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______

Thursday

July 27, 1989

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PEW Part IV

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Protection Agency

~ 49 CFR Part 721

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Significant New Use Rules; General

~ Provisions for New Chemical Follow-up;

Final Rule

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p. 2

31298 Federal Register J Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules, and Regulations

ENVIRONMENTAL PROTECTION reducing this burden, to Chief, use the same language in future SNURs,

AGENCY Information Policy Branch, PM-223, U.S. EPA will amend Subpart B to include the

Environmental Protection Agency. 401 M new use designation. The hazard

40 CFR Part721 St., SW., Washington, DC 20460 and to communication provisions contained in

[OPTS-60553B; FRL-350

4-6] the Office of Information and Regulatory Subpart B were proposed on April 22,

Affairs, Office of Management and 1986 ( 51 FR 15104) . All other provisions

Significant New Use Rules; General Budget, Washington, DC 20503 marked contained in Subpart B were proposed

P rovisions For New Chemical Follow- "Attention: Desk Officer for EPA." in the Federal Register of April 29, 1987

Up I. Authority (SSubpatt C establishes recordkeeping AGENCY: Environmental Protection Section 5(a)(2) of TSCA (15 U.S.C . requirements which will apply for a Agency (EPA). 2804(a)(2)) authorizes EPA to designate specific substance only if cited in the ACTION: Final rule . a use of a substance as a significant new SNUR for that specific substance . EPA

SUMMARY: EPA, under sections 5 and uae. EPA makes this designation by may designate recordkeeping

28(c) of the Toxic Substances Control issuing a SNUR after it has considered , requirements other than those for which

Act (TSCA), is establishing an expedited all relevant factors, including those standard designations are provided for

process for issuing significant new use listed in section 5(a)(2) . Under section in Subpart C. When the standar d

rules (SNURs) for certain new chemical 5(a)(1)(B) of TSCA, persons must submit designations contained in Subpart C do

substances. The new process will apply a si gnificant new use notice to EPA at not provide an adequate description of a

to: (1) New chemical substances for least 90 days before they manufacture, needed recordkeeping requirement, EPA

which EPA has issued orders under import, or process a substance for a will develop an appropriate description

section 5(e) of TSCA, and (2) other new significant new use. Persons subject to a and place it in the SNUR for the specific

chemical substances for which no SNUR must follow the same rules and substance . If EPA expects to use the

section 5(e) orders have been issued, but procedures as persons who are required same language in future SNURs, EPA

which may present hazards to human by section 5(a)(1)(A) of TSCA to submit will amend Subpart C to include the

health or the environment if exposures a PMN• new recordkeeping requirement . Subpart

or releases are significantly different Section 26(c) of TSCA ( 15 U.S.C . C was proposed in the Federal Register

from those described in the 2625(c)) authorizes EPA to take action of April 29,1987 ( 52 FR 15594).

premanufacture notice (PMN). EPA is under other Sections of TSCA with Subpart D contains expedited

also establishing standard language for respect to categories of chemical procedures for establishing significant

designating certain significant new uses, substances. new use requirements for certain new

recordkeeping, and other requirements. II. Intrailuction substances that have completed PMN

DATES: In accordance with 40 CFR 23 .5 A. Summa

review and are regulated by an order

(50 FR 7271), this rule shall be 'y issued under section 5(e) of TSCA .

promulgated for purposes of judicial This rule amends 40 CFR Part 721 by Subpart D also contains criteria used to

review at I p.m.eastem time on August establishing new Subparts B. C, and D determine whether uses not 'identified in

10,1989, This rule shall become effective and by amending Subpart A . Other the PMN of substances which have

October 10,1989 . amendments to Subpart A were recently completed PMN review and have not

FOR FURTHER INFORMATION CONTACT: promulgated at 53 FR 28358 (July 27, been the subject of a section 5(e) order

Michael M. Stahl, Director, TSCA 1988) . will be considered candidates for a

Assistance Office (TS-799), Office of In Subpart A this rule establishes SNUR under expedited procedures. In

Toxic Substances, Environmental definitions of terms found in Subparts B, addition, Subpart D contains a

Protection Agency, 401 M St., SW., C, and D. Some of the terms were procedure through which a person may

Washington, DC 20460, Telephone : (202) proposed in the )r'ederal Register of April request limitation or revocation of

554-1404, TDD: (202) 544- 0551 . 22, 1986 (51 FR 15104), and of April 29, SNURs which were promulgated under

SUPPLEMENTARY INFORMATION: This rule 1987 (52 FR 15593) ; other terms were this expedited procedure. Subpart D

establishes standardized significant new added in response to comments made on limits the significant new us e

uses and recordkeeping requirements the proposed rules. The new terms were designations that may be included in

which can be cited in SNURa applicable included because they were necessary SNURs issued under the expedited

to individual substances. The rule also for the practical functioning of Subparts procedures for non-section 5(e)

establishes procedures for expedited B, C, and D . None of the new terms substances. Subpart D was proposed in

promulgation of SNURs, and for EPA modifies the substance of the proposed the Federal Register of April 29,1987 (52

consideration of requests from rules. FR 15593).

interested parties to amend or revoke Subpart B establishes standard Subpart E was established in the

SNURs. significant new use designations. Each Federal Register of February 2, 1988 (53

Public reporting burden for this standard significant new use will apply FR 2845). It contains SNURs for specific

collection of information is estimated to to a specific substance only if it is cited chemical substances .

average 12.2 hours per response for in the SNUR for that specific substance.

Subpart B, and to average 25 B. Changes From the Proposed Rule .3 hours per EPA may designate as significant ne w

response for Subpart C, including time uses activities other than those for As discussed above, the hazard

for reviewing instructions, iearching which standard designations are communication provisions of this final

existing data sources, gathering and provided for in Subpart B. When the rule were proposed on April 22,198 6,

maintaining the data needed, and standard designations contained in and the remainder of this rule was

completing and reviewing the collection Subpart B do not provide an adequate proposed on April 29,1987 . The

of information . Send comments description of a significant new use, following changes have been

regarding the burden estimate or any EPA will develop an appropriate incorporated in this final rule :

other aspect of this collection of designation and use it .in the SNUR for 1. The proposed standard significant

information, including suggestions for the specific substance . If EPA expects to new use designations and recordkeeping
p. 3

Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations 31299

requirements in Subparts B and C have document will state that the SNUR'will regulate under a SNUR, it also gives

been modified to be consistent with the be effective 60 days from the date of maximum public notice, and ensures a

standard provisions for section 5(e) publication, unless, within 30 days from full period to address any significant

consent orders which were developed in the date of publication, EPA receives issues. A full notice and comment cycle

a public comment process announced in written notice that someone intends to requires publication of two documents, the Federal Register of March 6, 1988. submit adverse or critical comments. If, and thus will cost more than the direct 2 . This rule adopts most of the within 30 days from the date of final method in most cases

. Occupational Safety and Health publication, EPA receives notice that 4 . EPA had proposed that information Administration's (OSHA) hazard someone intends to submit adverse or submission requirements be imposed

communication standard (29 CFR critical comments, EPA will withdraw under TSCA section 8(d) for all • 1910.1200). EPA is not adopting certain the direct final rule by issuing a substances, and under section 8(a) for

parts of OSHA's hazard communication document in the final rule section of the some substances, subject to SNURs on

standard because they either are Federal Register. EPA will an expedited basis. EPA has not covered in other sections of EPA rules or simultaneously issue a proposed rule in adopted this aspect of the proposal are not applicable .

. EPA did not adopt a the proposed rule section of the Federal Such rules will be issued on a case-by- requirement in OSHA's standard Register. The proposed rule will case basis as necessary, and (pertaining to trade secrets) that the establish a 30-day comment period, and consequently will not be issued under

identity of the substance must be will identify any objections to the rule of the expedited procedures of this final

released to a physician or nurse during a which EPA has been notified . EPA will rule medical emergency .

. Instead, EPA has then consider any comments received 5. EPA's response to comments required that a person who can provide and decide either to issue a final rule document (available in the public docket treatment information when a .person promulgating the SNUR or withdraw the for this rule) supplements this preamble has been exposed to the SNUR proposal

. ' by addressing the public comments substance be designated in the material EPA believes that this process received on all aspects of this rule

. safety data sheet (MSDS) and on the provides an improved opportunity for

label. EPA received no comment on this public participation consistent with the III. Provisions of the Final Rule

issue. objective of providing for prompt

3. On April 29, 1987, EPA had promulgation of SNURs to follow-up on A. Amendments to Subparts A and B.-

proposed a program under which it new chemical substances Standard Language Describing . EPA wil l

would issue immediately effective final generally use this approach because it Significant New Uses

SNURs for new chemical substances significantly reduces the time, relative to Subpart A is amended to establish

subject to TSCA section 5(e) orders, or notice and comment rulemaking, during new definitions needed for th e

which met certain hazard and exposure which a person may legally engage in a functioning of Subparts B, C, and D. The criteria . significant new use before the SNUR new Subpart B contains standar d This final rule significantly changes effective date. This option saves EPA language which EPA will use in

the proposed approach to provide a resources because routinely only one designating certain activities as greater opportunity for public comment . Federal Register document Is required to significant new uses. Using standard EPA will issue SNURa under one of establish a SNUR . language will reduce potential confusion three procedures. The three mechanisms Immediately effective interim final due to minor language variations from are: direct final rules, immediately rules will work as follows : These SNURs SNUR to SNUR. When EPA wishes to effective interim final rules, and notice will be issued as interim final rules and designate an activity described b y and comment rulemaking . EPA intends will be effective on the day of standardized language as a significant

to use the direct final rulemaking publication. A 30-day comment period new use for a particular substance, it process as its usual method for issuing begins on the day after publication. The will list the substance in Subpart E and new substance follow-up SNURs, but rule ceases to be in effect 180 days from reference the appropriate standard new

reserves the right to use immediately the date of publication unless during use language from Subpart B

effective Interim final or notice and that time . Subpart B

. EPA issues a final rule now contains the following sections : comment rulemaking as appropriate . addressing any comments received. This g 721,50 Applicability . Direct final rulemaking is the same as option provides the greatest possible 721, 63 Protection in the workplace. a procedure that is used by EPA for reduction in the period during which a § 721 .72 Hazard communication program . rulemaking under the Clean Air Act . In person may legally engage in an activity $ 721 .80 Industrial, commercial, and

the Federal Register of June 23, 1982 (47 EPA intends to regulate as a significant consumer activities.

FR 27073), EPA discussed streamlining new use because the rule is immediately $ 721 .85 Disposal.

the State Implementation Plan (SIP) effective and enforceable. EPA expects § 721 •90 Release to water.

review process. In that notice, EPA to use interim final rulemaking for § 721 .91 Computation of estimated surface

announced that it would promulgate SNURs when EPA has reason to believe water concentrations: instructions.

certain SIP revisions for which no public that someone is likely to engage in the When appropriate standard language

comment was expected using an significant new use before the rule is not contained in Subpart B . EPA may "immediate final rulemaking." EPA has would go into effect under direct final or amend Subpart B to add additional

decided to adopt the same process for notice and comment rulemaking . EPA standardized language . This standard

issuing SNURs under this rule because will explain its reasons when it uses this language will establish a significant new

EPA does not generally anticipatapublic procedure for a specific SNUR . use for a particular new chemical

comment on these SNURs. EPA expects to follow notice and substance only when it has been cited in

The process adopted for SNURs under comment rulemaking procedures to a SNUR in Subpart E . EPA also intends

this rule as "direct final rulemaking" issue SNURs in cases where it expects to use standard provisions in section

works as follows: EPA will issue a adverse or critical public comments on a 5(e) consent orders ; the standard SNUR document in the final rule section of the SNUR. While this option maximizes the language is designed to track the

Federal Register which contains the period during which a person may corresponding section 5(e) orde r

final SNUR. The Federal Register engage in the activity EPA intends to provisions.
p. 4

31300 Federal Register / Vol . 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulation s

In codifying standard language for a section 5(e) order on which the SNUR respirators from which EPA will make

designation of significant new uses, it is Is based. selections has been expanded to provide not EPA's intent to discourage persons Section 721 .63(b) exempts mixtures a more complete range of options and a

subject to SNURs from proposing more containing a concentration less than or list of physical states has been added at

effective alternative approaches to limit equal to a concentration specified in § 721 .63(a)(6) to allow EPA to specify exposure or environmental release. EPA Subpart E of this Part for a substance protective measures against respiratory

encourages manufacturers, importers, from dermal protection requirements, exposure from low-vapor pressur e

and processors to seek approval of more but excludes from exemption mixtures substances (e .g., acrylates) when they

effective alternative control measures which might concentrate above the are used in a manner likely to cause

under § 721.30 . exemption limit. The concentration exposure, while allowing the measures

1 . Section 721.83 Protection in the specified will ordinarily be one percent to be omitted when the substances are

workplace, This section designates new of the chemical substance (one tenth used in a manner not likely to cause the

uses based on dermal and respiratory percent if the chemical substance is a exposure.

exposure and requires that employers carcinogen), which is consistent with the EPA encourages employers to

demonstrate that chemical protective similar OSHA exemption, but other evaluate their work areas and to

clothing is impervious to the substance. concentrations will be specified when implement industrial hygiene programs

Changes from the proposal are designed appropriate . This exemption is not that consider the use of engineerin g

to enable the Agency to more precisely intended is cover

exposure. If a

n eliminate

in inhalation t

o

cite exposures of concern and protective present in the mixture Posure employer

measures. The rule provides an concentrations greater than the level set wishes to use respiratory protection

exclusion from the workplace protection in Subpart E of this Part, even though " controls which differ from those

provision for mixtures containing low the airborne concentration of the specified in a SNUR, the employer may

concentrations of the substance and mixture may be less than the level set in request EPA approval for their use

establishes procedures persons must Subpart E of this Part. under § 721.30.

follow if EPA has added definitions for "work EPA received comments suggesting

they discover that their area" and "workplace" to Subpart A to that it adopt a performance-based customers are engaging in activities clarify use of those terms in § 721 .63. approach to control respiratory

inconsistent with the provisions of EPA developed the performance-based exposure § 721 .63(a) . EPA is considering

. dermal protection provisions in development of performance based I. Dermal protection. Section 721.63(a) response to comments favoring use of provisions and will incorporate them

will be cited whenever dermal exposure performance- based provisions • into § 721 .63 when developed. However, is a concern. This provi•sion establishes whenever appropriate . EPA has retained until performance-based provisions are

a performance-based approach to standard language for describing -available and the rule is amended, EPA

dermal protection . The language allows specific types of personal protective will continue to specify respiratory employers to determine which equipment . EPA will cite this language protection equipment .

employees are reasonably likely to be when it determines that a particular iv. Low concentrations in mixtures.

dermally exposed by evaluating the , type of personal protective equipment is As noted above, § 721 work area .63(b) provides an

. Each employer has the essential for adequate worker exemption from use of controls on responsibility to select, provide, and protection : exposure when the substance is present enforce the correct use of the ii

. Demonstration of imperviousness, in the workplace in a mixture with

appropriate personal protective EPA requires that employers concentration of the substance less than equipment for dermal protection. demonstrate that chemical protective or equal to a concentration specified in

Employer selection of control measures clothing is impervious to the substance Subpart E of this Part for a substance

may take into account engineering under the conditions and duration of from dermal-protection requirements,

controls and work practices instead of, exposure .

