the subject of the adverse or 

critical comments, if several SNURs 

are established through the direct final 

rule. If notice is received within 30 

days that someone wishes to submit 

adverse or critical comments, the section(s) of the direct final rule containing the SNUR(s) for which a notice 

of intent to comment was received will 

be withdrawn by EPA issuing a document in the final rule section of the 

FEDERAL REGISTER, and a proposal will 

be published in the proposed rule section of the FEDERAL REGISTER. The proposal will establish a 30-day comment 

period. 

(iii) If EPA, having considered any 

timely comments submitted in response to the proposal, decides to establish notification requirements 

under this section, EPA will issue a 

final rule adding the substance to subpart E of this part and designating the 

significant new uses subject to notification. 

(4) Notice and comment rulemaking. (i) 

When EPA uses a notice and comment 

procedure to issue a significant new 

use rule, EPA will issue a proposal in 

the FEDERAL REGISTER following its decision to develop a significant new use 

rule under this section for a specific 

new chemical substance. Persons will 

be given 30 days to comment on whether EPA should establish notification 

requirements for the substance under 

this part. 

(ii) If EPA, having considered any 

timely comments, decides to establish 

notification requirements under this 

section, EPA will issue a final rule adding the substance to subpart E of this 

part and designating the significant 

new uses subject to notification. 

(5) Interim final rulemaking. (i) When 

EPA uses the interim final rulemaking 

procedure to issue a significant new 

use rule, EPA will issue an interim 

final rule in the final rule section of 

the FEDERAL REGISTER following its decision to develop a significant new use 

rule for a specific new chemical substance. The document will state EPA’s 

reasons for using the interim final 

rulemaking procedure. 

(A) The significant new use rule will 

take effect on the date of publication. 

(B) Persons will be given 30 days from 

the date of publication to submit comments. 

(ii) Interim final rules issued under 

this section shall cease to be in effect 

180 days after publication unless, within the 180-day period, EPA issues a 

final rule in the FEDERAL REGISTER responding to any written comments received during the 30-day comment period specified in paragraph (c)(5)(i)(B) 

of this section and promulgating final 

significant new use notification requirements and other requirements for 

the substance. 

(d) Schedule for issuing significant new 

use rules. (1) Unless EPA determines 

that a significant new use rule should 

not be issued under this section, EPA 

will issue a proposed rule, a direct final 

rule, or an interim final rule within 180 


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§ 721.170 40 CFR Ch. I (7–1–07 Edition) 

days of receipt of a valid notice of commencement under §720.102 of this chapter for any substance for which the notice of commencement was received on 

or after October 10, 1989. 

(2) Unless EPA determines that a significant new use rule should not be 

issued under this section, EPA will 

issue a proposed rule, a direct final 

rule, or an interim final rule within 1 

year of October 10, 1989, for any substance for which the valid notice of 

commencement under §720.102 of this 

chapter was received before October 10, 

1989. 

(3) If EPA receives adverse or critical 

significant comments following publication of a proposed or interim final 

rule, EPA will either withdraw the rule 

or issue a final rule addressing the 

comments received. 

§ 721.170 Notification requirements for 

selected new chemical substances 

that have completed premanufacture review. 

(a) Selection of substances. In accordance with the expedited process specified in this section, EPA may issue significant new use notification and recordkeeping requirements for any new 

chemical substance for which a 

premanufacture notice has been submitted under part 720 of this chapter if 

EPA determines that activities other 

than those described in the 

premanufacture notice may result in 

significant changes in human exposure 

or environmental release levels and/or 

that concern exists about the substance’s health or environmental effects. 

(b) Concern criteria. EPA may determine that concern exists about a substance’s health or environmental effects if EPA makes any one of the following findings: 

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

(A) Has been shown by valid test data 

to cause carcinogenic effects in humans or in at least one species of laboratory animal. 

(B) Has been shown to be a possible 

carcinogen based on the weight of the 

evidence in short-term tests indicative 

of the potential to cause carcinogenic 

effects. 

(C) Is closely analogous, based on 

toxicologically relevant similarities in 

molecular structure and physical properties, to another substance that has 

been shown by test data to cause carcinogenic effects in humans or in at 

least one species of laboratory animal, 

provided that if there is more than one 

such analogue, the greatest weight will 

be given to the relevant data for the 

most appropriate analogues. 

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

or established scientific principles, to 

be metabolized in humans or transformed in the environment to a substance which may have the potential to 

cause carcinogenic effects under the 

criteria in paragraphs (b)(1)(i) (A), (B), 

or (C) of this section. 

(ii) No substance may be regulated 

based on a finding under paragraph 

(b)(1) of this section unless EPA has 

also made the finding under 

§721.170(c)(2)(ii). 