. but excludes from exemption mixtures

or in addition to, personal protective EPA is allowing two methods to which might concentrate above the equipment. Dermal protection applies demonstrate imperviousness : (a) Actual exemption limit . The concentration

only to persons who are reasonably testing of the chemical protective specified will ordinarily be one percent likely to be dermally exposed . ' clothing by the employer, and/or (b) of the chemical substance (one tenth

Reasonable and feasible engineering evaluation of the chemical protective percent if the chemical substance is a

controls may often eliminate the need clothing manufacturer's specification carcinogen), which is consistent with the for personal protective equipment data . EPA expects the demonstration of similar OSHA exemption, but other

because the "reasonably likely to be imperviousness will address the total concentrations will be specified when

exposed" finding will not be made . environment to which the chemical appropriate . The exemption would not Under special circumstances EPA will protective clothing is exposed. EPA apply if using or processing a mixture cite the menu in § 721.63(a)(2) to specify expects that factors affecting physical containing the substance at a

the type of personal protective integrity such as abrasions, punctures, concentration below the exemption level

equipment that must be used for dermal and tears will be considered . The is likely to concentrate the substance

protection in addition to the employer must also consider penetration above the exemption level . This' performance-based approach . A menu of and permeation by the substance under exemption is not intended to cover a

physical forms at § 721.63(a)(8) allows the conditions and duration of exposure, case where the substance is present in

the SNUR to establish controls iii. Respiratory protection. Section the mixture in concentrations greater appropriate to substances which have 721 .63 (a)(4) and (5) will be cited when than the level set in Subpart E of this

high vapor pressure and to which inhalation exposure to the substance is Part, even though the airborn e

airborne exposures are likely as well as a concern, and will specify the concentration of the mixture may be less

to substances which have low vapor appropriate category of respirator for than the level set in Subpart E of this

pressure and to which airborne the substance from the lists contained in Part . This exemption was not included

exposures are unlikely, consistent with this section . The list of classes of in the proposed rule, but EPA has
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Federal Register / Vol. 54, No. 143 [Thursday, July 27, 1989 / Rules and Regulations 31301

included it in response to comments to language to be included on the label and obtain or develop an MSDS . The MSDS enable the provisions of § 721 .63 to be MSDS; (c) the OSHA standard has a format is not specified by EPA; however, consistent with the provisions of trade secrets provision while . § 721.72 ' EPA does specify information that must J 721.72(e) and OSHA practice . does not; and (d) § 721 .72 requires that be listed, if known, including: Physica l

v. Recipient activities inconsistent environmental hazards be listed on the and chemical characteristics, health and

with a program for protection in the container label and the MSDS while the environmental hazards, signs and workplace. Section 721.5(d)„ OSHA standard does not. The primary symptoms of exposure, medical

promulgated July 27, 1988 (53 FR 28354), reason for the first two differences is conditions which may be aggravated by

sets forth procedures that persons that, in evaluating new substances, EPA exposure, primary route(s) of exposure,

subject to a SNUR (suppliers) must is most often relying on a finding. that a and appropriate measures to control

follow if they become aware that a substance may present a risk, pending worker exposure and[or environmental

customer is engaging in a significant the development of additional data . release. The final rule does not make

new use, for example, the customer is OSHA's standard applies to substances any substantive changes to the proposal .

not complying with workplace for which more definitive data are An employer who distributes the

protection requirements. This section available and which are known to . substance must provide the MSDS at the

requires that the supplier stop present certain hazards. A separate time of the initial shipment and with the

distribution of the substance to that trade secrets provision is not required, first shipment after each MSDS update .

customer and notify EPA of the ' as section 14 of TSCA and EPA's rules if the substance is not currently being.

customer's failure to comply. EPA issued to implement section 14 produced, imported, processed, or used •

received comments that under some adequately address the issue . The fourth in the workplace, the employer must add

circumstances involving worker difference stems from EPA's broader . new information to the MSDS before the

protection measures this requirement• mandate to protect the environment, as substance is reintroduced into th e

could be unnecessarily harsh. In well as human health, from workplace .

response, EPA has added I 721.63(d); unreasonable risks. v. Employee information and training. which allows the supplier to notify, the ii. Written hazard communication The proposed employee information and

customer in writing if its activities are program. Section 721 .72(a) sets forth training requirements have been

inconsistent with, a required worker requirements for a written hazard changed to place more emphasis on

protection program. If the supplier can communication program, which requires training . The training and information

then document that the customer has that each employer develops a written must be provided at the time of Initial

provided a written statement of plan to ensure that employees who may employee assignment to a work area

assurance that appropriate measures to be exposed to the substance will be and whenever a substance subject to

provide a worker protection program made aware of the hazards involved, § 721 .72 is introduced into the work

have been taken, the supplier is not and specifies employee information and area .

required to stop supplying the customer. • training, such as control measures to The employee information and

If a supplier later learns that the prevent employee exposure and release training, program must identify and

customer has failed to provide required to the environment. The written program address each substance subject to these

worker protection, the supplier must. must be available to each employee,, provisions in the employee's work area.

stop distributing to that customer and upon request. The proposed rule did not EPA Intends that the employee who is follow the requirements of J 721.5(d). require a written hazard communication reasonably likely to be exposed b e

2 . Section 74.72 Hazard program.. EPA. included the written made aware of and understand the

communication program. - program in the final rule because EPA health and environmental hazards of the

i . Introduction. Section 721.72 determined that a written program is substance and the control measures the

establishes EPA's workplace hazard necessary for a complete hazard employer is providing . This training

communication program. The section communication program, and to parallel requires an explanation of•the MSDS

will be cited whenever EPA determines more closely the requirements of required for each substance . All acute

that it is necessary to inform workers of OSHA's standard, as suggested-by i and chronic human health hazards

potential hazards and exposures in the commenters .

. known by the employer and identified in

workplace and how they must act to iii. Labeling. Section 721 .72(b) sets Subpart E must,be listed, and the

protect themselves under both routine forth labeling requirements for warning terms and phrases used to

and emergency conditions. EPA has substances subject to J 721 .72. It indicate the hazard must be explained.

received comments that a program will addresses both labeling of substances in The personal protective equipment ,

be easier to implement and more the workplace and labeling for engineering controls, and other

effective if it parallels the OSHA hazard distribution in commerce . It requires measures used to control worker

communication standard to cover information on both types of labels to exposure and/or environmental release

numerous existing chemicals which are alert employees to the possible health must be listed and explained. The

present in the workplace . EPA agrees, and environmental hazards of the training must also include methods and

and the provisions of § 721.72 parallel substance and precautionary measures observations that may be used to detect

those of OSEiA's standard where to prevent exposure and/o% release to the presence or release of each

possible, but there are differences the. environment . The label must refer substance. Employees. of contractors,

between the two. The. most significant the user to the MSDS for details. and other workers not directly employed

differences are: (a) The OSHA standard' Container labels used outside the by the employer, must also receive the

requires an employer to make a hazard workplace must have, the name and training and written materials, if the

determination, while in the EPA . address of a responsible person who- can determination has been made that they

standard the hazard determination is be contacted for additional information are reasonably likely to be exposed to

made by EPA; (b) the OSHA standard on the substance, including appropriate: the substance.

allows the employer to develop emergency procedures . Employees must also be given

language for labels and for the MSDS, iv . Material safety data sheets. Under information to help them identify all

while in § 721.72 EPA provides certain § 721.72(c) an employer is required to operations in their work area where the
' 4 i .,

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.

;

.

p. 6

31302 Federal Register / Vol.' 54, No . 143 / Thursday, July 27, 1989 / Rules prio_'Regulations

.substance is present, and how they may processes; manufacture ( except for application of the specified treatment be exposed. Employees must be export) of the substance associated with technology would constitute a informed about the specific any use; use other than as an significant new use . Section 721.90 requirements of the labeling program, intermediate ; use other than as a site- the require (a)(4), (b)(4), and (c)(4) require ments for the MSDS, and all limited intermediate ; use as an notification only if the predicted

aspects of the hazard communication intermediate, where the concentration of environmental concentrations exceed a program that are relevant to their work the substance in products intended for specified ievel, assignments. distribution in commerce exceeds the In the proposed rule, reportin vi. Low concentrations in mixtures g . percentage specified by EPA Section 721 ; non- requirements for release to water were .72(e) provides an exemption industrial use ; commercial use from the requirements of § 721 ; use in a addressed in two sections. One covered .72 if a consumer product; annual manufacture process streams, the other, use streams: substance is present in the workplace and importation volume greater than The only in a mixture containing a that specified definition of process stream had by EPA; and manufacture , included both processing and concentration less than or equal to a processing, or use in physical forms manufacture

concentration specified in Subpart E of . EPA determined that it specified by EPA. will not always be appropriate to this Part for a substance, but excludes Some commenters on the proposed require reporting for both processing

from exemption mixtures which might rule stated that the uses described in and manufacture, so It has modified the

concentrate above the exemption limit . § 721

The .80 are too broad and might require language of the rule to allow each to be concentration specified will unnecessary notification

ordinarily be one percent of the conside . EPA has specified separately as well as to red the comments chemical substance (one tenth percent if added additional uses where possible ; and has specify them together. To do so, EPA

. has added a definition fo r the chemical substance is a carcinogen), For the most part, however, EPA has manufacturing stream and sharpened

which is consiste,nt with the similar decided to promulgate the uses as the definition of processing st OSHA exemption, but other proposed ream so

concentrations will be specified . EPA cannot predict and that it does not include manufacturing, when enumerate SNURs for every possible use and has established separate sections appropriate . : variation that might lead to significant for manufacturing and for processin This low concentration exemption exposure or release g . Often it is more was not included in the proposed rule ( § 721 .90 paragraphs (a)(2) and (b)(2)), . practical to simply identify the category allowing them to be specifie EPA decided to include this provision in of use that is of concern d . When EPA response to comments which stated that receives a significant new use separately. In cases where each should

without such an exemption the EPA notification, it will evaluate the specific be a significant new use, both will be

program would be inconsistent with the use that is then proposed to determine specified.

OSHA standard. whether it may present an unreasonable Section 721.91 provides a formula to

vii. Existing hazard communication risk, be used in projecting environmental

program. Section 721 .72(f) clarifies the 4. Section 721.85 Disposal. Section concentrations under § 721.90 ( a)(4),

status of programs and procedures 721 .85 designates specific ongoing or (b)(4), and (c)(4). A commenter noted

established under the OSHA standard allowed disposal methods. Any other that the formula established in § 721 .91 •

and other rules. EPA intends that no method is designated as a significant for calculating estimated surface water

unnecessary duplication of effort be new use, requiring that manufacturers, concentrations is difficult to use. EPA

required when complying with § 721 .72. importers, and processors submit a reviewed the formula but has been

Commenters voiced their concerns significant new use notice 90 days unable to devise a simpler calculation

about duplication of efforts because before employing such a disposal that would be suitable for general use . many already have a hazard method. EPA will consider alternative

communication program required under Some commenters argued that the mechanismsfor calculation on a case

other rules. In all situations, if an provisions of § 721 .85 duplicate EPA by-ease basis, and may employ them if

employer is complying with another rule rules issued under the Resource it determines that they are similar and

and those efforts meet or exceed the Conservation and Recovery Act and are, will lead to a reliable projection of

requirements of 1 721 .72, no additional therefore, unnecessary. EPA intends to environmental concentration . action is necessary to comply with include disposal provisions in SNURs § 721 B. Subpart Q Recordkeeping and Other

viii

.72

. Human

. when it determines that disposal of the Requirements

and environmental substance may not be adequately

hazard andprecautionarystatements. addressed by existing disposal rules. Subpart C establishes recordkeeping Section 721 .72(g) provides the standard EPA can consider requests to limit or requirements which apply to

language that EPA will specify for labels revoke SNURs under the provisions of manufacturers, importers, and

and MSDSa . EPA believes this § 721 .85, if submitters believe they are in processors of SNUR substances. The standardization will provide consistency fact redundant. specific records which are require d

in content and organization to the 5. Section 721.90 Release to water. depend upon the activities which have writing of SNURs. EPA's requirements Section 721 .90 contains standard been designated as signifi cant new uses.

do not exclude the addition of other language for designating significant new EPA will specify the appropriate

material to the labels and MSDSs, but uses involving release to water. Section recordkeeping requirements in Subpart they provide a minimum set of 721.90(a) addresses manufacture E at the time it issues the SNUR for a information which must be provided . streams, § 721.90(b) addresses . particular substance . Such records must 3 . Section 721 .80 Industrial, processing streams, and § 721 .90(c) be maintained for 5 years from the date commercial, and consumer activities. addresses use streams. Section 721.90 of their creation.

Section 721 .80 designates certain {a)(2). (b)(2), and (c)(2) include a list of Several commenters voiced concerns activities as significant new uses. treatment technologies. EPA may that they will be required to keep Significant new uses described in this specify one or more of these separate records to documen t

section include: Manufacture, technologies for a substance if it compliance with SNURs when records processing, .or use in non-enclosed determines that release without kept under other regulatory programs
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Federal Register ,l Vol. 54, No. 143 J. Thursday, July 27, 1-989, / Rules and -Regulations •33303

should suffice to demonstrate intends that normal business records. • compliance in one case may not be compliance . In general, EPA has sought will usually suffice. In a few cases, the sufficient in another. to frame recordkeeping. requirements in generation of additional records will be Table 1 illustrates EPA's approach to flexible, performance- oriented terms. required. It is the responsibility of the recordkeeping by providing

Rather than specify the particular types manufacturer, importer, or processor to the records that might documen examples of

of records that must be kept, the rule t assess the adequacy of existing records lists the general types of information add' to them if necessary, and maintai ; compliance with different SNUR

n required to document compliance with them in a form accessible to EPA for the requirements . These examples are

SNUR requirements. Thus, required length of time . intended merely to be illustrative . In

manufacturers, importers, and . EPA expects firms subject to SNUR many cases, the examples listed in the

processors will have . discretion to requirements to exercise. reasonable -following Table 1 would be sufficient to

determine which specific records must judgment in determining the steps document SNUR compliancew in other

be retained . The records required to be necessary to, document compliance with • cases more or fewer records might be

maintained under this section often will SNUR requirements. Records that are necessary.

be normal business records, and EPA sufficient to document SNU R

TABLE i-ADMINISTRATIVE EXAMPLES OF RECORDS COMPLYING WITH § 721.125.

Significant New Use Requ"nt Examples

Disposal Methods. Records demonstrating establishment and: tmptemen- Certificates of destruction from disposal facility.

tation of pro cedures that ensure compliance with Bills of lading.

any disposat limitations referencod in 1721 .85. Manifests.

Waste treatment systems InventOdes..

Use In non•encbsed processes Records documenting compliance with any applicable Batch s8ps . Any manner or method of manufacture or processing . industrial, commercial, and consumer use limitation - Procesadascripttons. -in non -enclosed processes associated with . any referenced in ¢ 721 .80-. . . Chemical inveMorylptantlave cry'

u se . Storage and productionrecords. Use beyond the site of manufacture. Any manner or method of manufacture (excluding

Import} within the United States.

Use other than as an intermed •iate.

Use as an Intermediate where the aoncentratfo n of the intermediate substance In the prodUet intended for distribution in commerce exceeds X percent

Non-industrial use .

Commercial use.

Use In a consumer prodUct.

Use other than as sitednnited Intermediate,

Use In the form of a powder. Records documenting compliance with any apptlcable Process description. Any manner or method of manufacture or processing Indushiat.. commarciaJ , and consumer use Gmifation'.

in the form of a powder associated with any use (or referenced In ¢, 721.81k other formj .

Use invofving application methods that. generate

vapors, mists. or aerosols.

Use trrvoMny application methods that generate - dusts:

Hazard Communication Employee Training.' Records documenting establishment and knplemanta- Written hazard communication program lion of a program, for employea infonaation and . Attendance aheats from training aesetoaa

training referenced In ¢72t.72. Copies of written material sdistributed attraining sea610M. Copies of labefs.

Copies of MSDSs.

Hazard Communication Labeling•• Records daaxnenttng, the names and addresses of Bills of sale~

all persona to whom the substance Is sold or Copies of labels.

transferred, On dater of each sale or transfer, and

the quantity of, ;the substance sold or transferred an

such date.

Copies of labels used.

Manufacture, import, or processing without establish- Records documenting establisi ment.and implententa- Written hazard communication program.

ing a program whereby

mally exposed to the substance are

persons who may be der. lionof a program for the use of personat. protacttva. For gloves-specifications. supplied by the manutao• required to equipment referenced' in g 721 .83(a). - turer of glover, results of left done on gloves.

goggles

wear protective

. ¢ 72t

clothing; bnpewious fffovea. and Records documenting determinations under Attendance sheets from training.sessfarm 43(a) (3) that protective gtoves are impervtous

to the substante..

Manufacture. Utqiort, or processing without eatabGsh• Records documenting establishment and 6npfements- Wrilten• hazard- communication program : Ing a program whereby persons who may be ex- tion of a program for the use of personal protective Process desoriptions, posed to the substance In the form of an ae ro sol equipment referenced in ¢721 .83(a). Records of fit tests, or mist are required to wear respirators. A ttendance sheets from training sessions.

Annual productfon-volUme greater than X. Records documenting, the manufacture and Imports, Production iecorft

tion volume of the substance . Import records.

. ~

9

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31304 Federal Register / Vol. 54, No. 143 / Thursday, July 27,

-- -- ~

1989 / Rules and Regulations

....r .~.

TABLE 1-AOMINISTRATIVE EXAMPLES OF RECORDS COMPLYING WITH § 721 .125-Continued

Significant New Use Requirement Examples

Water Release Umitations. Records demonstrating establishment and Implemen• Process description diagram (as described in

tation of procedures that ensure compliance with § 721 .91).

any water discharge limitations referenced in Equatiori computation and paperwork supporting

§ 721 .90 equationresults.

C. Subpart D. Expedited Process for likelihood that there will be order'as long as it makes the findings,

Issuing SNURs for New Chemical manufacturers or processors other than specified in section 5(a)(2) of TSCA . ~ Substances; Limitation and Revocation the PMN submitter, or for other reasons it. Concern criteria: information to be of New Chemical Substance SNURs believes that a SNUR for the substance used in choice 'of substances. Under - •

Subpart D establishes at § $ 721.160, is inappropriate, EPA may decide not to § 721.170, SNURa may be issued for new

721 .170, and 721 .185 expedited issue a SNUR for a substance subject to substances if they meet the concern

procedures for promulgation of, and for a section 5(e) order. In such cases EPA criteria established at § 721.170(b).

modifying or revoking, SNURs for new will issue a notice in the Federal , These are generally similar criteria to

chemical substances.

Register explaining its reasons for not those used by EPA in determining if a

1 . SNUR requirements for new issuing a SNUR. EPA expects that such section 5(e) order should be developed .

chemical substances regulated under cases will be rare . The criteria established at § 721 .170(b)

section 5(e) orders. Section 721.160 2 . SNUR requirements for new generally call for development of a

establishes expedited procedures for' chemical substances not regulated SNUR if the exposures likely to result

issuing SNURs for new substances that under a section 5(e) order. Section from uses not described in the PMN

are subject to TSCA section 5(e) orders. 721.170 establishes expedited would have called for the development

The SNUR issued for each substance procedures for issuing SNURs to of a section 5(e)-order if they had been

will be based on and be consistent with regulate activities not covered in a desi:ribed in a PMN.

the provisions included in the section section 5(e) order . Additionally, it • Several commenters expressed the 5(e) order governing use of the establishes criteria for choosing which view that,. under the language of the substance. EPA may also designate substances will be regulated ("concern rule, substances would be

additional uses as significant new uses criteria"), and limits the uses for which • propose d

for such substances under the SNURs will be written, under the subject to SNURs on the basis o

f rulemaking procedures and criteria of procedures of the section . Inadequate evidence. Appropriateness

~ 721 .170. 1 . Criteria other than concern criteria.

of EPA use of evidence was discussed at

I . Substances subject to section 5(e) EPA will only designate an activity as a length in the public meetings held prior

orders issued before the effective date significant new use under § 721.170 if t6publication of the proposed rule. A

of this rule. EPA requested comment in the activity was not described in the description of these discussions is in the

the 1987 proposal on whether § 722 .160 PMN for the substance, and the activity public record for this rule . EPA believes

(now § 721.160) should be applied to also satisfies a concern criterion that its criteria for concern are

substances subject to section 5(e) orders established at r; 721 .170(b). Such a use appropriate . In general, EPA regulates

negotiated prior to the effective date of may be made subject to a SNUR under on the basis of the weight of the

this rule. All commenters addressing this section whether or not a section 5(e) evidence available to it from all sources .

this issue requested that EPA modify the order is written for any other use of the A commenter asked for restraint by

rule to do so . EPA has modified . substance described in the PMN. EPA in use of structure activity

§ 721 .160 so that it can be applied to Procedures for issuing SNURs under relationship analysis (SAR) in assessing

substances subject to section 5(e) orders § 721.170 are in § 721.170(c). substances, and in framing SNUR

issued prior to the effective date of this EPA decided that certain designations restrictions for substances not subjected

rule. If the notice of commencement of in § 721.80 are, by their nature, not to a section 5(e) order. EPA makes its

manufacture for the substance was appropriate for expedited SNURs issued decisions based on the entire body of

received prior to the effective date of under the procedure described in available evidence, and attempts t o

this rule, the direct final, interim final, or § 721 .170. Expedited procedures will be assign appropriate weight to each piece

proposed SNUR will be issued within 1 used to issue SNURs including these of evidence used . Often SAR is the best

year of the effective date of this rule . If designations only for SNURs based on evidence available for new, little-tested

the notice of commencement of section 5(e) orders . These designations substances. When better evidence is

manufacture is received after the include, for example, designation of uses available, it will be given du e

effective date of this rule, the direct other than those described in the PMN consideration .

final, interim final, or proposed SNUR described in J 721.80(j), designation of Two commenters requested that.EPA

will be issued within 180 days of receipt cumulative manufacture or import in convene open scientific meetings prior

of the notice. If EPA receives adverse or excess of specified quantities in the to issuance of this final rule to identify

critical comments on a proposed SNUR, absence of test data ($ 721.80(r)), and the best scientific basis for applying

publication of the final rule may be the failure to use personal protective SAR: A commenter, noting that under

delayed. equipment (described in 1721.63). the proposed rule notice and comment

if, Non-issuance of SNURs for Although these activities are not rulemaking would be curtailed, asked

substances made subject to section 5(e) included under the expedited that EPA convene workshops and public

orders. EPA will generally issue SNURs procedures of § 721 .170, EPA may at any meetings to•receive comments on its use

for substances made subject to section time include them in a SN.UR adopted of SAR. In addition, the commente r

5(e) orders, However, in cases where through separate rulemaking for a asked that EPA annually reconvene the

EPA believes that there is little substance not subject to a section 5(e) original Toxic Substances Dialogue

9
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Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations 31305

Group to assess how well the rule is issue a document in the final rule final rule adding the substance t o working . section of the Federal Register which Subpart E and identifying the significant

EPA is always interested in receiving contains the final SNUR . The Federal new uses and recordkeeping

comments and responses on its Register document will state that, unless requirements to which the substance is

procedures and policies from regulated written notice is received by EPA within subject

.

industry and the public . The change in 30 days of publication that someone The proposed version of this Subpart

this final rule from immediately effective wishes to submit adverse or critical D called for EPA to promulgat e

final rules to procedures that will allow comments, the SNUR will be effective 60 immediately effective final SNURs.

for public comment on each individual days from when the notice is published . Several commenters indicated that they

SNUR as necessary should provide If notice is received within 30 days that did not believe that the proposed

adequate opportunity for comment on someone wishes to submit adverse or process would have given an adequate

SAR use, and on the ongoing use of this critical comments, EPA will withdraw opportunity for public comment on the rule. the direct final rule by publishing a terms of SNURs before they went into Another commenter suggested that notice in the final rule section of the effect . EPA has modified the rule to written SAR guidelines be released for Federal Register, and EPA will propose provide for opportunity for public

public comment, and made a general a rule in the proposed rule section of the comment in rulemaking for all SNURs

. request that scientific issues affecting Federal Register. The proposed rule will Additionally, EPA has substantially PMN submitters receive the benefit of establish a 30-day comment period. EPA changed its internal review process to public comment . then will consider any comments reduce the time it takes to propose and