(2) The substance has been shown by 

valid test data to cause acutely toxic 

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

based on toxicologically relevant similarities in molecular structure and 

physical properties, to another substance that has been shown by valid 

test data to cause acutely toxic effects 

in at least one species of laboratory 

animal, provided that if there is more 

than one such analogue, the greatest 

weight will be given to the relevant 

data for the most appropriate analogues. 

(3) The substance may cause serious 

chronic effects, serious acute effects, 

or developmentally toxic effects under 

reasonably anticipated conditions of 

exposure because the substance: 

(i) Has been shown by valid test data 

to cause serious chronic effects, serious 

acute effects, or developmentally toxic 

effects in humans or in at least one 

species of laboratory animal at dose 

levels that could be of concern under 

reasonably anticipated conditions of 

exposure. 

(ii) Is closely analogous, based on 

toxicologically relevant similarities in 

molecular structure and physical properties, to another chemical substance 

that has been shown by valid test data 

to cause serious chronic effects, serious 


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Environmental Protection Agency § 721.170 

acute effects, or developmentally toxic 

effects in humans or in at least one 

species of laboratory animal at dose 

levels that could be of concern under 

reasonably anticipated conditions of 

exposure, provided that if there is more 

than one such analogue, the greatest 

weight will be given to the relevant 

data for the most appropriate analogues. 

(iii) Is known or can reasonably be 

anticipated, based on valid scientific 

data or established scientific principles, to be metabolized in humans or 

transformed in the environment to a 

substance which may have the potential to cause serious chronic effects, serious acute effects, or developmentally 

toxic effects under the criteria in paragraph (b)(3) (i) and (ii) of this section. 

(iv) Has been shown to potentially 

cause developmentally toxic effects 

based on the weight of the evidence in 

short-term tests indicative of the potential to cause developmentally toxic 

effects. 

(4) The substance may cause significant adverse environmental effects 

under reasonably anticipated conditions of release because the substance: 

(i) Has been shown by valid test data 

to cause significant adverse environmental effects at dose levels that could 

be of concern under reasonably anticipated conditions of release. 

(ii) Is closely analogous, based on 

toxicologically relevant similarities in 

molecular structure and physical properties, to another substance that has 

been shown by valid test data to cause 

significant adverse environmental effects at dose levels that could be of 

concern under reasonably anticipated 

conditions of release, provided that if 

there is more than one such analogue, 

the greatest weight will be given to the 

relevant data for the most appropriate 

analogues. 

(iii) Has been determined, based on 

calculations using the substance’s 

physical and chemical properties, to be 

potentially able to cause significant 

adverse environmental effects at dose 

levels that could be of concern under 

reasonably anticipated conditions of 

release. 

(iv) Is known or can reasonably be 

anticipated, based on valid scientific 

data or established scientific principles, to be environmentally transformed to a substance which may have 

the potential to cause significant adverse environmental effects under the 

criteria in paragraph (b)(4) (i), (ii), and 

(iii) of this section. 

(5) Concern exists about the health or 

environmental effects of one or more 

impurities or byproducts of the substance because the impurity or byproduct meets one or more of the criteria in 

paragraph (b) (1) through (4) of this section and either: 

(i) The impurity or byproduct is a 

new chemical substance and may be 

present in concentrations that could 

cause adverse health or environmental 

effects under reasonably anticipated 

conditions of exposure or release. 

(ii) Reasonably anticipated manufacture, processing, or use activities involving the substance for which a 

premanufacture notice has been submitted may result in significantly increased human exposure to or environmental release of the impurity or byproduct compared to exposure or release levels resulting from existing activities involving the impurity or byproduct. 

(c) Designation of requirements. (1) 

When EPA decides to establish significant new use reporting requirements 

under this section, EPA may designate 

as a significant new use any one or 

more of the activities set forth in subpart B of this part. In addition, EPA 

may designate specific recordkeeping 

requirements described under subpart 

C of this part that are applicable to the 

substance. 

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

(i) are different from those described in 

the premanufacture notice for the substance, including any amendments, deletions, and additions of activities to 

the premanufacture notice, and (ii) 

may be accompanied by changes in exposure or release levels that are significant in relation to the health or environmental concerns identified under 

paragraph (b) of this section. 

(d) Procedures for issuing significant 

new use rules. (1) Significant new use 

requirements designated under this 

section will be listed in subpart E of 

this part. For each substance, subpart 

E of this part will identify: 


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§ 721.170 40 CFR Ch. I (7–1–07 Edition) 

(i) The chemical name. 

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

one or more of the activities described 

in paragraph (c) of this section. 

(iii) Other specific requirements applicable to the substance. 