EPA does not intend to maintain a received and decide either to issue a promulgate most SNURs under this written SAR guidance document. EPA final rule promulgating the SNUR or subpart. This expedited internal review use of SAR to assess the possible risk withdraw the proposal . procedure will provide for the speedy posed by a substance is based on In implementing the provisions of protection of the public and equal

professional judgment on a case-by-case Subpart D, EPA intends as much as treatment of PMN submitters and new

basis. A general discussion of EPA's possible to include more than one SNUR users as contemplated in the April 29,

approach to SAR use was presented in in a single Federal Register document to 1987 proposal, but will allow publi c

the public discussions prior to the provide administrative efficiencies and comments to be reviewed before the

proposal, and is available in the public save publication costs. With respect to SNUR is promulgated as a final rule . record maintained for this rulemaking. direct final rulemaking procedures, 4. Procedures to modify or revoke EPA will hold meetings on its use of when EPA publishes a number of SNURs for new substances. Section SAR and on other subjects as the need SNURs in a single Federal Register 721 .185 establishes procedures to modif arises, but does not have plans for document as direct final SNURs, the or revoke SNURs issued under this y

regular meetings at this time, nor does it person notifying EPA of intent to submit Subpart D. and informs the public of foresee using the Dialogue Group as a adverse or crilical comments will be criteria EPA will consider in determining formal ongoing advisory group. asked to indicate to which SNUR the whether to do so

3 . Procedures for issuing expedited . EPA ma at an time comments will apply. EPA would then y y SNURs. The three procedures which publish a notice in the final rule section modify the activities designated a s

may be used to issue SNURs under § § of the Federal Register withdrawing significant new uses of a substance, or it

721 .160 and 721.170 are: Direct final only that specific direct final SNUR and may entirely revoke any specific

rulemaking, immediately effective significant new use notificatio n

publish a separate proposal for that requirement interim final rulemaking, and notice and specific SNUR . EPA will consider

comment rulemaking . However, EPA would modif in or revokin a SNUR issued . EPA will generally not withdraw the direct final SNURs y g g

use direct final rulemaking to issue new which are unaffected by the person's

S

unde

r ubpart D, other considerat o sf do not substance SNURs, unless it determines wish to submit adverse or critical justify retaining the SNUR unchanged, that use of immediately effective interim comments

final rulemaking or notice and comment ii . when it finds that one of the criteria at

. Immediately effective interim final

rulemaking is more appropriate . EPA rules. When using the interim final § 721.185(a) is met.

will use immediately effective interim rulemaking procedure, EPA will issue a The procedures established under

final rulemaking iri cases where it notice of interim final rulemaking. The § 721.185 to petition EPA to modify or

believes there may be particularly high rule will be effective on the day of revoke SNURs are similar to those in

potential hazard from uncontrolled use publication; however, EPA will accept TSCA section 21 . Section 21 does not

of the substance, or a particularly high comments for 30 days following apply to SNURs .

likelihood that someone would engage publication. The SNUR will cease to be Decisions to revoke or limit SNUR

in a significant new use between the in effect 180 days after publication requirements may be made either at

time EPA announces its intention to unless in the intervening time EPA has EPA's initiative or in response to a

issue a SNUR and the time the SNUR issued a final rule addressing any request by interested persons. Section

would take effect. When EPA comments received during the 30-day 721.185(c) provides that EPA will

determines that it is necessary to issue comment period. respond by certified letter to a request

an immediately effective interim final iii . Notice and comment rulemaking. for modification or revocation of a

SNUR, it will make the necessary When EPA uses notice and comment SNUR and, if EPA denies the request,

findings and explain its reasons in the rulemaking, EPA will first issue a will explain EPA's reasons for

rule . proposed rule in the Federal Register concluding that the SNUR requirements

EPA will use notice and comment stating that a SNUR will be developed should remain in effect . Rules revoking

rulemaking to establish a SNUR when it for the substance, explaining the basis or limiting SNURa under § 721 .185 will

believes there is a very high likelihood for the SNUR, listing the uses it be issued under notice and commen t

of public interest in commenting on the proposes to designate as significant new rulemaking procedures . Section 721.185

rule . uses, and soliciting public comment. will help ensure that well-founde d

I. Direct final rulemaking. Under the After consideration of any comment on concerns about the validity of SNUR

direct final rulemaking process, EPA will the proposed SNUR, EPA will issue a requirements are acted on expeditiously,

9
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31306 Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulation s

and that the public understands the and, therefore, requires a Regulatory reporting requirements, Significant new procedure for modifying or limiting Impact Analysis. EPA has determined uses.

those requirements. that this rule is not a "major rule" Dated: July 14, 1989. D. Removal of Proposed Information because it will not have an effect on the F. Henry yabid,t, Requirements Under TSCA Sections economy of $100 million or more, and it ActinBAdministrator.

8(a) and (d) will not have a signifi cant effect on

competition, costs, or prices. EPA has In the proposed rule, EPA included determined this PART 721--SIGNIFfCANT NEW USES rule procedures for automatically requiring because it to be "significant," OF CHEMICAL SUBSTANCES will represent a significan t

reporting for certain new substances change in the New Chemical Follow-up Therefore, 40 CFR Chapter 1 is

under TSCA section 8(a) at 40 CFR Part Program under TSCA. ainended as-follows: 704 and section 8(d) at 40 CFR Part 716

A commenter suggested that EPA of Management and Budget . This rule was submitted to the Office 1 . By revising the authority citation for

(OMB) for Part 721 to read as follows: carefully consider the conditions under review as required by Executive Orde r which section 8(a) reporting on a 12291 .

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

substance that has been the subject of a 2. In § 721 .3 by alphabetically adding SNUR is appropriate. EPA has B. Regulatory Flexibility Act the following definitions: considered the need to issue these Under the Regulatory Flexibility Act, 5

information collection rules in an U.S.C. 605(b), EPA has determined that § 721 .3 Definitions.

expedited manner, and has decided not this rule will not have a significant • • • • •

to do so. When section 8(a) and (d) rules impact on a substantial number of small

are appropriate for new substances, businesses "Acutely toxic effects" A chemical . EPA cannot determine EPA substance p roduces acutely toxic effects

basis.

Will issue them on a case-by-case whether parties affected by this rule are if it kills within a short time period likely to be small businesses. However, (usually 14 days) : N. Economic Analysis EPA believes that the number of small (1) At least 50 percent of the exposed

EPA has evaluated the potential costs businesses affected by this rule will not mammalian test animals following oral

and benefits of establishing significant be substantial even if all the companies administration of a single dose of the

new use requirements for manufacture, affected by this rule are small test substance at 25 milligrams or less

import, and processing of new chemical companies. EPA does not expect to per kilogram of body weight (LD„).

substances under the procedures regulate a large number of substances (2) At least 50 percent of the exposed

established in this rule. EPA's complete annually under this rule. mammalian test animals following

analysis is available in th e public record C. Paperwork Reduction Act dermal administration of a single dose

for this rule (OPTS-50553B). The The information collection of the test substance at 50 milligrams or

analysis is summarized in the preamble requirements in this rule have been less per kilogram of body weight (LDSO).

to the proposed rule . The costs and approved by OMB under the provisions (3) At least 50 percent of the exposed

benefits of this final rule do not vary of the Paperwork Reduction Act. 44 mammalian test animals following

significantly from those described in the U.S.C. 3501 et seq. P

and have been administration of the test substance for proposal. assigned OMB control number 2070- 8 hours or less by continuous inhalation

V. Rulemaking Record 0012. at a steady concentration in air at 0.5

Public reporting burden for this milligrams or less per liter of air (LC,o). EPA has established a record for this . . . ,

rulemaking (docket control number collection of information is estimated to

OPTS-505538): The record includes average 12.2 hours per response for "Chemical name" means the scientific

basic information considered by EPA in Subpart B, and to average 25 .3 hours per designation of a chemical substance in

developing this rule . The record includes response for Subpart C. including time accordance with the nomenclature

the following: for reviewing instructions, searching system developed by the International

1. The proposed rules. existing data sources, gathering and Union of Pure and Applied Chemistry or

2. Comments received on the maintaining the data needed, and the Chemical Abstracts Service's rules

proposals leading to this rule . completing and reviewing the collection of nomenclature, or a name which will

3 . Summaries of public meetings held of information. clearly identify a chemical substance for

to discuss the p roposed rules. Send comments regarding the burden the purpose of conducting a hazard

4 . The economic analysis of the rule. estimate or any other aspect of this evaluation .

5 . Comment response document.

collection of information, including "Chemical protective clothing" means

6 . This final rule . suggestions for reducing this burden, to items of clothing that p rovide a

This record is available to the public in Chief, Information Policy Branch, PM- protective barrier to prevent dermal

the TSCA Public Docket Office from 8 223, U .S. Environmental Protection contact with chemical substances of

a .m . to 4 p.m., Monday through Friday, Agendy, 401 M St., SW., Washington, DC concern . Examples can include, but are

excluding legal holidays. The TSCA 20460 and to the Office of Information not limited to: full body protective

Public Docket Office is located in Rm . and Regulatory Affairs, Office of clothing, boots, coveralls, gloves,

NE-G004, Management and Budget . Washington, Jackets, and pants. 401 M St., SW

DC ., Washington, DC 20503 marked "Attention: Desk "Commercial use" means the use of a

. Officer for EPA." chemical substance or any mixture

VI. Regulatory Assessment List of Subjectsin 40 CFR Part 721 containing the chemical substance in a

Requirements commercial enterprise providing

A. Executive Order 12291 Chemicals, Confidential business saleable goods or a service to

information. Environmental protection, consumers (e .g. . a commercial dry Under Executive Order 12291, EPA Hazardous substances, Health and cleaning establishment or painting

must judge whether a rule is "major" safety, Imports, Recordkeeping and contractor) .
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Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations 31307

"Common name" means any chemical substance as required under "Short-term test indicative of the

designation or identification such as $ 721.72(c). potentialto cause a developmentally

code name, code number, trade name, * * * * * toxic' effect" means either any in vivo

brand name, or generic chemical name "NIOSH" means the National Institute preliminary development toxicity screen

used to identify a chemical substance for Occupational Safety and Health of conducted in a mammalian species, or

other than by its chemical name . the U.S. Department of Health and any in vitro developmental toxicity

"Consumer" means a private Human Services. screen, including any test system other

individual who uses a chemical * * * * * than the intact pregnant mammal, that

substance or any product containing the "Non-enclosed process" means any has been extensively evaluated and

chemical substance in or around a equipment system (such as an open-top judged reliable for its ability to predict

permanent or temporary household or reactor, storage tank, or mixing vessel) the potential to cause developmentally

residence, during recreation, or for any in which a chemical substance is toxic effects in intact 'syatems across a

personal use or enjoyment. manufactured, processed, or otherwise broad range of chemicals or within a

"Consumer product" means a used where significant direct contact of class of chemicals that includes the

chemical substance that is directly, or as the bulk chemical substance and the substance of concern .

part of a mixture, sold or made available workplace air may occur. "Significant adverse environmenta l

to consumers for their use in or around a "Non-industrial use" means use other effects" means injury to the environment

permanent or temporary household or than at a facility where chemical by a chemical substance which reduces

residence, in or around a school, or in substances or mixtures are or adversely affects the productivity,

recreation. manufactured, imported, or processed. utility, value, or function of biological,

* * * * * "Personal protective equipment" commercial, or agricultural resources, or

"Director of the Office of Toxic means any chemical protective clothing which may adversely affect a threatened

Substances" means the Director of the or device placed on the body ,to prevent or endangered species. A substance will

contact with, and exposure to, an be considered to have the potential for

EPA Office of Toxic Substances or any identified chemical substance or significant adverse environmental

EPA employee delegated by the Office substances in the work area. Examples effects if it has one of the following :

Director to carry out the Office include, but are not limited to, chemical (1) An acute aquatic EQo of I mg/L or

Director's functions under this part. protective clothing, aprons, hoods, less.

"Employer" means any manufacturer, chemical goggles, face splash shields, or (2) An acute aquatic ECo of 20 mg/L

importer, processor, or user of chemical equivalent eye protection, and various or less where the ratio of aquatic

substances or mixtures. types of respirators. Barrier creams are vertebrate 24-hour to 48-hour EC,o i s

"Environmentally transformed" A not included in this definition . greater than or equal to 2.0.

chemical substance is "environmentally * * * * * (3) A Maximum Acceptable Toxicant

transformed" when its chemical "Process stream" means all . Concentration (MATC) of less than or

structure changes as a result of the reasonably anticipated transfer; flow, or equal to 100 parts per billion (100 ppb).

action of environmental processes on it . disposal of a chemical substance, (4) An acute aquatic EC6o of 20 mg/L

"Identity" means any chemical or regardless of physical state or . or less coupled with either a measured

common name used to identify a concentration, through all intended bioconcentration factor (BCF) equal to

chemical substance or a mixture operations of processing, including the or greater than 1,000x or in the absence

containing that substance . cleaning of equipment. of bioconcentration data a log P value

"Immediate use" A chemical * * * ` * equal to or greater than 4.3.

substance is for the "immediate use" of "Serious acute effects" means human *' * * * +

a person if it is under the control of, and injury or human disease processes that "Use stream" means all reasonably

used only by, the person who have a short latency period for anticipated transfer, flow, or disposal of

transferred it from a labeled container development, result from short-term a chemical substance, regardless o f

and will only be used by that person exposure to a chemical substance, or are physical state or concentration, through

within the work shift in which it is a combination of these factors and all intended operations of industrial,

transferred from the labeled container. which are likely to result in death or commercial, or consumer use .

"Impervious" Chemical protective severe or prolonged incapacitation . * * * * *

clothing is "impervious" to a chemical "Serious chronic effects" means "Work area" means a room or defined

substance if the substance causes no human injury or human disease

chemical or mechanical degradation, processes that have a long latency space in a workplace where a chemical period for development, result from substance is manufactured, processed,

permeation, or penetration of the P or used and where employees are

chemical protective clothing under the long-term exposure to a chemical resent

.

conditions of, and the duration of, substance, or are a combination of these p .

.Work lace" means an establishment

exposure. factors and which are likely. to result in at one geographic location containing

* „ * * * death or severe or prolonge d

incapacitation . one or more work areas.

"Manufacturing stream" means all "Short-term test indicative of 3 . By adding a new Subpart B to Part

reasonably anticipated transfer, flow, or carcinogenic potential'•' means either 721 to read as follows :

disposal of a chemical substance, any limited bioassay that measures Subpa rt B--Ce rtain Significant New Uses

regardless of physical state or tumor or preneoplastic induction, or any

concentration, through all intended test indicative of interaction of a sec .

operations of manufacture, including the chemical substance with DNA (i.e

., 721.50 Applicability.

721 .63 Protection in the workplace.

cleaning of * equipment .

. Positive response in assays for gene 721.72 Hazard communication program.

mutation, chromosomal aberrations, 721,80 Industrial, commercial, pnd consume r

"MSDS" means material safety data DNA damage and repair, or cellular activities .

sheet, the written listing of data for the transformation) . 721.e5 Disposal.
p. 12

31308 Federal Register / Vol . 54, No. 143 / Thursday, July 27, 1989 / Rules, and Regulation s

Sec' (i) Testing the material used to make for paints, lacquers, and enamels 7 21.9 0 Release to water .

721 .91 Computation of estimated surface y p use for . the chemical protective clothing and the (Approval label ma reclud e

. water concentrations; instructions. construction of the clothing to establish some paints, lacquers, or enamels.)

that the protective clothing will be (ix) Category 23C powered airSubpart B-Certain Significant New impervious for the expected duration purifying respirator equipped with a

Uses , and conditions of exposure. The testing tight-fitting facepiece and combination

must subject the chemical protective cartridges approved for paints, lacquers , § 721 .50 Applicability. clothing to the expected conditions of and enamels. (Approval label may

This Subpart B identifies certain exposure, including the likely preclude use for some paints, lacquers,

significant new uses of chemical combinations of chemical substances to or enamels . )

substances identified in Subpart E of which the clothing may be exposed in (x) Category 23C powered airthis part. The provisions of this Subpart the work area . purifying respirator equipped with a 13 apply only when referenced as (ii) Evaluating the specifications from loose-fitting hood or helmet and

applying to a chemical substance the manufacturer or supplier of the combination cartridges approved for

identified in Subpart E of this part . chemical protective clothing, or of the paints, lacquers, and enamels

.

§ 721.63 Protection In the workplace. material used in construction of the (Approval label may preclude use for

clothing, to establish that the chemical some paints, lacquers, or enamels.) (a) Whenever a substance is identified protective clothing will be impervious to )

in Subpart E of this part as being subject the chemical substance alone and in (xi) Category 23C air-purifyin g

to this section, a significant new use of respirator equipped with combination

likely combination with other chemical cartridges approved for paints, lacquers, the substance is any manner or method substances in the work area

. and enamels, including disposabl e

of manufacturing, Importing, or (4) Each person who is reasonably respirators . (Approvallabel may processing associated with any use of likely to be exposed to the chemical preclude use for some paints, lacquers,

the substance without establishing a substance by inhalation in the work or enamels

program whereby . )

: area in one or more of the forms listed in (xii) Category 23C air-purifyin

g

(1) Each person who is reasonably paragraph (a)(6) of this section and cited respirator equipped with a full facepiece

likely to be dermally exposed in the in Subpart E of this part for the• chemica l

work area to the chemical substance substance, is provided with, and is and organic gas/vapor cartridges .

through direct handling of the substance required to wear, at a minimum, a (xiii) Category 23C powered atr- airor through contact with equipment on NIOSH- approved respirator from one of purifying re fairator equipped with

substanc a ch the e bealanse the substan e by the categories-listed in paragraph (a)(5) vapor ca tgridges~tece and organic gas/

airborne in the form listed in paragraph of this section, and the respirator is used (xiv) Category 23C powered air- P g p in accordance with 29 CFR 1910 .134 an d

(a)(6) of this section, and cited in 30 CFR Part 11 . purifying respirator equipped with a

Subpart E of this part for the chemical (5) The following NIOSH approved loose-fitting hood or helmet and organic

substance, is provided with, and is respirators meet the minimum gas/vapor cartridges.

required to wear, personal protective requirements for paragraph (a)(4) of this (xv) Category 23C air-purifying

equipment that provides a barrier to section: respirator equipped with organic gas/

prevent dermal exposure to the . (i) Category 19C Type C supplied-air vapor cartridges, including disposable

substance in the specific work area respirator operated in pressure demand respirators.

where it is selected for use. Each such or other positive pressure mode and (6) When cited in Subpart E of this

item of personal protective equipment equipped with a full facepiece . part for a substance, the following

must be selected and used in (ii) Category 19C Type C supplied-air airborne form(s) of the substance apply

accordance with 29 CFR 1910.132 and respirator operated in pressure demand to paragraphs (a)(1) and (4) of this

1910.133 . or continuous flow mode and equipped section :

(2) In addition to any other personal with a tight-fitting facepiece . (i) Dust.

protective equipment selected in (iii) Category 19C Type C supplied-air (ii) Mist .

paragraph (a)(1) of this section, the respirator operated in pressure demand (iii) Fume.

following items are required : or continuous flow mode and equipped (iv) Smoke.

(i) Gloves. with a hood or helmet or tight-fitting (v) Vapor.

(ii) Full body chemical protective facepiece. (vi) Gas.

clothing. (iv) Category 21C air-purifying. (b) If a substance identified in Subpart

(iii) Chemical goggles or equivalent respirator equipped with a full facepiece E of this part is present in the work area

eye protection. and high efficiency particulate filters. only as a mixture, an employer is

(iv) Clothing which covers any other (v) Category 21C powered air- exempt from the provisions of this

exposed areas of the arms, legs, and purifying respirator equipped with a section if the concentration of the

torso. Clothing provided under this tight-fitting facepiece and high efficiency substance in the mixture does not

paragraph need not be tested or particulate filters. exceed a concentration set in Subpart E

evaluated under the requirements of (vi) Category 21C powered air- of this part . The exemption does not

paragraph (a)(3) of this section. ' purifying respirator equipped with a apply if the employer has reason to

(3) The employer is able to loose-fitting hood or helmet and high believe that during intended use or

demonstrate that each item of chemical efficiency particulate filters. . processing in the work area, the

protective clothing, including gloves, (vii) Category 21C air-purifying substance in the mixture may be

selected provides an impervious barrier respirator equipped with a high concentrated above the level set in

to prevent dermal exposure during efficiency particulate filter including Subpart E of this part.

normal and expected duration and disposable respirators . • (c)(1) If at any time after commencing

conditions of exposure within the work (viii) Category 23C air-purifying distribution in commerce of a chemical

area by any one or a combination of the respirator equipped with a full facepiece substance that is identified in Subpart E

following: and combination cartridges approved of this part as subject to this section, the

NOW
p.13

Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations 31309

person has knowledge that a recipient of employees, contractor employees, and method identifies the containers to

the substance is engaging in an activity their designated representatives . The which it is applicable and conveys

that is not consistent with the employer may rely on an existing hazard information specified by paragraph

implementation of a program specified communication program, including an (b)(1)(i) of this section . Any writte n

in paragraph (a) of this section, the existing program established under the materials must be readily accessible to

person is considered to have knowledge Occupational Health and Safety the employees in their work area

s

that the recipient is engaging in a Administration (OSHA) Hazard throughout each work shift

.

significant new use and is required to Communication Standard (29 CFR (iii) The employer need not label

follow the procedures in § 721 .5(d) i900.1200), to comply with this

unless the person is able to document portable containers into which the

the following : paragraph provided that the existing substance is transferred from labele d g : hazard communication program satisfies containers, and which are intended only

(i) That the person has notified the the requirements of this paragraph . The for the immediate use of the employee recipient in writing within 15 working written program shall include the who performs the transfer

. days of the time the person first has following: (iv) The employer shall not remove or knowledge that the recipient is engaging (1) A list of each substance identified deface an existing label on incomin

g

in an activity that is not consistent with in Subpart E of this part as subject to containers of the substance unless the

the implementation of a program this section known to be present in the container is immediately relabeled with

specified in paragraph (a) of this section, work area . The list must be maintained the information specified in paragraph and that the person has knowledge of in the work area and must use the (b)(1)(i) of this section

. the failure of implementation. identity provided on the appropriat e

(ii) That within 15 working days of MSDS for each substance required (2) Each employer shall ensure that

notifying the recipient that the recipient under paragraph (c) of this section . The each container of the substance leaving

is engaging in an activity that is not list may be compiled for the workplace its workplace for distribution in

consistent with the implementation of a or for individual work areas . commerce is labeled in accordance with

program specified in paragraph (a) of (2) The methods the employer will use this paragraph .

this section the person has received to inform employees of the hazards of (ij The label shall, at a minimum,

from the recipient, in writing, a non-routine tasks involving the contain the following information :

statement of assurance that the recipient substance, for example, the cleaning of (A) The information required under

has established the program required reactor vessels, and the hazards paragraph (b)(1)(i) of this section .

under paragraph (a) of this section, and associated with the substance contained (B) The name and address of the

will take appropriate measures to avoid in unlabeled pipes in their work area . manufacturer or a responsible party

activities that are inconsistent with (3) The methods the employer will use who can provide additional information

implementation of the program required to inform contractors of the presence of on the substance for hazard evaluation

under paragraph (a) of this section. the substance in the employer's and any appropriate emergenc y

(2) If, after receiving a statement of workplace and of the provisions of this procedures .

assurance from a recipient under part applicable to the substance if (ii) The label shall not conflict with

paragraph (c)(1)(ii) of this section, a employees of the contractor work in the the requirements of the Hazardous

manufacturer, importer, or processor has employer's workplace and are Materials Transportation Act (18 U.S .C.

knowledge that the recipient is engaging reasonably likely to be exposed to the 1801 et, seq .) and regulations issued

in an activity that is not consistent with substance while in the employer's under that Act by the Department of

the implementation of the program workplace . Transportation.

specified in paragraph (a) of this section, (b) Labeling. (1) Each employer shall (3) The label, or alternative forms of

that person is considered to have ensure that each container of the warning, shall be legible and

knowledge that the person is engaging in substance in the workplace is labeled in prominently displayed.

a significant new use and is required to accordance with this paragraph (b)(1). (4) The label, or alternative forms of

follow the procedures in § 721 .5(d). (i) The label shall, at a minimum, warning, shall be in English ; however,

§ 721 .72 Hazard communication program.

contain the following information: the information may be repeated in.

(A) A statement of health hazard(s) other languages . Whenever a substance is identified in and precautionary measure(s) for the (5) If the label or alternative form of

Subpart E of this part as being subject to substance, if any, Identified in Subpart E warning is to be applied to a mixture

this section, a significant new use of that of this part or by the employer . containing a substance identified in

substance is any manner or method of (B) The identity by which the Subpart E of this part as subject to this

manufacture, import, or processing substance may be commonly section in combination with another

associated with any use of that recognized . substance identified in Subpart E of this

substance without establishing a hazard (C) A statement of environmental part and/or a substance defined as a

communication program as described in hazard(s) and precautionary measure(s) "hazardous chemical" under th e

this section. for the substance, if any, identified in Occupational Safety and Health (a) Written hazard communication Subpart E of this part or by the Administration (OSHA) Hazard

program. Each employer shall develop employer. Communication Standard (29 CFR

and implement a written hazard (D) A statement of exposure and 1900 .1200), the employer may prescribe

communication program for the precautionary measure(s), if any, on the label . MSDS, or alternative form substance in each workplace . The identified in Subpait E of this part or by of warning, the measures to control written program will, at a minimum, the employer. worker exposure or environmental

describe how the requirements of this (ii) The employer may use signs, release which the employer determines

section for labels, MSDSs, and other placards, process sheets, batch tickets, provide the greatest degree of

forms of warning material will be operating procedures, or other such protection . However, should these satisfied. The employer must make the written materials in lieu of affixing control measures differ from the

written hazard communication program labels to individual stationary process applicable measures required under

available, upon request, to all containers, as long as the alternative Subpart E of this part, the employer
p.14

31310 Federal Register / Vol. 54, No. 143, / Thursday,

. . _. _, . . July 27, 1989 / Rules and Regulation s . .

must seek a determination of MSDS, the employer must mark the (I) The requirements of this section.

equivalency for such alternative cont rol MSDS to indicate that no applicable ( ii) Any operations in the work area measures pursuant to § 721 .30 before information was found. where the substance is present. prescribing them under this p aragraph. (4) Where multiple mixtures (iii) The location and availability o f

(c) Material safety data sheets. (1) containing the substance have similar the written hazard communicatio n

Each employer must obtain or develop a compositions (i.e., the chemical pro gram required under paragraph (a) of MSDS for the substance. ingredients are essentially the same, but • this section, including the list of