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

new use rule under this section, it will 

notify the person that submitted the 

premanufacture notice for the substance no later than 7 calendar days 

before the expiration of the notice review period under §720.75 of this chapter. In providing this notice, EPA will 

describe the health or environmental 

concerns identified under paragraph (b) 

of this section and the activities under 

consideration for designation as significant new uses. Such notice may be 

by telephone, but in this event will be 

confirmed in writing no later than 30 

days after completion of the notice review period. 

(3) FEDERAL REGISTER documents 

issued to propose or establish significant new uses under this section will 

contain the following: 

(i) The chemical identity of the substance or, if its specific identity is 

claimed confidential, an appropriate 

generic chemical name and an accession number assigned by EPA. 

(ii) The premanufacture notice number. 

(iii) The CAS number, where available and not claimed confidential. 

(iv) A summary of the basis for action under this section. 

(v) Designation of the significant new 

uses subject to, or proposed to be subject to, notification and any other applicable requirements. 

(vi) Any modifications of subpart A 

of this part applicable to the specific 

substance and significant new uses. 

(vii) If the FEDERAL REGISTER document establishes a final rule, or notifies the public that a final rule will not 

be issued after public comment has 

been received, the document will describe comments received and EPA’s 

response. 

(4) EPA will issue significant new use 

rules under this section by one of the 

following three processes: direct final 

rulemaking, interim final rulemaking, 

or notice and comment rulemaking. 

EPA will use the direct final rulemaking process to issue significant 

new use rules unless it determines 

that, in a particular case, one of the 

other processes is more appropriate. 

(i)(A) When EPA uses the direct final 

rulemaking procedure to issue a significant new use rule it will issue a direct final rule in the final rule section 

of the FEDERAL REGISTER following its 

decision to develop a significant new 

use rule under this section for a specific new chemical substance. 

(B) The FEDERAL REGISTER document 

will state that, unless written notice is 

received by EPA within 30 days after 

the date of publication that someone 

wishes to submit adverse or critical 

comments, the SNUR will be effective 

60 days from date of publication. The 

written notice of intent to submit adverse or critical comments should state 

which SNUR(s) will be the subject of 

the adverse or critical comments, if 

several SNURs are established through 

the direct final rule. If notice is received within 30 days after the date of 

publication that someone wishes to 

submit adverse or critical comments, 

the section(s) of the direct final rule 

containing the SNUR(s) for which a notice of intent to comment was received 

will be withdrawn by EPA issuing a 

document in the final rule section of 

the FEDERAL REGISTER, and EPA will 

issue a proposed rule in the proposed 

rule section of the FEDERAL REGISTER. 

The proposed rule will establish a 30- 

day comment period. 

(C) If EPA, having considered any 

timely comments submitted in response to the proposal, decides to establish notification requirements 

under this section, EPA will issue a 

final rule adding the substance to subpart E of this part and designating the 

significant new uses subject to notification. 

(ii)(A) When EPA uses a notice and 

comment procedure to issue a significant new use rule, EPA will issue a 

proposed rule in the FEDERAL REGISTER

following its decision to develop a significant new use rule under this section 

for a specific new chemical substance. 

Persons will be given 30 days to comment on whether EPA should establish 

notification requirements for the substance under this part. 


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Environmental Protection Agency § 721.185 

(B) If EPA, having considered any 

timely comments, decides to establish 

notification requirements under this 

section, EPA will issue a final rule adding the substance to subpart E of this 

part and designating the significant 

new uses subject to notification. 

(iii)(A) When EPA uses the interim 

final rulemaking procedure to issue a 

significant new use rule, EPA will issue 

an interim final rule in the final rule 

section of the FEDERAL REGISTER following its decision to develop a significant new use rule for a specific new 

chemical substance. The document will 

state EPA’s reasons for using the interim final rulemaking procedure. 

(1) The significant new use rule will 

take effect on the date of publication. 

(2) Persons will be given 30 days from 

the date of publication to submit comments. 

(B) An interim final rule issued under 

this section shall cease to be in effect 

180 days after publication unless, within the 180-day period, EPA issues a 

final rule in the FEDERAL REGISTER responding to any written comments received during the 30-day comment period specified in paragraph 

(d)(4)(iii)(A)(2) of this section and promulgating final significant new use notification requirements and other requirements for the substance. 

(e) Schedule for issuing significant new 

use rules. (1) EPA will issue a proposed 

rule, an interim final rule, or a direct 

final rule within 270 days of receipt of 

the notice of commencement under 

§720.102 of this chapter for any substance for which the notice of commencement was received on or after 

October 10, 1989. 

(2) If EPA receives adverse or critical 

comments within the designated comment period following publication of a 

proposed rule or an interim final rule, 

EPA will either withdraw the rule or 

issue a final rule addressing the comments received. 