(2) Each MSDS shall contain, at a the specific composition varies from substances identified in Subpart E of

minimum, the following information: mixture to mixture) and similar hazards, this part as subject to this section, and (I) The identity used on the container the employer may prepare one MSDS to MSDSs required by paragraph (c) of this label of the substance under this apply to all of these multiple mixtures. section.

section, and, if not claimed confidential, (5) If the employer becomes aware of (2) Training provided to employees

the chemical and common name of the any significant new information shall include : substance. If the chemical and common regarding the hazards of the substance (i) Methods and observations that name are claimed confidential, a generic or ways to protect against the hazards, may be used to detect the presence or

chemical name must be used . this new information must be added to release of the substance in or f rom an (ii) Physical and chemical the MSDS within 3 months from the time employee's work area (such a s

characteristics of the substance known the employer becomes aware of the new monitoring conducted by the employer,

to the employer (such as vapor pressure, information. If the substance is not continuous monitoring devices, visual flash point). currently being manufactured, imported, appearance, or odor of the substance (iii) The physical hazards of the processed, or used in the employer's when being released)

.

substance known to the employer, workplace, the employer must add the

*including (ii) The potential human health and the potential for fire, new information to the MSDS before the environmental hazards of the

explosion, and reactivity substance

. substance is reintroduced into the as specified in Subpart E of this part . (iv) The potential human and workplace.

environmental hazards as specified in (iii) The measures employees take (6) The employer-must ensure that

Subpart E of this part for the substance to protect themselves anthecan . persons receiving the substance from environment f

rom the substance,

(v) Signs and symptoms of exposure, the employer are provided an including specific procedures the and any medical conditions which are appropriate MSDS with their initial

expected to be aggravated by exposure shipment and with the first shipment has implemented t employer o protect

to the substance known to the employer. after an MSDS is revised. The employer employees and the environment from

(vi) The primary routes of exposure to may either p ro vide the MSDS with the exposure to the substance, including

the substance . shipped containers or send it to the appropriate work practices, emergency

(vii) Precautionary measures to person prior to or at the time of procedures, personal protective

contro l worker exposure and/or shipment.

equipment, engineering controls, and

environmental release identified in (7) The employer must maintain a other measures to control worker

Subpart E of this part for the substance, copy of the MSDS in its workplace, and exposure and/or environmental release

or alternative control measures which must ensure that it is readily accessible required under Subpa rt E of the part, or

EPA has determined under § 721 .30 during each work shift to employees alternative control measures which EPA

provide substantially the same degree of when they are in their work areas. has determined under § 721.30 provide

protection as the identified control •(8) The MSDS may be kept in any substantially the same degree of

measures. form, including as operating procedures, protection as the specified contro l

(viii) Any generally applicable and may be designed to cover groups of measures.

precautions for safe handling and use of substances in a work area where it may (iv) The requirements of the hazard

the substance which are known to the be more appropriate to address the communication program developed by

employer, including appropriate potential hazards of a process rather the employer under this section,

hygienic practices, p ro tective measures than individual substances. However, in including an explanation of the labeling

during repair and maintenance of all'cases, the required information must system and the MSDS required by this

contaminated equipment, and be provided for each substance and section and guidance on obtaining and

procedures for response to spills and must be readily accessible during each using app ropriate hazard information.

leaks. work shift to employees when they are ( e) Low concentrations in mixtures. I f

(ix) Any generally applicable control in their work areas. a substance identified in Subpart E of

measures which are known to the ( 9) The MSDS must be printed in this part is present in the work area only

employer, such as appropriate English; however, the information may as a mixture, an employer is exempt

engineering controls, work practices, or be repeated in other languages . from the provisions of this section if the

personal protective equipment. (d) Employee information and concentration of the substance in the

(x) Emergency first aid procedures training. Each employer must ensure mixture does not exceed a concentration

known to the employer. that employees are provided with set in Subpart E of this part . Th e

(xi) The date of preparation of the Information and training on the exemption does not apply if the

MSDS or of its last revision . substance identified in Subpart E of this employer has reason to believe that

(xii) The name, address, and part. This information and training must during intended use or processing in th e

telephone number of the individual be provided at the time of each work area, the substance in the mixture

preparing or distributing the MSDS, or a employee's initial assignment to a work may be concentrated above the level set

responsible party who can provide area containing the substance and in Subpart E of this part .

additional information on the substance whenever the substance subject to this (f) Eristing hazard communication

for hazard evaluation and any section is introduced into the employee's program. The employer need not take

appropriate emergency procedures . work area for the first time. additional actions if existing program s

(3) If no relevant information is found ( 1) Information provided to employees and pro cedures satisfy the requirements

or known for any given category on the under this paragraph shall include : of this section.

9
p. 15

Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 J Rules and Regulations 31311

(g) Human health, environmental (g) Use other than ag an intermediate . (w) Any manner or method of

hazard, exposure, and precautionary (h) Use other than as a site-limited manufacture of the substance in the statements. Whenever referenced in intermediate . following form associated with any use : Subpart E of this part for a substance, (i) Use as an intermediate where the (1) A powder.

the following human health and concentration of the intermediate (2) A solid

.

environmental hazard, exposure, and substance in the product intended for (3) A liquid

precautionary .

statements shall appear distribution in commerce exceeds the (4) A gas

.

on each label as specified in paragraph concentration specified in Subpart E of (x) Any manner or method of

specified of this section and the MSDS as this part for the aubstance, processing of the substance in th pecified in paragraph (c) of this section e

Additional statements may be included premanufacture notice referenced in (1) A powder . (j) Use other than as described in the following form associated with any use :

. as long as they are true and do not alter Subpart E of this part for the substance

the meaning of the required statements . (2) A solid.

. (k) Use other than allowed by the (3) A liquid

(1) Human health hazard statements . : section 5(e) consent order referenced in

This substance may cause: Subpart E of this part for the substance . (4) A gas.

(i) Skin imitation, (1) Non-industrial use. (y) Use involving an application

(ii) Respiratory complications. (m) Commercial use, method that generates:

(iii) Central nervous system effects . (n) Non-commercial use. (1) A vapor, mist, or aerosol.

(iv) Internal organ effects. (o) Use in a consumer product. (2) A dust.

(v) Birth defects. (p) Aggregate manufacture and § 721 (vi) Reproductive effects .85 Disposal.

. importation volume for any use greate r

(vii) Cancer. Whenever a substance is identified in than that specified in Subpart E of this

(viii) Immune system effects. Subpart E of this part as being subject to part for the substance.

(ix) Developmental effects. (q) Aggregate manufacture and this section, a significant new use of the

(2) Human health hazard importation volume for any use greater substance is any method of

precautionary statements: When using than that allowed by the section 5(e) (a) Disposal of the process stream this substance: consent order referenced in Subpart E of associated with any use of th e

(i) Avoid skin contact. this part for the substance. substance or with any manner o r

(ii) Avoid breathing substance. (r) Aggregate manufacture and . method of manufacturing associate d (iii) Avoid ingestion . with any use of the substance other than

(iv) Use respiratory protection . importation volume for any use greater

than that specified in Subpart E of this by the following . This provision does not (v) Use skin protection. part for thsubstance unless the supercede any applicable Federal, State, (3) Environmental hazard statements: or local laws and regulations. This substance may be : manufacturer or importer has submitte d

(i) Toxic to fish . the results of the health or • (1) Incineration.

(ii) Toxic to aquatic organisms. environmental effects studies identified (2) Landfill .

(4) Environmental hazard in Subpart E of this part for the (3) Deep well injection.

precautionary statements: Notice to substance and those studies comply (b) Disposal of the process stream

users: with the procedures and criteria for associated with any use or with an y

(i) Disposal restrictions apply. developing and evaluating data manner or method of processing

(ii) Spill clean-up restrictions apply . identified in Subpart E of this part for associated with any use other than by

(iii) Do not release to water. the substance. the following. This provision does not

(5) Each human health or (s) Annual manufacture and supercede any applicable Federal, State ,

environmental hazard precautionary importation volume for any use greater or local laws and regulations .

statement identified in Subpart E of this than that specified in Subpart E of this (1) Incineration.

part for the label on the substance part for the substance. (2) Landfill.

container must be followed by the (t) Annual manufacture and (3) Deep well injection.

statement, "See MSDS for details." Importation volume for any use greater (c) Disposal of the use stream

than that allowed by the section 5(e) associated with any use, other than by §721.60 Industrial, commercial, and consent order referenced in Subpart E of the following . This provision does not consumer activities. this part for the substance . supercede any applicable Federal, State,

Whenever a substance is identified in (u) Annual manufacture and or local laws and regulations .

Subpart E of this part as being subject to importation volume for any use greater (1) Incineration.

this section, a significant new use of the than that specified in Subpart E of this (2) Landfill

.

substance is: part for the substance unless the (3) Deep well injection.

(a) Use in non-enclosed processes. manufacturer or importer has submitted (d) Disposal of the substance

(b) Any manner or method of the results of the health or associated with any use of the

manufacture in non-enclosed processes environmental effects studies identified substance, or with any manner or

associated with any use . in Subpart E of this part for the method of manufacture or processing i n

(c) Any manner or method of substance and those studies comply association with any use . This provision processing in non-enclosed processes with the procedures and criteria for does 'not supercede any applicable

associated with any use. developing and evaluating data Federal, State, or local laws and

(d) Use beyond the site of identified in Subpart E of this part for regulations

. manufacture or import. the substance.

(e) Processing beyond the site of (v) Use in the form of: § 721.90 Release to water. manufacture ar import. (1) A powder. Whenever a substance is identified in (f) Any manner or method of (2) A solid . Subpart E of this part as being subject to

manufacture (excluding import) of the (3) A liquid. this section, a significant new use of the substance associated with any use. (4) A gas. . substance is:
p. 16

31312 Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations

..~.~..r« - -

(a) Any predictable or purposeful this part either by the discharger or, in (iv) Resin or activated carbon

release of a manufacturing stream the case 'of a release through publicly- adsorption

. associated with any use of the owned treatment works, by a (v) Chemical destruction o r

substance, from any site: combination of treatment by the conversion.

(1) Into the waters of the United discharger and the publicly-owned (vi) Primary wastewater treatment

. States. treatment works: (3) Into. the waters of the United

(2) Into the waters of the United (i) Chemical precipitation and settling . States without primary wastewater States without application of one or (ii) Biological treatment (activated treatment, and secondary wastewater

more of the following treatment • sludge or equivalent) plus clarification . treatment as defined in 40 CFR Part 133 .

technologies as specified in Subpart E of (iii) Steam stripping . (4) Into the waters of the United this part either by the discharger or, in (iv) Resin or activated carbon States if the quotient from:

the case of a release through publicly- adsorption.

owned treatment works, by a (v) Chemical destruction or

combination of treatment by the conversion. number of kilograms/

discharger and the publicly-owned (vi) Primary wastewater treatment . day/site released 1000 s N parts per treatment works: (3) Into the waters of the United x billion

(i) Chemical precipitation and settling . States without primary wastewater raceiving stream flow (million liters/day)

(ii) Biological treatment (activated treatment, and secondary wastewater

sludge or equivalent) plus clarification . treatment as defined in 40-CFR Part 133.

(iii) Steam stripping. (4) Into the waters of the United

(iv) Resin or activated carbon States if the quotient from the following

adsorption. formula: exceeds the Ievel'specified in Subpart E

(v) Chemical destruction or of this part, when calculated using the

conversion. • methods described in § 721.91 . In lieu o f

(vi) Primary wastewater treatment. number of kilograms/ calculating the above quotient, however,

(3) Into the waters of the United day/site released x 1000 = N parts per monitoring or alternative calculations

States without primary wastewater receiving stream flow . billion may be used to predict the surface water

treatment, and secondary wastewater (million liters/day) concentration expected to result from

treatment as defined in 40 CFR Part 133. intended release of the substance, if the

(4) Into the waters of the United monitoring procedures or calculations

States if the quotient from the following have been approved for such purpose by

formula: exceeds the level specified in Subpart E EPA. EPA will review and act on written

of this part when calculated using the requests to approve monitorin g

methods described in § 721.91 . In lieu of procedures or alternative calculations number of kilograms/

day/site released calculating the above quotient, within 90 days after such requests are

x 1 000 = billion N parts per monitoring or alternative calculations received . EPA will inform submitters of receiving stream flow may be used to predict the surface water the disposition of such requests in

(million stersroay> concentration which will result from the writing, and will explain the reasons

intended release of the substance, if the therefor when they are denied .

monitoring procedures or calculations § 721.91 Computation of estEmated

have been approved for such purpose by surface water concentrattons: instructions.

exceeds the level specified in Subpart E EPA

. EPA will review and act on written These instructions describe the use of of this part when calculated using the requests to approve morlitoring the equation specified in § 721

methods described in § 721 .90(a)(4) .91 . In lieu of procedures or alternative calculations and (b)(4) to compute estimated surface

calculating the above quotient, within 90 days after such requests are water concentrations which will result

monitoring or alternative calculations received. EPA will inform submitters of wate

may be used to predict the surface water the disposition of such requests in Subpart E of this part r from release of a substance identified in

. The equation concentration which will result from the writing, and will explain the reasoris shall be com eited for eaeh~site using the

intended release of the substance, if the therefor when they are denied

monitoring procedures or calculations (c) Any predictable or purposeful stream flow rate appropriate for the site

. p g

have been approved for such purpose by release of a use stream containing the according to paragraph (b) of thi s

EPA. EPA will review and act an written substance associated with any use of section, and the highest number of

requests to approve monitoring the substance from any site : kilograms calculated to be released for

procedures or alternative calculations (1) Into the waters of the United that site on a given day according to

within 90 days after such requests are States. paragraph (a) of this section. Two

received. EPA will inform submitters of (2) Into the waters of the United variables shall be considered i n

the disposition of such requests in States without application of one or computing the equation, the number of

writing, and will explain the reasons more of the following treatment kilograms released, and receiving

therefor when they are denied. technologies as specified in Subpart E of stream flow.

(b) Any predictable or purposeful this part either by the discharger or, in (a) Number of kilograms released. (1)

release of a process stream containing the case of a release through publicly- To calculate the number of kilograms of

the substance associated with any use owned treatment works, by a substance to be released from

of the substance from any site : combination of treatment by the manufacturing, processing, or us e

(1) Into the waters of the United discharger and the publicly-owned operations, as specified in the numerator •

States. treatment works: of the equation, develop a process

(2) Into the waters of the United (i) Chemical precipitation and settling . description diagram which describes

States without application of one or (ii) Biological treatment (activated each manufacturing, processing, or use

more of the following treatment sludge or equivalent) plus clarification. operation involving the substance . The

technologies as specified in Subpart E of (iii) Steam stripping . process description-must include the
p. 17

Federal Register f Vol. 54, No. 143 / Thursday, July 27, 1969 / Rules and Regulations 31313

major unit operation steps and chemical (b) Receiving stream flow. (1) The identified in that Subpart E. If the

conversions. A unit operation is a receiving stream flow shall be expressed provisions in this Subpart C conflict

functional step in a manufacturing, in million liters per day (NII,D) . The flow with general provisions of Subpart A of

processing, or use operation where rate data to be used must be for the this part, the provisions of this Subpart

substances undergo chemical changes point of release on the water body that C shall apply . .

and/or changes in location, temperature, first receives release of the substance § 721 .12S RecordkeepUg requirements.

pressure, physical state, or similar whether by direct discharge from a site ,

characteristics. Include steps in which or by Indirect discharge through a At the time EPA adds a substance to

the substance is formulated into Publicly-Owned Treatment Works Subpart E of this part, EPA will specify

mixtures, suspensions, solutions, etc. (POTW) for each site. The flow rate appropriate recordkeeping requirement s

(2) Indicate on each diagram the entry reported shall be the lowest 7-day which correspond to the significant new

point of all feedstocks (e.g., reactants. average stream flow with a recurrence use designations for the substance

solvents, and catalysts) used in the interval of 10 years (7-Q- 10). If the 7-Q- selected from Subpart B of this part.

operation. Identify each feedstock and 10 flow rate is not available for the Each manufacturer, importer, and

specify its approximate weight actual point of release, the stream flow processor of the substance shall

regardless of whether the process is rate should be used from the U .S . maintain the records for 5 years from

continuous or batch. Geological Survey (USGS) gauging the date of their creation. In addition t o

(3) Identify all release points from station that is nearest the point of the records specified in J 722.40, the

which the substance or wastes release that is expected to have a flow records whose maintenance this section

containing the substance will be rate less than or equal to the receiving requires may include the following :

released into air, land, or water. Indicate stream flow at the point of release . (a) Records documenting the

these release points on the diagram . Do (2) Receiving stream flow data may be manufacture and importation volume of

not include accidental releases or available from the National Pollutant the substance and the corresponding

fugitive emissions. Discharge Elimination System (NPDES) dates of manufacture and import .

(4) For releases identified in the permit for the site or the POTW (b) Records documenting volumes of

diagram that are destined for water, releasing the substance to surface water, the substance purchased in the United

estimate the amount of substance that from the NPDES permit-writing States by processors of the substance,

will be released before the substance authority for the site or the POTW, or names and addresses of suppliers, and

.enters control technology. The kilograms from USGS publications, such as the corresponding dates of purchase .

of substance released may be estimated water-data report series. (c) Records documenting the names

based on: (3) If receiving stream flow data are and addresses (including shipment

(i) The mass balance of the operation, not available for a stream, either the destination address, if different) of all

i .e., totaling inputs and outputs, value of 10 MM or the daily flow of persons outside the site of manufacture,

including wastes for each part of the wastewater from the site or the POTW importation, or processing to whom the

process such that outputs equal inputs. releasing the substance must be used as manufacturer, importer, or processor

The amount released to water may be an assumed minimum stream flow. directly sells or transfers the substance,

the difference between the amount of Similarly, if stream flow data are not the date of each sale or transfer, and the

the substance in the starting material (or available because the location of the quantity of the substance sold or

formed in a reaction) minus the amount point of release of the substance to transferred on such date.

of waste material removed from each surface water Is a take, estuary, bay, or (d) Records documenting

part of the process and not released to ocean, then the flow rate to be used establishment and implementation of a

water and the amount of the substance must be the daily flow of wastewater program for the use of any applicable in the final product. from the site or the POTW releasing the personal protective equipment required (ii) Physical properties such as water substance to surface water . Wastewater under § 721 .83.

solubility where a known volume of flov~, data may be available from the (e) Records documenting the

water being discharged is assumed to NPDES permit or NPDES authority for determinations required by §

contain the substance at concentrations the site or the POTW releasing the 721.63(a)(3) that chemical protective equal to its solubility in water. This substance to water. clothing is impervious to the substance.

approach is particularly useful wher e

the waste stream results from 4. By adding a new Subpart C to Part (f) Records documenting

separation of organic/water phases or 721 to read as foilows: establishment and implementation of

filtration of the substance from an Subpart C--Recordkeeping Requirements the hazard communication program

aqueous stream to be discharged . required under $ 721.72.

(iu) Mea9urements of flow rates of the sec . (g) Copies of labels required unde

r process/use stream and known 721 .100 Applicability

. Recordkeeping requirements . $ 721.72(b).

concentrations of the substance in the 721 .125 (h) Copies of material safety data

stream. Subpart C-Recordkeeping sheets required under § 721.72(c).

(5) After releases of a substance to Requirements (i) Records documenting compliance

water are estimated for each operation with any applicable industrial,

on a site, total the releases of the § 721 .100 Appticability, commercial, and consumer use

substance to water from all operations This Subpart C identifies certain limitations under § 721 .80.

at that site. The value (number of , additional recordkeeping requirements (j) Records documenting compliance

kilograms) specified in the numerator of applicable to manufacturers, importers, with any applicable disposa l

the equation should reflect total and processors of substances identified requirements under § 721 .85, including

kilograms of substance released to in Subpart E of this part for each the method of disposal, location of

water per day from all operations at a specific substahce . The provisions of disposal sites, dates of disposal, and

single site . this Subpart C apply only when volume of the substance disposed .

(B) Use the highest expected daily referenced in Subpart E of this part for a Where the estimated disposal volume is

release of the substance for each site. substance and significant new use not known to or reasonably
( . ,

p. 18

31314 Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations

ascertainable by the manufacturer, uses which will be subject to (ii) The Federal Register document importer, or processor, that person must notification. Designation of additional will state that, unless written notice is maintain other records which • activities as significant new uses will be received by EPA within 30 days of

demonstrate establishment and done in accordance with the criteria and publication that someone wishes to

implementation of a program that procedures under § 721 .170, or through a submit adverse or critical comments, the ensures compliance with, any applicable separate rulemaking proceeding. rule will be effective ti0 days from the disposal

(k) Records

requirements. (2) Significant new use requirements date of publication . The written notice

documenting and other specific requirements of intent to submit adverse or critical establishment and implementation of designated under this section will be comments should state which SNUR(s) procedures that ensure compliance. with listed in Subpart E of this part

any . For each will be the subject of the adverse or applicable water discharge substance, Subpart E will identify: criti cal comments, if several SNURs are limitations under 1 721 .90. (1) The chemical name . established through the direct final rule. 5. By adding a new Subpart D to Part

721 to read as

( ii) The activities designated as If notice is received within 30 days that follows: significantnew uses. someone wishes'to submit adverse or

Subpart D--Expedited Process for issuing (Iii) Other specific requirements critical comments, the section(s) of the Significant New Use Rules for Selected applicable to the substance, including direct final rule containing the SNUR(s) Chemical Substances and Limitation or recordkeeping requirements or any other for which a notice of intent to comment Revocation of Selected Significant New requirements

Use Rules included in the final was received will be withdrawn by EPA

section 5(e) order. issuing a documentin the final rule

Sec. (c) Proceduresfor issuing significant section of the Federal Register, and a 721 .18o Notification requirements for new

chemical new use rules. (1) EPA will issue proposal will be published in the substances subject to section significant new use rules under this proposed rule section of the Federal 5(e) orders

721.170 Notification requirements for•sefected g . section by one of the following three Rester i . The ro p p0

o

sal will establish a

new chemical substances that have .

processes: direct final rulemaking, 30-day comment period.

completed premanufacture review , interim final rulemaking, or notice and (iiI) If EPA, having considered any 721.165 t.imitation or revocation of certain comment rulemaking. EPA will use the . timely conpnents•submitted in response notification requirements. '• direct final rulemaking process to issue to the proposal, decides to establis h

significant new use rules unless Subpart t> it notification requirements under this

-Expedited Process for determines that, in a particular case, one section, EPA will issue a final rule Issuing Significant New Use Rules for of the other pro cesses is more adding the substance to Subpart E of Selected Chemical Substances and appropriate

Llmitation or Revocation of Selected ( . this part and designating the significant 2) Federal Register Significant New Use Rules to propose or estab documents issued new uses subject to notification .

lish significant new

§ 721.160 Notification requirements for uses under this section Will contain the (4) Notice and comment rulemaking.

following: (i) When EPA uses a notice and

new chemical substances subject

section B(e) orders to comment procedure to issue a

. (i) The chemical identity of the

(a) Selection ofsubstances. (1) In substance or, if its specific identity is significant new use rule, EPA will issue

accordance with the expedited process claimed confidential, an app ropriate a proposal in the Federal Register

following its decision to develop- a

specified in this section, EPA will issue generic chemical name and an accession significant new use rule under this significant new use notification number assigned by EPA.

- :action for a specific new chemical requirements and other specifi

c mber

.e premanufacture notice substance

. Persons will be given 30 days requirements for each new chemical nu to comment on whether EPA should

substance that is the subject of a final (Ili) The CAS number, where available establish notification requirements for order issued under section 5(e) of the and not claimed confidential . thesubstance-under this Act, except for an order that prohibits (iv) A summary of EPA's findings ~~ If EPA, having part

.

manufacture and import of the under section 5(e)(1)(A) of the Act for (~~) considered any

substance, -unless EPA determines'that the final order issued under section 5(e).

timely comments, decides to establish •

significant new use 'notification (v) Designation of the significant new notification requirements under this

requirements are not needed for the • uses subject to, or proposed' to be section, EPA will issue a final rule

substance. subject to, notification and any other adding the substance to Subpart E o f

(2) If EPA determines that significant applicable requirements. this part and designating the significant

new use notification requirements are (vi) Any modifications of Subpart A of new uses subject to notification .

not needed for a substance that is this part applicable to the specific ( 5) Interim final rulemaking. (1) When

subject to a final order issued under - substance and significant new uses.

EPA uses the interim final rulemaking

section 5(e) of the Act, except for an (vii) If the Federal Register document p ro cedure to issue a significant new use

order that prohibits manufacture or' establishes a final rule, or notifies the rule, EPA will issue an interim final rule

import of the substance, EPA will issue public that a final rule will not be issued in the final rule section of the Federa l

a notice in the Federal Register after public comment has been received, Register following its decision to

explaining why the significant new use the document will describe comments • develop a significant new use rule for a

requirements are not needed . received and EPA's response . specific new chemical substance. The

.(b) Designation of requirements. (1) .(3) Directfinal rnlemaking. (i) When document will state EPA's reasons for

The significant new use notification and EPA uses the direct final rulemaking using the interim final rulemaking

other specific requirements will be pro cedure to issue a significant new .-use -procedure .

based on and be consistent with the • rule, It will issue a final rule in the (A) The significant new use rule will

provisions included in the final order - • . Federal Register following its decision to -take effect on the date of publication .

issued for the substance under section develop a si gnificant new use rule under (B) Persons will be given 30 days from 5(e) of the Act. EPA may also designate this section for a specific new chemical the date of publication to submit - additional activities as significant new substance. comments.