[54 FR 31314, July 27, 1989, as amended at 60 

FR 16316, Mar. 29, 1995] 

§ 721.185 Limitation or revocation of 

certain notification requirements. 

(a) Criteria for modification or revocation. EPA may at any time modify or 

revoke significant new use notification 

requirements for a chemical substance 

which has been added to subpart E of 

this part using the procedures under 

§721.160 or §721.170. Such action may be 

taken under this section if EPA makes 

one of the following determinations, 

unless other information shows that 

the requirements should be retained: 

(1) Test data or other information obtained by EPA provide a reasonable 

basis for concluding that activities designated as significant new uses of the 

substance will not present an unreasonable risk of injury to human health 

or the environment. 

(2) EPA has promulgated a rule under 

section 4 or 6 of the Act, or EPA or another agency has taken action under 

another law for the substance that 

eliminates the need for significant new 

use notification under section 5(a)(2) of 

the Act. 

(3) EPA has received significant new 

use notices for some or all of the activities designated as significant new 

uses of the substance and, after reviewing such notices, concluded that there 

is no need to require additional notice 

from persons who propose to engage in 

identical or similar activities. 

(4) EPA has examined new information, or has reexamined the test data 

or other information or analysis supporting its decision to add the substance to subpart E of this part under 

§721.170 and has concluded that the 

substance does not meet the criteria 

under §721.170(b). 

(5) For a substance added to subpart 

E of this part under §721.160, EPA has 

examined new information, or has reexamined the test data or other information or analysis supporting its finding 

under section 5(e)(1)(A)(ii)(I) of the 

Act, and has concluded that a rational 

basis no longer exists for the findings 

that activities involving the substance 

may present an unreasonable risk of 

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

of the Act. 

(6) For a substance added to subpart 

E of this part under §721.160, certain 

activities involving the substance have 

been designated as significant new uses 

pending the completion of testing, and 

adequate test data developed in accordance with applicable procedures and 

criteria have been submitted to EPA. 


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§ 721.225 40 CFR Ch. I (7–1–07 Edition) 

(b) Procedures for limitation or revocation. Modification or revocation of significant new use notification requirements for a substance that has been 

added to subpart E of this part using 

the procedures described under §721.160 

or §721.170 may occur either at EPA’s 

initiative or in response to a written 

request. 

(1) Any affected person may request 

modification or revocation of significant new use notification requirements 

for a substance that has been added to 

subpart E of this part using the procedures described in §721.160 or §721.170 

by writing to the Director of the Office 

of Pollution Prevention and Toxics and 

stating the basis for such request. All 

requests should be sent to the Document Control Office (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 

§ 721.225 2-Chloro-N-methyl-N-substituted acetamide (generic name). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance 2-chloro-N-methylN-substituted acetamide (PMN P-84– 

393) is subject to reporting under this 

section for the significant new uses described in paragraph (a)(2) of this section. 

(2) The significant new uses are: 

(i) Protection in the workplace. Requirements as specified in §721.63(a)(1), 

(a)(3), (b) (concentration set at 1.0 percent), and (c). 

(ii) Hazard communication program. 

Requirements as specified in §721.72 

(b)(2), (d), (e) (concentration set at 1.0 

percent), (f), (g)(1)(iv), (g)(2)(i), and 

(g)(2)(v). The provisions of §721.72(d) requiring employees to be provided with 

information on the location and availability of a written hazard communication program and MSDSs do not apply 

when the written program and MSDSs 

are not required under §721.72 (a) and 

(c), respectively. The provision of 

§721.72(g) requiring placement of specific information on an MSDS does not 

apply when an MSDS is not required 

under §721.72(c). 

(iii) Industrial, commercial, and consumer activities. Requirements as specified §721.80(g). 

(b) Specific requirements. The provisions of subpart A of this part apply to 

this section except as modified by this 

paragraph. 

(1) Recordkeeping. The recordkeeping 

requirements as specified in §721.125 (a) 

through (g) and (i) are applicable to 

manufacturers, importers, and processors of this substance. 

(2) Limitations or revocation of certain 

notification requirements. The provisions 

of §721.185 apply to this significant new 

use rule. 

[55 FR 32412, Aug. 9, 1990, as amended at 57 

FR 20424, May 13, 1992. Redesignated at 58 FR 

29946, May 24, 1993; 58 FR 34204, June 23, 1993] 

§ 721.267 N-[2-[(substituted 

dinitrophenyl)azo]diallylamino-4- 

substituted phenyl] acetamide (generic name). 

(a) Chemical substance and significant 

new uses subject to reporting. (1) The 

chemical substance identified generically as N-[2-[(substituted 

dinitrophenyl)azo]diallylamino-4-substituted phenyl] acetamide (PMN P-95– 

513) is subject to reporting under this 


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