9
. ~

. p.1 9

Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations 31315

(ii) Interim final rules issued under (A) Has been shown by valid test data developmentally toxic effects in humans

this section shall cease to be in effect to cause carcinogenic effects in humans or in at least one species of laboratory

180 days after publication unless, within or in at least one species of laboratory animal at dose levels that could be of

the 180-day period, EPA issues a final animal. concern under reasonably anticipated rule in the Federal Register responding (B) Has been shown to be a possible conditions of exposure, provided that if

to any written comments received carcinogen based on the weight of the there is more than one such analogue,

during the 30-ilay comment period evidence in short-term tests indicative the greatest weight will be given to the

specified in paragraph (c)(5)(i)(B) of this of the potential to cause carcinogenic relevant data for the most appropriate

section and promulgating final effects. analogues.

significant new use notification (C) Is closely analogous, based on (iii) Is known or can reasonably be

requirements and other requirements for toxicologically relevant similarities in anticipated, based on valid scientific

the substance . molecular structure and physical data or established scientific principles,

(d) Schedule for issuing significant properties, to another substance that has to be metabolized in humans or

new use rules. (1) Unless EPA been shown by test data to cause transformed in the environment to a

determines that a significant new use carcinogenic effects in humans or in at substance which may have the potential

rule should not be issued under this, least one species of laboratory animal, to cause serious chronic effects, serious

section, EPA will issue a proposed rule, provided that if there is more than one acute effects, or developmentally toxic

a direct final rule, or an interim final such analogue, the greatest weight will effects under the criteria in paragraph

rule within 180 days of receipt of a valid be given to the relevant data for the (b) (3)(i) and (ii) of this section . notice of commencement under most appropriate analogues. (iv) Has been shown to potentially § 720 .102 of this chapter for an (D) Is known or can reasonably b e

any anticipated, based on valid scientific cause developmentally toxic effects

substance for which the notice of les, based on the weight of the evidence in

commencement was received on or after data or established scientific principles, tests indicative of the

October 10, 1989 . to be metabolized in humans or potential to cause developmentally toxic transformed in the environment to a

(2) Unless EPA determines that a substance which may have the potential effects.

significant new use rule should not be to cause carcinogenic effects under the (4) The substance may cause

issued under ths section, EP wil issue ificant avers

e a proposed ru el a direct f"i ai rulelor an criteria in paragraphs (b) (1)(i)(A), (B), or effects undeareasonably anticipate d

interim final rule within l year of (C) of this section . conditions of release because the

October 10 . 1989, for any substance for (ii) No substance may be regulated substance:

based on a finding under paragraph

which the valid notice of (b)(1) of this section unless EPA has also (7 Has been shown by valid test data

commencement under § 720.102 of this to cause significant adverse

chapter was received before October 10, made the finding under environm'ental effecta at dose levels that

1989 . § 721.170(c)(9)(ii)

. could be of concern under reasonably

3 • () valid test data to cause acutely toxic If EPA receives adverse or critical (2) The substance has been shown by antici ated conditions of release p .

significant comments following effects in at least one species of (ii) Is closely analogous, based on

publication of a proposed or interim laboratory animal or is closely toxicologically relevant similarities in

final rule, EPA will either withdraw the analogous, based on toxicologically molecular structure and physica l

rule or issue a final rule addressing the relevant similarities in molecular properties, to another substance that has

comments received . structure and physical properties, to been shown by valid test data to cause

another substance that has been shown significant adverse environmenta l

§ 721 .170 Notification requirements for by valid test data to cause acutely toxic effects at dose levels that could be of selected new chemical substances that

have completed premanufacture review. effects in at least one species of concern under reasonably anticipated

(a) Selection of

substances.

In laboratory animal, provided that if there conditions of release, provided that If

is more than one such analogue, the there is more than one such analogue ,

accordance with the expedited process greatest weight will be given to the the greatest weight will be given to the

specified in this section, EPA may issue relevant data for the most appropriate relevant data for the most appiopriate significant new use notification and analogues. analogues.

recordkeeping requirements for any new (3) The substance may cause serious (iii) Has been determined, based on

chemical substance for which a chronic effects, serious acute effects, or calculations using the substance's

premanufacture notice has been developmentally toxic effects under physical and chemical properties, to be

submitted under Part 720 of this chapter reasonably anticipated conditions of potentially able to cause significan t

if EPA determines that activities other exposure because the substance: adverse environmental effects at dose

than those described in the (i) Has been shown by valid test data levels that could be of concern under

premanufacture notice may result in to cause serious chronic effects, serious reasonably anticipated conditions of

significant changes in human exposure acute effects, or developmentally toxic release .

or environmental release levels and/or effects in humans or in at least one (iv) Is known or can reasonably be

that concern exists about the species of laboratory animal at dose anticipated, based on valid scientific

substance's health or environmental levels that could be of concern under data or established scientific principles, effects. reasonably anticipated conditions of to be environmentally transformed to a

(b) Concern criteria. EPA may exposure. substance which may have the potential

determine that concern exists about a (ii) Is closely analogous, based on to cause significant advers e

substance's health or environmental toxicologically relevant similarities in environmental effects under the criteria

effects if EPA makes any one of the molecular structure and physical in paragraph (b) (4)(i), (ii), and (iii) of

following findings: properties, to another chemical this section.

(1)(i) The substance may cause substance that has been shown by valid (5) Concern exists about the health or

carcinogenic effects because the test data to cause serious chronic environmental effects of one or more

substance: effects, serious acute effects, or impurities or byproducts of the
p. 20

31316 Federal Register / Vol . 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulation s

..~..e' ~.~.~.,..~.....~...~...

substance because the impurity or chapter. In providing this notice, EPA the date of publication that someon e

byproduct meets one or more of the will describe the health or wishes to submit adverse .or critical

criteria in paragraph (b) (1) through (4) environmental concerns identified under comments, the section(s) of the direct

of this section and either: paragraph (b) of this section and the final rule containing the SNUR(s) for

(I) The impurity or byproduct is a new activities under consideration for which a notice of intent to comment was

chemical substance and may be present designation as significant new uses. received will be withdrawn by EPA

in concentrations that could cause Such notice may be by telephone ; but in issuing a document in the final rule

adverse health or environmental effects this event will be confirmed in writing section of the Federal Register, and EPA

under reasonably anticipated conditions no later than 30 days after completion of will issue a proposed rule in th e

of exposure or release. the notice review period. proposed rule section of the Federal

(ii) Reasonably anticipated (3) Federal Register documents issued Register. The proposed rule will

manufacture, processing, or use to propose or establish significant new establish a 30-day comment period .

activities involving the substance for uses under this section will contain the (C) If EPA, having considered any

which a premanufacture notice has been following: timely comments submitted in response

submitted may result in significantly (i) The chemical identity of the to the proposal, decides to establish

increased human exposure to or substance or, if its specific identity is notification requiremeints under this

environmental release of the impurity or claimed confidential, an appropriate section, EPA will issue a final rule

byproduct compared to exposure or generic chemical name and an accession adding the substance to Subpart E of

release levels resulting from existing number assigned by EPA . this part and designating the significant activities involving the impurity or (ii) The premanufacture -notice new uses subject to notification

.

byproduct. number. (ii)(A) When EPA uses a notice and

(c) Designation of requirements. (1) (iii) The CAS number, where available comment procedure to issue

When EPA decides to establish and not claimed confidential a

. significant new use rule, EPA will issue significant new use reporting (iv) A summary of the basis for action a proposed rule in the Federal Register

requirements under this section, it may under this section. following its decision to develop a designate as a significant new use one (v) Designation of the significant new significant new use rule under thi

s

or more of the industrial, commercial, or uses subject to, or proposed to be section for a specific new chemical

consumer activities specified under subject to, notification and any other substance . Persons will be given 30 days § 721 .80 (a) through (i), (1) through (o), applicable requirements. to comment on whether EPA should

and (v) through (y) ; environmental (vi) Any modifications of Subpart A of establish notification requirements for

release activities specified under this part applicable to the specifi c

§ 721 .85 or § 721.90: or subcategories of substance and significant new uses . the substance under this part.

these activities. In addition, EPA may (vii) If the Federal Register document (B) If EPA, having considered any

designate specific requirements establishes a final rule, or notifies the timely comments, decides to establish

described under Subpart C of this part public that .a final rule will not be issued notification requirements under this

that are applicable to the substance . after public comment has been received, section, EPA will issue a final rul e

(2) EPA may designate as a significant the document will describe comments adding the substance to Subpart E of

new use only those activities that (i) are received and EPA's response . this part and designating the significant

different from those described in the (4) EPA will issue significant new use new uses subject to notification.

premanufacture notice for the rules under this section by one of the (iii)(A) When EPA uses the interim

substance, including any amendments, following three processes: direct final final rulemaking procedure to issue a

deletions, and additions of activities to rulemaking, interim final rulemaking, or significant new use rule, EPA will issue'

the premanufacture notice, and (ii) may notice and comment rulemaking . EPA an interim final rule in the final rule

be accompanied by changes in exposure will use the direct final rulemaking section of the Federal Register following

or release levels that are significant in process to issue significant new use its decision to develop a significant new

relation to the health or environmental rules unless it determines that, in a use rule for a specific new chemical

concerns identified under paragraph (b) particular case, one of the other substance . The document will, state

of this section. processes is more appropriate. EPA's reasons for.using the interim final

(d) Procedures for issuing significant (i)(A) When EPA uses the direct final rulemaking procedure .

new use rules. (1) Significant new use rulemaking procedure to issue a (1) The significant new use rule will

requirements designated under this significant new use rule it will issue a take effect on the date of publication .

section will be listed in Subpart E of this direct final rule in the final rule section (2) Persons will be given 30 days from

part. For each substance, Subpart E of of the Federal Register following its the date of publication to submi t

this part will identify : decision to develop a significant new comments.

(i) The chemical name . use rule under this section for a specific (B) An interim final rule issued under

(ii) The activities designated as new chemical substance . this section shall cease to be in effect

significant new -uses, which may include (B) The Federal Register document 180 days after publication unless, within

one or more of the activities described will state that, unless written notice is the 180-day period, EPA issues a fina l

in paragraph (c) of this section . received by EPA within 30 days after the 'rule in the Federal Register responding

(iii) Other specific requirements date of pubtication that someone wishes to any written comments received

applicable to the substance . to submit adverse or critical comments, during the 30-day comment perio d

(2) When EPA determines that a• the SNUR will be effective 60 days from specified in paragraph (d)(4)(iii)(A)(2) of

substance is a candidate for a date of publication. The written notice this section and promulgating final

significant new use rule under this of intent to submit adverse or critical significant new use notificatio n

section, it will notify the person that comments should state which SNUR(s) requirements and other requirements for

submitted the premanufacture notice for will be the subject of the adverse. or the substance.

the substance no later than 7 calendar critical comments, if several SNURs are (e) Schedule for issuing significant

days before the expiration of the notice established through the direct final rule . new use rules. (1) EPA will issue a

review period under § 720.75 of this If notice is received within 30 days after proposed rule, an interim final rule, or a
p. 21

Federal Register / Vol. 54, No. 143 / Thursday, July 27, 1989 / Rules and Regulations 3131 7

direct final rule within 270 days of activities designated as significant new at EPA's initiative or in response to a

receipt of the notice of commencement uses of the substance and, after written request

.

under § 720.102 of this chapter for any reviewing such notices, concluded that (1) Any affected person may request

substance for which the notice of there is no need to require additional modification or revocation of significant

commencement was received on or after notice from persons who propose to new use notification requirements for a

October 10, 1989 . engage in identical or similar activities. substance that has been added to

(2) If EPA receives adverse or critical (4) EPA has examined new Subpart E of this part using the

comments within the designated information, or has reexamined the test procedures described in § 721 .160 or

comment period following publication of data or other information or analysis § 721 .170 by writing to the Director of

a proposed rule or an interim final rule, supporting its decision to add the the Office of Toxic Substances and

EPA will either withdraw the rule or substance to Subpart E of this part stating the basis for such request . All issue a final rule addressing the under § 721:170 and has concluded that requests should be sent to the TSCA

comments received. the substance does not meet the criteria Document Processing Center (TS-790),

§721.185 t.imltation or revocation of under § 721.170(b). Room L-100, U.S. Environmental

certain notification requirements. (5) For a substance added to Subpart Protection Agency, 401 M St ., SW. ,

(a) Criteria for modification or E of this part under § 721 .160, EPA has Washington, DC 20460. ATTN: Request

revocation. EPA may at any time modify examined new information, or has to amend significant new use rule . The

or revoke significant new use reexamined the test data or other request must be accompanied by

notification requirements. for a chemical information or analysis supporting its information sufficient to support the

substance which has been added to . finding under section 5(e)(1)[A)(Ii)[l) of request .

Subpart E of this part using the the Act, and has concluded that a (2) The Director of the Office of Toxic

procedures under § 721 .160 or § 721 .170 . rational basis no longer exists for the Substances will consider the request,

Such action may be taken under this findings that activities involving the make a determination whether to

section if EPA makes one of the substance may present an unreasonable initiate rulemaking to modify the

following determinations, unless other risk of injury to human health or the requirements, and notify the requester of

information shows that the requirements environment required under section that determination by certified letter . If

should be retained : 5(e)(1)(A) of the Act. the request is denied, the letter will

(1) Test data or other information (6) For a substance added to Subpart explain why EPA has concluded that the

obtained by EPA provide a reasonable E of this part under § 721 .160, certain significant new use notification

basis for concluding that activities activities involving the substance have requirements for that substance should

designated as significant new uses of been designated as significant new uses remain in effect.

the substance will not present an pending the completion of testing, and (3) If EPA concludes that significant

unreasonable risk of injury to human adequate test data developed in new use notification requirements for a

health or the environment. accordance with applicable procedures substance should be limited or revoked,

(2) EPA has promulgated a rule under and criteria have been submitted to EPA will propose the changes in the

section 4 or 6 of the Act, or EPA or EPA. FederalRegister, briefly describe the

another agency has taken action under (b) Procedures for limitation or grounds for the action, and provide

another law for the substance that revocation . Modification or revocation interested parties an opportunity to

eliminates the need for significant new of significant new use notification comment .

use notification under section 5(a)(2) of requirements for a substance that has (Approved by the Office of Management and

the Act. been added to Subpart E of this part Budget under OMB control number 2070-0012)

(3) EPA has received significant new using the procedures described under [FR Doc . 89-17429 Filed 7-26-89; 8:451

use notices for some or all of the § 721.160 or § 721 .170 may occur either BILLING CODE 6660 -WD